CN118766468B

CN118766468B - Bioelectric signal collector, wearable physiological monitoring device and physiological monitoring system

Info

Publication number: CN118766468B
Application number: CN202411268976.7A
Authority: CN
Inventors: 滕理君; 黄济超; 王子凡; 周煜; 李爽; 凌忠文
Original assignee: Wuhan United Imaging Zhirong Medical Technology Co Ltd
Current assignee: Wuhan United Imaging Zhirong Medical Technology Co Ltd
Priority date: 2024-09-11
Filing date: 2024-09-11
Publication date: 2025-02-28
Anticipated expiration: 2044-09-11
Also published as: CN119837536A; CN118766468A

Abstract

The application relates to a bioelectric signal collector, a wearable physiological monitoring device and a physiological monitoring system. The wearable physiological monitoring device comprises a signal collection host and a bioelectric signal collector. The bioelectric signal collector comprises a flexible substrate, and a conductive layer, a plurality of signal collecting electrodes and a connecting layer are arranged on the flexible substrate. By providing the connection layer it is beneficial to prevent leakage of energy applied to the body surface of the user to be tested and it is possible to suppress energy transfer via the conductive layer to the signal collection host, causing host damage.

Description

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

Technical Field

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

Background

Bioelectric signals, which are important indicators of various physiological parameters of human bodies, have always played an important role in life of people, and clinically people have obtained various bioelectric signals relatively accurately, but with the continuous demands of people on medical technology and the deep development of electrocardiographic diagnosis, neuro-medicine, cognitive psychology and artificial intelligence research, human body bioelectric signals are increasingly applied to fields such as telemedicine, medical monitoring, real-time monitoring and emerging brain-computer interfaces.

The most widely used human bioelectric signals are electrocardiosignals and electroencephalograms. The electrocardiosignals directly reflect various indexes in heart activities, people obtain the electrocardiosignals to monitor various symptoms such as atrial and ventricular septum, arteriovenous valve and the like, diagnose various symptoms, and monitor patients clinically or remotely, for example, the electrocardiosignals are designed into a wearable monitoring device to monitor special groups such as athletes, users to be tested for hypertension and users to be tested for cardiovascular diseases in real time. The brain electrical signals directly represent the nerve activity states of the cerebral cortex in different areas, have important references for detecting the physiological and psychological states of people, and can provide important diagnostic information for the diagnosis of brain diseases such as epilepsy, dementia, tumor and the like.

In specific use situations, such as defibrillation treatment, high-frequency electrotome treatment and the like, strong current is applied to the body of a user to be tested to achieve the purpose of treatment. At this time, the bioelectric signal collector worn by the user to be tested is used as an auxiliary monitoring means, the bioelectric signal is required to be monitored while the treatment is performed to reflect the physiological sign change of the user to be tested, however, defibrillation treatment, high-frequency electrotome treatment and the like have specific requirements on energy consumption, and meanwhile, the bioelectric signal collector worn by the user to be tested has extremely high use requirements on design safety, namely, the bioelectric signal collector cannot consume treatment energy, meanwhile, the damage of equipment caused by strong current is required to be avoided, and the interference of treatment signals is required to be eliminated by the bioelectric signal collected signals, so that the accuracy of signal collection is ensured.

Disclosure of Invention

Based on the problems, the bioelectric signal collector, the wearable physiological monitoring device and the physiological monitoring system are provided for solving the problems that the existing bioelectric signal collector meets multiple treatment scenes, the signal collection is accurate and the equipment is safe to use.

An embodiment of the present application provides a bioelectric signal collector, where the bioelectric signal collector is worn on skin of a user to be measured to obtain a bioelectric signal;

The bioelectric signal collector comprises a flexible substrate, wherein a conductive layer and a plurality of signal collecting electrodes are arranged on the flexible substrate, the plurality of signal collecting electrodes are used for collecting bioelectric signals of at least three different positions on the skin of the user to be tested, and the conductive layer is used for conducting the bioelectric signals to a signal collecting host;

and the flexible substrate is also provided with a connecting layer, and the conducting layer is in conductive connection with the signal acquisition electrode through the connecting layer.

In an embodiment, the conductive layer includes a first lead portion, and an isolation portion is disposed between the first lead portion and the signal acquisition electrode, and is used for isolating and contacting the conductive layer with the signal acquisition electrode.

In an embodiment, the connection layer and the first lead portion form a first connection region, the connection layer and the signal acquisition electrode form a second connection region, and the first connection region is in conductive communication with the second connection region.

In an embodiment, the first lead portion is disposed at the same layer as the signal acquisition electrode.

In an embodiment, a gap region between the first lead portion and the signal acquisition electrode constitutes the isolation portion.

In an embodiment, the first lead portion is provided with a first opening, the signal acquisition electrode is disposed in the first opening, and the connection layer is disposed at the first opening.

In an embodiment, a ratio of an inner diameter of the first lead portion to an outer diameter of the connection layer is 0.1 to 0.9.

In an embodiment, the shape of the flexible substrate corresponding to the first lead position is a circle, the first lead portion is disposed at the center of the flexible substrate, and the distance between the edge of the first lead portion and the edge of the flexible substrate is greater than or equal to 1.5mm.

In an embodiment, the cross-sectional shape of the signal acquisition electrode is a circle, and the ratio of the diameter of the signal acquisition electrode to the outer diameter of the connection layer is greater than or equal to 0.1 and less than 1.

In an embodiment, the cross section of the signal acquisition electrode is circular, and the diameter of the signal acquisition electrode is 1-20 mm.

In an embodiment, the connection layer is disposed on a side of the signal collecting electrode, which is close to the skin of the user to be tested, and the connection layer is provided with a second opening, where the second opening is used for exposing at least part of the conductive area of the signal collecting electrode.

In an embodiment, the connection layer is disposed on a side of the signal acquisition electrode, which is far away from the skin of the user to be tested, and the connection layer covers at least part of the signal acquisition electrode.

In one embodiment, the first lead portion is disposed in a stacked arrangement with the signal acquisition electrode.

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

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

In an embodiment, the conductive layer is made of a first conductive material, the signal acquisition electrode is made of a second conductive material, the connection layer is made of a third conductive material, the first conductive material, the second conductive material and the third conductive material are the same, or the connection layer is in contact with the signal acquisition electrode to form a second connection area, and the second conductive material is in contact with the third conductive material to form a first connection area, or/and the connection layer is in contact with the conductive layer to form a first connection area, and the first conductive material is in contact with the third conductive material to form a second connection area.

In an embodiment, the conductive layer includes a second lead portion for conductive communication with the signal collection host, and a lead layer having one end conductively connected to the first lead portion and the other end conductively connected to the second lead portion.

In an embodiment, the signal acquisition electrode, the connection layer, the first lead portion, the second lead portion, and the lead layer are printed on the flexible substrate by printing.

In an embodiment, the bioelectric signal collector further comprises a glue patch, and the glue patch is used for fixing the signal collecting electrode to be attached to the skin of the user to be tested.

In an embodiment, three signal collecting electrodes are provided, at least two signal collecting electrodes are adjacently arranged, and the adjacently arranged signal collecting electrodes are adhered to the skin of the user to be tested by using a piece of adhesive tape.

In an embodiment, the signal collecting electrodes are four, at least two signal collecting electrodes are adjacently arranged, and the adjacently arranged signal collecting electrodes are pasted on the skin of the user to be tested by using a piece of glue.

In an embodiment, ten signal collecting electrodes are provided, at least two signal collecting electrodes are adjacently arranged, and the adjacently arranged signal collecting electrodes are pasted on the skin of the user to be tested by using a piece of glue.

In an embodiment, the bioelectric signal collector further comprises a support, and the support and the adjacent signal collecting electrode are fixed on the skin of the user to be tested by using a glue.

In an embodiment, the ten signal acquisition electrodes include a first chest lead electrode group and a second chest lead electrode group, the first chest lead electrode group and the second chest lead electrode group are respectively arranged at the left side and the right side of the central extension line of the support, the flexible substrate is provided with an expansion opening along the central extension line of the support, and the expansion opening is used for expanding the distance between the first chest lead electrode group and the second chest lead electrode group.

In one embodiment, ten of the signal acquisition electrodes further comprise a limb lead electrode set comprising a first limb lead electrode, a second limb lead electrode, a third limb lead electrode, a fourth limb lead electrode, the first chest lead electrode set comprising a first chest lead electrode, the second chest lead electrode set comprising a second chest lead electrode, a third chest lead electrode, a fourth chest lead electrode, a fifth chest lead electrode, a sixth chest lead electrode,

Wherein the fourth limb lead electrode is disposed adjacent to the first limb lead electrode and a piece of the glue is used to fix the first limb lead electrode and the fourth limb lead electrode simultaneously, or the fourth limb lead electrode is disposed adjacent to the second limb lead electrode and a piece of the glue is used to fix the second limb lead electrode and the fourth limb lead electrode simultaneously, or the fourth limb lead electrode is disposed adjacent to the first chest lead electrode and a piece of the glue is used to fix the fourth limb lead electrode and the first chest lead electrode simultaneously.

In one embodiment, the flexible substrate is provided with at least one bending structure, and the bending structure is used for extending or shortening the length of the lead layer.

In one embodiment, a defibrillation resistor is disposed on the flexible substrate, the defibrillation resistor being connected in series with the lead layer.

The application further provides a wearable physiological monitoring device, which comprises the bioelectric signal collector and the signal collecting host.

The application also provides a physiological monitoring system, which comprises the bioelectric signal collector or the wearable physiological monitoring device.

The bioelectric signal collector provided by the embodiment of the application uses the connecting layer to electrically connect the signal collecting electrode and the conducting layer, so that the use of the connecting layer is beneficial to preventing the leakage of energy applied to the body surface of a user to be tested in a special treatment scene, and the energy can be restrained from being transmitted to the signal collecting host computer through the conducting layer, so that the host computer is damaged.

Drawings

FIG. 1 is a schematic view of a flexible substrate and signal acquisition electrode mounting bracket and signal collection host of an embodiment;

FIG. 2 is an exploded view of the structure of FIGS. 1 and 2 after installation and installation of a power component;

FIG. 3 is a schematic illustration of the structure of FIG. 1 without a mounting bracket and a signal collection host;

FIG. 4 is an enlarged view of FIG. 3 at A;

FIG. 5 is a schematic diagram of a wearable physiological monitoring device according to an embodiment;

FIG. 6 is a correspondence between the characters in FIG. 5 and a human body;

FIG. 7 is a schematic view of a sleeve;

FIG. 8 is a schematic view of a guide section between two adjacent patches;

FIG. 9 is a schematic view of a telescoping sheath;

FIG. 10 is a schematic diagram of a wearable physiological monitoring device according to yet another embodiment;

FIG. 11 is a schematic diagram of a wearable physiological monitoring device according to another embodiment;

FIG. 12 is a process flow diagram of a bioelectric signal collector according to an embodiment;

fig. 13 is a process flow diagram of a bioelectric signal collector according to another embodiment.

Reference numerals illustrate:

100-bioelectric signal collector, 110-flexible substrate, 111-guiding section, 112-attaching piece, 113-wire part, 114-wire part, 115-guiding section, 116-wire part, 120-signal collecting electrode, 121-second lead part, 122-first lead part, 124-connecting layer, 125-conductive layer, 126-second opening, 127-first opening, 128-conductive layer, 130-adhesive, 131-third opening, 140-conductive adhesive layer, 150-release film, 151-character, 160-sleeve, 161-telescopic sleeve, 162-bending structure, 163-defibrillation resistor, 164-adhesive piece, 165-fourth opening, 166-handle, 167-expanding opening, 200-wearable physiological monitoring device, 210-bracket, 211-bar-shaped hole, 220-power supply piece and 230-signal collecting host.

Detailed Description

In order that the above objects, features and advantages of the application will be readily understood, a more particular description of the application will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. The present application may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the application, whereby the application is not limited to the specific embodiments disclosed below.

In the description of the present application, it should be understood that, if any, these terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., are used herein with respect to the orientation or positional relationship shown in the drawings, these terms refer to the orientation or positional relationship for convenience of description and simplicity of description only, and do not indicate or imply that the apparatus or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the application.

Furthermore, the terms "first," "second," and the like, if any, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present application, the terms "plurality" and "a plurality" if any, mean at least two, such as two, three, etc., unless specifically defined otherwise.

In the present application, unless explicitly stated and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly. For example, they may be fixedly connected, detachably connected or integrally formed, mechanically connected, electrically connected, directly connected or indirectly connected through an intermediate medium, and communicated between two elements or the interaction relationship between two elements unless clearly defined otherwise. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art according to the specific circumstances.

In the present application, unless expressly stated or limited otherwise, the meaning of a first feature being "on" or "off" a second feature, and the like, is that the first and second features are either in direct contact or in indirect contact through an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.

It will be understood that if an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. If an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein, if any, are for descriptive purposes only and do not represent a unique embodiment.

Example 1:

Referring to fig. 1,2, 3 and 4, as shown in fig. 1, in a bioelectric signal collector 100 according to a first embodiment of the present application, the bioelectric signal collector 100 is configured to be worn on a skin of a user to be tested to obtain a bioelectric signal, and a signal collection host 230 is detachably mounted on the bioelectric signal collector 100 and configured to collect the bioelectric signal, where the bioelectric signal includes an electrocardiographic signal, an electromyographic signal, an electroencephalographic signal, an oculographic signal and the like. As in fig. 1.

The bioelectric signal collector 100 comprises a flexible substrate 110, a conductive layer 125 and a plurality of signal collecting electrodes 120 are arranged on the flexible substrate 110, the plurality of signal collecting electrodes 120 are used for collecting bioelectric signals of at least three different positions on the skin of a user to be tested, and the conductive layer 125 is used for conducting the bioelectric signals to a signal collecting host 230. The flexible substrate 110 is further provided with a connection layer 124, and the conductive layer 125 is electrically connected to the signal acquisition electrode 120 through the connection layer 124.

According to the embodiment of the application, the conductive layer 125 and the signal acquisition electrode 120 are respectively prepared on the flexible substrate 110 according to the conductive patterns, the conductive layer 125 and the signal acquisition electrode 120 are respectively lapped through the connecting layer 124 to realize conductive connection, and the outer contour of the flexible substrate 110 is cut along the conductive layer 125 and the signal acquisition electrode 120 according to the requirement, so that the outer contour of the bioelectric signal acquisition device 100 is formed. The connecting layer 124, the signal collecting electrode 120 and the conducting layer 125 form a series circuit, and in the strong current treatment scene of applying to defibrillation or high-voltage electric knife, the connecting layer 124 additionally arranged on the flexible substrate 110 can prevent defibrillation energy from being conducted and leaked through the signal collecting electrode 120 and the conducting layer 125, thereby affecting the treatment effect and not affecting the accuracy of bioelectric signals collected by the signal collecting electrode 120.

In one embodiment, the thickness of the connection layer 124 is 5 μm-200 μm and/or the resistance of the connection layer 124 is set to 1K-50K ohm to withstand the high current caused by the medical defibrillator or the electrostatic discharge, so as to prevent the signal collection host 230 from being destroyed by the high current. The embodiment provides that the connecting layer 124 made by using the printing process is light and thin, the product structure is compact, the thickness is not more than 200 μm, the connecting layer 124 is connected with the signal acquisition electrode 120 in series, the conducting layer 125 is not connected by other leads, the traditional defibrillation patch resistor which is necessary to be used in monitoring equipment due to equipment safety requirements can be replaced, the traditional patch resistor is overlarge in size, and needs to be connected by leads when in use, the use is heavy and cannot be used for compact physiological monitoring equipment application, and the product provided by the embodiment is light in size, miniaturized in structure and suitable for home remote monitoring. Particularly during defibrillation therapy, the patient needs to receive a plurality of defibrillation strong currents to restore heart function, and if the connection layer 124 is not provided, defibrillation energy enters the signal collecting main unit 230 through the signal collecting electrode 120 and the conductive layer 125, so that the signal collecting main unit 230 is destroyed by the strong current. The resistance value of the connection layer 124 provided in this embodiment is 1 k-50 k ohms, which can bear multiple strong current impact, and the signal collection host 230 can still be normally used after the end of the defibrillation treatment, so as to collect and record bioelectric signals, and enhance the use reliability of the device. If the resistance of the connection layer 124 is measured to be less than 1K ohm or more than 50K ohm, signal noise may be generated, affecting the accuracy of the bio-electrical signal acquisition.

In one embodiment, the connecting layer 124 is printed on the signal collecting electrode 120 and the conductive layer 125 by using a printing process, so that the wearing weight is not affected, the user to be tested can wear the device for a long time without interruption, and the bioelectric signals, especially the electrocardio signals, are monitored for a long time, so that the user to be tested can be helped to monitor the health or hidden trouble of the heart more comprehensively, and in a strong current treatment environment, such as defibrillation strong current or high voltage of an electric knife applied by the user to be tested is conducted to the signal collecting host 230 through the conductive layer 125, so that the host is damaged by the strong current. Therefore, the biological signal collector 100 provided by the embodiment of the application is light in wearing, is convenient for the user to be tested to wear for a long time without interruption, and is safer and more reliable by considering the use requirement of a monitoring scene, and ensuring that the biological signal collector 100 collects accurate biological signals in real time.

The bioelectric signal collector 100 is worn on the skin of the user to be measured to obtain bioelectric signals, the signal collection host 230 is mounted on the bioelectric signal collector 100 to realize signal collection and storage recording, and the plurality of signal collection electrodes 120 collect bioelectric signals at least at three different positions and transmit the bioelectric signals to the signal collection host 230 through the conductive layer 125. The signal acquisition electrode 120 and the conductive layer 125 are electrically connected through the connecting layer 124, so that the connecting layer 124 can inhibit the influence of strong current on the bioelectric signals acquired by the bioelectric signal acquisition device 100 on the basis of meeting the requirement of accurately acquiring the bioelectric signals. In this embodiment, the conductive layer 125, the signal collecting electrode 120 and the connection layer 124 may be printed on the flexible substrate 110 by using a printing process, and the conductive layer 125 and the signal collecting electrode 120 are electrically connected through the connection layer 124, so as to construct a lighter wearable product. Of course, the conductive layer 125, the signal collecting electrode 120, and the connection layer 124 may be respectively attached to the flexible substrate 110, and then a laser engraving or etching tool is used to remove the conductive material to obtain the conductive layer 125, the signal collecting electrode 120, and the connection layer 124, which is not limited herein.

Specifically, the present solution proposes that the conductive layers 125 are respectively connected to the signal collecting electrode 120 through the connection layers 124 to realize conductive communication, and the connection layers 124 are respectively connected to the conductive layers 125 and the signal collecting electrode 120 to construct a series circuit. The flexible substrate 110 may be a PET sheet that is more lightweight to use and easier to prepare the connection layer 124 and the conductive layer 125. The bioelectric signal collected by the signal collecting electrode 120 is conducted to the conducting layer 125 through the connecting layer 124, even if the bioelectric signal carrying strong current is conducted to the conducting layer 124 through the connecting layer 124, most of energy is inhibited by the connecting layer 124 and cannot be conducted to the signal collecting host 230 through the conducting layer 125, therefore, the signal collecting host 230 records the physiological signal processed through the connecting layer 124, and through the arrangement of the connecting layer 124, a defibrillation resistor device is not required to be additionally introduced, the product space size of the bioelectric signal collector 100 is reduced under the condition of inhibiting energy leakage, the construction of the lighter bioelectric signal collector 100 is facilitated, and the application scene of the product is enriched and expanded.

In an embodiment, the conductive layer 125 is isolated from the signal collecting electrode 120, the conductive layer 125 is made of a first conductive material, the signal collecting electrode 120 is made of a second conductive material different from the first conductive material, and the accuracy of signal collection is affected by avoiding chemical reaction, such as chemical reaction, substitution reaction, or oxidation-reduction reaction, between the conductive layer 125 and the signal collecting electrode 120. The connection layer 124 is prepared using a different third conductive material, wherein the second conductive material, the third conductive material, or the first conductive material and the third conductive material are in contact without chemical reaction, so that the accuracy of the collection and transmission of bioelectric signals is ensured. The wearable bioelectric signal collector 100 meeting different use scenes can be prepared according to actual product requirements, and the bioelectric signal collector 100 provided by the embodiment of the application fully considers the use requirements of high signal collection accuracy in different scenes and prevents the damage of different use scenes to the equipment reliability.

In a further embodiment, in order to meet the use requirement of more accurate bio-electric signal collection, the signal collection electrode 120 may be made of a second conductive material with higher signal collection precision, such as silver chloride, so as to ensure accurate and reliable bio-electric signal collection, the conductive layer 125 is made of a first conductive material different from the second conductive material to realize the signal transmission function, such as 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 requirement of the bio-electric signal collector 100, and the common conductive pattern processing method is not repeated here. At a preset electrode point, a silver chloride layer is generally used to prepare the signal collecting electrode 120, silver/silver chloride or a printed and coated silver chloride coating can be generated at the electrode point by electroplating silver and then chloridizing, wherein the conductive layer 125 is prepared by using a conductive material for signal transmission, and different conductive materials are easy to undergo contact reaction, such as chemical reaction after the silver chloride contacts with a conductive agent metal, for example, chloride ions corrode the conductive metal, so that the signal transmission accuracy is reduced. Therefore, a separation part is disposed between the signal collecting electrode 120 and the conductive layer 125, so as to isolate the first conductive material and the second conductive material that are easy to react, and influence the accuracy of signal transmission, for example, the separation part separates the signal collecting electrode 120 made of silver chloride from direct contact with the conductive layer 125 made of conductive metal.

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

In an embodiment, the conductive layer 125 includes a first lead portion 122, and an isolation portion (not shown in the figure) is disposed between the first lead portion 122 and the signal collecting electrode 120, where the isolation portion is used to isolate the conductive layer 125 from the signal collecting electrode 120, so as to ensure that the signal collecting electrode 120 and the first lead portion 122 using different conductive materials that are easy to react chemically in contact do not affect signal collection due to material contact and mixing, and in addition, the first lead portion 122 is electrically connected with the signal collecting electrode 120 through the connection layer 124, and ensure that the bioelectric signal collected by the signal collecting electrode 120 is accurately and reliably transmitted by the first lead portion 122.

In one embodiment, the connection layer 124 and the signal collecting electrode 120 are made of different conductive materials, and the first lead portion 122 is made of different conductive materials. The connection layer 124 and the first lead portion 122 form a first connection area, the connection layer 124 and the signal collection electrode 120 form a second connection area, the first connection area is in conductive communication with the second connection area, the connection layer 124 can electrically connect the signal collection electrode 120 and the first lead portion 122 through the first connection area and the second connection area, the conductive layer 125, the signal collection electrode 120 and the connection layer 124 which are designed separately are used for adapting to more use environments and preparation requirements, the applicability of the bioelectric signal collector 100 is improved, in the embodiment, the connection layer 124 is prepared by using a third conductive material, and the third conductive material does not generate chemical reaction when contacting with the second conductive material, the third conductive material may not react chemically when contacting the first conductive material, and typically, the signal collecting electrode 120 is made of silver chloride, and the first lead 122 may be at least one of conductive metal, conductive ink, conductive polymer or conductive carbon, and when the conductive layer 125 is made of metal, the connection layer 124 may be at least one of conductive ink, conductive polymer or conductive carbon, which may be understood that, for example, the first lead 122 is made of conductive metal, such as aluminum, and the connection layer 124 may not be made of conductive metal, because the signal collecting electrode 120 made of silver chloride may react with the connection layer 124 made of conductive metal in a combination manner, which increases signal interference. The connection layer 124 is guaranteed to conduct conductive communication between the signal acquisition electrode 120 and the conductive layer 125 and to conduct stable signal transmission.

In an embodiment, the first lead portion 122 and the signal collecting electrode 120 are arranged on the same layer, that is, the first lead portion 122 is printed on the flexible substrate 110 first, then the signal collecting electrode 120 is printed on the same layer, the connecting layer 124 is printed on the surface of the signal collecting electrode 120, and in addition, the areas where the connecting layer 124 connects the first lead portion 122 and the signal collecting electrode 120 respectively are smoother, so that the accuracy and stability in the signal collecting process caused by unbalanced printing of the connecting layer 124 are prevented.

In an embodiment, the gap area between the first lead portion 122 and the signal collecting electrode 120 is designed to form a separation portion, wherein the separation portion may be an air separation layer or an insulating layer, and the purpose of the separation portion is to prevent the conductive material of the first lead portion 122 from being mixed and contacted with the conductive material of the signal collecting electrode 120 to generate a chemical reaction, so as to affect the signal collecting performance of the signal collecting electrode 120.

In an embodiment, the first lead portion 122 is provided with the first opening 127, the signal collecting electrode 120 is disposed in the first opening 127, the connection layer 124 is disposed at the first opening 127, that is, the connection layer 124 is electrically connected with one side of the first lead portion 122, the overall size of the physiological electric signal collector 100 can be reduced, and the signal collecting electrode 120 is electrically connected with the first lead portion 122 through the connection layer 124, so that the planar size of the physiological electric signal collector 100 is greatly reduced. Moreover, the difficulty in processing the connection layer 124 is reduced, and the yield of products is improved, and it is further understood that the connection layer 124 may connect the first lead portion 122 and the signal acquisition electrode 120 at any angle.

Specifically, the ratio of the inner diameter of the first lead portion 122 to the outer diameter of the connection layer 124 is 0.1-0.9, so that the connection layer 124 and the first lead portion 122 are concentrically arranged, the connection area between the connection layer 124 and the first lead portion 122 is annular, the connection layer 124 uniformly covers the first lead portion 122, and it is ensured that the connection layer 124 can transmit the bioelectric signals collected by the signal collecting electrode 120 to the first lead portion 122 without damage.

In an embodiment, the shape of the flexible substrate 110 corresponding to the position of the first lead portion 122 is a circle, the first lead portion 122 is disposed at the center of the flexible substrate 110, the distance between the edge of the first lead portion 122 and the edge of the flexible substrate 110 is greater than or equal to 1.5mm, and the edge of the flexible substrate 110 exceeds the edge of the first lead portion 122, so that the first lead portion 122 can be protected from being damaged by external wear, and signal transmission is ensured not to be disturbed.

In one embodiment, the ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connection layer 124 is greater than or equal to 0.1 and less than 1. The ratio of the diameter of the signal collecting electrode 120 to the outer diameter of the connecting layer 124 is designed to be smaller than 1, so that absolute contact between the signal collecting electrode 120 and the connecting layer 124 can be ensured, the problems that the signal collecting electrode 120 is unevenly connected with the connecting layer 124 due to process processing errors and disconnection and the like are avoided, uneven signal transmission is caused, the ratio of the diameter of the signal collecting electrode 120 to the outer diameter of the connecting layer 124 is larger than 0.1, the signal transmission is prevented from being influenced by overlarge area of the connecting layer 124, the transmission of bioelectric signals is prevented from being hindered, and if the problems of long path, large resistance and the like occur, the signal collecting electrode 120 is ensured to collect bioelectric signals more accurately, and the bioelectric signals are transmitted more stably by the first lead part 122. More preferably, the cross-section of the signal collecting electrode 120 is circular, and the diameter of the signal collecting electrode 120 can be 1-20 mm. The processing signal collection electrode 120 and the first lead portion 122, the connection layer 124, are better controlled to facilitate collection and transmission of bioelectric signals.

In an embodiment, the connection layer 124 is disposed on a side of the signal collecting electrode 120 near the skin of the user to be tested, and the connection layer 124 is provided with a second opening 126, where the second opening 126 is used for exposing at least a portion of the conductive area of the signal collecting electrode 120, so that the conductive area of the signal collecting electrode 120 can be directly contacted with the skin of the human body to be tested, thereby ensuring that the signal collecting electrode 120 can completely collect the bioelectric signals of the human body. The cross-sectional shape of the connection layer 124 is annular. The annular connection layer 124 ensures uniform connection with the signal collection electrode 120 and the first lead portion 122, respectively, and ensures continuity of signal collection.

In yet another embodiment, the connection layer 124 is disposed on the side of the signal collecting electrode 120 far away from the skin of the user to be tested, and the connection layer 124 covers at least part of the signal collecting electrode 120, so as to ensure that the connection layer 124 is more firmly and electrically connected with the signal collecting electrode 120 and the first lead portion 122, respectively, and the connection layer 124 does not directly contact the skin of the human body to be tested, so that the signal collecting electrode 120 is not affected to collect bioelectric signals, and the signal collecting electrode 120 can be stably contacted with the skin of the human body to be tested, and the stability of signal collecting is ensured. The cross-sectional shape of the connection layer 124 designed in this embodiment is circular. By the design, the connecting layer 124, the signal collecting electrode 120 and the first opening of the first lead part 122 are round, so that the overall product shape and design style are uniform, and the design has more attractive value.

In an embodiment, the first lead portion 122 is stacked with the signal collecting electrode 120, and the isolation portion is disposed between the first lead portion 122 and the signal collecting electrode 120. The isolation part adopts an insulating layer to isolate the contact of the first lead part 122 and the signal acquisition electrode 120, so that the contact of the first lead part 122 prepared from different conductive materials and the signal acquisition electrode 120 is prevented from generating chemical reaction, the signal acquisition accuracy is influenced, and different forms of products are expanded.

In another embodiment, the connection layer 124 is disposed at the edges of the signal collecting electrode 120 and the first lead portion 122, and the connection layer 124 is not in conductive communication with the isolation portion, which has low requirements on the process when preparing the connection layer 124, the connection layer 124 is required to electrically connect the signal collecting electrode 120 and the first lead portion 122, so that the preparation difficulty is reduced.

In another embodiment, the connection layer 124 is disposed between the signal acquisition electrode 120 and the first lead portion 122, and the connection layer 124 may cover the signal acquisition electrode 120 such that the signal acquisition electrode 120 is spatially isolated from and electrically connected to the first lead portion 122.

In an embodiment, the conductive layer 125 includes a second lead portion 121 and a lead layer 128, the second lead portion 121 is used for being in conductive communication with the signal collecting host 230, one end of the lead layer 128 is in conductive connection with the first lead portion 122, the other end is in conductive connection with the second lead portion 121, so as to realize conductive connection between the bioelectric signal collector 100 and the signal collecting host 230, and the bioelectric signal collected by the signal collecting electrode 120 is transmitted to the signal collecting 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 may be integrally formed.

In an embodiment, the signal collecting electrode 120, the connection layer 124, the first lead portion 122, the second lead portion 121 and the lead layer 128 are printed on the flexible substrate 110 by printing, so as to ensure that the coating layers of the signal collecting electrode 120, the connection layer 124, the first lead portion 122, the second lead portion 121 and the lead layer 128 are uniform, and the signal transmission can be relatively stable.

In an embodiment, the bioelectric signal collector 100 further includes a glue patch 130, where the glue patch 130 is used to fix the signal collecting electrode 120 to the skin of the user to be tested. The bracket 210 and the signal-collecting electrode 120 are fixed to the skin by means of adhesive, so that the mounting or peeling is easy, and the product cost is controlled.

In an embodiment, the bioelectric signal collector 100 further includes a bracket 210, the bracket 210 and the adjacent signal collecting electrodes 120 are fixed on the skin of the user to be tested by using one adhesive tape 130, so that the user can more conveniently tear the protective layer of the adhesive tape 130 to fix the signal collecting electrodes 120 on the skin of the user to be tested, and ensure that the relative positions of the signal collecting electrodes 120 of the common adhesive tape 130 are determined, and more signal collecting electrodes 120 can be fixed by one adhesive tape 130 at the same time, so that the operation is simpler and more convenient. Preferably, the signal collection host 230 is detachably connected to the bracket 210, such as a snap connection, a screw-on connection, a combination of protrusions and recesses, etc., or the bracket 210 is provided with a grip and the signal collection host 230 is combined. The combination mounting or separation dismounting manner is not specifically exemplified in this embodiment.

Referring to fig. 10, in an embodiment, three signal collecting electrodes 120 are provided, that is, in the single-lead product embodiment provided in this embodiment, at least two signal collecting electrodes 120 are disposed adjacently, and preferably, electrode points are configured in a Y-type layout. Wherein two adjacent signal acquisition electrodes 120 are located above the bracket 210, a glue patch 130 can be shared, and one glue patch 130 can fix the two adjacent signal acquisition electrodes 120 and the bracket 210 on the skin of a human body at the same time, so that the installation is convenient. For the single-guide product, physiological electric signals can be collected only by being arranged at any position of the chest skin of a human body, and the single-guide product can be widely applied to real-time monitoring in the fields of electrocardio, electroencephalogram, myoelectricity, electrooculogram and the like. The present embodiment provides an illustration of single conductor product mounting, with the fixed mounting bracket 210 being on the mid-line of the human sternum and the signal acquisition electrode 120 being mounted along the conductive layer 125 on the human skin. Therefore, only the fixing bracket 210 is needed, the mounting point of the signal acquisition electrode 120 can be fixed, a more convenient mounting mode is provided, and the device is suitable for home remote use of a user. The variation of the single-guide product only needs to satisfy that three signal collecting electrodes 120 are provided, and the specific design manner of the signal collecting electrodes 120 is protected in this embodiment.

Referring to fig. 11, in an embodiment, four signal collecting electrodes 120 are provided, that is, the present embodiment provides a three-way product embodiment, at least two signal collecting electrodes 120 are disposed adjacently, in this embodiment, two adjacent signal collecting electrodes 120 are disposed below the support 210, one adhesive patch 130 may be used respectively, a third signal collecting electrode 120 is disposed above the support 210, a fourth signal collecting electrode 120 is disposed above the support 210, and two signal collecting electrodes 120 disposed above the support 210 use one adhesive patch 130 respectively. Wherein the bracket 210 and the signal acquisition electrode 120 may share a common adhesive 130. As in the previous embodiment, only the fixing bracket 210 is needed, the mounting point of the signal acquisition electrode 120 can be fixed, a more convenient mounting mode is provided, the device is suitable for home remote use of users, and the product applicability is further improved. The variation of the three-conductor product only needs to satisfy that the signal collecting electrodes 120 are provided with four, and the specific design mode of the signal collecting electrodes 120 is protected in the embodiment.

In the above embodiment, because the number of the signal collecting electrodes 120 is small, that is, the number of the signal collecting electrodes 120 is three or four, the signal collecting electrodes 120 can be installed on the skin of the human body according to the usage instructions of the product, no strict use requirement is required, the use of home care is facilitated, the use threshold is reduced, more users can obtain the bioelectric signal data through the bioelectric signal collector 100, even if special people can use the bioelectric signal collector conveniently, and the product usage population is further enlarged. In addition, the product uses the adhesive 130 to be applied on the skin, is used as a disposable product, and is more convenient for popularization and family nursing use.

In one embodiment, the signal acquisition electrodes 120 are provided in ten, at least two signal acquisition electrodes 120 being disposed adjacent. The ten signal acquisition electrodes 120 comprise six chest lead electrodes and four limb electrodes, the acquired bioelectric signals are richer, and the processing results are more accurate for the bioelectric signal analysis system or the monitoring system by providing rich bioelectric signals, so that the medical analysis requirements are met.

Referring to fig. 1 and 7, fig. 7 is another implementation of the flexible substrate 110 of the embodiment of fig. 1, where ten signal acquisition electrodes 120 include a first chest lead electrode set and a second chest lead electrode set, the first chest lead electrode set and the second chest lead electrode set are respectively disposed on two sides of a central extension line of the support 210, the flexible substrate 110 is provided with an expansion opening 167 along the central extension line of the support 210, and the expansion opening 167 is used for expanding a distance between the first chest lead electrode set and the second chest lead electrode set, so that the expansion opening 167 can be torn according to different users, and a distance between the first chest lead electrode set and the second chest lead electrode set can be adjusted to improve applicability of the wearable physiological monitoring device 200. For example, for a female user, the expansion opening 167 is more suitable for mounting a first chest lead electrode set, a second chest lead electrode set, to the breast site, and collecting signals.

Referring to fig. 5 and 6, in one embodiment, the ten signal acquisition electrodes further comprise a limb lead electrode set comprising a first limb lead electrode labeled R, a second limb lead electrode labeled L, a third limb lead electrode labeled F, a fourth limb lead electrode labeled N, the first chest lead electrode set comprising a first chest lead electrode labeled C1, the second chest lead electrode set comprising a second chest lead electrode labeled C2, a third chest lead electrode labeled C3, a fourth chest lead electrode labeled C4, a fifth chest lead electrode labeled C5, a sixth chest lead electrode labeled C6, wherein the fourth limb lead electrode is disposed adjacent to the first limb lead electrode and simultaneously fixes the first limb lead electrode to the first body lead electrode using a patch 130, or the fourth limb lead electrode is disposed adjacent to the first limb lead electrode and simultaneously fixes the fourth limb lead electrode with the fourth limb lead electrode using a patch 130 or the fourth limb lead electrode is disposed adjacent to the first limb lead electrode and simultaneously fixes the fourth limb lead electrode with the fourth limb lead electrode.

In an embodiment, at least one bending structure 162 is disposed on the flexible substrate 110, the bending structure 162 is used for extending or shortening the length of the lead layer 128, so that when the signal acquisition electrode 120 needs to be adhered to a more distant place, the bending structure 162 is only required to be stretched and deformed by holding the handle 166, thereby adjusting the mounting position of the signal acquisition electrode 120 according to the use requirement, and improving the applicability of the bioelectric signal acquisition device 100 to users to be tested with different sizes.

In an embodiment, the lead layer 128 is provided with a defibrillation resistor 163, and the defibrillation resistor 163 is used for bearing strong current caused by a medical defibrillator or electrostatic discharge, and the overcurrent generated by the defibrillation equipment is processed by the defibrillation resistor 163, so that signal acquisition is prevented from being influenced, and the use safety of the signal collection host 230 is ensured.

An embodiment of the present application further provides a wearable physiological monitoring device 200, including the bioelectric signal collector 100 of the above embodiment, which greatly expands the use scenario and provides a more accurate bioelectric signal monitoring function for the target user.

In an embodiment, the wearable physiological monitoring device 200 further includes a signal collection host 230 mounted in combination with or detached from the bioelectric signal collector 100, and the signal collection host 230 is used for collecting and recording bioelectric signals.

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

Example 2:

Embodiment 2 mainly expands part of the structure of embodiment 1, wherein the bioelectric signal collector 100, the wearable physiological monitoring device 200, and the physiological monitoring system correspond to the bioelectric signal collector 100, the wearable physiological monitoring device 200, and the physiological monitoring system in embodiment 1.

Referring to fig. 3, fig. 3 is a schematic structural diagram of a bioelectric signal collector 100 according to an embodiment of the application, and the bioelectric signal collector 100 is described in detail in this embodiment in connection with the electrocardiographic monitoring field. The bioelectric signal collector 100 is applied to collect electrocardiosignals of a human body, and the bioelectric signal collector 100 provided by an embodiment of the application comprises a flexible substrate 110 and a conductive pattern layer arranged on the surface of the flexible substrate 110. The conductive pattern layer includes a plurality of signal acquisition electrodes 120, a connection layer 124, and a conductive layer 125.

Referring to fig. 1,2 and 3, in the bioelectric signal collector 100, the signal collecting electrode 120 is used for contacting with the skin of the human body to obtain the electrocardiographic signal, the conductive layer 125 is used for transmitting the electrocardiographic signal, an isolation portion is formed between the signal collecting electrode 120 and the conductive layer 125, the isolation portion is used for isolating the signal collecting electrode 120 from directly contacting with the conductive layer 125, and the conductive layer 125 is electrically connected with the signal collecting electrode 120 through the connection layer 124. The bioelectric signal collector 100 provided by the application uses the connecting layer 124 to electrically connect the signal collecting electrode 120 and the conducting layer 125, so that in special treatment scenes, the use of the connecting layer 124 is beneficial to preventing the leakage of energy applied to the body surface of a user to be tested, and the transmission of the energy to the signal collecting host 230 through the conducting layer 125 can be restrained, thereby avoiding the damage to the host.

In an embodiment, the conductive layer 125 includes a plurality of first lead portions 122, the first lead portions 122 are provided with first openings 127, the signal collecting electrodes 120 are accommodated in the first openings 127, and a separation portion is formed between the signal collecting electrodes 120 and the first lead portions 122, which may allow the connection layer 124 to connect the first lead portions 122 and the signal collecting electrodes 120 at an arbitrary angle.

The gap region between the first lead portion 122 and the signal collecting electrode 120, which is designed separately, constitutes an isolation portion, where the isolation portion may be an air isolation layer or an insulating layer, and the purpose of the isolation portion is to prevent the conductive material of the first lead portion 122 from being mixed and contacted with the conductive material of the signal collecting electrode 120 to generate a chemical reaction, which affects the signal collecting performance of the signal collecting electrode 120.

Specifically, the conductive layer 125 includes a lead layer 128, the lead layer 128 is used to expand a contact point of the signal acquisition electrode 120 on the skin of the human body, and the lead layer 128 is electrically connected to the first lead portion 122. The first lead portion 122, the lead layer 128 and the signal collecting electrode 120 are in one-to-one correspondence, the first lead portion 122 and the lead layer 128 can be integrally printed and formed, so that the printing efficiency is improved, and the application range of the bioelectric signal collector 100 can be also improved by printing and connecting the first lead portion and the lead layer 128 respectively.

Specifically, in an embodiment, at least one first connection area is formed between the connection layer 124 and the first lead portion 122, and at least one second connection area is formed between the connection layer 124 and the signal acquisition electrode 120, and specifically, the connection layer 124 may be in direct contact with, or partially in contact with, the first lead portion 122 and the lead layer 128, or may be electrically connected by a component having a certain number of conductive functions.

In another embodiment, the outline shape of the signal acquisition electrode 120 is circular, the outline shape of the first lead portion 122 is annular, and the signal acquisition electrode 120 is located within the annular first lead portion 122.

Preferably, the signal acquisition electrode 120, the first lead portion 122 and the connection layer 124 are concentric, wherein the connection layer 124 is circular or annular, so as to ensure that the connection layer 124 forms annular connection areas with the signal acquisition electrode 120 and the first lead portion 122 respectively, and keep stable transmission of the acquired electrocardiograph signals.

Preferably, the ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connection layer 124 is 0.1 or more and less than 1. The cross-sectional shape of the signal collecting electrode 120 is designed to be circular, the cross-sectional shape of the connecting layer 124 is designed to be annular, and the ratio of the diameter of the signal collecting electrode 120 to the outer diameter of the connecting layer 124 is designed to be smaller than 1, so that absolute contact between the signal collecting electrode 120 and the connecting layer 124 can be ensured, the problems that the signal collecting electrode 120 is unevenly connected with the connecting layer 124 due to process machining errors and disconnection and the like are avoided, signal transmission is uneven, the ratio of the diameter of the signal collecting electrode 120 to the outer diameter of the connecting layer 124 is larger than or equal to 0.1, the signal transmission is prevented from being influenced by overlarge area of the connecting layer 124, and the transmission of bioelectric signals is blocked if the problems of long path, large resistance and the like occur, and the signal collecting electrode 120 is ensured to collect bioelectric signals more accurately, and the bioelectric signals are transmitted more stably by the first lead part 122. More preferably, the cross-section of the signal collecting electrode 120 is circular, and the diameter of the signal collecting electrode 120 can be 1-20 mm. The processing signal collection electrode 120 and the first lead portion 122, the connection layer 124, are better controlled to facilitate collection and transmission of bioelectric signals.

In one embodiment, bioelectric signal collector 100 further includes a support 210, where support 210 is used to mount an electrocardiograph, and lead layer 128 is mounted on support 210 in a collection manner and electrically connected to the electrocardiograph.

Specifically, the support 210 is provided with a strip hole 211, and one end of the plurality of lead layers 128 facing away from the corresponding first lead portion 122 is disposed through the strip hole 211 and attached to the support 210.

In an embodiment, the bioelectric signal collector 100 further includes a plurality of adhesive patches 130, the flexible substrate 110 is adhered to a non-adhesive layer of the adhesive patches 130, the adhesive layer of the adhesive patches 130 is used for adhering the signal collecting electrode 120 and the bracket 210 to the skin of the human body, the adhesive patches 130 are provided with third openings 131, and the third openings 131 are used for exposing the signal collecting electrode 120 so as to enable the signal collecting electrode 120 to be in contact with the skin of the human body.

In one embodiment, as shown in fig. 2 and 4, the bioelectric signal collector 100 further includes a conductive gel layer 140, and the conductive gel layer 140 may be a hydrogel. The signal collecting electrode 120 contacts with the skin of the human body through the conductive adhesive layer 140 to fix the signal collecting electrode 120 to the skin of the human body, and collect the electrocardiosignal.

In an embodiment, in fig. 10, the signal collecting electrode 120 is provided with three electrodes, including a first electrode, a second electrode and a third electrode, and the lead layer 128 extends upward with the support 210 as a center to form a first branch, a second branch, and the lead layer 128 extends downward to form a third branch, where the first branch includes the first electrode electrically connected to the signal collecting electrode 120, the second branch includes the second electrode electrically connected to the signal collecting electrode 120, and the third branch includes the third electrode electrically connected to the signal collecting electrode 120. The space layout of the first electrode, the second electrode and the bracket 210 forms a Y shape, the adhesive tape 130 comprises a first adhesive tape 130 and a second adhesive tape 130, the first adhesive tape 130 is used for fixing the first electrode, the second electrode and the bracket 210, and the second adhesive tape 130 is used for a third electrode.

In one embodiment, in fig. 11, four signal collecting electrodes 120 are provided, and the lead layer 128 extends downward to form a fourth branch, where the fourth branch includes a fourth electrode electrically connected to the signal collecting electrode 120, and the second electrode, the fourth electrode, and the support 210 form a Y-shape.

In an embodiment, the adhesive 130 further includes a third adhesive 130, and the third adhesive 130 is used for fixing the first electrode, the second electrode, the third electrode, the fourth electrode, and the bracket 210, respectively.

In the above embodiment, the signal collecting electrodes 120 are three or four, so that the user to be tested can attach the signal collecting electrodes 120 to the skin according to the needs, and the use threshold is reduced without using according to higher medical requirements, so that more users can obtain bioelectric signals through the bioelectric signal collector 100.

Referring to fig. 5 and 6, in an embodiment, the signal collecting electrodes 120 are ten, the signal collecting electrodes 120 further include a fifth electrode, the lead layer 128 extends downward to form a fifth branch, the fifth branch and the third branch are respectively disposed on two sides of the center line of the support 210, the third branch continues to extend and electrically connect to the fifth electrode, and the fifth branch is electrically connected to the six signal collecting electrodes 120. In this embodiment, specifically, a character 151 is printed on a side of the flexible substrate 110 facing away from the first lead portion 122 to display a position of the signal acquisition electrode 120 corresponding to a human body, where the character 151 includes R, L, N, F, C1, C2, C3, C4, C5, and C6, and in the following description, with reference to fig. 6, the bioelectric signal acquisition device 100 of different forms is described in the following positions:

the character R, the lead position is below the right collarbone midline;

Character L, the lead position is below the left collarbone midline;

character N, the lead position is the fifth intercostal space of the right collarbone midline;

character F, the lead position is the sixth intercostal space of the left collarbone midline;

character C1, the lead position is the right end of the sternum and the fourth intercostal;

character C2, the lead position is the left end of the sternum, and the fourth intercostal space;

Character C4, the lead position is the left collarbone midline, the fifth intercostal;

The lead position of the character C3 is the middle of the signal acquisition electrode 120 indicated by the character C2 and the signal acquisition electrode 120 indicated by the character C4, and the fifth intercostal;

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

the lead position of character C6 is the left axillary midline and is at the same level as the signal acquisition electrode 120 indicated by character C4.

The meaning of the character 151 set in the lead layer 128 at each position above is defined and referenced using existing standards, mainly with reference to the lead electrode of the American standard 12.

The bioelectric signal collector 100 with ten signal collecting electrodes 120 is mainly used in medical scenes, and more collected electrocardiosignals are used for accurate disease monitoring and analysis.

Referring to fig. 3, in an embodiment, the adhesive tape 130 includes a fourth adhesive tape 130, where the fourth adhesive tape 130 is used to fix two signal acquisition electrodes 120 of the third branch or at least two signal acquisition electrodes 120 adjacent to each other on the fifth branch.

The adhesive tape 130 exposes the signal collecting electrode 120 through the third opening 131, so that the signal collecting electrode 120 is attached to the skin surface of the user to be tested through the adhesive tape 130 surrounding the signal collecting electrode 120, the attaching efficiency is improved, and the attaching position is more accurate.

In one embodiment, any number of signal acquisition electrodes 120 share a common adhesive 130, and any number of signal acquisition electrodes 120 share a common adhesive 130.

Specifically, other possible embodiments are possible such that any number of signal acquisition electrodes 120 share one glue 130, and all such embodiments are within the scope of this embodiment.

Referring to fig. 8 and 10, in an embodiment, the lead layer 128 and the flexible substrate 110 between any two adjacent first lead portions 122 are curved, specifically, if the flexible substrate 110 is S-shaped or coil-shaped, when the signal collecting electrode 120 needs to be pasted further, the flexible substrate 110 is only required to be stretched and deformed, and the lead layer 128 can be stretched and deformed, so that the signal collecting electrode 120 can be moved further, and the applicability of the bioelectric signal collector 100 to users to be tested with different body types is improved.

Specifically, the flexible substrate 110 has light transmittance.

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

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

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

The signal collecting electrode 120 is made of silver chloride, and the connecting layer 124 is made of a conductive material which cannot react with the silver chloride in a contact way, for example, conductive metal is easy to react with the silver chloride in an electron transfer way, and metal atoms are corroded by chloride ions. The conductive layer 125 may be made of a conductive material that does not react with the connection layer 124, such as one of conductive ink, conductive polymer, conductive carbon, and conductive metal.

In an embodiment, the connection layer 124 and the first lead portion 122 are insulated from a side of the flexible substrate 110, so that the transmission of bioelectric signals through the connection layer 124 and the first lead portion 122 is prevented, the collection of the electrocardiographic signals only by the signal collecting electrode 120 through the conductive adhesive layer 140 is ensured, and the collection stability of the electrocardiographic signals is ensured.

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

Referring to fig. 1, 2 and 3, in an embodiment, the bioelectric signal collector 100 further includes a plurality of release films 150, the release films 150 are disposed corresponding to the adhesive tapes 130, and the release films 150 are attached to a side of the corresponding adhesive tape 130 facing away from the signal collecting electrode 120 and cover the conductive adhesive layer 140. In actual use, the operator needs to tear the release film 150 from the adhesive layer, thereby exposing the adhesive tape 130 and the conductive adhesive layer 140, and then attach the adhesive tape 130 and the conductive adhesive layer 140 to the corresponding positions of the skin of the user to be tested, thereby improving the adhering efficiency.

As shown in fig. 2 and 4, in detail, the sticker 130 is adhered to the flexible substrate by the adhesive member 164, the adhesive member 164 is provided with the fourth opening 165 such that the conductive adhesive layer 140 is in contact with the signal collecting electrode 120 through the third opening 131 and the fourth opening 165, so that the signal collecting electrode 120 is in contact with the skin of the human body through the conductive adhesive layer 140 to fix the signal collecting electrode 120 to the skin of the human body and conduct electricity.

Referring to fig. 1, 2 and 3, in an embodiment, the guiding section 111 includes a connecting wire portion 113 and a branching portion 114, a part of the guiding layer 128 is attached to the wire portion 113, another part is attached to the branching portion 114, one end of the wire portion 113 is connected to one end of the branching portion 114, the other end is connected to the attaching piece 112, and a plurality of wire portions 113 are connected, when the guiding layer 128 needs to be connected to the signal collecting electrode 120, the guiding layer 128 is led to the branching portion 114 from the wire portion 113, and then led to the signal collecting electrode 120 on the attaching piece 112, and is connected to the signal collecting electrode 120, so that the guiding layer 128 can extend along with the wire portion 113 and the branching portion 114, and the guiding layer 128 is more regular, and only needs to perform arrangement and pasting of the whole bioelectric signal collector 100 according to the extension of the guiding section 111.

Referring to fig. 7, in an embodiment, the bioelectric signal collector 100 further includes a sleeve 160, where a plurality of wire sections 113 are overlapped and disposed on the sleeve 160, the sleeve 160 is sleeved on the outer periphery of the plurality of wire sections 113, and an inner wall of the sleeve 160 abuts against the wire sections 113 and can slide along an extending direction of the wire sections 113, so that the wire sections 113 can be separated according to different body structures of different users to be tested, the length of the wire sections 114 is prolonged by changing phases, and then the sleeve 160 slides along the wire sections 113, so that the wire sections 114 capable of moving and changing directions can be attached according to actual conditions, so that a range in which the wire sections 114 deviate from the wire sections 113 can be attached is wider, and the applicability of the bioelectric signal collector 100 is improved.

In one embodiment, the adjacent branching portions 114 are partially connected.

Specifically, the branching portion 114 includes an extraction section 115 and a wire section 116, one end of the extraction section 115 is connected with one end of the wire section 116, the other end is connected with the attaching piece 112, one end of the wire section 116, which is away from the extraction section 115, is connected with the wire section 113, and any number of adjacent wire sections 116 can be selectively combined and connected, so that the lead layers 128 corresponding to the adjacent signal collecting electrodes 120 can be firstly combined and extracted at the wire section 116, and then when the adjacent signal collecting electrodes 120 need to be connected, the extraction section 115 is extracted from the wire section 116 to form an independent lead layer 128 to be connected with the signal collecting electrodes 120, so that the whole circuit extraction is smoother, the circuit disorder is avoided, the circuit is avoided from being regulated when the bonding device is used, and the bonding efficiency is improved.

Referring to fig. 5 and fig. 9, in an embodiment, the bioelectric signal collector 100 further includes a telescopic sleeve 161, the lead layer 128 and the flexible substrate 110 between any two adjacent first lead portions 122 are sequentially folded along the thickness direction of the flexible substrate 110 towards the direction away from the first lead portions 122 and towards the direction close to the first lead portions 122 to form a bending structure 162, the telescopic sleeve 161 is sleeved on the bending structure 162 and is abutted with the bending structure 162, so that when the signal collecting electrode 120 needs to be adhered to a farther place, the flexible substrate 110 on two sides of the telescopic sleeve 161 is only required to be subjected to tensile deformation, and the lead layer 128 can be subjected to tensile deformation, thereby enabling the signal collecting electrode 120 to move to the farther place and improving the applicability of the bioelectric signal collector 100 to users with different body types to be tested.

Referring to fig. 2, in an embodiment, the wearable physiological monitoring device 200 further includes a defibrillation resistor 163, where the defibrillation resistor 163 is connected to a side of the lead layer 128 facing away from the flexible substrate 110, specifically, the defibrillation resistor 163 may be set by a printing process, and the defibrillation resistor 163 proposed in the embodiment meets a high-resistance requirement, so that the wearable physiological monitoring device is further suitable for a defibrillation protection function.

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

Referring to fig. 1, fig. 2, fig. 3, and fig. 5, an embodiment of the application further provides a wearable physiological monitoring device 200, where the wearable physiological monitoring device 200 includes an electrocardiograph 230 and a bioelectric signal collector 100, and the electrocardiograph 230 is electrically connected to the bioelectric signal collector 100.

Referring to fig. 2, in an embodiment, the wearable physiological monitoring device 200 further includes a power component 220, where the power component 220 is connected to an end of the lead layer 128 away from the corresponding first lead portion 122, so as to be capable of supplying power to the electrocardiograph or the signal collection host 230.

Referring to fig. 2, in particular, the wearable physiological monitoring device 200 further includes a protection member covering the power supply member 220 and connected with the flexible substrate 110, thereby achieving the function of protecting the power supply member 220.

Example 3:

An embodiment of the present application provides a method for manufacturing a bioelectric signal collector, as shown in fig. 12, where the method is used to manufacture a bioelectric signal collector 100 with at least three different electrode points, and the method for manufacturing a bioelectric signal collector includes:

Providing a flexible substrate 110;

preparing a conductive layer 125 on the surface of the flexible substrate 110;

preparing signal acquisition electrodes 120 of at least three different electrode points on the surface of the flexible substrate 110;

a connection layer 124 is prepared on the surface of the flexible substrate 110, the signal acquisition electrode 120, the connection layer 124 and the conductive layer 125 construct a series conductive connection, and the thickness of the connection layer 124 is processed to be 5 μm-200 μm.

In this embodiment, the conductive layer 125, the signal collecting electrode 120 and the connection layer 124 are respectively prepared on the flexible substrate 110, and the connection layer 124, the signal collecting electrode 120 and the conductive layer 125 form a series circuit, so as to realize conductive connection between the connection layer 124, the conductive layer 125 and the signal collecting electrode 120. In this embodiment, the resistance of the connection layer 124 is measured by adjusting the thickness of the connection layer 124 and/or adjusting the resistivity of the connection layer 124 to be 1k to 50k ohms, specifically, the resistivity of the connection layer 124 can be adjusted by adjusting the sheet resistance or the resistivity of the printing paste of the connection layer 124, or the thickness of the connection layer 124 is processed to be 5 μm to 200 μm by a printing process to measure the resistance of the connection layer 124 to be 1k to 50k ohms, so as to withstand the strong current caused by the medical defibrillator or the electrostatic discharge, and avoid the signal collecting host 230 from being knocked down by the strong current. The present embodiment proposes that the connecting layer 124 made by printing process has a thin and thin shape, a thickness not exceeding 200 μm, and is connected in series with the signal acquisition electrode 120 and the conductive layer 125, and no other lead connection is needed, so that the traditional defibrillation chip resistor in the monitoring device which must be used due to the safety requirement of the device can be replaced, the traditional chip resistor has an excessively large volume, and when in use, the lead connection is needed, the use is heavy, and the device cannot be used for compact physiological monitoring device. Particularly during defibrillation therapy, the patient needs to receive a plurality of defibrillation strong currents to restore heart function, and if the connection layer 124 is not provided, defibrillation energy enters the signal collecting main unit 230 through the signal collecting electrode 120 and the conductive layer 125, so that the signal collecting main unit 230 is destroyed by the strong current. The resistance value measured by the connection layer 124 provided in this embodiment is 1 k-50 k ohms, and can bear multiple strong current impact, and after the defibrillation treatment is finished, the signal collection host 230 can still be normally used to collect and record bioelectric signals, so that the use reliability of the device is enhanced. If the resistance of the connection layer 124 is measured to be less than 1K ohm or more than 50K ohm, signal noise may be generated, affecting the accuracy of the bio-electrical signal acquisition.

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

In this embodiment, the factors of the printing paste selected by the connection layer 124 to inhibit the energy leakage mainly include the type of paste resin, the relative content between the resin and the conductive particles, the curing temperature, the size area of the connection layer 124, the resistance value, and the like.

In one embodiment, to provide a lighter wearing experience, the connecting layer 124 is printed on the signal collecting electrode 120 and the conductive layer 125 by using a printing process, so that the wearing weight is not affected, the user to be tested can wear the device for a long time without interruption, and the bioelectric signals, especially the electrocardio signals, are monitored for a long time, so that the user to be tested can be helped to monitor the health of the heart or hidden trouble diseases more comprehensively, and in a strong current treatment environment, such as defibrillation strong current or electrotome high voltage applied by the user to be tested is conducted to the signal collecting host 230 through the conductive layer 125, so that the host is damaged by the strong current. Therefore, the biological signal collector 100 provided by the embodiment of the application is light in wearing, is convenient for the user to be tested to wear for a long time without interruption, and is safer and more reliable by considering the use requirement of a monitoring scene, and ensuring that the biological signal collector 100 collects accurate biological signals in real time.

Specifically, the flexible substrate 110 may be a substrate formed of a flexible material, and may be a flexible material having advantages of light weight, transparency, flexibility, and stretchability, for example, the flexible substrate 110 may be polyvinyl alcohol (PVA), polyester (PET), polyimide (PI), polyethylene naphthalate (PEN), or the like, and as an example, the flexible substrate 110 using a PET film as a bioelectric signal collector is provided with the conductive layer 125 and the signal collecting electrode 120 on the flexible substrate 110.

The manufacturing method provided by the embodiment further comprises the following steps:

compounding the conductive layer 125 with the flexible substrate 110;

planning a conductive pattern of the conductive layer 125 according to design requirements of providing at least three signal acquisition electrodes 120 on the flexible substrate 110;

The conductive layer 125 is divided into a first lead part 122, a lead layer 128 and a second lead part 121 which are electrically connected, wherein the first lead part 122 is electrically connected with the signal acquisition electrode 120 through the connecting layer 124;

the connection layer 124 and the first lead portion 122 form a first connection region at the connection point;

the connection of the signal acquisition electrode 120 and the connection layer 124 forms a second connection region;

The first connection region is in conductive communication with the second connection region.

In this embodiment, in order to improve the signal collection accuracy, the signal collection electrode 120 may be made of a noble metal, such as silver, the first lead portion 122 may be made of at least one of conductive metal, conductive ink, conductive polymer or conductive carbon, the connection layer 124 may be made of at least one of conductive ink, conductive polymer or conductive carbon, for example, the first lead portion 122 may be made of a conductive metal, such as aluminum, the connection layer 124 may be made of conductive ink, but not be made of a conductive metal, because the signal collection electrode 120 made of silver chloride and the connection layer 124 made of conductive metal may undergo a chemical combination reaction when contacting, thereby increasing signal interference. The connection layer 124 and the first lead portion 122 form a first connection area, the connection layer 124 and the signal acquisition electrode 120 form a second connection area, the first connection area is in conductive communication with the second connection area, the signal acquisition electrode 120 and the first lead portion 122 are in conductive connection through the first connection area and the second connection area, the conductive layer 125, the signal acquisition electrode 120 and the connection layer 124 which are designed in a split mode are used for adapting to more use environments and preparation requirements, applicability of the bioelectric signal acquisition device 100 is improved, and a printing or coating process can be used for enabling connection between the connection layer 124 and the signal acquisition electrode 120 and connection between the connection layer 124 and the connection layer are even and guaranteeing lead quality.

In this embodiment, the first lead portion 122, the lead layer 128 and the second lead portion 121 may be integrally formed. The signal collecting electrode 120, the connection layer 124, the first lead portion 122, the second lead portion 121 and the lead layer 128 are printed on the flexible substrate 110 in a printing manner, so that the signal collecting electrode 120, the connection layer 124, the first lead portion 122, the second lead portion 121 and the lead layer 128 are uniformly coated, and signal transmission can be relatively stable. The bioelectric signal collector 100 further includes a support 210, the second lead portion 121 is exposed and mounted on the support 210, when the signal collecting host 230 is mounted on the support 210, the signal collecting 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, the other end is electrically connected to the second lead portion 121, the bioelectric signal is transmitted to the signal collecting host 230 through the signal collecting electrode 120 and the first lead portion 122, the first connection area, the lead layer 128, the second connection area and the second lead portion 121, and the purpose of signal transmission is achieved.

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

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

The connection layer 124 is formed on the surfaces of the first lead part 122 and the signal collection electrode 120 through a printing or plating process using at least one of conductive ink, conductive polymer, conductive carbon powder, and metal material.

In an embodiment, the signal collecting electrode 120 and the first lead portion 122 are formed on the same layer of the flexible substrate 110, the first lead portion 122 is provided to form the first opening 127, the signal collecting electrode 120 is provided in the first opening 127, and the signal collecting electrode 120 is electrically connected with the first lead portion 122 through the connection layer 124, so that the overall size of the physiological electric signal collector 100 can be reduced. Moreover, the difficulty in processing the connection layer 124 is reduced, and the yield of products is improved, and it is further understood that the connection layer 124 may electrically connect the first lead portion 122 and the signal acquisition electrode 120 at any angle. The signal collecting electrode 120 and the first lead part 122 are arranged on the same layer, namely, the first lead part 122 is firstly printed on the flexible substrate 110, then the signal collecting electrode 120 is printed on the same layer, the connecting layer 124 is printed on the surface of the signal collecting electrode 120, the areas where the connecting layer 124 is used for respectively connecting the first lead part 122 and the signal collecting electrode 120 are smoother, and the imbalance of the printing of the connecting layer 124 is prevented from affecting the accuracy and stability of signal collection. The gap between the signal collecting electrode 120 and the first lead portion 122 forms an isolation portion, the isolation portion is used for isolating the first lead portion 122 from being in direct contact with the signal collecting electrode 120, the isolation portion can be an air isolation layer or an insulating layer, and the purpose of the isolation portion is to prevent the conductive material of the first lead portion 122 from being in mixed contact with the conductive material of the signal collecting electrode 120 to generate chemical reaction, so that the signal collecting accuracy of the signal collecting electrode 120 is affected. Therefore, for the spacer provided by the embodiment of the present application, the signal acquisition electrode 120 and the first lead part 122 can be prepared using different conductive materials, and the acquisition and transmission of bioelectric signals are not affected.

In an embodiment, the cross-sectional shape of the signal collecting electrode 120 is circular, the cross-sectional shape of the connection layer is annular, and the ratio of the diameter of the signal collecting electrode 120 to the outer diameter of the connection layer 124 is greater than or equal to 0.1 and less than 1. Therefore, absolute contact between the signal collecting electrode 120 and the connecting layer 124 can be ensured, the problems that the signal collecting electrode 120 is not uniformly connected with the connecting layer 124 due to process processing errors, disconnection and the like are easy to occur, so that signal transmission is not uniform, the ratio of the diameter of the signal collecting electrode 120 to the outer diameter of the connecting layer 124 is 0.1, the signal transmission is prevented from being influenced by overlarge area of the connecting layer 124, the transmission of bioelectric signals is hindered, such as long path and large resistance, and the like are ensured, the bioelectric signals are collected more accurately by the signal collecting electrode 120, and the bioelectric signals are transmitted more stably by the first lead part 122. More preferably, the cross-section of the signal collecting electrode 120 is circular, and the diameter of the signal collecting electrode 120 can be 1-20 mm. The processing signal collection electrode 120 and the first lead portion 122, the connection layer 124, are better controlled to facilitate collection and transmission of bioelectric signals.

In an embodiment, the connection layer is disposed on the side of the signal collecting electrode 120 near the skin of the user to be tested, and the connection layer 124 is provided with a second opening 126, where the second opening 126 is used to expose at least a part of the conductive area of the signal collecting electrode 120, so that the conductive area of the signal collecting electrode 120 can be directly contacted with the skin of the human body to be tested, thereby ensuring that the signal collecting electrode 120 can completely collect the bioelectric signals of the human body. The cross-sectional shape of the connection layer 124 is annular. The annular connection layer 124 ensures uniform connection with the signal collection electrode 120 and the first lead portion 122, respectively, and ensures continuity of signal collection.

In an embodiment, the connecting layer 124 is disposed on one side of the signal collecting electrode 120 far away from the skin of the user to be tested, and the connecting layer 124 covers at least part of the signal collecting electrode 120, so that the connecting layer 124 is ensured to be connected with the signal collecting electrode 120 and the first lead portion 122 more firmly in a conductive manner, and the connecting layer 124 is not in direct contact with the skin of the human body to be tested, so that the signal collecting electrode 120 is not affected to collect bioelectric signals, the signal collecting electrode 120 can be ensured to be in stable contact with the skin of the human body to be tested, and the stability of signal collection is ensured. The cross-sectional shape of the connection layer 124 is circular. By the design, the connecting layer 124, the signal collecting electrode 120 and the first opening of the first lead part 122 are round, so that the overall product shape and design style are uniform, and the design has more attractive value.

And forming a flexible protective film on the protective layer. The protective layer may be a protective layer made of insulating oil. The flexible protective film may be a protective film for insulation and having flexible characteristics, and may be made of a polymer material such as polyethylene, polypropylene, or the like. The flexible protection film can realize the withstand voltage of protective layer to prevent to interfere the collection of electrocardiosignal, thereby can realize the effective collection of electrocardiosignal through frivolous wearable physiological monitoring device 200 of flexibility, reduce the thickness of the equipment of gathering the electrocardiosignal.

Optionally, a die-cutting process may be further used to die-cut and form the flexible substrate 110, the signal collecting electrode 120, the conductive layer 125, the conductive connection point, the protective layer, the flexible protective film, and the like according to a preset pattern, so as to obtain a printed die-cut finished product.

In one embodiment, a protective layer is formed on the surface of the conductive layer 125, and the protective layer may cover the connection layer 124, or may not cover the signal acquisition electrode 120. In some embodiments, by forming a protective layer on the conductive layer 125 and forming a flexible protective film on the protective layer, the withstand voltage of the protective layer can be achieved, and the collection of electrocardiograph signals is prevented from being disturbed, so that the effective collection of electrocardiograph signals can be achieved through the light and thin flexible wearable physiological monitoring device 200, and the thickness of the equipment for collecting electrocardiograph signals is reduced.

For example, a printing process may be used to form a layer of insulating oil on the conductive layer 125 as an insulating protective layer. And a flexible protective film may be formed over the protective layer as another insulating protective layer. As an example, the flexible protective film finished product may be directly covered on the protective layer as an insulating protective layer.

In some embodiments, the pressure resistance of the protective layer can be achieved and the acquisition of the electrocardiographic signals is prevented from being disturbed by forming the protective layer on the conductive layer 125 and forming the flexible protective film on the protective layer, so that the effective acquisition of the electrocardiographic signals can be achieved through the light and thin flexible wearable physiological monitoring device 200, and the thickness of equipment for acquiring the electrocardiographic signals is reduced.

Example 4:

an embodiment of the present application provides a method for manufacturing a bioelectric signal collector, as shown in fig. 13, where the method is used to manufacture a bioelectric signal collector 100 with at least three different electrode points, and the method for manufacturing a bioelectric signal collector includes:

Providing a flexible substrate 110;

A conductive layer 125 is prepared on the surface of the flexible substrate 110 using a first conductive material,

Preparing signal acquisition electrodes 120 of at least three different electrode sites on a surface of the flexible substrate 110 using a second conductive material, the second conductive material being different from the first conductive material;

forming an isolation part between the conductive layer 125 and the signal collection electrode 120, isolating the conductive layer 125 from direct contact with the signal collection electrode 120 through the isolation part;

Preparing a connecting layer 124 on the surface of the flexible substrate 110 by using a third conductive material, wherein the conductive layer 125 is in conductive communication with the signal acquisition electrode 120 through the connecting layer 124;

The connection layer 124 and the conductive layer 125 form a first connection region, the connection layer 124 and the signal acquisition electrode 120 form a second connection region, the first connection region is in conductive communication with the second connection region, the second conductive material in the second connection region is in contact with the third conductive material and does not react chemically, and the first conductive material in the first connection region is in contact with the third conductive material and does not react chemically. The signal collection electrode 120 is ensured to collect the signal accurately.

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

The manufacturing method of the bioelectric signal collector comprises the steps of compounding and forming the flexible substrate 110 and the conductive layer 125 prepared by at least one of conductive ink, conductive polymer, conductive carbon powder and metal material;

A conductive pattern for planning the conductive layer 125 according to the spatial distribution of at least three different electrode points;

Processing the conductive layer 125 according to the conductive pattern to obtain a first lead portion 122, a lead layer 128 and a second lead portion 121, wherein the first lead portion 122 is in conductive communication with the signal acquisition electrode 120 through the connection layer 124;

the first lead portion 122 is in conductive communication with the second lead portion 121 through the lead layer 128.

In the present embodiment, the first lead portion 122 is connected to the signal collecting electrode 120 through the conductive layer 125, and the signal transmission between the first lead portion 122 and the signal collecting electrode 120 is ensured to be accurate and reliable. The bioelectric signal collector 100 further comprises a support 210, the conductive layer 125 comprises a second lead portion 121 and a lead layer 128, the second lead portion 121 is fixed on the support 210, when the signal collecting host 230 is mounted on the support 210, the signal collecting host 230 is in conductive communication with the second lead portion 121, one end of the lead layer 128 is in conductive connection with the first lead portion 122, and the other end is in conductive connection with the second lead portion 121, so that the connection between the bioelectric signal collector 100 and the signal collecting host 230 can be realized through the support 210, the bioelectric signal is transmitted to the signal collecting host 230 through the signal collecting electrode 120, the connection layer 124, the first connection area and the second connection area, preferably, the signal collecting host 230 is detachably connected with the support 210, such as a snap connection, a threaded installation, a concave-convex combination, etc., or a gripper is arranged on the support 210 and the signal collecting host 230 is in combination. The combination mounting or separation dismounting manner is not specifically exemplified in this embodiment.

Specifically, the connection layer 124, the signal collecting electrode 120 and the conductive layer 125 form a series circuit, and in this embodiment, the resistance value 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.

The flexible substrate 110 may be a substrate formed of a flexible material, and may be a flexible material having advantages of light weight, transparency, flexibility, and stretchability, for example, the flexible substrate 110 may be polyvinyl alcohol (PVA), polyester (PET), polyimide (PI), polyethylene naphthalate (PEN), etc., and as an example, a PET film is used as the flexible substrate 110 of the bioelectric signal collector, and the conductive layer 125 and the signal collecting electrode 120 are disposed on the flexible substrate 110.

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

In this embodiment, the signal collecting electrode 120 may be made of a noble metal, such as silver, the first lead portion 122 may be made of at least one of conductive metal, conductive ink, conductive polymer or conductive carbon, the connection layer 124 may be made of at least one of conductive ink, conductive polymer or conductive carbon, and it is understood that, for example, the first lead portion 122 is made of conductive metal, such as aluminum, and the connection layer 124 is made of conductive ink, but not conductive metal. The connection layer 124 and the first lead portion 122 form a first connection area, the connection layer 124 and the signal acquisition electrode 120 form a second connection area, the first connection area is in conductive communication with the second connection area, the connection layer 124 can electrically connect the signal acquisition electrode 120 and the first lead portion 122 through the first connection area and the second connection area, the conductive layer 125, the signal acquisition electrode 120 and the connection layer 124 which are designed in a split mode are used for adapting to more use environments and preparation requirements, applicability of the bioelectric signal acquisition device 100 is improved, and the connection of the connection layer 124 and the signal acquisition electrode 120 and the first lead portion 122 is smoother and even due to a printing or coating process, so that lead quality is ensured.

In one embodiment, the second conductive material comprises silver chloride, the method for manufacturing the bioelectric signal collector comprises the steps of preparing a silver chloride layer at corresponding positions of at least three different electrode points, attaching the silver chloride layer to the skin of a user to be detected through a conductive gel paste, and collecting bioelectric signals of the user to be detected.

In an embodiment, the first lead portion 122 is etched to form a first opening 127, a silver chloride layer is formed in the first opening 127, the silver chloride layer and the first lead portion 122 are arranged in the same layer, that is, the first lead portion 122 is printed on the flexible substrate 110 first, then the signal collecting electrode 120 is printed on the same layer, the connecting layer 124 is printed on the surface of the signal collecting electrode 120, in addition, the connecting layer 124 is respectively connected with the first lead portion 122 and the signal collecting electrode 120, the areas of the connecting layer 124 are smoother, the accuracy and the stability in the signal collecting process caused by unbalanced printing of the connecting layer 124 are prevented, and a separation portion is formed between the silver chloride layer and the first lead portion 122. Because silver chloride and other metal conductive materials can undergo chemical replacement reaction, the chemical reaction can directly influence the accuracy of signal acquisition. The scheme of the isolation part provided by the embodiment of the application can reduce the overall size of the physiological electric signal collector 100, and the signal collecting electrode 120 is electrically connected with the first lead part 122 through the connecting layer 124, so that the plane size of the physiological electric signal collector 100 is greatly reduced. Moreover, the difficulty in processing the connection layer 124 is reduced, and the yield of products is improved, and it is further understood that the connection layer 124 may connect the first lead portion 122 and the signal acquisition electrode 120 at any angle. The isolation part is used for isolating and contacting the conductive layer 125 with the signal acquisition electrode 120, so that the signal acquisition electrode 120 and the first lead part 122 which use different conductive materials cannot influence signal acquisition due to material contact and mixing, in addition, the first lead part 122 is in conductive connection with the signal acquisition electrode 120 through the conductive layer 125, and the first lead part 122 is ensured to accurately and reliably transmit bioelectric signals acquired by the signal acquisition electrode 120.

In one embodiment, the cross-sectional shape of the etched silver chloride layer is circular, the cross-sectional shape of the etched connection layer 124 is annular, and the ratio of the diameter of the signal acquisition electrode 120 to the outer diameter of the connection layer 124 is greater than or equal to 0.1 and less than 1. In this embodiment, the ratio of the diameter of the signal collecting electrode 120 to the outer diameter of the connection layer 124 is designed to be smaller than 1, so that a sufficient gap can be ensured between the signal collecting electrode 120 and the first lead portion 122, thereby preventing direct connection and even overlapping connection of the signal collecting electrode 120 and the first lead portion 122 due to small offset during preparation of the signal collecting electrode 120 and the first lead portion 122, so that uneven signal transmission is caused, the ratio of the diameter of the signal collecting electrode 120 to the outer diameter of the connection layer 124 is larger than 0.1, the signal transmission is prevented from being influenced by excessive area of the connection layer 124, and the transmission of bioelectric signals is prevented from being hindered, such as problems of long path, large resistance and the like occur, thereby ensuring that the signal collecting electrode 120 collects bioelectric signals more accurately, and the first lead portion 122 transmits bioelectric signals more stably. More preferably, the cross-section of the signal collecting electrode 120 is circular, and the diameter of the signal collecting electrode 120 can be 1-20 mm. The processing signal collection electrode 120 and the first lead portion 122, the connection layer 124 are better controlled to facilitate collection and transmission of bioelectric signals.

In one embodiment, the silver chloride layer has a diameter dimension of 1-10 mm. More preferably, the cross section of the signal collecting electrode 120 is circular, and the diameter size range of the signal collecting electrode 120 made of silver chloride can be 1-20 mm. The processing signal collection electrode 120 and the corresponding first lead portion 122, the connection layer 124 are better controlled to facilitate collection and transmission of bioelectric signals.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the claims. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application. Accordingly, the scope of protection of the present application is to be determined by the appended claims.

Claims

1. A bioelectric signal collector, characterized in that the bioelectric signal collector (100) is used for being worn on the skin of a user to be tested to obtain bioelectric signals;

The bioelectric signal collector (100) comprises a flexible substrate (110), wherein a conductive layer (125) and a plurality of signal collecting electrodes (120) are arranged on the flexible substrate (110), the plurality of signal collecting electrodes (120) are used for collecting bioelectric signals of at least three different position points on the skin of the user to be tested, and the conductive layer (125) is used for conducting the bioelectric signals to a signal collecting host (230);

Still be equipped with tie layer (124) on flexible substrate (110), conducting layer (125) pass through tie layer (124) with signal acquisition electrode (120) are electrically conductive to be connected, wherein, use printing technology will tie layer (124) print in signal acquisition electrode (120) conducting layer (125) are last, conducting layer (125) include first lead portion (122), first lead portion (122) are equipped with first opening (127), signal acquisition electrode (120) set up in first opening (127), tie layer (124) set up in first opening (127) department.

2. Bioelectrical signal collector according to claim 1, characterized in that an isolating part is provided between the first lead part (122) and the signal collecting electrode (120), the isolating part being used for isolating the first lead part (122) from contact with the signal collecting electrode (120).

3. The bioelectric signal collector of claim 2, wherein the connection layer (124) forms a first connection region with the first lead portion (122), the connection layer (124) forms a second connection region with the signal acquisition electrode (120), the first connection region being in conductive communication with the second connection region.

4. A bioelectric signal collector according to claim 3, characterized in that the first lead portion (122) is arranged in the same layer as the signal collecting electrode (120).

5. The bioelectric signal collector of claim 4, wherein a gap region between the first lead portion (122) and the signal acquisition electrode (120) constitutes the isolation portion.

6. The bioelectric signal collector according to claim 5, wherein a ratio of an inner diameter of the first lead portion (122) to an outer diameter of the connection layer (124) is 0.1 to 0.9.

7. The bioelectric signal collector according to claim 6, characterized in that a shape of the flexible substrate (110) corresponding to the position of the first lead portion (122) is a circle, the first lead portion (122) is disposed at a center of the flexible substrate (110), and a distance between an edge of the first lead portion (122) and an edge of the flexible substrate (110) is 1.5mm or more.

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

9. Bioelectrical signal collector according to claim 8, characterized in that the connection layer (124) is arranged on the side of the signal acquisition electrode (120) close to the skin of the user to be measured, the connection layer (124) is provided with a second opening (126), the second opening (126) being adapted to expose at least part of the conductive area of the signal acquisition electrode (120).

10. The bioelectric signal collector according to claim 8, characterized in that the connection layer (124) is arranged on a side of the signal collection electrode (120) remote from the skin of the user to be measured, the connection layer (124) covering at least part of the signal collection electrode (120).

11. Bioelectrical signal collector according to any one of claims 1 to 7, characterized in that the thickness of the connection layer (124) is 5 μm-200 μm and/or the resistance of the connection layer (124) is 1 k-50 k ohm.

12. A wearable physiological monitoring device, characterized in that the wearable physiological monitoring device (200) comprises a bioelectric signal collector (100) according to any of claims 1 to 11 and a signal collection host (230).

13. A physiological monitoring system, characterized by comprising a bioelectric signal collector (100) according to any one of claims 1 to 11, or by comprising a wearable physiological monitoring device (200) as claimed in claim 12.