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

Abstract

This application relates to a bioelectric signal acquisition device, a wearable physiological monitoring device, and a physiological monitoring system. The wearable physiological monitoring device includes a signal collection host and a bioelectric signal acquisition device. The bioelectric signal acquisition device includes a flexible substrate, on which a conductive layer, multiple signal acquisition electrodes, and a connection layer are disposed. The connection layer helps prevent energy leakage applied to the user's body surface and also inhibits energy transmission through the conductive layer to the signal collection host, thus preventing damage to the host.

Description

[0001] This invention patent application is a divisional application of Chinese invention patent application filed on September 11, 2024, with application number 2024112689767 and titled "Bioelectric Signal Acquisition Device, Wearable Physiological Monitoring Device and Physiological Monitoring System". Technical Field

[0002] This application relates to the field of medical device technology, and in particular to a bioelectrical signal acquisition device, a wearable physiological monitoring device, and a physiological monitoring system. Background Technology

[0003] Bioelectric signals, as important indicators of various physiological parameters in the human body, have always played an important role in people's lives. Clinically, people have been able to obtain various bioelectric signals with relatively high accuracy. However, with the increasing demand for medical technology and the in-depth development of research in electrocardiogram diagnosis, neuromedicine, cognitive psychology and artificial intelligence, human bioelectric signals are being increasingly applied to fields such as telemedicine, medical monitoring, real-time monitoring and emerging brain-computer interfaces.

[0004] The most widely used bioelectrical signals in the human body are electrocardiogram (ECG) and electroencephalogram (EEG). ECG signals directly reflect various indicators of cardiac activity. People obtain ECG signals for monitoring and diagnosing various conditions such as atrioventricular septum and arteriovenous valve disorders, and for clinical or remote vital sign monitoring. For example, wearable monitoring devices can be designed to provide real-time health monitoring for specific populations such as athletes, individuals with hypertension, and those with cardiovascular diseases. EEG signals directly characterize the neural activity state of different areas of the cerebral cortex, providing important reference for detecting a person's physiological and psychological state. They can provide significant diagnostic information for brain diseases such as epilepsy, dementia, and tumors.

[0005] In specific application scenarios, such as defibrillation and high-frequency electrosurgical treatment, a strong current is applied to the body of the patient to achieve the therapeutic purpose. In these cases, the bioelectrical signal acquisition device worn by the patient serves as an auxiliary monitoring method. It needs to monitor the bioelectrical signals simultaneously with the treatment to reflect changes in the patient's physiological characteristics. However, defibrillation and high-frequency electrosurgical treatments have specific requirements regarding energy consumption. Furthermore, the design and safety of the bioelectrical signal acquisition device must meet extremely high requirements. Specifically, the bioelectrical signal acquisition device must not consume treatment energy, and it must also avoid damage to the device from the strong current. Moreover, the acquired bioelectrical signal must be free from interference from treatment signals to ensure the accuracy of signal acquisition. Summary of the Invention

[0006] Based on this, in order to solve the problems of existing bioelectric signal acquisition devices meeting multiple treatment scenarios, accurate signal acquisition, and safe use, this application provides a bioelectric signal acquisition device, a wearable physiological monitoring device, and a physiological monitoring system.

[0007] One embodiment of this application provides a bioelectric signal acquisition device, which is worn on the skin of a user to be tested to acquire bioelectric signals;

[0008] The bioelectric signal acquisition device includes a flexible substrate, on which a conductive layer and multiple signal acquisition electrodes are disposed. The multiple signal acquisition electrodes are used to acquire bioelectric signals at at least three different locations on the skin of the user under test. The conductive layer is used to transmit the bioelectric signals to the signal collection host.

[0009] The flexible substrate is further provided with a connection layer, and the conductive layer is electrically connected to the signal acquisition electrode through the connection layer.

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

[0011] In one embodiment, the connecting layer forms a first connecting region with the first conductive portion, and the connecting layer forms a second connecting region with the signal acquisition electrode, wherein the first connecting region and the second connecting region are electrically connected.

[0012] In one embodiment, the first lead portion is disposed on the same layer as the signal acquisition electrode.

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

[0014] In one embodiment, the first lead portion has a first opening, the signal acquisition electrode is disposed in the first opening, and the connection layer is disposed 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 to 0.9.

[0016] In one embodiment, the flexible substrate corresponding to the position of the first lead portion is circular, the first lead portion is disposed 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 acquisition electrode is circular, and the ratio of the diameter of the signal acquisition electrode to the outer diameter of the connecting layer is greater than or equal to 0.1 and less than 1.

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

[0019] In one embodiment, the connecting layer is disposed on the side of the signal acquisition electrode close to the skin of the user being tested, and the connecting layer has a second opening for exposing at least a portion of the conductive area of ​​the signal acquisition electrode.

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

[0021] In one embodiment, the first lead portion is stacked with the signal acquisition electrode.

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

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

[0024] In one embodiment, the conductive layer is made of a first conductive material, the signal acquisition electrode is made of a second conductive material, and the connection layer is made of a third conductive material. The first, second, and third conductive materials are the same, or the connection layer contacts the signal acquisition electrode to form a second connection region, and the second conductive material does not undergo a displacement reaction when in contact with the third conductive material, or / and the connection layer contacts the conductive layer to form a first connection region, and the first conductive material does not undergo a displacement reaction when in contact with the third conductive material.

[0025] In one embodiment, the conductive layer includes a second lead portion and a lead layer, the second lead portion being electrically connected to the signal collection host, one end of the lead layer being electrically connected to the first lead portion, and the other end being electrically connected to the second lead portion.

[0026] In one embodiment, the signal acquisition electrode, the connection layer, the first lead portion, the second lead portion, and the lead layer are printed on the flexible substrate by a printing method.

[0027] In one embodiment, the bioelectric signal acquisition device further includes an adhesive patch for fixing the signal acquisition electrode to the skin of the user to be tested.

[0028] In one embodiment, three signal acquisition electrodes are provided, with at least two of the signal acquisition electrodes arranged adjacent to each other, and the adjacent signal acquisition electrodes are attached to the skin of the user to be tested using an adhesive patch.

[0029] In one embodiment, four signal acquisition electrodes are provided, with at least two of the signal acquisition electrodes arranged adjacent to each other, and the adjacent signal acquisition electrodes are attached to the skin of the user to be tested using an adhesive strip.

[0030] In one embodiment, ten signal acquisition electrodes are provided, with at least two of the signal acquisition electrodes arranged adjacent to each other, and the adjacent signal acquisition electrodes are attached to the skin of the user to be tested using an adhesive strip.

[0031] In one embodiment, the bioelectric signal acquisition device further includes a support, which is fixed to the skin of the user being tested along with the adjacent signal acquisition electrode using an adhesive tape.

[0032] In one embodiment, the ten signal acquisition electrodes 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 disposed on the left and right sides of the center extension line of the support. The flexible substrate has an expansion opening along the center extension line of the support, 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 limb lead electrode groups, which include 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; and 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] Specifically, the fourth limb lead electrode is positioned adjacent to the first limb lead electrode, and both the first limb lead electrode and the fourth limb lead electrode are simultaneously fixed using a single adhesive patch; alternatively, the fourth limb lead electrode is positioned adjacent to the second limb lead electrode, and both the second limb lead electrode and the fourth limb lead electrode are simultaneously fixed using a single adhesive patch; or alternatively, the fourth limb lead electrode is positioned adjacent to the first chest lead electrode, and both the fourth limb lead electrode and the first chest lead electrode are simultaneously fixed using a single adhesive patch.

[0035] In one embodiment, the flexible substrate has at least one bending structure for extending or shortening the length of the conductive layer.

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

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

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

[0039] The bioelectric signal acquisition device provided in this application uses a connecting layer to conductively connect the signal acquisition electrode and the conductive layer. In special treatment scenarios, the use of the connecting layer helps to prevent energy leakage applied to the body surface of the user being tested, and can also suppress the transmission of energy through the conductive layer to the signal collection host, thus preventing damage to the host. Attached Figure Description

[0040] Figure 1 This is a schematic diagram of a flexible substrate, a signal acquisition electrode mounting bracket, and a signal acquisition host according to one embodiment;

[0041] Figure 2 for Figure 1 and Figure 2 Exploded view of the structure after installation and power supply components;

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

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

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

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

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

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

[0048] Figure 9 This is a schematic diagram of a telescopic sleeve;

[0049] Figure 10 This is a schematic diagram of another embodiment of a wearable physiological monitoring device;

[0050] Figure 11 This is a schematic diagram of another embodiment of a wearable physiological monitoring device;

[0051] Figure 12 This is a process flow diagram of a bioelectric signal acquisition device according to one embodiment;

[0052] Figure 13 This is a process flow diagram of a bioelectric signal acquisition device according to another embodiment.

[0053] Description of Figure Numbers:

[0054] 100-Bioelectric signal acquisition device; 110-Flexible substrate; 111-Guiding section; 112-Attachment patch; 113-Connecting section; 114-Branching section; 115-Leading section; 116-Connecting section; 120-Signal acquisition electrode; 121-Second lead section; 122-First lead section; 124-Connecting layer; 125-Conductive layer; 126-Second opening; 127-First opening; 128-Conducting layer; 130-Adhesive 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 component; 165-Fourth opening; 166-Handle; 167-Expanded opening; 200-Wearable physiological monitoring device; 210-Span; 211-Strip hole; 220-Power supply component; 230-Signal collection host. Detailed Implementation

[0055] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0056] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0057] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0058] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0059] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0060] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, 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 possible implementation.

[0061] Example 1:

[0062] See Figure 1 , Figure 2 , Figure 3 as well as Figure 4 ,like Figure 1This application provides a bioelectric signal acquisition device 100, which is worn on the skin of the user to acquire bioelectric signals. A signal collection host 230 is detachably mounted on the bioelectric signal acquisition device 100 to collect bioelectric signals, including electrocardiogram (ECG), electromyography (EMG), electroencephalogram (EEG), and electrooculography (EOG) signals. Figure 1 .

[0063] The bioelectric signal acquisition device 100 includes a flexible substrate 110, on which a conductive layer 125 and multiple signal acquisition electrodes 120 are disposed. The multiple signal acquisition electrodes 120 are used to acquire bioelectric signals at at least three different locations on the skin of the user to be tested. The conductive layer 125 is used to conduct the bioelectric signals to the signal collection host 230. A connection layer 124 is also provided on the flexible substrate 110, and the conductive layer 125 is electrically connected to the signal acquisition electrodes 120 through the connection layer 124.

[0064] In this embodiment, a conductive layer 125 and a signal acquisition electrode 120 are fabricated on a flexible substrate 110 according to a conductive pattern. A connecting layer 124 is used to connect the conductive layer 125 and the signal acquisition electrode 120 to achieve conductive connection. The outer contour of the flexible substrate 110 is cut along the conductive layer 125 and the signal acquisition electrode 120 as needed to form the outer contour of the bioelectric signal acquisition device 100. The connecting layer 124, the signal acquisition electrode 120, and the conductive layer 125 form a series circuit. In applications involving high-current treatments such as defibrillation or electrosurgical excision, the connecting layer 124 added to the flexible substrate 110 can prevent defibrillation energy from being conducted and leaked through the signal acquisition electrode 120 and the conductive layer 125, thus avoiding interference with the treatment effect. Furthermore, it does not affect the accuracy of the bioelectric signals acquired by the signal acquisition electrode 120.

[0065] In one embodiment, the thickness of the connecting layer 124 is 5μm-200μm and / or the resistance of the connecting layer 124 is set to 1K~50K ohms to withstand the strong current caused by medical defibrillators or electrostatic discharge, and to prevent the signal collection host 230 from being destroyed by the strong current. This embodiment proposes that the connecting layer 124, made by printing technology, is thin and light, with a compact product structure and a thickness not exceeding 200μm. The connecting layer 124 is connected in series with the signal acquisition electrode 120 and the conductive layer 125, and no other lead connection is required. It can replace the traditional defibrillator patch resistors that must be used in monitoring equipment due to equipment safety requirements. Traditional patch resistors are too large and require lead connection during use, making them cumbersome and unsuitable for compact physiological monitoring equipment applications. Moreover, the product provided in this embodiment is lightweight and miniaturized, making it suitable for home remote monitoring. Especially during defibrillation treatment, patients need to endure multiple high-current defibrillation events to restore cardiac function. Without the connection layer 124, defibrillation energy would pass through the signal acquisition electrodes 120 and the conductive layer 125 into the signal collection host 230, potentially destroying it due to the high current. The connection layer 124 provided in this embodiment has a resistance of 1K to 50K ohms, allowing it to withstand multiple high-current surges. After the defibrillation treatment, the signal collection host 230 can still function normally, collecting and recording bioelectrical signals, thus enhancing the reliability of the equipment. If the resistance of the connection layer 124 is less than 1K ohms or greater than 50K ohms, signal noise will occur, affecting the accuracy of bioelectrical signal acquisition.

[0066] In one embodiment, the connecting layer 124 is printed onto the signal acquisition electrode 120 and the conductive layer 125 using a printing process. This does not affect the wearing weight and facilitates long-term, uninterrupted use by the user. Long-term monitoring of bioelectrical signals, especially electrocardiograms, helps the user to more comprehensively monitor heart health or potential diseases. Furthermore, in high-current treatment environments, such as defibrillation currents or electrosurgical high voltages applied to the user, the conductive layer 125 will conduct the current to the signal acquisition host 230, potentially damaging the host. Therefore, the biosignal acquisition device 100 provided in this embodiment not only considers lightweight wear for long-term, uninterrupted use by the user but also takes into account the requirements of monitoring scenarios, ensuring accurate real-time acquisition of bioelectrical signals and making the device safer and more reliable.

[0067] A bioelectric signal acquisition device 100 is worn on the skin of the user to acquire bioelectric signals. A signal collection host 230 is installed on the bioelectric signal acquisition device 100 to collect and store signals. Multiple signal acquisition electrodes 120 collect bioelectric signals from at least three different locations and transmit the bioelectric signals to the signal collection host 230 through a conductive layer 125. This application proposes that the signal acquisition electrodes 120 and the conductive layer 125 are electrically connected through a connecting layer 124 to ensure accurate acquisition of bioelectric signals while suppressing the influence of strong currents on the bioelectric signals acquired by the bioelectric signal acquisition device 100. In this embodiment, a printing process can be used to print the conductive layer 125, the signal acquisition electrodes 120, and the connecting layer 124 on a flexible substrate 110, respectively. The conductive layer 125 and the signal acquisition electrodes 120 are electrically connected through the connecting layer 124, thus constructing a more lightweight wearable product. Alternatively, the conductive materials of the conductive layer 125, the signal acquisition electrode 120, and the connection layer 124 can be respectively attached to the flexible substrate 110, and then the conductive materials can be removed using laser engraving or etching tools to obtain the conductive layer 125, the signal acquisition electrode 120, and the connection layer 124. No limitation is imposed here.

[0068] Specifically, this solution proposes to achieve conductive connection by connecting the conductive layer 125 and the signal acquisition electrode 120 through the connecting layer 124, thereby constructing a series circuit. The flexible substrate 110 can be made of PET sheet, which is more convenient to use and makes it easier to fabricate the connecting layer 124 and the conductive layer 125. The bioelectrical signal collected by the signal acquisition electrode 120 is conducted to the conductive layer 125 through the connecting layer 124. Even if the bioelectrical 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, it is not necessary to introduce an additional defibrillator device, which reduces the product space size of the bioelectrical signal acquisition device 100 while improving the suppression of energy leakage. This is conducive to building a lighter bioelectrical signal acquisition device 100 and enriching and expanding the product application scenarios.

[0069] In one embodiment, the conductive layer 125 is insulated from the signal acquisition electrode 120. The conductive layer 125 is made of a first conductive material, while the signal acquisition electrode 120 is made of a second conductive material different from the first conductive material. This avoids chemical reactions, such as combination reactions, displacement reactions, or redox reactions, between the conductive layer 125 and the signal acquisition electrode 120, which could affect the accuracy of signal acquisition. A connecting layer 124 is made of a different third conductive material, where the second and third conductive materials, or the first and third conductive materials, do not react chemically, ensuring the accuracy of bioelectric signal acquisition and transmission. This embodiment can prepare a wearable bioelectric signal acquisition device 100 to meet different usage scenarios according to actual product needs. Furthermore, the bioelectric signal acquisition device 100 provided in this application fully considers the high accuracy requirements for signal acquisition in different scenarios and prevents damage to device reliability caused by different usage scenarios.

[0070] In a further embodiment, to meet the requirement of more accurate bioelectric signal acquisition, the signal acquisition electrode 120 can be made of a second conductive material with higher signal acquisition accuracy, such as silver chloride, to ensure accurate and reliable acquisition of bioelectric signals. The conductive layer 125 uses a first conductive material different from the second conductive material to achieve 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 acquisition device 100. It can be prepared by die-cutting + bonding process, bonding + etching process, or bonding + laser engraving process. Common conductive pattern processing methods will not be described in detail here. At the preset electrode point, the signal acquisition electrode 120 is prepared. Generally, a silver chloride layer is used. Silver can be electroplated at the electrode point and then chlorinated to generate silver / silver chloride, or a silver chloride coating can be printed or coated. The conductive layer 125 is prepared using a conductive material for signal transmission. Different conductive materials are prone to contact reactions. For example, silver chloride will react chemically with the conductive metal, such as chloride ions corroding the conductive metal, leading to problems such as reduced signal transmission accuracy. Therefore, an isolation section is provided between the signal acquisition electrode 120 and the conductive layer 125 to isolate the first conductive material and the second conductive material, which are prone to chemical reaction, from direct contact, thus affecting the accuracy of signal transmission. For example, the isolation section isolates the signal acquisition electrode 120 made of silver chloride from direct contact with the conductive layer 125 made of conductive metal.

[0071] The second conductive material used in the signal acquisition electrode 120 includes at least one of silver, or a silver-silver chloride mixture, or a carbon-silver mixture, or a carbon-silver-silver chloride mixture, or 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 acquisition electrode 120. The isolation portion is used to isolate the conductive layer 125 from the signal acquisition electrode 120, ensuring that the signal acquisition electrode 120 and the first lead portion 122, which are made of different conductive materials that are prone to chemical reaction upon contact, will not affect signal acquisition due to material mixing. In addition, the first lead portion 122 and the signal acquisition electrode 120 are electrically connected through a connecting layer 124, which ensures that the first lead portion 122 accurately and reliably transmits the bioelectrical signals acquired by the signal acquisition electrode 120.

[0073] In one embodiment, the conductive materials used for the connecting layer 124, the signal acquisition electrode 120, and the first lead portion 122 are all different. The connecting layer 124 and the first lead portion 122 form a first connecting region, and the connecting layer 124 and the signal acquisition electrode 120 form a second connecting region. The first connecting region and the second connecting region are electrically connected. The connecting layer 124 can electrically connect the signal acquisition electrode 120 and the first lead portion 122 through the first connecting region and the second connecting region. By using a separate design for the conductive layer 125, the signal acquisition electrode 120, and the connecting layer 124, it can adapt to more usage environments and manufacturing requirements, improving the applicability of the bioelectric signal acquisition device 100. In this embodiment, the connecting layer 124 is made of a third conductive material, and the third conductive material does not chemically react with the second conductive material when in contact. When the third conductive material comes into contact with the first conductive material, no chemical reaction occurs. Commonly, the signal acquisition electrode 120 is made of silver chloride. 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, or conductive carbon. This means that, for example, if the first lead 122 is made of a conductive metal, such as aluminum, the connecting layer 124 can be made of conductive ink, but not a conductive metal. This is because a chemical reaction would occur when the signal acquisition electrode 120 made of silver chloride comes into contact with the connecting layer 1247 made of conductive metal, increasing signal interference. This ensures that the connecting layer 124 provides conductive connection between the signal acquisition electrode 120 and the conductive layer 125, enabling stable signal transmission.

[0074] In one embodiment, the first lead portion 122 and the signal acquisition electrode 120 are disposed on the same layer. That is, the first lead portion 122 is first printed on the flexible substrate 110, and then the signal acquisition electrode 120 is printed on the same layer. A connection layer 124 is printed on the surface of the signal acquisition electrode 120. In addition, the area where the connection layer 124 connects the first lead portion 122 and the signal acquisition electrode 120 is more flat, which prevents uneven printing of the connection layer 124 from affecting the accuracy and stability of the signal acquisition process.

[0075] In one embodiment, the gap region between the separately designed first lead portion 122 and the signal acquisition electrode 120 constitutes an isolation portion. The isolation portion can be an air gap 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 coming into contact with the conductive material of the signal acquisition electrode 120 and causing a chemical reaction, which would affect the signal acquisition performance of the signal acquisition electrode 120.

[0076] In one embodiment, the first lead portion 122 has a first opening 127, the signal acquisition electrode 120 is disposed within the first opening 127, and the connecting layer 124 is disposed at the first opening 127, that is, the connecting layer 124 is electrically connected to one side of the first lead portion 122. This design can reduce the overall size of the physiological electrical signal acquisition device 100. The signal acquisition electrode 120 is electrically connected to the first lead portion 122 through the connecting layer 124, which greatly reduces the planar size of the physiological electrical signal acquisition device 100. Moreover, it reduces the processing difficulty of the connecting layer 124 and improves the product yield. Furthermore, the connecting layer 124 can connect the first lead portion 122 and the signal acquisition 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, the connection area between the connecting layer 124 and the first lead portion 122 is annular, and the connecting layer 124 uniformly covers the first lead portion 122, ensuring that the connecting layer 124 transmits the bioelectrical signal collected by the signal acquisition electrode 120 to the first lead portion 122 without loss.

[0078] In one embodiment, the flexible substrate 110 corresponding to the position of the first guide portion 122 is circular in shape. The first guide portion 122 is disposed at the center of the flexible substrate 110. The distance between the edge of the first guide portion 122 and the edge of the flexible substrate 110 is greater than or equal to 1.5 mm. The edge of the flexible substrate 110 extends beyond the edge of the first guide portion 122, which can protect the first guide portion 122 from external wear and damage and ensure that the signal transmission is not interfered with.

[0079] In one embodiment, the ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connecting layer 124 is greater than or equal to 0.1 and less than 1. Designing the ratio of the signal acquisition electrode 120's diameter to the outer diameter of the connecting layer 124 to be less than 1 ensures absolute contact between the signal acquisition electrode 120 and the connecting layer 124, preventing uneven connection due to manufacturing errors and potential breakage, which could lead to uneven signal transmission. Conversely, a ratio greater than 0.1 prevents the connecting layer 124 from having an excessively large area, which could hinder signal transmission and cause problems such as long paths and high resistance. This ensures that the signal acquisition electrode 120 can more accurately acquire bioelectrical signals, and the first lead 122 can transmit bioelectrical signals more stably. More preferably, the cross-sectional shape of the signal acquisition electrode 120 is circular, and the diameter of the signal acquisition electrode 120 can be selected from 1 to 20 mm. Better control of the processing signal acquisition electrode 120 and the first lead 122, and the connecting layer 124, facilitates the acquisition and transmission of bioelectric signals.

[0080] In one embodiment, a connecting layer 124 is disposed on the side of the signal acquisition electrode 120 near the skin of the user being tested. The connecting layer 124 has a second opening 126, which exposes at least a portion of the conductive area of ​​the signal acquisition electrode 120, allowing the conductive area of ​​the signal acquisition electrode 120 to directly contact the skin of the user, thereby ensuring that the signal acquisition electrode 120 can completely acquire the bioelectrical signals of the human body. The connecting layer 124 has an annular cross-sectional shape. The annular connecting layer 124 ensures uniform connection with the signal acquisition electrode 120 and the first lead portion 122, respectively, ensuring the continuity of signal acquisition.

[0081] In another embodiment, the connecting layer 124 is disposed on the side of the signal acquisition electrode 120 away from the skin of the user being tested. The connecting layer 124 covers at least a portion of the signal acquisition electrode 120, ensuring a more secure conductive connection between the connecting layer 124 and the signal acquisition electrode 120 and the first lead portion 122, respectively. Since the connecting layer 124 does not directly contact the skin of the user being tested, it will not affect the bioelectrical signal acquisition by the signal acquisition electrode 120, ensuring stable contact between the signal acquisition electrode 120 and the skin of the user being tested, thus guaranteeing the stability of signal acquisition. In this embodiment, the connecting layer 124 is designed with a circular cross-sectional shape. Through this design, the first opening of the connecting layer 124, the signal acquisition electrode 120, and the first lead portion 122 are all circular, resulting in a unified overall product design style and enhanced aesthetic appeal.

[0082] In one embodiment, the first lead portion 122 and the signal acquisition electrode 120 are stacked together, and an isolation portion is disposed between the first lead portion 122 and the signal acquisition electrode 120. The isolation portion uses an insulating layer to prevent the first lead portion 122 from contacting the signal acquisition electrode 120, avoiding chemical reactions between the first lead portion 122 made of different conductive materials and the signal acquisition electrode 120, which would affect the accuracy of signal acquisition and expand the product's different form factors.

[0083] In another embodiment, the connecting layer 124 is disposed at the edge of the signal acquisition electrode 120 and the first lead portion 122, and the connecting layer 124 is not electrically connected to the isolation portion. This embodiment has lower process requirements when preparing the connecting layer 124. The connecting layer 124 can electrically connect the signal acquisition electrode 120 and the first lead portion 122, which reduces the difficulty of preparation.

[0084] In another embodiment, the connection layer 124 is disposed between the signal acquisition electrode 120 and the first lead portion 122. The connection layer 124 can cover the signal acquisition electrode 120 so that the signal acquisition electrode 120 and the first lead portion 122 are spatially isolated and electrically 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, thereby realizing the conductive connection between the bioelectric signal acquisition device 100 and the signal collection host 230. The bioelectric signal collected by the signal acquisition electrode 120 is transmitted to the signal collection host 230 through the connection 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 acquisition 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 by printing, thereby ensuring that the coating of the signal acquisition 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 acquisition device 100 further includes an adhesive patch 130 for fixing the signal acquisition electrode 120 to the skin of the user to be tested. By using adhesive, the support 210 and the signal acquisition electrode 120 are fixed to the skin, making installation and removal easy and controlling product costs.

[0088] In one embodiment, the bioelectric signal acquisition device 100 further includes a support 210. The support 210 and the adjacent signal acquisition electrode 120 are fixed to the skin of the user under test using an adhesive tape 130. This is more convenient for the user; simply peel off the protective layer of the adhesive tape 130 to fix the signal acquisition electrode 120 to the user's skin, ensuring that the relative positions of the signal acquisition electrodes 120 sharing the adhesive tape 130 are determined. Furthermore, one adhesive tape 130 can simultaneously fix more signal acquisition electrodes 120, making operation simpler. Preferably, the signal collection host 230 and the support 210 are detachably connected, such as by a snap-fit ​​connection, threaded installation, or a combination of concave and convex parts. Alternatively, the support 210 can be equipped with a gripper for combined installation with the signal collection host 230. Various assembly and disassembly methods are not listed in this embodiment.

[0089] See Figure 10 In one embodiment, three signal acquisition electrodes 120 are provided, namely, in the single-conductor product embodiment provided in this embodiment, at least two signal acquisition electrodes 120 are arranged adjacently, preferably in a Y-shaped layout. Two adjacent signal acquisition electrodes 120 are located above the bracket 210 and can share a single adhesive patch 130. The adhesive patch 130 simultaneously fixes the two adjacent signal acquisition electrodes 120 and the bracket 210 to the human skin, facilitating installation. For single-conductor products, physiological electrical signals can be acquired at any location on the skin of the human chest, and can be widely used in real-time monitoring in fields such as electrocardiogram, electroencephalogram, electromyography, and electrooculography. This embodiment provides an installation demonstration of the single-conductor product, with the bracket 210 fixed on the midline of the human sternum, and the signal acquisition electrodes 120 installed along the conductive layer 125 on the human skin. Therefore, only the bracket 210 needs to be fixed to fix the installation point of the signal acquisition electrodes 120, providing a more convenient installation method suitable for remote use at home. In this embodiment, the variation of the single-conductor product only requires that three signal acquisition electrodes 120 are provided. The specific design of the signal acquisition electrodes 120 is protected.

[0090] See Figure 11In one embodiment, four signal acquisition electrodes 120 are provided, i.e., this embodiment provides a three-conductor product embodiment. At least two signal acquisition electrodes 120 are arranged adjacently. In this embodiment, two adjacent signal acquisition electrodes 120 are located below the bracket 210 and can each use an adhesive tape 130. The third signal acquisition electrode 120 is located above the bracket 210, and the fourth signal acquisition electrode 120 is located above the bracket 210. The two signal acquisition electrodes 120 located above the bracket 210 each use an adhesive tape 130. The bracket 210 and the signal acquisition electrodes 120 can share an adhesive tape 130. Similar to the previous embodiment, only the bracket 210 needs to be fixed to fix the mounting points of the signal acquisition electrodes 120, providing a more convenient installation method, suitable for users to use remotely at home, and further improving the applicability of the product. The variation of the three-conductor product only needs to satisfy the requirement that four signal acquisition electrodes 120 are provided. The specific design of the signal acquisition electrodes 120 is protected in this embodiment.

[0091] In the above embodiments, since the number of signal acquisition electrodes 120 is relatively small—that is, three or four—they can be installed on human skin according to the product instructions, without strict usage requirements. This facilitates home care and lowers the barrier to entry, allowing more users to obtain bioelectrical signal data through the bioelectrical signal acquisition device 100. Even special populations can use it conveniently, further expanding the product's user base. Furthermore, the product uses adhesive patches 130 for application to the skin, making it a disposable product, which further facilitates its promotion for home care.

[0092] In one embodiment, ten signal acquisition electrodes 120 are provided, with at least two signal acquisition electrodes 120 arranged adjacent to each other. The ten signal acquisition electrodes 120 include six chest lead electrodes and four limb electrodes, which collects richer bioelectrical signals. For bioelectrical signal analysis systems or monitoring systems, providing rich bioelectrical signals ensures more accurate processing results and meets medical analysis needs.

[0093] like Figure 1 and Figure 7 , Figure 7 for Figure 1In another embodiment of the flexible substrate 110, the ten signal acquisition electrodes 120 include a first chest lead electrode group and a second chest lead electrode group. The first and second chest lead electrode groups are respectively disposed on the left and right sides of the central extension line of the support 210. The flexible substrate 110 has an expansion opening 167 along the central extension line of the support 210. The expansion opening 167 is used to expand the distance between the first and second chest lead electrode groups, so that the expansion opening 167 can be torn open according to different users to adjust the distance between the first and second chest lead electrode groups, thereby improving the applicability of the wearable physiological monitoring device 200. For example, for female users, the expansion opening 167 is more suitable for installing the first and second chest lead electrode groups on the breast area to collect signals.

[0094] See Figure 5 and Figure 6 In one embodiment, the ten signal acquisition electrodes further include limb lead electrode groups, which include a first limb lead electrode labeled R, a second limb lead electrode labeled L, a third limb lead electrode labeled F, and a fourth limb lead electrode labeled N. A first chest lead electrode group includes a first chest lead electrode labeled C1. A second chest lead electrode group includes a second chest lead electrode labeled C2, a third chest lead electrode labeled C3, and a fourth chest lead electrode labeled C4. The fifth chest lead electrode is designated C5, and the sixth chest lead electrode is designated C6. Alternatively, the fourth limb lead electrode can be positioned adjacent to the first limb lead electrode, and both electrodes can be simultaneously fixed using a single adhesive patch 130. Or, the fourth limb lead electrode can be positioned adjacent to the second limb lead electrode, and both electrodes can be simultaneously fixed using a single adhesive patch 130. Finally, the fourth limb lead electrode can be positioned adjacent to the first chest lead electrode, and both electrodes can be simultaneously fixed using a single adhesive patch 130.

[0095] In one embodiment, the flexible substrate 110 is provided with at least one bending structure 162. The bending structure 162 is used to extend or shorten the length of the lead layer 128. When it is necessary to attach the signal acquisition electrode 120 to a more distant location, the bending structure 162 can be stretched and deformed by holding the handle 166, thereby adjusting the installation position of the signal acquisition electrode 120 according to the usage requirements. This improves the applicability of the bioelectric signal acquisition device 100 to users of different body sizes.

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

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

[0098] In one embodiment, the wearable physiological monitoring device 200 further includes a signal collection host 230 that is installed together with or detached from the bioelectric signal acquisition device 100, the signal collection host 230 being used to collect and record bioelectric signals.

[0099] An embodiment of this application also provides a physiological monitoring system, including the wearable physiological monitoring device 200 in the above embodiments or the bioelectric signal acquisition device 100 in the above embodiments.

[0100] Example 2:

[0101] Example 2 mainly expands some of the structures of Example 1, wherein the bioelectric signal acquisition device 100, the wearable physiological monitoring device 200 and the physiological monitoring system are all corresponding to the bioelectric signal acquisition device 100, the wearable physiological monitoring device 200 and the physiological monitoring system in Example 1.

[0102] See Figure 3 , Figure 3 A schematic diagram of a bioelectric signal acquisition device 100 according to an embodiment of this application is shown. This embodiment provides a detailed description of the bioelectric signal acquisition device 100 in the field of electrocardiogram (ECG) monitoring. The bioelectric signal acquisition device 100 is used to acquire human ECG signals. The bioelectric signal acquisition device 100 provided in one embodiment of this 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 acquisition electrodes 120, a connection layer 124, and a conductive layer 125.

[0103] See Figure 1 , Figure 2 as well as Figure 3In the aforementioned bioelectric signal acquisition device 100, the signal acquisition electrode 120 is used to obtain electrocardiogram (ECG) signals by contacting human skin, and the conductive layer 125 is used to transmit ECG signals. An isolation portion is formed between the signal acquisition electrode 120 and the conductive layer 125 to prevent direct contact between them. The conductive layer 125 is conductively connected to the signal acquisition electrode 120 via a connecting layer 124. The bioelectric signal acquisition device 100 provided in this application uses a connecting layer 124 to conductively connect the signal acquisition electrode 120 and the conductive layer 125. This satisfies the requirement that, in special treatment scenarios, the connecting layer 124 helps prevent energy leakage applied to the surface of the user's body and can also suppress energy transmission to the signal collection host 230 via the conductive layer 125, thus avoiding damage to the host.

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

[0105] The gap between the first lead portion 122 and the signal acquisition electrode 120, which are designed separately, constitutes an isolation portion. The isolation portion can be an air gap 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 coming into contact with the conductive material of the signal acquisition electrode 120, which would cause a chemical reaction and affect the signal acquisition performance of the signal acquisition electrode 120.

[0106] Specifically, the conductive layer 125 includes a connecting layer 128, which expands the contact points of the signal acquisition electrode 120 on human skin. The connecting layer 128 is electrically connected to the first connecting part 122. The first connecting part 122, the connecting layer 128, and the signal acquisition electrode 120 correspond one-to-one. The first connecting part 122 and the connecting layer 128 can be integrally printed to improve printing efficiency, or they can be printed separately and connected to each other, which improves the applicability of the bioelectric signal acquisition device 100.

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

[0108] In another embodiment, the signal acquisition electrode 120 has a circular outline, the first lead portion 122 has an annular outline, and the signal acquisition electrode 120 is located within the annular first lead portion 122.

[0109] Preferably, the signal acquisition 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 connection area with the signal acquisition electrode 120 and the first lead portion 122 respectively, and maintaining stable transmission of the acquired electrocardiogram signal.

[0110] Preferably, the ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connecting layer 124 is greater than or equal to 0.1 and less than 1. The cross-sectional shape of the signal acquisition electrode 120 is designed to be circular, and the cross-sectional shape of the connecting layer 124 is annular. The ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connecting layer 124 is less than 1, thus ensuring absolute contact between the signal acquisition electrode 120 and the connecting layer 124. This avoids uneven connection between the signal acquisition electrode 120 and the connecting layer 124 due to manufacturing errors, which could easily lead to disconnection and uneven signal transmission. The ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connecting layer 124 is greater than or equal to 0.1, preventing the connecting layer 124 from having an excessively large area that could affect signal transmission and obstruct bioelectric signal transmission, such as causing long paths and high resistance. This ensures that the signal acquisition electrode 120 can more accurately acquire bioelectric signals, and that the first lead 122 can transmit bioelectric signals more stably. More preferably, the cross-sectional shape of the signal acquisition electrode 120 is circular, and the diameter of the signal acquisition electrode 120 can be selected from 1 to 20 mm. This allows for better control over the fabrication of the signal acquisition electrode 120, the first lead portion 122, and the connecting layer 124, facilitating the acquisition and transmission of bioelectrical signals.

[0111] In one embodiment, the bioelectric signal acquisition device 100 further includes a support 210 for mounting an electrocardiogram recorder, and the lead layer 128 is assembled on the support 210 and electrically connected to the electrocardiogram recorder.

[0112] Specifically, the bracket 210 has a strip-shaped hole 211, and one end of the multiple lead layers 128 opposite to the corresponding first lead part 122 passes through the strip-shaped hole 211 and is attached to the bracket 210.

[0113] In one embodiment, the bioelectric signal acquisition device 100 further includes a plurality of adhesive patches 130. A flexible substrate 110 is attached to the non-adhesive layer of the adhesive patch 130. The adhesive layer of the adhesive patch 130 is used to attach the signal acquisition electrode 120 and the support 210 to human skin. The adhesive patch 130 is provided with a third opening 131, which is used to expose the signal acquisition electrode 120 so that the signal acquisition electrode 120 comes into contact with human skin.

[0114] In one embodiment, such as Figure 2 and Figure 4 The bioelectric signal acquisition device 100 also includes a conductive adhesive layer 140, which can be a hydrogel. The signal acquisition electrode 120 contacts the human skin through the conductive adhesive layer 140 to fix the signal acquisition electrode 120 to the human skin and acquire electrocardiogram signals.

[0115] In one embodiment, Figure 10 In the structure, three signal acquisition electrodes 120 are provided, including a first electrode, a second electrode, and a third electrode. Centered on the bracket 210, the connecting layer 128 extends upward to form a first branch, a second branch, and a third branch. The first branch includes the first electrode conductively connected to the signal acquisition electrode 120, the second branch includes the second electrode conductively connected to the signal acquisition electrode 120, and the third branch includes the third electrode conductively connected to the signal acquisition electrode 120. The spatial arrangement of the first electrode, the second electrode, and the bracket 210 forms a Y-shape. The adhesive 130 includes a first adhesive 130 and a second adhesive 130. The first adhesive 130 is used to fix the first electrode, the second electrode, and the bracket 210, and the second adhesive 130 is used for the third electrode.

[0116] In one embodiment, Figure 11 In the middle, there are four signal acquisition electrodes 120. The connecting layer 128 extends downward to form a fourth branch. The fourth branch includes a fourth electrode that is conductively connected to the signal acquisition electrodes 120. 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, which is used to fix the first electrode, the second electrode, the third electrode, the fourth electrode, and the bracket 210.

[0118] In the above embodiments, three or four signal acquisition electrodes 120 are provided, which can meet the needs of the user to attach the signal acquisition electrodes 120 to the skin as needed, without the need for high medical requirements, thus lowering the threshold for use and enabling more users to obtain bioelectric signals through the bioelectric signal acquisition device 100.

[0119] See Figure 5 and Figure 6In one embodiment, ten signal acquisition electrodes 120 are provided, and each signal acquisition electrode 120 further includes a fifth electrode. The conductive layer 128 extends downward to form a fifth branch. The fifth branch and the third branch are respectively located on both sides of the center line of the support 210. The third branch continues to extend and conductively connects to the fifth electrode. The fifth branch conductively connects to six signal acquisition electrodes 120. In this embodiment, specifically, the flexible substrate 110 has characters 151 printed on the side opposite to the first conductive portion 122 to indicate the position of the signal acquisition electrode 120 relative to the human body. The characters 151 include R, L, N, F, C1, C2, C3, C4, C5, and C6. The following is a detailed description... Figure 6 This section introduces different forms of bioelectric signal acquisition devices 100, located as shown below:

[0120] The letter R, the lead is located below the right midclavicular line;

[0121] The letter L indicates that the lead is located below the left midclavicular line.

[0122] The letter N indicates that the lead is located at the fifth intercostal space along the right midclavicular line.

[0123] The letter F indicates that the lead is located at the sixth intercostal space along the left midclavicular line.

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

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

[0126] The character C4, the lead location is the left midclavicular line, fifth intercostal space;

[0127] The lead position of character C3 is between the signal acquisition electrode 120 indicated by character C2 and the signal acquisition electrode 120 indicated by character C4, in the fifth intercostal space;

[0128] The character C5 indicates that the lead is located at the left anterior axillary line, and is on the same horizontal line as the signal acquisition electrode 120 indicated by the character C4.

[0129] The character C6 indicates that the lead is located at the left mid-axillary line, and is at the same horizontal level as the signal acquisition electrode 120 indicated by the character C4.

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

[0131] The bioelectric signal acquisition device 100, equipped with ten signal acquisition electrodes 120, is mainly used in medical settings to acquire more electrocardiogram signals for precise disease monitoring and analysis.

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

[0133] The adhesive 130 exposes the signal acquisition electrode 120 through the third opening 131, thereby attaching the signal acquisition electrode 120 to the skin surface of the user to be tested by the adhesive 130 surrounding the signal acquisition electrode 120, thereby improving the adhesion efficiency and making the adhesion position more accurate.

[0134] In one embodiment, any number of signal acquisition electrodes 120 share a single adhesive patch 130.

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

[0136] See Figure 8 and Figure 10 In one embodiment, the connecting layer 128 and the flexible substrate 110 between any two adjacent first connecting parts 122 are curved, specifically, such as S-shaped or coiled. This allows the connecting layer 128 to be stretched and deformed simply by stretching and deforming the flexible substrate 110 when the signal acquisition electrode 120 needs to be attached to a more distant location. This enables the signal acquisition electrode 120 to be moved to a more distant location, improving the applicability of the bioelectric signal acquisition device 100 to users of different body types.

[0137] Specifically, the flexible substrate 110 is transparent.

[0138] Specifically, the material of the signal acquisition 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, or conductive carbon.

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

[0141] The signal acquisition electrode 120 is made of silver chloride, and the connecting layer 124 is made of a conductive material that cannot react with silver chloride. For example, conductive metals readily undergo electron transfer reactions with silver chloride, and the 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 connecting layer 124, such as conductive ink, conductive polymer, conductive carbon, or a conductive metal.

[0142] In one embodiment, the side of the connecting layer 124 and the first lead portion 122 away from the flexible substrate 110 is insulated, thereby preventing bioelectrical signals from being transmitted through the connecting layer 124 and the first lead portion 122, ensuring that the electrocardiogram signal is collected only by the signal acquisition electrode 120 through the conductive adhesive layer 140, thus ensuring the stability of the electrocardiogram signal collection.

[0143] In one embodiment, an insulating protective layer is provided on the side of the connecting layer 124 and the first conductive 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 connecting layer 124 and the first conductive portion 122 facing away from the flexible substrate 110.

[0144] See Figure 1 , Figure 2 as well as Figure 3 In one embodiment, the bioelectric signal acquisition device 100 further includes multiple release films 150, which are correspondingly disposed with adhesive patches 130. The release film 150 is attached to the side of the corresponding adhesive patch 130 facing away from the signal acquisition electrode 120 and covers the conductive adhesive layer 140. In actual use, the operator needs to peel the release film 150 off the adhesive layer to expose the adhesive patch 130 and the conductive adhesive layer 140, and then attach the adhesive patch 130 and the conductive adhesive layer 140 to the corresponding position on the user's skin to be tested, thereby improving the adhesion efficiency.

[0145] like Figure 2 and Figure 4 Specifically, the adhesive 130 is attached to the flexible substrate via the adhesive member 164. The adhesive member 164 has a fourth opening 165 so that the conductive adhesive layer 140 can contact the signal acquisition electrode 120 through the third opening 131 and the fourth opening 165. This allows the signal acquisition electrode 120 to contact the human skin through the conductive adhesive layer 140, thereby fixing the signal acquisition electrode 120 to the human skin and enabling it to conduct electricity.

[0146] See Figure 1 , Figure 2In one embodiment, the guide segment 111 includes a connecting section 113 and a branch section 114; a portion of the lead layer 128 is attached to the connecting section 113 and another portion is attached to the branch section 114; one end of the connecting section 113 is connected to one end of the branch section 114 and the other end is connected to the attachment piece 112. Multiple connecting sections 113 are connected together. When it is necessary to connect to the signal acquisition electrode 120, the lead layer 128 is led from the connecting section 113 to the branch section 114, and then led to the signal acquisition electrode 120 on the attachment piece 112 and connected to the signal acquisition electrode 120. This allows the lead layer 128 to extend with the connecting section 113 and the branch section 114, making the lead layer 128 more regular. No wiring is required. The entire bioelectric signal acquisition device 100 can be arranged and pasted according to the extension of the guide segment 111.

[0147] See Figure 7 In one embodiment, the bioelectric signal acquisition device 100 further includes a sleeve 160, on which multiple junction portions 113 are stacked. The sleeve 160 is fitted around the outer periphery of the multiple junction portions 113, and the inner wall of the sleeve 160 abuts against the junction portions 113 and can slide along the extension direction of the junction portions 113. This allows the junction portions 113 to be separated according to the different body structures of different users being tested, effectively extending the length of the branch portions 114. Then, the sleeve 160 is slid along the junction portions 113, allowing the movable and direction-changing branch portions 114 to be attached according to the actual situation. This allows the signal acquisition electrode 120 of the branch portion 114 away from the junction portion 113 to be attached to a wider range, improving the applicability of the bioelectric signal acquisition device 100.

[0148] In one embodiment, two adjacent branch sections 114 are partially connected.

[0149] Specifically, the branch section 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 adhesive patch 112; the end of the merging section 116 facing away from the lead-out section 115 is connected to the merging section 113. Any number of adjacent merging sections 116 can be selectively merged and connected, so that the lead layers 128 corresponding to adjacent signal acquisition electrodes 120 can be merged and led out first at the merging section 116, and then when it is necessary to connect with the signal acquisition electrode 120, the lead-out section 115 is led out from the merging section 116 to form a separate lead layer 128 and connected to the signal acquisition electrode 120, so that the entire line lead-out is smoother, does not cause line disorder, avoids the need for line straightening during use, and improves the bonding efficiency.

[0150] See Figure 5 and Figure 9In one embodiment, the bioelectric signal acquisition device 100 further includes a telescopic sleeve 161. The connecting layer 128 and the flexible substrate 110 between any two adjacent first connecting parts 122 are folded sequentially along the thickness direction of the flexible substrate 110 in a direction away from the first connecting part 122 and in a direction close to the first connecting part 122 to form a bent structure 162. The telescopic sleeve 161 is fitted onto the bent structure 162 and abuts against the bent structure 162. When it is necessary to attach the signal acquisition electrode 120 to a farther distance, 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 connecting layer 128, thereby enabling the signal acquisition electrode 120 to be moved to a farther distance, improving the applicability of the bioelectric signal acquisition device 100 to users of different body sizes.

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

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

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

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

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

[0156] Example 3:

[0157] One embodiment of this application provides a method for manufacturing a bioelectric signal acquisition device, such as... Figure 12The fabrication method is used to prepare a bioelectric signal acquisition device 100 with at least three different electrode sites. The fabrication method of the bioelectric signal acquisition device includes:

[0158] Provide flexible substrate 110;

[0159] A conductive layer 125 is prepared on the surface of the flexible substrate 110;

[0160] At least three signal acquisition electrodes 120 with different electrode sites are fabricated on the surface of the flexible substrate 110;

[0161] A connection layer 124 is fabricated on the surface of a flexible substrate 110. The signal acquisition electrode 120, the connection layer 124, and the conductive layer 125 are connected in series and conductively connected. The thickness of the connection layer 124 is 5μm-200μm.

[0162] In this embodiment, a conductive layer 125, a signal acquisition electrode 120, and a connection layer 124 are respectively fabricated on a flexible substrate 110. The connection layer 124, the signal acquisition electrode 120, and the conductive layer 125 form a series circuit, realizing a conductive connection between the connection layer 124, the conductive layer 125, and the signal acquisition electrode 120. In this embodiment, the resistance of the connection layer 124 is determined to be 1K to 50K ohms by adjusting the thickness and / or the resistivity of the connection layer 124. Specifically, the resistivity of the connection layer 124 can be adjusted by adjusting the sheet resistance or resistivity of the printing paste of the connection layer 124, or the thickness of the connection layer 124 can be processed by printing process to be 5μm-200μm to determine the resistance of the connection layer 124 to be set to 1K to 50K ohms, so as to withstand the strong current caused by medical defibrillators or electrostatic discharge and avoid the signal collection host 230 being destroyed by the strong current. This embodiment proposes a thin and lightweight connecting layer 124, manufactured using a printing process, with a thickness not exceeding 200 μm. It is connected in series with the signal acquisition electrode 120 and the conductive layer 125, requiring no additional leads. This can replace the traditional defibrillator patch resistors required for safety in monitoring equipment. Traditional patch resistors are bulky and require lead connections, making them unsuitable for compact physiological monitoring devices. Especially during defibrillation treatment, patients need to withstand multiple high-current defibrillation events to restore cardiac function. Without the connecting layer 124, defibrillation energy would pass through the signal acquisition electrode 120 and the conductive layer 125 into the signal collection host 230, potentially destroying it. The connecting layer 124 provided in this embodiment has a measured resistance of 1K to 50K ohms, capable of withstanding multiple high-current surges. After defibrillation treatment, the signal collection host 230 can still function normally, collecting and recording bioelectrical signals, thus enhancing the reliability of the equipment. If the resistance of the connecting layer 124 is less than 1K ohm or greater than 50K ohm, signal noise will be generated, affecting the accuracy of bioelectric signal acquisition.

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

[0164] In this embodiment, the factors that affect the suppression of energy leakage in the printing paste selected for the connecting layer 124 mainly include the type of paste resin, the relative content between the resin and conductive particles, the curing temperature, the size and area of ​​the connecting layer 124, and the resistance value.

[0165] In one embodiment, to provide a more convenient wearing experience, the connecting layer 124 is printed onto the signal acquisition electrode 120 and the conductive layer 125 using a printing process. This does not affect the wearing weight and allows the user to wear it continuously for extended periods. Long-term monitoring of bioelectrical signals, especially electrocardiograms, can help the user more comprehensively monitor their heart health or potential diseases. Furthermore, in high-current treatment environments, such as defibrillation currents or high voltages applied to the user, the conductive layer 125 will conduct the current to the signal acquisition host 230, potentially damaging the host. Therefore, the biosignal acquisition device 100 provided in this embodiment not only considers lightweight wear for continuous use by the user but also takes into account the requirements of monitoring scenarios, ensuring accurate real-time acquisition of bioelectrical signals and making the device safer and more reliable.

[0166] A bioelectric signal acquisition device 100 is worn on the skin of the user to acquire bioelectric signals. A signal collection host 230 is installed on the bioelectric signal acquisition device 100 to collect and store signals. Multiple signal acquisition electrodes 120 collect bioelectric signals from at least three different locations and transmit the bioelectric signals to the signal collection host 230 through a conductive layer 125. This application proposes that the signal acquisition electrodes 120 and the conductive layer 125 are electrically connected through a connecting layer 124 to ensure accurate acquisition of bioelectric signals while suppressing the influence of strong currents on the bioelectric signals acquired by the bioelectric signal acquisition device 100. In this embodiment, a printing process can be used to print the conductive layer 125, the signal acquisition electrodes 120, and the connecting layer 124 on a flexible substrate 110, respectively. The conductive layer 125 and the signal acquisition electrodes 120 are electrically connected through the connecting layer 124, thus constructing a more lightweight wearable product. Alternatively, the conductive materials of the conductive layer 125, the signal acquisition electrode 120, and the connection layer 124 can be respectively attached to the flexible substrate 110, and then the conductive materials can be removed using laser engraving or etching tools to obtain the conductive layer 125, the signal acquisition electrode 120, and the connection layer 124. No limitation is imposed here.

[0167] Specifically, this solution proposes to achieve conductive connection by connecting the conductive layer 125 and the signal acquisition electrode 120 through the connecting layer 124, thereby constructing a series circuit. The flexible substrate 110 can be made of PET sheet, which is more convenient to use and makes it easier to fabricate the connecting layer 124 and the conductive layer 125. The bioelectrical signal collected by the signal acquisition electrode 120 is conducted to the conductive layer 125 through the connecting layer 124. Even if the bioelectrical 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, it is not necessary to introduce an additional defibrillator device, which reduces the product space size of the bioelectrical signal acquisition device 100 while improving the suppression of energy leakage. This is conducive to building a lighter bioelectrical signal acquisition device 100 and enriching and expanding the product application scenarios.

[0168] Specifically, the flexible substrate 110 can be a substrate formed of a flexible material, which can be a flexible material with advantages such as being 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 acquisition device, and a conductive layer 125 and a signal acquisition electrode 120 are disposed on the flexible substrate 110.

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

[0170] The conductive layer 125 is composite-formed with the flexible substrate 110;

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

[0172] The conductive layer 125 is divided into a first conductive part 122, a conductive layer 128, and a second conductive part 121. The first conductive part 122 is electrically connected to the signal acquisition electrode 120 through the connecting layer 124. The second conductive part 121 is used to electrically connect to the signal acquisition motor 230.

[0173] The connection between the connecting layer 124 and the first conductive part 122 forms a first connection area;

[0174] A second connection region is formed at the connection point between the signal acquisition electrode 120 and the connection layer 124;

[0175] The first connection region and the second connection region are electrically connected.

[0176] In this embodiment, to improve the accuracy of signal acquisition, the signal acquisition electrode 120 can be made of precious metals, such as silver. The first lead 122 can be made of at least one of conductive metal, conductive ink, conductive polymer, or conductive carbon. The connecting layer 124 can be made of at least one of conductive ink, conductive polymer, or conductive carbon. This can be understood as follows: for example, the first lead 122 can be made of conductive metal, such as aluminum, and the connecting layer 124 can be made of conductive ink. However, conductive metal cannot be used because a chemical reaction will occur when the signal acquisition electrode 120 made of silver chloride comes into contact with the connecting layer 1247 made of conductive metal, which will increase signal interference. The connecting layer 124 and the first lead portion 122 form a first connecting region, and the connecting layer 124 and the signal acquisition electrode 120 form a second connecting region. The first connecting region and the second connecting region are electrically connected. The signal acquisition electrode 120 and the first lead portion 122 are electrically connected through the first connecting region and the second connecting region. The separate design of the conductive layer 125, the signal acquisition electrode 120 and the connecting layer 124 is used to adapt to more usage environments and manufacturing requirements, which improves the applicability of the bioelectric signal acquisition device 100. Printing or coating processes can be used to make the connection between the connecting layer 124 and the signal acquisition electrode 120 and the first lead portion 122 smoother and more uniform, ensuring the quality of the lead.

[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 acquisition 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 by printing, thereby ensuring that the coating of the signal acquisition 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. The bioelectric signal acquisition device 100 also includes a support 210. The second lead 121 is exposed and installed on the support 210. When the signal acquisition host 230 is installed on the support 210, the signal acquisition host 230 is electrically connected to the second lead 121. One end of the lead layer 128 is electrically connected to the first lead 122, and the other end is electrically connected to the second lead 121. The bioelectric signal is transmitted to the signal acquisition host 230 through the signal acquisition electrode 120, the first lead 121, the first connection area, the lead layer 128, the second connection area, and the second lead 121, thereby achieving the purpose of signal transmission.

[0178] In one embodiment, the material used to prepare the conductive layer 125 includes at least one of conductive ink, conductive polymer, conductive carbon powder, and metallic material;

[0179] In one embodiment, the material used to prepare the connecting layer 124 includes at least one of conductive ink, conductive polymer, conductive toner, and metallic material;

[0180] A connecting layer 124 is formed on the surface of the first lead portion 122 and the signal acquisition electrode 120 using at least one of conductive ink, conductive polymer, conductive carbon powder, and metallic material through printing or coating processes.

[0181] In one embodiment, the signal acquisition electrode 120 and the first lead portion 122 are formed on the same layer of the flexible substrate 110. The first lead portion 122 is provided with a first opening 127, and the signal acquisition electrode 120 is disposed within the first opening 127. The signal acquisition electrode 120 is electrically connected to the first lead portion 122 through a connecting layer 124, which can reduce the overall size of the physiological electrophysiological signal acquisition device 100. Furthermore, it reduces the processing difficulty of the connecting layer 124 and improves the product yield. Further understanding is that the connecting layer 124 can electrically connect the first lead portion 122 and the signal acquisition electrode 120 at any angle. The signal acquisition electrode 120 and the first lead portion 122 are disposed on the same layer. That is, the first lead portion 122 is first printed on the flexible substrate 110, and then the signal acquisition electrode 120 is printed on the same layer. A connection layer 124 is printed on the surface of the signal acquisition electrode 120. The area connecting the first lead portion 122 and the signal acquisition electrode 120 using the connection layer 124 is flatter, preventing uneven printing of the connection layer 124 from affecting the accuracy and stability of signal acquisition. The gap between the signal acquisition electrode 120 and the first lead portion 122 forms an isolation portion. The isolation portion is used to prevent the first lead portion 122 from directly contacting the signal acquisition electrode 120. The isolation portion can be an air gap 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 acquisition electrode 120, which could cause a chemical reaction and affect the signal acquisition accuracy of the signal acquisition electrode 120. Therefore, the isolation section provided in this application embodiment can be fabricated using different conductive materials to prepare the signal acquisition electrode 120 and the first lead section 122 without affecting the acquisition and transmission of bioelectric signals.

[0182] In one embodiment, the cross-sectional shape of the signal acquisition electrode 120 is circular, and the cross-sectional shape of the connecting layer is annular. The ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connecting layer 124 is greater than or equal to 0.1 and less than 1. This ensures absolute contact between the signal acquisition electrode 120 and the connecting layer 124, preventing uneven connection due to manufacturing errors and potential breakage, which could lead to uneven signal transmission. The ratio of 0.1 between the diameter of the signal acquisition electrode 120 and the outer diameter of the connecting layer 124 prevents the connecting layer 124 from being too large, which could hinder signal transmission and cause problems such as long paths and high resistance. This ensures that the signal acquisition electrode 120 acquires bioelectric signals more accurately, and the first lead 122 transmits bioelectric signals more stably. More preferably, the cross-sectional shape of the signal acquisition electrode 120 is circular, and the diameter of the signal acquisition electrode 120 can be selected from 1 to 20 mm. Better control of the processing signal acquisition electrode 120 and the first lead 122, and the connecting layer 124, facilitates the acquisition and transmission of bioelectric signals.

[0183] In one embodiment, a connecting layer is disposed on the side of the signal acquisition electrode 120 near the skin of the user being tested. The connecting layer 124 has a second opening 126, which exposes at least a portion of the conductive area of ​​the signal acquisition electrode 120, allowing the conductive area of ​​the signal acquisition electrode 120 to directly contact the skin of the user being tested, thereby ensuring that the signal acquisition electrode 120 can completely acquire the bioelectrical signals of the human body. The cross-sectional shape of the connecting layer 124 is annular. The annular connecting layer 124 ensures uniform connection with the signal acquisition electrode 120 and the first lead portion 122, respectively, ensuring the continuity of signal acquisition.

[0184] In one embodiment, a connecting layer 124 is positioned on the side of the signal acquisition electrode 120 away from the user's skin. The connecting layer 124 covers at least a portion of the signal acquisition electrode 120, ensuring a more secure conductive connection between the connecting layer 124 and both the signal acquisition electrode 120 and the first lead portion 122. Since the connecting layer 124 does not directly contact the user's skin, it does not affect the bioelectrical signal acquisition by the signal acquisition electrode 120, ensuring stable contact between the signal acquisition electrode 120 and the user's skin, thus guaranteeing stable signal acquisition. The connecting layer 124 has a circular cross-sectional shape. This design, with the connecting layer 124, the signal acquisition electrode 120, and the first opening of the first lead portion 122 all circular, creates a unified overall product design style and enhances aesthetic appeal.

[0185] A flexible protective film is formed on the protective layer. The protective layer can be made of insulating oil. The flexible protective film is an insulating and flexible protective film, made of polymer materials such as polyethylene and polypropylene. The flexible protective film enables the protective layer to withstand pressure and prevents interference with the acquisition of electrocardiogram (ECG) signals. This allows for effective acquisition of ECG signals using a thin, flexible, wearable physiological monitoring device 200, reducing the thickness of the ECG signal acquisition equipment.

[0186] Optionally, a die-cutting process can be further employed to die-cut the flexible substrate 110, signal acquisition 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 product.

[0187] In one embodiment, a protective layer is formed on the surface of the conductive layer 125; the protective layer may or may not cover the connecting layer 124, and the protective layer may not cover the signal acquisition 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 protective layer can withstand pressure and prevent interference with the acquisition of ECG signals, thereby enabling effective acquisition of ECG signals through a thin and flexible wearable physiological monitoring device 200, reducing the thickness of the device for acquiring ECG signals.

[0188] In one embodiment, an insulating protective layer is provided on the side of the connecting layer 124 and the first conductive 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 connecting layer 124 and the first conductive portion 122 facing away from the flexible substrate 110.

[0189] For example, an insulating oil layer can be formed on the conductive layer 125 using a printing process as an insulating protective layer. A flexible protective film can then be formed over the protective layer as another insulating protective layer. As an example, the finished flexible protective film can be directly applied over 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 protective layer can withstand pressure and prevent interference with the acquisition of electrocardiogram signals. Thus, the electrocardiogram signals can be effectively acquired through the thin and flexible wearable physiological monitoring device 200, reducing the thickness of the device for acquiring electrocardiogram signals.

[0191] Example 4:

[0192] One embodiment of this application provides yet another method for manufacturing a bioelectric signal acquisition device, such as... Figure 13The fabrication method is used to prepare a bioelectric signal acquisition device 100 with at least three different electrode sites. The fabrication method of the bioelectric signal acquisition device includes:

[0193] Provide flexible substrate 110;

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

[0195] Signal acquisition electrodes 120 with at least three different electrode sites are fabricated on the surface of a flexible substrate 110 using a second conductive material, wherein 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 acquisition electrode 120 to prevent the conductive layer 125 from directly contacting the signal acquisition electrode 120.

[0197] A connection layer 124 is fabricated on the surface of the flexible substrate 110 using a third conductive material. The conductive layer 125 is electrically connected to the signal acquisition 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 connecting layer 124 and the conductive layer 125 form a first connecting region, and the connecting layer 124 and the signal acquisition electrode 120 form a second connecting region. The first connecting region and the second connecting region are electrically connected, and the second conductive material in the second connecting region will not chemically react with the third conductive material, and the first conductive material in the first connecting region will not chemically react with the third conductive material. This ensures that the signal acquisition electrode 120 acquires signals accurately.

[0199] In one embodiment, the first conductive material includes at least one of conductive ink, conductive polymer, conductive toner, and metallic material;

[0200] The method for manufacturing a bioelectric signal acquisition device includes: molding a flexible substrate 110 into a conductive layer 125 prepared from at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0201] A conductive pattern is planned for the conductive layer 125 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 conductive part 122, the conductive layer 128 and the second conductive part 121; the first conductive part 122 is electrically connected to the signal acquisition electrode 120 through the connecting layer 124.

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

[0204] In this embodiment, the first lead portion 122 is connected to the signal acquisition electrode 120 through the conductive layer 125, and the signal between the first lead portion 122 and the signal acquisition electrode 120 is transmitted accurately and reliably. The bioelectric signal acquisition device 100 also includes a support 210. The conductive layer 125 includes a second lead portion 121 and a lead layer 128. The second lead portion 121 is fixed on the support 210. When the signal collection host 230 is installed on the support 210, the signal collection host 230 is electrically connected to the second lead portion 121. One end of the lead layer 128 is electrically connected to the first lead portion 122, and the other end is electrically connected to the second lead portion 121. Thus, the bioelectric signal acquisition device 100 and the signal collection host 230 can be connected through the support 210. The bioelectric signal is transmitted to the signal collection host 230 through the signal acquisition electrode 120, the connecting layer 124, the first connecting area, and the second connecting area. Preferably, the signal collection host 230 and the support 210 are detachably connected, such as by snap-fit ​​connection, threaded installation, or concave-convex combination, or the support 210 is provided with a gripper for combined installation with the signal collection host 230. Various assembly or disassembly methods are not listed in this embodiment.

[0205] Specifically, the connection layer 124, the signal acquisition electrode 120, and the conductive layer 125 form a series circuit. In this embodiment, the resistance of the connection layer 124 is measured 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 can be a substrate formed of a flexible material, which can be a flexible material with advantages such as being 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 acquisition device, and a conductive layer 125 and a signal acquisition electrode 120 are disposed on the flexible substrate 110.

[0207] In one embodiment, the third conductive material includes at least one of conductive ink, conductive polymer, conductive toner, and metallic material;

[0208] A connecting layer 124 is formed on the surface of the first lead portion 122 and the signal acquisition electrode 120 using at least one of conductive ink, conductive polymer, conductive carbon powder, and metallic material through printing or coating processes.

[0209] In this embodiment, 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 metal, conductive ink, conductive polymer, or conductive carbon. The connecting layer 124 can be made of at least one of conductive ink, conductive polymer, or conductive carbon. This can be understood as follows: for example, the first lead portion 122 can be made of conductive metal, such as aluminum, and the connecting layer 124 can be made of conductive ink, but cannot be made of conductive metal. The connecting layer 124 and the first lead portion 122 form a first connecting region, and the connecting layer 124 and the signal acquisition electrode 120 form a second connecting region. The first connecting region and the second connecting region are electrically connected. The connecting layer 124 can electrically connect the signal acquisition electrode 120 and the first lead portion 122 through the first connecting region and the second connecting region. The use of a separate conductive layer 125, signal acquisition electrode 120 and connecting layer 124 can adapt to more usage environments and manufacturing requirements, improving the applicability of the bioelectric signal acquisition device 100. The printing or coating process makes the connection between the connecting layer 124 and the signal acquisition electrode 120 and the first lead portion 122 smoother and more uniform, ensuring the quality of the lead.

[0210] In one embodiment, the second conductive material includes silver chloride; the method for fabricating the bioelectric signal acquisition device includes: preparing a silver chloride layer at corresponding positions of at least three different electrode sites; attaching the silver chloride layer to the skin of the user to be tested using a conductive gel patch, and acquiring the bioelectric signal 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 within the first opening 127. The silver chloride layer is disposed on 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 acquisition electrode 120 is printed on the same layer. A connection layer 124 is printed on the surface of the signal acquisition electrode 120. In addition, the area where the connection layer 124 connects the first lead portion 122 and the signal acquisition electrode 120 is more even, preventing uneven printing of the connection layer 124 from affecting the accuracy and stability of the signal acquisition process. The gap between the silver chloride layer and the first lead portion 122 forms an isolation portion. Since silver chloride undergoes a chemical displacement reaction with other metallic conductive materials, this chemical reaction directly affects the accuracy of signal acquisition. The isolation portion solution provided in this application embodiment can reduce the overall size of the physiological electrophysiological signal acquisition device 100. The signal acquisition electrode 120 is electrically connected to the first lead portion 122 through the connection layer 124, which greatly reduces the planar size of the physiological electrophysiological signal acquisition device 100. Furthermore, by reducing the processing difficulty of the connecting layer 124 and improving the product yield, it can be further understood that the connecting layer 124 can connect the first lead portion 122 and the signal acquisition electrode 120 at any angle. The isolation portion is used to isolate the conductive layer 125 from the signal acquisition electrode 120, ensuring that the signal acquisition electrode 120 and the first lead portion 122, which use different conductive materials, will not affect signal acquisition due to material contact and mixing. In addition, the conductive layer 125 conducts a conductive connection between the first lead portion 122 and the signal acquisition electrode 120, and ensures that the first lead portion 122 accurately and reliably transmits the bioelectrical signals acquired by the signal acquisition electrode 120.

[0212] In one embodiment, the cross-sectional shape of the etched silver chloride layer is circular, and the cross-sectional shape of the etched connecting layer 124 is annular. The ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connecting 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 acquisition electrode 120 to the outer diameter of the connecting layer 124 is designed to be less than 1, thus ensuring sufficient gap between the signal acquisition electrode 120 and the first lead portion 122. This prevents direct connection or even overlapping connection between the signal acquisition electrode 120 and the first lead portion 122 due to slight offset during fabrication, which would lead to uneven signal transmission. The ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connecting layer 124 is greater than 0.1, preventing the area of ​​the connecting layer 124 from being too large and affecting signal transmission, thus avoiding problems such as long paths and high resistance. This ensures that the signal acquisition electrode 120 can more accurately acquire bioelectric signals, and the first lead portion 122 can transmit bioelectric signals more stably. More preferably, the cross-sectional shape of the signal acquisition electrode 120 is circular, and the diameter of the signal acquisition electrode 120 can be selected from 1 to 20 mm. This allows for better control over the fabrication of the signal acquisition electrode 120, the first lead portion 122, and the connecting layer 124, facilitating the acquisition and transmission of bioelectrical signals.

[0213] In one embodiment, the diameter of the silver chloride layer is 1–10 mm. More preferably, the cross-sectional shape of the signal acquisition electrode 120 is circular, and the diameter of the signal acquisition electrode 120 prepared with silver chloride can be selected from 1–20 mm. This allows for better control over the fabrication of the signal acquisition electrode 120 and the corresponding first lead portion 122, and the connecting layer 124, facilitating the acquisition and transmission of bioelectrical signals.

[0214] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above 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 embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A bioelectric signal acquisition device, characterized in that, The bioelectric signal acquisition device (100) is worn on the skin of the user to acquire bioelectric signals. The bioelectric signal acquisition device (100) includes a flexible substrate (110), on which a conductive layer (125) and multiple signal acquisition electrodes (120) are printed. The multiple signal acquisition electrodes (120) are used to acquire bioelectric signals. The conductive layer (125) is insulated from the signal acquisition electrodes (120). A connecting layer (124) is printed on the flexible substrate (110), and the conductive layer (125) is connected to the signal acquisition electrodes (120) through the connecting layer (124). The electrode (120) is electrically connected; the conductive layer (125) includes a first connecting part (122), a second connecting part (121) and a connecting layer (128). The first connecting part (122) has a first opening (127). The signal acquisition electrode (120) is disposed in the first opening (127). The connecting layer (124) is disposed at the first opening (127). The second connecting part (121) is used to electrically communicate with the signal acquisition host (230). One end of the connecting layer (128) is electrically connected to the first connecting part (122), and the other end is electrically connected to the second connecting part (121).

2. The bioelectric signal acquisition device 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 onto the signal acquisition electrode (120) and the conductive layer (125) using a printing process.

3. The bioelectric signal acquisition device 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. Within the first connecting region, the first conductive material and the third conductive material do not react chemically when in contact.

4. The bioelectric signal acquisition device according to claim 3, characterized in that, The signal acquisition electrode (120) is prepared using a second conductive material different from the first conductive material. The connecting layer (124) contacts the signal acquisition electrode (120) to form a second connecting region. In the second connecting region, the second conductive material and the third conductive material do not react chemically. The first connecting region is electrically connected to the second connecting region through the connecting layer (124).

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

6. The bioelectric signal acquisition device 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 acquisition device 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 toner, and metallic material.

8. The bioelectric signal acquisition device 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 acquisition device according to claim 1, characterized in that, An isolation portion is provided between the conductive layer (125) and the signal acquisition electrode (120), and the isolation portion is used to prevent the conductive layer (125) from contacting the signal acquisition electrode (120).

10. The bioelectric signal acquisition device according to claim 9, characterized in that, The gap region between the first lead portion (122) and the signal acquisition electrode (120) constitutes the isolation portion.

11. The bioelectric signal acquisition device according to claim 9, characterized in that, The first conductive part (122) is made of conductive metal, and the connecting layer (124) is made of non-conductive metal.

12. A bioelectric signal acquisition device, characterized in that, The bioelectric signal acquisition device (100) includes a flexible substrate (110), on which a conductive layer (125) and a plurality of signal acquisition electrodes (120) are printed. A connection layer (124) is printed on the surface of the signal acquisition electrodes (120). The conductive layer (125) is conductively connected to the signal acquisition electrodes (120) through the connection layer (124). The conductive layer (125) is prepared using a first conductive material, and the signal acquisition electrodes (120) are prepared using a second conductive material different from the first conductive material. The layer (125) includes a first lead portion (122), a second lead portion (121), and a lead layer (128). The first lead portion (122) has a first opening (127), the signal acquisition electrode (120) is disposed in the first opening (127), and the connection layer (124) is disposed at the first opening (127). The second lead portion (121) is used to electrically communicate with the signal acquisition host (230). One end of the lead layer (128) is electrically connected to the first lead portion (122), and the other end is electrically connected to the second lead portion (121).

13. The bioelectric signal acquisition device according to claim 12, characterized in that, A connecting layer (124) is prepared using a third conductive material, which is different from the first and second conductive materials.

14. The bioelectric signal acquisition device according to claim 13, characterized in that, The third conductive material does not react chemically with the second conductive material when in contact, and the third conductive material does not react chemically with the first conductive material when in contact.

15. The bioelectric signal acquisition device according to any one of claims 12 to 14, characterized in that, The conductive layer (125) includes a first conductive portion (122), and the connecting layer (124) and the first conductive portion (122) form a first connecting region.

16. The bioelectric signal acquisition device according to claim 15, characterized in that, The connecting layer (124) and the signal acquisition electrode (120) form a second connecting region, and the first connecting region and the second connecting region are electrically connected.

17. The bioelectric signal acquisition device according to claim 16, characterized in that, The second conductive material includes at least one of silver, or a silver-silver chloride mixture, or a carbon-silver mixture, or a carbon-silver-silver chloride mixture, or a titanium nitride-silver mixture, or a titanium nitride-silver-silver chloride mixture.

18. The bioelectric signal acquisition device according to claim 17, characterized in that, The first conductive material is at least one of conductive metal, conductive ink, conductive polymer or conductive carbon.

19. The bioelectric signal acquisition device according to claim 13, characterized in that, The third conductive material includes at least one of conductive ink, conductive polymer, conductive toner, and metallic material.

20. The bioelectric signal acquisition device according to claim 15, characterized in that, The first conductive part (122) is made of conductive metal, and the connecting layer (124) is made of non-conductive metal.

21. The bioelectric signal acquisition device according to claim 15, characterized in that, An isolation portion is provided between the signal acquisition electrode (120) and the first lead portion (122). The isolation portion is used to prevent the conductive material of the first lead portion (122) from mixing and coming into contact with the conductive material of the signal acquisition electrode (120) and causing a chemical reaction.

22. The bioelectric signal acquisition device according to claim 21, characterized in that, The connecting layer (124) is disposed at the edge of the signal acquisition electrode (120) and the first lead (122), and the connecting layer (124) is not electrically connected to the isolation part.

23. The bioelectric signal acquisition device according to claim 22, characterized in that, The isolation section is an air gap or an insulating layer.

24. A bioelectric signal acquisition device, characterized in that, The bioelectric signal acquisition device (100) includes a flexible substrate (110), on which a conductive layer (125) and a plurality of signal acquisition electrodes (120) are disposed. The conductive layer (125) is used to conduct the bioelectric signal to the signal collection host (230). A connection layer (124) is also printed on the flexible substrate (110). The connection layer (124) is used to suppress energy transmission to the signal collection host (230) via the conductive layer (125). The connection layer (124) electrically connects the conductive layer (125) and the signal acquisition electrodes (120) through the conductive layer (125). 0); The conductive layer (125) includes a first connecting part (122), a second connecting part (121) and a connecting layer (128). The first connecting part (122) has a first opening (127). The signal acquisition electrode (120) is disposed in the first opening (127). The connecting layer (124) is disposed at the first opening (127). The second connecting part (121) is used to electrically communicate with the signal acquisition host (230). One end of the connecting layer (128) is electrically connected to the first connecting part (122), and the other end is electrically connected to the second connecting part (121).

25. The bioelectric signal acquisition device according to claim 24, characterized in that, The connecting layer (124) is disposed on the side of the signal acquisition electrode (120) close to the skin of the user to be tested. The connecting layer (124) has a second opening (126) for exposing at least a portion of the conductive area of ​​the signal acquisition electrode (120).

26. The bioelectric signal acquisition device according to claim 24, characterized in that, The connecting layer (124) is disposed on the side of the signal acquisition electrode (120) away from the skin of the user to be tested, and the connecting layer (124) covers at least a portion of the signal acquisition electrode (120).

27. The bioelectrical signal acquisition device according to claim 25 or 26, characterized in that, The thickness of the connecting layer (124) is 5μm-200μm.

28. A bioelectric signal acquisition device, characterized in that, The bioelectric signal acquisition device (100) includes a flexible substrate (110), on which a conductive layer (125) and a plurality of signal acquisition electrodes (120) are disposed. The conductive layer (125) is used to conduct the bioelectric signals of the plurality of signal acquisition electrodes (120) to the signal collection host (230). Ten signal acquisition electrodes (120) are provided. The conductive layer (125) includes a first lead portion (122), a second lead portion (121), and a lead layer (128). The first lead portion (122) has a first opening (127), and the signal acquisition electrodes (120) are disposed in the first opening. Inside the opening (127), a connecting layer (124) is also printed on the flexible substrate (110). The conductive layer (125) is electrically connected to the signal acquisition electrode (120) through the connecting layer (124). The connecting layer (124) is disposed at the first opening (127). The second lead (121) is used to electrically communicate with the signal acquisition host (230). One end of the lead layer (128) is electrically connected to the first lead (122), and the other end is electrically connected to the second lead (121). The lead layer (128) extends downward to form a fifth branch, and the fifth branch is electrically connected to six signal acquisition electrodes (120).

29. The bioelectric signal acquisition device according to claim 28, characterized in that, The bioelectric signal acquisition device (100) also includes a support (210), and the ten signal acquisition 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 disposed on the left and right sides of the center extension line of the support (210). The flexible substrate (110) is provided with an expansion opening (167) along the center extension line of the support (210). The expansion opening (167) is used to expand the distance between the first chest lead electrode group and the second chest lead electrode group.

30. The bioelectric signal acquisition device according to claim 29, characterized in that, The ten signal acquisition electrodes (120) further include limb lead electrode groups, which include 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, and 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. The fourth limb lead electrode is positioned adjacent to the first limb lead electrode, or adjacent to the second limb lead electrode, or adjacent to the first chest lead electrode.

31. The bioelectric signal acquisition device according to any one of claims 28 to 30, characterized in that, The flexible substrate (110) includes a guide section (111), which includes a connecting section (113) and a branch section (114); a portion of the connecting layer (128) is attached to the connecting section (113) and another portion is attached to the branch section (114).

32. The bioelectric signal acquisition device according to claim 31, characterized in that, The bioelectric signal acquisition device (100) also includes an attachment plate (112), one end of the connecting part (113) is connected to one end of the branching part (114), and the other end is connected to the attachment plate (112), and multiple connecting parts (113) are connected together.

33. The bioelectric signal acquisition device according to claim 32, characterized in that, The branch section (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 piece (112); the end of the merging section (116) opposite to the lead-out section (115) is connected to the merging section (113).

34. A wearable physiological monitoring device, characterized in that, The wearable physiological monitoring device (200) includes a bioelectric signal acquisition device (100) and a signal collection host (100) according to any one of claims 1 to 33.

35. A physiological monitoring system, characterized in that, It includes the bioelectric signal acquisition device (100) according to any one of claims 1 to 33, or the wearable physiological monitoring device (200) according to claim 34.

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