Wearable physiological signal acquisition device and its manufacturing process, physiological monitoring system

Abstract

This application relates to a wearable physiological signal acquisition device, its fabrication process, and a physiological monitoring system. The fabrication process of the aforementioned wearable physiological signal acquisition device involves preparing a conductive layer and multiple signal acquisition electrodes on a flexible substrate. A connecting layer is used to conductively connect the signal acquisition electrodes and the conductive layer. In special treatment scenarios, the connecting layer helps prevent energy leakage applied to the user's body surface and also inhibits energy transmission via the conductive layer to the signal collection host, thus preventing damage to the host.

Description

[0001] This invention patent application is a divisional application of Chinese invention patent application filed on September 11, 2024, with application number 2024112691023 and titled "Wearable physiological signal acquisition device and its preparation process, physiological monitoring system". Technical Field

[0002] This application relates to the field of medical device technology, and in particular to wearable physiological signal acquisition devices and their manufacturing processes and physiological monitoring systems. Background Technology

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

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

[0005] In specific application scenarios, such as defibrillation and electrosurgical treatment, a strong current is applied to the body of the patient to achieve therapeutic goals. In these cases, a wearable physiological signal acquisition device worn by the patient serves as an auxiliary monitoring tool. It needs to monitor bioelectrical signals simultaneously with the treatment to reflect changes in the patient's physiological characteristics. However, defibrillation and electrosurgical treatments have strict requirements regarding energy consumption, and the wearable physiological signal acquisition device must be designed with extremely high safety standards. Specifically, the device must not consume treatment energy, and the strong current must be prevented from damaging the device. Therefore, ensuring the accuracy of bioelectrical signal acquisition while eliminating interference from treatment signals has become a critical problem that needs to be solved. Summary of the Invention

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

[0007] One embodiment of this application provides a fabrication process for a wearable physiological signal acquisition device, the process comprising:

[0008] Provide flexible substrates;

[0009] A conductive layer is prepared on the surface of the flexible substrate;

[0010] At least three signal acquisition electrodes with different electrode sites are fabricated on the surface of the flexible substrate;

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

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

[0013] The conductive layer is composited with the flexible substrate;

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

[0015] A first connection area is formed at the connection between the first lead portion and the connection layer;

[0016] A second connection region is formed at the junction of the signal acquisition electrode and the connection layer;

[0017] The first connection region and the second connection region are electrically connected.

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

[0019] A first opening is formed in the first lead portion, and the signal acquisition electrode is disposed in the first opening;

[0020] An isolation portion is formed in the gap between the signal acquisition electrode and the first lead portion, and the isolation portion is used to prevent the first lead portion from directly contacting the signal acquisition electrode.

[0021] The first connection area and the second connection area are respectively disposed on both sides of the isolation part.

[0022] In another embodiment, the connecting layer is disposed on the side of the signal acquisition electrode closer to the skin of the user being tested;

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

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

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

[0026] In another embodiment, the ratio of the inner diameter of the first guide portion to the outer diameter of the connecting layer is set to 0.1 to 0.9.

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

[0028] This application also provides a wearable physiological signal acquisition device, which is manufactured using the above-described manufacturing process for wearable physiological signal acquisition devices. The device includes multiple signal acquisition electrodes, with at least two adjacent electrodes attached to the body of the user under test using a single adhesive patch.

[0029] This application also provides a physiological monitoring system, including the wearable physiological signal acquisition device described above.

[0030] The wearable physiological signal acquisition device fabrication process provided in this application uses a conductive connection layer to connect the signal acquisition electrode and the conductive layer. This ensures that, in special treatment scenarios, the connection layer prevents the leakage of treatment energy applied to the surface of the user's body through the conductive layer, and also inhibits the transmission of energy through the conductive layer to the signal collection host, thus preventing damage to the host. Attached Figure Description

[0031] Figure 1 This is a process flow diagram of a wearable physiological signal acquisition device according to one embodiment;

[0032] Figure 2 This is a process flow diagram of a wearable physiological signal acquisition device according to another embodiment;

[0033] Figure 3 A schematic diagram illustrating the separation of the wearable physiological signal acquisition device and the signal collection host provided in an embodiment of this application;

[0034] Figure 4 for Figure 3 Exploded view;

[0035] Figure 5This is a schematic diagram of a wearable physiological signal acquisition device provided in an embodiment of this application;

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

[0037] Explanation of icon numbers:

[0038] 100-Wearable physiological signal acquisition device; 110-Flexible substrate; 120-Signal acquisition electrode; 121-Second lead; 122-First lead; 124-Connecting layer; 125-Conductive layer; 126-Second opening; 127-First opening; 128-Lead layer; 130-Adhesive patch; 163-Defibrillator resistor; 200-Wearable physiological monitoring device; 210-Stabilizer; 230-Signal collection host. Detailed Implementation

[0039] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0040] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0041] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0042] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0043] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

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

[0045] Example 1:

[0046] One embodiment of this application provides a fabrication process for a wearable physiological signal acquisition device, such as... Figure 1 The fabrication process is used to fabricate a wearable physiological signal acquisition device 100 with at least three different electrode sites. The fabrication process of the wearable physiological signal acquisition device includes:

[0047] Provide flexible substrate 110;

[0048] A conductive layer 125 is prepared on the surface of the flexible substrate 110;

[0049] At least three signal acquisition electrodes 120 with different electrode sites are fabricated on the surface of the flexible substrate 110;

[0050] A connection layer 124 is fabricated on the surface of a flexible substrate 110. The signal acquisition electrode 120, the connection layer 124, and the conductive layer 125 are connected in series and conductively connected. The thickness of the connection layer 124 is 5μm-200μm.

[0051] In this embodiment, a conductive layer 125, a signal acquisition electrode 120, and a connection layer 124 are respectively fabricated on the flexible substrate 110. The connection layer 124, the signal acquisition electrode 120, and the conductive layer 125 form a series circuit, realizing the conductive connection between the connection layer 124, the conductive layer 125, and the signal acquisition electrode 120. In this embodiment, the thickness of the connection layer 124 is 5μm-200μm and / or the resistance of the connection layer 124 is set to 1K-50K ohms to withstand the strong current caused by medical defibrillators or electrostatic discharge, and to prevent the signal collection host 230 from being destroyed by the strong current. This embodiment proposes a thin and lightweight connecting layer 124 manufactured using a printing process. The product has a compact structure and a thickness not exceeding 200 μm. The connecting layer 124 is connected in series with the signal acquisition electrode 120 and the conductive layer 125, requiring no other lead connections. This can replace the traditional defibrillator patch resistors that are necessary for safety in monitoring equipment. Traditional patch resistors are bulky and require lead connections, making them unsuitable for compact physiological monitoring devices. Furthermore, the product provided in this embodiment, due to its lightweight and miniaturized structure, is also suitable for home remote monitoring. Especially during defibrillation treatment, patients need to withstand multiple high-current defibrillation events to restore cardiac function. Without the connecting layer 124, defibrillation energy would pass through the signal acquisition electrode 120 and the conductive layer 125 into the signal collection host 230, potentially causing the host to be destroyed by the high current. The resistance of the connection layer 124 provided in this embodiment is 1K to 50K ohms, which can withstand multiple strong current surges. After the cardiac defibrillation treatment is completed, the signal collection host 230 can still be used normally to collect and record bioelectric signals, thus enhancing the reliability of the equipment. If the resistance of the connection layer 124 is less than 1K ohms or greater than 50K ohms, signal noise will be generated, affecting the accuracy of bioelectric signal acquisition.

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

[0053] In one embodiment, to provide a more convenient wearing experience, the connecting layer 124 is printed onto the signal acquisition electrode 120 and the conductive layer 125 using a printing process. This does not affect the wearing weight and allows the user to wear it continuously for extended periods. Long-term monitoring of bioelectrical signals, especially electrocardiograms, can help the user more comprehensively monitor their heart health or potential diseases. Furthermore, in high-current treatment environments, such as defibrillation currents or electrosurgical high voltages applied to the user, the conductive layer 125 will conduct the current to the signal collection host 230, potentially damaging the host. Therefore, the biosignal acquisition device 100 provided in this embodiment not only considers lightweight wear for continuous use by the user but also takes into account the requirements of monitoring scenarios, ensuring that the wearable physiological signal acquisition device 100 collects accurate bioelectrical signals in real time, making the device safer and more reliable.

[0054] A wearable physiological signal acquisition device 100 is worn on the skin of the user to acquire bioelectrical signals. A signal collection host 230 is installed on the wearable physiological signal acquisition device 100 to collect and store signals. Multiple signal acquisition electrodes 120 collect bioelectrical signals from at least three different locations and transmit the bioelectrical signals to the signal collection host 230 through a conductive layer 125. This application proposes that the signal acquisition electrodes 120 and the conductive layer 125 are electrically connected through a connecting layer 124 to ensure accurate acquisition of bioelectrical signals while suppressing the influence of strong current on the bioelectrical signals collected by the wearable physiological signal acquisition device 100. In this embodiment, a printing process can be used to print the conductive layer 125, the signal acquisition electrodes 120, and the connecting layer 124 on a flexible substrate 110, respectively. The conductive layer 125 and the signal acquisition electrodes 120 are electrically connected through the connecting layer 124, thus constructing a more lightweight wearable product. Alternatively, the conductive materials of the conductive layer 125, the signal acquisition electrode 120, and the connection layer 124 can be respectively attached to the flexible substrate 110, and then the conductive materials can be removed using laser engraving or etching tools to obtain the conductive layer 125, the signal acquisition electrode 120, and the connection layer 124. No limitation is imposed here.

[0055] Specifically, this solution proposes to achieve conductive connection by connecting the conductive layer 125 and the signal acquisition electrode 120 through the connecting layer 124, thereby constructing a series circuit. The flexible substrate 110 can be made of PET sheet, which is more convenient to use and makes it easier to fabricate the connecting layer 124 and the conductive layer 125. The bioelectrical signal collected by the signal acquisition electrode 120 is conducted to the conductive layer 125 through the connecting layer 124. Even if the bioelectrical signal carrying a strong current passes through the connecting layer 124, most of the energy is suppressed by the connecting layer 124 and will not be conducted to the signal collection host 230 by the conductive layer 125. Therefore, the signal collection host 230 records the physiological signal processed by the connecting layer 124. By setting the connecting layer 124, it is not necessary to introduce an additional defibrillator device, which reduces the product space size of the wearable physiological signal acquisition device 100 while improving the suppression of energy leakage. This is conducive to building a lighter wearable physiological signal acquisition device 100 and enriching and expanding the product application scenarios.

[0056] Specifically, the flexible substrate 110 can be a substrate formed of a flexible material, which can be a flexible material with advantages such as being thin, transparent, flexible and stretchable. For example, the flexible substrate 110 can be polyvinyl alcohol (PVA), polyester (PET), polyimide (PI), polyethylene naphthalate (PEN), etc. As an example, a PET film is used as the flexible substrate 110 of a wearable physiological signal acquisition device, and a conductive layer 125 and a signal acquisition electrode 120 are disposed on the flexible substrate 110.

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

[0058] The conductive layer 125 is composite-formed with the flexible substrate 110;

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

[0060] The conductive layer 125 is divided into a first conductive part 122, a conductive layer 128, and a second conductive part 121. The first conductive part 122 is electrically connected to the signal acquisition electrode 120 through the connecting layer 124. The second conductive part 121 is used to be electrically connected to the signal collection electrode 230.

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

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

[0063] The first connection region and the second connection region are electrically connected.

[0064] In this embodiment, to improve the accuracy of signal acquisition, the signal acquisition electrode 120 can be made of precious metals, such as silver. The first lead 122 can be made of at least one of conductive metal, conductive ink, conductive polymer, or conductive carbon. The connecting layer 124 can be made of at least one of conductive ink, conductive polymer, or conductive carbon. This can be understood as follows: for example, the first lead 122 can be made of conductive metal, such as aluminum, and the connecting layer 124 can be made of conductive ink. However, conductive metal cannot be used because a chemical reaction will occur when the signal acquisition electrode 120 made of silver chloride comes into contact with the connecting layer 1247 made of conductive metal, which will increase signal interference. The connecting layer 124 and the first lead portion 122 form a first connecting region, and the connecting layer 124 and the signal acquisition electrode 120 form a second connecting region. The first connecting region and the second connecting region are electrically connected. The signal acquisition electrode 120 and the first lead portion 122 are electrically connected through the first connecting region and the second connecting region. The separate design of the conductive layer 125, the signal acquisition electrode 120 and the connecting layer 124 is used to adapt to more usage environments and manufacturing requirements, which improves the applicability of the wearable physiological signal acquisition device 100. Printing or coating processes can be used to make the connection between the connecting layer 124 and the signal acquisition electrode 120 and the first lead portion 122 smoother and more uniform, ensuring the quality of the lead.

[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 acquisition electrode 120, the connecting layer 124, the first lead portion 122, the second lead portion 121, and the lead layer 128 are printed on the flexible substrate 110 by printing, thereby ensuring that the coating of the signal acquisition electrode 120, the connecting layer 124, the first lead portion 122, the second lead portion 121, and the lead layer 128 is uniform, and the signal transmission can be relatively stable. The wearable physiological signal acquisition device 100 also includes a support 210. The second lead 121 is exposed and installed on the support 210. When the signal collection host 230 is installed on the support 210, the signal collection host 230 is electrically connected to the second lead 121. One end of the lead layer 128 is electrically connected to the first lead 122, and the other end is electrically connected to the second lead 121. The bioelectric signal is transmitted to the signal collection host 230 through the signal acquisition electrode 120, the first lead 121, the first connection area, the lead layer 128, the second connection area, and the second lead 121, thereby achieving the purpose of signal transmission.

[0066] In one embodiment, the material used to prepare the conductive layer 125 includes at least one of conductive ink, conductive polymer, conductive carbon powder, and metallic material;

[0067] In one embodiment, the material used to prepare the connecting layer 124 includes at least one of conductive ink, conductive polymer, conductive toner, and metallic material;

[0068] A connecting layer 124 is formed on the surface of the first lead portion 122 and the signal acquisition electrode 120 using at least one of conductive ink, conductive polymer, conductive carbon powder, and metallic material through printing or coating processes.

[0069] In one embodiment, the signal acquisition electrode 120 and the first lead portion 122 are formed on the same layer of the flexible substrate 110. The first lead portion 122 is provided with a first opening 127, and the signal acquisition electrode 120 is disposed within the first opening 127. The signal acquisition electrode 120 is electrically connected to the first lead portion 122 through a connecting layer 124, which can reduce the overall size of the physiological electrophysiological signal acquisition device 100. Furthermore, it reduces the processing difficulty of the connecting layer 124 and improves the product yield. Further understanding is that the connecting layer 124 can electrically connect the first lead portion 122 and the signal acquisition electrode 120 at any angle. The signal acquisition electrode 120 and the first lead portion 122 are disposed on the same layer. That is, the first lead portion 122 is first printed on the flexible substrate 110, and then the signal acquisition electrode 120 is printed on the same layer. A connection layer 124 is printed on the surface of the signal acquisition electrode 120. The area connecting the first lead portion 122 and the signal acquisition electrode 120 using the connection layer 124 is flatter, preventing uneven printing of the connection layer 124 from affecting the accuracy and stability of signal acquisition. The gap between the signal acquisition electrode 120 and the first lead portion 122 forms an isolation portion. The isolation portion is used to prevent the first lead portion 122 from directly contacting the signal acquisition electrode 120. The isolation portion can be an air gap or an insulating layer. The purpose of the isolation portion is to prevent the conductive material of the first lead portion 122 from mixing and contacting with the conductive material of the signal acquisition electrode 120, which could cause a chemical reaction and affect the signal acquisition accuracy of the signal acquisition electrode 120. Therefore, the isolation section provided in this application embodiment can be fabricated using different conductive materials to prepare the signal acquisition electrode 120 and the first lead section 122 without affecting the acquisition and transmission of bioelectric signals.

[0070] In one embodiment, the cross-sectional shape of the signal acquisition electrode 120 is circular, and the cross-sectional shape of the connecting layer is annular. The ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connecting layer 124 is greater than or equal to 0.1 and less than 1. This ensures absolute contact between the signal acquisition electrode 120 and the connecting layer 124, preventing uneven connection due to manufacturing errors and potential breakage, which could lead to uneven signal transmission. The ratio of 0.1 between the diameter of the signal acquisition electrode 120 and the outer diameter of the connecting layer 124 prevents the connecting layer 124 from being too large, which could hinder signal transmission and cause problems such as long paths and high resistance. This ensures that the signal acquisition electrode 120 acquires bioelectric signals more accurately, and the first lead 122 transmits bioelectric signals more stably. More preferably, the cross-sectional shape of the signal acquisition electrode 120 is circular, and the diameter of the signal acquisition electrode 120 can be selected from 1 to 20 mm. Better control of the processing signal acquisition electrode 120 and the first lead 122, and the connecting layer 124, facilitates the acquisition and transmission of bioelectric signals.

[0071] In one embodiment, a connecting layer is disposed on the side of the signal acquisition electrode 120 near the skin of the user being tested. The connecting layer 124 has a second opening 126, which exposes at least a portion of the conductive area of ​​the signal acquisition electrode 120, allowing the conductive area of ​​the signal acquisition electrode 120 to directly contact the skin of the user being tested, thereby ensuring that the signal acquisition electrode 120 can completely acquire the bioelectrical signals of the human body. The cross-sectional shape of the connecting layer 124 is annular. The annular connecting layer 124 ensures uniform connection with the signal acquisition electrode 120 and the first lead portion 122, respectively, ensuring the continuity of signal acquisition.

[0072] In one embodiment, a connecting layer 124 is positioned on the side of the signal acquisition electrode 120 away from the user's skin. The connecting layer 124 covers at least a portion of the signal acquisition electrode 120, ensuring a more secure conductive connection between the connecting layer 124 and both the signal acquisition electrode 120 and the first lead portion 122. Since the connecting layer 124 does not directly contact the user's skin, it does not affect the bioelectrical signal acquisition by the signal acquisition electrode 120, ensuring stable contact between the signal acquisition electrode 120 and the user's skin, thus guaranteeing stable signal acquisition. The connecting layer 124 has a circular cross-sectional shape. This design, with the connecting layer 124, the signal acquisition electrode 120, and the first opening of the first lead portion 122 all circular, creates a unified overall product design style and enhances aesthetic appeal.

[0073] A flexible protective film is formed on the protective layer. The protective layer can be made of insulating oil. The flexible protective film is an insulating and flexible protective film, made of polymer materials such as polyethylene and polypropylene. The flexible protective film enables the protective layer to withstand pressure and prevents interference with the acquisition of electrocardiogram (ECG) signals. This allows for effective acquisition of ECG signals using a thin, flexible, wearable physiological monitoring device 200, reducing the thickness of the ECG signal acquisition equipment.

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

[0075] In one embodiment, a protective layer is formed on the surface of the conductive layer 125; the protective layer may or may not cover the connecting layer 124, and the protective layer may not cover the signal acquisition electrode 120. In some specific embodiments, by forming a protective layer on the conductive layer 125 and forming a flexible protective film on the protective layer, the protective layer can withstand pressure and prevent interference with the acquisition of ECG signals, thereby enabling effective acquisition of ECG signals through a thin and flexible wearable physiological monitoring device 200, reducing the thickness of the device for acquiring ECG signals.

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

[0077] For example, an insulating oil layer can be formed on the conductive layer 125 using a printing process as an insulating protective layer. A flexible protective film can then be formed over the protective layer as another insulating protective layer. As an example, the finished flexible protective film can be directly applied over the protective layer as an insulating protective layer.

[0078] Example 2:

[0079] One embodiment of this application provides a fabrication process for another wearable physiological signal acquisition device, such as... Figure 2 The fabrication process is used to fabricate a wearable physiological signal acquisition device 100 with at least three different electrode sites. The fabrication process of the wearable physiological signal acquisition device includes:

[0080] Provide flexible substrate 110;

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

[0082] Signal acquisition electrodes 120 with at least three different electrode sites are fabricated on the surface of a flexible substrate 110 using a second conductive material, wherein the second conductive material is different from the first conductive material.

[0083] An isolation portion is formed between the conductive layer 125 and the signal acquisition electrode 120 to prevent the conductive layer 125 from directly contacting the signal acquisition electrode 120.

[0084] A connection layer 124 is fabricated on the surface of the flexible substrate 110 using a third conductive material. The conductive layer 125 is electrically connected to the signal acquisition electrode 120 through the connection layer 124. The third conductive material is different from the first conductive material and the second conductive material.

[0085] The connecting layer 124 and the conductive layer 125 form a first connecting region, and the connecting layer 124 and the signal acquisition electrode 120 form a second connecting region. The first connecting region and the second connecting region are electrically connected, and the second conductive material in the second connecting region will not chemically react with the third conductive material, and the first conductive material in the first connecting region will not chemically react with the third conductive material. This ensures that the signal acquisition electrode 120 acquires signals accurately.

[0086] In one embodiment, the first conductive material includes at least one of conductive ink, conductive polymer, conductive toner, and metallic material;

[0087] The fabrication process of the wearable physiological signal acquisition device includes: composite molding a flexible substrate 110 with a conductive layer 125 prepared from at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material;

[0088] A conductive pattern is planned for the conductive layer 125 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 conductive part 122, the conductive layer 128 and the second conductive part 121; the first conductive part 122 is electrically connected to the signal acquisition electrode 120 through the connecting layer 124.

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

[0091] In this embodiment, the first lead portion 122 is connected to the signal acquisition electrode 120 through the conductive layer 125, and the signal between the first lead portion 122 and the signal acquisition electrode 120 is transmitted accurately and reliably. The wearable physiological signal acquisition device 100 also includes a support 210. The conductive layer 125 includes a second lead portion 121 and a lead layer 128. The second lead portion 121 is fixed on the support 210. When the signal collection host 230 is installed on the support 210, the signal collection host 230 is electrically connected to the second lead portion 121. One end of the lead layer 128 is electrically connected to the first lead portion 122, and the other end is electrically connected to the second lead portion 121. Thus, the wearable physiological signal acquisition device 100 and the signal collection host 230 can be connected through the support 210. The bioelectric signal is transmitted to the signal collection host 230 through the signal acquisition electrode 120, the connecting layer 124, the first connecting area, and the second connecting area. Preferably, the signal collection host 230 and the support 210 are detachably connected, such as by a snap-fit ​​connection, threaded installation, or a concave-convex combination. Alternatively, a gripper can be provided on the support 210 for combined installation with the signal collection host 230. Various assembly and disassembly methods are not listed in this embodiment.

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

[0093] The flexible substrate 110 can be a substrate formed of a flexible material, which can be a flexible material with advantages such as being thin, transparent, flexible and stretchable. For example, the flexible substrate 110 can be polyvinyl alcohol (PVA), polyester (PET), polyimide (PI), polyethylene naphthalate (PEN), etc. As an example, a PET film is used as the flexible substrate 110 of a wearable physiological signal acquisition device, and a conductive layer 125 and a signal acquisition electrode 120 are disposed on the flexible substrate 110.

[0094] In one embodiment, the third conductive material includes at least one of conductive ink, conductive polymer, conductive toner, and metallic material;

[0095] A connecting layer 124 is formed on the surface of the first lead portion 122 and the signal acquisition electrode 120 using at least one of conductive ink, conductive polymer, conductive carbon powder, and metallic material through printing or coating processes.

[0096] In this embodiment, the signal acquisition electrode 120 can be made of precious metals, such as silver. The first lead portion 122 can be made of at least one of conductive metal, conductive ink, conductive polymer, or conductive carbon. The connecting layer 124 can be made of at least one of conductive ink, conductive polymer, or conductive carbon. This can be understood as follows: for example, the first lead portion 122 can be made of conductive metal, such as aluminum, and the connecting layer 124 can be made of conductive ink, but cannot be made of conductive metal. The connecting layer 124 and the first lead portion 122 form a first connecting region, and the connecting layer 124 and the signal acquisition electrode 120 form a second connecting region. The first connecting region and the second connecting region are electrically connected. The connecting layer 124 can electrically connect the signal acquisition electrode 120 and the first lead portion 122 through the first connecting region and the second connecting region. The use of a separate conductive layer 125, signal acquisition electrode 120 and connecting layer 124 can adapt to more usage environments and manufacturing requirements, improving the applicability of the wearable physiological signal acquisition device 100. The printing or coating process makes the connection between the connecting layer 124 and the signal acquisition electrode 120 and the first lead portion 122 smoother and more uniform, ensuring the quality of the lead.

[0097] In one embodiment, the second conductive material includes silver chloride; the fabrication process of the wearable physiological signal acquisition device includes: preparing a silver chloride layer at corresponding positions of at least three different electrode sites; attaching the silver chloride layer to the skin of the user to be tested using a conductive gel, and acquiring the bioelectrical signal 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 within the first opening 127. The silver chloride layer is disposed on the same layer as the first lead portion 122, that is, the first lead portion 122 is first printed on the flexible substrate 110, and then the signal acquisition electrode 120 is printed on the same layer. A connection layer 124 is printed on the surface of the signal acquisition electrode 120. In addition, the area where the connection layer 124 connects the first lead portion 122 and the signal acquisition electrode 120 is more even, preventing uneven printing of the connection layer 124 from affecting the accuracy and stability of the signal acquisition process. The gap between the silver chloride layer and the first lead portion 122 forms an isolation portion. Since silver chloride undergoes a chemical displacement reaction with other metallic conductive materials, this chemical reaction directly affects the accuracy of signal acquisition. The isolation portion solution provided in this application embodiment can reduce the overall size of the physiological electrophysiological signal acquisition device 100. The signal acquisition electrode 120 is electrically connected to the first lead portion 122 through the connection layer 124, which greatly reduces the planar size of the physiological electrophysiological signal acquisition device 100. Furthermore, by reducing the processing difficulty of the connecting layer 124 and improving the product yield, it can be further understood that the connecting layer 124 can connect the first lead portion 122 and the signal acquisition electrode 120 at any angle. The isolation portion is used to isolate the conductive layer 125 from the signal acquisition electrode 120, ensuring that the signal acquisition electrode 120 and the first lead portion 122, which use different conductive materials, will not affect signal acquisition due to material contact and mixing. In addition, the conductive layer 125 conducts a conductive connection between the first lead portion 122 and the signal acquisition electrode 120, and ensures that the first lead portion 122 accurately and reliably transmits the bioelectrical signals acquired by the signal acquisition electrode 120.

[0099] In one embodiment, the cross-sectional shape of the etched silver chloride layer is circular, and the cross-sectional shape of the etched connecting layer 124 is annular. The ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connecting layer 124 is greater than or equal to 0.1 and less than 1. In this embodiment, the ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connecting layer 124 is designed to be less than 1, thus ensuring sufficient gap between the signal acquisition electrode 120 and the first lead portion 122. This prevents direct connection or even overlapping connection between the signal acquisition electrode 120 and the first lead portion 122 due to slight offset during fabrication, which would lead to uneven signal transmission. The ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connecting layer 124 is greater than 0.1, preventing the area of ​​the connecting layer 124 from being too large and affecting signal transmission, thus avoiding problems such as long paths and high resistance. This ensures that the signal acquisition electrode 120 can more accurately acquire bioelectric signals, and the first lead portion 122 can transmit bioelectric signals more stably. More preferably, the cross-sectional shape of the signal acquisition electrode 120 is circular, and the diameter of the signal acquisition electrode 120 can be selected from 1 to 20 mm. This allows for better control over the fabrication of the signal acquisition electrode 120, the first lead portion 122, and the connecting layer 124, facilitating the acquisition and transmission of bioelectrical signals.

[0100] In one embodiment, the diameter of the silver chloride layer is 1–10 mm. More preferably, the cross-sectional shape of the signal acquisition electrode 120 is circular, and the diameter of the signal acquisition electrode 120 prepared with silver chloride can be selected from 1–20 mm. This allows for better control over the fabrication of the signal acquisition electrode 120 and the corresponding first lead portion 122, and the connecting layer 124, facilitating the acquisition and transmission of bioelectrical signals.

[0101] Example 3:

[0102] See Figure 3 , Figure 4 , Figure 5 as well as Figure 6 ,like Figure 3 This application provides a wearable physiological signal acquisition device 100, which is worn on the skin of the user to be tested to obtain bioelectric signals. The signal collection host 230 is detachably installed on the wearable physiological signal acquisition device 100 to collect bioelectric signals, including electrocardiogram signals, electromyogram signals, electroencephalogram signals, electrooculogram signals, etc.

[0103] The wearable physiological signal acquisition device 100 includes a flexible substrate 110, on which a conductive layer 125 and multiple signal acquisition electrodes 120 are disposed. The multiple signal acquisition electrodes 120 are used to acquire bioelectrical signals at at least three different locations on the skin of the user being tested. The conductive layer 125 is used to conduct the bioelectrical signals to the signal collection host 230. A connection layer 124 is also provided on the flexible substrate 110, and the conductive layer 125 is electrically connected to the signal acquisition electrodes 120 through the connection layer 124.

[0104] In this embodiment, a conductive layer 125 and a signal acquisition electrode 120 are fabricated on a flexible substrate 110 according to a conductive pattern. A connecting layer 124 is used to connect the conductive layer 125 and the signal acquisition electrode 120 to achieve conductive connection. The outer contour of the flexible substrate 110 is cut along the conductive layer 125 and the signal acquisition electrode 120 as needed to form the outer contour of the wearable physiological signal acquisition device 100. The connecting layer 124, the signal acquisition electrode 120, and the conductive layer 125 form a series circuit. In applications involving high-current treatments such as defibrillation or electrosurgical excision, the connecting layer 124 added to the flexible substrate 110 can prevent defibrillation energy from being conducted and leaked through the signal acquisition electrode 120 and the conductive layer 125, thus affecting the treatment effect, and will not affect the accuracy of the bioelectrical signals acquired by the signal acquisition electrode 120.

[0105] In one embodiment, the resistance of the connection layer 124 is determined to be 1K to 50K ohms by adjusting the thickness and / or resistivity of the connection layer 124. Specifically, the resistivity of the connection layer 124 can be adjusted by adjusting the sheet resistance or resistivity of the printing paste of the connection layer 124, or the thickness of the connection layer 124 can be processed by printing process to be 5μm-200μm to determine the resistance of the connection layer 124 to be set to 1K to 50K ohms, so as to withstand the strong current caused by medical defibrillators or electrostatic discharge and avoid the signal collection host 230 being destroyed by strong current. This embodiment proposes that the connection layer 124 made by printing process is thin and light, with a thickness of no more than 200μm, and is connected in series with the signal acquisition electrode 120 and the conductive layer 125. Moreover, no other lead connection is required. It can replace the traditional defibrillator patch resistor that must be used in monitoring equipment due to equipment safety requirements. Traditional patch resistors are too large and require lead connection during use, making them cumbersome and unsuitable for compact physiological monitoring equipment applications. Especially during defibrillation treatment, patients need to endure multiple high-current defibrillation events to restore cardiac function. If the connection layer 124 is not provided, defibrillation energy will enter the signal collection host 230 through the signal acquisition electrode 120 and conductive layer 125, causing the signal collection host 230 to be destroyed by the high current. The connection layer 124 provided in this embodiment has a measured resistance of 1K to 50K ohms, which can withstand multiple high-current impacts. After the cardiac defibrillation treatment is completed, the signal collection host 230 can still be used normally to collect and record bioelectrical signals, enhancing the reliability of the equipment. If the measured 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 bioelectrical signal acquisition.

[0106] In one embodiment, the connecting layer 124 is printed onto the signal acquisition electrode 120 and the conductive layer 125 using a printing process. This does not affect the wearing weight and facilitates long-term, uninterrupted use by the user. Long-term monitoring of bioelectrical signals, especially electrocardiograms, helps the user to more comprehensively monitor heart health or potential diseases. Furthermore, in high-current treatment environments, such as defibrillation currents or electrosurgical high voltages applied to the user, the conductive layer 125 will conduct the current to the signal collection host 230, potentially damaging the host. Therefore, the biosignal acquisition device 100 provided in this embodiment not only considers lightweight wear for long-term, uninterrupted use by the user but also takes into account the requirements of monitoring scenarios, ensuring that the wearable physiological signal acquisition device 100 acquires accurate bioelectrical signals in real time, making the device safer and more reliable.

[0107] A wearable physiological signal acquisition device 100 is worn on the skin of the user to acquire bioelectrical signals. A signal collection host 230 is installed on the wearable physiological signal acquisition device 100 to collect and store signals. Multiple signal acquisition electrodes 120 collect bioelectrical signals from at least three different locations and transmit the bioelectrical signals to the signal collection host 230 through a conductive layer 125. This application proposes that the signal acquisition electrodes 120 and the conductive layer 125 are electrically connected through a connecting layer 124 to ensure accurate acquisition of bioelectrical signals while suppressing the influence of strong current on the bioelectrical signals collected by the wearable physiological signal acquisition device 100. In this embodiment, a printing process can be used to print the conductive layer 125, the signal acquisition electrodes 120, and the connecting layer 124 on a flexible substrate 110, respectively. The conductive layer 125 and the signal acquisition electrodes 120 are electrically connected through the connecting layer 124, creating a more lightweight wearable product. Alternatively, the conductive materials of the conductive layer 125, the signal acquisition electrodes 120, and the connecting layer 124 can be respectively attached to the flexible substrate 110 and then laser-engraved.

[0108] In one embodiment, the conductive layer 125 is insulated from the signal acquisition electrode 120. The conductive layer 125 is made of a first conductive material, while the signal acquisition electrode 120 is made of a second conductive material different from the first conductive material. This avoids chemical reactions, such as combination reactions, displacement reactions, or redox reactions, between the conductive layer 125 and the signal acquisition electrode 120, which could affect the accuracy of signal acquisition. A third conductive material is used to prepare the connecting layer 124, where the second and third conductive materials, or the first and third conductive materials, do not react chemically, ensuring the accuracy of bioelectrical signal acquisition and transmission. This embodiment can prepare a wearable physiological signal acquisition device 100 to meet different usage scenarios according to actual product needs. Furthermore, the wearable physiological signal acquisition device 100 provided in this application fully considers the high accuracy requirements for signal acquisition in different scenarios and prevents damage to device reliability caused by different usage scenarios.

[0109] In a further embodiment, to meet the requirement of more accurate bioelectric signal acquisition, the signal acquisition electrode 120 can be made of a second conductive material with higher signal acquisition accuracy, such as silver chloride, to ensure accurate and reliable acquisition of bioelectric signals. The conductive layer 125 uses a first conductive material different from the second conductive material to achieve the signal transmission function, such as a conductive metal. The conductive layer 125 is prepared on the flexible substrate 110, and the conductive pattern is processed according to the electrode point design requirements of the wearable physiological signal acquisition device 100. It can be prepared by die-cutting + bonding process, bonding + etching process, or bonding + laser engraving process. Common conductive pattern processing methods will not be described in detail here. At the preset electrode point, the signal acquisition electrode 120 is prepared. Generally, a silver chloride layer is used. Silver can be electroplated at the electrode point and then chlorinated to generate silver / silver chloride, or a silver chloride coating can be printed or coated. The conductive layer 125 is prepared using a conductive material for signal transmission. Different conductive materials are prone to contact reactions. For example, silver chloride will react chemically with the conductive metal, such as chloride ions corroding the conductive metal, leading to problems such as reduced signal transmission accuracy. Therefore, an isolation section is provided between the signal acquisition electrode 120 and the conductive layer 125 to isolate the first conductive material and the second conductive material, which are prone to chemical reaction, from direct contact, thus affecting the accuracy of signal transmission. For example, the isolation section isolates the signal acquisition electrode 120 made of silver chloride from direct contact with the conductive layer 125 made of conductive metal.

[0110] The second conductive material used in the signal acquisition electrode 120 includes at least one of silver, or a silver-silver chloride mixture, or a carbon-silver mixture, or a carbon-silver-silver chloride mixture, or a titanium nitride-silver mixture, or a titanium nitride-silver-silver chloride mixture.

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

[0112] In one embodiment, the conductive materials used for the connecting layer 124, the signal acquisition electrode 120, and the first lead portion 122 are all different. The connecting layer 124 and the first lead portion 122 form a first connecting region, and the connecting layer 124 and the signal acquisition electrode 120 form a second connecting region. The first connecting region and the second connecting region are electrically connected. The connecting layer 124 can electrically connect the signal acquisition electrode 120 and the first lead portion 122 through the first connecting region and the second connecting region. By using a separate design for the conductive layer 125, the signal acquisition electrode 120, and the connecting layer 124, it can adapt to more usage environments and manufacturing requirements, improving the applicability of the wearable physiological signal acquisition device 100. In this embodiment, the connecting layer 124 is made of a third conductive material, and the third conductive material does not undergo a chemical reaction when in contact with the second conductive material. Therefore, when the third conductive material comes into contact with the first conductive material, no chemical reaction will occur. Commonly, the signal acquisition electrode 120 is made of silver chloride. The first lead 122 can be made of at least one of conductive metal, conductive ink, conductive polymer, or conductive carbon. When the conductive layer 125 is made of metal, the connecting layer 124 can be made of at least one of conductive ink, conductive polymer, or conductive carbon. This can be understood as follows: for example, if the first lead 122 is made of a conductive metal, such as aluminum, the connecting layer 124 can be made of conductive ink, but not a conductive metal. This is because a chemical reaction will occur when the signal acquisition electrode 120 made of silver chloride comes into contact with the connecting layer 1247 made of conductive metal, increasing signal interference. This ensures that the connecting layer 124 provides conductive connection between the signal acquisition electrode 120 and the conductive layer 125, enabling stable signal transmission.

[0113] In one embodiment, the first lead portion 122 and the signal acquisition electrode 120 are disposed on the same layer. That is, the first lead portion 122 is first printed on the flexible substrate 110, and then the signal acquisition electrode 120 is printed on the same layer. A connection layer 124 is printed on the surface of the signal acquisition electrode 120. In addition, the area where the connection layer 124 connects the first lead portion 122 and the signal acquisition electrode 120 is more flat, which prevents uneven printing of the connection layer 124 from affecting the accuracy and stability of the signal acquisition process.

[0114] In one embodiment, the gap region between the separately designed first lead portion 122 and the signal acquisition electrode 120 constitutes an isolation portion. The isolation portion can be an air gap or an insulating layer. The purpose of the isolation portion is to prevent the conductive material of the first lead portion 122 from mixing and coming into contact with the conductive material of the signal acquisition electrode 120 and causing a chemical reaction, which would affect the signal acquisition performance of the signal acquisition electrode 120.

[0115] In one embodiment, the first lead portion 122 has a first opening 127, the signal acquisition electrode 120 is disposed within the first opening 127, and the connecting layer 124 is disposed at the first opening 127, that is, the connecting layer 124 is electrically connected to one side of the first lead portion 122. This design can reduce the overall size of the physiological electrical signal acquisition device 100. The signal acquisition electrode 120 is electrically connected to the first lead portion 122 through the connecting layer 124, which greatly reduces the planar size of the physiological electrical signal acquisition device 100. Moreover, it reduces the processing difficulty of the connecting layer 124 and improves the product yield. Furthermore, the connecting layer 124 can connect the first lead portion 122 and the signal acquisition electrode 120 at any angle.

[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, the connection area between the connecting layer 124 and the first lead portion 122 is annular, and the connecting layer 124 uniformly covers the first lead portion 122, ensuring that the connecting layer 124 transmits the bioelectrical signal collected by the signal acquisition electrode 120 to the first lead portion 122 without loss.

[0117] In one embodiment, the flexible substrate 110 corresponding to the position of the first guide portion 122 is circular in shape. The first guide portion 122 is disposed at the center of the flexible substrate 110. The distance between the edge of the first guide portion 122 and the edge of the flexible substrate 110 is greater than or equal to 1.5 mm. The edge of the flexible substrate 110 extends beyond the edge of the first guide portion 122, which can protect the first guide portion 122 from external wear and damage and ensure that the signal transmission is not interfered with.

[0118] In one embodiment, the ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connecting layer 124 is greater than or equal to 0.1 and less than 1. Designing the ratio of the signal acquisition electrode 120's diameter to the outer diameter of the connecting layer 124 to be less than 1 ensures absolute contact between the signal acquisition electrode 120 and the connecting layer 124, preventing uneven connection due to manufacturing errors and potential breakage, which could lead to uneven signal transmission. Conversely, a ratio greater than 0.1 prevents the connecting layer 124 from having an excessively large area, which could hinder signal transmission and cause problems such as long paths and high resistance. This ensures that the signal acquisition electrode 120 can more accurately acquire bioelectrical signals, and the first lead 122 can transmit bioelectrical signals more stably. More preferably, the cross-sectional shape of the signal acquisition electrode 120 is circular, and the diameter of the signal acquisition electrode 120 can be selected from 1 to 20 mm. Better control of the processing signal acquisition electrode 120 and the first lead 122, and the connecting layer 124, facilitates the acquisition and transmission of bioelectric signals.

[0119] In one embodiment, a connecting layer 124 is disposed on the side of the signal acquisition electrode 120 near the skin of the user being tested. The connecting layer 124 has a second opening 126, which exposes at least a portion of the conductive area of ​​the signal acquisition electrode 120, allowing the conductive area of ​​the signal acquisition electrode 120 to directly contact the skin of the user, thereby ensuring that the signal acquisition electrode 120 can completely acquire the bioelectrical signals of the human body. The connecting layer 124 has an annular cross-sectional shape. The annular connecting layer 124 ensures uniform connection with the signal acquisition electrode 120 and the first lead portion 122, respectively, ensuring the continuity of signal acquisition.

[0120] In another embodiment, the connecting layer 124 is disposed on the side of the signal acquisition electrode 120 away from the skin of the user being tested. The connecting layer 124 covers at least a portion of the signal acquisition electrode 120, ensuring a more secure conductive connection between the connecting layer 124 and the signal acquisition electrode 120 and the first lead portion 122, respectively. Since the connecting layer 124 does not directly contact the skin of the user being tested, it will not affect the bioelectrical signal acquisition by the signal acquisition electrode 120, ensuring stable contact between the signal acquisition electrode 120 and the skin of the user being tested, thus guaranteeing the stability of signal acquisition. In this embodiment, the connecting layer 124 is designed with a circular cross-sectional shape. Through this design, the first opening of the connecting layer 124, the signal acquisition electrode 120, and the first lead portion 122 are all circular, resulting in a unified overall product design style and enhanced aesthetic appeal.

[0121] In one embodiment, the first lead portion 122 and the signal acquisition electrode 120 are stacked together, and an isolation portion is disposed between the first lead portion 122 and the signal acquisition electrode 120. The isolation portion uses an insulating layer to prevent the first lead portion 122 from contacting the signal acquisition electrode 120, avoiding chemical reactions between the first lead portion 122 made of different conductive materials and the signal acquisition electrode 120, which would affect the accuracy of signal acquisition and expand the product's different form factors.

[0122] In another embodiment, the connecting layer 124 is disposed at the edge of the signal acquisition electrode 120 and the first lead portion 122, and the connecting layer 124 is not electrically connected to the isolation portion. This embodiment has lower process requirements when preparing the connecting layer 124. The connecting layer 124 can electrically connect the signal acquisition electrode 120 and the first lead portion 122, which reduces the difficulty of preparation.

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

[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, thereby realizing the conductive connection between the wearable physiological signal collector 100 and the signal collection host 230. The bioelectrical signals collected by the signal collection electrode 120 are transmitted to the signal collection host 230 through the connection layer 124, the first lead portion 122, the lead layer 128, and the second lead portion 121. In this embodiment, the first lead portion 122, the lead layer 128, and the second lead portion 121 can also be integrally formed.

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

[0126] In one embodiment, the wearable physiological signal acquisition device 100 further includes a support 210. The support 210 and the adjacent signal acquisition electrodes 120 are fixed to the skin of the user using an adhesive patch 130. This is more convenient for the user; simply peel off the protective layer of the adhesive patch 130 to fix the signal acquisition electrodes 120 to the user's skin, ensuring that the relative positions of the signal acquisition electrodes 120 sharing the adhesive patch 130 are determined. Furthermore, one adhesive patch 130 can simultaneously fix more signal acquisition electrodes 120, making operation simpler. Preferably, the signal collection host 230 and the support 210 are detachably connected, for example, by a snap-fit ​​connection, threaded installation, or a combination of concave and convex parts. Alternatively, the support 210 can be equipped with a gripper for combined installation with the signal collection host 230. Various assembly and disassembly methods are not listed in this embodiment.

[0127] In one embodiment, three signal acquisition electrodes 120 are provided, namely, in the single-conductor product embodiment provided in this practice, at least two signal acquisition electrodes 120 are arranged adjacently, preferably in a Y-shaped layout. Two adjacent signal acquisition electrodes 120 are located above the bracket 210 and can share a single adhesive patch 130. The adhesive patch 130 simultaneously fixes the two adjacent signal acquisition electrodes 120 and the bracket 210 to the human skin, facilitating installation. For single-conductor products, physiological electrical signals can be acquired at any location on the skin of the human chest, and can be widely used in real-time monitoring in fields such as electrocardiogram, electroencephalogram, electromyography, and electrooculography. This embodiment provides an installation demonstration of the single-conductor product, with the bracket 210 fixed on the midline of the human sternum, and the signal acquisition electrodes 120 installed along the conductive layer 125 on the human skin. Therefore, only the bracket 210 needs to be fixed to fix the installation point of the signal acquisition electrodes 120, providing a more convenient installation method suitable for remote use at home. In this embodiment, the variation of the single-conductor product only requires that three signal acquisition electrodes 120 are provided. The specific design of the signal acquisition electrodes 120 is protected.

[0128] In one embodiment, four signal acquisition electrodes 120 are provided, i.e., this embodiment provides a three-conductor product embodiment. At least two signal acquisition electrodes 120 are arranged adjacently. In this embodiment, two adjacent signal acquisition electrodes 120 are located below the bracket 210 and can each use an adhesive tape 130. The third signal acquisition electrode 120 is located above the bracket 210, and the fourth signal acquisition electrode 120 is located above the bracket 210. The two signal acquisition electrodes 120 located above the bracket 210 each use an adhesive tape 130. The bracket 210 and the signal acquisition electrodes 120 can share an adhesive tape 130. Similar to the previous embodiment, only the bracket 210 needs to be fixed to fix the mounting points of the signal acquisition electrodes 120, providing a more convenient installation method, suitable for remote use at home, and further improving product applicability. The variation of the three-conductor product only requires that four signal acquisition electrodes 120 are provided; the specific design of the signal acquisition electrodes 120 is protected in this embodiment.

[0129] In the above embodiments, since the number of signal acquisition electrodes 120 is relatively small, i.e., there are three or four signal acquisition electrodes 120, they can be installed on human skin according to the product instructions, without strict usage requirements. This facilitates home care and lowers the barrier to entry, allowing more users to obtain bioelectrical signal data through the wearable physiological signal acquisition device 100. Even special populations can use it conveniently, further expanding the product's user base. Moreover, this product uses adhesive patches 130 for application to the skin, making it a disposable product, which further facilitates its promotion for home care.

[0130] In one embodiment, ten signal acquisition electrodes 120 are provided, with at least two signal acquisition electrodes 120 arranged adjacent to each other. The ten signal acquisition electrodes 120 include six chest lead electrodes and four limb electrodes, which collects richer bioelectrical signals. For bioelectrical signal analysis systems or monitoring systems, providing rich bioelectrical signals ensures more accurate processing results and meets medical analysis needs.

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

[0132] An embodiment of this 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 application scenarios and provide target users with more accurate bioelectric signal monitoring functions.

[0133] In one embodiment, the wearable physiological monitoring device 200 further includes a signal collection host 230 that is installed together with or detached from the wearable physiological signal collector 100, the signal collection host 230 being used to collect and record bioelectrical signals.

[0134] One embodiment of this application also provides a physiological monitoring system, including the wearable physiological monitoring device 200 in the above embodiments or the wearable physiological signal acquisition device 100 in the above embodiments.

[0135] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0136] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A fabrication process for a wearable physiological signal acquisition device, characterized in that, The process includes: Provides a flexible substrate (110); A conductive layer (125) is prepared on the surface of the flexible substrate (110); Signal acquisition electrodes (120) with at least three different electrode sites are prepared on the surface of the flexible substrate (110); A connection layer (124) is printed on the surface of the flexible substrate (110). The signal acquisition electrode (120), the connection layer (124) and the conductive layer (125) are connected in series and the conductive layer (125) is isolated from the signal acquisition electrode (120). The conductive layer (125) is divided into a first conductive section (122), a conductive layer (128), and a second conductive section (121). The first conductive section (122) is configured to form a first opening (127). The signal acquisition electrode (120) is disposed in the first opening (127). The signal acquisition electrode (120) is conductively connected to the first conductive section (122) through the connecting layer (124). The second conductive section (121) is used to be conductively connected to the signal collection host (230). The conductive layer (128) is provided with a defibrillator (163). The defibrillator (163) is used to withstand the strong current caused by medical defibrillation equipment or electrostatic discharge.

2. The fabrication process of the wearable physiological signal acquisition device according to claim 1, characterized in that, The connection layer (124) is prepared using a third conductive material, and the connection layer (124) is printed onto the signal acquisition electrode (120) and the conductive layer (125) using a printing process.

3. The fabrication process of the wearable physiological signal acquisition device 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). Within the first connection region, the first conductive material and the third conductive material will not react chemically upon contact.

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

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

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

7. The manufacturing process of the wearable physiological signal acquisition device according to any one of claims 2 to 5, characterized in that, The third conductive material includes at least one of conductive ink, conductive polymer, conductive toner, and metallic material.

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

9. The manufacturing process of the wearable physiological signal acquisition device according to claim 1, characterized in that, An isolation portion is formed in the gap between the conductive layer (125) and the signal acquisition electrode (120), and the isolation portion is used to prevent the conductive layer (125) from contacting the signal acquisition electrode (120).

10. The fabrication process of the wearable physiological signal acquisition device according to claim 9, characterized in that, The isolation section is formed in the gap region between the first lead section (122) and the signal acquisition electrode (120).

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

12. A fabrication process for a wearable physiological signal acquisition device, characterized in that, The fabrication process of the wearable physiological signal acquisition device includes: Provides a flexible substrate (110); A conductive layer (125) is prepared on the surface of the flexible substrate (110); Signal acquisition electrodes (120) with at least three different electrode sites are prepared on the surface of the flexible substrate (110); A connection layer (124) is printed on the surface of the flexible substrate (110), and the signal acquisition electrode (120), the connection layer (124), and the conductive layer (125) are connected in series to form a conductive connection; the conductive layer (125) is prepared using a first conductive material; the signal acquisition electrode (120) is prepared using a second conductive material different from the first conductive material; The conductive layer (125) is divided into a first conductive section (122), a conductive layer (128), and a second conductive section (121). The first conductive section (122) is configured to form a first opening (127). The signal acquisition electrode (120) is disposed in the first opening (127). The signal acquisition electrode (120) is conductively connected to the first conductive section (122) through the connecting layer (124). The second conductive section (121) is used to be conductively connected to the signal collection host (230). The conductive layer (128) is provided with a defibrillator (163). The defibrillator (163) is used to withstand the strong current caused by medical defibrillation equipment or electrostatic discharge.

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

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

15. The manufacturing process of the wearable physiological signal acquisition device according to any one of claims 12 to 14, characterized in that, The conductive layer (125) is divided into a first conductive portion (122) to form a conductive connection, and a first connection region is formed between the connection layer (124) and the first conductive portion (122).

16. The fabrication process of the wearable physiological signal acquisition device according to claim 15, characterized in that, A second connection region is formed between the connection layer (124) and the signal acquisition electrode (120), and the first connection region is electrically connected to the second connection region through the connection layer (124).

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

18. The fabrication process of the wearable physiological signal acquisition device according to claim 16, characterized in that, The first conductive material is at least one of conductive metal, conductive ink, conductive polymer or conductive carbon.

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

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

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

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

23. The fabrication process of the wearable physiological signal acquisition device according to claim 22, characterized in that, The isolation section is an air gap or an insulating layer.

24. A manufacturing process for a wearable physiological signal acquisition device, characterized in that, The fabrication process of the wearable physiological signal acquisition device includes: Provides a flexible substrate (110); A conductive layer (125) is prepared on the surface of the flexible substrate (110), the conductive layer (125) being used to conduct bioelectric signals to the signal collection host (230); Signal acquisition electrodes (120) with at least three different electrode sites are prepared 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 the transmission of energy to the signal acquisition host (230) via the conductive layer (125). The signal acquisition electrode (120), the connection layer (124), and the conductive layer (125) are connected in series. The conductive layer (125) is prepared using a first conductive material. The signal acquisition electrode (120) is prepared using a second conductive material different from the first conductive material. The conductive layer (125) is divided into a first conductive section (122), a conductive layer (128), and a second conductive section (121). The first conductive section (122) is configured to form a first opening (127). The signal acquisition electrode (120) is disposed in the first opening (127). The signal acquisition electrode (120) is conductively connected to the first conductive section (122) through the connecting layer (124). The second conductive section (121) is used to be conductively connected to the signal collection host (230). The conductive layer (128) is provided with a defibrillator (163). The defibrillator (163) is used to withstand the strong current caused by medical defibrillation equipment or electrostatic discharge.

25. The fabrication process of the wearable physiological signal acquisition device according to claim 24, characterized in that, A connecting layer (124) is provided on the side of the signal acquisition electrode (120) near the skin of the user to be tested. A second opening (126) is provided in the connecting layer (124), and the second opening (126) is used to expose at least a portion of the conductive area of ​​the signal acquisition electrode (120).

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

27. The fabrication process of the wearable physiological signal acquisition device according to claim 24, characterized in that, The conductive layer (125) is composite-formed with the flexible substrate (110).

28. The fabrication process of the wearable physiological signal acquisition device according to claim 24, characterized in that, The signal acquisition 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 acquisition electrode (120) and the first lead portion (122), and the isolation portion is used to prevent the first lead portion (122) from directly contacting the signal acquisition electrode (120).

29. The fabrication process of the wearable physiological signal acquisition device according to claim 24, characterized in that, The cross-sectional shape of the signal acquisition electrode (120) is circular, and the cross-sectional shape of the connecting layer (124) is annular.

30. The fabrication process of the wearable physiological signal acquisition device according to claim 24, characterized in that, A protective layer is formed on the surface of the conductive layer (125).

31. A wearable physiological signal acquisition device, characterized in that, The wearable physiological signal acquisition device is manufactured using the manufacturing process described in any one of claims 1 to 30, wherein multiple signal acquisition electrodes (120) are provided, and at least two adjacent signal acquisition electrodes (120) are attached to the body of the user to be tested using an adhesive patch (130).

32. A physiological monitoring system, characterized in that, Includes the physiological signal acquisition device (100) as described in claim 31.

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