Probe, detection apparatus, and terminal device

Abstract

The present application relates to the field of monitoring instruments, and in particular, to a probe, a detection apparatus, and a terminal device. The present application is intended to solve the problem of large errors in in vivo monitoring results of probes. The specific solution is as follows: The probe comprises a probe body and a detection module. The probe body is provided with an accommodating groove, and the detection module is located in the accommodating groove. The detection module comprises a sensing portion. During the process that the probe body punctures the skin, the friction between the detection module accommodated in the accommodating groove and the skin is small, so that the detection module can be prevented from being separated from the probe body, thereby preventing the displacement of the detection module in the body from affecting the position of the sensing portion and facilitating the improvement in the accuracy. The probe tip performs a puncture function, and the sensing portion does not participate in the puncture process, thereby preventing friction and shear from affecting the sensing portion. The integrity of the sensing portion after entering the body is improved, thereby improving the durability and signal reliability of the probe.

Description

A probe, detection device and terminal equipment

[0001] This application claims priority to Chinese Patent Application No. 202410927389.8, filed on July 10, 2024, entitled "A Probe, Detection Device and Terminal Equipment", the entire contents of which are incorporated herein by reference. Technical Field

[0002] This application relates to the field of monitoring devices, and more particularly to a probe, detection device, and terminal equipment. Background Technology

[0003] Monitoring in vivo physiological indicators using probes has the advantages of small incisions, less bleeding, and less pain. The probe has a working electrode-counter electrode-reference electrode system or a working electrode-reference electrode system. The working electrode is modified with a sensing layer material corresponding to the analyte.

[0004] For example, the principle of in vivo probe monitoring is as follows: using a reference electrode as a reference, a constant voltage is applied to the working electrode; the analyte generates a current signal on the working electrode, and the current signal is monitored.

[0005] Currently, probes have the problem of large errors in in vivo monitoring results. Summary of the Invention

[0006] This application provides a probe, a detection device, and a terminal device. The aim is to improve the problem of large errors in in vivo probe monitoring results.

[0007] To achieve the above objectives, this application adopts the following technical solution.

[0008] In a first aspect, embodiments of this application provide a probe. The probe includes a needle body and a detection module. The needle body includes a receiving groove, a piercing portion, and a base, with the piercing portion and the base connected. The receiving groove extends from the piercing portion to the base. The detection module includes a first electrical connector, a first sensing portion, a first insulating layer, a first conductive layer, and a second insulating layer. The first conductive layer is located between the first insulating layer and the second insulating layer. The first insulating layer, the first conductive layer, and the second insulating layer are all located within the receiving groove, with the first insulating layer being closer to the bottom wall of the receiving groove than the second insulating layer. The first electrical connector penetrates the second insulating layer and is electrically connected to the first conductive layer, with its vertical projection on the needle body at least partially located on the base. The first sensing portion penetrates the second insulating layer and is connected to the first conductive layer, with its vertical projection on the needle body located at the piercing portion.

[0009] Because the first insulating layer, the first conductive layer, and the second insulating layer are all located within the receiving groove, and the first electrical connector and the first sensing element both penetrate the second insulating layer and are connected to the first conductive layer, at least a portion of the first electrical connector and at least a portion of the first sensing element are also located within the receiving groove. During the needle piercing the skin, the friction between the detection module contained within the receiving groove and the skin is small, which can prevent the detection module from separating from the needle and prevent the detection module from displacing within the body. Since the displacement of the detection module is small or almost non-existent, when the piercing part is inserted into the body, the displacement of the first sensing element is small or almost non-existent. The position of the first sensing element does not change, and the current received by the first sensing element can more accurately reflect the physiological indicators in the body fluid. This improves the detection accuracy of the probe.

[0010] In conjunction with the first aspect, in some feasible implementations, the puncture portion includes a needle tip and a probe segment, one end of which is connected to the needle tip and the other end to the base; the receiving groove extends from the base to the probe segment. Thus, if the receiving groove does not extend to the needle tip, the probe module connected to the receiving groove may also not extend to the needle tip. When the probe is used, the needle tip needs to pierce the skin and penetrate into the dermis. During the process of piercing the skin, the skin exerts a relatively large reaction force on the needle tip. Since the receiving groove does not extend to the needle tip, this large reaction force has a smaller impact on the probe module within the receiving groove, thus preventing cracking or peeling of the probe module. In other words, the needle tip performs the puncture function, and the probe module does not participate in the puncture process, avoiding the influence of friction and shear forces on the probe module, and improving the integrity, durability, and signal reliability of the probe module.

[0011] In conjunction with the first aspect, in some feasible embodiments, the needle body also includes barbs that are connected to the piercing portion. Thus, after the piercing portion penetrates the skin, the barbs can increase the bond between the needle body and the skin, creating a self-locking structure that prevents the needle from detaching.

[0012] In conjunction with the first aspect, in some feasible embodiments, the needle body includes two receiving slots and two detection modules, with one detection module connected to one of the receiving slots. Thus, a probe can have two detection modules, increasing the probe's integration and reducing its volume.

[0013] In conjunction with the first aspect, in some feasible embodiments, the detection module further includes: a second electrical connector, a second sensing element, a second conductive layer, and a third insulating layer. The second conductive layer is located between the third insulating layer and the second insulating layer; both the first electrical connector and the first sensing element penetrate the third insulating layer; the first electrical connector is electrically isolated from the second conductive layer. The second sensing element penetrates the third insulating layer and is connected to the second conductive layer; the vertical projection of the second sensing element on the needle body is located at the puncture site. The second electrical connector penetrates the third insulating layer and is electrically connected to the second conductive layer; the vertical projection of the second electrical connector on the needle body is at least partially located on the base. Thus, the detection module includes a first sensing element and a second sensing element, both of which can detect physiological indicators in body fluids. The probe has multiple sensing positions, which helps to further increase the accuracy of the probe. Furthermore, since the first electrical connector and the second conductive layer are electrically isolated, both the second sensing element and the second electrical connector are electrically connected to the second conductive layer. The first and second conductive layers are electrically isolated, which can prevent the current signals collected by the first and second sensing units from interfering with each other, thereby improving the accuracy of the probe.

[0014] In conjunction with the first aspect, in some feasible embodiments, the material of the first sensing unit includes a redox polymer and a sensing material. The sensing material includes glucose oxidase, lactate oxidase, uricase oxidase, or ethanol oxidase.

[0015] In conjunction with the first aspect, in some feasible embodiments, the probe further includes an insulating membrane covering the surface of the puncture site. Thus, when the puncture site is inserted into the skin, the insulating membrane can isolate the body fluid from the puncture site. Preventing the puncture site from reacting with the body fluid and affecting the current signal acquired by the first sensing element is beneficial for improving the accuracy of the probe. Particularly in embodiments where the needle body material includes a conductive material, the insulating membrane can prevent the conductive material within the puncture site from contacting the body fluid.

[0016] In conjunction with the first aspect, in some feasible embodiments, the detection module includes multiple of the first sensing units. This allows the probe to measure multiple locations within the bodily fluid, improving the probe's accuracy.

[0017] In conjunction with the first aspect, in some feasible ways, the first insulating layer and the needle body are connected as a single molded part.

[0018] Secondly, embodiments of this application provide a detection device. The detection device includes a printed circuit board and any of the probes provided in the first aspect, with the first electrical connector electrically connected to the printed circuit board. Thus, the detection device has the advantage of high measurement accuracy.

[0019] In conjunction with the second aspect, in some feasible embodiments, the detection device further includes a reference electrode needle and a counter electrode needle; both the reference electrode needle and the counter electrode needle are electrically connected to the printed circuit board.

[0020] In conjunction with the second aspect, in some feasible implementations, the detection device further includes a monitoring needle comprising a needle portion and a monitoring electrode connected to the needle portion and electrically connected to the printed circuit board. Along the length of the probe, the distance from the monitoring electrode to the free end of the needle body is greater than or equal to the distance from the first sensing element to the free end of the needle body. Thus, the presence of the first sensing element can be determined by the signal monitored by the monitoring electrode. The monitoring electrode can provide anomaly alerts, provide in-vivo calibration data for the detection device, and improve the reliability and accuracy of the detection device's signals.

[0021] In conjunction with the second aspect, in some feasible methods, the distance from the free end of the needle to the base along the length of the probe is greater than or equal to the distance from the free end of the needle body to the base. Thus, when both the probe and the monitoring needle are inserted into the skin, the free end of the needle further from the base penetrates the skin more deeply than the free end of the needle body further from the base, making it less prone to dislodgement. The needle serves to secure the detection device within the body, preventing it from dislodging.

[0022] Thirdly, embodiments of this application provide a reference electrode needle. The reference electrode needle includes a needle body and a detection module.

[0023] The needle body includes a receiving groove, a piercing portion, and a base, with the piercing portion and the base connected. The receiving groove extends from the piercing portion to the base. The detection module includes a first electrical connector, a reference electrode portion, a first insulating layer, a first conductive layer, and a second insulating layer. The first conductive layer is located between the first insulating layer and the second insulating layer, and all three layers are located within the receiving groove, with the first insulating layer being closer to the receiving groove than the second insulating layer. The first electrical connector penetrates the second insulating layer and is electrically connected to the first conductive layer, with its vertical projection on the needle body located on the base. The reference electrode portion penetrates the second insulating layer and is electrically connected to the first conductive layer, with its vertical projection on the needle body located on the piercing portion.

[0024] Fourthly, embodiments of this application provide a counter electrode needle. The counter electrode needle includes a needle body and a detection module. The needle body includes a receiving groove, a piercing portion, and a base, the piercing portion and the base being connected; the receiving groove extends from the piercing portion to the base. The detection module includes a first electrical connector, a first insulating layer, a first conductive layer, and a second insulating layer. The first conductive layer is located between the first insulating layer and the second insulating layer, and the first insulating layer, the first conductive layer, and the second insulating layer are all located within the receiving groove, with the first insulating layer being closer to the receiving groove than the second insulating layer. The first electrical connector penetrates the second insulating layer and is electrically connected to the first conductive layer; the vertical projection of the first electrical connector on the needle body is located on the base. The second insulating layer has a through hole that penetrates the second insulating layer; the vertical projection of the through hole on the needle body is located on the piercing portion.

[0025] Regarding the beneficial effects of any of the implementation methods in the second, third, or fourth aspects, please refer to the description of any optional implementation method in the first aspect, which will not be repeated here. Based on the implementation methods provided in the above aspects, this application can also make further combinations to provide more implementation methods. Attached Figure Description

[0026] Figure 1a is a schematic diagram of the structure of a terminal device in a wearable state.

[0027] Figure 1b is a schematic diagram of the structure of a terminal device.

[0028] Figure 2a is a schematic diagram of the structure of a detection device provided in an embodiment of this application.

[0029] Figure 2b is a schematic diagram of the structure of multiple probes provided in the embodiments of this application.

[0030] Figure 3 is a cross-sectional schematic diagram of section AA in Figure 2b.

[0031] Figure 4 is a schematic diagram of the structure of the probe after it is inserted into the skin according to an embodiment of this application.

[0032] Figure 5 is a schematic diagram of the structure of the second insulating layer provided in the embodiment of this application.

[0033] Figure 6 is a cross-sectional schematic diagram of another probe provided in an embodiment of this application.

[0034] Figure 7a is a schematic diagram of the structure of a needle body provided in an embodiment of this application.

[0035] Figure 7b is a schematic diagram of another needle body provided in an embodiment of this application.

[0036] Figure 8a is a process flow diagram of probe preparation provided in an embodiment of this application.

[0037] Figure 8b is a schematic diagram of the structure after S1 in Figure 8a is executed.

[0038] Figure 8c is a schematic diagram of the structure after S2 in Figure 8a is executed.

[0039] Figure 8d is a schematic diagram of the structure after S3 in Figure 8a is executed.

[0040] Figure 8e is a schematic diagram of the structure after S4 in Figure 8a is executed.

[0041] Figure 8f is a schematic diagram of the structure after S5 in Figure 8a is executed.

[0042] Figure 9 is a schematic diagram of the structure of another probe provided in an embodiment of this application.

[0043] Figure 10 is a schematic diagram of the internal structure of the counter electrode needle provided in an embodiment of this application.

[0044] Figure 11 is a schematic diagram of the internal structure of the reference electrode needle provided in the embodiment of this application.

[0045] Figure 12 is a schematic diagram of another detection device provided in an embodiment of this application.

[0046] Figure 13 is a schematic diagram of the probe and monitoring needle provided in the embodiments of this application.

[0047] In the diagram: 10-Detection device; 20-Printed circuit board; 30-Reference electrode needle; 40-Counter electrode needle; 50-Monitoring needle; 51-Needle section; 52-Monitoring electrode; 60-Cover; 100-Probe; 110-Needle body; 111-Base; 112-Piercing section; 1121-Needle tip; 1122-Detection section; 113-Barb; 120-Detection module; 121-First sensing unit; 122-First insulating layer; 123-First conductive layer; 124-Second insulating layer; 125-First electrical connection Components; 126-Second electrical connector; 127-Second sensing part; 128-Second conductive layer; 129-Third insulating layer; 101-Receiving groove; 102-Biocompatibility layer; 201-Prefabricated part; 301-First isolation part; 302-Second isolation part; 1241-First mounting hole; 1242-Second mounting hole; 1123-First segment; 1124-Second segment; 200-Terminal device; 212-Display screen; 213-Frame; 214-Back cover; 215-Watch strap; 11-Wearing part. Detailed Implementation

[0048] This application provides a probe and a detection device. The probe includes a needle body and a detection module. The needle body includes a receiving groove, and at least a portion of the detection module is located within the receiving groove. Thus, during the process of the probe piercing the skin, the detection module located within the receiving groove is less likely to detach from the receiving groove, preventing separation of the needle body and the detection module from affecting the measurement accuracy of the probe. Furthermore, the detection module is firmly attached to the needle body, reducing displacement of the detection module within the body. This prevents the sensing layer within the probe from detaching from bodily fluids (e.g., entering the epidermal layer), increasing detection accuracy.

[0049] To make the objectives, technical solutions, and advantages of this application clearer, the application will now be described in further detail with reference to the accompanying drawings.

[0050] In the following description, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this application, unless otherwise stated, "a plurality of" means two or more.

[0051] Furthermore, in the embodiments of this application, directional terms such as "upper" and "lower" are defined relative to the orientation in which the components are schematically placed in the accompanying drawings. It should be understood that these directional terms are relative concepts, used for relative description and clarification, and can change accordingly depending on the orientation in which the components are placed in the accompanying drawings.

[0052] Figure 1a is a schematic diagram of the structure of a terminal device 200 in a worn state. Exemplarily, the terminal device 200 can be a wearable device, a portable device that is worn directly on the user's body or integrated into the user's clothing or accessories. Wearable devices can include, but are not limited to, watches, bracelets, smart wristbands, smart glasses, necklaces, headbands, rings, or helmets, etc. In some embodiments, the terminal device 200 can also be a handheld device, etc.

[0053] Figure 1a illustrates the use of a wristband as an example for the terminal device 200. In Figure 1a, the terminal device 200 is worn on the user's wearing part 211. This embodiment does not limit the user's wearing part 11; for example, the user's wearing part 11 can be the arm, shoulder, or head, etc.

[0054] For example, the terminal device 200 includes a main body and a detection device 10. The detection device 10 is used to detect physiological indicators.

[0055] Figure 1b is a schematic diagram of a terminal device 200. Referring to Figure 1b, the terminal device 200 may include: a display screen 212, a bezel 213, a back cover 214, and a strap 215. The display screen 212, bezel 213, back cover 214, and strap 215 can also be referred to as the main body. The display screen 212 may be disposed within the bezel 213, which surrounds and secures the display screen 212. The display surface of the display screen 212 is located on the side opposite to the back cover 214. The back cover 214, also called the rear cover, is located on the side of the bezel 213 opposite to the display screen 212. The bezel 213 is circumferentially connected between the display screen 212 and the back cover 214. The detection device 10 is connected to the strap 215 or the back cover 214.

[0056] The material of the frame 213 may include conductive portions, which may be made of conductive materials, such as metallic materials. In some embodiments, the frame 213 may consist entirely of conductive portions, for example, forming the appearance of a metallic frame, suitable for industrial design (ID). In other embodiments, the conductive portions are located on the outer surface of the frame 213, thereby forming the appearance of a metallic frame. In still other embodiments, the conductive portions are located on the inner surface of the frame 213. In these implementations, the conductive portions of the frame 213 can be used as antenna radiators of the terminal device 200. It is understood that the conductive portions disposed on the inner surface of the frame 213 are disposed in conjunction with the non-conductive material of the frame 213 to facilitate antenna radiation; both the conductive and non-conductive materials should be considered as part of the frame 213.

[0057] The aforementioned display screen 212 can be a liquid crystal display (LCD), an organic light emitting diode (OLED) display screen, or a micro (or mini) light emitting diode (LED) display screen.

[0058] This application does not limit the shape of the display screen 212. For example, the display screen 212 can be circular or rectangular. This application also does not limit the shape of the border 213; it can be circular, square, polygonal, or any other regular or irregular shape. For the sake of brevity, the following embodiments will use a circular border 213 as an example.

[0059] For example, the chip of the terminal device 200 can be connected to a sensor to convert the signal detected by the sensor into a corresponding health indicator. The chip may include one or more processing units, such as an application processor (AP), a modem processor, a memory, a digital signal processor (DSP), a baseband processor, and / or a neural network processing unit (NPU).

[0060] Figure 2a is a schematic diagram of a detection device 10 provided in an embodiment of this application. Referring to Figure 2a, the detection device 10 includes a printed circuit board (PCB) 20 and a probe 100. The PCB 20 and the probe 100 are electrically connected. The probe 100 is provided with a first sensing element. When data is detected using the detection device 10, the first sensing element of the probe 100 extends into the dermis and reacts with body fluids to collect a current signal that can indicate physiological indicators of the body fluids, and transmits this current signal to the PCB 20. An effective signal path is formed between the probe 100 and the PCB 20.

[0061] It is understood that the printed circuit board 20 can share a single printed circuit board with the aforementioned display screen 212, etc. Alternatively, the printed circuit board 20 of the detection device 10 and the printed circuit board 20 of the aforementioned display screen 212 can be set independently.

[0062] For example, the printed circuit board 20 may be made of flame-retardant material (FR-4) dielectric substrate, Rogers dielectric substrate, or a hybrid dielectric substrate of Rogers and FR-4, etc. Here, FR-4 is a designation for a flame-retardant material grade, and Rogers dielectric substrate is a high-frequency board. Electronic components, such as radio frequency chips, are carried on the printed circuit board 20.

[0063] In some embodiments, probe 100 may also be referred to as a working electrode probe or an indicator electrode probe.

[0064] This application does not limit the type of body fluid. For example, body fluid can be interstitial fluid. Interstitial fluid is formed by the filtration of plasma through capillary walls, and its components are essentially the same as plasma, except that it does not contain large protein molecules. Physiological indicators of body fluids include, but are not limited to, physiological parameters that can be detected by enzyme electrodes, such as glucose, ketone bodies, lactic acid, uric acid, and alcohol.

[0065] In some embodiments, the detection device 10 may further include a reference electrode needle 30 and a counter electrode needle 40. Both the reference electrode needle 30 and the counter electrode needle 40 are electrically connected to the printed circuit board 20. The three-electrode system includes a working electrode, a counter electrode, and a reference electrode. The probe 100 provides the working electrode, the reference electrode needle 30 provides the reference electrode, and the counter electrode needle 40 provides the counter electrode.

[0066] The reference electrode needle 30 provides a reference potential for the probe 100. The counter electrode needle 40 provides a counter electrode, also known as a reverse electrode. The counter electrode needle 40 and the probe 100 form a circuit to allow current to pass through.

[0067] In some embodiments of this application, the detection device 10 includes a plurality of probes 100, a plurality of reference electrode needles 30, and a plurality of counter electrode needles 40. In FIG. 2a, the plurality of probes 100 are arranged in an array, which can be regarded as a probe array. Similarly, the plurality of reference electrode needles 30 are arranged in an array, which can be regarded as a reference electrode needle array. The plurality of counter electrode needles 40 are arranged in an array, which can be regarded as a counter electrode needle array.

[0068] For example, the number of probes 100 can be one, two, three, four, five, six, or more. The number of reference electrode needles 30 can be one, two, three, four, five, six, or more. The number of counter electrode needles 40 can be one, two, three, four, five, six, or more. Furthermore, the embodiments of this application do not limit the relationship between the number of probes 100, the number of reference electrode needles 30, and the number of counter electrode needles 40; the numbers of these three can be set independently.

[0069] The detection device 10 provided in this application embodiment can be used independently, for example, as a patch. It is not limited to being installed on a terminal device.

[0070] Figure 2b is a schematic diagram of the structure of multiple probes 100 provided in an embodiment of this application. Referring to Figure 2b, the probe 100 includes a needle body 110 and a detection module 120. The needle body 110 includes a receiving groove 101 (as shown in Figure 3), a base 111, and a piercing portion 112. The base 111 and the piercing portion 112 are connected, and the receiving groove 101 extends from the piercing portion 112 to the base 111. The detection module 120 is connected to the receiving groove 101.

[0071] Figure 3 is a cross-sectional view of section AA in Figure 2b. Referring to Figure 3, the detection module 120 includes a first sensing unit 121, a first insulating layer 122, a first conductive layer 123, a second insulating layer 124, and a first electrical connector 125. The first insulating layer 122, the first conductive layer 123, and the second insulating layer 124 are all located within the receiving groove 101. The first insulating layer 122 is closer to the bottom wall of the receiving groove 101 than the second insulating layer 124. The first insulating layer 122, the first conductive layer 123, and the second insulating layer 124 are stacked sequentially. In other words, the first conductive layer 123 is located between the first insulating layer 122 and the second insulating layer 124.

[0072] A first electrical connector 125 penetrates the second insulating layer 124 and is electrically connected to the first conductive layer 123. The vertical projection of the first electrical connector 125 onto the needle body 110 is at least partially located on the base 111. In other words, the first electrical connector 125 is stacked on the base 111. A first sensing portion 121 penetrates the second insulating layer 124 and is connected to the first conductive layer 123. The vertical projection of the first sensing portion 121 onto the needle body 110 is located on the puncture portion 112. In other words, the first sensing portion 121 is stacked on the puncture portion 112.

[0073] Because the first insulating layer 122, the first conductive layer 123, and the second insulating layer 124 are all located within the receiving groove 101, and the first electrical connector 125 and the first sensing part 121 both penetrate the second insulating layer 124 and are connected to the first conductive layer 123, at least a portion of the first electrical connector 125 and at least a portion of the first sensing part 121 are also located within the receiving groove 101. During the process of the needle body 110 piercing the skin, the friction between the detection module 120, which is contained within the receiving groove 101, and the skin is relatively small, it can prevent the detection module 120 from separating from the needle body 110 and prevent the detection module 120 from displacing within the body. Since the displacement of the detection module 120 is small or almost negligible, when the piercing part 112 is inserted into the body, the displacement of the first sensing part 121 is small or almost negligible. The position of the first sensing part 121 does not change, and the current received by the first sensing part 121 can more accurately reflect the physiological indicators in the body fluid, thereby improving the detection accuracy of the probe 100.

[0074] Furthermore, the first conductive layer 123 is located between the first insulating layer 122 and the second insulating layer 124, and is situated within the receiving groove 101. Therefore, during the puncture process of the probe 100, the friction between the probe 100 and the skin has a smaller impact on the first conductive layer 123, making it less prone to cracking. Preventing current drift or loss within the cracked first conductive layer 123 helps improve the accuracy of the probe 100.

[0075] The aforementioned "vertical projection of the first electrical connector 125 on the needle body 110" refers to the projection of the first electrical connector 125 onto the needle body 110 along a direction perpendicular to the surface of the needle body 110. The other descriptions of "vertical projection" in this document are similar.

[0076] The aforementioned "the vertical projection of the first electrical connector 125 on the needle body 110 is at least partially located on the base 111" includes: the entire vertical projection of the first electrical connector 125 on the needle body 110 is located on the base 111, for example, the length of the first electrical connector 125 is relatively small. The end of the first electrical connector 125 away from the first conductive layer 123 does not extend beyond the needle body 110. Alternatively, the vertical projection of the first electrical connector 125 on the needle body 110 is partially located on the base 111, for example, the length of the first electrical connector 125 is relatively long. The end of the first electrical connector 125 away from the first conductive layer 123 extends beyond the needle body 110.

[0077] In some embodiments of this application, the first sensing part 121 and the second insulating layer 124 are both located within the receiving groove 101. In other words, the height of both the first sensing part 121 and the second insulating layer 124 is lower than the opening of the receiving groove 101.

[0078] This application does not limit the size of the receiving groove 101. Exemplarily, the depth of the receiving groove 101 can be from 5 μm (micrometers) to 60 μm, for example, 5 μm, 6 μm, 8 μm, 10 μm, 15 μm, 20 μm, 25 μm, 30 μm, 35 μm, 40 μm, 50 μm, or 60 μm. The width of the receiving groove 101 can be from 120 μm to 230 μm, for example, 120 μm, 130 μm, 140 μm, 150 μm, 180 μm, 200 μm, 220 μm, or 230 μm.

[0079] Referring to the description of the electrical connection between probe 100 and printed circuit board 20 in Figure 2a above, in embodiments of this application, the first electrical connector 125 and the printed circuit board 20 are electrically connected. In some embodiments, the first electrical connector 125 and the printed circuit board 20 are directly electrically connected, thus the length of the first electrical connector 125 is relatively long. A portion of the vertical projection of the first electrical connector 125 onto the needle body 110 may be located outside the base 111. In some embodiments, the first electrical connector 125 and the printed circuit board 20 are electrically connected via other conductor structures such as wires. Thus, the length of the first electrical connector 125 is short. The entire vertical projection of the first electrical connector 125 onto the needle body 110 can be located within the base 111.

[0080] In some embodiments of this application, the probe 100 may further include a biocompatibility layer 102. The biocompatibility layer 102 covers the first sensing portion 121. The biocompatibility layer 102 has an in vivo anti-protein adsorption function, preventing an in vivo immune response after the first sensing portion 121 penetrates the skin. It improves the accumulation or contamination of substances in body fluids after the first sensing portion 121 penetrates the skin. It prevents fibers and proteins in the body from encapsulating or adhering near the first sensing portion 121, thus avoiding interference with the sensitivity and stability of the first sensing portion 121. Furthermore, the biocompatibility layer 102 does not affect the detection results during the probe 100's detection of physiological indicators in body fluids.

[0081] In some embodiments of this application, the biocompatibility layer 102 may cover the outer surface of the puncture portion 112, and the biocompatibility layer 102 may also cover the portion of the second insulating layer 124 located in the puncture portion 112. In other words, the biocompatibility layer 102 covers the entire surface of the probe 100 inserted into the skin. Thus, during the formation of the biocompatibility layer 102, the biocompatibility layer 102 does not need to avoid the second insulating layer 124 and the puncture portion 112. The manufacturing process of the biocompatibility layer 102 is simpler.

[0082] In some embodiments of this application, as shown in FIG3, the biocompatibility layer 102 can cover the entire outer surface of the probe 100. Similarly, during the formation of the biocompatibility layer 102, the biocompatibility layer 102 can cover the outer surface of the probe 100 indiscriminately, reducing the precision requirements of the biocompatibility layer 102 process and reducing the process difficulty.

[0083] Figure 4 is a schematic diagram of the structure of the probe 100 provided in this embodiment after it is inserted into the skin. Referring to Figure 4, when the probe 100 is used, the piercing part 112 is inserted into the skin, and the first sensing part 121 is located inside the skin. As can be seen in Figure 4, the first sensing part 121 is inserted into the dermis and is in contact with the body fluid in the dermis.

[0084] In embodiments of this application, the probe 100 may further include a confinement layer. The confinement layer is located inside the biocompatibility layer 102. Similarly, the confinement layer covers the first sensing portion 121. In some embodiments, the confinement layer covers the outer surface of the puncture portion 112. Further, in some embodiments, the confinement layer covers the entire outer surface of the probe 100.

[0085] The confinement layer can limit the concentration of the analyte diffused from the body fluid to the first sensing element. Exemplarily, the material of the confinement layer includes polyurethane (PU). Referring back to Figure 3, the material of the needle body 110 is not limited in this embodiment. In some embodiments, the needle body 110 includes a conductive material. Conductive materials may include, for example, at least one selected from stainless steel, copper and its alloys, aluminum and its alloys, and titanium and its alloys. In some embodiments, the needle body 110 includes an insulating material. Insulating materials may include, for example, silicon, silica, plastic, or insulating rubber.

[0086] In some embodiments of this application, the probe 100 may further include an insulating film covering the surface of the puncture portion 112. When the puncture portion 112 is inserted into the skin, the insulating film isolates the body fluid from the puncture portion 112. Preventing the puncture portion 112 from reacting with the body fluid and affecting the current signal collected by the first sensing unit 121 is beneficial for improving the accuracy of the probe 100. Especially in embodiments where the needle body 110 is made of a conductive material, the insulating film can prevent the conductive material within the puncture portion 112 from contacting the body fluid.

[0087] In some embodiments of this application, the insulating film may also cover the base 111. In other words, the insulating film covers the entire surface of the needle body 110. Thus, the material of the needle body 110 has less influence on bodily fluids, which is beneficial for improving the accuracy of the probe 100's detection results.

[0088] In some embodiments of this application, the insulating film can be integrally formed with the first insulating layer 122. The portion of the insulating film located within the receiving groove 101 can be considered as the first insulating layer 122.

[0089] In some embodiments of this application, the insulating film and the needle body 110 are integrally formed. For example, in embodiments where the needle body 110 is made of an insulating material, the surface layer of the needle body 110 can be considered as an insulating film. Alternatively, the probe 100 can be considered to not include an insulating film.

[0090] It is understood that in embodiments where the needle body 110 is made of a conductive material (e.g., stainless steel), the probe 100 may also be without an insulating film.

[0091] The materials used for the first conductive layer 123 are not limited in this application embodiment. Exemplarily, the materials for the first conductive layer 123 include: platinum or platinum nanoparticles, gold or gold nanoparticles, graphite, carbon powder, carbon nanotubes, graphene, etc. The first conductive layer 123 can be formed, for example, by coating a conductive layer, screen printing, curing a conductive paste, or depositing a conductive layer.

[0092] The shape of the first electrical connector 125 is not limited in this application embodiment. Exemplarily, the first electrical connector 125 can be a strip, wire, or rod-shaped structure. Exemplarily, the first electrical connector 125 and the first conductive layer 123 can be connected, for example, by conductive adhesive, solder, etc.

[0093] This application does not limit the materials of the first insulating layer 122 and the second insulating layer 124. Exemplarily, the materials of the first insulating layer 122 and the second insulating layer 124 may include insulating metal oxides, such as aluminum oxide or titanium dioxide. Alternatively, the materials of the first insulating layer 122 and the second insulating layer 124 may include a poly-para-xylene polymer, for example, by using chemical vapor deposition to deposit poly-para-xylene within the receiving tank 101 to form the first insulating layer 122.

[0094] In embodiments where the needle body 110 includes insulating material, the material of the first insulating layer 122 and the material of the needle body 110 can be the same. Exemplarily, the first insulating layer 122 and the needle body 110 can be joined as a single molded part. Thus, the first insulating layer 122 and the needle body 110 can be formed in the same process, saving manufacturing steps.

[0095] It is understood that in embodiments where the needle body 110 includes insulating material, the materials of the first insulating layer 122 and the needle body 110 may be different. For example, the first insulating layer 122 may be formed in the receiving groove 101 by deposition, screen printing, or coating. Similarly, the second insulating layer 124 may be formed by deposition, screen printing, or coating, for example.

[0096] The materials used in this embodiment of the application are not limited. The settings are based on physiological indicators detected by the probe 100 in the body fluid. Exemplarily, the materials of the first sensing unit 121 include a redox polymer and a sensing material. The sensing material includes glucose oxidase, lactate oxidase, uricase oxidase, or ethanol oxidase. The redox polymer may include, for example, Prussian blue, ferrocene and its derivatives, or rhodium, osmium, and ruthenium complex molecules with polyvinylpyrrolidone, polyvinylimidazolium, or polyetherimide as the main chain.

[0097] This application does not limit the connection method between the first sensing part 121 and the first conductive layer 123. For example, the first sensing part 121 and the first conductive layer 123 can be connected by an adhesive layer. Alternatively, the first sensing part 121 can be cured on the surface of the first conductive layer 123 in the form of a paste. Alternatively, the first sensing part 121 can be formed using an inkjet printing process.

[0098] The dimensions of the first sensing unit 121 are not limited in this embodiment. For example, the length of the first sensing unit 121 can be 130μm to 300μm, such as 130μm, 150μm, 160μm, 180μm, 190μm, 200μm, 220μm, 250μm, 280μm, or 300μm. The width of the first sensing unit 121 is greater than or equal to 120μm, such as 120μm to 260μm, such as 120μm, 130μm, 150μm, 160μm, 180μm, 190μm, 200μm, 220μm, 250μm, or 260μm.

[0099] In the embodiments of this application, both the first electrical connector 125 and the first sensing part 121 penetrate the second insulating layer 124 and are connected to the first conductive layer 123.

[0100] Figure 5 is a schematic diagram of the structure of the second insulating layer 124 provided in an embodiment of this application. Referring to Figure 5, the second insulating layer 124 has a first mounting hole 1241 and a second mounting hole 1242, both of which penetrate the second insulating layer 124. The first mounting hole 1241 is located on the base 111 (as shown in Figure 3). The second mounting hole 1242 is located on the piercing portion 112 (as shown in Figure 3). The first mounting hole 1241 allows the first electrical connector 125 to pass through. The second mounting hole 1242 allows the first sensing portion 121 to pass through.

[0101] The first mounting hole 1241 can be located at the edge or center of the second insulating layer 124. For example, in Figure 5, the first mounting hole 1241 is located in the center of the second insulating layer 124, and its outer periphery is completely surrounded by the second insulating layer 124; therefore, the first mounting hole 1241 can be considered a closed hole. In some embodiments, the first mounting hole 1241 can be located at the edge of the second insulating layer 124, in which case the second insulating layer 124 does not completely surround the outer periphery of the first mounting hole 1241, and the first mounting hole 1241 has a notch. Similarly, the positional relationship of the second mounting hole 1242 is the same.

[0102] The shape of the first mounting hole 1241 is not limited in this embodiment. For example, the first mounting hole 1241 can be a circular hole, a strip hole, an elliptical hole, a square hole, or an irregularly shaped hole. The shape of the second mounting hole 1242 is similar and will not be described again here.

[0103] In some embodiments of this application, the first sensing part 121 (as shown in FIG3) also covers the entire second mounting hole 1242. This prevents bodily fluids from seeping from the second mounting hole 1242 into the space between the first conductive layer 123 (as shown in FIG3) and the second insulating layer 124, thus avoiding interference with the current on the first conductive layer 123 and further improving the accuracy of the probe. In some embodiments, the first sensing part 121 may also cover a portion of the second mounting hole 1242.

[0104] Similarly, in some embodiments, the first electrical connector 125 (as shown in FIG3) covers the entire first mounting hole 1241. In some embodiments, the first electrical connector 125 covers a portion of the first mounting hole 1241.

[0105] Please refer back to Figure 3. In this embodiment, the number of first sensing units 121 is not limited. In Figure 3, there is one first sensing unit 121. In some embodiments, the number of first sensing units 121 can be two, three, four, or more. Thus, the probe 100 measures multiple locations in the body fluid, improving the accuracy of the probe.

[0106] In embodiments where there are multiple first sensing units 121, the sensing materials in the multiple first sensing units 121 may be the same or different.

[0107] In some embodiments of this application, the detection module may further include a second sensing unit.

[0108] Figure 6 is a cross-sectional schematic diagram of another probe 100 provided in an embodiment of this application. The difference between Figure 6 and Figure 3 includes that the structure of the probe module 120 is different.

[0109] In Figure 6, the detection module 120 further includes: a second electrical connector 126, a second sensing unit 127, a second conductive layer 128, and a third insulating layer 129. The second insulating layer 124, the second conductive layer 128, and the third insulating layer 129 are stacked sequentially. The second conductive layer 128 is located between the second insulating layer 124 and the third insulating layer 129. The first electrical connector 125 and the first sensing unit 121 both penetrate the third insulating layer 129. The first electrical connector 125 and the second conductive layer 128 are electrically isolated.

[0110] The second sensing element 127 penetrates the third insulating layer 129 and is electrically connected to the second conductive layer 128. The vertical projection of the second sensing element 127 on the needle body 110 is located at the puncture portion 112. The second electrical connector 126 penetrates the third insulating layer 129 and is electrically connected to the second conductive layer 128. The vertical projection of the second electrical connector 126 on the needle body 110 is at least partially located at the base 111.

[0111] Thus, the detection module 120 includes a first sensing unit 121 and a second sensing unit 127, both of which can detect physiological indicators in body fluids. The probe 100 has multiple sensing positions, which helps to further increase the probe's accuracy. Furthermore, since the first electrical connector 125 and the second conductive layer 128 are electrically isolated, and both the second sensing unit 127 and the second electrical connector 126 are electrically connected to the second conductive layer 128, the first conductive layer 123 and the second conductive layer 128 are electrically isolated, which can prevent mutual interference between the current signals collected by the first sensing unit 121 and the second sensing unit 127, thereby improving the accuracy of the probe 100.

[0112] In some embodiments, the second sensing unit 127 and the first sensing unit 121 may be made of different materials to monitor different physiological indicators. A single probe 100 can monitor multiple physiological indicators.

[0113] The materials, quantity, and connection relationship between the second sensing unit 127 and the second conductive layer 128 are described in the previous description of the first sensing unit 121. Similarly, the materials and processes of the second conductive layer 128 are described in the previous description of the first conductive layer 123. The materials and processes of the third insulating layer 129 are described in the previous description of the second insulating layer 124. The materials, processes, and structures of the second electrical connector 126 are described in the previous description of the first electrical connector 125, and will not be repeated here.

[0114] Similarly, referring to the description of the electrical connection between probe 100 and printed circuit board 20 in Figure 2a above, in an embodiment where the probe module 120 includes a second electrical connector 126, the second electrical connector 126 is electrically connected to the printed circuit board 20. The connection method between the second electrical connector 126 and the printed circuit board 20 is described above in the description of the electrical connection between the first electrical connector 125 and the printed circuit board 20, and will not be repeated here.

[0115] For the biocompatibility layer and other structures in Figure 6, please refer to the description in Figure 3 above.

[0116] Figure 6 shows two conductive layers (first conductive layer 123 and second conductive layer 128) and two sensing elements (first sensing element 121 and second sensing element 127). In some embodiments of this application, the detection module 120 may further include more conductive layers and more sensing elements. An insulating layer is disposed between adjacent conductive layers. Each conductive layer may contain one sensing element and one electrical connector. And so on, which will not be elaborated further here.

[0117] As described above, the needle body 110 includes a connected piercing portion 112 and a base 111. In the embodiments of this application, the piercing portion 112 and the base 111 are connected as a single molded part.

[0118] For example, a thin sheet is cut to form a connected piercing portion 112 and a base 111. For instance, both the piercing portion 112 and the base 111 are sheet-like structures. The surfaces of the piercing portion 112 and the base 111 can be coplanar. The probe 100 can be considered as a two-dimensional structure. Processing the sheet-like structure can improve controllability, consistency, processing efficiency, and reduce processing costs.

[0119] Wherein, the receiving groove 101 extends from the piercing part 112 to the base 111, with one end of the receiving groove 101 located at the piercing part 112 and the other end located at the base 111.

[0120] Please refer back to Figure 3. In some embodiments of this application, the piercing portion 112 includes a needle tip 1121 and a probe segment 1122. One end of the probe segment 1122 is connected to the needle tip 1121. The other end of the probe segment 1122 is connected to the base 111. The receiving groove 101 extends from the base 111 to the probe segment 1122. Thus, since the receiving groove 101 does not extend to the needle tip 1121, the probe module 120 connected to the receiving groove 101 also does not need to extend to the needle tip 1121. When the probe 100 is in use, the needle tip 1121 needs to pierce the skin and penetrate into the dermis. During the process of the needle tip 1121 piercing the skin, the skin exerts a relatively large reaction force on the needle tip 1121. Since the receiving groove 101 does not extend to the needle tip 1121, this relatively large reaction force has a smaller impact on the receiving groove 101 and the probe module 120, which can prevent the probe module 120 from cracking or peeling due to large frictional forces. In other words, the needle tip 1121 performs the puncture function, while the detection module 120 does not participate in the puncture process, thus avoiding the influence of friction and shearing force on the detection module 120 and improving the integrity, durability, and signal reliability of the detection module 120.

[0121] Furthermore, to quickly pierce the skin, the cross-sectional area of ​​the needle tip 1121 is smaller than that of the piercing portion 112. For example, the needle tip can be thinned in the thickness direction using laser line scanning or grinding processes to create a thickness gradient, thus forming the needle tip. By not creating the receiving groove 101 on the small-section needle tip 1121, the difficulty of the grooving process can be reduced. In some embodiments of this application, the receiving groove 101 may also extend to the needle tip 1121. The process for creating the receiving groove 101 can be, for example, a laser ablation process.

[0122] For example, the cross-sectional area of ​​the needle tip 1121 is smaller than the cross-sectional area of ​​the detection section 1122. The shape of the needle tip 1121 is not limited in this embodiment. In some embodiments, the needle tip 1121 is conical, frustum-shaped, or prismatic, etc.

[0123] This application embodiment does not limit the dimensions of the base 111 and the piercing portion 112. Referring back to Figure 2b, in some embodiments, the length d2 of the base 111 is 1.5 mm to 5 mm, for example, d2 can be 1.5 mm, 1.6 mm, 2 mm, 3 mm, 4 mm, or 5 mm, etc. The length d1 of the piercing portion 112 is 1000 μm to 1500 μm, for example, d1 can be 1000 μm, 1050 μm, 1100 μm, 1200 μm, 1300 μm, 1400 μm, or 1500 μm, etc.

[0124] For example, the thickness H of the base 111 and the piercing portion 112 can be 200μm to 250μm, for example, H can be 200μm, 210μm, 220μm, 230μm, 240μm or 250μm, etc.

[0125] The angle O between the surface of the needle tip 1121 and the length direction of the probe 100 is 30° to 60°. For example, O can be 30°, 35°, 40°, 45°, 50°, 55° or 60°, etc.

[0126] In some embodiments of this application, barbs may be provided on the piercing portion 112 to prevent the probe 100 from dislodging. The following description, in conjunction with FIG7a, provides an exemplary illustration.

[0127] Figure 7a is a schematic diagram of the structure of a needle body 110 provided in an embodiment of this application. Referring to Figure 7a, the needle body 110 (as shown in Figure 6) also includes barbs 113, which are connected to the piercing portion 112. Thus, after the piercing portion 112 extends into the skin, the barbs 113 can increase the degree of adhesion between the needle body 110 and the skin, and the barbs 113 make the needle body 110 form a self-locking structure, preventing the needle body 110 from falling off.

[0128] For example, in some embodiments, the end of the barb 113 facing the base 111 is the larger end, and the end facing away from the base 111 is the smaller end.

[0129] In some embodiments, a barb 113 is provided at the end of the needle tip 1121 near the base 111.

[0130] In the embodiment shown in Figure 7a, the barb 113 is a protruding structure. The barb 113 is connected to the needle tip 1121. The barb 113 and the needle tip 1121 together form a triangular prism structure. The barb 113 protrudes from the detection section 1122.

[0131] In some embodiments, the width at the location of the barb 113 is abruptly increased, giving the barb 113 a self-locking, anti-detachment function.

[0132] Exemplarily, the detection segment 1122 includes a first segment 1123 and a second segment 1124. The first segment 1123 and the second segment 1124 are connected. The barb 113 is connected to the end of the first segment 1123 away from the second segment 1124. The width of the first segment 1123 is smaller than the width of the second segment 1124. A stepped surface with a sudden increase in width is formed between the barb 113 and the first segment 1123, and this stepped surface has a self-locking anti-detachment function.

[0133] For example, in Figure 7a, the apex angle α of the triangular prism structure of the needle tip 1121 is 30° to 60°. For example, α can be 30°, 35°, 40°, 45°, 50°, 55°, or 60°, etc. The base angle β1 of the triangular prism structure (the angle closest to the second segment 1124) is 60° to 120°. For example, β1 can be 60°, 70°, 80°, 90°, 100°, 110°, 120°, etc. The angle θ between the surface of the barb 113 and the surface of the probe segment 1122 can be 90° to 165°. For example, θ can be 90°, 95°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, or 165°, etc.

[0134] For example, the length L of the first segment 1123 is 15% to 30% of the total length of the needle body 110. For example, L is 15%, 16%, 18%, 20%, 23%, 25%, 28% or 30% of the total length of the needle body 110.

[0135] For example, the width W of the first segment 1123 is 60% to 80% of the width of the second segment 1124. Similarly, the width W of the probe segment 1122 is 60%, 65%, 70%, 72%, 75%, 78%, or 80% of the width of the base 111. The width of the second segment 1124 is greater than the width of the first segment 1123. Thus, a stepped surface is formed at the junction of the first segment 1123 and the second segment 1124. In some embodiments, this stepped surface can be a plane perpendicular to the length direction of the needle body. In some embodiments, this stepped surface can also be an inclined surface inclined to the length direction of the needle body. Exemplarily, the angle γ between the inclined surface and the length direction of the needle body is 120° to 150°. For example, the angle γ can be 120°, 125°, 130°, 135°, 140°, 145°, or 150°, etc.

[0136] Figure 7b is a schematic diagram of another needle body 110 provided in an embodiment of this application. The difference between Figure 7b and Figure 7a includes the different structure of the barb 113. In Figure 7b, the barb 113 has a convex ridge structure. The end where the barb 113 connects to the needle tip 1121 is larger in size, while the end where the barb 113 connects to the first segment 1123 is smaller in size.

[0137] For example, the included angle β2 between the surface of the barb 113 and the surface of the needle tip 1121 can be, for example, 60° to 120°. For example, β2 can be 60°, 70°, 80°, 90°, 100°, 110°, 120°, etc.

[0138] The remaining structures are described in Figure 7a and will not be repeated here. In some embodiments of this application, the probe 100 may not have barbs 113.

[0139] Please refer back to Figure 2b. In the embodiments of this application, the detection device has multiple probes 100. In Figure 2b, the bases 111 of the multiple probes 100 are connected. Exemplarily, the bases 111 of the multiple probes 100 are connected as a single molded part. The multiple probes 100 can collect current signals from multiple regions in the body fluid, which can increase the detection accuracy.

[0140] Furthermore, since the first sensing part 121 of each probe 100 is independently configured, each probe 100 can independently collect current signals in body fluids. If some probes 100 are damaged or detached from the skin, the impact on the detection results of the detection device is minimal. The signal channels of individual probes 100 are independent, and multiple probes 100 can be connected in series to effectively identify the working status of individual probes 100 within the skin, eliminate failed signals, and improve the reliability of the microneedle sensor signal. In addition, multiple probes 100 can be fabricated simultaneously using the same process, saving costs.

[0141] For example, in embodiments where the probe 100 has multiple probes, the distance between two adjacent probes (m as shown in FIG. 2b) can be, for example, 1 mm to 2 mm. The distance between two adjacent probes can be, for example, 1 mm, 1.3 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, or 2 mm, etc.

[0142] In some embodiments of this application, the bases 111 of the plurality of probes 100 can be connected in other ways, such as by adhesive layers, solder layers or snap-fit ​​connectors.

[0143] This application does not limit the process for preparing probe 100. Figure 8a shows the process flow for preparing probe 100 provided in this application embodiment. Referring to Figure 8a, the probe preparation process includes:

[0144] S1. Form the preform 201 as shown in Figure 8b.

[0145] The shape of the outer contour of the preform 201 is the same as that of the needle body. For example, the preform can be formed by cutting or etching a thin sheet. In Figure 8b, multiple preforms 201 are interconnected, which can reduce the number of cuts and lower costs.

[0146] In some embodiments, multiple preforms 201 as shown in FIG8b can be formed in the same process. The multiple preforms 201 are connected by a cutting section. After the probe is fabricated, cutting at the cutting point can form multiple components as shown in FIG8f.

[0147] S2. A receiving groove 101 as shown in FIG8c is formed on the preform 201.

[0148] The receiving groove 101 can be formed by etching.

[0149] S3. Form the first insulating layer 122 as shown in Figure 8d.

[0150] S4. Form the first conductive layer 123 as shown in Figure 8e.

[0151] S5. Form the second insulating layer 124, the first electrical connector 125 and the first sensing part 121 as shown in FIG8f.

[0152] The materials and fabrication processes of the first insulating layer, the first conductive layer, the second insulating layer, the first electrical connector, and the first sensing element are described in Figure 4 above and will not be repeated here.

[0153] After completing S5 and drying for 24 hours, the structure shown in Figure 8f can be subjected to post-cutting or biocompatible layer impregnation.

[0154] In the examples of Figures 3 and 6 above, probe 100 includes a needle body 110 and a detection module 120. In some embodiments of this application, probe 100 may include two detection modules 120.

[0155] Figure 9 is a schematic diagram of another probe 100 provided in an embodiment of this application. Referring to Figure 9, the probe body 110 includes two receiving slots 101 and two detection modules 120, with one detection module 120 connected to one receiving slot 101. Thus, a probe 100 can have two detection modules 120, increasing the integration of the probe 100 and reducing the volume occupied by the probe 100.

[0156] In Figure 9, two receiving slots 101 are located on opposite sides of the needle body 110, such as the upper and lower sides in Figure 9. Each receiving slot 101 is connected to a detection module 120.

[0157] In some embodiments of this application, two receiving grooves 101 may be provided on adjacent sides of the needle body 110.

[0158] Similarly to Figure 9, in some embodiments, one probe 100 may be configured with three or four probe modules 120. The configuration depends on the size of the needle body 110.

[0159] Please refer back to Figure 2a. In some embodiments of this application, the detection device 10 may further include a cover 60. A portion of the probe 100 is located inside the cover 60, and a portion is located outside the cover 60. For example, the piercing portion 112 is located outside the cover 60, and at least a portion of the base 111 is located inside the cover 60. The cover 60 can secure the probe 100, preventing it from falling out.

[0160] In Figure 2a, the piercing portion 112 and the base 111 are connected by a stepped surface. In other words, the width of the piercing portion 112 is smaller than the width of the base 111, forming a stepped surface at the connection between the piercing portion 112 and the base 111. This stepped surface can support the cover 60, allowing the probe to fit well with the cover 60. This stepped surface can also limit the base 111 from cutting out of the cover 60, thus providing a limiting effect.

[0161] By way of example, the cover 60 can also fix the reference electrode needle 30 and the counter electrode needle 40. Part of the reference electrode needle 30 is located inside the cover 60 and part of it is located outside the cover 60. Part of the counter electrode needle 40 is located inside the cover 60 and part of it is located outside the cover 60. In this way, the cover 60 can simultaneously constrain the probe 100, the reference electrode needle 30, and the counter electrode needle 40.

[0162] In the embodiment of the detection device 10 and the watch strap 215 (as shown in FIG. 1b), the cover 60 is connected to the watch strap 215. Alternatively, the detection device 10 may not have a cover 60, and the base 111 and the watch strap 215 may be connected. The connection method between the base 111 and the watch strap 215 may be, for example, adhesive bonding, welding, or snap-fit.

[0163] Similarly, in the embodiment where the detection device 10 and the rear shell 214 (as shown in Figure 1b) are connected, the cover 60 is connected to the rear shell 214. Alternatively, the detection device 10 may not have a cover 60, and the base 111 is connected to the rear shell 214. The probe 100 is inserted through the rear shell 214. The piercing portion 112 is located on the side of the rear shell 214 away from the display screen 212. The base 111 is located on the side of the rear shell 214 closer to the display screen 212.

[0164] In Figure 2a, there are also multiple counter electrode needles 40. In the embodiments of this application, the structural differences between the counter electrode needle 40 and the probe 100 include: the counter electrode needle 40 does not include a sensing part (including the first sensing part and the second sensing part mentioned above). In other words, the difference between the structure of the counter electrode needle 40 and the probe 100 shown in Figure 3 or Figure 6 above is that it does not include a sensing part.

[0165] In an electrochemical system, the counter electrode transfers electrons without participating in electrochemical reactions or involving material changes; therefore, the counter electrode needle 40 does not require a sensing element. A through-hole can be provided at the location of the sensing element on the probe 100 to expose a portion of the conductive layer.

[0166] For example, Figure 10 is a schematic diagram of the internal structure of the counter electrode needle 40 provided in an embodiment of this application. In Figure 10, the counter electrode needle 40 includes a needle body, an electrical connector, a first insulating layer, a first conductive layer, and a second insulating layer. For the structure and connection relationship of the needle body, electrical connector, first insulating layer, first conductive layer, and second insulating layer of the counter electrode needle 40, as well as the fabrication process, please refer to the description in the probe 100 above, which will not be repeated here.

[0167] Thus, the process flow for electrode needle 40 and probe is relatively similar. For example, the same process flow can be used to prepare the needle body, electrical connector, first insulating layer, first conductive layer and second insulating layer, eliminating the need for repeated mold making, improving processing efficiency and reducing processing costs.

[0168] It is understood that in some embodiments of this application, the counter electrode needle 40 may also be provided as a counter electrode in other structures.

[0169] Similarly, the structural differences between the reference electrode needle 30 and the probe 100 include: the reference electrode needle 30 does not include a sensing part (including the first sensing part and the second sensing part mentioned above), while the reference electrode needle 30 includes a reference electrode part. In other words, the reference electrode needle 30 is formed by replacing the sensing part of the probe 100 (such as the first sensing part and the second sensing part mentioned above) with a reference electrode part.

[0170] For example, Figure 11 is a schematic diagram of the internal structure of the reference electrode needle 30 provided in an embodiment of this application. In Figure 11, the reference electrode needle 30 includes a needle body, an electrical connector, a first insulating layer, a first conductive layer, a second insulating layer, and a reference electrode portion. The reference electrode portion penetrates the second insulating layer and is connected to the first conductive layer, and the vertical projection of the first sensing portion on the needle body is located at the puncture portion. For the structure and connection relationship of the needle body, electrical connector, first insulating layer, first conductive layer, and second insulating layer of the reference electrode needle 30, as well as the manufacturing process, please refer to the description in the probe 100 above, which will not be repeated here.

[0171] For example, the material of the reference electrode may include silver, silver chloride, etc. Silver or silver chloride provides a reference potential to the working electrode (probe) in the electrochemical system. This is to ensure a stable potential.

[0172] In Figure 11, the reference electrode portion penetrates the second insulating layer. In some embodiments, the reference electrode portion may not penetrate the second insulating layer; in other words, the reference electrode portion is completely covered by the second insulating layer, as long as the reference electrode portion and the first conductive layer are electrically connected.

[0173] As described in Figure 2a above, the detection device 10 provided in this embodiment includes a plurality of reference electrode needles 30, a plurality of probes 100, and a plurality of counter electrode needles 40. The detection device 10 can be regarded as a plurality of microneedle array structures.

[0174] In the example of Figure 2a, multiple reference electrode needles 30 are arranged side by side, multiple probes 100 are arranged side by side, and multiple counter electrode needles 40 are arranged side by side. In other embodiments, the multiple reference electrode needles 30, multiple probes 100, and multiple counter electrode needles 40 may be arranged in a row. Alternatively, the multiple reference electrode needles 30, multiple probes 100, and multiple counter electrode needles 40 may be arranged in no particular order, and this application embodiment does not limit this.

[0175] In some embodiments, the detection device 10 may further include a first spacer 301 located between the counter electrode needle 40 and the probe 100. The distance between the counter electrode needle 40 and the probe 100 can be adjusted by setting the thickness of the first spacer 301. In some embodiments, the first spacer 301 is located within a cover body.

[0176] For example, the connection between the first isolator 301 and the counter electrode 40 can be achieved by abutment, bonding, or welding. Similarly, the connection between the first isolator 301 and the probe 100 can be achieved by abutment, bonding, or welding. It is understood that the first isolator 301 is not essential, and the detection device 10 may omit the first isolator 301.

[0177] Similarly, in some embodiments, the detection device 10 may further include a second spacer 302. The second spacer 302 is located between the counter electrode needle 40 and the reference electrode needle 30. The distance between the counter electrode needle 40 and the reference electrode needle 30 can be adjusted by setting the thickness of the second spacer 302.

[0178] Understandably, the second isolator 302 is not necessary, and the detection device 10 may not be equipped with the second isolator 302.

[0179] In some embodiments of this application, the detection device 10 may further include a monitoring needle for detecting whether the probe 100 has detached.

[0180] Figure 12 is a schematic diagram of another detection device 10 provided in an embodiment of this application. Referring to Figure 12, the difference between Figure 12 and Figure 2a includes that the detection device 10 may further include a monitoring needle 50. The structures of the probe 100, the reference electrode needle 30, and the counter electrode needle 40 are described in Figure 2a above and will not be repeated here.

[0181] As described in Figures 7a and 7b above, the probe may include barbs. It is understood that in some embodiments of this application, the probe may not have barbs, while the monitoring needle 50 may have barbs.

[0182] Figure 13 is a schematic diagram of the probe 100 and monitoring needle 50 provided in the embodiment of this application. Referring to Figure 13, the monitoring needle 50 includes a needle portion 51 and a monitoring electrode 52, which are connected together. The monitoring electrode 52 is electrically connected to the printed circuit board 20.

[0183] Along the length of the probe 100, the distance K1 from the monitoring electrode 52 to the free end of the needle body 110 is greater than or equal to the distance K2 from the first sensing part 121 to the free end of the needle body 110. When both the probe 100 and the monitoring electrode 52 are inserted into the skin, the distance from the first sensing part 121 to the skin surface is less than or equal to the distance from the monitoring electrode 52 to the skin surface. If the monitoring electrode 52 is dislodged from the skin, the first sensing part 121 is also highly likely to be dislodged from the skin. Thus, the signal monitored by the monitoring electrode 52 can be used to determine whether the first sensing part 121 remains in the body, thereby monitoring whether the first sensing part 121 is present in the body. The monitoring electrode 52 can provide an abnormal state alert, provide an in-body calibration basis for the detection device 10, and improve the signal reliability and accuracy of the detection device 10.

[0184] For example, the state of the first sensor 121 in the skin can be determined by monitoring the signal of electrode 52: if the signal of electrode 52 is stable, it indicates that the first sensor 121 is relatively stable in the skin and has not experienced large displacement, at which point the signal of the first sensor 121 is highly reliable. If the signal of electrode 52 changes abruptly, it indicates that the first sensor 121 has undergone relative displacement with respect to the skin. If electrode 52 cannot recover, it indicates that the reliability of the signal of the first sensor 121 is reduced; this provides a basis for the monitoring system.

[0185] The aforementioned "free end of needle body 110" refers to the end of needle body 110 that is away from the printed circuit board 20. Alternatively, it refers to the end of needle body 110 where the needle tip is located.

[0186] In the embodiments of this application, the structure of the needle portion 51 is described in the aforementioned structural description of the needle body 110. In some embodiments, the needle portion 51 may be provided with barbs as shown in Figures 7a and 7b. The monitoring electrode 52 can be considered as replacing the first sensing part in the aforementioned detection module with a monitoring electrode layer; the structure and fabrication process of the monitoring electrode 52 will not be described in detail here. The material of the monitoring electrode layer may be, for example, platinum or platinum nanoparticles, gold or gold nanoparticles, graphite or carbon nanotubes, etc.

[0187] In some embodiments of this application, along the length of the probe 100, the distance K3 from the free end of the needle portion 51 to the base 111 is greater than or equal to the distance K4 from the free end of the needle body 110 to the base 111. Thus, when both the probe 100 and the monitoring needle 50 are inserted into the skin, the free end of the needle portion 51, which is further from the base 111 than the free end of the needle body 110, penetrates the skin more deeply, making it less likely for the needle portion 51 to dislodge. The needle portion 51 serves to secure the detection device 10 within the body, preventing the detection device 10 from dislodging.

[0188] In embodiments of this application, the number of monitoring needles 50 can be one, two, three, four, or more. In embodiments where the detection device 10 includes multiple monitoring needles 50, the multiple monitoring needles 50 can be arranged in a row. Alternatively, the multiple monitoring needles 50 can be arranged in different rows; for example, some of the monitoring needles 50 are arranged in a row with the probe 100, some of the monitoring needles 50 are arranged in a row with the counter electrode needle 40, and some of the monitoring needles 50 are arranged in a row with the reference electrode needle 30. Alternatively, the multiple monitoring needles 50 can be arranged around the probe 100, the counter electrode needle 40, and the reference electrode needle 30. Alternatively, the multiple monitoring needles 50 can be dispersed in various areas of the detection device 10. This enhances the anti-detachment effect of the monitoring needles 50.

[0189] It is understood that in some embodiments of this application, the distance K3 from the free end of the needle 51 to the base 111 along the length direction of the probe 100 may be less than the distance K4 from the free end of the needle body 110 to the base 111.

[0190] In the embodiments of this application, the monitoring needle 50 is not necessary and may be omitted.

[0191] In the description of this specification, specific features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments or examples.

[0192] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application.

Claims

1. A probe, characterized in that, The probe includes: The needle body includes a receiving groove, a piercing portion, and a base, the piercing portion and the base being connected; the receiving groove extends from the piercing portion to the base; and The detection module includes a first electrical connector, a first sensing part, a first insulating layer, a first conductive layer, and a second insulating layer; the first conductive layer is located between the first insulating layer and the second insulating layer, and the first insulating layer, the first conductive layer, and the second insulating layer are all located within the receiving groove, with the first insulating layer being closer to the bottom wall of the receiving groove than the second insulating layer; The first electrical connector penetrates the second insulating layer and is electrically connected to the first conductive layer. The vertical projection of the first electrical connector on the needle body is at least partially located on the base. The first sensing part penetrates the second insulating layer and is connected to the first conductive layer. The vertical projection of the first sensing part on the needle body is located at the puncture portion.

2. The probe according to claim 1, characterized in that, The piercing portion includes a needle tip and a probe section, one end of which is connected to the needle tip and the other end of which is connected to the base; the receiving groove extends from the base to the probe section.

3. The probe according to claim 1, characterized in that, The needle body also includes barbs, which are connected to the piercing portion.

4. The probe according to claim 1, characterized in that, The needle body includes two receiving slots and two detection modules, with one detection module connected to one of the receiving slots.

5. The probe according to claim 1, characterized in that, The detection module further includes: a second electrical connector, a second sensing unit, a second conductive layer, and a third insulating layer, wherein the second conductive layer is located between the third insulating layer and the second insulating layer; the first electrical connector and the first sensing unit both penetrate the third insulating layer; the first electrical connector is electrically isolated from the second conductive layer. The second sensing element penetrates the third insulating layer and is connected to the second conductive layer; the vertical projection of the second sensing element on the needle body is located at the puncture site. The second electrical connector penetrates the third insulating layer and is electrically connected to the second conductive layer; the vertical projection of the second electrical connector on the needle body is at least partially located on the base.

6. The probe according to claim 1, characterized in that, The material of the first sensing unit includes a redox polymer and a sensing material, wherein the sensing material includes glucose oxidase, lactate oxidase, uricase oxidase or ethanol oxidase.

7. The probe according to claim 1, characterized in that, The probe also includes an insulating film that covers the surface of the puncture site.

8. The probe according to claim 1, characterized in that, The detection module includes multiple first sensing units.

9. The probe according to claim 1, characterized in that, The first insulating layer and the needle body are connected as an integral molded part.

10. A detection device, characterized in that, The detection device includes: The printed circuit board and the probe according to any one of claims 1-9, wherein the first electrical connector is electrically connected to the printed circuit board.

11. The detection device according to claim 10, characterized in that, The detection device further includes a reference electrode needle and a counter electrode needle; both the reference electrode needle and the counter electrode needle are electrically connected to the printed circuit board.

12. The detection device according to claim 10, characterized in that, The detection device further includes a monitoring needle, which includes a needle portion and a monitoring electrode. The monitoring electrode is connected to the needle portion and electrically connected to the printed circuit board. Along the length of the probe, the distance from the monitoring electrode to the free end of the needle body is greater than or equal to the distance from the first sensing part to the free end of the needle body.

13. The detection device according to claim 12, characterized in that, Along the length of the probe, the distance from the free end of the needle to the base is greater than or equal to the distance from the free end of the needle body to the base.

14. A terminal device, characterized in that, The terminal device includes: a main body and a detection device according to any one of claims 10-13, wherein the main body is connected to the detection device.

15. A reference electrode needle, characterized in that, The reference electrode needle includes: The needle body includes a receiving groove, a piercing portion, and a base, the piercing portion and the base being connected; the receiving groove extends from the piercing portion to the base; and A detection module includes an electrical connector, a reference electrode, a first insulating layer, a conductive layer, and a second insulating layer; the conductive layer is located between the first insulating layer and the second insulating layer, and the first insulating layer, the conductive layer, and the second insulating layer are all located within the receiving groove, with the first insulating layer being closer to the receiving groove than the second insulating layer; The electrical connector penetrates the second insulating layer and is electrically connected to the conductive layer, and the vertical projection of the electrical connector on the needle body is located on the base; the reference electrode portion penetrates the second insulating layer and is electrically connected to the conductive layer, and the vertical projection of the reference electrode portion on the needle body is located on the puncture portion.

16. A counter electrode needle, characterized in that, The counter electrode needle includes: The needle body includes a receiving groove, a piercing portion, and a base, the piercing portion and the base being connected; the receiving groove extends from the piercing portion to the base; and A detection module includes an electrical connector, a first insulating layer, a conductive layer, and a second insulating layer; the conductive layer is located between the first insulating layer and the second insulating layer, and the first insulating layer, the conductive layer, and the second insulating layer are all located within the receiving groove, with the first insulating layer being closer to the receiving groove than the second insulating layer; The electrical connector penetrates the second insulating layer and is electrically connected to the conductive layer; the vertical projection of the electrical connector on the needle body is located on the base. The second insulating layer is provided with a through hole that penetrates the second insulating layer, and the vertical projection of the through hole on the needle body is located at the puncture portion.

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