Wearable physiological signal collector, preparation process thereof and physiological monitoring system

Abstract

The invention relates to a wearable physiological signal collector, a preparation process thereof and a physiological monitoring system. According to the manufacturing process of the wearable physiological signal collector, the conductive layer and the signal collecting electrodes are prepared on the flexible substrate, and the signal collecting electrodes and the conductive layer are conductively connected through the connecting layer, so that in a special treatment scene, the connecting layer is used for preventing leakage of energy applied to the body surface of a to-be-detected user, and the wearable physiological signal collector is convenient to use. And the energy can be prevented from being transmitted to the signal collection host through the conductive layer to damage the host.

Description

[0001] This invention patent application is a divisional application of the Chinese invention patent application with application date of September 11, 2024, application number 2024112691023, and name “Wearable physiological signal collector and its preparation process, physiological monitoring system”. Technical Field

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

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

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

[0005] In specific usage scenarios, such as defibrillation therapy and high-frequency 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 wearable physiological signal collector worn by the user to be tested is used as an auxiliary monitoring method. It is necessary 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 and strict requirements on energy consumption, and there are extremely high requirements for the design safety of the wearable physiological signal collector worn by the user to be tested. That is, the wearable physiological signal collector cannot consume treatment energy, and it is also necessary to avoid strong current damage to the equipment. How to meet the needs of bioelectric signal collection to eliminate the interference of treatment signals and ensure the accuracy of signal collection has become an urgent problem to be solved. Summary of the invention

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

[0007] An embodiment of the present application provides a preparation process of a wearable physiological signal collector, the process comprising:

[0008] providing a flexible substrate;

[0009] preparing a conductive layer on the surface of the flexible substrate;

[0010] Prepare at least three signal collection electrodes at different electrode points on the surface of the flexible substrate;

[0011] A connection layer is prepared on the surface of the flexible substrate, and the signal collection electrode, the connection layer and the conductive layer are connected in series, and the thickness of the connection layer is processed to be 5 μm-200 μm.

[0012] In another embodiment, the process further comprises:

[0013] Composite forming of the conductive layer and the flexible substrate;

[0014] The conductive layer is divided into a conductively connected first lead portion, a lead layer and a second lead portion, wherein the first lead portion is conductively connected to the signal collection electrode through the connection layer; the second lead portion is used to conductively connect to the signal collection electrode;

[0015] forming a first connection area at the connection between the first lead portion and the connection layer;

[0016] forming a second connection region at the connection between the signal collection electrode and the connection layer;

[0017] The first connection region is electrically connected to the second connection region.

[0018] In yet another embodiment, the signal collection electrode and the first lead portion are formed on the same layer of the flexible substrate;

[0019] forming a first opening in the first lead portion, and disposing the signal collection electrode in the first opening;

[0020] An isolation portion is formed in the gap between the signal collection electrode and the first lead portion, and the isolation portion is used to isolate the first lead portion from direct contact with the signal collection electrode;

[0021] The first connection region and the second connection region are respectively arranged on both sides of the isolation portion.

[0022] In another embodiment, the connection layer is arranged on a side of the signal collection electrode close to the skin of the user to be tested;

[0023] A second opening is formed in the connection layer, and the second opening is used to expose at least a portion of the conductive area of ​​the signal collection electrode.

[0024] In yet another embodiment, the cross-sectional shape of the signal collection electrode is circular, and the cross-sectional shape of the connection layer is annular.

[0025] In yet another embodiment, a ratio of a diameter of the signal collection electrode to an outer diameter of the connection layer is set to be greater than or equal to 0.1 and less than 1.

[0026] In yet another embodiment, a ratio of an inner diameter of the first lead portion to an outer diameter of the connecting layer is set to 0.1-0.9.

[0027] In yet another embodiment, a protective layer is formed on the surface of the conductive layer.

[0028] The embodiment of the present application also provides a wearable physiological signal collector, which is made using the above-mentioned preparation process of the wearable physiological signal collector, wherein a plurality of signal collection electrodes are provided, and at least two adjacent signal collection electrodes are attached to the body of the user to be tested using a piece of adhesive sticker.

[0029] An embodiment of the present application also provides a physiological monitoring system, including the above-mentioned wearable physiological signal collector.

[0030] The preparation process of the wearable 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, so as to meet the requirements of special treatment scenarios. The connecting layer prevents the treatment energy applied to the body surface of the user to be tested from leaking through the conductive layer, and can inhibit the energy from being transmitted to the signal collection host through the conductive layer, causing damage to the host. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 This is a process flow chart of a wearable physiological signal collector according to an embodiment;

[0032] Figure 2 A process flow chart of a wearable physiological signal collector according to another embodiment;

[0033] Figure 3 A schematic diagram of the separation of the wearable physiological signal collector and the signal collection host provided in an embodiment of the present application;

[0034] Figure 4 for Figure 3 Exploded diagram of

[0035] Figure 5A schematic diagram of a wearable physiological signal collector provided in an embodiment of the present application;

[0036] Figure 6 for Figure 5 Enlarged view of point A in the middle.

[0037] Description of Figure Numbers:

[0038] 100-wearable physiological signal collector; 110-flexible substrate; 120-signal collection electrode; 121-second lead part; 122-first lead part; 124-connecting layer; 125-conductive layer; 126-second opening; 127-first opening; 128-lead layer; 130-adhesive patch; 163-defibrillation resistor; 200-wearable physiological monitoring device; 210-bracket; 230-signal collection host. DETAILED DESCRIPTION

[0039] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0040] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0041] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0042] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0043] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0044] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0045] Embodiment 1:

[0046] An embodiment of the present application provides a preparation process of a wearable physiological signal collector, such as Figure 1 The preparation process is used to prepare a wearable physiological signal collector 100 with at least three different electrode points. The preparation process of the wearable physiological signal collector includes:

[0047] Providing a flexible substrate 110;

[0048] Prepare a conductive layer 125 on the surface of the flexible substrate 110;

[0049] Prepare at least three signal collection electrodes 120 at different electrode points on the surface of the flexible substrate 110;

[0050] A connection layer 124 is prepared on the surface of the flexible substrate 110 , and the signal collection electrode 120 , the connection layer 124 and the conductive layer 125 form a series conductive connection. The thickness of the connection layer 124 is processed to be 5 μm-200 μm.

[0051] In this embodiment, a conductive layer 125, a signal collection electrode 120, and a connecting layer 124 are respectively prepared on the flexible substrate 110, and the connecting layer 124, the signal collection electrode 120, and the conductive layer 125 form a series circuit to achieve 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 5 μm-200 μm and / or the resistance of the connecting layer 124 is set to 1K to 50K ohms to withstand the strong current caused by the medical defibrillator or electrostatic discharge, so as to prevent the signal collection host 230 from being destroyed by the strong current. This embodiment proposes that the connection layer 124 made by the printing process is thin and light, the product structure is compact, and the thickness does not exceed 200μm. The connection layer 124 is connected in series with the signal collection electrode 120 and the conductive layer 125, and no other lead connection is required. It can replace the traditional defibrillation patch resistor that must be used in the monitoring equipment due to equipment safety requirements. The traditional patch resistor is too large and requires lead connection when used. It is cumbersome to use and cannot be used for compact physiological monitoring equipment applications. In addition, the product provided by this embodiment is also suitable for home remote monitoring due to its light size and miniaturized structure. In particular, during the defibrillation treatment process, the patient needs to withstand multiple strong defibrillation currents to restore heart function. If the connection layer 124 is not provided, the defibrillation energy will enter the signal collection host 230 through the signal collection electrode 120 and the conductive layer 125, causing the signal collection host 230 to be destroyed by the strong current. The resistance of the connection layer 124 provided in this embodiment is 1K to 50K ohms, which can withstand multiple strong current shocks. After the cardiac defibrillation treatment is completed, the signal collection host 230 can still be used normally to collect and record bioelectric signals, thereby enhancing the reliability of the device. If the resistance of the connection layer 124 is less than 1K ohms or greater than 50K ohms, signal noise will be generated, affecting the accuracy of bioelectric signal collection.

[0052] In this embodiment, the factors that affect the energy leakage of the printing paste selected for the connection layer 124 mainly include the type of paste resin, the relative content between the resin and the conductive particles, the curing temperature, the size and area of ​​the connection layer 124, and the resistance value.

[0053] In one embodiment, in order to provide a lighter wearing experience, the connection layer 124 is printed on the signal collection electrode 120 and the conductive layer 125 using a printing process, which will not affect the wearing weight and is convenient for the user to be tested to wear and use it for a long time without interruption. The long-term monitoring of bioelectric signals, especially electrocardiogram, can help the user to be tested to more comprehensively monitor the health of the heart or potential diseases. Moreover, in a high-current treatment environment, such as the strong defibrillation current or the high voltage of the electric knife applied to the user to be tested, it will be conducted to the signal collection host 230 through the conductive layer 125, causing the host to be damaged by the strong current. Therefore, the biosignal collector 100 provided in the embodiment of the present application not only takes into account the lightness of wearing and is convenient for the user to be tested to wear it for a long time without interruption, but also takes into account the use requirements of the monitoring scene, ensuring that the wearable physiological signal collector 100 collects accurate bioelectric signals in real time, and the equipment is safer and more reliable.

[0054] The wearable 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 wearable physiological signal collector 100 to realize signal collection and storage recording. Multiple signal collection electrodes 120 collect bioelectric signals at least at three different positions, and transmit the bioelectric signals to the signal collection host 230 through the conductive layer 125. The present application proposes that the signal collection electrode 120 and the conductive layer 125 are conductively connected through the connecting layer 124 to ensure that the connecting layer 124 suppresses the influence of strong current on the bioelectric signals collected by the wearable physiological signal collector 100 on the basis of accurately collecting bioelectric signals. In this embodiment, the conductive layer 125, the signal collection electrode 120 and the connecting layer 124 can be printed on the flexible substrate 110 respectively by a printing process, and the conductive layer 125 and the signal collection electrode 120 are conductively connected through the connecting layer 124 to construct a more lightweight wearable product. Of course, the conductive layer 125, the signal collection electrode 120, and the conductive materials of the connecting layer 124 can also be adhered to the flexible substrate 110 respectively, and then the conductive materials can be removed using tools such as laser engraving or etching to obtain the conductive layer 125, the signal collection electrode 120, and the connecting layer 124, without limitation here.

[0055] Specifically, the present solution proposes to connect the conductive layer 125 and the signal collection electrode 120 respectively through the connecting layer 124 to achieve conductive connection, and the connecting layer 124 connects the conductive layer 125 and the signal collection electrode 120 respectively to construct a series circuit. The flexible substrate 110 can be made of PET sheet, which is more convenient to use and easier to prepare the connecting layer 124 and the conductive layer 125. The bioelectric signal collected by the signal collection electrode 120 is transmitted to the conductive layer 125 via the connecting layer 124. Even if the bioelectric signal carrying a strong current passes through the connecting layer 124, most of the energy is suppressed by the connecting layer 124 and will not be conducted to the signal collection host 230 by the conductive layer 125. Therefore, the signal collection host 230 records the physiological signal processed by the connecting layer 124. By setting the connecting layer 124, there is no need to introduce an additional defibrillation resistor device, which improves the suppression of energy leakage and reduces the product space size of the wearable physiological signal collector 100, which is conducive to building a lighter wearable physiological signal collector 100 and enriching and expanding the product application scenarios.

[0056] 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 a wearable physiological signal collector, and a conductive layer 125 and a signal collection electrode 120 are arranged on the flexible substrate 110.

[0057] The preparation process provided in this embodiment also includes:

[0058] Composite forming of the conductive layer 125 and the flexible substrate 110;

[0059] The conductive pattern of the conductive layer 125 is planned according to the design requirement of providing at least three signal collection electrodes 120 on the flexible substrate 110;

[0060] The conductive layer 125 is divided into a first lead portion 122, a lead layer 128 and a second lead portion 121 which are conductively connected; the first lead portion 122 is conductively connected to the signal collection electrode 120 through the connection layer 124; the second lead portion 121 is used for conductively connecting to the signal collection electrode 230;

[0061] A first connection region is formed at the connection between the first lead portion 122 and the connection layer 124;

[0062] A second connection region is formed at the connection between the signal collection electrode 120 and the connection layer 124;

[0063] The first connection region is electrically connected to the second connection region.

[0064] In this embodiment, in order to improve the accuracy of signal acquisition, the signal acquisition electrode 120 can be made of precious metals, such as silver, the first lead portion 122 can be made of at least one of conductive metals, conductive inks, conductive polymers or conductive carbon, and the connecting layer 124 can be made of at least one of conductive inks, conductive polymers and conductive carbon. It can be understood that, for example, the first lead portion 122 is made of conductive metals, such as aluminum, and the connecting layer 124 is made of conductive ink, but not conductive metals, because the signal acquisition electrode 120 made of silver chloride will react with the connecting layer 1247 made of conductive metal to increase signal interference. The connecting layer 124 and the first lead part 122 form a first connecting area, and the connecting layer 124 and the signal collection electrode 120 form a second connecting area. The first connecting area and the second connecting area are conductively connected, and the signal collection electrode 120 and the first lead part 122 are conductively connected through the first connecting area and the second connecting area. The conductive layer 125, the signal collection electrode 120 and the connecting layer 124 are designed separately to adapt to more usage environments and preparation requirements, thereby improving the applicability of the wearable physiological signal collector 100. Printing or coating technology can be used to make the connection between the connecting layer 124 and the signal collection electrode 120 and the first lead part 122 smoother and more uniform to ensure the lead quality.

[0065] In this embodiment, the first lead portion 122, the lead layer 128 and the second lead portion 121 can also be integrally formed. The signal collection electrode 120, the connection layer 124, the first lead portion 122, the second lead portion 121 and the lead layer 128 are printed on the flexible substrate 110 by printing, thereby ensuring that the coating of the signal collection electrode 120, the connection layer 124, the first lead portion 122, the second lead portion 121 and the lead layer 128 is uniform, and the signal transmission can be relatively stable. The wearable 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.

[0066] 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;

[0067] 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;

[0068] A connection layer 124 is formed on the surface of the first lead portion 122 and the signal collection electrode 120 by printing or coating process using at least one of conductive ink, conductive polymer, conductive carbon powder and metal material.

[0069] In one embodiment, the signal collection electrode 120 and the first lead part 122 are formed on the same layer of the flexible substrate 110; the first lead part 122 is provided to form a first opening 127, the signal collection electrode 120 is provided in the first opening 127, and the signal collection electrode 120 is conductively connected to the first lead part 122 through the connection layer 124, which can reduce the overall size of the physiological electrical signal collector 100. In addition, the processing difficulty of the connection layer 124 is reduced, and the product yield rate is improved. It is further understood that the connection layer 124 can conductively connect the first lead part 122 and the signal collection electrode 120 at any angle. The signal collection electrode 120 is arranged in the same layer as the first lead portion 122, that is, the first lead portion 122 is first printed on the flexible substrate 110, and then the signal collection electrode 120 is printed in the same layer, and the connection layer 124 is printed on the surface of the signal collection electrode 120. The connection layer 124 is used to connect the first lead portion 122 and the signal collection electrode 120 area respectively, so as to make it smoother and prevent the uneven printing of the connection layer 124 from affecting the accuracy and stability of signal collection. The gap between the signal collection electrode 120 and the first lead portion 122 forms an isolation portion, which is used to isolate the first lead portion 122 from direct contact with the signal collection electrode 120. The isolation portion can be an air barrier or an insulating layer. The purpose of the isolation portion is to prevent the conductive material of the first lead portion 122 from mixing with the conductive material of the signal collection electrode 120 to cause a chemical reaction, thereby affecting the signal collection accuracy of the signal collection electrode 120. Therefore, for the isolation part provided in the embodiment of the present application, it is possible to use different conductive materials to prepare the signal collection electrode 120 and the first lead part 122 without affecting the collection and transmission of bioelectric signals.

[0070] In one embodiment, the cross-sectional shape of the signal collection electrode 120 is set to be circular, the cross-sectional shape of the connection layer is annular, and the ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is greater than or equal to 0.1 and less than 1. Therefore, it can ensure that the signal collection electrode 120 is in absolute contact with the connection layer 124, and ensure that the process processing error avoids the uneven connection between the signal collection electrode 120 and the connection layer 124, which is prone to disconnection and other problems, thereby causing uneven signal transmission. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is 0.1, which prevents the area of ​​the connection layer 124 from being too large to affect signal transmission, resulting in obstruction of bioelectric signal transmission, such as long path, high resistance and other problems, thereby ensuring that the signal collection electrode 120 collects bioelectric signals more accurately, and the first lead part 122 transmits bioelectric signals more stably. More preferably, the cross-sectional shape of the signal collection electrode 120 is circular, and the diameter size range of the signal collection electrode 120 can be selected from 1 to 20 mm. The signal collection electrode 120, the first lead portion 122 and the connecting layer 124 can be better controlled and processed to facilitate the collection and transmission of bioelectric signals.

[0071] In one embodiment, a connection layer is provided on the side of the signal collection electrode 120 close to the skin of the user to be tested, and the connection layer 124 is provided with a second opening 126, and the second opening 126 is used to expose at least part of the conductive area of ​​the signal collection electrode 120, so that the conductive area of ​​the signal collection electrode 120 can be in direct contact with the skin of the human body to be tested, thereby ensuring that the signal collection electrode 120 can completely collect the human body bioelectric signal. The cross-sectional shape of the connection layer 124 is annular. The annular connection layer 124 ensures uniform connection with the signal collection electrode 120 and the first lead portion 122, respectively, to ensure the continuity of signal collection.

[0072] In one embodiment, a connection layer 124 is provided on the side of the signal collection electrode 120 away from the skin of the user to be tested, and the connection layer 124 covers at least a portion of the signal collection electrode 120, ensuring that the connection layer 124 is more firmly conductively connected to the signal collection electrode 120 and the first lead portion 122, respectively. Since the connection layer 124 is not in direct contact with the skin of the human body to be tested, it will not affect the signal collection electrode 120 to collect bioelectric signals, ensuring that the signal collection electrode 120 can stably contact the skin of the human body to be tested, ensuring the stability of signal collection. The cross-sectional shape of the connection layer 124 is circular. Through this design, the connection layer 124, the signal collection electrode 120, and the first opening of the first lead portion 122 are designed to be circular, and the overall product form design style is unified, which has more aesthetic value.

[0073] A flexible protective film is formed on the protective layer. The protective layer may be a protective layer made of insulating oil. The flexible protective film may be a protective film for insulation and having flexible properties, and may be made of a polymer material, such as polyethylene, polypropylene, etc. The flexible protective film can achieve the pressure resistance of the protective layer and prevent interference with the collection of ECG signals, so that the ECG signals can be effectively collected through the thin and flexible wearable physiological monitoring device 200, reducing the thickness of the device for collecting ECG signals.

[0074] Optionally, a die-cutting process may be further used to die-cut the flexible substrate 110, signal collection electrode 120, conductive layer 125, conductive connection point, protective layer, flexible protective film, etc. according to a preset pattern to obtain a printed die-cut finished product.

[0075] In one embodiment, a protective layer is formed on the surface of the conductive layer 125; the protective layer may cover the connection layer 124 or may not cover the connection layer 124, and the protective layer may not cover the signal collection electrode 120. In some specific embodiments, by forming a protective layer on the conductive layer 125 and forming a flexible protective film on the protective layer, the pressure resistance of the protective layer can be achieved, and interference with the collection of the electrocardiogram signal can be prevented, so that the electrocardiogram signal can be effectively collected through the thin and flexible wearable physiological monitoring device 200, and the thickness of the device for collecting the electrocardiogram signal can be reduced.

[0076] In one embodiment, an insulating protective layer is disposed on the side of the connection layer 124 and the first lead portion 122 facing away from the flexible substrate 110. Providing the insulating protective layer includes providing insulating protective oil and / or a flexible protective film on the side of the connection layer 124 and the first lead portion 122 facing away from the flexible substrate 110.

[0077] For example, a printing process can be used to form a layer of insulating oil on the conductive layer 125 as an insulating protective layer. A flexible protective film can be formed on the protective layer as another insulating protective layer. As an example, a finished flexible protective film can be directly covered on the protective layer as an insulating protective layer.

[0078] Embodiment 2:

[0079] An embodiment of the present application provides another preparation process of a wearable physiological signal collector, such as Figure 2 The preparation process is used to prepare a wearable physiological signal collector 100 with at least three different electrode points. The preparation process of the wearable physiological signal collector includes:

[0080] Providing a flexible substrate 110;

[0081] A conductive layer 125 is prepared on the surface of the flexible substrate 110 using a first conductive material.

[0082] On the surface of the flexible substrate 110, a second conductive material is used to prepare at least three signal collection electrodes 120 at different electrode points, and the second conductive material is different from the first conductive material;

[0083] An isolation portion is formed between the conductive layer 125 and the signal collection electrode 120, and the conductive layer 125 is isolated from direct contact with the signal collection electrode 120 by the isolation portion;

[0084] A connection layer 124 is prepared on the surface of the flexible substrate 110 using a third conductive material, and the conductive layer 125 is conductively connected to the signal collection electrode 120 through the connection layer 124; the third conductive material is different from the first conductive material and the second conductive material;

[0085] The connection layer 124 and the conductive layer 125 form a first connection area, the connection layer 124 and the signal collection electrode 120 form a second connection area, the first connection area and the second connection area are electrically connected, and the second conductive material in the second connection area does not chemically react with the third conductive material, and the first conductive material in the first connection area does not chemically react with the third conductive material, so as to ensure that the signal collection electrode 120 collects signals accurately.

[0086] In one embodiment, the first conductive material includes at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0087] The manufacturing process of the wearable physiological signal collector includes: composite molding of a flexible substrate 110 and a conductive layer 125 made of at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0088] A conductive pattern of the conductive layer 125 is planned according to the spatial distribution of at least three different electrode points;

[0089] The conductive layer 125 is processed according to the conductive pattern to obtain the first lead portion 122, the lead layer 128 and the second lead portion 121; the first lead portion 122 is conductively connected to the signal collection electrode 120 through the connecting layer 124;

[0090] The first lead portion 122 is electrically connected to the second lead portion 121 through the lead layer 128 .

[0091] 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 wearable physiological signal collector 100 also includes a bracket 210, and the conductive layer 125 includes a second lead portion 121 and a lead layer 128. The second lead portion 121 is fixed on the bracket 210. When the signal collection host 230 is installed on the bracket 210, the signal collection host 230 is conductively connected to the second lead portion 121. One end of the lead layer 128 is conductively connected to the first lead portion 122, and the other end is conductively connected to the second lead portion 121, so that the wearable physiological signal collector 100 can be connected to the signal collection host 230 through the bracket 210. The bioelectric signal is transmitted to the signal collection host 230 through the signal collection electrode 120, the connecting layer 124, the first connecting area, and the second connecting area. Preferably, the signal collection host 230 is detachably connected to the bracket 210, such as snap connection, threaded installation, concave-convex combination, etc., or a gripper is provided on the bracket 210 to be combined and installed with the signal collection host 230. The combined installation or separate disassembly methods are not listed one by one in this embodiment.

[0092] Specifically, the connection layer 124, the signal collection electrode 120 and the conductive layer 125 form a series circuit. In this embodiment, the resistance of the connection layer 124 is determined to be 1K to 50K ohms by adjusting the thickness of the connection layer 124 and / or adjusting the resistivity of the connection layer 124.

[0093] The flexible substrate 110 may be a base formed of a flexible material, and may be a flexible material having the advantages of being light, thin, transparent, flexible, and stretchable. For example, the flexible substrate 110 may be polyvinyl alcohol (PVA), polyester (PET), polyimide (PI), polyethylene naphthalate (PEN), etc. As an example, a PET film is used as the flexible substrate 110 of a wearable physiological signal collector, and a conductive layer 125 and a signal collection electrode 120 are arranged on the flexible substrate 110.

[0094] In one embodiment, the third conductive material includes at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0095] A connection layer 124 is formed on the surface of the first lead portion 122 and the signal collection electrode 120 by printing or coating process using at least one of conductive ink, conductive polymer, conductive carbon powder and metal material.

[0096] In this embodiment, the signal collection electrode 120 can use precious metals, such as silver, the first lead portion 122 can be made of at least one of conductive metals, conductive inks, conductive polymers or conductive carbon, and the connecting layer 124 can be made of at least one of conductive inks, conductive polymers and conductive carbon. It can be understood that, for example, the first lead portion 122 is made of conductive metals, such as aluminum, and the connecting layer 124 is made of conductive ink, but not conductive metals. The connecting layer 124 and the first lead part 122 form a first connecting area, and the connecting layer 124 and the signal collection electrode 120 form a second connecting area. The first connecting area and the second connecting area are conductively connected. The connecting layer 124 can conductively connect the signal collection electrode 120 and the first lead part 122 through the first connecting area and the second connecting area. The conductive layer 125, the signal collection electrode 120 and the connecting layer 124 are designed separately to adapt to more usage environments and preparation requirements, thereby improving the applicability of the wearable 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 part 122 smoother and more uniform to ensure the lead quality.

[0097] In one embodiment, the second conductive material includes silver chloride; the preparation process of the wearable 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.

[0098] In one embodiment, the first lead portion 122 is etched to form a first opening 127, and a silver chloride layer is formed in the first opening 127. The silver chloride layer is arranged in the same layer as the first lead portion 122, that is, the first lead portion 122 is first printed on the flexible substrate 110, and then the signal collection electrode 120 is printed in the same layer, and the connection layer 124 is printed on the surface of the signal collection electrode 120. In addition, the connection layer 124 connects the first lead portion 122 and the signal collection electrode 120 area respectively, which is more flat, and prevents the connection layer 124 from printing unevenly, resulting in accuracy and stability during the signal collection process. The gap between the silver chloride layer and the first lead portion 122 forms an isolation portion. Since silver chloride and other metal conductive materials will undergo a chemical replacement reaction, the chemical reaction will directly affect the accuracy of signal collection. The isolation portion solution provided in the embodiment of the present application can reduce the overall size of the physiological electrical signal collector 100. The signal collection electrode 120 is conductively connected to the first lead portion 122 through the connection layer 124, which greatly reduces the plane size of the physiological electrical signal collector 100. Moreover, the processing difficulty of the connection layer 124 is reduced, and the product yield is improved. It is further understood that the connection layer 124 can connect the first lead part 122 and the signal collection electrode 120 at any angle. The isolation part is used to isolate the conductive layer 125 from the signal collection electrode 120, ensuring that the signal collection electrode 120 and the first lead part 122 using different conductive materials will not affect signal collection due to material contact and mixing. In addition, the first lead part 122 is conductively connected to the signal collection electrode 120 through the conductive layer 125, and it is ensured that the first lead part 122 accurately and reliably transmits the bioelectric signal collected by the signal collection electrode 120.

[0099] In one embodiment, the cross-sectional shape of the etched silver chloride layer is circular, the cross-sectional shape of the etched connection layer 124 is annular, and the ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is greater than or equal to 0.1 and less than 1. In this embodiment, the ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is designed to be less than 1, so that it can ensure that there is a sufficient gap between the signal collection electrode 120 and the first lead part 122, thereby preventing the signal collection electrode 120 and the first lead part 122 from being directly connected or even overlapped due to a slight offset when preparing the signal collection electrode 120 and the first lead part 122, thereby causing uneven signal transmission. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is greater than 0.1, which prevents the area of ​​the connection layer 124 from being too large to affect signal transmission, resulting in obstruction of bioelectric signal transmission, such as long path, large resistance, etc., thereby ensuring that the signal collection electrode 120 collects bioelectric signals more accurately and the first lead part 122 transmits bioelectric signals more stably. More preferably, the cross-section of the signal collection electrode 120 is circular, and the diameter of the signal collection electrode 120 can be selected from 1 to 20 mm. The signal collection electrode 120 and the first lead portion 122 and the connecting layer 124 are better controlled and processed to facilitate the collection and transmission of bioelectric signals.

[0100] In one embodiment, the diameter of the silver chloride layer is 1 to 10 mm. More preferably, the cross-sectional shape of the signal collection electrode 120 is circular, and the diameter of the signal collection electrode 120 made of silver chloride can be selected from 1 to 20 mm. The signal collection electrode 120 and the corresponding first lead portion 122 and the connecting layer 124 are better controlled and processed to facilitate the collection and transmission of bioelectric signals.

[0101] Embodiment 3:

[0102] See also Figure 3 , Figure 4 , Figure 5 as well as Figure 6 ,like Figure 3 A wearable physiological signal collector 100 is provided in the first embodiment of the present application. The wearable physiological signal collector 100 is used to be worn on the skin of a user to be tested to obtain bioelectric signals. The signal collection host 230 can be detachably installed on the wearable physiological signal collector 100 to collect bioelectric signals. The bioelectric signals include electrocardiogram signals, electromyography signals, electroencephalogram signals, electrooculogram signals, etc.

[0103] The wearable physiological signal collector 100 includes a flexible substrate 110, on which a conductive layer 125 and a plurality of signal collection electrodes 120 are provided. The plurality of signal collection electrodes 120 are used to collect bioelectric signals from at least three different positions on the skin of the user to be tested, and the conductive layer 125 is used to conduct the bioelectric signals to the signal collection host 230. A connecting layer 124 is also provided on the flexible substrate 110, and the conductive layer 125 is conductively connected to the signal collection electrodes 120 through the connecting layer 124.

[0104] In the embodiment of the present application, a conductive layer 125 and a signal collection electrode 120 are prepared on a flexible substrate 110 according to a conductive pattern, and the conductive layer 125 and the signal collection electrode 120 are overlapped by a connecting layer 124 to achieve a conductive connection. The outer contour of the flexible substrate 110 is cut along the conductive layer 125 and the signal collection electrode 120 as needed, thereby forming the outer contour of the wearable physiological signal collector 100. The connecting layer 124, the signal collection electrode 120, and the conductive layer 125 form a series circuit. In the application of high-current treatment scenarios such as defibrillation or high-voltage electric knife, the connecting layer 124 added to the flexible substrate 110 can prevent the defibrillation energy from being conducted and leaked through the signal collection electrode 120 and the conductive layer 125, affecting the treatment effect, and will not affect the accuracy of the bioelectric signal collected by the signal collection electrode 120.

[0105] In one embodiment, the resistance of the connecting layer 124 is determined to be 1K to 50K ohms by adjusting the thickness of the connecting layer 124 and / or adjusting the resistivity of the connecting layer 124. Specifically, the resistivity of the connecting layer 124 can be adjusted by adjusting the square resistance or resistivity of the printed paste of the connecting layer 124, or the thickness of the connecting layer 124 is processed by a printing process to be 5μm-200μm to determine that the resistance of the connecting layer 124 is set to 1K to 50K ohms, so as to withstand the strong current caused by the medical defibrillator or electrostatic discharge, and prevent the signal collection host 230 from being destroyed by the strong current. This embodiment proposes that the connecting layer 124 made by the printing process is thin and light, with a thickness not exceeding 200μm, and is connected in series with the signal collection electrode 120 and the conductive layer 125, and does not require other lead connections, so it can replace the traditional defibrillation patch resistor that must be used in the monitoring equipment due to equipment safety requirements. The traditional patch resistor is too large in size and requires lead connections when used. It is bulky to use and cannot be used in compact physiological monitoring equipment applications. In particular, during the defibrillation treatment, the patient needs to withstand multiple strong defibrillation currents to restore heart function. If the connection layer 124 is not provided, the defibrillation energy will enter the signal collection host 230 through the signal collection electrode 120 and the conductive layer 125, causing the signal collection host 230 to be destroyed by the strong current. The resistance value of the connection layer 124 provided in this embodiment is measured to be 1K to 50K ohms, which can withstand multiple strong current shocks. After the cardiac defibrillation treatment is completed, the signal collection host 230 can still be used normally to collect and record bioelectric signals, thereby enhancing the reliability of the equipment. If the resistance value of the connection layer 124 is measured to be less than 1K ohms or greater than 50K ohms, signal noise will be generated, affecting the accuracy of bioelectric signal collection.

[0106] In one embodiment, the connection layer 124 is printed on the signal collection electrode 120 and the conductive layer 125 using a printing process, which will not affect the wearing weight, and is convenient for the user to be tested to wear it for a long time without interruption. The long-term monitoring of bioelectric signals, especially electrocardiogram, can help the user to be tested to more comprehensively monitor the health of the heart or potential diseases. Moreover, in a high-current treatment environment, such as the strong defibrillation current or the high voltage of the electric knife applied to the user to be tested, it will be conducted to the signal collection host 230 through the conductive layer 125, causing the host to be damaged by the strong current. Therefore, the biosignal collector 100 provided in the embodiment of the present application is not only light to wear, and convenient for the user to be tested to wear it for a long time without interruption, but also considers the use requirements of the monitoring scene, ensuring that the wearable physiological signal collector 100 collects accurate bioelectric signals in real time, and the equipment is safer and more reliable.

[0107] The wearable 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 wearable physiological signal collector 100 to realize signal collection and storage recording. The multiple signal collection electrodes 120 collect bioelectric signals at least at three different positions, and transmit the bioelectric signals to the signal collection host 230 through the conductive layer 125. The present application proposes that the signal collection electrode 120 and the conductive layer 125 are conductively connected through the connecting layer 124 to ensure that the connecting layer 124 suppresses the influence of strong current on the bioelectric signals collected by the wearable physiological signal collector 100 on the basis of accurately collecting bioelectric signals. In this embodiment, the conductive layer 125, the signal collection electrode 120 and the connecting layer 124 can be printed on the flexible substrate 110 respectively by a printing process, and the conductive layer 125 and the signal collection electrode 120 are conductively connected through the connecting layer 124 to construct a more portable wearable product. Of course, the conductive materials of the conductive layer 125, the signal collection electrode 120 and the connecting layer 124 can also be attached to the flexible substrate 110 respectively, and then laser engraved.

[0108] 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, so as to avoid the conductive layer 125 of different conductive materials from contacting with the signal acquisition electrode 120 to cause chemical reactions, such as chemical reactions, replacement reactions, or oxidation-reduction reactions, etc., which affect the accuracy of signal acquisition. The connecting layer 124 is prepared using a different third conductive material, wherein the second conductive material, the third conductive material, or the first conductive material, the third conductive material do not chemically react when in contact, thereby ensuring the accuracy of bioelectric signal acquisition and transmission. This embodiment can prepare a wearable physiological signal collector 100 that meets different usage scenarios according to actual product requirements, and the wearable physiological signal collector 100 provided in the embodiment of the present application fully considers the use requirements for high accuracy of signal acquisition in different scenarios, and prevents damage to the reliability of the device in different usage scenarios.

[0109] Among them, in a further embodiment, in order to meet the use requirements of more accurate bioelectric signal collection, the signal collection electrode 120 can use a second conductive material with higher signal collection accuracy, such as silver chloride, to ensure accurate and reliable collection of bioelectric signals. The conductive layer 125 uses a first conductive material different from the second conductive material to realize the signal transmission function, such as a conductive metal. The conductive layer 125 is prepared on the flexible substrate 110, and the conductive pattern is processed according to the electrode point design requirements of the wearable physiological signal collector 100; it can be processed by die cutting + laminating process or laminating + etching process or laminating + laser engraving process, and the commonly used conductive pattern processing method is not repeated here. At the preset electrode point, the signal collection electrode 120 is prepared, and a silver chloride layer is generally used. Silver plating can be used at the electrode point and then chlorinated to generate silver / silver chloride or printed and coated with a silver chloride coating; wherein, the conductive layer 125 is prepared using a conductive material for signal transmission, and different conductive materials are prone to contact reaction. For example, a chemical reaction will occur after silver chloride contacts with a conductive agent metal, such as chloride ions corroding the conductive metal, resulting in problems such as reduced signal transmission accuracy. Therefore, an isolation portion is provided between the signal collection electrode 120 and the conductive layer 125 to isolate the first conductive material that is prone to chemical reaction from being in direct contact with the second conductive material, thereby affecting the accuracy of signal transmission. For example, the isolation portion isolates the signal collection electrode 120 made of silver chloride from being in direct contact with the conductive layer 125 made of conductive metal.

[0110] 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.

[0111] In one embodiment, the conductive layer 125 includes a first lead portion 122, and an isolation portion (not shown in the figure) is provided between the first lead portion 122 and the signal collection electrode 120. The isolation portion is used to isolate the conductive layer 125 from the signal collection electrode 120, thereby ensuring that the signal collection electrode 120 and the first lead portion 122 using different conductive materials that are prone to chemical reactions in contact will not affect signal collection due to material contact and mixing. In addition, the first lead portion 122 and the signal collection electrode 120 are conductively connected through the connecting layer 124, and it is ensured that the first lead portion 122 accurately and reliably transmits the bioelectric signal collected by the signal collection electrode 120.

[0112] In one embodiment, the conductive materials selected for the connection layer 124, the signal collection electrode 120, and the first lead portion 122 are all different. The connection layer 124 and the first lead portion 122 form a first connection area, and the connection layer 124 and the signal collection electrode 120 form a second connection area. The first connection area and the second connection area are conductively connected. The connection layer 124 can conductively connect the signal collection electrode 120 and the first lead portion 122 through the first connection area and the second connection area. The conductive layer 125, the signal collection electrode 120, and the connection layer 124 are designed separately to adapt to more use environments and preparation requirements, thereby improving the applicability of the wearable 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 contacts the second conductive material. The third conductive material will not chemically react when in contact with the first conductive material. Generally, the signal collection electrode 120 is made of silver chloride, and the first lead 122 can be made of at least one of conductive metal, conductive ink, conductive polymer or conductive carbon. When the conductive layer 125 is made of metal, the connecting layer 124 can be made of at least one of conductive ink, conductive polymer and conductive carbon. It can be understood that, for example, the first lead 122 is made of conductive metal, such as aluminum, and the connecting layer 124 is made of conductive ink, but not conductive metal, because the signal collection electrode 120 made of silver chloride will react with the connecting layer 1247 made of conductive metal, which will increase signal interference. Ensure that the connecting layer 124 connects the signal collection electrode 120 with the conductive layer 125 and transmits stable signals.

[0113] In one embodiment, the first lead portion 122 and the signal collection electrode 120 are arranged in the same layer, that is, the first lead portion 122 is first printed on the flexible substrate 110, and then the signal collection electrode 120 is printed in the same layer, and the connection layer 124 is printed on the surface of the signal collection electrode 120. In addition, the connection layer 124 connects the first lead portion 122 and the signal collection electrode 120 area respectively to make it smoother, thereby preventing the uneven printing of the connection layer 124 from causing accuracy and stability in the signal collection process.

[0114] 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.

[0115] In one embodiment, the first lead portion 122 is provided with a first opening 127, the signal collection electrode 120 is arranged in the first opening 127, and the connection layer 124 is arranged at the first opening 127, that is, the connection layer 124 is conductively connected to one side of the first lead portion 122. This design can reduce the overall size of the physiological electrical signal collector 100. The signal collection electrode 120 is conductively connected to the first lead portion 122 through the connection layer 124, which greatly reduces the plane size of the physiological electrical signal collector 100. In addition, the processing difficulty of the connection layer 124 is reduced, and the product yield is improved. It is further understood that the connection layer 124 can connect the first lead portion 122 and the signal collection electrode 120 at any angle.

[0116] Specifically, the ratio of the inner diameter of the first lead portion 122 to the outer diameter of the connecting layer 124 is greater than or equal to 0.1 and less than 0.9, so that the connecting layer 124 and the first lead portion 122 are concentrically arranged, and the connecting area between the connecting layer 124 and the first lead portion 122 is annular, and the connecting layer 124 is evenly covered on the first lead portion 122, ensuring that the connecting layer 124 transmits the bioelectric signal collected by the signal acquisition electrode 120 to the first lead portion 122 without loss.

[0117] In one embodiment, the shape of the flexible substrate 110 corresponding to the position of the first lead portion 122 is circular, the first lead portion 122 is arranged at the center of the flexible substrate 110, the distance between the edge of the first lead portion 122 and the edge of the flexible substrate 110 is greater than or equal to 1.5 mm, and the edge of the flexible substrate 110 exceeds the edge of the first lead portion 122, which can protect the first lead portion 122 from being worn and damaged by the outside world, ensuring that signal transmission is not interfered with.

[0118] In one embodiment, the ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is greater than or equal to 0.1 and less than 1. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is designed to be less than 1, so that the signal collection electrode 120 can be in absolute contact with the connection layer 124, ensuring that the process error avoids uneven connection between the signal collection electrode 120 and the connection layer 124, which is prone to disconnection and other problems, thereby causing uneven signal transmission. The ratio of the diameter of the signal collection electrode 120 to the outer diameter of the connection layer 124 is greater than 0.1, preventing the area of ​​the connection layer 124 from being too large to affect signal transmission, resulting in obstruction of bioelectric signal transmission, such as long path, high resistance and other problems, thereby ensuring that the signal collection electrode 120 collects bioelectric signals more accurately, and the first lead portion 122 transmits bioelectric signals more stably. More preferably, the cross-sectional shape of the signal collection electrode 120 is circular, and the diameter size range of the signal collection electrode 120 can be selected from 1 to 20 mm. The signal collection electrode 120, the first lead portion 122 and the connecting layer 124 can be better controlled and processed to facilitate the collection and transmission of bioelectric signals.

[0119] In one embodiment, the connection layer 124 is disposed on the side of the signal collection electrode 120 close to the skin of the user to be tested, and the connection layer 124 is provided with a second opening 126, and the second opening 126 is used to expose at least part of the conductive area of ​​the signal collection electrode 120, so that the conductive area of ​​the signal collection electrode 120 can be in direct contact with the skin of the human body to be tested, thereby ensuring that the signal collection electrode 120 can completely collect the human body bioelectric signal. The cross-sectional shape of the connection layer 124 is annular. The annular connection layer 124 ensures uniform connection with the signal collection electrode 120 and the first lead portion 122, respectively, to ensure the continuity of signal collection.

[0120] In another embodiment, the connection layer 124 is arranged on the side of the signal collection electrode 120 away from the skin of the user to be tested, and the connection layer 124 covers at least a portion of the signal collection electrode 120, ensuring that the connection layer 124 is more firmly conductively connected to the signal collection electrode 120 and the first lead part 122, respectively. Since the connection layer 124 is not in direct contact with the skin of the human body to be tested, it will not affect the signal collection electrode 120 to collect bioelectric signals, ensuring that the signal collection electrode 120 can stably contact the skin of the human body to be tested, and ensuring the stability of signal collection. The cross-sectional shape of the connection layer 124 designed in this embodiment is circular. Through this design, the connection layer 124, the signal collection electrode 120, and the first opening of the first lead part 122 are designed to be circular, and the overall product form design style is unified, which has more aesthetic value.

[0121] In one embodiment, the first lead portion 122 and the signal collection electrode 120 are stacked, and the isolation portion is disposed between the first lead portion 122 and the signal collection electrode 120. The isolation portion uses an insulating layer to isolate the first lead portion 122 from contacting the signal collection electrode 120, thereby preventing the first lead portion 122 made of different conductive materials from contacting the signal collection electrode 120 and causing a chemical reaction, thereby affecting the accuracy of signal collection, and expanding different forms of products.

[0122] In another embodiment, the connecting layer 124 is disposed at the edges of the signal collection electrode 120 and the first lead portion 122, and the connecting layer 124 is not conductively connected to the isolation portion. This embodiment has lower process requirements when preparing the connecting layer 124. The connecting layer 124 only needs to conductively connect the signal collection electrode 120 and the first lead portion 122, thereby reducing the difficulty of preparation.

[0123] In another embodiment, the connection layer 124 is disposed between the signal collection electrode 120 and the first lead portion 122 . The connection layer 124 may cover the signal collection electrode 120 so that the signal collection electrode 120 and the first lead portion 122 are spatially isolated and conductively connected.

[0124] In one embodiment, the conductive layer 125 includes a second lead portion 121 and a lead layer 128, the second lead portion 121 is used for conductive communication with the signal collection host 230, one end of the lead layer 128 is conductively connected to the first lead portion 122, and the other end is conductively connected to the second lead portion 121, so as to realize the conductive connection between the wearable physiological signal collector 100 and the signal collection host 230, and the bioelectric signal collected by the signal collection electrode 120 is transmitted to the signal collection host 230 through the connecting layer 124, the first lead portion 122, the lead layer 128 and the second lead portion 121. In this embodiment, the first lead portion 122, the lead layer 128 and the second lead portion 121 can also be integrally formed.

[0125] In one embodiment, the signal collection electrode 120, the connecting layer 124, the first lead portion 122, the second lead portion 121 and the lead layer 128 are printed on the flexible substrate 110, thereby ensuring that the coating of the signal collection electrode 120, the connecting layer 124, the first lead portion 122, the second lead portion 121 and the lead layer 128 is uniform, and the signal transmission can be relatively stable.

[0126] In one embodiment, the wearable physiological signal collector 100 also includes a bracket 210, and the bracket 210 and the adjacent signal collection electrode 120 are fixed on the skin of the user to be tested using an adhesive sticker 130, which is more convenient for the user. The protective layer of the adhesive sticker 130 is torn off to fix the signal collection electrode 120 on the skin of the user to be tested, and the relative position of the signal collection electrodes 120 sharing the adhesive sticker 130 is determined, and one piece of adhesive sticker 130 can fix more signal collection electrodes 120 at the same time, which is easier to operate. Preferably, the signal collection host 230 is detachably connected to the bracket 210, such as a snap connection, 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.

[0127] 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. Among them, two adjacent signal acquisition electrodes 120 are located above the bracket 210, and can share a sticker 130. One sticker 130 fixes two adjacent signal acquisition electrodes 120 and the bracket 210 on the human skin at the same time, which is convenient for installation. For single-lead products, as long as they are installed at any position on the human chest skin, physiological electrical signals can be collected, and they can be widely used in real-time monitoring in the fields of electrocardiography, electroencephalography, electromyography and electrooculography. This embodiment provides a demonstration of the installation of a single-lead product, and the bracket 210 is fixedly installed on the midline of the human sternum, and the signal acquisition electrode 120 is installed on the human skin along the conductive layer 125. It can be seen that only the bracket 210 needs to be fixed, and the installation point of the signal acquisition electrode 120 can be fixed, providing a more convenient installation method, which is suitable for users to use remotely at home. Among them, the variation example of the single-conductor product only needs to satisfy the requirement that three signal collection electrodes 120 are provided, and the specific design method of the signal collection electrode 120 is protected in this embodiment.

[0128] In one embodiment, four signal collection electrodes 120 are provided, that is, this embodiment provides a three-conductor product embodiment, at least two signal collection electrodes 120 are arranged adjacent to each other. In this embodiment, two adjacent signal collection electrodes 120 are located below the bracket 210, and one adhesive sticker 130 can be used respectively. The third signal collection electrode 120 is located above the bracket 210, and the fourth signal collection electrode 120 is located above the bracket 210. The two signal collection electrodes 120 located above the bracket 210 use one adhesive sticker 130 respectively. Among them, the bracket 210 and the signal collection electrode 120 can share one adhesive sticker 130. Similar to the previous embodiment, only the bracket 210 needs to be fixed, and the installation point of the signal collection electrode 120 can be fixed, providing a more convenient installation method, which is suitable for users to use remotely at home, and further improves the applicability of the product. Among them, the variation of the three-conductor product only needs to meet the requirement that four signal collection electrodes 120 are provided, and the specific design method of the signal collection electrode 120 is protected in this embodiment.

[0129] In the above embodiment, since the number of signal acquisition electrodes 120 is small, that is, there are three or four signal acquisition electrodes 120, the signal acquisition electrodes 120 can be installed on the human skin according to the product instructions, without strict usage requirements, which is convenient for home care use, lowering the usage threshold, allowing more users to obtain bioelectric signal data through the wearable physiological signal collector 100, even special groups can use it conveniently, further expanding the user group of the product. In addition, this product uses an adhesive patch 130 for application on the skin, and as a disposable product, it is more convenient to promote home care use.

[0130] In one embodiment, ten signal collection electrodes 120 are provided, and at least two signal collection electrodes 120 are provided adjacent to each other. The ten signal collection electrodes 120 include six chest lead electrodes and four limb electrodes, and the collected bioelectric signals are richer. For the bioelectric signal analysis system or monitoring system, rich bioelectric signals are provided to ensure that the processing results are more accurate and meet the medical analysis needs.

[0131] In one embodiment, a defibrillator resistor 163 is provided on the lead layer 128. The defibrillator resistor 163 is capable of withstanding the strong current caused by a medical defibrillator or electrostatic discharge. The overcurrent generated by the defibrillator device is processed by the defibrillator resistor 163 to avoid affecting signal collection, thereby ensuring the safe use of the signal collection host 230.

[0132] An embodiment of the present application also provides a wearable physiological monitoring device 200, including the wearable physiological signal collector 100 of the above embodiment, which will greatly expand the usage scenarios and provide more accurate bioelectric signal monitoring functions for target users.

[0133] In one embodiment, the wearable physiological monitoring device 200 further includes a signal collection host 230 which is assembled with or separated from the wearable physiological signal collector 100 , and the signal collection host 230 is used to collect and record bioelectric signals.

[0134] 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 wearable physiological signal collector 100 in the above embodiment.

[0135] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0136] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A preparation process of a wearable physiological signal collector, characterized in that: The process comprises: Providing a flexible substrate (110); Preparing a conductive layer (125) on the surface of the flexible substrate (110); Prepare at least three signal collection electrodes (120) at different electrode points on the surface of the flexible substrate (110); A connection layer (124) is printed 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, and the conductive layer (125) is isolated from contact with the signal collection electrode (120).

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

3. The preparation process of the wearable physiological signal collector according to claim 2, characterized in that: The conductive layer (125) is prepared using a first conductive material, and a first connection region is formed at the connection between the conductive layer (125) and the connection layer (124). In the first connection region, the first conductive material and the third conductive material are in contact without chemical reaction.

4. The preparation process of the wearable physiological signal collector according to claim 3, characterized in that: The signal collection electrode (120) is prepared using a second conductive material different from the first conductive material, and a second connection region is formed at the connection between the signal collection electrode (120) and the connection layer (124). In the second connection region, the second conductive material and the third conductive material do not chemically react when in contact, and the first connection region is conductively connected to the second connection region via the connection layer (124).

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

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

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

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

9. The preparation process of the wearable physiological signal collector according to claim 1, characterized in that: An isolation portion is formed in the gap between the conductive layer (125) and the signal collection electrode (120), and the isolation portion is used to isolate the conductive layer (125) from contact with the signal collection electrode (120).

10. The preparation process of the wearable physiological signal collector according to claim 9, characterized in that: The conductive layer (125) is divided to form a conductively connected first lead portion (122), the first lead portion (122) is arranged to form a first opening (127), the signal collection electrode (120) is arranged in the first opening (127), and the signal collection electrode (120) is conductively connected to the first lead portion (122) via a connection layer (124).

11. The preparation process of the wearable physiological signal collector according to claim 10, characterized in that: The gap area between the first lead part (122) and the signal collection electrode (120) constitutes the isolation part.

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

13. A preparation process of a wearable physiological signal collector, characterized in that: The preparation process of the wearable physiological signal collector comprises: Providing a flexible substrate (110); Preparing a conductive layer (125) on the surface of the flexible substrate (110); Prepare at least three signal collection electrodes (120) at different electrode points on the surface of the flexible substrate (110); A connection layer (124) is printed 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 conductive layer (125) is prepared using a first conductive material; and the signal collection electrode (120) is prepared using a second conductive material different from the first conductive material.

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

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

16. The preparation process of the wearable physiological signal collector according to any one of claims 13 to 15, characterized in that: The conductive layer (125) is divided to form a first conductively connected lead portion (122), and a first connection region is formed between the connection layer (124) and the first lead portion (122).

17. The preparation process of the wearable physiological signal collector according to claim 16, characterized in that: A second connection region is formed between the connection layer (124) and the signal collection electrode (120), and the first connection region is conductively connected to the second connection region through the connection layer (124).

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

19. The preparation process of the wearable physiological signal collector according to claim 17, characterized in that: The first conductive material is at least one of conductive metal, conductive ink, conductive polymer or conductive carbon.

20. The preparation process of the wearable physiological signal collector according to claim 14, characterized in that: The third conductive material includes at least one of conductive ink, conductive polymer, conductive carbon powder and metal material.

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

22. The preparation process of the wearable physiological signal collector according to claim 16, characterized in that: The gap area between the signal collection electrode (120) and the first lead part (122) forms an isolation part, and the isolation part is used to prevent the conductive material of the first lead part (122) from mixing with the conductive material of the signal collection electrode (120) to cause a chemical reaction.

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

24. The preparation process of the wearable physiological signal collector according to claim 23, characterized in that: The isolation portion is an air barrier or an insulating layer.

25. A preparation process of a wearable physiological signal collector, characterized in that: The preparation process of the wearable physiological signal collector comprises: Providing a flexible substrate (110); A conductive layer (125) is prepared on the surface of the flexible substrate (110), wherein the conductive layer (125) is used to conduct the bioelectric signal to a signal collection host (230); Prepare at least three signal collection electrodes (120) at different electrode points on the surface of the flexible substrate (110); A connection layer (124) is prepared on the surface of the flexible substrate (110), the connection layer (124) is used to suppress energy from being transmitted to a signal collection host (230) via a conductive layer (125), the signal collection electrode (120), the connection layer (124) and the conductive layer (125) form a series conductive connection; the conductive layer (125) is prepared using a first conductive material; and the signal collection electrode (120) is prepared using a second conductive material different from the first conductive material.

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

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

28. According to the preparation process of the wearable physiological signal collector according to claim 25, the conductive layer (125) and the flexible substrate (110) are composite-molded.

29. The preparation process of the wearable physiological signal collector according to claim 25, characterized in that: The conductive layer (125) is divided into a conductively connected first lead portion (122), a lead layer (128) and a second lead portion (121); the second lead portion (121) is used for conductively connecting to a signal collection host (230).

30. The preparation process of the wearable physiological signal collector according to claim 29, characterized in that: The signal collection electrode (120) and the first lead portion (122) are formed on the same layer of the flexible substrate (110); An isolation portion is formed in the gap between the signal collection electrode (120) and the first lead portion (122), and the isolation portion is used to isolate the first lead portion (122) from direct contact with the signal collection electrode (120).

31. The preparation process of the wearable physiological signal collector according to claim 25, characterized in that: The cross-sectional shape of the signal collection electrode (120) is set to be circular, and the cross-sectional shape of the connection layer (124) is set to be ring-shaped.

32. The preparation process of the wearable physiological signal collector according to claim 25, characterized in that: A protective layer is formed on the surface of the conductive layer (125).

33. A wearable physiological signal collector, characterized in that: The wearable physiological signal collector is manufactured using the preparation process of any one of claims 1 to 32, wherein the signal collection electrodes (120) are provided in plurality, and at least two adjacent signal collection electrodes (120) are attached to the body of the user to be tested using a piece of adhesive tape (130).

34. A physiological monitoring system, characterized in that: Includes the bioelectric signal collector (100) described in claim 33.

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