Body fluid detection module, body fluid detection device and its detection method

Abstract

This invention relates to the field of body fluid detection technology, and particularly to a body fluid detection module and its preparation method. The body fluid detection module includes at least two electrodes, and at least one of the electrodes includes at least one contact surface that contacts the body fluid to be tested. The contact surface is distributed in a discrete point pattern. During the detection process, when the body fluid to be tested contacts the electrode, a current loop is formed between the electrode and the body fluid to be tested, thereby enabling the electrode to output a body fluid detection signal corresponding to the body fluid to be tested. In this invention, the contact surface of the electrode is designed to be distributed in a discrete point pattern, so that the effective alternating electric field is forcibly compressed into a very thin space. Therefore, only a small amount of body fluid is needed for detection, and no additional processing of the body fluid is required. The body fluid detection device and its detection method can achieve high accuracy in body fluid detection while simplifying the measurement steps.

Description

[Technical Field]

[0001] This invention relates to the field of body fluid detection technology, and particularly to a body fluid detection module, a body fluid detection device, and a detection method thereof. [Background Technology]

[0002] Human and animal bodily fluids contain a wealth of biochemical information, including ions, heavy metal ions, proteins, and DNA. These are not independent parameters but are strongly correlated with certain diseases or physiological changes within the body. For example, cystic fibrosis leads to abnormal concentrations of chloride ions in sweat, and weakened liver function leads to abnormal concentrations of ammonia ions in sweat. By observing specific changes in one or more parameters in sweat, it is easy to directly infer changes and conditions in various bodily functions.

[0003] However, traditional body fluid testing requires a large volume of liquid, or the test liquid needs to be stored in a specific environment to prevent electrode deterioration due to air or liquid contamination, which could lead to electromotive force shift and loss. Therefore, traditional body fluid testing methods cannot meet the specific needs of convenient testing after rapid sweat collection. [Summary of the Invention]

[0004] To address the problems of existing body fluid detection methods, this invention provides a body fluid detection module, a body fluid detection device, and a detection method thereof.

[0005] To solve the above-mentioned technical problems, the present invention provides the following technical solution: a body fluid detection module, comprising electrodes and a substrate for accommodating the electrodes, wherein the electrodes comprise four electrodes, two of which are excitation electrodes, namely a first excitation electrode and a second excitation electrode; the other two electrodes are sensing electrodes, namely a first sensing electrode and a second sensing electrode; wherein the second excitation electrode is arranged around the first excitation electrode, and within the area enclosed by the second excitation electrode, the first sensing electrode and the second sensing electrode are arranged around the first excitation electrode; each excitation electrode or sensing electrode includes at least one electrode block, the electrode block including at least one contact surface that contacts the body fluid to be tested, the contact surface being distributed in a discrete point-like manner; when the body fluid to be tested contacts the first excitation electrode, the second excitation electrode, the first sensing electrode, and the second sensing electrode, and a current loop is formed between the first excitation electrode, the second excitation electrode, and the body fluid to be tested, the first sensing electrode and the second sensing electrode correspondingly output a body fluid detection signal of the body fluid to be tested, wherein the body fluid detection signal includes a current signal and / or a voltage signal corresponding to the voltage drop; wherein the substrate is provided with a recess, and the electrodes are accommodated within the recess.

[0006] Preferably, the contact surface is distributed in a discrete point pattern, including any one of discrete central symmetric distribution, staggered point lattice distribution, array point lattice distribution, and non-uniform point lattice distribution.

[0007] Preferably, the area of ​​a single contact surface is 0.01 mm. 2 -10mm 2 ; and / or the distance between the edges of the contact surfaces of adjacent electrode blocks is less than 2 mm.

[0008] Preferably, the shape of the contact surface of the electrode block includes any one of a circle, a regular polygon, or an irregular polygon; and / or the body fluid to be tested includes any one of sweat, urine, saliva, and tears.

[0009] Preferably, the electrode further includes an electrical connector for electrical connection to a peripheral circuit, the electrical connector being disposed at one end of the electrode block away from the contact surface; and / or the substrate includes any one of ceramic and insulating polymer.

[0010] Preferably, the ratio of the total area of ​​the contact surfaces corresponding to the two excitation electrodes to the total area of ​​the contact surfaces corresponding to the two sensing electrodes is 1:(0.1-10).

[0011] To solve the above-mentioned technical problems, the present invention provides another technical solution as follows: a method for detecting body fluids, the steps of which include: providing electrodes and a substrate for accommodating the electrodes, wherein the electrodes include four electrodes, two of which are excitation electrodes, namely a first excitation electrode and a second excitation electrode; the other two electrodes are sensing electrodes, namely a first sensing electrode and a second sensing electrode; wherein the second excitation electrode is arranged around the first excitation electrode, and within the area enclosed by the second excitation electrode, the first sensing electrode and the second sensing electrode are arranged around the first excitation electrode;

[0012] Each of the excitation electrode or the sensing electrode includes at least one electrode block, the electrode block including at least one contact surface that contacts the body fluid to be tested, the contact surface being distributed in a discrete point pattern; the body fluid to be tested is brought into contact with the contact surfaces of the first excitation electrode, the second excitation electrode, the first sensing electrode, and the second sensing electrode, so that a current loop is formed between the first excitation electrode, the second excitation electrode, and the body fluid to be tested; and detection signals of the body fluid to be tested corresponding to the output of the first sensing electrode and the second sensing electrode are detected; wherein, the detection signals include current signals and / or voltage signals corresponding to the voltage drop; wherein, the substrate is provided with a recess, and the electrode is housed in the recess.

[0013] To solve the above-mentioned technical problems, the present invention provides another technical solution as follows: a body fluid detection device, comprising a processing module and the body fluid detection module as described above, wherein the processing module receives the body fluid detection signal output by the body fluid detection module and processes it to analyze the ion concentration of the body fluid to be tested, wherein the detection signal includes a current signal and / or a voltage signal corresponding to the voltage drop.

[0014] Compared with the prior art, the body fluid detection module and its preparation method, body fluid detection device and its detection method provided by the present invention have the following beneficial effects:

[0015] The body fluid detection module provided by this invention includes at least two electrodes, and at least one of the electrodes includes at least one contact surface that contacts the body fluid to be tested. The contact surface is distributed in a discrete point pattern. Therefore, by designing the contact surfaces of the electrodes in a discrete point pattern, the effective alternating electric field is forcibly compressed into a very thin space. Thus, only a small amount of body fluid is needed for detection, and no pretreatment of the body fluid is required. During the detection process, when the body fluid to be tested contacts the electrode, a current loop is formed between the electrode and the body fluid to be tested, thereby enabling the electrode to output a body fluid detection signal corresponding to the body fluid being tested. The body fluid detection signal includes a current signal and / or a voltage signal corresponding to the voltage drop. Using the above-mentioned body fluid detection module simplifies the measurement method and, based on the output body fluid detection signal, improves the accuracy of body fluid detection.

[0016] In this invention, the contact surfaces of the body fluid detection module are distributed in a discrete point-like pattern, including any one of the following: discrete central symmetric distribution, staggered point lattice distribution, arrayed point lattice distribution, and non-uniform point lattice distribution. Different distribution methods of the contact surfaces can meet the needs of different body fluids, different measurement environments, different size requirements, and different levels of accuracy and sensitivity, thus making the body fluid detection module more widely applicable.

[0017] In this invention, the area of ​​a single contact surface is 0.01 mm. 2 -10mm 2 To meet the needs of body fluid detection with different levels of accuracy and sensitivity.

[0018] Due to the size requirements of the detection equipment, in order to meet the needs of body fluid detection, the distance between the edges of the contact surfaces of adjacent electrode blocks is further limited to less than 2mm, so as to ensure that people can maintain high detection reliability and stability with a small amount of sweat.

[0019] The limitations on the shape of the contact surface of the electrode block in this invention, such as limiting it to a circle, a regular polygon, or an irregular polygon, can improve the requirements of the body fluid detection module for different body fluids, different measurement environments, different size requirements, and different accuracy and sensitivity, thus making the body fluid detection module more widely applicable.

[0020] To further improve the stability of the body fluid detection module, the electrode further includes an electrical connector for electrical connection to an external circuit. The electrical connector is located at the end of the electrode block away from the contact surface. Because the contact surface with the body fluid to be tested is not coplanar with the electrode, the body fluid detection module can be made smaller, and the waterproofness of the device containing the body fluid detection module can be further improved. The electrical connector is electrically connected to one electrode block; or the electrical connector is electrically connected to multiple electrode blocks. Different electrical connection methods can meet the needs of different device sizes and sensitivities.

[0021] In this invention, the limitations on the substrate accommodating the electrodes in the body fluid detection module ensure insulation between different electrode blocks and between contact surfaces, while also improving the service life of the body fluid detection module. The substrate can be any one of ceramic or insulating polymer, satisfying the needs of electrode designs with different shapes.

[0022] To further improve the contact between the test fluid and the electrode contact surface, a recess can be provided on one surface of the substrate. The electrode is housed within the recess, which has a bottom surface. The contact surface of the electrode block is exposed on the bottom surface of the recess. The test fluid can remain on the bottom surface of the recess, allowing for more thorough contact between the test fluid and the electrode block contact surface, thus achieving accurate detection with a small amount of test fluid. Furthermore, the recess has an opening, and the distance from the bottom surface of the recess to the opening is less than 3 mm. This limited depth of the recess ensures that even when the test sweat reaches a certain thickness, it can still be contained within the recess, resulting in more thorough contact between the test fluid and the electrode block contact surface, and preventing spillage of the test sweat during detection. In addition, the recessed portion can separate the contact surfaces between the skin and the electrodes. Especially in wearable applications, the recessed portion can store and guide bodily fluids flowing out of the skin, thereby enabling better detection of the bodily fluids to be tested.

[0023] In the body fluid detection module provided by this invention, the electrodes include four components: two excitation electrodes and two sensing electrodes, wherein the two sensing electrodes are disposed between the two excitation electrodes. Using four electrodes for detection improves detection accuracy. Furthermore, since the AC signals generated by the two excitation electrodes cancel out the polarization phenomenon caused by contact with sweat, the body fluid detection module with two excitation electrodes and two sensing electrodes achieves higher stability and sensitivity.

[0024] In the body fluid detection module provided by this invention, the electrode block corresponding to one of the excitation electrodes is located at the center, the electrode block corresponding to the other excitation electrode is arranged in a ring around the outermost edge, and the electrode blocks corresponding to the two sensing electrodes are divided into two rings and arranged between the electrode blocks corresponding to the two excitation electrodes. Further defining the distribution of the electrode blocks in each electrode not only meets the small size design requirements of the body fluid detection module but also satisfies the requirements for high detection stability and sensitivity.

[0025] The ratio of the total contact area of ​​the two excitation electrodes to the total contact area of ​​the two sensing electrodes is limited to 1:(0.1-10). This allows for a smaller body fluid detection module size while meeting the stability and sensitivity requirements of body fluid detection, making it suitable for applications such as smart wearables.

[0026] The body fluid detection module provided by this invention can detect any of the body fluids to be tested, such as sweat, urine, saliva, and tears, and has wide applicability.

[0027] This invention also provides a method for fabricating a body fluid detection module, comprising two methods. One method involves first providing a substrate and then forming the required electrodes by electroplating; the other method involves first obtaining an electrode conductive component with electrode blocks and electrical connectors, and then fabricating the required body fluid detection module by mold casting. Different fabrication methods can be selected based on the needs of body fluid detection modules of different sizes and shapes to obtain the desired body fluid detection module.

[0028] This invention also provides a method for detecting body fluids, comprising the steps of: providing at least two electrodes, at least one of the electrodes including at least one contact surface in contact with the body fluid to be tested, the contact surface being distributed in a discrete point pattern; contacting the body fluid to be tested with the contact surface to form a current loop between the electrode and the body fluid; and detecting a detection signal of the body fluid output by the electrode; wherein the detection signal includes a current signal and / or a voltage signal corresponding to the voltage drop. In the body fluid detection method provided by this invention, the contact surfaces of the electrodes are designed to be distributed in a discrete point pattern, so that the effective alternating electric field is forcibly compressed into a very thin space. Therefore, only a small amount of body fluid is needed for detection, and no treatment of the body fluid is required. Using the above-mentioned body fluid detection method, the measurement steps are simple, and the accuracy of body fluid detection can be improved based on the output body fluid detection signal.

[0029] This invention also provides a body fluid detection device, comprising a processing module and the body fluid detection module as described above. The processing module receives the body fluid detection signal output by the body fluid detection module and processes it to analyze the ion concentration of the body fluid to be tested. The detection signal includes a current signal and / or a voltage signal corresponding to a voltage drop. The contact surfaces of the electrodes included in the body fluid detection device are designed with a discrete point distribution, so that the effective alternating electric field is forcibly compressed into a very thin space. Therefore, only a small amount of body fluid is needed for detection, and no pretreatment of the body fluid is required. Using the above-described body fluid detection method, the measurement steps are simple, and the accuracy of body fluid detection can be improved based on the output body fluid detection signal.

[0030] The processing module in the body fluid detection device provided by this invention includes an analog-to-digital converter (ADC) circuit and a processor. The ADC circuit is electrically connected to the body fluid detection module. The body fluid detection signal output by the body fluid detection module is converted into a resistance value signal by the ADC circuit and then processed by the processor. By processing the body fluid detection signal from the body fluid detection module, corresponding detection results can be output, simplifying the measurement steps and data processing. [Attached Image Description]

[0031] Figure 1 This is a schematic diagram of the body fluid detection module provided in the first embodiment of the present invention.

[0032] Figure 2 yes Figure 1 The diagram shows the electrode structure in the body fluid detection module.

[0033] Figure 3A This is one of the schematic diagrams showing the distribution of the contact surfaces of the electrodes in a body fluid detection module.

[0034] Figure 3B This is the second schematic diagram showing the distribution of the contact surfaces of the electrodes in the body fluid detection module.

[0035] Figure 3C This is the third schematic diagram showing the distribution of the contact surfaces of the electrodes in the body fluid detection module.

[0036] Figure 3D This is the fourth schematic diagram showing the distribution of the contact surfaces of the electrodes in the body fluid detection module.

[0037] Figure 4 This is one of the schematic diagrams showing the distribution of electrical connectors for electrodes in a body fluid detection module.

[0038] Figure 5 This is the second schematic diagram showing the distribution of electrical connectors for electrodes in a body fluid detection module.

[0039] Figure 6These are schematic diagrams of the body fluid detection module in some specific implementations.

[0040] Figure 7 This is a schematic diagram of the structure of the body fluid detection module in the first specific embodiment of the first example.

[0041] Figure 8 yes Figure 7 The diagram shows the structure of the electrode block and electrical connector in the body fluid detection module.

[0042] Figure 9A This is a schematic diagram of the circuit principle of the body fluid detection module using a four-wire measurement method.

[0043] Figure 9B This is a schematic diagram of the circuit principle of the body fluid detection module using a two-wire measurement method.

[0044] Figure 10 This is a schematic diagram of the body fluid detection module in the second specific embodiment of the first embodiment.

[0045] Figure 11 yes Figure 10 The diagram shows the structure of the electrical connectors in the body fluid detection module.

[0046] Figure 12 This is a schematic diagram of the body fluid detection module in the third specific embodiment of the first embodiment.

[0047] Figure 13 yes Figure 12 The diagram shows the structure of the electrical connectors in the body fluid detection module.

[0048] Figure 14 This is one of the step flow diagrams of the preparation method of the body fluid detection module provided in the second embodiment of the present invention.

[0049] Figure 15 yes Figure 14 The flowchart of step S2 shown is a detailed step diagram.

[0050] Figure 16 This is the second step flow diagram of the preparation method of the body fluid detection module provided in the second embodiment.

[0051] Figure 17 This is a flowchart illustrating the steps of the body fluid detection method provided in the third embodiment.

[0052] Figure 18 yes Figure 17 The flowchart of step P3 in the body fluid detection method shown is illustrated.

[0053] Figure 19This is a schematic diagram showing the relationship between the volume, thickness, and stability of experimental group 1 and control group 1-2 using physiological saline as the measurement liquid.

[0054] Figure 20 This is a schematic diagram showing the relationship between the volume, thickness, and stability of physiological saline as the measurement liquid in experimental group 1 and control group 1.

[0055] Figure 21 This is a schematic diagram of the functional modules of the body fluid detection device provided in the fourth embodiment of the present invention.

[0056] Figure 22 This is a schematic diagram of the heat detection device provided in the fifth embodiment of the present invention.

[0057] Figure 23 yes Figure 22 The diagram shows the explosion state of the heat detection device shown.

[0058] Figure 24 yes Figure 22 The diagram shows the structure of the body fluid detection module and the mounting base in the heat detection device shown.

[0059] Figure 25 This is a cross-sectional schematic diagram of the body fluid detection module and the mounting base in the heat detection device.

[0060] Figure 26 These are schematic diagrams of functional modules of some embodiments of the heat detection device.

[0061] Figure 27 This is a schematic diagram of the heat detection device from another angle.

[0062] Figure 28 This is one of the functional module diagrams of the sweat detection device provided in the sixth embodiment of the present invention.

[0063] Figure 29 This is a schematic diagram of the sweat detection device.

[0064] Figure 30 yes Figure 29 One of the schematic diagrams of the distribution of body surface electrodes in the body surface detection module of the sweat detection device shown.

[0065] Figure 31 yes Figure 29 The second schematic diagram shows the distribution of body surface electrodes in the body surface detection module of the sweat detection device shown.

[0066] Figure 32 yes Figure 29 The diagram shows the third schematic of the distribution of body surface electrodes in the body surface detection module of the sweat detection device shown.

[0067] Figure 33This is a schematic diagram of the sweat detection device from another angle.

[0068] Figure 34 This is the second schematic diagram of the functional modules of the sweat detection device.

[0069] Figure 35 This is a schematic diagram of the functional modules of the sweat detection device, including the heart rate detection module, processing module, and control module.

[0070] Figure 36 This is a side view of the sweat detection device.

[0071] Figure 37 This is a side view of the sweat detection device including the supporting structure.

[0072] Figure 38 This is a schematic diagram of a sweat detection device that includes a recessed structure.

[0073] Figure 39 This is a schematic diagram of the sweat detection device in some other implementations.

[0074] Figure 40 This is a schematic flowchart of the sweat detection method according to the seventh embodiment of the present invention.

[0075] Explanation of reference numerals in the attached diagram:

[0076] 10. Body fluid detection module; 11. Electrode; 111. Electrode block; 1110. Contact surface; 112. Electrical connector; 12. Substrate; 121. Recess; 1211. Bottom surface of the recess; 1212. Opening of the recess; 101. Excitation electrode; 1011. First excitation electrode; 1012. Second excitation electrode; 102. Sensing electrode; 1021. First sensing electrode; 1022. Second sensing electrode; 105. Working electrode; 106. Reference electrode; 107. Counter electrode;

[0077] 40. Body fluid detection device; 41. Processing module; 411. Analog-to-digital conversion circuit; 412. Processor;

[0078] 50. Heatstroke detection device; 51. Housing; 511. Main body; 5110. Surface; 5111. First opening; 5112. Second opening; 5113. Third opening; 5114. Fourth opening; 5115. Fifth opening; 512. Fixing structure; 512. Fixing structure; 510. Opening; 52. Main circuit board; 53. Body fluid detection module; 531. Electrode; 5311. Electrode block; 5310. Contact surface; 532. Substrate; 54. Temperature sensing module; 55. Processing module; 551. Analog-to-digital conversion circuit; 552. Processor; 56. Control module; 561. Control component; 562. Indicator component; 57. Power supply module; 571. Charging component; 581. Ultraviolet detection module; 582. Ambient temperature and humidity detection module; 59. Mounting base; 590. Body fluid chamber; 591. Sealing component;

[0079] 60. Sweat detection device; 61. Sweat detection module; 611. Electrode; 6110. Contact surface; 62. Body surface detection module; 621. Body surface electrode; 6210. Detection surface; 63. Processing module; 64. Power supply module; 601. Temperature detection module; 602. Heart rate detection module; 65. Ultraviolet detection module; 66. Ambient temperature and humidity detection module; 67. Control module; 68. Housing; 680. Anti-slip structure; 681. First surface; 6811. First step; 6812. Second step; 6819. Reference surface; 682. Second surface; 6821. Waterproof and breathable membrane; 6822. Optical lens; 683. Support structure; 684. Recessed structure; 69. Fixing component; 690. Clamping space; 609. Charging structure.

Detailed Implementation Methods

[0080] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0081] Please see Figure 1 The first embodiment of the present invention provides a body fluid detection module 10, which includes at least two electrodes 11 and a substrate 12 accommodating the electrodes 11. At least one electrode 11 includes at least one contact surface 1110 that contacts the body fluid to be tested, and the contact surfaces 1110 are distributed in a dotted pattern. Figure 1 As shown, the electrode 11 includes a plurality of electrode blocks 111, and the contact surface 1110 corresponds one-to-one with the electrode blocks 111, or a single electrode block 111 includes a plurality of contact surfaces 1110.

[0082] The body fluid detection module 10 can detect the body fluid to be tested and output the corresponding detection data. The body fluid to be tested may include sweat, urine, saliva, tears, etc., and the subject to be tested may be a human or an animal.

[0083] like Figure 1 As shown, the contact surface 1110 is coplanar with the surface of the substrate 12. In some other embodiments, the contact surface 1110 is higher or lower than the surface of the substrate 12.

[0084] The structure of the electrode block 111 includes any one or a combination of several of the following: cylinder, prism, pyramid, cone, and sphere. For example... Figure 2 As shown in the figure, in this embodiment, the electrode block 111 has a cylindrical structure, and each electrode block 111 includes a contact surface 1110.

[0085] Combination Figure 1 and Figure 2 As shown, the area of ​​a single contact surface 1110 is 0.01 mm. 2 -10mm 2 Specifically, it can also be 0.01mm. 2 -2mm 2 0.1mm 2 -5mm 2 2mm 2 -6mm 2 4mm 2 -8mm 2 6mm 2 -10mm 2 Specifically, the area of ​​the contact surface 1110 can also be 0.01 mm. 2 1mm 2 3mm 2 5mm 2 8mm 2 or 10mm 2 To meet the needs of measuring different types of body fluids.

[0086] It is understood that if the area of ​​the contact surface 1110 of a single electrode block 111 is within the above-mentioned range, the electrode 11 formed by combining multiple electrode blocks 111 can have an appropriate electromagnetic field coverage range, and at the same time, the body fluid detection module 10 can maintain good sensor sensitivity, thereby obtaining more accurate and stable detection data.

[0087] In this embodiment, as Figures 3A-3DAs shown, the body fluid detection module 10 includes multiple electrode blocks 111 arranged in a dispersed manner. The distance between the electrode blocks 111 is small, which can forcibly compress the effective alternating electric field formed between the electrode blocks 111 into a small space. Figure 3A As shown, in order to further improve the stability and sensitivity of the detection, the distance L between the edges of the contact surfaces 1110 of adjacent electrode blocks 111 is less than 2 mm. Further, the distance L between the edges of the contact surfaces 1110 of adjacent electrode blocks 111 can be 0.01 mm-2 mm, 0.01 mm-1 mm, 0.05 mm-1.5 mm, etc. Specifically, the distance L can be 0.005 mm, 0.01 mm, 0.5 mm, 1 mm, 1.5 mm or 1.9 mm.

[0088] The shape of the contact surface 1110 of the electrode block 111 may include a circle, a regular polygon, or an irregular polygon. Multiple electrode blocks 111 contained in the same electrode 11 may have the same or different shapes for their contact surfaces 1110. The specific shape can be adjusted based on the usage scenario of the body fluid detection module 10.

[0089] As shown in 3A, multiple contact surfaces 1110 are distributed in a discrete center-symmetric manner, wherein the area of ​​the contact surface 1110 of the electrode block 111 at different positions is not the same.

[0090] like Figure 3B As shown, multiple contact surfaces 1110 are distributed in a staggered matrix, wherein the contact surfaces 1110 of electrode blocks 111 at different positions have the same area size.

[0091] like Figure 3C As shown, multiple contact surfaces 1110 are distributed in an array, wherein the contact surfaces 1110 of electrode blocks 111 at different positions have the same area size.

[0092] like Figure 3D As shown, multiple contact surfaces 1110 are distributed in a non-uniform lattice, wherein the area of ​​the contact surface 1110 of the electrode block 111 at different positions is not the same.

[0093] like Figure 4 As shown, to make the body fluid detection module 10 operate more stably, the electrode 11 further includes an electrical connector 112 for electrical connection with peripheral circuitry. The electrical connector 112 is located at the end of the electrode block 111 away from the contact surface 1110. One electrical connector 112 can be connected to one electrode block 111, or the electrical connector 112 can be electrically connected to multiple electrode blocks 111. The shape of the electrical connector 112 can be adjusted based on the distribution of the electrode blocks 111, and no corresponding limitation is made here.

[0094] Combination Figure 4 and Figure 5 As shown, in the body fluid detection module 10, the number of electrical connectors 112 can be 4, 2, or adjusted according to requirements.

[0095] Combination Figure 1 and Figure 6 In this embodiment, the substrate 12 is made of either ceramic or an insulating polymer. The insulating polymer includes, but is not limited to, any one or a combination of several of polyethylene, polypropylene, polyvinyl chloride, polystyrene, polyurethane, polyamide, and polyimide.

[0096] Specifically, such as Figure 6 As shown, in some specific embodiments, a recess 121 is provided on one surface of the substrate 12, and the electrode 11 is accommodated in the recess 121. The recess 121 has a bottom surface 1211 and an opening 1212. The distance h from the bottom surface 1211 to the opening 1212 is less than 3 mm, that is, the depth of the recess 121 is less than 3 mm. Specifically, the distance h from the bottom surface 1211 to the opening 1212 can also be 0.5 mm-3 mm, 0.5 mm-2 mm, 0.6 mm-1.5 mm, etc.

[0097] It is understood that, in order for the recessed portion 121 to better perform its function of collecting bodily fluids, the size of the opening 1212 of the recessed portion is larger than the size of the bottom surface 1211 of the recessed portion.

[0098] The contact surface 1110 of the electrode block 111 is exposed on the bottom surface 1211 of the recess, thereby allowing for better contact with the body fluid to be tested.

[0099] The recessed portion 121 of the substrate 12 provides a certain storage space for the body fluid to be tested, so that the body fluid to be tested can reach the measurement height within the recessed portion 121, thereby improving the accuracy of the detection of the body fluid to be tested.

[0100] The protective electrode blocks 111 provided in this embodiment are arranged in a discrete point manner, which can compress the alternating electric field between the electrode blocks 111 into a very small space, while taking into account the accuracy and durability of the body fluid detection module 10.

[0101] Please see Figure 7In the body fluid detection module 10 of the first specific embodiment of the first embodiment, the electrode 11 can be further subdivided into two excitation electrodes 101 and two sensing electrodes 102, wherein the two sensing electrodes 102 are disposed between the two excitation electrodes 101. Each excitation electrode 101 or sensing electrode 102 includes at least one electrode block 111, the electrode block 111 including a contact surface 1110 that contacts the body fluid to be tested, the contact surface 1110 being distributed in a discrete point shape; when the body fluid to be tested contacts the electrode 11 and a current loop is formed between the electrode 11 and the body fluid to be tested, the electrode 11 outputs a body fluid detection signal for the body fluid to be tested, wherein the body fluid detection signal includes a current signal and / or a voltage signal corresponding to the voltage drop.

[0102] Specifically, such as Figure 7 As shown in the figure, in this embodiment, the two excitation electrodes 101 can be further divided into a first excitation electrode 1011 and a second excitation electrode 1012, and the two sensing electrodes 102 are the first sensing electrode 1021 and the second sensing electrode 1022, respectively. The second excitation electrode 1012 is disposed around the first excitation electrode 1011, and within the area enclosed by the second excitation electrode 1012, the first sensing electrode 1021 and the second sensing electrode 1022 are disposed around the first excitation electrode 1011.

[0103] It is understood that when the body fluid to be tested comes into contact with the first excitation electrode 1011, the second excitation electrode 1012, the first sensing electrode 1021, and the second sensing electrode 1022, the first excitation electrode 1011 and the second excitation electrode 1012 generate current, and the current passes through the body fluid to be tested so that the sensing electrode generates a voltage signal with a corresponding voltage drop.

[0104] To achieve better detection results, the ratio of the total area of ​​the contact surfaces 1110 corresponding to the two excitation electrodes 101 to the total area of ​​the contact surfaces 1110 corresponding to the two sensing electrodes 102 is 1:(0.1-10). Specifically, the ratio of the total area of ​​the contact surfaces 1110 corresponding to the two excitation electrodes 101 to the total area of ​​the contact surfaces 1110 corresponding to the two sensing electrodes 102 can also be 1:0.1, 1:0.5, 1:1, 1:2, 1:3, 1:5, 1:7, or 1:10, etc.

[0105] Furthermore, such as Figure 7 As shown, the contact surfaces 1110 of the sensing electrode 102 and the electrode blocks 111 corresponding to the excitation electrode 101 are all distributed in a discrete point pattern.

[0106] Continue as Figure 7As shown, in a specific example: the number of electrode blocks 111 corresponding to the two sensing electrodes 102 is 12, the number of electrode blocks 111 arranged around the outermost edge is also 12, and the number of electrode blocks 111 arranged at the center position is 1.

[0107] In this specific embodiment, combined with Figure 7 , Figure 8 as well as Figures 9A-9B As shown, the operating principle of the above-mentioned body fluid detection module 10 is as follows:

[0108] A current loop is formed between the first excitation electrode 1011 and the second excitation electrode 1012. An external power supply applies alternating current to the first excitation electrode 1011. Since the body fluid covers the first excitation electrode 1011, the second excitation electrode 1012, the first sensing electrode 1021, and the second sensing electrode 1022, that is, the body fluid is in contact with the first excitation electrode 1011, the second excitation electrode 1012, the first sensing electrode 1021, and the second sensing electrode 1022, an alternating electric field is generated between the first excitation electrode 1011 and the second excitation electrode 1012. After the current generated by the first excitation electrode 1011 and the second excitation electrode 1012 passes through the body fluid covering it, the total ion concentration in the body fluid generates a voltage drop. This voltage drop can be detected by an external voltage through the first sensing electrode 1021 and the second sensing electrode 1022.

[0109] To illustrate this more clearly, this specific implementation uses sweat as an example to further explain the electrolyte concentration and electrical resistance of sweat:

[0110] It's understandable that when the electrolyte concentration in sweat is low, the total ion concentration in sweat is also low, resulting in low sweat conductivity. For a given volume of sweat, its equivalent impedance (i.e., resistance) is also quite high. When the electrolyte impedance is very high...

[0111] To further correlate the resistance of the sweat sample with its electrolyte concentration, a sweat electrolyte concentration of known value can be prepared and detected by the body fluid detection module 10 to obtain its corresponding resistance. This allows for the establishment of a calibration database of sweat resistance values ​​and sweat electrolyte concentrations, pre-stored with different resistance values ​​and their corresponding ion concentrations. Once the body fluid detection module 10 measures the resistance of the body fluid, it can obtain the corresponding electrolyte concentration.

[0112] Specifically, when sweat covers the first excitation electrode 1011, the second excitation electrode 1012, the first sensing electrode 1021, and the second sensing electrode 1022, the first excitation electrode 1011 and the second excitation electrode 1012 output excitation current, and the first sensing electrode 1021 and the second sensing electrode 1022 detect their corresponding excitation voltage. The resistance of the sweat to be tested can be obtained by calculating the excitation current and the excitation voltage, which is also the electrolyte concentration of the sweat to be tested.

[0113] Furthermore, since sodium ions account for more than 90% of the total electrolyte concentration in sweat, and the sodium ion concentration is an order of magnitude higher than the potassium ion concentration, the sodium ion concentration in sweat can be approximated by multiplying the electrolyte concentration in sweat by a coefficient. This can be expressed by the following formula:

[0114] Na+ = Electrolyte * C;

[0115] Where Na+ represents the sodium ion concentration, Electrolyte represents the electrolyte concentration, and C is the correction factor. The correction factor can be adjusted based on the body fluid being tested. Taking human sweat as an example, the correction factor can be the ratio of sodium ion concentration in sweat to the total electrolyte concentration in sweat. This system can be preset based on the usage scenario. It can be understood that this correction factor is adjusted accordingly based on different body fluids.

[0116] Further integration Figure 7 , Figure 8 as well as Figures 9A-9B As shown, the four electrodes in the sweat detection module can be measured using a four-wire method or a two-wire method.

[0117] Specifically, such as Figure 8 as well as Figure 9A As shown, in some specific embodiments, a four-wire measurement method is used for detection. Specifically, the electrode blocks 111 of the excitation electrode 101 and the sensing electrode 102 can be electrically connected to multiple electrical connectors 112. In this specific embodiment, there are four electrical connectors 112, which are respectively electrically connected to the electrode blocks 111 corresponding to the two excitation electrodes 101 and the two sensing electrodes 102, and the electrical connectors 112 are mutually insulated. The four electrical connectors 112 are arranged in a ring from the inside out. Among them, the two electrical connectors 112 corresponding to the excitation electrode 101 are located at the center and the outermost edge of the ring, respectively, while the two electrical connectors 112 corresponding to the sensing electrode 102 are located between the electrical connector 112 at the center and the electrical connector 112 at the outermost edge.

[0118] In addition, the four-electrode measurement method can cancel out the contact resistance between the metal electrode and the sweat, thereby obtaining the resistance of the sweat to be measured.

[0119] like Figure 9B As shown, in some other specific examples of this embodiment, the body fluid detection module 10 uses a two-wire measurement method for measurement. Specifically, the electrode 11 further includes two electrical connectors 112 for electrical connection with the peripheral circuit. The electrical connectors 112 are located at the end of the electrode block 111 away from the contact surface 1110. One electrical connector 112 is arranged in a ring with the other electrical connector 112 as the center. The first excitation electrode 1011 and the first sensing electrode 1021 share one electrical connector 112 and are interconnected. The second sensing electrode 1022 and the second excitation electrode 1012 share another electrical connector 112 and are interconnected.

[0120] In this specific embodiment, a four-electrode measurement method or a two-electrode measurement method is used for measurement. Since the AC signal generated by the excitation electrode 101 cancels the polarization phenomenon caused by contact with sweat, the detection results obtained by the body fluid detection module 10 provided in this embodiment are stable and sensitive. Among them, the detection stability and sensitivity corresponding to the four-electrode measurement method are better.

[0121] Please see Figure 10 and Figure 11 A second specific embodiment of the first embodiment provides a body fluid detection module 10 based on two-wire measurement. The differences between this module and the first specific embodiment, besides the different measurement methods, include the following: the electrode comprises two electrodes 11, each electrode 11 including at least one electrode block 111 and an electrical connector 112 connected to the electrode block 111, and each electrode 11 is mutually insulated. The electrode block 111 includes a contact surface 1110 that contacts the body fluid to be measured, and the contact surface 1110 is distributed in a discrete point pattern.

[0122] It is understood that, specifically, the contact surface 1110 may be distributed in a manner such as discrete central symmetric distribution, staggered lattice distribution, array lattice distribution, non-uniform lattice distribution, etc.

[0123] An electrical connector 112 is also connected to the end of the electrode block 111 away from the contact surface 1110.

[0124] In this embodiment, the body fluid detection module 10 performs two-wire measurement as follows:

[0125] When the body fluid to be tested covers the two electrodes 11, a current loop is formed between the electrodes 11, and the current can pass through the body fluid to be tested to generate a voltage drop. A current signal can be obtained based on one electrode 11, while a voltage signal corresponding to the voltage drop can be obtained from the other electrode 11.

[0126] Therefore, the body fluid detection module 10 based on two-wire measurement provided in this embodiment can also detect the components of the body fluid to be tested.

[0127] Please see Figure 12 In the third specific embodiment of the first embodiment, the body fluid detection module 10 includes three electrodes 11, which correspond to a working electrode 105, a reference electrode 106, and a counter electrode 107. The working electrode 105, the reference electrode 106, and the counter electrode 107 are made of different materials and can be measured based on an electrochemical method.

[0128] In this embodiment, the working electrode 105, the reference electrode 106, and the counter electrode 107 each include at least one electrode block 111. The electrode block 111 includes a contact surface 1110 that contacts the body fluid to be tested, and the contact surface 1110 is distributed in a discrete point pattern.

[0129] It is understood that in this embodiment, the contact surfaces 1110 of the electrode blocks 111 corresponding to the working electrode 105, the reference electrode 106 and the counter electrode 107 can all be distributed in a discrete point-like manner, which can specifically include the distribution in the form of discrete central symmetric distribution, staggered point lattice distribution, array point lattice distribution, non-uniform point lattice distribution and other methods.

[0130] A sodium ion-selective layer material is disposed on the surface of the working electrode 105 of the body fluid detection module. Due to the stable potential of the reference electrode 106, the potential of the working electrode 105 can be obtained from the reference electrode 106 during operation, and the current can be directly measured by the working electrode 105-counter electrode 107 circuit. Specifically, the ion-selective layer of the working electrode 105 is used to capture sodium ions, the reference electrode 106, which is mainly composed of Ag / AgCl, provides a comparison standard for the potential electrode, and the counter electrode 107 is subjected to polarization current.

[0131] like Figure 13 As shown, an electrical connector 112 is also connected to the end of the electrode block 111 away from the contact surface 1110. Figure 13 As shown, there are three electrical connectors 112, all of which are in a ring design. Each electrical connector 112 is connected to the working electrode 105, the reference electrode 106 and the counter electrode 107 respectively.

[0132] As can be seen, in this embodiment, the three-electrode measurement method uses an electrochemical approach to measure the body fluid to be tested, wherein the multiple electrode blocks 111 in each electrode are distributed in a separate point-like manner.

[0133] In some specific examples, assuming the need to perform an electrochemical measurement of sodium ions in sweat, the steps include the following:

[0134] A sodium ion-selective layer material is provided on the surface of the working electrode 105 of the body fluid detection module. In the working state, a current loop is formed between the working electrode 105 and the counter electrode 107, so that the ion-selective layer on the working electrode 105 can capture sodium ions, thereby allowing the concentration of sodium ions to be deduced.

[0135] Please see Figure 14 The second embodiment of the present invention provides a method S20 for preparing a body fluid detection module, which can be used to prepare the body fluid detection module described in the first embodiment above. In some specific embodiments of this embodiment, the preparation method may include the following steps:

[0136] Step S1: Provide a substrate, and form at least two separate through holes on the substrate; and

[0137] Step S2: An electrode block and an electrical connector are formed in the through hole and on the surface of the through hole, respectively. The electrode block and the electrical connector are electrically connected, and the electrode block protrudes from one end of the through hole to obtain the desired body fluid detection module.

[0138] The end face of the electrode block exposed on the substrate is the contact surface that comes into contact with the body fluid to be tested, and the multiple contact surfaces are distributed in a discrete point pattern. The contact surfaces and the electrical connectors are not coplanar. Preferably, the electrical connectors are located at the end of the electrode block furthest from the contact surfaces.

[0139] In step S1 above, the through hole may include a central through hole and a plurality of peripheral through holes arranged around the central through hole.

[0140] like Figure 15 As shown, in step S2, an electrode block is formed inside the through hole, and an electrical connector is formed on the surface of the through hole. The specific steps are as follows:

[0141] Step S21: Chemical deposition is performed inside and on the surface of the vias in the substrate to form a conductive layer; and

[0142] Step S22 involves etching away unwanted copper layers through exposure and development to form corresponding electrode blocks and electrical connectors inside and on the surface of the vias in the substrate.

[0143] During the chemical deposition process, if the thickness of the deposited conductive material is insufficient to cover the gaps in the through-hole, electroplating is required to fill the through-hole. After electroplating is completed, another chemical deposition of conductive material is performed.

[0144] The conductive material deposited by the above chemical deposition includes, but is not limited to, one or a combination of copper, gold, silver, aluminum, etc.

[0145] To meet the needs of different body fluid detection module preparation, such as Figure 16 As shown in the figure, in this embodiment, the preparation method T10 of the body fluid detection module may further include the following specific implementation steps:

[0146] Step T1: Obtain at least two conductive electrodes, each conductive electrode comprising electrically connected electrode blocks and electrical connectors; and

[0147] Step T2: After injecting the at least two conductive electrodes into the mold for spaced positioning, the substrate material is poured in, and the desired body fluid detection module is obtained after shaping.

[0148] The end face of the electrode block exposed on the substrate is the contact surface that comes into contact with the body fluid to be tested, and the multiple contact surfaces are distributed in a discrete point pattern. The contact surfaces and the electrical connectors are not coplanar. Preferably, the electrical connectors are located at the end of the electrode block furthest from the contact surfaces.

[0149] In step T1 above, the electrode block may include a centrally located electrode block and multiple electrode blocks arranged around the central through hole. The electrical connector also includes a centrally located electrical connector and multiple electrical connectors arranged around the center. The conductive electrode can be fabricated using methods such as 3D printing or casting.

[0150] The preparation method provided in this embodiment yields a body fluid detection module as described in the first embodiment above. The relevant limitations on the size, shape, material, and positional relationship of the middle electrode block and electrical connectors of the body fluid detection module also apply to the scope of protection of this embodiment.

[0151] Please see Figure 17 The third embodiment of the present invention provides a body fluid detection method P30, which includes the following steps:

[0152] Step P1: Provide at least two electrodes, at least one of the electrodes including at least one contact surface that contacts the body fluid to be tested, the contact surface being distributed in a discrete point pattern;

[0153] Step P2 involves bringing the body fluid to be tested into contact with the contact surface, thereby forming a current loop between the electrode and the body fluid; and

[0154] Step P3: Detect the detection signal of the body fluid to be tested output by the electrode;

[0155] The detection signals include current signals and / or voltage signals corresponding to the voltage drop.

[0156] In this implementation, the body fluids to be tested may include human secretions such as sweat, urine, saliva, and tears.

[0157] The described body fluid detection method can also be applied to the body fluid detection module described in the first embodiment above.

[0158] To further illustrate the above-mentioned body fluid detection method, in some specific embodiments, the body fluid detection module is used to detect human sweat using a four-wire measurement method, as detailed below:

[0159] The body fluid detection module includes four electrodes, two of which are excitation electrodes and the other two are sensing electrodes, wherein the two sensing electrodes are located between the two excitation electrodes.

[0160] It is understood that in the body fluid detection module, the electrode blocks include multiple blocks, and the sweat to be tested needs to completely or partially cover all the electrode blocks in the body fluid detection module. When the sweat to be tested only covers part of the electrode blocks, the multiple covered electrode blocks must originate from four electrodes to achieve the excitation and sensing functions.

[0161] In this embodiment, the electrode structure needs to be adjusted accordingly if different bodily fluids need to be detected. For example, when measuring bodily fluids such as urine and saliva, which are corrosive, the contact surface of the corresponding electrode structure needs to be designed to be corrosion-resistant to further improve the stability of the bodily fluid detection module. Furthermore, the thickness and area of ​​the electrode structure also need to be adjusted. A four-electrode bodily fluid detection module can offer superior detection stability.

[0162] The detection principle and specific details of the body fluid detection module with four electrodes are the same as those described in the first embodiment above, and will not be repeated here.

[0163] It should be further explained that when the body fluid detection module has a four-electrode structure, the detection signal of the corresponding output of the electrode in step P3 above is specifically defined as follows: the two excitation electrodes can be further divided into a first excitation electrode and a second excitation electrode, and the two sensing electrodes are the first sensing electrode and the second sensing electrode, respectively. The second excitation electrode is arranged around the first excitation electrode, and within the area enclosed by the second excitation electrode, the first sensing electrode and the second sensing electrode are arranged around the first excitation electrode.

[0164] It can be seen that, as Figure 18 As shown, in some specific embodiments, step P3 may further include the following steps:

[0165] Step P31: An alternating current is applied between the first excitation electrode and the second excitation electrode that are in contact with the body fluid to be tested to form a current loop and generate a current signal.

[0166] Step P32: Current can pass through the body fluid to be tested, generating a voltage drop, and a voltage signal corresponding to the voltage drop is formed between the first sensing electrode and the second sensing electrode in contact with the body fluid to be tested; and

[0167] Step P33: Output the current signal and the voltage signal corresponding to the voltage drop.

[0168] It can be understood that the output current signal and the corresponding voltage signal of the voltage drop in step P33 above can be further converted into the resistance value of the body fluid to be measured based on the formula R=U / I.

[0169] As described in the first embodiment above regarding the principle of the body fluid detection module, the resistance value of the body fluid being tested is directly proportional to its electrolyte concentration, thereby establishing a calibration database. This calibration database pre-stores different resistance values ​​and their corresponding ion concentrations. Therefore, based on the pre-set calibration database, the electrolyte concentration of the body fluid being tested can be further obtained from its resistance value.

[0170] Furthermore, the ion concentrations in different body fluids to be tested follow a pattern. Therefore, based on a preset correction coefficient, the concentration of a certain ion in the body fluid to be tested can be calculated using the electrolyte concentration and the correction coefficient, so as to achieve the detection of the body fluid to be tested.

[0171] In this embodiment, a two-wire measurement method or a three-electrode measurement method can also be used to detect the concentration of ions in body fluids.

[0172] Specifically, the steps for detecting ion concentration in body fluids based on the two-wire measurement method are as follows:

[0173] When the body fluid to be tested covers the two electrodes, a current loop is formed between the electrodes, and the current can pass through the body fluid to generate a voltage drop. A current signal can be obtained based on one electrode, while a voltage signal corresponding to the voltage drop can be obtained based on the other electrode.

[0174] In some other embodiments, the detection steps based on a three-electrode electrochemical method are as follows:

[0175] A sodium ion-selective layer material is set on the surface of the working electrode of the body fluid detection module. Sodium ions are captured by the ion-selective layer of the working electrode. A reference electrode mainly composed of Ag / AgCl provides a comparison standard for the potential electrode. The counter electrode is subjected to polarization current.

[0176] A sodium ion-selective layer material is provided on the surface of the working electrode of the body fluid detection module. In the working state, a current loop is formed between the working electrode and the counter electrode, so that the ion-selective layer on the working electrode can capture sodium ions, thereby allowing the concentration of sodium ions to be deduced.

[0177] Compared with existing measurement methods, the body fluid detection method provided in this embodiment can still perform stable and accurate body fluid detection with a small amount of body fluid, because the electrodes in the body fluid detection module include multiple contact surfaces that are distributed in a discrete point shape.

[0178] Furthermore, the following testing method is provided to further illustrate the effects of the body fluid detection module of the first embodiment and the body fluid detection method of the third embodiment.

[0179] Experimental group 1, control group 1, and control group 2 were established, and stability tests were conducted using physiological saline. The measurement method adopted the two-electrode measurement principle.

[0180] Experimental Group 1: The body fluid detection module includes two electrodes, each consisting of multiple electrode blocks, with the contact surfaces of the electrode blocks distributed in a separate point pattern.

[0181] Comparative Group 1: A combination of a central electrode and an outer ring electrode was used.

[0182] Comparative group 2: Measurements were performed using traditional plate electrodes.

[0183] The corresponding test results are as follows Figure 19 and Figure 20 As shown in the image.

[0184] From Figure 19 As can be seen from the results, experimental group 1 corresponds to a rectangular lattice, which exhibits good stability. Even with a small volume and thickness of physiological saline, it shows good stability, with a stability of over 95%.

[0185] The control group 1 corresponds to the triangle marker, and its stability is worse than that of the experimental group 1, especially when the thickness of the physiological saline is less than 1.6 mm and the volume is less than 0.5 ml, its stability is significantly lower than that of the experimental group 1.

[0186] The control group 2 corresponds to the circular marker, and its stability varies greatly with the volume and thickness of the saline solution.

[0187] based on Figure 19 It can be seen that experimental group 1 corresponding to this invention only requires a small amount of liquid to reach a stable state.

[0188] Furthermore, the stability changes of experimental group 1 and control group 1 under different liquid volumes and thicknesses can be compared. Combined with... Figure 20 It can be known that:

[0189] Experimental group 1 corresponds to a rectangular lattice, which exhibits good stability. It shows good stability even with small volumes and thicknesses of physiological saline, with a stability of over 97%.

[0190] The control group 1 corresponds to the triangle marker, and its stability is worse than that of the experimental group 1, especially when the thickness of the physiological saline is less than 0.2 mm and the volume is less than 0.1 ml, its stability is significantly lower than that of the experimental group 1.

[0191] As the volume and thickness of the saline solution increased, the stability of control group 1 also increased.

[0192] The following table shows the results obtained by comparing experimental group 1 with control group 1:

[0193] Table 1. Comparison of effective liquid coverage area and stability between experimental group 1 and control group 1.

[0194] Table 1

[0195]

[0196] Combination Figure 19 - Figure 20 As shown in Table 1, the stability of experimental group 1 provided by this invention exceeds 96% even with minimal liquid coverage. However, for control group 1, a certain volume of liquid is required to achieve stability above 96%. Therefore, under the same conditions, the body fluid detection module and corresponding body fluid detection method provided by this invention can achieve stable and accurate detection of body fluid ion concentrations with a smaller volume of body fluid.

[0197] Please see Figure 21 A fourth embodiment of the present invention provides a body fluid detection device 40, which includes a body fluid detection module 10 as provided in the first embodiment and a processing module 41 connected to the body fluid detection module 10. The processing module 41 can receive body fluid detection signals output by the body fluid detection module 10 and process them to analyze the components of the body fluid to be tested. The body fluid detection signals include current signals and / or voltage signals corresponding to the pressure drop of the body fluid to be tested.

[0198] The processing module 41 includes an analog-to-digital converter (ADC) 411 and a processor 412. The ADC 411 is electrically connected to the body fluid detection module 10 to convert the current and voltage signals output by the body fluid detection module 10 and output a resistance value signal to the processor 412 for processing. Specifically, the ADC 411 can be electrically connected to the electrical connectors of the body fluid detection module 10.

[0199] The processor 412 can store a preset calibration database or be connected to a calibration database stored in the cloud. The calibration database contains different resistance values ​​and the ion concentrations corresponding to each resistance value. The processor 412 compares the received resistance value signal with the calibration database to output the ion concentration data of the body fluid to be tested corresponding to the resistance value.

[0200] Furthermore, the processor stores a preset calibration database containing different resistance values ​​and their corresponding ion concentrations. The processor compares the received resistance value signal with the calibration database to output the ion concentration of the body fluid to be tested corresponding to the received resistance value. Unlike electrochemical detection methods, the body fluid detection device provided by this invention can establish a calibration database based on the detected resistance value and its corresponding ion concentration, thereby converting the detection signal into the corresponding ion concentration, simplifying the measurement method while ensuring accuracy.

[0201] The body fluid detection device 20 provided in this embodiment can be used for the detection of human secretions or animal secretions such as sweat, urine, saliva, and tears.

[0202] In this embodiment, sweat is used as an example of bodily fluid. Since the concentration of sodium ions in sweat accounts for more than 90% of the total electrolyte concentration in sweat, and the concentration of sodium ions is an order of magnitude higher than that of potassium ions, the sodium ion concentration in sweat can be approximated by multiplying the electrolyte concentration of sweat by a coefficient. This can be expressed by the following formula:

[0203] Na+ = Electrolyte * C;

[0204] Where Na+ represents the sodium ion concentration, Electrolyte represents the electrolyte concentration, and C is the correction factor. The correction factor can be adjusted based on the characteristics of the body fluid being tested. Taking human sweat as an example, the correction factor can be the ratio of sodium ion concentration in sweat to the total electrolyte concentration in sweat. This system can be preset based on the usage scenario.

[0205] In this formula, the correction factor C is a pre-set coefficient, and the body fluid component concentration data is the electrolyte concentration (Electrolyte). Therefore, the corresponding sodium ion concentration can be calculated based on the above formula. It can be understood that different correction factors C will be used for different body fluids.

[0206] The body fluid detection device provided in this embodiment can achieve stable and accurate detection of body fluid ion concentration with a smaller volume of body fluid.

[0207] Please see Figure 22 and Figure 23 The fifth embodiment of the present invention provides a heat detection device 50, which is also a specific application of the body fluid detection device 40 described in the fourth embodiment above. The heat detection device 50 includes a housing 51, a main circuit board 52, a body fluid detection module 53, a temperature sensing module 54, a processing module 55, a control module 56, and a power supply module 57. The housing 51 has a space for accommodating the main circuit board 52, the body fluid detection module 53, the temperature sensing module 54, the processing module 55, the control module 56, and the power supply module 57. The housing 51 also has an opening 510 that exposes at least part of the body fluid detection module 53 and the temperature sensing module 54 to realize the detection function.

[0208] In some specific embodiments, the body fluid detection module 53, the temperature sensing module 54, the processing module 55, the control module 56, and the power supply module 57 can be connected to the main circuit board 52.

[0209] Specifically, such as Figure 23 As shown, the main circuit board 52 includes two opposing surfaces, wherein the body fluid detection module 53, the temperature sensing module 54 and the control module 56 are disposed on one surface of the main circuit board 52, while the processing module 55 and the power module 57 are disposed on the other surface of the main circuit board 52.

[0210] like Figure 24 As shown, the body fluid detection module 53 includes at least two electrodes 531, each electrode 531 including at least one electrode block 5311, each electrode block 5311 including a contact surface 5310 that contacts the body fluid to be tested, the contact surface 5310 being distributed in a discrete point pattern; when the body fluid to be tested contacts the electrode 531, forming a current loop between the electrode 531 and the body fluid to be tested, the electrode 531 outputs a detection signal for the body fluid to be tested, wherein the detection signal includes a current signal and / or a voltage signal corresponding to the voltage drop. The body fluid detection module 53 includes a substrate 532, the substrate 532 housing the electrode 531, the substrate 532 including any one of ceramic and insulating polymer, the contact surface 5310 being exposed on the substrate 532 and at least partially exposed through the opening 510 of the housing 51. Other limitations of the body fluid detection module are consistent with those of the body fluid detection module provided in the first embodiment above, and will not be repeated here.

[0211] like Figure 23 , Figure 24 and Figure 25As shown, the heat detection device 50 includes a mounting base 59, which is disposed between the housing 58 and the main circuit board 52. Specifically, in some embodiments, the main circuit board 52 is further provided with a mounting base 59, which has a through cavity. The body fluid detection module 53 is installed in the mounting base 59, and the side of the substrate 532 of the body fluid detection module away from the contact surface 5310 is mounted on the main circuit board 52 in a fitted manner, with the edge of the substrate 532 accommodated within the mounting base 59. Sealing elements 591 are provided between the substrate 532 and the main circuit board 52, and between the substrate 532 and the mounting base 59, to provide waterproof isolation. Specifically, in this embodiment, the sealing element 591 is an O-ring. A sealing element 591 can also be provided between the mounting base 59 and the housing 51 to improve the waterproof effect.

[0212] like Figure 25 As shown, the mounting base 59 has a body fluid cavity 590 for accommodating the body fluid detection module, and the depth of the body fluid cavity 590 is 0.5mm-3mm. Furthermore, when body fluid drips in from the opening 510, the body fluid can remain in the body fluid cavity 590, allowing the electrode 531 to detect the body fluid. It can be understood that the body fluid cavity 590 has a certain depth, ranging from 0.5mm to 3mm.

[0213] Further as Figure 23 and Figure 26 As shown, the body fluid detection module 53 and the temperature sensing module 54 are respectively connected to the processing module 55, and the power module 57 provides electrical energy to the body fluid detection module 53, the temperature sensing module 54 and the processing module 55 respectively.

[0214] The body fluid detection module 53 can detect the ion concentration in body fluids; the temperature sensing module 54 can detect the skin surface temperature of the subject and can be used for temperature compensation of the body fluid; during the heatstroke detection process, the processing module 55 can collect and process the corresponding data detected by the body fluid detection module 53 and the temperature sensing module 54. This allows for simultaneous analysis of changes in human body temperature and changes in the ion concentration in body fluids, thus providing a more accurate reflection of the body's heatstroke index.

[0215] The bodily fluid detection module 53 is as described in the first embodiment above, and will not be repeated here. To achieve better waterproofing, a waterproof silicone ring can also be provided between the bodily fluid detection module 53 and the main circuit board 52 to prevent sweat from affecting the circuit operation of the main circuit board 52.

[0216] The processing module 55 includes an analog-to-digital converter circuit 551 and a processor 552. The analog-to-digital converter circuit 551 is electrically connected to the body fluid detection module 53. The detection signal output by the body fluid detection module 53 is converted by the analog-to-digital converter circuit 551 and then outputs a resistance value signal to the processor 552 for processing.

[0217] The analog-to-digital converter circuit 551 provides excitation voltage and excitation current to the multiple electrodes 531 of the body fluid detection module 53, and transmits the current signal and the corresponding voltage signal to the processor via an ADC for further data analysis. The electrical connectors of the multiple electrodes 531 of the body fluid detection module 53 are located on the reverse side in contact with sweat and are electrically connected to the analog-to-digital converter circuit 551.

[0218] Combination Figure 23 and Figure 26 As shown, the power module 57 includes any one or a combination of several of the following: wired charging component, contact charging component, wireless charging component, etc. Specifically, the power module 57 includes a battery pack and a charging component 571 connected to the battery pack. The charging component 571 can use AC charging, Type-C charging, USB charging port, etc., and the charging component 571 can also be a contact charging component, etc.

[0219] In this embodiment, the charging component 571 includes four contacts, which correspond to the positive and negative terminals of the power supply and the contacts corresponding to data transmission, respectively.

[0220] Continue to combine Figure 23 and Figure 26 As shown, the control module 56 includes a control component 561 and an indicator component 562. The control component 561 includes buttons, slide switches, touch screens, touch switches, infrared switches, sound switches, etc., and the indicator component 562 may include indicator lights, displays, or voice prompts, etc.

[0221] In some specific implementations of this embodiment, such as Figure 26 As shown, the heat detection device 50 may further include an ultraviolet detection module 581 and / or an ambient temperature and humidity detection module 582, which can be adjusted based on actual usage needs and usage scenarios.

[0222] Among them, the ultraviolet detection module 581 is a detector designed based on the principle of solute molecules absorbing ultraviolet light. Its working principle is the Lambert-Beer law: when a beam of monochromatic light passes through a flow cell, if the mobile phase does not absorb light, the absorbance A is proportional to the concentration C of the light-absorbing component and the optical path length L of the flow cell.

[0223] The ambient temperature and humidity detection module 582 can detect the temperature and humidity of the environment in which the heat detection device 50 is located. The ultraviolet detection module 581 and the ambient temperature and humidity detection module 582 are mounted on the main circuit board. The ultraviolet detection module 581 and the ambient temperature and humidity detection module 582 are electrically connected to the processing module 55 and output corresponding ultraviolet detection signals and ambient temperature and humidity detection signals to the processing module 55. The power supply module 57 can provide electrical energy to the ultraviolet detection module 581 and the ambient temperature and humidity detection module 582.

[0224] It is understandable that the degree of sweating varies when the human body is exposed to different ultraviolet radiation and in different temperature and humidity environments. Therefore, in order to improve the accuracy of sweat detection, it is often necessary to further correct the sweat detection data for accurate detection.

[0225] In some superior heatstroke detection applications, the use of temperature sensing module 54, ultraviolet detection module 581, and environmental temperature and humidity detection module 582 can further detect environmental ultraviolet intensity, environmental temperature, and humidity. Furthermore, data on changes in human skin temperature, ultraviolet intensity, and environmental temperature and humidity are combined as auxiliary data for correcting sweat detection data. During correction, different computational weights can be assigned to body fluid detection, skin surface temperature changes, ultraviolet intensity, and environmental temperature and humidity detection data based on different subjects and their physiological characteristics. This allows for adjustment of the criteria for judging heatstroke detection, thereby making heatstroke detection more accurate.

[0226] Combination Figure 23 , Figure 26 and Figure 27 As shown, in some specific embodiments, the housing 51 includes a main body 511 and a fixing structure 512 disposed on the main body 511. The fixing structure 512 may be a clamping member, an adhesive member, or a hanging hole, etc. The fixing structure 512 is a hanging hole directly formed on the main body.

[0227] The main body 511 includes at least two surfaces 5110. One surface 5110 has a first opening 5111 that exposes part of the body fluid detection module 53. The other surface 5110 has a second opening 5112 and a third opening 5113 that expose part of the ultraviolet detection module 581 and the ambient temperature and humidity detection module 582. In some specific embodiments, the first opening and the second opening 5112 and the third opening 5113 are respectively disposed on two opposite surfaces 5110 of the main body 511.

[0228] In order to make the temperature sensing module 54 fit better against the skin surface of the subject to be measured, a fourth opening 5114 is also provided at a position near the subject 511 and the first opening 5111.

[0229] Combination Figure 23 and Figure 27 As shown, the main body 511 is also provided with a fifth opening 5115 that cooperates with the control module 56. The fifth opening 5115 is coplanar with the first opening 5111. The fifth opening 5115 allows the control component 561 and the indicator component 562 to be exposed, facilitating user operation.

[0230] To make the heat detection device 50 smaller, the housing 51 of the heat detection device 50 has a teardrop shape for easy carrying by the user. It is understood that in some other embodiments, only the main body 511 may be teardrop-shaped.

[0231] To better illustrate the heat detection device 50 provided in this embodiment, its usage steps are as follows:

[0232] When using the heat detection device 50 for detection, the sweat of the subject to be tested is first dripped into the body fluid chamber 590 of the heat detection device 50. The electrodes included in the body fluid detection module 53 can apply excitation voltage and excitation current to the sweat. Since the sodium ion concentration in the sweat is different, the resistance value generated by the sweat is also different. Therefore, when the body fluid detection module 53 outputs the body fluid detection signal to the processing module 55, the analog-to-digital conversion circuit 551 in the processing module 55 will convert the body fluid detection signal and output it to the processor 552.

[0233] Furthermore, simultaneously with or before sweat analysis, the temperature sensing module 54 of the heat detection device 50 measures the skin surface temperature of the subject and outputs a skin surface temperature detection signal to the processing module 55; the ultraviolet detection module 581 also detects the ultraviolet intensity of the environment and outputs an ultraviolet detection signal to the processing module 55; the environmental temperature and humidity detection module 582 detects the temperature and humidity of the environment and outputs an environmental temperature and humidity detection signal to the processing module 55. Specifically, upon acquiring the corresponding skin surface temperature detection signal, ultraviolet detection signal, and environmental temperature and humidity detection signal, the processing module 55 uses an analog-to-digital conversion circuit 551 to convert the acquired signals and transmits them to the processor 552 for processing, thereby obtaining the relationship between the sweat impedance value, the proportional relationship between the ion concentration in the sweat, and the skin surface temperature, ultraviolet intensity, and environmental temperature and humidity.

[0234] In this embodiment, the initial sweat levels of the subject under test can be used as a reference value. Then, combined with the above data analysis, different actual sweat levels can be compared to assess the heat stress. Alternatively, a pre-established database corresponding to sweat ion concentration and heat stress can be used as a reference value for specific analysis and comparison.

[0235] In this embodiment, sweat, as the test subject, is considered the primary stress product during exercise. The components secreted in sweat, as products of the body's current exercise state, can serve as a source of the most real-time biomarkers for analyzing the user's physical condition. In an exercise environment, when the human body is in a high-temperature environment, blood vessels on the skin dilate to accelerate heat dissipation and produce profuse sweating. Besides water loss, sweating also results in significant salt loss, leading to a decrease in blood sodium ion concentration, which may cause cramps. If exposure to high temperatures continues, heat exhaustion and heat syncope may gradually develop. Therefore, the sodium ion concentration in sweat is of great reference value for assessing an individual's heatstroke condition.

[0236] Compared with existing heat detection methods or equipment, the heat detection device 50 provided in this embodiment not only considers the shortcomings of existing heat indexes that judge the heat level solely based on the temperature and humidity of the environment, but also takes into account individual differences and the limitations of exercise conditions. Moreover, the heat detection device 50 provided in this embodiment has a simple structure and is easy to use, thereby overcoming the deficiencies of existing personal heat detection devices.

[0237] Please refer to Figure 28 The sixth embodiment of the present invention provides a sweat detection device 60, which can detect the sweat of a subject. The sweat detection device 60 can analyze the composition of sweat and can also be used to detect the degree of heat experienced by a user.

[0238] The sweat detection device 60 includes a sweat detection module 61 and a body surface detection module 62. The sweat detection module 61 comes into contact with the sweat of the subject and generates a sweat detection signal. The body surface detection module 62 comes into contact with the skin and generates a skin moisture signal. Within a preset measurement time, if the change in the skin moisture signal is less than a set order of magnitude, sweat detection data is output. If the change in the skin moisture signal is greater than or equal to a set order of magnitude, sweat correction data based on the skin moisture signal is output.

[0239] Continue as Figure 28As shown, the sweat detection device 60 further includes a processing module 63 and a power module 64. The sweat detection module 61 and the skin surface detection module 62 respectively transmit sweat detection data and skin moisture signals to the processing module 63. The power module 64 is connected to the sweat detection module 61, the skin surface detection module 62, and the processing module 63, and provides them with electrical energy.

[0240] like Figure 29 As shown in the diagram, in this embodiment, the sweat detection module 61 includes multiple electrodes 611, each electrode 611 including a contact surface 6110. When the sweat of the subject being tested comes into contact with the contact surface 6110, the electrode 611 outputs a current signal corresponding to the sweat and / or a voltage signal corresponding to the voltage drop. The specific limitations of the sweat detection module 61 are consistent with the relevant limitations in the body fluid detection module 10 described in the first embodiment above. The only difference is that the subject being tested is limited to sweat; therefore, the descriptions of the same content will not be repeated here.

[0241] like Figure 29 As shown, the body surface detection module 62 also includes at least two body surface electrodes 621, and the body surface detection module 62 includes a detection surface 6210 for detecting the skin surface impedance of the subject. When the number of body surface electrodes 621 is two, the body surface electrodes 621 of the body surface detection module 62 can be configured as follows: Figure 29 The diagram shows a central electrode and a ring electrode arranged around the central electrode; or as shown in the diagram. Figure 30 As shown, the body surface electrodes 621 are symmetrically arranged.

[0242] When the number of surface electrodes 621 is four, such as Figure 31 As shown, the surface electrodes 621 of the surface detection module 62 can be circumferential electrodes arranged from the inside out; or as shown in the figure. Figure 32 As shown, each body surface electrode 621 includes multiple body surface electrode blocks 6211, which are distributed in a dispersed manner. Specifically, they can be distributed in a discrete center symmetric manner, a staggered lattice manner, an array lattice manner, etc., and body surface electrode blocks with different functions can also be interspersed.

[0243] In this embodiment, the material of the surface electrode 621 of the surface detection module 62 includes any one or a combination of gold, silver, and titanium; and / or the material of the electrode 611 of the sweat detection module 61 may also include any one or a combination of gold, silver, and titanium.

[0244] In this embodiment, both the sweat detection module 61 and the body surface detection module 62 can adopt a four-wire measurement method or a two-wire measurement method.

[0245] It can be understood that the skin hydration described in this embodiment is inversely proportional to the skin's surface impedance. Specifically, when the skin is dry, its surface impedance is relatively high, ranging from several thousand to tens of thousands. When the skin is moist, its surface impedance is relatively low, ranging from tens to hundreds. The human body produces sweat due to movement or environmental temperature and humidity to maintain comfort. Therefore, by detecting the impedance of the skin surface, the degree of skin hydration can be reflected, thereby enabling the detection of the body's sweating state.

[0246] Within a preset measurement time, such as the time from when the user starts exercising until they start sweating (e.g., 1-5 minutes), if the change in skin moisture signal is less than a preset order of magnitude (e.g., less than 2 orders of magnitude), then the skin is either consistently dry (the subject is not sweating) or consistently moist (the subject is sweating). In this case, the sweat detection data obtained by the sweat detection module 61 can accurately reflect the true ion concentration of the subject's sweat.

[0247] Within a preset measurement time, such as the time from when the user stops exercising and starts sweating until the body stops sweating (e.g., 1-5 minutes), if the change in skin hydration signal is greater than or equal to a preset order of magnitude (e.g., greater than or equal to 2 orders of magnitude), it indicates that the skin has abruptly changed from a dry to a moist state, corresponding to the subject producing sweat and the skin gradually becoming moist, or the skin has abruptly changed from a moist to a dry state, corresponding to the subject stopping sweating and the skin gradually drying. In this case, the measured sweat detection data needs to be corrected to obtain corrected sweat data.

[0248] It is understood that the above-mentioned preset measurement time can be adjusted according to the different physiological characteristics of the subject being tested and the different detection accuracy. This is only an example and is not intended to limit the present invention.

[0249] Based on the detection of skin moisture signals by the surface detection module 62, the sweating state of the subject can be determined, thus enabling more accurate detection of body fluid status. When the data meets the valid criteria, it is considered that the user is sweating. At this time, the sweat detection data from the sweat detection module 61 is further read to determine the specific electrical characteristics of the sweat.

[0250] Since the body surface detection module 62 is used to pre-judge sweating, as the user gradually stops exercising, the body begins to cool down and sweating gradually decreases. At this time, the body surface detection module 62 will detect specific body surface features, namely, skin hydration data. However, since the subject has stopped sweating, sweat secretion has decreased, and with sweat evaporation, the concentration of sweat remaining on the electrodes 611 of the sweat detection module 61 gradually increases. At this point, the sweat concentration information cannot be directly read; instead, the sweat detection signal data should be corrected using the skin hydration signal from the body surface electrodes 621.

[0251] In this embodiment, correcting the sweat detection signal data using the skin moisture signal from the surface electrode 621 can include two methods:

[0252] The first method is to establish a database relating skin hydration signals and sweat detection signals. If the change in skin hydration signals exceeds a preset order of magnitude within a preset measurement time, the corrected sweat signal is then retrieved and output based on the aforementioned database.

[0253] The second approach involves establishing a computational model that correlates skin hydration signals with sweat detection signals. If the change in skin hydration signals exceeds a preset order of magnitude within a predetermined measurement time, the corresponding skin hydration signals and sweat detection signals are input into the computational model for calculation, and a sweat correction signal is output. It is understandable that this computational model can also be obtained using deep learning.

[0254] It is evident that the combination of the sweat detection module 61 and the body surface detection module 62 can achieve more accurate sweat detection.

[0255] Combination Figure 29 and Figure 33 As shown, the sweat detection device 60 further includes a housing 68 and a fixing member 69. The housing 68 can accommodate the sweat detection module 61 and the body surface detection module 62, or the housing 68 and the fixing member 69 can enclose a space that can accommodate the sweat detection module 61 and the body surface detection module 62. The fixing member 69 is integrally formed with the housing 68 or detachably connected, and the fixing member 69 can be a clamp, adhesive attachment, or hook, etc.

[0256] Continue as Figure 33 As shown, the outer shell 68 and the fixing member 69 form a U-shaped structure, wherein the outer shell 68 is located on the outward-facing side, and the fixing member 69 is located on the inward-facing side. The fixing member 69 forms a clamping space 690 for clamping luggage, clothing, etc., of the subject being tested.

[0257] Combination Figure 29 and 33As shown, the surface of the outer shell 68 can be divided into a first surface 681 and a second surface 682. The sweat detection module 61 is partially exposed on the first surface 681; the body surface detection module 62 can be disposed on the first surface 681, or on the second surface 682 or other surfaces of the outer shell.

[0258] like Figure 29 and Figure 34 As shown, the sweat detection device 60 further includes a temperature detection module 601, and the sweat detection module 61, the body surface detection module 62, and the temperature detection module 601 are partially exposed on the first surface 681. The temperature detection module 601 is a metal sheet capable of measuring body surface temperature.

[0259] Combination Figure 33 and Figure 34 The sweat detection device 60 further includes an ultraviolet detection module 65, an ambient temperature and humidity detection module 66, and a control module 67. The ultraviolet detection module 65 and the ambient temperature and humidity detection module 66 are electrically connected to the processing module 63 and output corresponding ultraviolet detection signals and ambient temperature and humidity detection signals; the control module 67 is connected to the ultraviolet detection module 65, the ambient temperature and humidity detection module 66, the sweat detection module 61, the body surface detection module 62, and the temperature detection module 601.

[0260] Furthermore, combined Figure 33 and Figure 34 As shown, a waterproof and breathable membrane 6821 and an optical lens 6822 are provided on the second surface 682 of the outer casing 68. The waterproof and breathable membrane 6821 corresponds to the environmental temperature and humidity detection module 66, and can be combined with the environmental temperature and humidity detection module 66 for internal sensors to measure the temperature and humidity of the external air. The optical lens 6822 corresponds to the ultraviolet detection module 65, allowing ultraviolet light to pass through the optical lens 6822 to reach the ultraviolet detection module 65, thereby realizing the detection of ambient ultraviolet light.

[0261] In order to make the sweat detection device 60 smaller and more compact, in this embodiment, the ultraviolet detection module 65, the ambient temperature and humidity module 66, and the control module 67 are not coplanar with the body surface detection module 62 and the sweat detection module 61.

[0262] It is understood that, in order to meet the needs of various sweat detection, the sweat detection device 60 may also include an ultraviolet detection module 65 or an ambient temperature and humidity detection module 66, and the corresponding processing module 63 may be connected to the ultraviolet detection module 65 or the ambient temperature and humidity detection module 66.

[0263] Furthermore, such as Figure 35 As shown, to improve the accuracy of sweat analysis in the sweat detection device 60, in this embodiment, the sweat detection device 60 may further include a heart rate detection module 602. The heart rate monitoring module 602 can be connected to the processing module 63 and the control module 67 via signal connection. The heart rate detection module 602 can detect changes in the heartbeat, heart rate, etc. of the subject being tested. The heart rate detection module 602 can be disposed inside the housing 68, and part of the heart rate detection module 602 is exposed on the first surface 681 or the second surface 682.

[0264] In some specific embodiments, the heart rate detection module 602 can also be set independently of the housing 68. For example, the heart rate detection module 602 can be set on a smart wearable device (such as a watch, heart rate monitor, etc.). When the heart rate detection module 602 is set independently of the housing 68, the heart rate detection module 602 is wirelessly connected to the processing module 63 and the control module 67 via Bluetooth, 4G / 5G signal connection, etc., to realize signal communication between the heart rate detection module 602 and the processing module 63 and the control module 67.

[0265] To meet the diverse needs of the sweat detection device 60, the functional modules of the sweat detection device 60, such as the body surface detection module 62, the ultraviolet detection module 65, and the environmental temperature and humidity detection module 66, can all be non-coplanar with the sweat detection module 61. Specifically, the contact surface 6110 of the sweat detection module 61 and the detection surface 6210 of the body surface detection module 62 can be set on planes facing different directions.

[0266] Combination Figure 33 and Figure 36 As shown, to facilitate detection using the sweat detection device 60, the body surface detection module 62 and the sweat detection module 61 are located on the same side of the outer casing 68. However, to avoid direct contact between the sweat detection module 61 and the skin, the distance from the contact surface 6110 of the sweat detection module 61 to the skin surface is greater than the distance from the detection surface 6210 of the body surface detection module 62 to the skin surface.

[0267] Combination Figure 33 and Figure 36As shown, in some specific embodiments, to meet the distance limitation between the contact surface 6110 of the sweat detection module 61 and the skin surface, a first step 6811 and a second step 6812 are correspondingly provided on the first surface 681 of the outer shell 68. The contact surface 6110 of the sweat detection module 61 is exposed on the first step 6811, and the detection surface 6210 of the body surface detection module 62 is exposed on the second step 6812. Wherein, if a plane inside the sweat detection device 60 is set as a reference plane 6819, then the height h1 of the first step 6811 to the reference plane 6819 is less than the height h2 of the second step 6812 to the reference plane 6819. It can be seen that the detection surface 6210 of the body surface detection module 62 and the contact surface 6110 of the sweat detection module 61 are located on different planes.

[0268] Furthermore, such as Figure 29 as well as Figure 37 As shown, in order to prevent the contact surface 6110 of the sweat detection module 61 from contacting the skin of the subject during use, in some specific examples, a support structure 683 is provided on the first step 6811. The support structure 683 is located at the edge of the detection surface of the sweat detection module 61, and the support structure 683 does not completely surround the detection surface of the sweat detection module 61. Specifically, the support structure 683 includes two symmetrically arranged arc-shaped protrusions. The height of the support structure 683 is 0.5mm-3mm, specifically, the height of the support structure 683 can also be 0.5mm, 0.9mm, 1mm, 1.2mm, 1.5mm, 1.8mm, 2.1mm, 2.4mm, 2.7mm, and 3mm, etc.

[0269] Or in other specific examples, such as Figure 38 As shown, a recessed structure 684 is provided on the first step 6811, and the contact surface 6110 of the sweat detection module 61 is located in the recessed structure 684. The depth of the recessed structure 684 is 0.5mm-3mm. Specifically, the depth of the recessed structure 684 can also be 0.5mm, 1mm, 1.2mm, 1.5mm, 2mm, 2.3mm, and 3mm, etc.

[0270] It is understandable that, in order to increase the portability of the sweat detection device 60, such as... Figure 39 As shown, anti-slip structures 680 are provided on both the first surface 681 and the second surface (not shown) of the outer casing 68.

[0271] Continue as Figure 39As shown in the illustration, in some other embodiments of this example, the sweat detection device 60 further includes a charging structure 609, which is specifically formed on the surface of the fixing member 69. The charging structure 609 is electrically connected to the power module 64, and the charging structure 609 can be any one or a combination of several of the following: a plug-in charging port, a magnetic charging port, a contact charging port, or a wireless charging structure. Figure 39 As shown in the figure, in this embodiment, the charging structure 609 is specifically a metal pin, and the charging structure 609 can be used in conjunction with the power module 64.

[0272] The sweat detection device 60 provided in this embodiment can be used to detect human sweat. The specific usage steps include:

[0273] When not in use, the sweat detection device 60 is clipped to clothing or an armband via a fastener 69 for easy portability. When the sweat detection device 60 is needed for detection, the sweat detection module 61, the body surface detection module 62, and the temperature detection module 601, partially exposed on the first surface 681, are positioned towards the skin, ensuring close contact between the body surface detection module 62 and the temperature detection module 601 and the skin. Based on the skin hydration signal detected by the body surface detection module 62, a judgment is made, and corresponding sweat detection data is output; or, after correcting the sweat detection data based on the skin hydration signal, sweat correction data is output.

[0274] In some preferred embodiments, the ultraviolet detection module 65 and the ambient temperature and humidity detection module 66 located on the second surface 682 can further detect the ultraviolet intensity, ambient temperature and humidity, etc.

[0275] Further data such as changes in skin surface temperature, ultraviolet radiation intensity, and ambient temperature and humidity can be used as supplementary data for correcting sweat detection data. Specific correction methods can include the following two approaches:

[0276] The first method involves establishing a database relating skin hydration signals, temperature detection signals, ultraviolet detection signals, ambient temperature and humidity signals, and sweat detection signals. If the change in skin hydration signals exceeds a preset order of magnitude within a preset measurement time, the corrected sweat signal is retrieved and output based on the aforementioned database.

[0277] The second approach involves establishing a computational model that relates skin hydration signals, temperature detection signals, ultraviolet (UV) radiation detection signals, ambient temperature and humidity signals, and sweat detection signals. If the change in skin hydration signal exceeds a preset order of magnitude within a predetermined measurement time, the corresponding signals are input into the computational model for calculation, and a sweat correction signal is output. It's understandable that this computational model can also be obtained using deep learning.

[0278] It is understandable that, in order to meet different usage scenarios, the aforementioned ultraviolet intensity detection signal and ambient temperature and humidity detection signal can be selected based on different needs.

[0279] Furthermore, in this embodiment, the heart rate detection signal can also be used as auxiliary data for sweat test data correction. The corresponding heart rate detection signal can be obtained by the heart rate detection module 602. The heart rate detection module 602 can be located inside the housing 68 or can be set independently of the housing 68.

[0280] The sweat detection device 60 provided in this embodiment has superior stability, durability, and sensitivity. Therefore, it can be used not only in smartwatches but also in professional fitness equipment. The sweat detection device 60 will also be configured with different physical dimensions for different applications.

[0281] Please refer to Figure 40 The seventh embodiment of the present invention provides a sweat detection method Q10, which specifically includes the following steps:

[0282] Step Q1: Provide a body surface detection module and a sweat detection module; make the body surface detection module contact the skin and generate a skin moisture signal, and make the sweat of the subject to be tested contact the sweat detection module, wherein the sweat detection module generates a corresponding sweat detection signal;

[0283] Step Q2 involves determining the amplitude of changes in the skin hydration signal within a preset measurement time; and

[0284] Step Q3: Based on the judgment result, output the corresponding sweat detection data; or output the sweat correction data after correction based on the skin moisture signal.

[0285] Specifically, in order to improve the accuracy of the relevant sweat test data, step Q3 above may further include:

[0286] Step Q31: When the change in the skin hydration signal is less than a set order of magnitude, the corresponding sweat detection data is output; or

[0287] Step Q32: When the change in the skin hydration signal is greater than a set order of magnitude, the corresponding sweat correction data based on the skin hydration signal is output.

[0288] It is understood that the sweat detection method described in this embodiment is based on the sweat detection device described above. Therefore, the relevant limitations of the body surface detection module and the sweat detection module are consistent with the relevant limitations of the sweat detection device in the sixth embodiment described above, and the same descriptions will not be repeated here.

[0289] In steps Q31 and Q32 above, the change amplitude of the skin hydration signal can be understood as the change in the impedance value of the surface skin of the subject under test within a certain preset measurement time, that is, within one minute or five minutes.

[0290] Within a preset measurement time, such as the time from when the user starts exercising until they start sweating (specifically, any time between 1 and 5 minutes), if the change in skin hydration signal is less than a preset order of magnitude (e.g., less than 2 orders of magnitude), it indicates that the skin has been in a dry state and the subject has not sweated, or the skin has been in a moist state and the subject has been sweating. In this case, the sweat detection data obtained by the sweat detection module can accurately reflect the true ion concentration of the subject's sweat.

[0291] Within a preset measurement time, such as the time from when the user stops exercising and starts sweating until the body stops sweating (specifically, any time between 1 and 5 minutes), if the change in skin hydration signal is greater than or equal to a preset order of magnitude (e.g., greater than or equal to 2 orders of magnitude), it indicates that the skin has abruptly changed from a dry state to a moist state, corresponding to the subject producing sweat and the skin gradually becoming moist. Alternatively, if the skin changes from a moist state to a dry state, corresponding to the subject having stopped sweating and the skin gradually drying, then the measured sweat detection data needs to be corrected to obtain corrected sweat data.

[0292] In this embodiment, the corresponding sweat detection module and body surface detection module can measure simultaneously or in stages. In some specific embodiments, the sweat detection module can only detect data after the body surface measurement module has detected data. Therefore, combining sweat detection with body surface detection can prevent some sweat from embedding in the contact surface of the sweat detection module and failing to flow away, resulting in excessively high sweat moisture concentration and causing misjudgment.

[0293] It is understandable that, in this embodiment, the preset measurement time and the variation amplitude of skin moisture signal in the corresponding body surface detection module will be affected by different subjects, different body parts, and environmental temperature and humidity conditions. For example, different subjects may sweat to different degrees under the same amount of exercise. For the same subject, sweating is generally faster in the upper body than in the lower body. The influence of environmental temperature and humidity is even more pronounced. Therefore, to improve the accuracy of sweat detection, it is often necessary to further correct the sweat detection data or establish a calibration database for different subjects to facilitate accurate detection.

[0294] Some superior sweat detection methods further incorporate ultraviolet (UV) detection modules and environmental temperature and humidity detection modules to further measure environmental UV intensity, temperature, and humidity. UV intensity and environmental temperature and humidity data can be used as auxiliary data for sweat detection data correction. During correction, different weights can be assigned to different detection data based on different subjects and their physiological characteristics to make sweat detection more accurate.

[0295] In the embodiments provided by this invention, it should be understood that "B corresponding to A" means that B is associated with A, and B can be determined based on A. However, it should also be understood that determining B based on A does not mean determining B solely based on A; B can also be determined based on A and / or other information.

[0296] It should be understood that the phrase "one embodiment" or "an embodiment" throughout the specification means that a specific feature, structure, or characteristic related to the embodiment is included in at least one embodiment of the invention. Therefore, "in one embodiment" or "in an embodiment" appearing throughout the specification does not necessarily refer to the same embodiment. Furthermore, these specific features, structures, or characteristics can be combined in any suitable manner in one or more embodiments. Those skilled in the art should also recognize that the embodiments described in the specification are optional embodiments, and the actions and modules involved are not necessarily essential to the invention.

[0297] In various embodiments of the present invention, it should be understood that the sequence number of each process does not necessarily imply the order of execution. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present invention.

[0298] The flowcharts and block diagrams in the accompanying drawings illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of this application. In this regard, each block in a flowchart or block diagram may represent a module, segment, or portion of code containing one or more executable instructions for implementing a specified logical function. It should also be noted that in some alternative implementations, the functions indicated in the blocks may occur in a different order than those indicated in the drawings. For example, two consecutively indicated blocks may actually be executed substantially in parallel, and they may sometimes be executed in reverse order, depending on the functions involved. It is particularly important to note that each block in the block diagrams and / or flowcharts, and combinations of blocks in the block diagrams and / or flowcharts, can be implemented using a dedicated hardware-based system that performs the specified function or operation, or using a combination of dedicated hardware and computer instructions.

[0299] The foregoing has provided a detailed description of a body fluid detection module, its preparation method, its detection device, and its detection method as disclosed in the embodiments of the present invention. Specific examples have been used to illustrate the principles and implementation methods of the present invention. The descriptions of the embodiments above are only for the purpose of helping to understand the method and core ideas of the present invention. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the ideas of the present invention. Therefore, the content of this specification should not be construed as a limitation of the present invention. Any modifications, equivalent substitutions, and improvements made within the principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A body fluid detection module, characterized by: The electrode includes four electrodes, two of which are excitation electrodes, namely a first excitation electrode and a second excitation electrode, and the other two are sensing electrodes, namely a first sensing electrode and a second sensing electrode; the second excitation electrode is arranged around the first excitation electrode, and the first sensing electrode and the second sensing electrode are arranged around the first excitation electrode within the range enclosed by the second excitation electrode. Each of the excitation electrodes or the sensing electrodes includes at least one electrode block, and the electrode block includes at least one contact surface in contact with the body fluid to be detected, and the contact surface is in the form of a separate point; when the body fluid to be detected is in contact with the first excitation electrode, the second excitation electrode, the first sensing electrode, and the second sensing electrode, an electric current loop is formed between the first excitation electrode and the body fluid to be detected, and the first sensing electrode and the second sensing electrode correspondingly output a body fluid detection signal of the body fluid to be detected, wherein the body fluid detection signal includes an electric current signal and / or a voltage signal corresponding to a pressure drop. The substrate is provided with a lower recess, and the electrode is accommodated in the lower recess.

2. The body fluid detection module according to claim 1, wherein: The contact surface in the form of a separate point includes any one of a discrete central symmetric distribution, a staggered lattice distribution, a displayed lattice distribution, and a non-uniform lattice distribution.

3. The body fluid detection module of claim 1, wherein: The area of the individual contact faces is 0.01 mm 2 - 10 mm 2 ; and / or the distance between the edges of the contact faces of adjacently arranged electrode blocks is less than 2 mm.

4. The body fluid detection module of claim 1, wherein: The shape of the contact surface of the electrode block includes any one of a circle, a regular polygon, and an irregular polygon; and / or the body fluid to be detected includes any one of sweat, urine, saliva, and tears.

5. The body fluid detection module of claim 1, wherein: The electrode further includes an electrical connector for electrical connection with an external circuit, and the electrical connector is arranged at an end of the electrode block away from the contact surface; and / or the substrate includes any one of a ceramic and an insulating polymer.

6. The body fluid detection module of claim 1, wherein: The ratio of the total area of the contact surfaces corresponding to the two excitation electrodes to the total area of the contact surfaces corresponding to the two sensing electrodes is 1:(0.1-10).

7. A method of detecting a body fluid, characterized by: The steps include: providing an electrode and a substrate accommodating the electrode, the electrode including four electrodes, two of which are excitation electrodes, namely a first excitation electrode and a second excitation electrode, and the other two are sensing electrodes, namely a first sensing electrode and a second sensing electrode; the second excitation electrode is arranged around the first excitation electrode, and the first sensing electrode and the second sensing electrode are arranged around the first excitation electrode within the range enclosed by the second excitation electrode; Each of the excitation electrodes or the sensing electrodes includes at least one electrode block, and the electrode block includes at least one contact surface in contact with the body fluid to be detected, and the contact surface is in the form of a separate point; the contact surface of the first excitation electrode, the second excitation electrode, the first sensing electrode, and the second sensing electrode is contacted with the body fluid to be detected, so that an electric current loop is formed between the first excitation electrode and the body fluid to be detected; and the first sensing electrode and the second sensing electrode correspondingly output a detection signal of the body fluid to be detected; wherein the detection signal includes an electric current signal and / or a voltage signal corresponding to a pressure drop. The substrate is provided with a lower recess, and the electrode is accommodated in the lower recess.

8. A bodily fluid detection device characterized by: The application also provides a body fluid detection system comprising the body fluid detection module as claimed in any one of claims 1-6 and a processing module, wherein the processing module receives the body fluid detection signal output by the body fluid detection module and processes the signal to analyze the ion concentration of the body fluid to be detected, and wherein the detection signal comprises a current signal and / or a voltage signal corresponding to a pressure drop.

Images