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

Abstract

The utility model relates to a physiological signal collector, a wearable physiological monitoring device and a physiological monitoring system. The physiological signal collector comprises a plurality of signal collecting electrodes and a conducting layer, the signal collecting electrodes are used for collecting bio-electricity signals of at least three different position points on the skin of a user to be detected, the conducting layer is used for conducting the bio-electricity signals, and the signal collecting electrodes and the conducting layer are conductively connected through a connecting layer; and safer and more reliable equipment is provided for a user.

Description

Technical Field

[0001] The present application relates to the technical field of medical equipment, and in particular to a physiological signal collector, a wearable physiological monitoring device, and a physiological monitoring system. Background Art

[0002] Bioelectric signals, as important indicators of various physiological parameters of the human body, have always played an important role in people's lives. In clinical practice, people have obtained various bioelectric signals relatively accurately. However, with the continuous demand for medical technology and the in-depth development of electrocardiogram diagnosis, neuromedicine, cognitive psychology and artificial intelligence research, human bioelectric signals are being increasingly applied to telemedicine, medical monitoring, real-time monitoring and emerging brain-computer interfaces.

[0003] 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. They are used to monitor the heart's atrial and ventricular septum, arteriovenous valves, and other conditions, and to provide clinical or remote vital signs monitoring. For example, wearable monitoring devices can provide real-time health monitoring for special populations such as athletes, those undergoing hypertension testing, and those undergoing cardiovascular disease testing. EEG signals directly represent the neural activity of different regions of the cerebral cortex, providing a crucial reference for monitoring a person's physiological and psychological state. They can also provide valuable diagnostic information for brain diseases such as epilepsy, dementia, and tumors.

[0004] In specific usage scenarios, such as defibrillation therapy and high-frequency electrosurgery therapy, strong current is applied to the body of the user to be tested to achieve the purpose of treatment. At this time, the physiological signal collector worn by the user to be tested serves as an auxiliary monitoring method. It needs to monitor the bioelectric signals during treatment to reflect the changes in the physiological signs of the user to be tested. However, defibrillation therapy and high-frequency electrosurgery therapy have specific requirements for energy consumption. At the same time, there are extremely high requirements for the design safety of the physiological signal collector worn by the user to be tested. That is, the physiological signal collector cannot consume treatment energy, and it is also necessary to avoid damage to the equipment caused by strong current. In addition, the signal collected by the bioelectric signal must also exclude interference from the treatment signal to ensure the accuracy of signal acquisition. Utility Model Content

[0005] Based on this, in order to solve the problems that existing physiological signal collectors meet multiple treatment scenarios and accurately collect signals and are safe to use, the present application provides a physiological signal collector, a wearable physiological monitoring device and a physiological monitoring system.

[0006] An embodiment of the present application provides a physiological signal collector, which includes multiple signal collection electrodes and a conductive layer. The multiple signal collection electrodes are used to collect bioelectric signals from at least three different locations on the skin of a user to be tested, and the conductive layer is used to conduct the bioelectric signals to a signal collection host; the signal collection electrodes are conductively connected to the conductive layer through a connecting layer.

[0007] In one embodiment, the conductive layer includes a first lead portion, the connecting layer and the first lead portion form a first connecting region, the connecting layer and the signal acquisition electrode form a second connecting region, and the first connecting region and the second connecting region are conductively connected.

[0008] In one embodiment, an isolation portion is provided between the signal collection electrode and the first lead portion, and the isolation portion is used to isolate the signal collection electrode from contact with the first lead portion.

[0009] In one embodiment, the signal collection electrode and the first lead portion are provided in the same layer.

[0010] In one embodiment, the gap region between the first lead portion and the signal collection electrode constitutes the isolation portion.

[0011] In one embodiment, the first lead portion is provided with a first opening, the signal collection electrode is provided in the first opening, and the connection layer is provided at the first opening.

[0012] 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.

[0013] In one embodiment, the ratio of the diameter of the signal collection electrode to the outer diameter of the connection layer is greater than or equal to 0.1 and less than 1.

[0014] In one embodiment, the cross-section of the signal collection electrode is circular, and the diameter of the signal collection electrode is 1 to 20 mm.

[0015] In one embodiment, the thickness of the connection layer is 5 μm-200 μm and / or the resistance of the connection layer is 1K-50K.

[0016] In one embodiment, the connection layer is provided on a side of the signal acquisition electrode close to the skin of the user to be measured, and the connection layer is provided with a second opening, and the second opening is used to expose at least a portion of the conductive area of ​​the signal acquisition electrode.

[0017] In one embodiment, the cross-section of the connection layer is annular.

[0018] In one embodiment, the connection layer is provided on a side of the signal collection electrode away from the skin of the user to be measured, and the connection layer covers at least a portion of the conductive area of ​​the signal collection electrode.

[0019] In one embodiment, the cross-section of the connecting layer is circular.

[0020] In one embodiment, the first lead portion and the signal collection electrode are stacked.

[0021] In one embodiment, the connection layer is provided at the edges of the signal collection electrode and the first lead portion, and the connection layer is not electrically connected to the isolation portion.

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

[0023] In one embodiment, the conductive layer further includes a second lead portion and a lead layer, the second lead portion is used to be conductively connected to the signal collection host, one end of the lead layer is conductively connected to the first lead portion, and the other end is conductively connected to the second lead portion.

[0024] In one embodiment, the physiological signal collector further includes a flexible substrate, and the signal collection electrodes, the connection layer, the first lead portion, the second lead portion, and the lead layer are printed on the flexible substrate.

[0025] In one embodiment, the flexible substrate corresponding to the position of the first lead portion is circular, the first lead portion is arranged at the center of the flexible substrate, and the distance between the edge of the first lead portion and the edge of the flexible substrate is greater than 1.5 mm.

[0026] In one embodiment, the physiological signal collector further includes an adhesive patch, and the adhesive patch is used to fix the signal collection electrode on the skin of the user to be measured.

[0027] In one embodiment, three signal collection electrodes are provided, at least two of the signal collection electrodes are adjacent to each other, and the adjacent signal collection electrodes are attached to the skin of the user to be measured using a piece of adhesive tape.

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

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

[0030] In one embodiment, the physiological signal collector further includes a bracket, and the bracket and the adjacent signal collection electrodes are fixed on the skin of the user to be measured using an adhesive patch.

[0031] In one embodiment, the ten signal acquisition electrodes include a first chest lead electrode group and a second chest lead electrode group, and the first chest lead electrode group and the second chest lead electrode group are respectively arranged on the left and right sides of the central extension line of the bracket, and the flexible substrate is provided with an expansion opening along the central extension line of the bracket, and the expansion opening is used to expand the distance between the first chest lead electrode group and the second chest lead electrode group.

[0032] In one embodiment, the ten signal acquisition electrodes further include a limb lead electrode group, the limb lead electrode group includes a first limb lead electrode, a second limb lead electrode, a third limb lead electrode, and a fourth limb lead electrode; the first chest lead electrode group includes a first chest lead electrode; the second chest lead electrode group includes a second chest lead electrode, a third chest lead electrode, a fourth chest lead electrode, a fifth chest lead electrode, and a sixth chest lead electrode;

[0033] The fourth limb lead electrode is arranged adjacent to the first limb lead electrode, and a piece of the adhesive tape is used to simultaneously fix the first limb lead electrode and the fourth limb lead electrode; or the fourth limb lead electrode is arranged adjacent to the second limb lead electrode, and a piece of the adhesive tape is used to simultaneously fix the second limb lead electrode and the fourth limb lead electrode; or the fourth limb lead electrode is arranged adjacent to the first chest lead electrode, and a piece of the adhesive tape is used to simultaneously fix the fourth limb lead electrode and the first chest lead electrode.

[0034] In one embodiment, the lead layer is provided with at least one bending structure, and the bending structure is used to extend or shorten the length of the lead layer.

[0035] In one embodiment, a defibrillation resistor is provided on the flexible substrate, and the defibrillation resistor is connected in series with the lead layer.

[0036] In one embodiment, the physiological signal collector further includes a power supply, which is conductively connected to the conductive layer and is used to provide power to the signal collection host.

[0037] In one embodiment, the conductive layer is a first conductive material, the signal collection electrode is a second conductive material, and the connecting layer is a third conductive material. No chemical reaction occurs when the first conductive material contacts the second conductive material, and no chemical reaction occurs when the first conductive material contacts the third conductive material.

[0038] An embodiment of the present application further provides a wearable physiological monitoring device, comprising the above-mentioned physiological signal collector and a signal collection host.

[0039] An embodiment of the present application further provides a physiological monitoring system, including the above-mentioned physiological signal collector, or including the above-mentioned wearable physiological monitoring device.

[0040] The physiological signal collector provided in the embodiment of the present application uses a connecting layer to conductively connect the signal collection electrode and the conductive layer, which meets the requirements of special treatment scenarios. The use of the connecting layer is beneficial to preventing the leakage of treatment energy applied to the surface of the body of the user to be tested, and can also inhibit the energy from being transmitted to the signal collection host through the conductive layer, causing damage to the host. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 A schematic diagram of a flexible substrate, a signal collection electrode mounting bracket, and a signal collection host according to an embodiment;

[0042] Figure 2 for Figure 1 Exploded view of the structure after installing the power supply;

[0043] Figure 3 for Figure 1 Schematic diagram of the structure without the bracket and signal collection host installed;

[0044] Figure 4 for Figure 3 Enlarged view of point A in the middle;

[0045] Figure 5 is a schematic diagram of a wearable physiological monitoring device according to an embodiment;

[0046] Figure 6 for Figure 5 The correspondence between the characters in and the human body;

[0047] Figure 7 is a schematic diagram of the sleeve;

[0048] Figure 8 is a schematic diagram of a guide section between two adjacent attachment sheets;

[0049] Figure 9 is a schematic diagram of a telescopic sleeve;

[0050] Figure 10 is a schematic diagram of a physiological signal collector according to an embodiment;

[0051] Figure 11 is a schematic diagram of a physiological signal collector according to another embodiment;

[0052] Figure 12 is a schematic diagram of a physiological signal collector according to an embodiment;

[0053] Figure 13 is a schematic diagram of a physiological signal collector according to an embodiment;

[0054] Figure 14 is a schematic diagram of a physiological signal collector according to an embodiment;

[0055] Figure 15 is a schematic diagram of a physiological signal collector according to an embodiment;

[0056] Figure 16 is a schematic diagram of a physiological signal collector according to an embodiment;

[0057] Figure 17 is a schematic diagram of a physiological signal collector according to an embodiment;

[0058] Figure 18 is a schematic diagram of a physiological signal collector according to an embodiment;

[0059] Figure 19 is a schematic diagram of a physiological signal collector according to an embodiment;

[0060] Figure 20 is a schematic diagram of a physiological signal collector according to an embodiment;

[0061] Figure 21 is a schematic diagram of a physiological signal collector according to an embodiment;

[0062] Figure 22 is a schematic diagram of a physiological signal collector according to an embodiment;

[0063] Figure 23 is a schematic diagram of a physiological signal collector according to an embodiment;

[0064] Figure 24 is a schematic diagram of a physiological signal collector according to an embodiment;

[0065] Figure 25 is a schematic diagram of a wearable physiological monitoring device according to another embodiment;

[0066] Figure 26 is a schematic diagram of a wearable physiological monitoring device according to another embodiment;

[0067] Figure 27 is a schematic diagram of a wearable physiological monitoring device according to another embodiment;

[0068] Figure 28 for Figure 27 Schematic diagram from another perspective;

[0069] Figure 29 is a schematic diagram of a wearable physiological monitoring device according to another embodiment;

[0070] Figure 30 for Figure 29 Schematic diagram from another perspective;

[0071] Figure 31 This is a process flow chart of a physiological signal collector according to one embodiment;

[0072] Figure 32 This is a process flow chart of a physiological signal collector according to another embodiment.

[0073] Description of Figure Numbers:

[0074] 100 - physiological signal collector; 110 - flexible substrate; 111 - guide section; 112 - attachment sheet; 113 - line junction; 114 - line branching section; 115 - lead section; 116 - line junction; 120 - signal acquisition electrode; 121 - second lead section; 122 - first lead section; 124 - connection layer; 125 - conductive layer; 126 - second opening; 127 - first opening; 128 - lead layer; 130 - adhesive tape ;131-third opening;140-conductive adhesive layer;150-release film;151-character;160-sleeve;161-telescopic sleeve;162-bending structure;163-defibrillator resistor;164-adhesive;165-fourth opening;166-handle;167-extended opening;200-wearable physiological monitoring device;210-bracket;211-bar hole;220-power supply;230-signal collection host. DETAILED DESCRIPTION

[0075] To make the above-mentioned objects, features, and advantages of the present application more clearly understood, the specific embodiments of the present application are described in detail below with reference to the accompanying drawings. The following description sets forth many specific details to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways than those described herein, and those skilled in the art can make similar improvements without violating the scope of the present application. Therefore, the present application is not limited to the specific embodiments disclosed below.

[0076] In the description of this application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application.

[0077] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the number of technical features indicated. Therefore, a feature specified as "first" or "second" may explicitly or implicitly include at least one of such features. In the description of this application, if the term "plurality" appears, "plurality" means at least two, for example, two, three, etc., unless otherwise specifically defined.

[0078] In this application, unless otherwise specified or limited, the terms "mounted," "connected," "connected," "fixed," etc., should be interpreted broadly. For example, these terms may refer to fixed connections, removable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediary; and internal communication between two components or interaction between two components, unless otherwise specified. Those skilled in the art will understand the specific meanings of these terms in this application based on the specific circumstances.

[0079] In this application, unless otherwise expressly specified or limited, if a first feature is described as being "above" or "below" a second feature, or similar descriptions, this may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Furthermore, when a first feature is described as being "above," "above," or "above" a second feature, it may mean that the first feature is directly above or diagonally above the second feature, or simply means that the first feature is at a higher level than the second feature. When a first feature is described as being "below," "below," or "below" a second feature, it may mean that the first feature is directly below or diagonally below the second feature, or simply means that the first feature is at a lower level than the second feature.

[0080] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be an intermediate element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only embodiment.

[0081] Example 1:

[0082] See Figure 1 、 Figure 2 、 Figure 3 as well as Figure 4 ,like Figure 1The first embodiment of the present application provides a physiological signal collector 100, which is used to be worn on the skin of a user to be tested to obtain bioelectric signals. The signal collection host 230 is detachably mounted on the physiological signal collector 100 to collect bioelectric signals, which include electrocardiogram signals, electromyography signals, electroencephalogram signals, and electrooculogram signals. Figure 1 .

[0083] The physiological signal collector 100 includes a flexible substrate 110, on which is disposed a conductive layer 125 and a plurality of signal collection electrodes 120. The plurality of signal collection electrodes 120 are used to collect bioelectrical signals from at least three different locations on the skin of the user being tested. The conductive layer 125 is used to transmit the bioelectrical signals to the signal collection host 230. The flexible substrate 110 is also provided with a connection layer 124, through which the conductive layer 125 is electrically connected to the signal collection electrodes 120.

[0084] In the embodiment of the present application, a conductive layer 125 and a signal collection electrode 120 are formed on a flexible substrate 110 according to a conductive pattern. A connecting layer 124 is used to overlap the conductive layer 125 and the signal collection electrode 120 to achieve a conductive connection. The outer contour of the flexible substrate 110 is cut along the conductive layer 125 and the signal collection electrode 120 as needed to form the outer contour of the physiological signal collector 100. The connecting layer 124, the signal collection electrode 120, and the conductive layer 125 form a series circuit. In applications such as defibrillation or high-voltage electrosurgical surgeries, the addition of the connecting layer 124 to the flexible substrate 110 prevents defibrillation energy from being conducted and leaked through the signal collection electrode 120 and the conductive layer 125, potentially affecting the therapeutic effect. Furthermore, the connection layer 124 does not affect the accuracy of the bioelectrical signals collected by the signal collection electrode 120.

[0085] In one embodiment, the thickness of the connecting layer 124 is 5 μm to 200 μm and / or the resistance of the connecting layer 124 is set to 1K to 50K ohms to withstand the high current caused by medical defibrillators or electrostatic discharge, thereby preventing the signal collection host 230 from being damaged by the high current. This embodiment proposes that the connecting layer 124, manufactured using a printing process, is lightweight and thin, with a compact product structure and a thickness of no more than 200 μm. The connecting layer 124 is connected in series with the signal collection electrode 120 and the conductive layer 125, and no additional wires are required for connection. This can replace traditional defibrillation chip resistors that are required for safety reasons in monitoring equipment. Traditional chip resistors are too large and require wire connections, making them cumbersome to use and unsuitable for compact physiological monitoring equipment. Furthermore, the product provided in this embodiment, due to its lightweight size and compact structure, is also suitable for remote monitoring at home. Especially during defibrillation therapy, patients need to withstand multiple high-current defibrillation surges to restore cardiac function. If the connection layer 124 is not provided, the defibrillation energy will enter the signal collection host 230 through the signal collection electrode 120 and the conductive layer 125, causing the signal collection host 230 to be destroyed by the high current. The connection layer 124 provided in this embodiment has a resistance of 1K to 50K ohms, which can withstand multiple high-current surges. After the cardiac defibrillation therapy is completed, the signal collection host 230 can still be used normally to collect and record bioelectric signals, thereby enhancing the reliability of the device. If the resistance of the connection layer 124 is measured to be less than 1K ohms or greater than 50K ohms, signal noise will be generated, affecting the accuracy of bioelectric signal acquisition.

[0086] The printing paste provided in this embodiment may be a resin paste.

[0087] In one embodiment, the connection layer 124 is printed on the signal collection electrode 120 and the conductive layer 125 using a printing process. This does not affect the wearing weight, making it easy for the user to wear it for a long time without interruption. Long-term monitoring of bioelectric signals, especially electrocardiograms, can help the user to monitor the health of the heart or potential diseases more comprehensively. Moreover, in a high-current treatment environment, such as the high current of defibrillation or high voltage of an electric knife applied to the user to be tested, it will be conducted through the conductive layer 125 to the signal collection host 230, causing the host to be damaged by the high current. Therefore, the physiological signal collector 100 provided in the embodiment of the present application is not only lightweight and easy for the user to wear for a long time without interruption, but also takes into account the use requirements of the monitoring scenario, ensuring that the physiological signal collector 100 collects accurate bioelectric signals in real time, and the device is safer and more reliable.

[0088] The physiological signal collector 100 is worn on the skin of the user to be tested to obtain bioelectric signals. The signal collection host 230 is installed on the physiological signal collector 100 to realize signal collection and storage recording. The multiple signal collection electrodes 120 collect bioelectric signals at at least three different locations and transmit the bioelectric signals to the signal collection host 230 through the conductive layer 125. The present application proposes that the signal collection electrodes 120 and the conductive layer 125 are conductively connected through the connecting layer 124 to ensure that the connecting layer 124 suppresses the influence of strong current on the bioelectric signals collected by the physiological signal collector 100 while ensuring the accurate collection of bioelectric signals. In this embodiment, the conductive layer 125, the signal collection electrodes 120 and the connecting layer 124 can be printed separately on the flexible substrate 110 using a printing process, and the conductive layer 125 and the signal collection electrodes 120 are conductively connected through the connecting layer 124 to construct a more lightweight wearable product. Of course, the conductive layer 125, the signal collection electrode 120, and the conductive materials of the connecting layer 124 can also be adhered to the flexible substrate 110 respectively, and then the conductive materials can be removed using tools such as laser engraving or etching to obtain the conductive layer 125, the signal collection electrode 120, and the connecting layer 124. There is no limitation here.

[0089] Specifically, this solution proposes connecting the conductive layer 125 and the signal collection electrode 120 via a connecting layer 124 to achieve electrical connectivity. The connecting layer 124 connects the conductive layer 125 and the signal collection electrode 120 to form a series circuit. The flexible substrate 110 can be made of PET sheet material, which is more lightweight and easier to prepare. The bioelectrical signals collected by the signal collection electrode 120 are transmitted to the conductive layer 125 via the connecting layer 124. Even if the bioelectrical signals carry strong currents, most of the energy is suppressed by the connecting layer 124 and is not transmitted to the signal collection host 230 by the conductive layer 125. Therefore, the signal collection host 230 records the physiological signals processed by the connecting layer 124. The provision of the connecting layer 124 eliminates the need for an additional defibrillation resistor, effectively suppressing energy leakage while reducing the product size of the physiological signal collector 100. This facilitates a more portable physiological signal collector 100 and expands its application scenarios.

[0090] In one embodiment, the conductive layer 125 is isolated from the signal acquisition electrode 120. The conductive layer 125 is made of a first conductive material, and the signal acquisition electrode 120 is made of a second conductive material different from the first conductive material. This prevents the conductive layer 125, made of different conductive materials, from contacting the signal acquisition electrode 120 and causing chemical reactions, such as chemical reactions, replacement reactions, or redox reactions, that could affect the accuracy of signal acquisition. The connecting layer 124 is made of a different third conductive material, wherein the second conductive material and the third conductive material do not chemically react when in contact, or the first conductive material and the third conductive material do not chemically react when in contact, thereby ensuring the accuracy of bioelectrical signal acquisition and transmission. This embodiment can be used to prepare a wearable physiological signal collector 100 that meets different usage scenarios based on actual product requirements. The physiological signal collector 100 provided in this embodiment of the application fully considers the requirements for high signal acquisition accuracy in different scenarios and prevents damage to the device reliability due to different usage scenarios.

[0091] In a further embodiment, to meet the requirements for 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 can be made of a first conductive material different from the second conductive material to achieve signal transmission, such as a conductive metal. The conductive layer 125 is prepared on the flexible substrate 110, and a conductive pattern is processed according to the electrode point design requirements of the physiological signal collector 100. This can be done through a die-cutting + laminating process, a laminating + etching process, or a laminating + laser engraving process. Common conductive pattern processing methods are not described in detail here. At the predetermined electrode points, the signal acquisition electrode 120 is prepared, generally using a silver chloride layer. Silver can be electroplated at the electrode points and then chlorinated to form a silver / silver chloride coating, or a silver chloride coating can be printed or applied. The conductive layer 125 is made of a conductive material for signal transmission. Different conductive materials are prone to contact reactions. For example, when silver chloride comes into contact with a conductive metal, a chemical reaction occurs, such as chloride ion corrosion of the conductive metal, resulting in reduced signal transmission accuracy. Therefore, an isolation portion is provided between the signal collection electrode 120 and the conductive layer 125 to isolate the first conductive material that is prone to chemical reaction from direct contact with the second conductive material, thereby affecting the accuracy of signal transmission. For example, the isolation portion isolates the signal collection electrode 120 made of silver chloride from direct contact with the conductive layer 125 made of conductive metal.

[0092] The second conductive material used in the signal collection electrode 120 includes at least one of silver, a silver-silver chloride mixture, a carbon-silver mixture, a carbon-silver-silver chloride mixture, a titanium nitride-silver mixture, or a titanium nitride-silver-silver chloride mixture.

[0093] In one embodiment, the conductive layer 125 includes a first lead portion 122, and an isolation portion (not shown in the figure) is provided between the first lead portion 122 and the signal collection electrode 120. The isolation portion is used to isolate the conductive layer 125 from the signal collection electrode 120, ensuring that the signal collection electrode 120 and the first lead portion 122 will not affect signal collection due to material contact and mixing. In addition, the first lead portion 122 is conductively connected to the signal collection electrode 120 through the connecting layer 124, and it is ensured that the first lead portion 122 accurately and reliably transmits the bioelectric signal collected by the signal collection electrode 120.

[0094] In one embodiment, the conductive materials selected for the connection layer 124, the signal collection electrode 120, and the first lead portion 122 are all different. The connection layer 124 and the first lead portion 122 form a first connection area, and the connection layer 124 and the signal collection electrode 120 form a second connection area. The first connection area and the second connection area are conductively connected. The connection layer 124 can conductively connect the signal collection electrode 120 and the first lead portion 122 through the first connection area and the second connection area. The conductive layer 125, the signal collection electrode 120, and the connection layer 124 are designed separately to adapt to more usage environments and preparation requirements, thereby improving the applicability of the physiological signal collector 100. In this embodiment, the connection layer 124 is made of a third conductive material, and no chemical reaction occurs when the third conductive material comes into contact with the second conductive material. The third conductive material does not chemically react with the first conductive material when in contact. Typically, the signal collection electrode 120 is made of silver chloride, and the first lead 122 can be made of at least one of a conductive metal, conductive ink, a 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 a conductive ink, a conductive polymer, or conductive carbon. 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, rather than conductive metal, because contact between the signal collection electrode 120 made of silver chloride and the connecting layer 1247 made of a conductive metal can chemically react, increasing signal interference. This ensures that the connecting layer 124 provides conductive connectivity between the signal collection electrode 120 and the conductive layer 125, ensuring stable signal transmission.

[0095] In one embodiment, the first lead portion 122 and the signal collection electrode 120 are arranged on the same layer, that is, the first lead portion 122 is first printed on the flexible substrate 110, and then the signal collection electrode 120 is printed on the same layer, and the connection layer 124 is printed on the surface of the signal collection electrode 120. In addition, the connection layer 124 connects the first lead portion 122 and the signal collection electrode 120 respectively, making the area smoother, thereby preventing uneven printing of the connection layer 124 from affecting accuracy and stability during the signal collection process.

[0096] In one embodiment, the gap area between the separately designed first lead portion 122 and the signal collection electrode 120 constitutes an isolation portion, wherein the isolation portion can be an air barrier layer or an insulating layer. The purpose of the isolation portion is to prevent the conductive material of the first lead portion 122 from mixing and contacting with the conductive material of the signal collection electrode 120 to cause a chemical reaction, thereby affecting the signal collection performance of the signal collection electrode 120.

[0097] In one embodiment, the first lead portion 122 is provided with a first opening 127, the signal collection electrode 120 is disposed within the first opening 127, and the connection layer 124 is disposed at the first opening 127, i.e., the connection layer 124 is conductively connected to one side of the first lead portion 122. This design can reduce the overall size of the physiological electrical signal collector 100. The signal collection electrode 120 is conductively connected to the first lead portion 122 via the connection layer 124, significantly reducing the planar size of the physiological electrical signal collector 100. Furthermore, the processing difficulty of the connection layer 124 is reduced, thereby improving product yield. Furthermore, it is understood that the connection layer 124 can connect the first lead portion 122 and the signal collection electrode 120 at any angle.

[0098] 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 arranged concentrically, and the connection area between the connecting layer 124 and the first lead portion 122 is annular. The connecting layer 124 evenly covers the first lead portion 122, ensuring that the connecting layer 124 transmits the bioelectric signal collected by the signal acquisition electrode 120 to the first lead portion 122 without loss.

[0099] In one embodiment, the flexible substrate 110 corresponding to the position of the first lead portion 122 is circular in shape. The first lead portion 122 is disposed at the center of the circle of the flexible substrate 110. The distance between the edge of the first lead portion 122 and the edge of the flexible substrate 110 is greater than or equal to 1.5 mm. The edge of the flexible substrate 110 extends beyond the edge of the first lead portion 122, thereby protecting the first lead portion 122 from external wear and tear and ensuring that signal transmission is not interfered with.

[0100] In one embodiment, the ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connecting layer 124 is greater than or equal to 0.1 and less than 1. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connecting layer 124 is designed to be less than 1. This ensures absolute contact between the signal collection electrode 120 and the connecting layer 124, preventing uneven connection between the signal collection electrode 120 and the connecting layer 124 due to processing errors, which can easily lead to disconnection and other problems, thereby causing uneven signal transmission. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connecting layer 124 is greater than 0.1 to prevent the excessive area of ​​the connecting layer 124 from affecting signal transmission and causing obstruction of bioelectric signal transmission, such as long path length and high resistance. This ensures that the signal collection electrode 120 more accurately collects bioelectric signals and that the first lead portion 122 more stably transmits bioelectric signals. More preferably, the cross-section of the signal collection electrode 120 is circular, and the diameter of the signal collection electrode 120 can range from 1 to 20 mm. The signal collection electrode 120, the first lead portion 122, and the connecting layer 124 can be better controlled and processed to facilitate the collection and transmission of bioelectric signals.

[0101] In one embodiment, a connection layer 124 is disposed on the side of the signal collection electrode 120 proximal to the skin of the user to be measured. The connection layer 124 has a second opening 126, which is used to expose at least a portion of the conductive area of ​​the signal collection electrode 120. This allows the conductive area of ​​the signal collection electrode 120 to directly contact the skin of the user to be measured, thereby ensuring that the signal collection electrode 120 can fully collect the human bioelectrical signals. The cross-sectional shape of the connection layer 124 is annular. The annular connection layer 124 ensures uniform connection with the signal collection electrode 120 and the first lead portion 122, ensuring continuous signal collection.

[0102] In another embodiment, the connection layer 124 is disposed on the side of the signal acquisition electrode 120 away from the skin of the user to be tested, ensuring that the connection layer 124 is more firmly conductively connected to the signal acquisition electrode 120 and the first lead portion 122. Since the connection layer 124 does not directly contact the skin of the person to be tested, it will not affect the signal acquisition electrode 120 in collecting bioelectric signals, ensuring that the signal acquisition electrode 120 can stably contact the skin of the person to be tested, ensuring the stability of signal collection. The cross-sectional shape of the connection layer 124 designed in this embodiment is circular. Through this design, the connection layer 124, the signal acquisition electrode 120, and the first opening of the first lead portion 122 are designed to be circular, and the overall product shape design style is unified, which is more aesthetically pleasing.

[0103] In one embodiment, the first lead portion 122 and the signal collection electrode 120 are stacked, with an isolation portion disposed between the first lead portion 122 and the signal collection electrode 120. The isolation portion uses an insulating layer to isolate the first lead portion 122 from contact with the signal collection electrode 120, thereby preventing chemical reactions caused by contact between the first lead portion 122 and the signal collection electrode 120 made of different conductive materials, which could affect signal collection accuracy and expand product variations.

[0104] In another embodiment, the connecting layer 124 is arranged at the edge of the signal collection electrode 120 and the first lead portion 122, and the connecting layer 124 is not conductively connected to the isolation portion. This embodiment has lower process requirements when preparing the connecting layer 124. The connecting layer 124 only needs to conductively connect the signal collection electrode 120 and the first lead portion 122, which reduces the difficulty of preparation.

[0105] In another embodiment, a connecting layer 124 is used instead of the isolation layer. The connecting layer 124 is arranged between the signal collection electrode 120 and the first lead portion 122. The connecting layer 124 can cover the signal collection electrode 120 so that the signal collection electrode 120 and the first lead portion 122 are spatially isolated and conductively connected.

[0106] In one embodiment, the conductive layer 125 includes a second lead portion 121 and a lead layer 128. The second lead portion 121 is configured to be electrically connected to the signal collection 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, thereby achieving an electrically conductive connection between the physiological signal collector 100 and the signal collection host 230. The bioelectrical signals collected by the signal collection electrode 120 are transmitted to the signal collection host 230 via the connecting layer 124, the first lead portion 122, the lead layer 128, and the second lead portion 121. In this embodiment, the first lead portion 122, the lead layer 128, and the second lead portion 121 may also be integrally formed.

[0107] In one embodiment, the signal collection electrode 120, the connecting layer 124, the first lead portion 122, the second lead portion 121, and the lead layer 128 are printed on the flexible substrate 110, thereby ensuring that the coating of the signal collection electrode 120, the connecting layer 124, the first lead portion 122, the second lead portion 121, and the lead layer 128 is uniform, and signal transmission can be relatively stable.

[0108] In one embodiment, the physiological signal collector 100 further includes an adhesive patch 130 for securing the signal collection electrodes 120 to the skin of the user being tested. The adhesive fixes the bracket 210 and the signal collection electrodes 120 to the skin, making installation and removal easy and reducing product costs.

[0109] In one embodiment, the physiological signal collector 100 also includes a bracket 210. The bracket 210 and the adjacent signal collection electrode 120 are fixed to the skin of the user to be tested using an adhesive sticker 130. This is more convenient for the user. The protective layer of the adhesive sticker 130 is torn off to fix the signal collection electrode 120 on the skin of the user to be tested, and the relative positions of the signal collection electrodes 120 sharing the adhesive sticker 130 are determined. Moreover, a piece of adhesive sticker 130 can fix more signal collection electrodes 120 at the same time, making the operation easier. Preferably, the signal collection host 230 is detachably connected to the bracket 210, such as by snap connection, threaded installation, concave-convex combination, etc., or a gripper is provided on the bracket 210 to be installed in combination with the signal collection host 230. The combined installation or separate disassembly methods are not listed one by one in this embodiment.

[0110] See Figure 24 、 Figure 26 、 Figure 27 and Figure 28 In one embodiment, three signal acquisition electrodes 120 are provided, that is, in the single-lead product embodiment provided in this embodiment, at least two signal acquisition electrodes 120 are arranged adjacent to each other, and the electrode points are preferably arranged in a Y-shaped layout. The two adjacent signal acquisition electrodes 120 are located above the bracket 210 and can share a sticker 130. One sticker 130 fixes the two adjacent signal acquisition electrodes 120 and the bracket 210 on the human skin at the same time, which is convenient for installation. For a single-lead product, as long as it is installed at any position on the human chest skin, physiological electrical signals can be collected, and it can be widely used in real-time monitoring in the fields of electrocardiogram, electroencephalogram, electromyography and electrooculography. This embodiment provides a demonstration of the installation of a single-lead product. The mounting bracket 210 is fixed on the midline of the human sternum, and the signal acquisition electrode 120 is installed on the human skin along the conductive layer 125. It can be seen that only the bracket 210 needs to be fixed, and the installation point of the signal acquisition electrode 120 can be fixed, providing a more convenient installation method, which is suitable for remote use by users at home. Among them, the variation example of the single-conductor product only needs to meet the requirement of having three signal collection electrodes 120. The specific design method of the signal collection electrode 120 is protected in this embodiment.

[0111] See Figure 22 、 Figure 23In one embodiment, four signal collection electrodes 120 are provided. This means that this embodiment provides a three-conductor product embodiment, in which at least two signal collection electrodes 120 are adjacently arranged. In this embodiment, two adjacent signal collection electrodes 120 are located below the bracket 210 and can each use a separate adhesive patch 130. The third signal collection electrode 120 is located above the bracket 210, and the fourth signal collection electrode 120 is located above the bracket 210. The two signal collection electrodes 120 located above the bracket 210 each use a separate adhesive patch 130. The bracket 210 and the signal collection electrodes 120 can share a single adhesive patch 130. Similar to the previous embodiment, only the bracket 210 needs to be fixed to secure the mounting points of the signal collection electrodes 120, providing a more convenient installation method, suitable for remote use at home, and further improving the product's applicability. The variation of the three-conductor product only requires four signal collection electrodes 120. The specific design of the signal collection electrodes 120 is provided in this embodiment.

[0112] In the above embodiment, since the number of signal acquisition electrodes 120 is relatively small, namely, three or four, the signal acquisition electrodes 120 can be installed on human skin according to the product instructions. There are no strict usage requirements, which makes it convenient for home care use and lowers the threshold for use. This allows more users to obtain bioelectrical signal data through the physiological signal collector 100, and even special groups can use it conveniently, further expanding the user base of the product. In addition, this product uses an adhesive patch 130 for application to the skin, making it a disposable product, which is more convenient for home care use.

[0113] In one embodiment, ten signal collection electrodes 120 are provided, with at least two adjacent electrodes 120 disposed therebetween. The ten signal collection electrodes 120 include six chest lead electrodes and four limb electrodes, which collect a richer set of bioelectric signals. This rich set of bioelectric signals ensures more accurate processing results for bioelectric signal analysis systems or monitoring systems, meeting medical analysis requirements.

[0114] like Figure 1 and Figure 7 , Figure 7 for Figure 1In another embodiment of the flexible substrate 110, ten signal collection electrodes 120 include a first chest lead electrode group and a second chest lead electrode group. The first chest lead electrode group and the second chest lead electrode group are respectively arranged on the left and right sides of the central extension line of the bracket 210. The flexible substrate 110 is provided with an expansion opening 167 along the central extension line of the bracket 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. Therefore, the expansion opening 167 can be torn open to adjust the distance between the first chest lead electrode group and the second chest lead electrode group according to different users, 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 chest lead electrode group and the second chest lead electrode group on the breast to collect signals.

[0115] See Figure 5 and Figure 6 In one embodiment, the ten signal acquisition electrodes further include a limb lead electrode group, the limb lead electrode group includes a first limb lead electrode marked as R, a second limb lead electrode marked as L, a third limb lead electrode marked as F, and a fourth limb lead electrode marked as N, the first chest lead electrode group includes a first chest lead electrode marked as C1, the first chest lead electrode group includes a first chest lead electrode marked as C1, the second chest lead electrode group includes a second chest lead electrode marked as C2, a third chest lead electrode marked as C3, a fourth chest lead electrode marked as C4, a fifth chest lead electrode marked as C5, and a sixth chest lead electrode marked as C6.

[0116] The fourth limb lead electrode is arranged adjacent to the first limb lead electrode, and a piece of adhesive tape 130 is used to simultaneously fix the first limb lead electrode and the fourth limb lead electrode, or the fourth limb lead electrode is arranged adjacent to the second limb lead electrode, and a piece of adhesive tape 130 is used to simultaneously fix the second limb lead electrode and the fourth limb lead electrode, or the fourth limb lead electrode is arranged adjacent to the first chest lead electrode, and a piece of adhesive tape 130 is used to simultaneously fix the fourth limb lead electrode and the first chest lead electrode.

[0117] In one embodiment, at least one bending structure 162 is provided on the flexible substrate 110. The bending structure 162 is used to extend or shorten the length of the lead layer 128. When the signal collection electrode 120 needs to be pasted to a farther distance, it is only necessary to hold the handle 166 to stretch and deform the bending structure 162, thereby adjusting the installation position of the signal collection electrode 120 according to the usage requirements, thereby improving the suitability of the physiological signal collector 100 for users of different body shapes.

[0118] In one embodiment, a defibrillation resistor 163 is provided on the lead layer 128. The defibrillation resistor 163 is capable of withstanding the strong current caused by a 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.

[0119] An embodiment of the present application further provides a wearable physiological monitoring device 200, including the physiological signal collector 100 of the above embodiment, which will greatly expand the usage scenarios and provide target users with more accurate bioelectrical signal monitoring functions.

[0120] In one embodiment, the wearable physiological monitoring device 200 further includes a signal collection host 230 that is assembled with or separated from the physiological signal collector 100 , and the signal collection host 230 is used to collect and record bioelectric signals.

[0121] An embodiment of the present application further provides a physiological monitoring system, including the wearable physiological monitoring device 200 in the above embodiment or the physiological signal collector 100 in the above embodiment.

[0122] Example 2:

[0123] Example 2 mainly expands part of the structure of Example 1, wherein the physiological signal collector 100, the wearable physiological monitoring device 200 and the physiological monitoring system all correspond to the physiological signal collector 100, the wearable physiological monitoring device 200 and the physiological monitoring system in Example 1.

[0124] See Figure 3 , Figure 3 The following figure shows a schematic diagram of the structure of a physiological signal collector 100 in one embodiment of the present application. This embodiment describes the physiological signal collector 100 in detail in conjunction with the field of electrocardiogram (ECG) monitoring. The physiological signal collector 100 is used to collect human ECG signals. The physiological signal collector 100 includes a flexible substrate 110 and a conductive pattern layer disposed on the surface of the flexible substrate 110. The conductive pattern layer includes a plurality of signal collection electrodes 120, a connection layer 124, and a conductive layer 125.

[0125] See Figure 1 、 Figure 2 as well as Figure 3In the aforementioned physiological signal collector 100, the signal collection electrode 120 is used to contact human skin to obtain ECG signals, and the conductive layer 125 is used to transmit ECG signals. An isolation portion is formed between the signal collection electrode 120 and the conductive layer 125 to isolate the signal collection electrode 120 from direct contact with the conductive layer 125. The conductive layer 125 is conductively connected to the signal collection electrode 120 via the connecting layer 124. The physiological signal collector 100 provided in this application uses the connecting layer 124 to conductively connect the signal collection electrode 120 and the conductive layer 125. In special treatment scenarios, the use of the connecting layer 124 is beneficial for preventing the leakage of energy applied to the surface of the user's body to be tested, and can also inhibit the transmission of energy through the conductive layer 125 to the signal collection host 230, thereby avoiding damage to the host.

[0126] In one embodiment, the conductive layer 125 includes a plurality of first lead portions 122, each of which is provided with a first opening 127. The signal collection electrode 120 is accommodated in the first opening 127, and an isolation portion is formed between the signal collection electrode 120 and the first lead portion 122. This embodiment allows the connecting layer 124 to connect the first lead portion 122 and the signal collection electrode 120 at any angle.

[0127] Among them, the gap area between the separately designed first lead part 122 and the signal collection electrode 120 constitutes an isolation part, wherein the isolation part can be an air barrier layer or an insulating layer. The purpose of the isolation part is to prevent the conductive material of the first lead part 122 from mixing and contacting with the conductive material of the signal collection electrode 120 to cause a chemical reaction, thereby affecting the signal collection performance of the signal collection electrode 120.

[0128] Specifically, the conductive layer 125 includes a lead layer 128, which is used to expand the contact points of the signal collection electrode 120 on the human skin. The lead layer 128 is electrically connected to the first lead portion 122. The first lead portion 122, the lead layer 128, and the signal collection electrode 120 correspond one to one. The first lead portion 122 and the lead layer 128 can be printed integrally to improve printing efficiency, or they can be printed separately and then electrically connected, thereby expanding the applicability of the physiological signal collector 100.

[0129] Specifically, in one embodiment, at least one first connection area is formed between the connection layer 124 and the first lead portion 122, and at least one second connection area is formed between the connection layer 124 and the signal acquisition electrode 120. Specifically, the connection layer and the first lead portion 122 and the lead layer 128 can be in direct contact, or partial contact, or can be conductively connected through a certain number of conductive functional components.

[0130] In another embodiment, the outline of the signal collection electrode 120 is circular, the outline of the first lead portion 122 is annular, and the signal collection electrode 120 is located in the annular first lead portion 122 .

[0131] 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 connecting area with the signal acquisition electrode 120 and the first lead portion 122 respectively. The bridge resistor formed by the annular connecting area can process the defibrillation discharge current, and the bridge resistor can prevent large current from damaging the signal collection host 230.

[0132] Preferably, the ratio of the diameter of the signal collection 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 collection electrode 120 is designed to be circular, and the cross-sectional shape of the connecting layer 124 is designed to be annular. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connecting layer 124 is designed to be less than 1. This ensures absolute contact between the signal collection electrode 120 and the connecting layer 124, ensuring that processing errors prevent uneven connection between the signal collection electrode 120 and the connecting layer 124, which can easily cause disconnection and other problems, thereby leading to uneven signal transmission. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connecting layer 124 is greater than or equal to 0.1, preventing the excessive area of ​​the connecting layer 124 from affecting signal transmission and causing obstruction of bioelectric signal transmission, such as long path length, high resistance, etc., thereby ensuring that the signal collection electrode 120 more accurately collects bioelectric signals and the first lead portion 122 more stably transmits bioelectric signals. More preferably, the cross-section of the signal collection electrode 120 is circular, and the diameter of the signal collection electrode 120 can be selected from 1 to 20 mm. The signal collection electrode 120, the first lead portion 122, and the connecting layer 124 can be processed more controlled to facilitate the collection and transmission of bioelectrical signals.

[0133] In one embodiment, the physiological signal collector 100 further includes a bracket 210 , which is used to install an electrocardiograph recorder. The lead layer 128 is assembled and installed on the bracket 210 and is electrically connected to the electrocardiograph recorder.

[0134] Specifically, the bracket 210 is provided with a strip-shaped hole 211 , and ends of the plurality of lead layers 128 facing away from the corresponding first lead portions 122 are passed through the strip-shaped hole 211 and attached to the bracket 210 .

[0135] In one embodiment, the physiological signal collector 100 further includes a plurality of adhesive stickers 130, the flexible substrate 110 is attached to the non-adhesive layer of the adhesive sticker 130, the adhesive layer of the adhesive sticker 130 is used to attach the signal acquisition electrode 120 and the bracket 210 to the human skin, and the adhesive sticker 130 is provided with a third opening 131, the third opening 131 is used to expose the signal acquisition electrode 120 so that the signal acquisition electrode 120 is in contact with the human skin.

[0136] In one embodiment, if Figure 2 and Figure 4 The physiological signal collector 100 further includes a conductive adhesive layer 140, which may be a hydrogel. The signal collection electrode 120 contacts the human skin through the conductive adhesive layer 140 to fix the signal collection electrode 120 to the human skin and collect ECG signals.

[0137] In one embodiment, Figure 26 、 Figure 27 、 Figure 28 In the embodiment, three signal collection electrodes 120 are provided, including a first electrode, a second electrode, and a third electrode. With the bracket 210 as the center, the lead layer 128 extends upward to form a first branch and a second branch, respectively. The lead layer 128 extends downward to form a third branch. The first branch includes the first electrode conductively connected to the signal collection electrode 120, the second branch includes the second electrode conductively connected to the signal collection electrode 120, and the third branch includes the third electrode conductively connected to the signal collection electrode 120. The spatial layout of the first and second electrodes and the bracket 210 forms a Y-shape. The adhesive tape 130 includes a first adhesive tape 130 and a second adhesive tape 130. The first adhesive tape 130 is used to fix the first and second electrodes and the bracket 210, and the second adhesive tape 130 is used to fix the third electrode.

[0138] In one embodiment, Figure 29 、 Figure 30 In the embodiment, four signal collection electrodes 120 are provided, and the lead layer 128 extends downward to form a fourth branch. The fourth branch includes a fourth electrode conductively connected to the signal collection electrode 120 , and the second electrode, the fourth electrode and the bracket 210 form a Y shape.

[0139] In one embodiment, the adhesive tape 130 further includes a third adhesive tape 130 , and the third adhesive tape 130 is used to fix the first electrode, the second electrode, the third electrode, the fourth electrode, and the bracket 210 , respectively.

[0140] In the above embodiment, three or four signal acquisition electrodes 120 are provided, which can meet the needs of the user to be tested to stick the signal acquisition electrodes 120 to the skin as needed, without the need to use them according to higher medical requirements, thereby lowering the usage threshold and enabling more users to obtain bioelectric signals through the physiological signal collector 100.

[0141] See Figure 5 and Figure 6 In one embodiment, ten signal collection electrodes 120 are provided, and the signal collection electrodes 120 also include a fifth electrode. The lead layer 128 extends downward to form a fifth branch. The fifth branch and the third branch are respectively arranged on both sides of the center line of the bracket 210. The third branch continues to extend and is conductively connected to the fifth electrode. The fifth branch is conductively connected to the six signal collection electrodes 120. In this embodiment, specifically, characters 151 are printed on the side of the flexible substrate 110 away from the first lead portion 122 to indicate the position of the signal collection electrode 120 relative to the human body. The characters 151 and their corresponding positions are as follows: Specifically, the flexible substrate 110 is printed with characters 151 to indicate the position of the signal collection electrode 120 relative to the human body. The characters 151 include R, L, N, F, C1, C2, C3, C4, C5, and C6. Figures 12 to 21 , introduces different forms of physiological signal collectors 100, and the fitting positions are as follows:

[0142] Letter R, lead position is below the right midclavicular line;

[0143] Letter L, lead position is below the left midclavicular line;

[0144] Character N, lead position is the fifth intercostal space at the right midclavicular line;

[0145] Character F, lead position is the sixth intercostal space at the left midclavicular line;

[0146] Character C1, lead position is the right end of the sternum, the fourth intercostal space;

[0147] Character C2, lead position is the left end of the sternum, the fourth intercostal space;

[0148] Character C4, lead position is the left midclavicular line, fifth intercostal space;

[0149] Character C3, the lead position is between the signal collection electrode 120 indicated by character C2 and the signal collection electrode 120 indicated by character C4, at the fifth intercostal space;

[0150] Character C5, lead position is the left anterior axillary line, and is located on the same horizontal line as the signal collection electrode 120 indicated by character C4;

[0151] Character C6, the lead position is the left mid-axillary line, and is located at the same horizontal position as the signal collection electrode 120 indicated by character C4.

[0152] The meanings of the characters 151 set in the lead layer 128 at each position above all use existing standards, mainly referring to the American standard 12-lead electrode definition and reference connection method.

[0153] The physiological signal collector 100 with ten signal collection electrodes 120 is mainly used in medical scenarios, and collects more electrocardiogram signals for accurate disease monitoring and analysis.

[0154] See Figure 3 In one embodiment, the adhesive tape 130 includes a fourth adhesive tape 130 , and the fourth adhesive tape 130 is used to fix the two signal collection electrodes 120 on the third branch or at least two adjacent signal collection electrodes 120 on the fifth branch.

[0155] The adhesive tape 130 exposes the signal collection electrode 120 through the third opening 131 , so that the signal collection electrode 120 is attached to the skin surface of the user to be tested by the adhesive tape 130 surrounding the signal collection electrode 120 , thereby improving the pasting efficiency and making the pasting position more accurate.

[0156] In one embodiment, any number of signal collection electrodes 120 share one adhesive patch 130 . Any number of signal collection electrodes 120 share one adhesive patch 130 .

[0157] Specifically, the shared sticker 130 is expressed using characters 151:

[0158] R, L, (C1, N), (C2, C3), C4, (C5, C6), F, the signal collection electrodes 120 corresponding to C1 and N share a glue 130, the signal collection electrodes 120 corresponding to C5 and C6 share a glue 130, and the signal collection electrodes 120 corresponding to C2 and C3 share a glue 130, as shown in FIG. Figure 12 shown.

[0159] R, L, (C1, N), (C2, C3), (C4, F), (C5, C6), the signal collection electrodes 120 corresponding to C1 and N share a glue 130, the signal collection electrodes 120 corresponding to C5 and C6 share a glue 130, the signal collection electrodes 120 corresponding to C2 and C3 share a glue 130, and the signal collection electrodes 120 corresponding to C4 and F share a glue 130, as shown in FIG. Figure 13 shown.

[0160] R, L, C1, (C2, C3), C4, (C5, C6), F, N, the signal collection electrodes 120 corresponding to C5 and C6 share a glue 130, and the signal collection electrodes 120 corresponding to C2 and C3 share a glue 130, such as Figure 14 shown.

[0161] R, (L, N), (C1, C2), (C3, C4), (C5, C6), F, the signal collection electrodes 120 corresponding to L and N share a sticker 130, the signal collection electrodes 120 corresponding to C1 and C2 share a sticker 130, the signal collection electrodes 120 corresponding to C3 and C4 share a sticker 130, and the signal collection electrodes 120 corresponding to C5 and 6 share a sticker 130, as shown in FIG. Figure 15 shown.

[0162] L, (R, N), (C1, C2), (C3, C4), (C5, C6), F, the signal collection electrodes 120 corresponding to R and N share a glue 130, the signal collection electrodes 120 corresponding to C1 and C2 share a glue 130, the signal collection electrodes 120 corresponding to C3 and C4 share a glue 130, and the signal collection electrodes 120 corresponding to C5 and 6 share a glue 130, as shown in FIG. Figure 16 shown.

[0163] R, L, (C1, C2), (C3, C4), (C5, C6), F, N, means that the signal collection electrodes 120 corresponding to C1 and C2 share a glue 130, the signal collection electrodes 120 corresponding to C3 and C4 share a glue 130, and the signal collection electrodes 120 corresponding to C5 and C6 share a glue 130. Figure 17 Or 18 shown.

[0164] R, L, (C1, N), (C2, C3, C4), (C5, C6), F, the signal collection electrodes 120 corresponding to C1 and N share a glue 130, the signal collection electrodes 120 corresponding to C5 and C6 share a glue 130, and the signal collection electrodes 120 corresponding to C2, C3 and C4 share a glue 130, as shown in FIG. Figure 19 shown.

[0165] R, L, (C1, N), (C2, C3, C4, F), (C5, C6), the signal collection electrodes 120 corresponding to C1 and N share a glue 130, the signal collection electrodes 120 corresponding to C5 and C6 share a glue 130, and the signal collection electrodes 120 corresponding to C2, C3, C4 and F share a glue 130, as shown in FIG. Figure 20 shown.

[0166] R, L, (C1, N), (C2, C3, C4, F, C5, C6), the signal collection electrodes 120 corresponding to C1 and N share a glue 130, the signal collection electrodes 120 corresponding to C5 and C6 share a glue 130, and the signal collection electrodes 120 corresponding to C2, C3, C4, F, C5 and C6 share a glue 130, as shown Figure 21 shown.

[0167] Specifically, there are other feasible embodiments in which any number of signal collection electrodes 120 share one adhesive patch 130 , which should all fall within the protection scope of this embodiment.

[0168] See Figure 11 Specifically, the lead layer 128 corresponding to R and L is at a right angle. Specifically, after the lead layer 128 is bent, it forms a straight line segment leading to the signal collection electrode 120 .

[0169] See Figure 10 Specifically, the lead layers 128 corresponding to R and L form an obtuse angle.

[0170] See Figure 8 and Figure 25 In one embodiment, the lead layer 128 and the flexible substrate 110 between any two adjacent first lead portions 122 are curved, specifically, S-shaped or coiled. When the signal acquisition electrode 120 needs to be attached to a farther location, the lead layer 128 can be stretched and deformed simply by stretching and deforming the flexible substrate 110, thereby enabling the signal acquisition electrode 120 to be moved farther away, thereby improving the applicability of the physiological signal collector 100 to users of different body shapes.

[0171] Specifically, the flexible substrate 110 has light-transmitting properties.

[0172] Specifically, the material of the signal collection electrode 120 is one of silver chloride, metal, conductive ink, conductive polymer, and conductive carbon, preferably silver chloride.

[0173] Specifically, the conductive layer 125 is one of metal, conductive ink, conductive polymer, and conductive carbon.

[0174] Specifically, the connection layer 124 is one of conductive ink, conductive polymer, and conductive carbon, preferably conductive carbon.

[0175] In one embodiment, the signal collection electrode 120 is made of silver chloride, and the connecting layer 124 is made of a conductive material that does not react with silver chloride. For example, conductive metals are susceptible to 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 conductive metal.

[0176] In one embodiment, the connection layer 124 and the first lead portion 122 are insulated on a side facing away from the flexible substrate 110, thereby preventing bioelectric signals from being transmitted through the connection layer 124 and the first lead portion 122, ensuring that the ECG signals are collected only by the signal collection electrode 120 through the conductive adhesive layer 140, thereby ensuring the stability of ECG signal collection.

[0177] In one embodiment, an insulating protective layer is provided on the side of the connection layer 124 and the first lead portion 122 facing away from the flexible substrate 110 . Providing the insulating protective layer includes providing insulating protective oil and / or a flexible protective film on the side of the connection layer 124 and the first lead portion 122 facing away from the flexible substrate 110 .

[0178] See Figure 1 、 Figure 2 as well as Figure 3 In one embodiment, the physiological signal collector 100 further includes multiple release films 150. These release films 150 are positioned corresponding to the adhesive patches 130. These release films 150 are attached to the side of the corresponding adhesive patches 130 facing away from the signal collection electrodes 120 and cover the conductive adhesive layer 140. During use, the operator peels the release films 150 from the adhesive layer, exposing the adhesive patches 130 and the conductive adhesive layer 140. The operator then applies the adhesive patches 130 and the conductive adhesive layer 140 to the corresponding locations on the user's skin, thereby improving attachment efficiency.

[0179] like Figure 2 and Figure 4 Specifically, the adhesive patch 130 is adhered to the flexible substrate via an adhesive member 164. The adhesive member 164 has a fourth opening 165, so that the conductive adhesive layer 140 contacts the signal collection electrode 120 through the third opening 131 and the fourth opening 165, thereby allowing the signal collection electrode 120 to contact the human skin through the conductive adhesive layer 140, thereby fixing the signal collection electrode 120 to the human skin and conducting electricity.

[0180] See Figure 1 、 Figure 2 And 3. In one embodiment, the guide section 111 includes a connecting portion 113 and a branching portion 114 that are connected to each other; a portion of the lead layer 128 is attached to the connecting portion 113, and the other portion is attached to the branching portion 114; one end of the connecting portion 113 is connected to one end of the branching portion 114, and the other end is connected to the attachment piece 112. Multiple connecting portions 113 are connected. When it is necessary to connect to the signal acquisition electrode 120, the lead layer 128 is led from the connecting portion 113 to the branching portion 114, and then to the signal acquisition electrode 120 on the attachment piece 112, and connected to the signal acquisition electrode 120, so that the lead layer 128 can extend with the connecting portion 113 and the branching portion 114, making the lead layer 128 more regular, without the need for line arrangement, and only the entire physiological signal collector 100 needs to be arranged and pasted according to the extension of the guide section 111.

[0181] See Figure 7In one embodiment, the physiological signal collector 100 further includes a sleeve 160, and a plurality of joining portions 113 are overlapped and arranged on the sleeve 160; the sleeve 160 is sleeved on the outer periphery of the plurality of joining portions 113, and the inner wall of the sleeve 160 abuts against the joining portions 113 and can slide along the extension direction of the joining portions 113, so that the joining portions 113 can be separated according to the different body structures of different users to be tested, thereby extending the length of the branching portion 114 in disguised form, and then the sleeve 160 is slid along the joining portions 113, so that the movable and direction-changing branching portion 114 can be attached according to actual conditions, so that the signal collection electrode 120 at the section of the branching portion 114 away from the joining portion 113 can be attached to a wider range, thereby improving the applicability of the physiological signal collector 100.

[0182] In one embodiment, two adjacent dividing line portions 114 are partially connected.

[0183] Specifically, the branching portion 114 includes a lead-out segment 115 and a merging segment 116; one end of the lead-out segment 115 is connected to one end of the merging segment 116, and the other end is connected to the attachment piece 112; the end of the merging segment 116 facing away from the lead-out segment 115 is connected to the merging portion 113, and any number of adjacent merging segments 116 can be selectively merged and connected, so that the lead layers 128 corresponding to adjacent signal acquisition electrodes 120 can first be merged and led out in the merging segment 116, and then when it is necessary to connect to the signal acquisition electrode 120, the lead-out segment 115 is led out from the merging segment 116 to form a separate lead layer 128 connected to the signal acquisition electrode 120, so that the entire line lead-out is smoother, will not cause line disorder, avoids the need for line regularization during use, and improves the pasting efficiency.

[0184] See Figure 5 and Figure 9 In one embodiment, the physiological signal collector 100 further includes a telescopic sleeve 161. The lead layer 128 and the flexible substrate 110 between any two adjacent first lead portions 122 are folded sequentially along the thickness direction of the flexible substrate 110 in a direction away from the first lead portion 122 and in a direction toward the first lead portion 122 to form a bent structure 162. The telescopic sleeve 161 is sleeved over the bent structure 162 and abuts against the bent structure 162. When the signal collection electrode 120 needs to be attached to a farther location, the flexible substrate 110 on both sides of the telescopic sleeve 161 can be stretched and deformed to stretch and deform the lead layer 128, thereby enabling the signal collection electrode 120 to be moved farther away. This improves the applicability of the physiological signal collector 100 to users of different body shapes.

[0185] See Figure 2In one embodiment, the wearable physiological monitoring device 200 further includes a defibrillation resistor 163, which is connected to the side of the lead layer 128 facing away from the flexible substrate 110. Specifically, the defibrillation resistor 163 can be set through a printing process. The defibrillation resistor 163 proposed in this embodiment meets the high resistance requirement, and is thus further suitable for the defibrillation protection function.

[0186] In one embodiment, the outer diameter of the signal collection electrode 120 is 1 to 20 mm. More preferably, the outer diameter of the signal collection electrode 120 is 3 to 10 mm.

[0187] See Figure 1 Figure 2 、 Figure 3 as well as Figure 5 An embodiment of the present application further provides a wearable physiological monitoring device 200 , which includes an electrocardiogram recorder 230 and a physiological signal collector 100 , wherein the electrocardiogram recorder 230 and the physiological signal collector 100 are conductively connected.

[0188] See Figure 1 、 Figure 2 And 25. In one embodiment, the wearable physiological monitoring device 200 further includes a power supply 220, which is connected to one end of the conductive layer 125, so as to supply power to the electrocardiograph or the signal collecting host 230.

[0189] See Figure 1 、 Figure 2 And 25. Specifically, the wearable physiological monitoring device 200 further includes a protective member, which covers the power supply member 220 and is connected to the flexible substrate 110 , thereby protecting the power supply member 220 .

[0190] In one embodiment, the wearable physiological monitoring device 200 further includes a first electrical connection component (not shown) and a second electrical connection component (not shown); the first electrical connection component is attached to the side of the bracket 210 facing away from the flexible substrate 110 and is connected to the lead layer 128; the second electrical connection component is connected to the side of the transmission component close to the bracket 210, and the second electrical connection component is detachably connected to the first electrical connection component, so that the electrocardiograph can be conveniently and quickly electrically connected to the bracket 210 through the detachable connection between the second electrical connection component and the first electrical connection component.

[0191] Example 3:

[0192] An embodiment of the present application provides a method for manufacturing a physiological signal collector, such as Figure 31 The manufacturing method is used to prepare a physiological signal collector 100 with at least three different electrode points. The manufacturing method of the physiological signal collector includes:

[0193] Providing a flexible substrate 110;

[0194] A conductive layer 125 is formed on the surface of the flexible substrate 110 ;

[0195] Prepare at least three signal collection electrodes 120 at different electrode locations on the surface of the flexible substrate 110;

[0196] A connection layer 124 is prepared on the surface of the flexible substrate 110 . The signal collection electrode 120 , the connection layer 124 and the conductive layer 125 form a series conductive connection. The thickness of the connection layer 124 is processed to be 5 μm-200 μm.

[0197] In this embodiment, a conductive layer 125, a signal collection electrode 120, and a connecting layer 124 are separately formed on the flexible substrate 110. The connecting layer 124, the signal collection electrode 120, and the conductive layer 125 form a series circuit, thereby achieving an electrically conductive connection between the connecting layer 124, the conductive layer 125, and the signal collection electrode 120. In this embodiment, the thickness of the connecting layer 124 is adjusted and / or the resistance of the connecting layer 124 is set to 1K to 50K ohms. Specifically, the resistivity of the connecting layer 124 can be adjusted by adjusting the sheet resistance or resistivity of the printing paste of the connecting layer 124, or the resistance of the connecting layer 124 can be set to 1K to 50K ohms by printing the connecting layer 124 to a thickness of 5μm to 200μm. This allows the connecting layer 124 to withstand the high current caused by a medical defibrillator or electrostatic discharge, thereby preventing the signal collection host 230 from being damaged by the high current. This embodiment proposes a thin, lightweight connection layer 124, manufactured using a printing process, with a thickness of no more than 200 μm. It is connected in series with the signal collection electrode 120 and the conductive layer 125, eliminating the need for additional wire connections. This replaces conventional defibrillation patch resistors, which are required for safety reasons in monitoring devices. Conventional patch resistors are bulky and require wire connections, making them cumbersome and unsuitable for compact physiological monitoring applications. During defibrillation therapy, patients must endure multiple bursts of high defibrillation current to restore cardiac function. Without the connection layer 124, the defibrillation energy could pass through the signal collection electrode 120 and the conductive layer 125 and enter the signal collection host 230, potentially damaging the host 230. The connection layer 124 provided in this embodiment has a measured resistance of 1K to 50K ohms, making it capable of withstanding multiple bursts of high current. After defibrillation therapy is complete, the signal collection host 230 can continue to function normally, collecting and recording bioelectrical signals, enhancing device reliability. If the resistance of the connection layer 124 is measured to be less than 1K ohm or greater than 50K ohm, signal noise may be generated, affecting the accuracy of bioelectrical signal collection.

[0198] The printing paste provided in this embodiment may be a resin material.

[0199] In one embodiment, to provide a lighter wearing experience, a printing process is used to print the connection layer 124 on the signal collection electrode 120 and the conductive layer 125. This does not affect the wearing weight and is convenient for the user to wear for a long time without interruption. Long-term monitoring of bioelectric signals, especially electrocardiogram, can help the user to monitor the health of the heart or potential diseases more comprehensively. Moreover, in a high-current treatment environment, such as the high current of defibrillation or high voltage of an electric knife applied to the user to be tested, it will be conducted through the conductive layer 125 to the signal collection host 230, causing the host to be damaged by the high current. Therefore, the physiological signal collector 100 provided in the embodiment of the present application is not only lightweight and convenient for the user to wear for a long time without interruption, but also takes into account the use requirements of the monitoring scenario, ensuring that the physiological signal collector 100 collects accurate bioelectric signals in real time, and the device is safer and more reliable.

[0200] The physiological signal collector 100 is worn on the skin of the user to be tested to obtain bioelectric signals. The signal collection host 230 is installed on the physiological signal collector 100 to realize signal collection and storage recording. The multiple signal collection electrodes 120 collect bioelectric signals at at least three different locations and transmit the bioelectric signals to the signal collection host 230 through the conductive layer 125. The present application proposes that the signal collection electrodes 120 and the conductive layer 125 are conductively connected through the connecting layer 124 to ensure that the connecting layer 124 suppresses the influence of strong current on the bioelectric signals collected by the physiological signal collector 100 while ensuring the accurate collection of bioelectric signals. In this embodiment, the conductive layer 125, the signal collection electrodes 120 and the connecting layer 124 can be printed separately on the flexible substrate 110 using a printing process, and the conductive layer 125 and the signal collection electrodes 120 are conductively connected through the connecting layer 124 to construct a more lightweight wearable product. Of course, the conductive layer 125, the signal collection electrode 120, and the conductive materials of the connecting layer 124 can also be adhered to the flexible substrate 110 respectively, and then the conductive materials can be removed using tools such as laser engraving or etching to obtain the conductive layer 125, the signal collection electrode 120, and the connecting layer 124. There is no limitation here.

[0201] Specifically, this solution proposes connecting the conductive layer 125 and the signal collection electrode 120 via a connecting layer 124 to achieve electrical connectivity. The connecting layer 124 connects the conductive layer 125 and the signal collection electrode 120 to form a series circuit. The flexible substrate 110 can be made of PET sheet material, which is more lightweight and easier to prepare. The bioelectrical signals collected by the signal collection electrode 120 are transmitted to the conductive layer 125 via the connecting layer 124. Even if the bioelectrical signals carry strong currents, most of the energy is suppressed by the connecting layer 124 and is not transmitted to the signal collection host 230 by the conductive layer 125. Therefore, the signal collection host 230 records the physiological signals processed by the connecting layer 124. The provision of the connecting layer 124 eliminates the need for an additional defibrillation resistor, effectively suppressing energy leakage while reducing the product size of the physiological signal collector 100. This facilitates a more portable physiological signal collector 100 and expands its application scenarios.

[0202] Specifically, the flexible substrate 110 can be a base formed of a flexible material, and can be a flexible material with the advantages of being light, thin, transparent, flexible and stretchable. For example, the flexible substrate 110 can be polyvinyl alcohol (PVA), polyester (PET), polyimide (PI), polyethylene naphthalate (PEN), etc.; as an example, a PET film is used as the flexible substrate 110 of the physiological signal collector, and a conductive layer 125 and a signal collection electrode 120 are set on the flexible substrate 110.

[0203] The manufacturing method provided in this embodiment also includes:

[0204] Composite forming of the conductive layer 125 and the flexible substrate 110;

[0205] Planning the conductive pattern of the conductive layer 125 according to the design requirement of providing at least three signal collection electrodes 120 on the flexible substrate 110;

[0206] The conductive layer 125 is divided into a first lead portion 122, a lead layer 128 and a second lead portion 121 that are conductively connected. The first lead portion 122 is conductively connected to the signal collection electrode 120 through the connection layer 124. The second lead portion 121 is used to be conductively connected to the signal collection motor 230.

[0207] The connection layer 124 and the first lead portion 122 are connected to form a first connection area;

[0208] The connection between the signal collection electrode 120 and the connection layer 124 forms a second connection area;

[0209] The first connection region is electrically connected to the second connection region.

[0210] In this embodiment, in order to improve the accuracy of signal acquisition, the signal acquisition electrode 120 can be made of precious metals, such as silver, the first lead portion 122 can be made of at least one of conductive metal, conductive ink, conductive polymer or conductive carbon, and the connecting layer 124 can be made of at least one of conductive ink, conductive polymer, and conductive carbon. It can be understood that, for example, the first lead portion 122 is made of conductive metal, such as aluminum, and the connecting layer 124 is made of conductive ink, but not conductive metal, because the signal acquisition electrode 120 made of silver chloride will react with the connecting layer 1247 made of conductive metal to increase signal interference. The connecting layer 124 and the first lead portion 122 form a first connecting area, and the connecting layer 124 and the signal collection electrode 120 form a second connecting area. The first connecting area and the second connecting area are conductively connected, and the signal collection electrode 120 and the first lead portion 122 are conductively connected through the first connecting area and the second connecting area. The conductive layer 125, the signal collection electrode 120 and the connecting layer 124 are designed separately to adapt to more usage environments and preparation requirements, thereby improving the applicability of the physiological signal collector 100. Printing or coating processes can be used to make the connection between the connecting layer 124 and the signal collection electrode 120 and the first lead portion 122 smoother and more uniform to ensure the quality of the lead.

[0211] In this embodiment, the first lead portion 122, the lead layer 128, and the second lead portion 121 can also be integrally formed. The signal collection electrode 120, the connection layer 124, the first lead portion 122, the second lead portion 121, and the lead layer 128 are printed on the flexible substrate 110, thereby ensuring that the coating of the signal collection electrode 120, the connection layer 124, the first lead portion 122, the second lead portion 121, and the lead layer 128 is uniform, and signal transmission can be relatively stable. The physiological signal collector 100 also includes a bracket 210, and the second lead part 121 is exposed and installed on the bracket 210. When the signal collection host 230 is installed on the bracket 210, the signal collection host 230 is conductively connected to the second lead part 121, one end of the lead layer 128 is conductively connected to the first lead part 122, and the other end is conductively connected to the second lead part 121. The bioelectric signal is transmitted to the signal collection host 230 through the signal collection electrode 120, the first lead part 121, the first connection area, the lead layer 128, the second connection area and the second lead part 121, thereby achieving the purpose of signal transmission.

[0212] In one embodiment, the material for preparing the conductive layer 125 includes at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0213] In one embodiment, the material for preparing the connection layer 124 includes at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0214] A connection layer 124 is formed on the surface of the first lead portion 122 and the signal collection electrode 120 by a printing or coating process using at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material.

[0215] In one embodiment, the signal collection 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 to form a first opening 127, and the signal collection electrode 120 is disposed within the first opening 127. The signal collection electrode 120 is conductively connected to the first lead portion 122 via a connecting layer 124. This can reduce the overall size of the physiological electrical signal collector 100. Furthermore, the processing difficulty of the connecting layer 124 is reduced, thereby improving product yield. Furthermore, it is understood that the connecting layer 124 can conductively connect the first lead portion 122 and the signal collection electrode 120 at any angle. The signal collection electrode 120 is provided on the same layer as the first lead portion 122. Specifically, the first lead portion 122 is first printed on the flexible substrate 110, and then the signal collection electrode 120 is printed on the same layer. A connection layer 124 is printed on the surface of the signal collection electrode 120. Using connection layer 124 to connect the first lead portion 122 and the signal collection electrode 120 creates a smoother surface and prevents uneven printing of connection layer 124 that could affect the accuracy and stability of signal collection. The gap between the signal collection electrode 120 and the first lead portion 122 forms an isolation portion, which serves to isolate the first lead portion 122 from direct contact with the signal collection electrode 120. The isolation portion can be an air barrier or an insulating layer. The isolation portion prevents the conductive material of the first lead portion 122 from mixing with the conductive material of the signal collection electrode 120, causing a chemical reaction that could affect the accuracy of signal collection by the signal collection electrode 120. Therefore, for the isolation portion provided in the embodiment of the present application, it is possible to use different conductive materials to prepare the signal collection electrode 120 and the first lead portion 122 without affecting the collection and transmission of bioelectric signals.

[0216] In one embodiment, the signal collection electrode 120 has a circular cross-section, the connecting layer has a ring-shaped cross-section, and the ratio of the diameter of the signal collection 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 collection electrode 120 and the connecting layer 124, preventing uneven connection between the signal collection electrode 120 and the connecting layer 124 due to processing errors, which can easily lead to disconnection and other problems, resulting in uneven signal transmission. The 0.1 ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connecting layer 124 prevents an excessively large area of ​​the connecting layer 124 from affecting signal transmission and causing obstruction of bioelectrical signal transmission, such as long paths and high resistance. This ensures that the signal collection electrode 120 more accurately collects bioelectrical signals and that the first lead portion 122 more stably transmits bioelectrical signals. More preferably, the signal collection electrode 120 has a circular cross-section, and the diameter of the signal collection electrode 120 can range from 1 to 20 mm. The signal collection electrode 120, the first lead portion 122, and the connecting layer 124 can be better controlled and processed to facilitate the collection and transmission of bioelectric signals.

[0217] In one embodiment, a connection layer is disposed on the side of the signal collection electrode 120 proximal to the skin of the user to be measured. The connection layer 124 has a second opening 126. The second opening 126 is configured to expose at least a portion of the conductive area of ​​the signal collection electrode 120, enabling direct contact between the conductive area of ​​the signal collection electrode 120 and the skin of the user to be measured, thereby ensuring that the signal collection electrode 120 can fully collect the human bioelectrical signals. The cross-sectional shape of the connection layer 124 is annular. The annular connection layer 124 ensures uniform connection with the signal collection electrode 120 and the first lead portion 122, ensuring continuous signal collection.

[0218] In one embodiment, a connecting layer 124 is provided on the side of the signal collection electrode 120 away from the skin of the user to be tested. The connecting layer 124 covers at least a portion of the signal collection electrode 120, ensuring a more secure conductive connection between the connecting layer 124 and the signal collection electrode 120 and the first lead portion 122. Since the connecting layer 124 does not directly contact the skin of the user to be tested, it does not affect the bioelectrical signal collection by the signal collection electrode 120, ensuring that the signal collection electrode 120 can stably contact the skin of the user to be tested, thereby ensuring the stability of signal collection. The cross-sectional shape of the connecting layer 124 is circular. Through this design, the connecting layer 124, the signal collection electrode 120, and the first opening of the first lead portion 122 are designed to be circular, resulting in a unified overall product design style and greater aesthetic value.

[0219] A flexible protective film is formed on the protective layer. The protective layer may be made of insulating oil. The flexible protective film may be a flexible insulating film, and may be made of a polymer material such as polyethylene or polypropylene. The flexible protective film can ensure the pressure resistance of the protective layer and prevent interference with the acquisition of ECG signals, thereby enabling effective acquisition of ECG signals through the thin, flexible, wearable physiological monitoring device 200, and reducing the thickness of the device used to collect ECG signals.

[0220] Optionally, a die-cutting process can be further used to die-cut the flexible substrate 110, signal collection electrode 120, conductive layer 125, conductive connection points, protective layer, flexible protective film, etc. according to a preset pattern to obtain a printed die-cut product.

[0221] 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 a flexible protective film on the protective layer, the protective layer can be made pressure-resistant and prevent interference with ECG signal acquisition. This allows for effective ECG signal acquisition by the thin, flexible wearable physiological monitoring device 200, reducing the thickness of the device used to acquire ECG signals.

[0222] In one embodiment, an insulating protective layer is provided on the side of the connection layer 124 and the first lead portion 122 facing away from the flexible substrate 110 . Providing the insulating protective layer includes providing insulating protective oil and / or a flexible protective film on the side of the connection layer 124 and the first lead portion 122 facing away from the flexible substrate 110 .

[0223] For example, a printing process can be used to form a layer of insulating oil on the conductive layer 125 as an insulating protective layer. Furthermore, a flexible protective film can be formed over the protective layer as another insulating protective layer. As an example, a finished flexible protective film can be directly overlaid on the protective layer as an insulating protective layer.

[0224] In some specific embodiments, by forming a protective layer on the conductive layer 125; and forming a flexible protective film on the protective layer, the pressure resistance of the protective layer can be achieved, and interference with the collection of electrocardiographic signals can be prevented, so that effective collection of electrocardiographic signals can be achieved through a thin and flexible wearable physiological monitoring device 200, and the thickness of the device for collecting electrocardiographic signals can be reduced.

[0225] Example 4:

[0226] An embodiment of the present application provides another method for manufacturing a physiological signal collector, such as Figure 32The manufacturing method is used to prepare a physiological signal collector 100 with at least three different electrode points. The manufacturing method of the physiological signal collector includes:

[0227] Providing a flexible substrate 110;

[0228] A conductive layer 125 is prepared on the surface of the flexible substrate 110 using a first conductive material.

[0229] On the surface of the flexible substrate 110 , a second conductive material is used to prepare at least three signal collection electrodes 120 at different electrode locations, where the second conductive material is different from the first conductive material;

[0230] An isolation portion is formed between the conductive layer 125 and the signal collection electrode 120 , and the isolation portion isolates the conductive layer 125 from direct contact with the signal collection electrode 120 ;

[0231] A connection layer 124 is prepared on the surface of the flexible substrate 110 using a third conductive material, and the conductive layer 125 is electrically connected to the signal collection electrode 120 through the connection layer 124; the third conductive material is different from the first conductive material and the second conductive material;

[0232] The connecting layer 124 and the conductive layer 125 form a first connecting region, and the connecting layer 124 and the signal collection 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 does not chemically react with the third conductive material, and the first conductive material in the first connecting region does not chemically react with the third conductive material. This ensures that the signal collection electrode 120 accurately collects signals.

[0233] In one embodiment, the first conductive material includes at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0234] The manufacturing method of the physiological signal collector includes: composite molding a flexible substrate 110 and a conductive layer 125 made of at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0235] A conductive pattern of the conductive layer 125 is planned according to the spatial distribution of at least three different electrode points;

[0236] The conductive layer 125 is processed according to the conductive pattern to obtain the first lead portion 122, the lead layer 128 and the second lead portion 121; the first lead portion 122 is electrically connected to the signal collection electrode 120 through the connecting layer 124;

[0237] The first lead portion 122 is electrically connected to the second lead portion 121 through the lead layer 128 .

[0238] In this embodiment, the first lead portion 122 is connected to the signal collection electrode 120 through the conductive layer 125 , and accurate and reliable signal transmission between the first lead portion 122 and the signal collection electrode 120 is ensured. The physiological signal collector 100 also includes a bracket 210. The conductive layer 125 includes a second lead portion 121 and a lead layer 128. The second lead portion 121 is fixed to the bracket 210. When the signal collection host 230 is mounted on the bracket 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 physiological signal collector 100 and the signal collection host 230 can be connected through the bracket 210. The bioelectrical signals are transmitted to the signal collection host 230 through the signal collection electrodes 120, the connecting layer 124, the first connecting region, and the second connecting region. Preferably, the signal collection host 230 and the bracket 210 are detachably connected, such as by snap-fit ​​connection, threaded installation, or a combination of concave and convex parts, or a gripper is provided on the bracket 210 to be assembled with the signal collection host 230. The combined assembly or detachable disassembly methods are not listed one by one in this embodiment.

[0239] Specifically, the connection layer 124 , the signal collection electrode 120 , and the conductive layer 125 form a series circuit. In this embodiment, the thickness of the connection layer 124 is 5 μm-200 μm and / or the resistance of the connection layer 124 is 1K-50K.

[0240] The flexible substrate 110 can be a base formed of a flexible material, and can be a flexible material with the advantages of being light, thin, transparent, flexible and stretchable. For example, the flexible substrate 110 can be polyvinyl alcohol (PVA), polyester (PET), polyimide (PI), polyethylene naphthalate (PEN), etc.; as an example, a PET film is used as the flexible substrate 110 of the physiological signal collector, and a conductive layer 125 and a signal collection electrode 120 are set on the flexible substrate 110.

[0241] In one embodiment, the third conductive material includes at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0242] A connection layer 124 is formed on the surface of the first lead portion 122 and the signal collection electrode 120 by a printing or coating process using at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material.

[0243] In this embodiment, the signal acquisition electrode 120 can use 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, and the connecting layer 124 can be made of at least one of conductive ink, conductive polymer, and conductive carbon. It can be understood that, for example, the first lead portion 122 is made of conductive metal, such as aluminum, and the connecting layer 124 is made of conductive ink, but not conductive metal. The connecting layer 124 and the first lead portion 122 form a first connecting area, and the connecting layer 124 and the signal collection electrode 120 form a second connecting area. The first connecting area and the second connecting area are conductively connected. The connecting layer 124 can conductively connect the signal collection electrode 120 and the first lead portion 122 through the first connecting area and the second connecting area. The conductive layer 125, the signal collection electrode 120 and the connecting layer 124 are designed separately to adapt to more usage environments and preparation requirements, thereby improving the applicability of the physiological signal collector 100. The printing or coating process makes the connection between the connecting layer 124 and the signal collection electrode 120 and the first lead portion 122 smoother and more uniform to ensure the lead quality.

[0244] In one embodiment, the second conductive material includes silver chloride; the method for manufacturing the physiological signal collector includes: preparing a silver chloride layer at corresponding positions of at least three different electrode points; adhering the silver chloride layer to the skin of a user to be tested through a conductive gel to collect bioelectric signals of the user to be tested.

[0245] 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 provided 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 collection electrode 120 is printed on the same layer. The connection layer 124 is printed on the surface of the signal collection electrode 120. In addition, the connection layer 124 connects the first lead portion 122 and the signal collection electrode 120 to form a smoother area, preventing uneven printing of the connection layer 124, which may lead to accuracy and stability during signal collection. The gap between the silver chloride layer and the first lead portion 122 forms an isolation portion. Since silver chloride undergoes a chemical replacement reaction with other metallic conductive materials, this chemical reaction can directly affect the accuracy of signal collection. The isolation portion solution provided in the embodiment of the present application can reduce the overall size of the physiological electrical signal collector 100. The signal collection electrode 120 is conductively connected to the first lead portion 122 via the connection layer 124, greatly reducing the planar size of the physiological electrical signal collector 100. Furthermore, the processing difficulty of the connection layer 124 is reduced, and the product yield rate is improved. Furthermore, it is understood that the connection layer 124 can connect the first lead portion 122 and the signal collection electrode 120 at any angle. The isolation portion is used to isolate the conductive layer 125 from the signal collection electrode 120, ensuring that the signal collection electrode 120 and the first lead portion 122, which are made of different conductive materials, do not mix due to material contact and affect signal collection. In addition, the conductive layer 125 electrically connects the first lead portion 122 to the signal collection electrode 120, ensuring that the first lead portion 122 accurately and reliably transmits the bioelectrical signals collected by the signal collection electrode 120.

[0246] In one embodiment, the cross-sectional shape of the etched silver chloride layer is circular, the cross-sectional shape of the etched connecting layer 124 is annular, and the ratio of the diameter of the signal collection 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 collection electrode 120 to the outer diameter of the connecting layer 124 is designed to be less than 1. This ensures a sufficient gap between the signal collection electrode 120 and the first lead portion 122, thereby preventing direct connection or even overlapping connection between the signal collection electrode 120 and the first lead portion 122 due to slight offset during fabrication, which could lead to uneven signal transmission. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connecting layer 124 is greater than 0.1, preventing the excessive area of ​​the connecting layer 124 from affecting signal transmission and causing obstruction of bioelectrical signal transmission, such as long path length and high resistance. This ensures that the signal collection electrode 120 more accurately collects bioelectrical signals and the first lead portion 122 more stably transmits bioelectrical signals. More preferably, the cross-section of the signal collection electrode 120 is circular, and the diameter of the signal collection electrode 120 can be selected from 1 to 20 mm. The signal collection electrode 120, the first lead portion 122, and the connecting layer 124 can be processed more controlled to facilitate the collection and transmission of bioelectrical signals.

[0247] In one embodiment, the diameter of the silver chloride layer is 1 to 10 mm. More preferably, the cross-section of the signal collection electrode 120 is circular, and the diameter of the silver chloride-based signal collection electrode 120 can range from 1 to 20 mm. This allows for better control over the processing of the signal collection electrode 120, the corresponding first lead portion 122, and the connecting layer 124, facilitating the collection and transmission of bioelectrical signals.

[0248] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned 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.

[0249] The above-described embodiments merely represent several implementation methods of the present application. 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 a person of ordinary skill in the art may make various modifications and improvements without departing from the spirit of the present application, and these modifications and improvements fall within the scope of protection of the present application. Therefore, the scope of protection of the present patent application shall be determined by the appended claims.

Claims

1. A physiological signal collector, characterized in that: The physiological signal collector (100) comprises a plurality of signal collection electrodes (120) and a conductive layer (125), wherein the plurality of signal collection electrodes (120) are used to collect bioelectric signals from at least three different locations on the skin of a user to be measured, and the conductive layer (125) is used to conduct the bioelectric signals to a signal collection host (230); the signal collection electrodes (120) are electrically connected to the conductive layer (125) via a connecting layer (124).

2. The physiological signal collector according to claim 1, characterized in that: The conductive layer (125) includes a first lead portion (122), the connecting layer (124) and the first lead portion (122) form a first connecting region, the connecting layer (124) and the signal collection electrode (120) form a second connecting region, and the first connecting region and the second connecting region are electrically connected.

3. The physiological signal collector according to claim 2, characterized in that: An isolation portion is provided between the signal collection electrode (120) and the first lead portion (122), and the isolation portion is used to isolate the signal collection electrode (120) from contact with the first lead portion (122).

4. The physiological signal collector according to claim 3, characterized in that: The signal collection electrode (120) and the first lead portion (122) are arranged in the same layer.

5. The physiological signal collector according to claim 4, characterized in that: The gap area between the first lead portion (122) and the signal collection electrode (120) constitutes the isolation portion.

6. The physiological signal collector according to claim 5, characterized in that: The first lead portion (122) is provided with a first opening (127), the signal collection electrode (120) is arranged in the first opening (127), and the connection layer (124) is arranged at the first opening (127).

7. The physiological signal collector according to claim 6, characterized in that: 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.

8. The physiological signal collector according to any one of claims 1 to 7, characterized in that: The ratio of the diameter of the signal collection electrode (120) to the outer diameter of the connection layer (124) is greater than or equal to 0.1 and less than 1.

9. The physiological signal collector according to claim 8, characterized in that: The thickness of the connecting layer (124) is 5 μm-200 μm and / or the resistance of the connecting layer (124) is 1K-50K.

10. The physiological signal collector according to claim 9, characterized in that: The connection layer (124) is arranged on a side of the signal collection electrode (120) close to the skin of the user to be measured, and the connection layer (124) is provided with a second opening (126), and the second opening (126) is used to expose at least part of the conductive area of ​​the signal collection electrode (120).

11. The physiological signal collector according to claim 9, characterized in that: The connection layer (124) is arranged on a side of the signal collection electrode (120) away from the skin of the user to be measured, and the connection layer (124) covers at least a portion of the conductive area of ​​the signal collection electrode (120).

12. The physiological signal collector according to claim 2 or 3, characterized in that: The first lead portion (122) and the signal collection electrode (120) are stacked.

13. The physiological signal collector according to any one of claims 2 to 7, characterized in that: The conductive layer (125) further includes a second lead portion (121) and a lead layer (128), wherein the second lead portion (121) is used for conductive communication with the signal collection host (230), and 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).

14. The physiological signal collector according to claim 13, characterized in that: The physiological signal collector (100) further comprises a flexible substrate (110), and the signal collection electrode (120), the connection layer (124), the first lead portion (122), the second lead portion (121) and the lead layer (128) are printed on the flexible substrate (110).

15. The physiological signal collector according to claim 14, characterized in that: The shape of the flexible substrate (110) corresponding to the position of the first lead portion (122) is circular, the first lead portion (122) is arranged at the center of the circle of the flexible substrate (110), and the distance between the edge of the first lead portion (122) and the edge of the flexible substrate (110) is greater than 1.5 mm.

16. The physiological signal collector according to claim 14, characterized in that: The physiological signal collector (100) further comprises an adhesive patch (130), wherein the adhesive patch (130) is used to fix the signal collection electrode (120) on the skin of the user to be measured.

17. The physiological signal collector according to claim 16, characterized in that: Three signal collection electrodes (120) are provided, at least two of the signal collection electrodes (120) are adjacently provided, and the adjacently provided signal collection electrodes (120) are attached to the skin of the user to be tested using a piece of adhesive tape (130).

18. The physiological signal collector according to claim 16, characterized in that: Four signal collection electrodes (120) are provided, at least two of the signal collection electrodes (120) are adjacently provided, and the adjacently provided signal collection electrodes (120) are attached to the skin of the user to be tested using a piece of adhesive tape (130).

19. The physiological signal collector according to claim 16, characterized in that: Ten signal collection electrodes (120) are provided, at least two of the signal collection electrodes (120) are arranged adjacent to each other, and the adjacently arranged signal collection electrodes (120) are attached to the skin of the user to be tested using a piece of adhesive tape (130).

20. The physiological signal collector according to claim 19, characterized in that: The physiological signal collector (100) further comprises a bracket (210), wherein the bracket (210) and the adjacent signal collection electrode (120) are fixed on the skin of the user to be measured using an adhesive patch (130).

21. The physiological signal collector according to claim 20, characterized in that: The ten signal acquisition electrodes (120) include a first chest lead electrode group and a second chest lead electrode group, wherein the first chest lead electrode group and the second chest lead electrode group are respectively arranged on the left and right sides of the central extension line of the bracket (210), and the flexible substrate (110) is provided with an expansion opening (167) along the central extension line of the bracket (210), and the expansion opening (167) is used to expand the distance between the first chest lead electrode group and the second chest lead electrode group.

22. The physiological signal collector according to claim 21, characterized in that: The ten signal acquisition electrodes (120) further include a limb lead electrode group, the limb lead electrode group includes a first limb lead electrode, a second limb lead electrode, a third limb lead electrode, and a fourth limb lead electrode, the first chest lead electrode group includes a first chest lead electrode, the second chest lead electrode group includes a second chest lead electrode, a third chest lead electrode, a fourth chest lead electrode, a fifth chest lead electrode, and a sixth chest lead electrode, The fourth limb lead electrode is arranged adjacent to the first limb lead electrode, and a piece of the adhesive tape (130) is used to simultaneously fix the first limb lead electrode and the fourth limb lead electrode, or the fourth limb lead electrode is arranged adjacent to the second limb lead electrode, and a piece of the adhesive tape (130) is used to simultaneously fix the second limb lead electrode and the fourth limb lead electrode, or the fourth limb lead electrode is arranged adjacent to the first chest lead electrode, and a piece of the adhesive tape (130) is used to simultaneously fix the fourth limb lead electrode and the first chest lead electrode.

23. The physiological signal collector according to claim 14, characterized in that: At least one bending structure (162) is provided on the flexible substrate (110), and the bending structure (162) is used to extend or shorten the length of the lead layer (128).

24. The physiological signal collector according to claim 14, characterized in that: A defibrillation resistor (163) is provided on the flexible substrate (110), and the defibrillation resistor (163) is connected in series with the lead layer (128).

25. The physiological signal collector according to any one of claims 1 to 7, characterized in that: The physiological signal collector (100) further comprises a power supply unit (220), wherein the power supply unit (220) is conductively connected to the conductive layer (125), and the power supply unit (220) is used to provide power to the signal collection host (230).

26. The physiological signal collector according to any one of claims 1 to 7, characterized in that: The conductive layer (125) is a first conductive material, the signal collection electrode (120) is a second conductive material, the connection layer (124) is a third conductive material, and no chemical reaction occurs when the first conductive material contacts the second conductive material, and no chemical reaction occurs when the first conductive material contacts the third conductive material.

27. A wearable physiological monitoring device, characterized in that: The wearable physiological monitoring device (200) comprises a physiological signal collector (100) according to any one of claims 1 to 26 and a signal collection host (230).

28. A physiological monitoring system, characterized in that: The device comprises the physiological signal collector (100) according to any one of claims 1 to 26, or comprises the wearable physiological monitoring device (200) according to claim 27.

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