Sensor protection device for an analyte detection device

Abstract

The invention discloses a sensor protection device for an analyte detection device, a sensor substrate of the analyte detection device is made of a rigid material, in the daily activity process of a user, the rigid substrate cannot bend or displace along with muscle peristalsis, and after the sensor is percutaneously punctured into the skin, the sensor can be protected. The sensor with the rigid substrate can be always kept at the preset detection position, the detection reliability of the analyte detection device is ensured, meanwhile, the protection device can provide protection for the rigid sensor, unnecessary damage to a user caused by the rigid sensor is avoided, and the use experience of the user is improved.

Description

Technical Field

[0001] This invention relates primarily to the field of medical devices, and in particular to a sensor protection device for an analyte detection apparatus. Background Technology

[0002] In a healthy person, the pancreas automatically detects the glucose level in the blood and secretes the necessary insulin / glucagon. However, in diabetic patients, the pancreas malfunctions and cannot secrete the required insulin. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic function, and it is a lifelong condition. Currently, medical technology cannot cure diabetes; it can only control the occurrence and development of diabetes and its complications by stabilizing blood sugar levels.

[0003] Diabetic patients need to have their blood sugar checked before injecting insulin. Most current testing methods can continuously monitor blood sugar and send the data to an external device in real time for user viewing; this method is called Continuous Glucose Monitoring (CGM). This method requires a device to be attached to the skin surface, with its sensor inserted into the subcutaneous tissue fluid to complete the detection. However, current analyte detection devices use sensor substrates made of flexible materials such as Teflon, polyethylene (PE), polyvinyl chloride (PVC), acrylonitrile-butadiene-styrene copolymer (ABS), polymethyl methacrylate (PMMA), polycarbonate (PC), and polyimide (PI). After being inserted percutaneously, the sensor substrate bends or shifts due to muscle movement caused by daily activities, leading to the electrode detaching from its normal detection position. In severe cases, the sensor may detach from the subcutaneous tissue and protrude from the skin surface, affecting the accuracy of analyte detection in the tissue fluid.

[0004] Therefore, there is an urgent need in the existing technology for an analyte detection device that can prevent the sensor from leaving its detection position during users' daily activities. Summary of the Invention

[0005] This invention discloses a sensor protection device for an analyte detection device. The sensor substrate of the analyte detection device is made of a rigid material. During the user's daily activities, the rigid substrate will not bend or shift with muscle peristalsis. After the sensor is inserted percutaneously into the subcutaneous tissue, the sensor on the rigid substrate can remain in its predetermined detection position, ensuring the detection reliability of the analyte detection device. At the same time, the protection device can protect the rigid sensor, avoiding unnecessary harm to the user and improving the user experience.

[0006] This invention provides a sensor protection device for an analyte detection apparatus, comprising: a housing; a sensor for detecting analyte parameter information in bodily fluids; a transmitter for transmitting the analyte parameter information to an external device; a circuit board and a battery disposed within the housing, the circuit board being electrically coupled to the sensor, and the battery providing power to the analyte detection apparatus; adhesive tape for attaching the analyte detection apparatus to the skin surface; the sensor comprising a substrate, pins, electrodes, and wires, the substrate being made of a rigid material and comprising an external portion and an internal portion; pins disposed in the external portion for electrical connection to the circuit board; electrodes disposed in the internal portion for percutaneous insertion into the subcutaneous tissue to contact bodily fluids and acquire analyte parameter information in the bodily fluids; wires disposed on the substrate for electrical connection between the pins and the electrodes; and a protection device, which, after use of the analyte detection apparatus, at least accommodates the internal portion.

[0007] According to one aspect of the invention, the rigid material includes at least medical-grade stainless steel, or pure metals such as titanium, tantalum, niobium, or their alloys.

[0008] According to one aspect of the invention, the stiffness of the substrate is not less than 1 N / mm.

[0009] According to one aspect of the invention, the protective device is a protective cap made of an elastic material, which is operablely assembled with the analyte detection device after use.

[0010] According to one aspect of the present invention, the protective cap is a solid three-dimensional structure, and the internal part is left inside the protective cap after being punctured.

[0011] According to one aspect of the invention, the protective cap includes a cavity for enclosing the inner portion.

[0012] According to one aspect of the invention, the length of the protective cap is not less than the length of the internal portion exposed outside the analyte detection device.

[0013] According to one aspect of the invention, the cavity is open on one side facing the analyte detection device and closed on the opposite side.

[0014] According to one aspect of the invention, the length of the cavity is not less than the length of the portion of the body exposed outside the analyte detection device.

[0015] According to one aspect of the invention, the inner diameter of the cavity is smaller than the outer diameter of the inner part, and when the cavity encloses the inner part, the cavity and the inner part are interference-fitted.

[0016] According to one aspect of the invention, the protective cap is adhered to adhesive tape to achieve assembly of the protective cap with the analyte detection device.

[0017] According to one aspect of the invention, the protective cap is coated with an adhesive material on the protective cap surface facing the analyte detection device.

[0018] According to one aspect of the invention, the protective cap is made of one of plastic, foam, or sponge.

[0019] According to one aspect of the present invention, the protective device is a protective shell, the protective shell including a protective shell cavity and an encapsulation structure. After the analyte detection device is used, the analyte detection device is placed in the protective shell cavity, the inner diameter of the protective shell cavity being larger than the outer diameter of the analyte detection device. The encapsulation structure encapsulates the analyte detection device in the protective shell cavity to prevent the analyte detection device from detaching from the protective shell cavity.

[0020] According to one aspect of the invention, a positioning post is also included, which abuts against the lower outer casing to prevent interference between the sensor and the cavity of the protective casing.

[0021] According to one aspect of the invention, the height of the positioning post is not less than the length of the inner portion protruding from the lower outer shell.

[0022] According to one aspect of the invention, the encapsulation structure is a beveled snap fastener disposed on the cavity of the protective shell, the beveled snap fastener abutting against the outer shell body.

[0023] According to one aspect of the invention, the beveled snap fastener is a bevel that gradually thins towards the inside of the protective shell cavity.

[0024] According to one aspect of the invention, the inner diameter of the beveled snap fastener is smaller than the outer diameter of the analyte detection device.

[0025] According to one aspect of the invention, the inner diameter of the beveled buckle is 0.1 to 1 mm smaller than the outer diameter of the analyte detection device.

[0026] According to one aspect of the invention, the protective shell is made of one of the following materials: elastic plastic, elastic steel, foam adhesive, and sponge.

[0027] According to one aspect of the invention, the encapsulation structure is a protective cover, which is operably fixedly connected to the protective shell.

[0028] According to one aspect of the present invention, the fixed connection method between the protective cover and the protective shell includes at least one of thread, adhesive, and snap-fit.

[0029] According to one aspect of the invention, one side of the protective cover is connected to the protective shell by a movable bolt, and the protective cover can rotate or slide relative to the protective shell about the movable bolt.

[0030] According to one aspect of the invention, the other side of the protective cover can be opened and closed relative to the protective cover.

[0031] According to one aspect of the invention, the other side of the protective cover is connected to the protective cover by at least one of adhesive or snap-fit.

[0032] According to one aspect of the present invention, when installing the analyte detection device, the analyte detection device is placed on the skin surface with the adhesive side of the adhesive tape facing the skin and the internal part abutting against the skin. The analyte detection device is pressed by hand, and the internal part is inserted percutaneously into the subcutaneous tissue.

[0033] According to one aspect of the invention, the adhesive tape further includes release paper, which is used to protect the adhesive side of the tape before it is applied to the skin.

[0034] According to one aspect of the invention, it further includes a mounting unit for mounting the analyte detection device onto the skin surface.

[0035] According to one aspect of the invention, the mounting unit includes a housing, a protective cover and a trigger module disposed near the proximal end of the housing, and a parallel slider module and an elastic module disposed inside the housing. The parallel slider module is used to carry the analyte detection device, and the elastic module is used to push the parallel slider module. The elastic module includes an elastic element, and the internal portion can be inserted percutaneously into the subcutaneous tissue under the elastic force of the elastic module.

[0036] Compared with the prior art, the technical solution of the present invention has the following advantages: The present invention discloses a sensor protection device for an analyte detection device. The sensor substrate of the analyte detection device is made of a rigid material. During the user's daily activities, the rigid substrate will not bend or shift with muscle peristalsis. After the sensor is inserted subcutaneously, the sensor on the rigid substrate can remain in its predetermined detection position, ensuring the detection reliability of the analyte detection device. At the same time, the protection device can protect the rigid sensor, avoid unnecessary injury to the user, and improve the user experience.

[0037] Furthermore, the protective device is a protective cap, which can be fitted onto the internal part of the sensor body. It has a simple structure, uses less material, is easy to operate, and can effectively prevent the rigid sensor from causing unnecessary damage to the user.

[0038] Furthermore, the protective device is a protective shell. After use, the user can place the analyte detection device in the protective shell and seal it. The protective shell has a simple structure and is easy to operate, which can effectively prevent the rigid sensor from causing unnecessary damage to the user.

[0039] Furthermore, the user presses the analyte detection device with their hand, and the sensor autonomously penetrates the skin. The analyte detection device can then be installed on the skin surface. The installation process is simple, requires no installation unit, and is easy to use.

[0040] Furthermore, the sensor substrate of the analyte detection device is made of a rigid material, and the sensor can be autonomously inserted percutaneously, making the structure of the installation unit simpler. Attached Figure Description

[0041] Figure 1 This is a schematic diagram of the external structure of the analyte detection device mounting unit according to the first embodiment of the present invention; Figure 2a This is a schematic diagram of the external structure of the housing according to the first embodiment of the present invention; Figure 2b This is a schematic diagram of the structure of the protective cover according to the first embodiment of the present invention; Figure 3 This is an exploded structural diagram of the analytical substance detection device mounting unit according to the first embodiment of the present invention; Figure 4 This is a schematic diagram of the internal structure of the housing according to the first embodiment of the present invention; Figure 5a This is a schematic diagram of the structure of the distal end face of the parallel slider module according to the first embodiment of the present invention; Figure 5b This is a schematic diagram of the near-end face of the parallel slider module according to the first embodiment of the present invention; Figure 6a This is a schematic diagram of the analyte detection device according to the first embodiment of the present invention; Figure 6b This is a schematic diagram of a linear sensor structure according to the first embodiment of the present invention; Figure 6c This is a schematic diagram of the bent sensor structure according to the first embodiment of the present invention; Figure 6d This is a schematic diagram illustrating the electrical connection achieved by the dielectric according to the first embodiment of the present invention; Figure 6e This is a schematic diagram of an analyte detection device with a rigid sensor according to a first embodiment of the present invention; Figure 6f This is a schematic diagram of a linear rigid sensor structure according to the first embodiment of the present invention; Figure 6g This is a schematic diagram of a bent rigid sensor structure according to the first embodiment of the present invention; Figure 6h This is a schematic cross-sectional view of the rigid sensor according to the first embodiment of the present invention; Figure 6i This is a schematic diagram of the structure of a multilayer substrate sensor according to the first embodiment of the present invention; Figure 6j This is a schematic diagram of the structure of an embedded electrode sensor according to the first embodiment of the present invention; Figure 6k , Figure 6lAccording to the first embodiment of the present invention Figure 6e A schematic diagram of the cross-sectional structure; Figure 6m This is a schematic diagram of a protective cap as a sensor protection device according to the first embodiment of the present invention; Figure 6n This is a schematic diagram of a protective shell as a sensor protection device according to the first embodiment of the present invention; Figure 6o According to the first embodiment of the present invention Figure 6l Schematic diagram of the z-z' cross-sectional structure; Figure 7 This is a schematic diagram of the auxiliary needle module according to the first embodiment of the present invention; Figure 8 This is a schematic diagram of the trigger module according to the first embodiment of the present invention; Figure 9 This is a top view of the mounting unit according to the first embodiment of the present invention; Figure 10a for Figure 9 A schematic diagram of the cross-sectional structure at section A; Figure 10b for Figure 9 A schematic diagram of the B-section structure; Figure 10c for Figure 9 A schematic diagram of the C-section structure; Figure 11 This is a schematic diagram of the first buckle under stress and bending according to the first embodiment of the present invention; Figure 12 This is an exploded structural diagram of the analyte detection device and mounting unit according to the second embodiment of the present invention; Figure 13 This is a schematic diagram of the internal structure of the housing according to the second embodiment of the present invention; Figure 14a This is a schematic diagram of the structure of the distal end face of the parallel slider module according to the second embodiment of the present invention; Figure 14b This is a schematic diagram of the near-end face of the parallel slider module according to the second embodiment of the present invention; Figure 15a This is a schematic diagram of the analyte detection device with a rigid sensor according to the second embodiment of the present invention; Figure 15b This is a schematic diagram of the exploded structure of an analyte detection device with a rigid sensor according to a second embodiment of the present invention; Figure 15c This is a schematic diagram of a linear rigid sensor structure according to a second embodiment of the present invention; Figure 15d This is a schematic diagram of a bent rigid sensor structure according to a second embodiment of the present invention; Figure 15e-15hAccording to the second embodiment of the present invention Figure 15a A schematic diagram of the cross-sectional structure; Figure 16 This is a schematic diagram illustrating the use of the analyte detection device according to the third embodiment of the present invention. Detailed Implementation

[0042] As mentioned earlier, the sensor substrate of the existing analyte detection device is made of flexible material. After being inserted percutaneously into the subcutaneous tissue, the sensor substrate bends or shifts due to muscle peristalsis caused by the user's daily activities, causing the electrode to detach from its normal detection position. In severe cases, the sensor detaches from the subcutaneous tissue and protrudes from the skin surface, affecting the detection accuracy of tissue fluid analytes.

[0043] To address this issue, the present invention provides a sensor protection device for an analyte detection apparatus. The sensor substrate of the analyte detection apparatus is made of a rigid material. During the user's daily activities, the rigid substrate will not bend or shift with muscle peristalsis. After the sensor is inserted percutaneously into the subcutaneous tissue, the sensor on the rigid substrate can remain in its predetermined detection position, ensuring the detection reliability of the analyte detection apparatus. At the same time, the protection device can protect the rigid sensor, preventing unnecessary harm to the user and improving the user experience.

[0044] Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that, unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps set forth in these embodiments should not be construed as limiting the scope of the invention.

[0045] Furthermore, it should be understood that, for ease of description, the dimensions of the various components shown in the accompanying drawings are not necessarily drawn to actual scale; for example, the thickness, width, length, or distance of some units may be enlarged relative to other structures.

[0046] The following description of exemplary embodiments is merely illustrative and is not intended to limit the invention or its application or use in any way. Techniques, methods, and apparatus known to those skilled in the art may not be discussed in detail herein, but where applicable, such techniques, methods, and apparatus should be considered part of this specification.

[0047] It should be noted that similar labels and letters in the following figures indicate similar items; therefore, once an item is defined or described in a figure, it will not need to be discussed further in the subsequent description of the figures.

[0048] First Embodiment Figure 1This is a schematic diagram of the external structure of the analyte detection device mounting unit according to the first embodiment of the present invention. The external structure of the mounting unit 100 includes a housing 101 and a protective cover 102. The housing 101 is used to support the internal structural components. In use, the end of the mounting unit 100 closest to the user's skin is the proximal end, and the end furthest from the skin is the distal end. A first opening is provided at the proximal end of the housing 101. The protective cover 102 is used to protect, seal, and prevent triggering of the internal structure and internal structural components of the housing 101.

[0049] External casing Figure 2a This is a schematic diagram of the external structure of the housing according to the first embodiment of the present invention. Figure 2b This is a schematic diagram of the protective cover. The protective cover 102 includes an outer cover body 1021, a clamp 1022, and an inner cover body 1023. A second opening is provided at the distal end of the outer cover body 1021, facing the first opening. Through the second opening, the outer cover body 1021 and the clamp 1022 are connected by breakable posts 10211, which are distributed at certain intervals between the outer cover body 1021 and the clamp 1022. When the outer cover body 1021 rotates relative to the clamp 1022, the posts 10211 can be broken, separating the outer cover body 1021 from the clamp 1022.

[0050] The inner side of the outer cover 1021 is provided with an internal thread 10212, and the outer side of the inner cover 1023 is provided with an external thread 10231. The internal thread 10212 and the external thread 10231 can be connected to connect the outer cover 1021 and the inner cover 1023 together and keep them fixed.

[0051] The inner side of the clamp 1022 is provided with a protrusion 10221, and correspondingly, the outer side of the housing 101 is provided with a groove 1011. The groove 1011 surrounds the outer side of the housing to form a circumference, and the protrusion 10221 can be embedded in the groove 1011. The outer cover 1021 is first fixed to the inner cover 1023 by threaded engagement, and then connected to the housing 101 by the clamp 1022. The outer cover 1021 and the inner cover 1023 can protect, seal and prevent triggering of the internal structure of the housing 101. The anti-triggering function will be further explained below.

[0052] In other embodiments of the present invention, the outer cover 1021 and the inner cover 1023 may also be fixedly connected by friction engagement or snap-fit ​​engagement.

[0053] In other embodiments of the present invention, the clamp 1022 and the housing 101 can also be connected by friction fit, snap fit or threaded fit.

[0054] Inside the shell Figure 3This is an exploded structural diagram of the analytical substance detection device mounting unit according to the first embodiment of the present invention. The dashed lines in the diagram indicate the installation and fitting relationship of each structural component. The internal structural components of the analytical substance detection device mounting unit 100 include a parallel slider module 103, an analytical substance detection device 104, an auxiliary needle module 105, a trigger module 106, and an elastic module 107. The elastic module 107 includes a first elastic element 1071 and a second elastic element 1072.

[0055] Figure 4 This is a schematic diagram of the internal structure of the housing 101 in the first embodiment of the present invention.

[0056] In some embodiments of the present invention, at least two first buckles 1012 are provided inside the housing 101. The first buckles 1012 are integrally formed with the housing 101 and protrude towards the proximal end of the housing 101. The first buckles 1012 are made of flexible material and their ends can be bent or folded outward from the housing 101.

[0057] In a preferred embodiment of the present invention, there are two first buckles 1012, which are symmetrically distributed inside the housing 101 and are spaced 180° apart from each other.

[0058] In other preferred embodiments of the present invention, the number of first buckles 1012 is three or four, symmetrically distributed inside the housing 101, with an angular interval of 120° or 90° between them. The number of first buckles 1012 may also be five or more, and is not limited herein.

[0059] In some embodiments of the present invention, the housing 101 is further provided with at least two limiting grooves 1013, at least two card slots 1014 and an auxiliary pin limiting groove 1015.

[0060] In some embodiments of the present invention, the limiting groove 1013 includes at least two ribs protruding from the inner wall of the housing 101. In a preferred embodiment of the present invention, the ribs are parallel to each other, and a groove is formed between adjacent ribs.

[0061] In other embodiments of the present invention, the limiting groove 1013 is a groove recessed into the inner wall of the housing 101.

[0062] In some embodiments of the present invention, the card slot 1014 includes two card slot positions, namely a first card slot position 10141 and a second card slot position 10142, such as... Figure 10a As shown, the first card slot 10141 is closer to the proximal end than the second card slot 10142.

[0063] In a preferred embodiment of the present invention, there are two limiting grooves 1013 and two card slots 1014, which are symmetrically distributed inside the housing 101 and are spaced 180° apart from each other.

[0064] In other preferred embodiments of the present invention, the number of limiting grooves 1013 and slots 1014 is three or four, symmetrically distributed inside the housing 101, with an angular interval of 120° or 90° between them. The number of limiting grooves 1013 and slots 1014 may also be five or more, which is not limited here.

[0065] Parallel slider module Figure 5a This is a structural schematic diagram of the distal end face of the parallel slider module 103. Figure 5b This is a structural schematic diagram of the near end face of the parallel slider module 103.

[0066] In some embodiments of the present invention, the distal end face 1031 of the parallel slider module 103 is provided with a circular groove 1032 protruding distally. The circular groove 1032 is a hollowed-out cylindrical structure with an inner diameter of d1. At least two slider latches 10321 extend distally from the sidewall of the circular groove 1032. The latching part of the slider latch 10321 is a plane or approximately a plane and forms a fixed angle with the horizontal plane. Its extended ends m0 converge at the distal end.

[0067] In some embodiments of the present invention, the slider buckle 10321 is made of a flexible material, so it can be bent or folded outward of the circular groove 1032.

[0068] In other embodiments of the present invention, the slider buckle 10321 can be directly disposed on the far end face of the parallel slider module 103 without the need for a circular groove structure.

[0069] In some embodiments of the present invention, a boss 10322 is provided at one end of the circular groove 1032 near the distal end face 1031. The boss 10322 is a hollowed-out cylindrical structure with an inner diameter of d2, where d1 > d2. The hollowed-out circular groove 1032 and the boss 10322 form a through hole 10323, which extends from the distal end face 1031 of the parallel slider module to the proximal end face 1034.

[0070] In a preferred embodiment of the present invention, there are two slider buckles 10321, which are symmetrically distributed on the side wall of the circular groove 1032, and the angle between the two slider buckles 10321 is 180°.

[0071] In other preferred embodiments of the present invention, the number of slider latches 10321 can be three or four, symmetrically distributed on the sidewall of the circular groove 1032, and the angular interval between the slider latches 10321 is 120° or 90°. The number of slider latches 10321 can also be five or more, which is not limited here.

[0072] Continue to refer to Figure 5aIn some embodiments of the present invention, at least two second buckles 1033 are provided on the side of the distal end face 1031 of the parallel slider module 103. The second buckles 1033 are symmetrically distributed on the side of the distal end face 1031, and the angular interval between them is 180°.

[0073] In other embodiments of the present invention, the number of second snap-fits 1033 is three or four, symmetrically distributed on the side of the distal end face 1031, with an angular interval of 120° or 90° between them. The number of second snap-fits 1033 may also be five or more, without limitation. In the mounting unit 100, the second snap-fits 1033 are coupled to the first snap-fits 1012. The position and number of the second snap-fits 1033 are consistent with those of the first snap-fits 1012.

[0074] Reference Figure 5b In some embodiments of the present invention, at least two T-shaped structures 1035 are provided on the side of the proximal end face 1034 of the parallel slider module 103. The vertical part of the T-shaped structure 1035 is connected to the proximal end face 1034, and the horizontal part includes a T-shaped structure slider 10351 and a T-shaped structure buckle 10352. The T-shaped structure slider 10351 faces the outside of the parallel slider module 103 and protrudes from the outer ring of the parallel slider module 103; the T-shaped structure buckle 10352 faces the inside of the parallel slider module 103 and protrudes from the inner ring of the parallel slider module 103.

[0075] In the mounting unit 100, the T-shaped slider 10351 is located within the limiting groove 1013 to restrict the position of the parallel slider module 103 and prevent the parallel slider module 103 from rotating within the mounting unit 100. The number and position of the T-shaped sliders 10351 are consistent with the limiting groove 1013. During the movement of the parallel slider module 103 towards its proximal end, the T-shaped sliders 10351 slide within the limiting groove 1013.

[0076] In a preferred embodiment of the present invention, the vertical part of the T-shaped structure 1035 is made of flexible material, the vertical part and the horizontal part are integrally formed, and the horizontal part can be bent or flexed around the vertical part.

[0077] In other preferred embodiments of the present invention, the vertical part of the T-shaped structure 1035 is made of an elastic material, such as a spring or a sheet, and the horizontal part is fixedly connected to the vertical part by welding or hot melting processes. The horizontal part can also be bent or flexed around the vertical part.

[0078] Analyte detection device Figure 6a This is a schematic diagram of the analyte detection device according to the first embodiment of the present invention. Figure 6b This is a schematic diagram of the linear sensor structure according to the first embodiment of the present invention. Figure 6c This is a schematic diagram of the bent sensor structure according to the first embodiment of the present invention. Figure 6d This is a schematic diagram of the dielectric realizing electrical connection in the first embodiment of the present invention. Figure 6e This is a schematic diagram of an analyte detection device with a rigid sensor according to the first embodiment of the present invention. Figure 6f This is a schematic diagram of the structure of the linear rigid sensor according to the first embodiment of the present invention. Figure 6g This is a schematic diagram of the structure of the bending rigid sensor according to the first embodiment of the present invention. Figure 6h For the present invention Figure 6g A schematic diagram of the v-v' cross-sectional structure of the sensor. Figure 6i This is a schematic diagram of the structure of the multilayer substrate sensor according to the first embodiment of the present invention. Figure 6j This is a schematic diagram of the embedded electrode sensor according to the first embodiment of the present invention. Figure 6k , Figure 6l This is the first embodiment of the present invention. Figure 6e A cross-sectional structural schematic diagram. 6m is a schematic diagram of the protective cap as a sensor protection device in the first embodiment of the present invention. Figure 6n This is a schematic diagram of the protective shell as a sensor protection device according to the first embodiment of the present invention. Figure 6o for Figure 6l A schematic diagram of the z-z' cross-sectional structure.

[0079] Combined with reference Figure 6a and Figure 3 In some embodiments of the present invention, the analyte detection device 104 includes a housing 1041, a transmitter (not shown), a sensor 1042, and a circuit board (not shown) disposed within the housing 1041 and electrically coupled to the sensor 1042. The sensor 1042 is used to detect the analyte parameter information of the user's bodily fluids, and transmits the analyte parameter information to the transmitter via the circuit board, and then the transmitter sends it to the external device 200.

[0080] In a preferred embodiment of the present invention, before the analyte detection device 104 is installed on the user's skin surface, at a first frequency f 1. Transmits a signal to an external device 200. After being installed on the user's skin, it operates at a second frequency. f 2. Transmits signals to external device 200 at a second frequency. f 2 is greater than the first frequency f 1. In a further preferred embodiment of the present invention, the first frequency f 1 represents 0-12 times / hour, the second frequency. f 2 represents 12 to 3600 times per hour.

[0081] In a more preferred embodiment of the present invention, the first frequency f1 means 0 times / hour, that is, no signal is transmitted to external equipment 200 before the analyzer detection device 104 is installed on the user's skin surface, which can save the power consumption of the analyzer detection device 104 before installation.

[0082] In some embodiments of the present invention, the outer casing 1041 includes an upper outer casing 10411 and a lower outer casing 10413, which are joined together to form an internal space. The sensor 1042 includes an external portion (not shown in the figure) and an internal portion (not shown in the figure). The external portion, transmitter, and circuit board are disposed within the internal space of the analyte detection device 104, and the external portion is electrically coupled to the circuit board. The internal portion is provided with electrodes, membranes, and other structures, and can detect analyte parameters when inserted subcutaneously. When the internal portion is inserted subcutaneously, a correct angle is required, for example, perpendicular to the skin surface. After the analyte detection device 104 reaches the end of its lifespan, it is removed from the user's skin and discarded entirely.

[0083] In some embodiments of the present invention, the lower outer shell 10413 includes a through first through hole 10414, and correspondingly, on the axis of the first through hole 10414, the upper outer shell 10411 includes a through second through hole (not shown in the figure), and the inner part passes through the first through hole 10414 to the outside of the outer shell so as to be inserted under the user's skin.

[0084] In some embodiments of the present invention, the side of the upper outer shell 10411 includes a locking hole 10412 corresponding to the T-shaped structure buckle 10352. Here, "corresponding" means that the position and number of the locking holes 10412 are consistent with the T-shaped structure buckle 10352. In the mounting unit 100, the upper outer shell 10411 is fitted with the proximal end face 1034, and the T-shaped structure buckle 10352 and the locking hole 10412 form a snap-fit ​​connection, and the analyte detection device 104 is fixed on the parallel slider module 103. When the horizontal part of the T-shaped structure bends or flexes around the vertical part, the snap-fit ​​connection between the T-shaped structure buckle 10352 and the locking hole 10412 is released, and the analyte detection device 104 is separated from the parallel slider module 103. Therefore, in the mounting unit 100, the analyte detection device 104 and the parallel slider module 103 are releasable connections.

[0085] In some embodiments of the present invention, the substrate of the sensor 1042 is made of one or more of the following materials: polytetrafluoroethylene (Teflon), polyethylene (PE), polyvinyl chloride (PVC), acrylonitrile-butadiene-styrene copolymer (ABS), polymethyl methacrylate (PMMA), polycarbonate (PC), and polyimide (PI). Preferably, in some embodiments of the present invention, the substrate of the sensor 1042 is polyimide. Polyimide has the physical properties of being soft, insulating, and tough, and is not easily broken. After being inserted under the skin, it will not cause a rejection reaction with human tissue, and is widely used in in vivo analyte detection sensors.

[0086] Combined with reference Figure 6b In some embodiments of the present invention, the sensor 1042 based on polyimide is as follows: Figure 6b As shown, the sensor 1042 includes at least a substrate 10421, a pin (PAD) 10422, an electrode 10423, and a wire 10424 that electrically connects the pin 10422 to the electrode 10423.

[0087] In some embodiments of the present invention, electrode 10423 may be a two-electrode system, including working electrode 104231 and counter electrode 104232, or a three-electrode system, including working electrode 104231, counter electrode 104232 and reference electrode 104233, without limitation.

[0088] In other embodiments of the present invention, electrode 10423 may be multiple sets of electrodes. For example, multiple working electrodes 104231 and multiple counter electrodes 104232 may be disposed on a polyimide substrate. At least one working electrode 104231 and at least one counter electrode 104232 constitute a set of electrodes 10423. Different sets of electrodes 10423 may mutually calibrate analyte detection data, or different sets of electrodes 10423 may be used alternately and in relay. When the service life of a set of electrodes ends, the next set of electrodes takes over from the previous set of electrodes to start detecting analyte parameter information. In the embodiments of the present invention, multiple sets of electrodes may be either a two-electrode system or a three-electrode system, and no limitation is made herein.

[0089] In some embodiments of the present invention, the substrate 10421 may be bent along the XY zigzag line, as shown in the figure. Figure 6cThe electrodes are arranged in a figure-7 shape and installed in the analyte detection device 104. Pin 10422 is located in region X, serving as the external part. This external part is laid flat on and electrically connected to circuit board 1044. It can be adhered to circuit board 1044 with insulating adhesive, thus fixing sensor 1042 in the analyte detection device 104. Electrode 10423 is located in region Y, serving as the internal part. It is inserted percutaneously into the subcutaneous tissue to detect analyte parameters in body fluids. The external part is perpendicular or approximately perpendicular to the internal part; for example, the angle between them is 50° to 90°. Preferably, the angle is 90°, allowing the internal part to be inserted subcutaneously, substantially perpendicular to the skin surface, when installing the analyte detection device 104.

[0090] In other embodiments of the present invention, the substrate 10421 is not bent along the XY zigzag line, but is mounted in the analyte detection device 104 in a straight line ("I" shape). The pins 10422 are located in the X region, serving as an external part, and are electrically connected to the circuit board 1044 via a dielectric 1043 (e.g., ...). Figure 6d As shown), electrode 10423 is located in the Y region as the in vivo part, which is inserted percutaneously into the subcutaneous tissue to detect the parameters of the body fluid analyte. The in vivo part and the external part share the same axis.

[0091] In some embodiments of the present invention, the substrate 10421 of the sensor 1042 is planar, with an external portion length of 0.5-20 mm, an internal portion length of 0.5-100 mm, and a thickness of 0.01-5 mm. In other embodiments of the present invention, the substrate 10421 is cylindrical, with an external portion length of 0.5-20 mm, an internal portion length of 0.5-100 mm, and a diameter of 0.01-5 mm. In this embodiment, the cylindrical shape of the substrate 10421 can be a hollow cylinder, a solid cylinder, or a hollow semi-enclosed cylinder, and is not limited thereto.

[0092] In some embodiments of the present invention, pin 10422 can also establish an electrical connection with the circuit board through dielectric 1043 to improve the reliability of the electrical connection. Dielectric 1043 refers to a material including conductive region 10431 and insulating region 10432, wherein conductive region 10431 enables pin 10422 to be electrically connected to circuit board 1044, and insulating region 10432 insulates the conductive paths between different pins 10422 and circuit board 1044 from each other.

[0093] In some embodiments of the present invention, the dielectric 1043 can be a spaced-apart conductive elastic element, such as a conductive metal spring or a conductive metal sheet. In this case, the insulating region 10432 is the air between the conductive regions 10431. In other embodiments of the present invention, the dielectric 1043 can be a strip of adhesive with the conductive regions 10431 and the insulating regions 10432 spaced-apart. Conductive metal particles are incorporated into the insulating material of the adhesive strip to form a continuous conductive strip, which serves as the conductive region 10431. The conductive regions 10431 and the insulating regions 10432 are spaced apart on the adhesive strip. The adhesive strip itself has insulating properties and serves as an insulating strip, insulating the conductive regions 10431 from each other to form the insulating region 10432. For example, a conductive zebra strip can achieve multi-path conductivity on adjacent or opposite surfaces, and the multiple conductive paths are insulated from each other by the adhesive strip itself. Of course, conductive zebra strips can be designed into other three-dimensional shapes, such as triangular prisms, spheres, Π shapes, etc., to adapt to different installation sizes, installation methods, and electrical connection and insulation requirements.

[0094] Reference Figure 6d In some embodiments of the present invention, when the dielectric 1043 is a conductive zebra stripe, different pins 10422 of the sensor 1042 are electrically connected to different conductive areas 10431 on one side of the conductive zebra stripe, while the same conductive area 10431 on the other side of the conductive zebra stripe is electrically connected to conductive contacts 10441 on the circuit board 1044. Figure 6d In the design of the conductive zebra strip, the conductive area 10431 and the insulating area 10432 have been simplified. In reality, the size and spacing of the pins 10422 and the conductive contacts 10441 are not standardized. Depending on the different design requirements of the sensor 1042 and the circuit board 1044, the size and spacing of the pins 10422 and the conductive contacts 10441 may vary. To establish a correct electrical connection between the pins 10422 and the conductive contacts 10441, and to ensure… Both pins 10422 and conductive contacts 10441 can contact the corresponding conductive areas 10431, increasing the conductivity reliability of the conductive zebra strip. The widths of the conductive areas 10431 and insulating areas 10432 are typically designed to be small, for example, 0.1~2mm. The dense conductive areas 10431 and insulating areas 10432 ensure that pins 10422 and conductive contacts 10441 can contact the conductive areas 10431. Figure 6d In this embodiment, pin 10422 and conductive contact 10441 are electrically connected through the opposite surfaces of the conductive zebra strip. In other embodiments, depending on the different configurations of circuit board 1044 or sensor 1042, pin 10422 and conductive contact 10441 may also be electrically connected through adjacent surfaces of the conductive zebra strip.

[0095] In the above embodiments, during daily activities, the muscles in the waist or arms are constantly moving. After the sensor 1042, based on a flexible material such as polyimide, is inserted subcutaneously, its soft nature causes the internal portion to bend or shift with the muscle movement. This can cause the electrode 10423 to detach from its normal detection position, and in severe cases, detach from the subcutaneous tissue and protrude onto the skin surface, affecting the accuracy of detecting tissue fluid analytes. Therefore, ensuring the sensor remains in its normal subcutaneous position is crucial.

[0096] Combined with reference Figure 6b and Figure 6e In some embodiments of the present invention, the material of the substrate 10421 is changed to a rigid material, such as medical-grade metal materials, such as medical-grade stainless steel (refer to standard ASTM F138 / F139), or metals and alloys that can generate a passivating oxide protective layer, such as pure metals and alloys of titanium, tantalum, and niobium. Among them, titanium and tantalum metals will spontaneously form dense oxide films of titanium dioxide (TiO2) and tantalum pentoxide (Ta2O5) in the human body environment. These oxide layers are chemically stable and can effectively block the direct contact between the user's body fluids and the substrate 10421, reduce metal corrosion and ion precipitation, and avoid triggering inflammation or immune rejection reactions.

[0097] Continue to refer to Figure 6e In some embodiments of the present invention, the substrate material parameters of the sensor 2042 can be implemented with reference to the standard GB / T 18457-2024. The stiffness of the substrate 20421 material should be not less than 1 N / mm, preferably not less than 5 N / mm, so that the sensor 2042 can autonomously puncture the skin and enter the subcutaneous tissue. More preferably, the stiffness of the substrate 20421 material is not less than 8 N / mm, reducing the possibility of the sensor 2042 bending or folding during skin puncture and subsequent use. The width or diameter of the substrate 20421 is between 0.1 and 2 mm, preferably between 0.5 and 1 mm.

[0098] In some other embodiments of the present invention, if the rigidity of the base 20421 is sufficient, the sensor 2042 can be inserted percutaneously without the need for other auxiliary puncture tools, such as auxiliary needles. The corresponding technical solutions are described in detail in the second embodiment below. In this embodiment, the sensor 2042 still needs to be inserted percutaneously with the aid of auxiliary puncture tools.

[0099] In some embodiments of the present invention, after the base 20421 is made of a rigid material, the base 20421 will not bend or fold with the peristalsis of the user's muscles, and can maintain its factory shape for a long time. Moreover, after being inserted into the subcutaneous tissue, the detection position of the sensor 2042 will not change significantly, which is beneficial to ensuring the detection accuracy of the sensor 2042.

[0100] In some embodiments of the present invention, the rigid substrate 20421 may be adopted as follows: Figure 6b , Figure 6c The planar shape shown is not ideal. However, when the planar base 20421 is subjected to external forces, such as when a user unpacks the package or uses the mounting unit 100 to eject the sensor 2042, the base 20421 may bend or bend. Furthermore, the rigid material base 20421 cannot return to its original shape on its own after bending or bending, which will still affect the installation and detection accuracy of the sensor 2042.

[0101] In some embodiments of the present invention, in order to further enhance the rigidity of the substrate 20421 and make it less prone to bending or folding, the shape of the substrate 20421 can be rolled into a circle or an arc, specifically including a solid circle, a hollow semi-enclosed arc, or a hollow circle. Under the premise of using the same material and thickness, a circle or arc shape has greater structural rigidity than a planar substrate.

[0102] In some embodiments of the present invention, after the shape of the substrate 20421 is rolled into a circle or arc, the electrode 20423, the wire 20424 and the pin 20422 are all disposed on the outer surface of the substrate 20421.

[0103] In other embodiments of the present invention, when the substrate 20421 is rolled into a hollow semi-enclosed arc shape or a hollow circle, the hollow space inside the substrate 20421 can be used to set the electrode 20423 and the wire 20424. Setting the electrode 20423 in the hollow space inside the substrate 20421 can prevent the surface film of the electrode 20423 from being worn by packaging or the auxiliary needle 1052 during transportation and installation, thus avoiding any impact on the performance of the sensor 2042.

[0104] In some embodiments of the present invention, the rigid substrate 20421 is still divided into an X region and a Y region. The X region is provided with pins 20422 for electrical connection to the circuit board 2044 and for fixing the sensor 2042 in the analyte detection device 104. The Y region is provided with electrodes 20423 for percutaneous subcutaneous detection of analyte parameters in tissue fluid. Wires 20424 electrically connecting the electrodes 20423 and pins 20422 are also laid on the substrate 20421. For specific connection methods, please refer to [reference needed]. Figure 6b This will not be elaborated upon here.

[0105] Reference Figure 6f , Figure 6f This is a schematic diagram of the linear rigid sensor according to the first embodiment of the present invention. In some other embodiments of the present invention, the substrate 20421 is not bent along the XY zigzag line, but is installed in the analyte detection device 104 in a "1" shape (linear type). The pin 20422 is located in the X region as the external part, electrically connected to the circuit board 2044 via the dielectric 2043. The electrode 20423 is located in the Y region as the internal part, percutaneously inserted subcutaneously to detect analyte parameters in body fluids. The external and internal parts share a common axis.

[0106] Reference Figure 6g , Figure 6g This is a schematic diagram of the structure of the bent rigid sensor according to the first embodiment of the present invention. In some embodiments of the present invention, the substrate 20421 can be bent along the XY fold line to form a "7" shape (bent type) and is installed in the analyte detection device 104. The pins 20422 are located in the X region, as an external part, laid flat on the circuit board 2044 and electrically connected to the circuit board 2044 (e.g., ...). Figure 6i As shown in the diagram, the electrode 20423 is located in the Y region, serving as the fixed area of ​​the sensor 2042. As the in vivo part, it is percutaneously inserted subcutaneously to detect the analyte parameters in the body fluid. The external part is perpendicular or approximately perpendicular to the in vivo part; for example, the angle between the external and internal parts is 50° to 90°. Preferably, the angle between the external and internal parts is 90°, allowing the in vivo part to be inserted subcutaneously, substantially perpendicular to the skin surface, when the analyte detection device 204 is installed.

[0107] Combined with reference Figure 6h , Figure 6h for Figure 6g v-v' profile of sensor 2042 Figure 6hThis diagram illustrates the structure of electrode 20423 disposed on substrate 20421. In some embodiments of the present invention, some rigid materials, such as 304 and 316 medical-grade stainless steel, are inherently conductive. This can cause short circuits between different electrodes, wires, and pins directly laid on substrate 20421, affecting sensor detection. Therefore, when using these conductive rigid materials as substrates, an insulating material needs to be coated on the substrate surface first to form an insulating layer 204211. For example, one or more combinations of medical silicone rubber, medical polyurethane rubber, medical siloxane, polytetrafluoroethylene (Teflon), polyethylene (PE), polyvinyl chloride (PVC), acrylonitrile-butadiene-styrene copolymer (ABS), polymethyl methacrylate (PMMA), polycarbonate (PC), and polyimide (PI) are used. Then, electrodes 20423, wires 20424, and pins 20422 are fabricated on the insulating layer 204211. This avoids short circuits between different electrodes 20423, wires 20424, and pins 20422.

[0108] In some embodiments of the present invention, electrode 20423 includes at least an electron conduction layer a, an anti-interference layer b, an enzyme layer c, a regulatory layer d, and a biocompatible layer e. Electron conduction layer a is disposed on insulating layer 204211 of substrate 20421. Insulating layer 204211 prevents current from flowing from electrode 20423 to substrate 20421, thus avoiding short circuits with other electrodes. In embodiments of the present invention, wires 20424 and pins 20422 corresponding to each electrode 20423 are also disposed on insulating layer 204211 to prevent short circuits between different wires and pins.

[0109] Continue to refer to Figure 6h In some embodiments of the present invention, the conductivity of the rigid substrate 20421 can be utilized to directly mount the anti-interference layer b, enzyme layer c, regulatory layer d, and biocompatible layer e onto the substrate 20421, using the substrate 20421 as the electron conduction layer a. Regardless of whether it is a two-electrode or three-electrode system, only one electrode 20423 can be directly mounted on the substrate 20421, using the substrate 20421 as the electron conduction layer a. The electron conduction layers a of the remaining electrodes still need to be mounted on the insulating layer 204211 to avoid short circuits between different electrodes 20423. In embodiments of the present invention, the corresponding wires 20424 and pins 20422 of the electrode 20423 used as the electron conduction layer a on the substrate 20421 can also be directly mounted on the substrate 20421. The wires and pins corresponding to the remaining electrodes still need to be mounted on the insulating layer 204211 to avoid short circuits between different wires and pins.

[0110] In some embodiments of the present invention, one electrode 20423 and its corresponding wire 20424 and pin 20422 are directly disposed on the substrate 20421, while the remaining electrodes 20423 and their corresponding wires 20424 and pins 20422 are disposed on the insulating layer 204211. This can significantly increase the usable area of ​​the electrodes 20423, wires 20424 and pins 20422. Compared with the sensor 2042, in which all electrodes 20423, wires 20424 and pins 20422 are disposed on the insulating layer 204211, the area of ​​a single electrode 20423, wire 20424 and pin 20422 in this embodiment can be made larger to improve the performance of the sensor 2042.

[0111] Reference Figure 6i , Figure 6i This is a schematic diagram of the structure of a multilayer substrate sensor according to a first embodiment of the present invention. In this embodiment, the sensor 2042 includes at least two substrates 20421, such as substrate 20421a and substrate 20421b. Adjacent substrates 20421 are separated by an insulating layer 204211a to prevent short circuits between adjacent substrates 20421. An electrode 20423 and a corresponding wire 20424 can be disposed on each substrate 20421, for example, electrode 20423a and wire 20424a on substrate 20421a, and electrode 20423b and wire 20424b on substrate 20421b. An insulating layer 204211 is also disposed on the outermost substrate 20421. For example, when substrate 20421b is used as the outer substrate, an insulating layer 204211b is disposed on substrate 20421b for setting pins 20422. Setting pins 20422 on the insulating layer 204211b can prevent short circuits between pins 20422 corresponding to different electrodes 20423, for example, preventing short circuits between pins 20422a corresponding to electrode 20423a and pins 20422b corresponding to electrode 20423b.

[0112] In the aforementioned embodiments, the electrodes 20423 are all disposed on the outer surface of the substrate 20421. During the transportation and installation of the analyte detection device 204, the sensor 2042 will inevitably rub against the outer packaging, installation unit, etc., which will cause the film layer on the electrode 20423 to be damaged, affecting the detection effect of the electrode 20423.

[0113] Considering this issue, refer to Figure 6jIn some embodiments of the present invention, the electrode 20423 can be embedded in the substrate 20421, so that the electrode 20423 no longer protrudes from the substrate 20421, thereby reducing the possibility of damage to the film layer on the electrode 20423. Specifically, the electrode 20423 and the substrate 20421 are spaced apart and together form the bulk portion. In embodiments of the present invention, the substrate 20421 needs to be insulated, for example, by forming a dense metal oxide film on the surface of the substrate 20421, or by using an insulating material for the substrate 20421 itself, so as to insulate the spaced-apart electrodes 20423 from each other and avoid short circuits between adjacent electrodes 20423.

[0114] In some embodiments of the present invention, taking into account the human body's rejection, stiffness and insulation of the material, the material of the substrate 20421 can be polyetheretherketone (PEEK), ultra-high molecular weight polyethylene (UHMWPE), medical-grade polyurethane, etc.

[0115] In some embodiments of the present invention, when the substrate 20421 is a hollow semi-enclosed arc or a hollow circle, its internal cavity can prevent different electrodes 20423 from directly contacting each other. When the substrate 20421 is a solid circle, it is necessary to prevent different electrodes 20423 from directly contacting each other at the center.

[0116] Figure 6k , Figure 6l for Figure 6e A schematic diagram of the u-u' cross-sectional structure, in Figure 6k , Figure 6l The internal structure of the analyte detection device 204 has been simplified, such as the electronic components on the circuit board, as well as the transmitter and battery inside the analyte detection device 204.

[0117] Reference Figure 6k In some embodiments of the present invention, taking the analyte detection device 204 using a bent sensor 2042 as an example, the X region (external part) of the sensor 2042 is laid flat on the circuit board 2044, and the pin 20422 is electrically connected to the conductive contact 20441 on the circuit board 2044 through the dielectric (conductive zebra strip) 2043. At the same time, the external part of the sensor 2042 is attached to the circuit board 2044 with insulating glue to fix the sensor 2042.

[0118] Before installing the analyte detection device 204, the Y region (in vivo part) of the sensor 2042 is pre-accommodated in the cavity of the auxiliary needle 1052 so that the sensor 2042 can be percutaneously inserted into the subcutaneous tissue along with the auxiliary needle 1052 during installation.

[0119] In some embodiments of the present invention, when installing the analyte detection device 204, to reduce user pain, a spring-loaded installation method is often used. A spring pushes the auxiliary needle 1052 towards the puncture end, and then a spring retracts the auxiliary needle 1052 in the opposite direction to the puncture end to remove it from the subcutaneous tissue. During this process, the auxiliary needle 1052 slides rapidly relative to the sensor 2042. To prevent the auxiliary needle 1052 from damaging the electrode 20423 and the wire 20424, the electrode 20423 and the wire 20424 need to be positioned on the side of the sensor 2042 facing away from the auxiliary needle 1052, such as... Figure 6k As shown.

[0120] In the above embodiments, with Figure 6k Taking the direction shown as an example, the external part of the sensor 2042 is located on the upper side of the circuit board 2044, while the internal part is bent in the puncture direction. Therefore, the circuit board 2044 needs to avoid the internal part of the sensor 2042. For example, by designing a through hole 20442 on the circuit board 2044 for the internal part of the sensor 2042 to pass through, or by designing the side of the circuit board 2044 facing the internal part of the sensor 2042 as a concave arc shape to avoid the internal part of the sensor 2042.

[0121] In other embodiments of the present invention, the following continues... Figure 6k With the indicated direction as a reference, the external portion of sensor 2042 can also be disposed below circuit board 2044. In this case, pin 20422 will be located above the external portion of sensor 2042 for electrical connection to circuit board 2044. In this embodiment, the wire 20424 of sensor 2042 will be routed from the upper side of the external portion and electrically connected to electrode 20423 located on the right side of the internal portion of sensor 2042. In this embodiment, electrode 20423 located on the right side of the internal portion will contact auxiliary pin 1052. During installation, auxiliary pin 1052 may damage electrode 20423 or wire 20424.

[0122] In the above embodiments, only Figure 6k The structural features and orientations shown in the schematic diagram are for illustrative purposes only. In some other embodiments of the invention, the external portion of the sensor 2042 may be bent to the right relative to the internal portion, and the auxiliary needle 1052 is located on the left side of the internal portion of the sensor 2042 before installation.

[0123] Reference Figure 6lIn some embodiments of the present invention, taking the analyte detection device 204 using a linear sensor 2042 as an example, the pins 20422 on the X region (external part) of the sensor 2042 are electrically connected to the conductive contacts 20441 on the circuit board 2044 through a dielectric (conductive zebra strip) 2043. At the same time, the external part of the sensor 2042 is fixed on the circuit board 2044 to fix the sensor 2042. Specifically, a through hole 20442 is provided on the circuit board 2044, the external part of the sensor 2042 is placed in the through hole 20442, and the side of the external part is fixed to the inner wall of the through hole 20442 by means of insulating adhesive, etc., and a fixing structure 20443 is formed on the inner wall of the through hole 20442. In the analyte detection device 204, the linear sensor 2042 is set basically perpendicular to the circuit board 2044. Before installing the analyte detection device 204, the Y region (in vivo part) of the sensor 2042 is pre-accommodated in the cavity of the auxiliary needle 1052 so that the sensor 2042 can be inserted into the subcutaneous tissue by percutaneous puncture with the auxiliary needle 1052 during installation.

[0124] In some embodiments of the present invention, the pins 20422 of the linear sensor 2042 are disposed on the sidewall of the external portion. Therefore, the conductive area 20431 and the insulating area 20432 of the dielectric (conductive zebra strip) 2043 need to be bent. Since the sensor 2042 is perpendicular to the circuit board 2044, the pins 20422 are also perpendicular to the conductive contacts 20441. Figure 6d The structure of the dielectric shown prevents a direct electrical connection between pin 20422 and conductive contact 20441. (Continue referring to...) Figure 6l The conductive region 20431 and the insulating region 20432 of the dielectric 2043 are structurally bent, so that the dielectric 2043 can establish an electrical connection between the mutually perpendicular pins 20422 and conductive contacts 20441.

[0125] In some embodiments of the present invention, the dielectric 2043 is adhered and fixed to the circuit board 2044 by an adhesive material, such as insulating adhesive.

[0126] In some embodiments of the present invention, the length of the in vitro portion is 0.5-20 mm, the length of the in vivo portion is 0.5-100 mm, and the diameter of the 20421 substrate is 0.01-5 mm. In a preferred embodiment of the present invention, the length of the in vitro portion is 1-5 mm, the length of the in vivo portion is 5-20 mm, and the diameter of the 20421 substrate is 1-3 mm.

[0127] Combined with reference Figure 6f and Figure 6gIn some embodiments of the present invention, the pins 20422 are arranged side-by-side and spaced apart along the axial direction in the external portion, and the electrodes 20423 are arranged side-by-side and spaced apart along the axial direction in the internal portion. This maximizes the utilization of the surface area of ​​the arc-shaped substrate 20421, ensuring that the pins 20422 have sufficient area to contact the dielectric 2043, and that the electrodes 20423 have sufficient area to contact the body fluid. Considering that the diameter of the substrate 20421 is only 1~3mm, when the pins 20422 and electrodes 20423 are arranged side-by-side and spaced apart along the circumference of the substrate 20421, their width is too narrow, increasing the manufacturing difficulty of the pins 20422 and electrodes 20423.

[0128] In some embodiments of the present invention, when the analyte detection device 204 reaches the end of its lifespan, the user removes the analyte detection device 204 from the skin surface, exposing the rigid substrate's internal portion. Without protective measures, this internal portion may cause unnecessary harm to the user or others, such as puncturing fingers or everyday items. Some users may choose to bend the internal portion by hand to avoid this inconvenience; however, this bending process may still puncture the user's fingers, causing injury. Furthermore, bodily fluids and blood adhering to the internal portion can cause physiological transmission and contamination. Therefore, it is necessary to avoid exposing the internal portion after using the analyte detection device 204.

[0129] Figure 6m and Figure 6n These are schematic diagrams of sensor protection devices according to different embodiments of the present invention.

[0130] Reference Figure 6m In some embodiments of the present invention, the protective device of the sensor 2042 is a protective cap 2045 that is sleeved on the outside of the inner part of the sensor 2042. The protective cap 2045 has a hollow structure, forming a cavity 20451. The cavity 20451 is used to wrap the inner part, which can prevent the user or other personnel from contacting the inner part and avoid causing unnecessary harm.

[0131] In some embodiments of the present invention, the protective cap 2045 needs to be continuously mounted on the analyte detection device 204 until the analyte detection device 204 is destroyed or recycled by professionals or institutions, at which point the protective cap 2045 is also destroyed or recycled. Therefore, how to stably mount the protective cap 2045 on the analyte detection device 204 after use is a consideration.

[0132] In some embodiments of the present invention, the protective cap 2045 is made of an elastic material, such as silicone rubber, silicone, or medical rubber.

[0133] In some embodiments of the present invention, the protective cap 2045 has a certain three-dimensional structure, such as a cylindrical shape, a cuboid shape, or other irregular three-dimensional structures.

[0134] In some embodiments of the present invention, taking a cylindrical three-dimensional protective cap 2045 as an example, one end of the protective cap 2045 is provided with a cavity 20451, which is used to accommodate the inner part. The inner diameter d3 of the cavity 20451 is slightly smaller than the outer diameter d4 of the inner part. For example, when the outer diameter d4 of the inner part is 2 mm, the inner diameter d3 of the cavity 20451 is 1.5~1.9 mm. Figure 6m The relative dimensions of the hollow cavity 20451 and the sensor 2042 are described illustratively only and are not intended as actual references. When the user installs the protective cap 2045 onto the analyte detection device 204, the hollow cavity 20451 forms an interference fit with the internal part. Simultaneously, due to the elastic material of the protective cap 2045, it can be stably fitted onto the internal part. Furthermore, due to the rigid base support of the internal part, the elastic protective cap 2045 is not easily deformed after being fitted onto the internal part, effectively preventing unnecessary harm to the user from the internal part.

[0135] In some embodiments of the present invention, the cavity 20451 is only open on the protective cap surface 20452 facing the analyte detection device 204, and is closed on the opposite side. That is, the cavity 20451 is not a through hole. The closed structure can prevent the internal parts from being exposed from the other end of the protective cap 2045, and can effectively prevent the internal parts from causing unnecessary harm to the user.

[0136] In some embodiments of the present invention, the protective cap 2045 is a solid three-dimensional structure, that is, the protective cap 2045 does not have a cavity 20451. When the user assembles the protective cap 2045 onto the analyte detection device 204, the inner part of the rigid substrate can directly puncture the protective cap 2045. Since the protective cap 2045 is made of elastic material, after the inner part is inserted into the protective cap 2045, it can remain inside the protective cap 2045. The protective cap 2045 covers the inner part, which can effectively prevent the inner part from causing unnecessary harm to the user.

[0137] In some embodiments of the present invention, when the user assembles the protective cap 2045 onto the analyte detection device 204, the protective cap 2045 should be kept as parallel as possible to the sensor 2042; otherwise, the internal part may be pierced through the side wall of the protective cap 2045, and the protective cap 2045 will lose its protective effect.

[0138] In some embodiments of the present invention, the outer diameter d5 of the protective cap 2045 is 2.5~100mm, preferably 5~20mm. If the outer diameter of the protective cap 2045 is too small, the inner part can easily penetrate through the side wall of the protective cap 2045, and the protective cap 2045 will lose its protective effect. If the outer diameter of the protective cap 2045 is too large, it will result in material waste and increase costs.

[0139] In some embodiments of the present invention, the overall length of the protective cap 2045 should be greater than the length of the internal portion exposed outside the analyte detection device 204, so that the protective cap 2045 can completely cover the internal portion. Furthermore, the length of the cavity 20451 should be greater than the length of the internal portion exposed outside the analyte detection device 204, so that the cavity 20451 can completely cover the internal portion.

[0140] In some embodiments of the present invention, the length of the internal part protruding outside the analyte detection device 204 is 0.5 to 20 mm. Therefore, the overall length of the protective cap 2045 should be at least 20 mm so that the internal part will not puncture the protective cap 2045.

[0141] In other embodiments of the present invention, the length of the protective cap 2045 is not particularly required; the protective cap 2045 only needs to cover the front end of the internal part. For example, the length of the protective cap 2045 covering the front end of the internal part is 0.5~5mm, which can also achieve protection for the internal part and avoid unnecessary harm to the user. However, during the subsequent transfer and transportation of the analyte detection device 204, the internal part may puncture the protective cap 2045, or the protective cap 2045 may loosen or detach from the internal part, causing the protective cap 2045 to lose its protective effect.

[0142] In some embodiments of the present invention, the protective cap 20452 facing the analyte detection device 204 is coated with an adhesive material. After the user has finished using and removed the analyte detection device 204, the protective cap 2045 can be placed on the internal part, with the internal part placed inside the cavity 20451. The protective cap 20452 is then pressed against the adhesive tape 2046 of the analyte detection device 204. The adhesive material on the protective cap 20452 forms a strong adhesive contact with the adhesive tape 2046, thereby fixing the protective cap 2045 to the adhesive tape 2046. At the same time, the protective cap 2045 covers the internal part, effectively preventing the internal part from causing unnecessary harm to the user. In this embodiment of the present invention, the cavity 20451 is only open on the protective cap 20452 facing the analyte detection device 204, while the opposite side is closed. That is, the cavity 20451 is not a through hole. The closed structure prevents the internal part from being exposed from the protective cap 2045, effectively preventing the internal part from causing unnecessary harm to the user.

[0143] In other embodiments of the present invention, the protective cap 20452 may not be coated with an adhesive material. The adhesive tape 2046 of the analyte detection device 204 is itself adhesive, and a certain amount of adhesiveness remains on the tape 2046 after the user has finished using the analyte detection device 204. By placing the internal part inside the cavity 20451 or piercing the solid protective cap 2045 with the internal part, the protective cap 2045 can be directly pressed against the adhesive tape 2046, and the protective cap 2045 can be adhered to the adhesive tape 2046.

[0144] In the above embodiments, when the protective cap 2045 is fixed to the analyte detection device 204 by adhesive, the protective cap 2045 can be made of non-elastic materials, such as plastic, foam, sponge, etc., which can also effectively prevent the internal parts from causing unnecessary harm to the user.

[0145] Reference Figure 6n , Figure 6n This is a schematic diagram of a protective device for another sensor of the present invention, where w-w' is a cross-sectional view of the protective shell 208.

[0146] In some embodiments of the present invention, the protective device for the in vivo part may also be a protective shell 208 that accommodates the entire analyte detection device 204, the protective shell 208 including a protective shell cavity 2081 for accommodating the analyte detection device 204.

[0147] In some embodiments of the present invention, the shape of the protective shell cavity 2081 is adapted to the shape of the analyte detection device 204, and the internal dimensions of the protective shell cavity 2081 should be slightly larger than the external dimensions of the analyte detection device 204, so that the analyte detection device 204 can be accommodated within the protective shell cavity 2081. Figure 6l Taking the analyte detection device 204 as an example, when the analyte detection device 204 is cylindrical (its cross-section is circular), the protective shell cavity 2081 is also cylindrical, and the inner diameter of the protective shell cavity 2081 is slightly larger than the outer diameter of the analyte detection device 204. For example, the inner diameter of the protective shell cavity 2081 is 1 to 10 mm larger than the outer diameter of the analyte detection device 204.

[0148] In some embodiments of the present invention, reference is made to Figure 6nAs shown, the positioning post 2082 supports the lower outer shell 20413 of the analyte detection device 204. When the analyte detection device 204 is housed within the protective shell cavity 2081, it prevents interference between the internal portion and the lower inner wall of the protective shell cavity 2081, thus ensuring the analyte detection device 204 can enter the protective shell cavity 2081. Therefore, the height of the positioning post 2082 should be at least slightly greater than the length of the internal portion protruding from the lower outer shell 20413. For example, the height of the positioning post 2082 should be 1-5 mm greater than the length of the internal portion protruding from the lower outer shell 20413, allowing the protective shell cavity 2081 to fully accommodate the analyte detection device 204 and preventing interference between the internal portion and the lower inner wall of the protective shell cavity 2081, facilitating the entry of the analyte detection device 204 into the protective shell cavity 2081. In this embodiment, the lower outer shell 20413 of the analyte detection device 204 faces the positioning post 2082.

[0149] In other embodiments of the present invention, the protective shell 208 may not contain the positioning post 2082. The protective shell 208 only needs to have sufficient depth for the analyte detection device 204 to fully enter, and the shell of the protective shell 208 need not be easily punctured by the internal parts. In this embodiment, the analyte detection device 204 can enter the cavity 2081 of the protective shell in any direction.

[0150] In some embodiments of the present invention, the protective shell 208 also requires an encapsulation structure to encapsulate the analyte detection device 204 within the protective shell cavity 2081, so as to prevent the analyte detection device 204 from detaching from the protective shell cavity 2081.

[0151] In some embodiments of the present invention, the encapsulation structure is a beveled buckle 2083 disposed on the protective shell 208. The beveled buckle 2083 is a bevel that gradually thins towards the inside of the protective shell cavity 2081, and its inner diameter D1 is slightly smaller than the outer diameter D2 of the lower outer shell 20413 of the analyte detection device 204. For example, the inner diameter of the beveled buckle 2083 is 0.1~1mm smaller than the outer diameter D2 of the lower outer shell 20413. When the analyte detection device 204 enters the protective shell cavity 2081, the lower outer shell 20413 abuts against the beveled buckle 2083. If the user continues to apply slight pressure to the analyte detection device 204, the lower outer shell 20413 squeezes the beveled buckle 2083, causing the beveled buckle 2083 to bend outward, thus allowing the analyte detection device 204 to enter the protective shell cavity 2081. Once the analyte detection device 204 is fully inserted into the cavity 2081 of the protective shell, the analyte detection device 204 no longer presses against the inclined buckle 2083, the inclined buckle 2083 returns to its original shape, and the upper outer shell 20411 of the analyte detection device 204 is held in place by the inclined buckle 2083. The analyte detection device 204 is placed inside the protective shell 208, and unless there is sufficient external force to bend the inclined buckle 2083, the analyte detection device 204 cannot detach from the protective shell 208, thus providing protection for the internal components.

[0152] In some embodiments of the present invention, considering that when the analyte detection device 204 enters the protective shell cavity 2081, the inclined buckle 2083 needs to bend outward without being damaged, and that the inclined buckle 2083 needs to recover its deformation after entering the protective shell cavity 2081, the material for making the protective shell 208 should have a certain elastic deformation capacity, such as elastic plastic, elastic steel, foam adhesive, and sponge. Considering that the internal part of the analyte detection device 204 cannot puncture the protective shell 208 after entering the protective shell cavity 2081, and taking into account cost factors, the material for making the protective shell 208 is preferably elastic plastic, such as polycarbonate and nylon.

[0153] In this embodiment of the invention, when the inclined buckle 2083 is provided on the protective shell 208, the user's operation of placing the analyte detection device 204 into the protective shell 208 is irreversible. Once the analyte detection device 204 enters the cavity 2081 of the protective shell, it cannot be removed.

[0154] In some other embodiments of the present invention, the protective shell 208 may not have the beveled buckle 2083, and the encapsulation structure is a protective shell cover 2084 that is operably connected to the protective shell 208. After the user places the analyte detection device 204 inside the protective shell 208, the protective shell cover 2084 is then fixed to the protective shell 208 to seal the protective shell cavity 2081, thus encapsulating the analyte detection device 204 inside the protective shell 208.

[0155] In this embodiment of the invention, the protective cover 2084 can be used as a structural component independent of the protective cover 208, and can be fixedly connected to the protective cover 208 by means of threads, adhesive, snaps, etc.

[0156] In other embodiments of the present invention, one side of the protective cover 2084 can be pre-installed on the protective shell 208 via a structure such as a hinge (not shown in the figure), so that the protective cover 2084 is no longer independent of the protective shell 208. When the protective cover 2084 rotates or slides around the movable bolt, the other side of the protective cover 2084 can be opened or closed relative to the protective shell 208. When the protective cover 2084 is closed relative to the protective shell 208, the other side of the protective cover 2084 can be fixed to the protective shell 208 by means of snap-fit, adhesive, etc., to close the protective shell cavity 2081 and encapsulate the analyte detection device 204 inside the protective shell 208. Compared with the inclined snap-fit ​​structure 2083, the user can more conveniently place the analyte detection device 204 inside the protective shell 208.

[0157] In some embodiments of the present invention, when a protective cover 2084 is provided on the protective shell 208, the operation of the user placing the analyte detection device 204 into the protective shell 208 is reversible, and the analyte detection device 204 can be removed after entering the cavity 2081 of the protective shell.

[0158] In some embodiments of the present invention, when a protective cover 2084 is provided on the protective shell 208, the materials of the protective shell 208 and the protective cover 2084 can be selected from a wider range. In addition to the elastic plastics, elastic steels, foam adhesives and sponges described above, they can also be rigid plastics, rubbers, alloys, etc., without specific limitations here.

[0159] In some embodiments of the present invention, whether the protective cap 2045 or the protective shell 208 is used as a protective device for the internal part, it is disposable and is discarded together with the analyte detection device 204.

[0160] In other embodiments of the present invention, the electronic system and sensor 2042 of the analyte detection device 204 are separable, wherein the electronic system is reusable and the sensor 2042 is discarded after use. In embodiments of the present invention, the protective cap 2045 or the protective shell 208 serves as a protective device for the sensor 2042 and is discarded together with the sensor 2042.

[0161] In some embodiments of the present invention, the protective cap 2045 or the protective shell 208 is included in the packaging when the analyte detection device 204 leaves the factory, or is purchased by the user as a separate component or given to the user by the manufacturer.

[0162] Figure 6o for Figure 6l A schematic diagram of the z-z' cross-sectional structure. (Reference) Figure 6o In some embodiments of the present invention, the surface of the substrate 20421 dielectric 2043 facing the pin 20422 can be planar to facilitate the processing of the dielectric 2043. In other embodiments of the present invention, the surface of the dielectric 2043 facing the pin 20422 can also be an inwardly concave curved surface to increase the contact area between the dielectric 2043 and the pin 20422, ensuring the electrical contact performance between the dielectric 2043 and the pin 20422. In embodiments of the present invention, the substrate 20421 can be planar, or it can be rolled into a circle or an arc shape.

[0163] In the above embodiments and their corresponding figures 6o, the relative dimensional relationships of the substrate 20421, pins 20422 and dielectric 2043 are described illustratively only.

[0164] Auxiliary needle module Figure 7 This is a schematic diagram of the auxiliary needle module according to the first embodiment of the present invention.

[0165] In some embodiments of the present invention, the auxiliary needle module 105 includes an auxiliary needle fixing structure 1051 and an auxiliary needle 1052. In the mounting unit 100, the auxiliary needle fixing structure 1051 is located at the distal end, and the auxiliary needle 1052 is located at the proximal end.

[0166] In some embodiments of the present invention, the auxiliary needle fixing structure 1051 includes an auxiliary needle slider 10511 and an auxiliary needle fixing block 10512. The diameter or width of the auxiliary needle slider 10511 is greater than the diameter or width of the auxiliary needle fixing block 10512, forming a convex surface 10513 facing the proximal end.

[0167] In some embodiments of the present invention, the auxiliary needle 1052 includes a fully enclosed needle body 10521 and a semi-enclosed needle body 10522. The fully enclosed needle body 10521 is located between the auxiliary needle fixing block 10512 and the semi-enclosed needle body 10522, and is fixedly connected to the auxiliary needle fixing block 10512. The hollow structure of the semi-enclosed needle body 10522 can be used to accommodate the internal part of the sensor 1042. When the semi-enclosed needle body 10522 is inserted into the user's subcutaneous tissue, the internal part can be inserted into the subcutaneous tissue along with it, and the state of the internal part under the skin is not affected when the needle body is retracted.

[0168] In other embodiments of the present invention, the auxiliary needle 1052 only includes a semi-enclosed needle body 10522, that is, the semi-enclosed needle body 10522 is fixedly connected to the auxiliary needle fixing block 10512. This can reduce the material used in the auxiliary needle 1052 and save costs, but at the same time, it also reduces the rigidity of the auxiliary needle 1052.

[0169] In the mounting unit 100, the auxiliary needle 1052 passes through the second through hole and the first through hole 10414 in sequence, thereby penetrating the analyte detection device 104, and the body part of the sensor 1042 is located in the semi-enclosed needle body 10522.

[0170] Trigger module Figure 8 This is a schematic diagram of the trigger module in the first embodiment of the present invention.

[0171] In some embodiments of the present invention, the trigger module 106 is provided with at least two fixing buckles 1061 corresponding to the first buckle 1012. In the mounting unit 100, the fixing buckles 1061 contact the first buckle 1012 to prevent the first buckle 1012 from bending or folding outwards from the housing. The contact between the fixing buckles 1061 and the first buckle 1012 can be point contact, line contact, or surface contact. When the contact is surface contact, the contact surfaces of the fixing buckles 1061 and the first buckle 1012 form a fixed angle with the horizontal plane and converge at the near end of the mounting unit 100. The number and position of the fixing buckles 1061 are the same as those of the first buckle 1012.

[0172] In some embodiments of the present invention, the trigger module 106 is further provided with at least two latches 1062. In the mounting unit 100, the latches 1062 engage with the slots 1014 to fix the trigger module 106. The number and position of the latches 1062 are consistent with those of the slots 1014. (Refer to reference...) Figure 10a Before the installation unit 100 is used, the ear 1062 is located in the first slot 10141, at which time the fixing buckle 1061 is in contact with the first buckle 1012.

[0173] In some embodiments of the present invention, the trigger module 106 further includes an outer ring 1063, which connects the aforementioned fixing buckle 1061 and the ear 1062 into a whole. In the installation unit 100, the outer ring 1063 is closer to the proximal end relative to the ear 1062, located in the first opening and protruding from the first opening. When using the installation unit 100, the outer ring 1063 conforms to the user's skin surface.

[0174] Elastic module Reference Figure 3 The elastic module 107 includes a first elastic element 1071 and a second elastic element 1072.

[0175] In some embodiments of the present invention, the first elastic element 1071 is located between the parallel slider module 103 and the housing 101, that is, one end of the first elastic element 1071 is located on the far end face of the parallel slider module 103, and the other end is located inside the housing 101. In the mounting unit 100, the first elastic element 1071 is in a compressed state and can provide elastic force.

[0176] In some embodiments of the present invention, the second elastic element 1072 is located between the parallel slider module 103 and the auxiliary needle module 105, that is, one end of the second elastic element 1072 is located on the boss 10322 of the parallel slider module 103, and the other end is located on the convex surface 10513 of the auxiliary needle module 105. In the mounting unit 100, the second elastic element 1072 is in a compressed state and can provide elastic force.

[0177] In a preferred embodiment of the present invention, the first elastic element 1071 or the second elastic element 1072 is a metal spring.

[0178] In some embodiments of the present invention, the inner diameter of the first elastic member 1071 is larger than the outer diameter of the circular groove 1032 and the auxiliary needle slider 10511. In the mounting unit 100, the first elastic member 1071 surrounds the auxiliary needle slider 10511 and the outer side of the circular groove 1032, which can make full use of the internal space of the mounting unit 100.

[0179] In some embodiments of the present invention, the outer diameter of the second elastic member 1072 is larger than the outer diameter of the auxiliary needle fixing block 10512 and the inner diameter of the boss 10322, but smaller than the outer diameter of the auxiliary needle slider 10511 and the inner diameter of the circular groove 1032. Therefore, one end of the second elastic member 1072 is placed in the circular groove 1032, and the other end surrounds the outside of the auxiliary needle fixing block 10512, so that the internal space of the mounting unit 100 can be fully utilized.

[0180] How to use the installation unit Figure 9 This is a top view of the mounting unit according to the first embodiment of the present invention.

[0181] Figure 10a for Figure 9 A schematic diagram of the cross-sectional structure at section A; Figure 10b for Figure 9 A schematic diagram of the B-section structure; Figure 10c for Figure 9 A schematic diagram of the C-section structure; Figure 11 This is a schematic diagram of the first buckle bending under stress.

[0182] Combined with reference Figure 10a and Figure 10bIn some embodiments of the present invention, the card slot 1014 is provided with two card slot positions: a first card slot position 10141 and a second card slot position 10142. Before the installation unit 100 is used, the trigger module 106 is fixed to the housing 101 by the latching action of the first card slot position 10141 through the latching ear 1062. At this time, the fixing latch 1061 contacts the first latch 1012, preventing the first latch 1012 from bending or folding outward from the housing 101. The fixing latch 1061, the first latch 1012, and the second latch 1033 are located on the same horizontal line. In a preferred embodiment of the present invention, from the inside to the outside of the housing 101, the sequence is the second latch 1033, the first latch 1012, and the fixing latch 1061.

[0183] In some embodiments of the present invention, the contact between the fixed buckle 1061 and the first buckle 1012 is one of point contact, line contact or surface contact. When the contact is surface contact, the extension lines m1 of the contact surfaces converge at the proximal end. This structural design allows the fixed buckle 1061 to move towards the distal end relative to the first buckle 1012.

[0184] In a preferred embodiment of the present invention, the coupling surface between the second buckle 1033 and the first buckle 1012 is a plane, which forms a fixed angle with the horizontal plane, and its extended end m2 converges at the proximal end.

[0185] Combined with reference Figure 11 This structural design allows the second latch 1033 to move towards the proximal end relative to the first latch 1012, thereby pushing the first latch 1012 away from the outer side of the housing 101 and releasing the coupling between the first latch 1012 and the second latch 1033.

[0186] In some embodiments of the present invention, the first elastic element 1071 is in a compressed state and has elastic potential energy. Its own elastic force gives the parallel module slider 103 a pushing force Fr towards the proximal end. The pushing force Fr acts on the first buckle 1012 through the coupling surface of the second buckle 1033 and the first buckle 1012, and generates a component force Fsin perpendicular to the plane of the first buckle 1012. This component force Fsin can push the first buckle 1012 outward of the housing 101 and bend or fold it, thereby releasing the coupling state between the first buckle 1012 and the second buckle 1033.

[0187] In some embodiments of the present invention, when using the mounting unit 100, the outer cover 1021 is rotated to break the column 10211, the protective cover 102 is separated from the housing 101, and the proximal end of the mounting unit 100 is brought close to the user's skin until the outer ring 1063 of the trigger module 106 is attached to the skin surface. The user presses the housing 101 at the distal end, the housing 101 moves toward the skin, and the trigger module 106 remains stationary. Therefore, the trigger module 106 moves distally relative to the housing 101, the ear 1062 disengages from the first slot 10141 and enters the second slot 10142, and at the same time the fixing buckle 1061 no longer contacts the first buckle 1012. The first buckle 1012 bends or folds outward toward the housing 101 due to the component force Fsin, and the coupling state between the first buckle 1012 and the second buckle 1033 is released.

[0188] In some embodiments of the present invention, after the coupling is released, the parallel slider module 103 continues to move proximally under the elastic force of the first elastic element 1071, while simultaneously driving the analyte detection device 104 to move proximally until the lower outer shell 10413 of the analyte detection device 104 contacts the user's skin surface.

[0189] Reference Figure 10c In some embodiments of the present invention, the slider buckle 10321 is buckled to the auxiliary needle slider 10511. When the first elastic element 1071 pushes the parallel slider module 103 to move towards the proximal end, it drives the auxiliary needle module 105 to move towards the proximal end as well.

[0190] In some embodiments of the present invention, the connection between the slider latch 10321 and the auxiliary needle slider 10511 is a plane or approximately a plane, which forms a fixed angle with the horizontal plane, and its extension line m3 converges at the distal end. The pushing force of the second elastic member 1072 on the auxiliary needle slider 10511 is directed towards the distal end, so the auxiliary needle slider 10511 can push the slider latch 10321 away from the outside of the housing 101, causing the slider latch 10321 to bend or fold. The principle is equivalent to... Figure 11 .

[0191] In some embodiments of the present invention, in the mounting unit 100, the sidewall of the auxiliary needle limiting groove 1015 prevents the slider buckle 10321 from bending or twisting, and the buckle connection state between the slider buckle 10321 and the auxiliary needle slider 10511 remains unchanged. As the parallel slider module 103 and the auxiliary needle module 105 move towards the proximal end, until the slider latch 10321 disengages from the auxiliary needle limiting groove 1015, the inner wall of the auxiliary needle limiting groove 1015 no longer prevents the slider latch 10321 from bending or folding. The second elastic element 1072 pushes the auxiliary needle slider 10511 towards the distal end, while the auxiliary needle slider 10511 pushes the slider latch 10321 to bend or fold outward. The latching connection between the slider latch 10321 and the auxiliary needle slider 10511 is released. The second elastic element 1072 continues to push the auxiliary needle slider 10511 towards the distal end. Finally, the auxiliary needle module 105 returns to its initial position, and the auxiliary needle 1052 retracts into the housing 101 to prevent the auxiliary needle 1052 from being exposed outside the housing 101 and to avoid unnecessary damage.

[0192] In some embodiments of the present invention, when the slider buckle 10321 disengages from the auxiliary needle limiting groove 1015, the auxiliary needle semi-enclosed needle body 10522 pierces the user's subcutaneous tissue.

[0193] In some embodiments of the present invention, in the installation unit 100, the T-shaped slider 10351 is located in the limiting groove 1013. The limiting groove 1013 restricts the position and direction of the parallel slider module 103 through the T-shaped slider 10351 to ensure that the parallel slider module 103 remains perpendicular to its sliding direction. This ensures that the analyte detection device 104 located at the front end of the parallel slider module 103 remains perpendicular to its movement direction, while the auxiliary needle 1052 remains parallel to its movement direction. This allows the auxiliary needle 1052 and the sensor body portion it envelops to pierce the user's subcutaneous tissue at a vertical angle, reducing the user's pain.

[0194] In some embodiments of the present invention, during the sliding of the parallel slider module 103 toward the proximal end, the T-shaped slider 10351 slides within the limiting groove 1013 until it contacts the outer ring 1063 of the trigger module 106. Under the push of the first elastic member 1071, the parallel slider module 103 continues to move toward the proximal end, while the outer ring 1063 blocks the T-shaped slider 10351 from continuing to move toward the proximal end. Therefore, the T-shaped slider 10351 bends or folds around the vertical part, the snap-fit ​​connection between the T-shaped buckle 10352 and the buckle hole 10412 is released, and the analyte detection device 104 is disengaged from the parallel slider module 103, so that it can be installed on the user's skin surface.

[0195] In some embodiments of the present invention, when the T-shaped slider 10351 contacts the outer ring 1063, the parallel slider module 103 is in a predetermined position, and at this time, the lower outer shell 10413 of the analyte detection device contacts the user's skin surface.

[0196] In some embodiments of the present invention, the auxiliary needle 1052 passes sequentially through the second through hole and the first through hole 10414, and penetrates the analyte detection device 104. Simultaneously, the auxiliary needle's semi-enclosed needle body 10522 surrounds the sensor 1042. During the proximal movement of the parallel slider module 103 and the auxiliary needle module 105, the semi-enclosed needle body 10522 carries the sensor 1042 subcutaneously. After the auxiliary needle 1052 retracts, the internal portion of the sensor 1042 remains subcutaneously, and the retraction of the needle body does not affect the state of the internal portion of the sensor 1042.

[0197] In some embodiments of the present invention, during the installation process, the user needs to press the housing 101 at the distal end, applying a force F towards the proximal end to the housing 101. The outer ring 1063 of the trigger module 106 contacts the user's skin surface, and the user's skin applies a force F' to the outer ring 1063 in the opposite direction to the force F, thereby achieving relative movement between the trigger module 106 and the housing 101. In the actual installation process, the absolute position of the trigger module 106 remains unchanged, while the housing 101 moves towards the proximal end.

[0198] Before installation, to prevent the trigger module 106 from moving relative to the housing 101, a protective cover 102 is installed at the near end of the housing 101. The protective cover 102 surrounds the outer ring 1063 of the trigger module, which can prevent the installation from being performed in the wrong position due to accidental contact with the outer ring 1063, and plays a role in preventing triggering.

[0199] The distal end face 10232 of the inner cover 1023 contacts the analyte detection device 104. At the same time, the auxiliary needle 1052 and the sensor 1042 extend into the groove 10233 of the inner cover, which can play a sealing role to prevent external dust, particles and other dirt from contacting the needle and sensor and causing contamination.

[0200] In some embodiments of the present invention, an adhesive tape (not shown in the figure) is also provided on the lower outer shell 10413 of the analyte detection device for fixing the analyte detection device 104 to the user's skin surface.

[0201] Second Embodiment In the "First Embodiment," an analyte detection device, a mounting unit, and a method of using the mounting unit are described. The sensor's substrate material is selected from one or more combinations of polytetrafluoroethylene (Teflon), polyethylene (PE), polyvinyl chloride (PVC), acrylonitrile-butadiene-styrene copolymer (ABS), polymethyl methacrylate (PMMA), polycarbonate (PC), and polyimide (PI). The substrate material is soft and requires a rigid auxiliary needle to be inserted percutaneously. When the sensor substrate is replaced with a rigid material, such as medical-grade stainless steel, pure metals like titanium, tantalum, and niobium, or their alloys, if the substrate's rigidity is sufficient, an auxiliary needle may not be needed; the sensor itself can be inserted percutaneously. In this solution, the mounting unit no longer requires an auxiliary needle module, the upper shell of the analyte detection device does not need a through-hole for the auxiliary needle, and the elastic module does not need an elastic element to retract the auxiliary needle. The structure of the analyte detection device and the mounting unit will be more streamlined, facilitating miniaturization and reducing costs. The corresponding solution will be described in detail below.

[0202] In the "Second Embodiment", when the rigidity of the sensor substrate is sufficient, for example, the substrate rigidity is not less than 5 N / mm, the proximal end of the body part of the sensor is designed as a tip, and the sensor can be autonomously inserted into the subcutaneous tissue without the need for auxiliary needles or other structures.

[0203] For technical solutions not described in detail in the "Second Embodiment", please refer to the "First Embodiment".

[0204] Installation unit Figure 12 This is an exploded structural diagram of the analytical substance detection device and installation unit according to the second embodiment of the present invention. The dashed lines in the diagram represent the installation and fitting relationships of each structural component.

[0205] refer to Figure 12 In some embodiments of the present invention, the mounting unit 300 includes a housing 301 and a protective cover 302. The housing 301 is used to support internal structural components. When in use, the end of the mounting unit 300 closest to the user's skin is the proximal end, and the end furthest from the skin is the distal end. A first opening is provided at the proximal end of the housing 301. The protective cover 302 is used to protect, seal, and prevent triggering of the internal structure and internal structural components of the housing 301.

[0206] In some embodiments of the present invention, the internal structural components of the mounting unit 300 include a parallel slider module 303, an analyte detection device 304, a trigger module 306, and an elastic module 307. Before using the mounting unit 300, the analyte detection device 304 is pre-installed in the mounting unit 300.

[0207] In some embodiments of the present invention, the protective cover 302 includes an outer cover body 3021, a clamp 3022, and an inner cover body 3023. The outer cover body 3021 has a second opening at its distal end, the second opening facing the first opening. For other structural embodiments of the protective cover 302, please refer to the foregoing text. Figure 1 , Figure 2b The relevant structural descriptions will not be repeated here.

[0208] Figure 13 This is a schematic diagram of the internal structure of the housing 301 according to the second embodiment of the present invention. (Refer to...) Figure 13 In some embodiments of the present invention, at least two first buckles 3012 are provided inside the housing 301. The first buckles 3012 are integrally formed with the housing 301 and protrude towards the proximal end of the housing 301. The first buckles 3012 are made of flexible material and their ends can be bent or folded outward from the housing 301.

[0209] In a preferred embodiment of the present invention, there are two first buckles 3012, which are symmetrically distributed inside the housing 301 and are spaced 180° apart from each other.

[0210] In other preferred embodiments of the present invention, the number of first buckles 3012 is three or four, symmetrically distributed inside the housing 301, with an angular interval of 120° or 90° between them. The number of first buckles 3012 may also be five or more, which is not limited here.

[0211] In some embodiments of the present invention, at least two limiting grooves 3013 and at least two card slots 3014 are also provided inside the housing 301.

[0212] In some embodiments of the present invention, the limiting groove 3013 includes at least two ribs protruding from the inner wall of the housing 301. In a preferred embodiment of the present invention, the ribs are parallel to each other, and a groove is formed between adjacent ribs.

[0213] In other embodiments of the present invention, the limiting groove 3013 is a groove recessed into the inner wall of the housing 301.

[0214] In a preferred embodiment of the present invention, there are two limiting grooves 3013 and two card slots 3014, which are symmetrically distributed inside the housing 301 and are spaced 180° apart from each other.

[0215] In other preferred embodiments of the present invention, the number of limiting grooves 3013 and slots 3014 is three or four, symmetrically distributed inside the housing 301, with an angular interval of 120° or 90° between them. The number of limiting grooves 3013 and slots 3014 may also be five or more, which is not limited here.

[0216] Parallel slider module Figure 14a This is a structural schematic diagram of the distal end face of the parallel slider module 303. Figure 14b This is a structural schematic diagram of the near end face of the parallel slider module 303.

[0217] Reference Figure 14a In some embodiments of the present invention, the distal end surface 3031 of the parallel slider module 303 is provided with a circular groove 3032 protruding to the distal end for limiting the elastic module 307, which will be described in detail below.

[0218] In some embodiments of the present invention, at least two second buckles 3033 are provided on the side of the distal end face 3031 of the parallel slider module 303. The second buckles 3033 are symmetrically distributed on the side of the distal end face 3031, and the angular interval between them is 180°.

[0219] In some embodiments of the present invention, the number of second snap fasteners 3033 is three or four, symmetrically distributed on the side of the distal end face 3031, with an angular interval of 120° or 90° between them. The number of second snap fasteners 3033 may also be five or more, without limitation. In the mounting unit 300, the second snap fasteners 3033 are coupled to the first snap fastener 3012. The position and number of the second snap fasteners 3033 are consistent with those of the first snap fasteners 3012.

[0220] Reference Figure 14b In some embodiments of the present invention, at least two T-shaped structures 3035 are provided on the side of the proximal end face 3034 of the parallel slider module 303. The vertical part of the T-shaped structure 3035 is connected to the proximal end face 3034, and the horizontal part includes a T-shaped structure slider 30351 and a T-shaped structure buckle 30352. The T-shaped structure slider 30351 faces the outer side of the parallel slider module 303 and protrudes from the outer ring of the parallel slider module 303. The T-shaped structure buckle 30352 faces the inner side of the parallel slider module 303 and protrudes from the inner ring of the parallel slider module 303.

[0221] In the mounting unit 300, the T-shaped slider 30351 is located within the limiting groove 3013 to restrict the position of the parallel slider module 303 and prevent the parallel slider module 303 from rotating within the mounting unit 300. The number and position of the T-shaped sliders 30351 are consistent with the limiting groove 3013. During the movement of the parallel slider module 303 towards its proximal end, the T-shaped sliders 30351 slide within the limiting groove 3013.

[0222] In a preferred embodiment of the present invention, the vertical part of the T-shaped structure 3035 is made of flexible material, the vertical part and the horizontal part are integrally formed, and the horizontal part can be bent or flexed around the vertical part.

[0223] In other preferred embodiments of the present invention, the vertical part of the T-shaped structure 3035 is made of an elastic material, such as a spring or a sheet, and the horizontal part is fixedly connected to the vertical part by welding or hot melting processes. The horizontal part can also be bent or flexed around the vertical part.

[0224] Analyte detection device Figure 15a This is a schematic diagram of the analyte detection device with a rigid sensor according to the second embodiment of the present invention. Figure 15b This is a schematic diagram of the exploded structure of the analyte detection device with a rigid sensor according to the second embodiment of the present invention. Figure 15c This is a schematic diagram of the linear rigid sensor structure according to the second embodiment of the present invention. Figure 15d This is a schematic diagram of the bending rigid sensor structure according to the second embodiment of the present invention. Figure 15e-15h This is the second embodiment of the present invention. Figure 15a A schematic diagram of the cross-sectional structure.

[0225] Combined with reference Figure 15a , Figure 15b and Figure 12 In some embodiments of the present invention, the analyte detection device 304 includes a housing 3041, a transmitter, a sensor 3042, a battery, and a circuit board 3044 disposed within the housing 3041 and electrically coupled to the sensor 3042. The sensor 3042 is used to detect analyte parameter information from the user's bodily fluids, and transmits the analyte parameter information to the transmitter via the circuit board 3044, which then sends it to the external device 200.

[0226] In some embodiments of the present invention, the outer casing 3041 includes an upper outer casing 30411 and a lower outer casing 30413, which are joined together to form an internal space. The sensor 3042 includes an external portion and an internal portion. The external portion, transmitter, and circuit board 3044 are disposed within the internal space of the analyte detection device 304, and the external portion is electrically coupled to the circuit board 3044. The internal portion is provided with electrodes and other structures, which can be inserted subcutaneously to detect analyte parameters. When the internal portion is inserted subcutaneously, a correct angle is required, for example, perpendicular to the skin surface. After the analyte detection device 304 reaches the end of its lifespan, it is removed from the user's skin and discarded entirely.

[0227] In some embodiments of the present invention, the proximal end of the outer shell 3041 further includes an adhesive tape 3046 and a release paper 3047. The adhesive tape 3046 is fixedly connected to the lower outer shell 30413 for attaching and fixing the analyte detection device 304 to the skin surface.

[0228] In some embodiments of the present invention, release paper 3047 is used to protect the adhesive material on adhesive tape 3046. Before using the installation unit 300, release paper 3047 is pasted on the adhesive surface of adhesive tape 3046. When using the installation unit, the user needs to first peel off release paper 3047 to expose the adhesive surface of adhesive tape 3046.

[0229] Considering that the analyte detection device 304 is pre-installed in the installation unit 300, if the user peels off the release paper 3047 before using the installation unit 300, it may disturb the internal structure of the installation unit 300 and cause false triggering. Therefore, in some embodiments of the present invention, the release paper 3047 is peeled off before the analyte detection device 304 and the installation unit 300 leave the factory, exposing the adhesive tape 3046. When using the installation unit 300, the user does not need to peel off the release paper 3047, thus avoiding false triggering of the installation unit 300 and ensuring the reliability of the installation unit 300.

[0230] In some embodiments of the present invention, the lower outer shell 30413 includes a through-hole 30414, and the inner portion passes through the first through-hole 30414 to the outside of the outer shell 3041, so as to facilitate insertion under the user's skin. In the embodiments of the present invention, since the sensor 3042 can be inserted into the subcutaneous tissue autonomously, auxiliary needles and other structures are no longer needed. Compared with the first embodiment, the upper outer shell 30411 does not need to have a through-hole.

[0231] In some embodiments of the present invention, the side of the upper outer shell 30411 includes a locking hole 30412 corresponding to the T-shaped structure buckle 30352. Here, "corresponding" means that the position and number of the locking holes 30412 are consistent with the T-shaped structure buckle 30352. In the mounting unit 300, the upper outer shell 30411 is fitted with the proximal end face 3034, and the T-shaped structure buckle 30352 and the locking hole 30412 form a snap-fit ​​connection, and the analyte detection device 304 is fixed on the parallel slider module 303. When the horizontal part of the T-shaped structure bends or flexes around the vertical part, the snap-fit ​​connection between the T-shaped structure buckle 30352 and the locking hole 30412 is released, and the analyte detection device 304 is separated from the parallel slider module 303. Therefore, in the mounting unit 300, the analyte detection device 304 and the parallel slider module 303 are releasable connections.

[0232] In some embodiments of the present invention, the sensor 3042 based on a rigid material includes at least a substrate 30421, a pin (PAD) 30422, an electrode 30423, and a wire 30424 that electrically connects the pin 30422 and the electrode 30423.

[0233] In some embodiments of the present invention, the rigid substrate 30421 may be planar. However, when the planar substrate 30421 is subjected to external forces, such as when a user unpacks the packaging, uses the installation unit 300 for ejection installation, accidentally touches the sensor 3042, or when the sensor 3042 is inserted into the subcutaneous tissue through percutaneous puncture, the substrate 30421 may bend or bend. Furthermore, the rigid material substrate 30421 cannot autonomously return to its original shape after bending or bending, which will still affect the installation and detection accuracy of the sensor 3042.

[0234] Based on the above-mentioned problems, in some embodiments of the present invention, in order to further enhance the rigidity of the substrate 30421 and make it less prone to bending or kinking, the shape of the substrate 30421 can be designed as circular or arc-shaped, specifically including a solid circle, a hollow semi-enclosed arc, or a hollow circle. Under the premise of using the same material and thickness, a circular or arc-shaped substrate has greater structural rigidity than a planar substrate. During percutaneous insertion into the subcutaneous tissue, the sensor 3042 is less prone to bending or kinking, thus increasing the reliability of the sensor 3042.

[0235] In some embodiments of the present invention, electrode 30423 may be a two-electrode system, including working electrode 304231 and counter electrode 304232, or a three-electrode system, including working electrode 304231, counter electrode 304232 and reference electrode 304233, without limitation.

[0236] In other embodiments of the present invention, electrode 30423 may be multiple sets of electrodes, for example, multiple working electrodes 304231 and multiple counter electrodes 304232 are provided. At least one working electrode 304231 and at least one counter electrode 304232 constitute a set of electrodes 30423. Different sets of electrodes 30423 can mutually calibrate analyte detection data, or different sets of electrodes 30423 can be used alternately and in relay. When the service life of a set of electrodes ends, the next set of electrodes takes over from the previous set of electrodes to start detecting analyte parameter information. In the embodiments of the present invention, multiple sets of electrodes can be either a two-electrode system or a three-electrode system, and there is no limitation herein.

[0237] In some embodiments of the present invention, multiple substrates 30421 may be provided in the sensor 3042, and different electrodes 30423, such as working electrode, reference electrode and counter electrode, may be provided on different substrates 30421 respectively.

[0238] In some other embodiments of the present invention, the sensor 3042 has only one substrate 30421, and all electrodes 30423 are disposed on the same substrate 30421.

[0239] In some embodiments of the present invention, the analyte detection device 304 may be provided with multiple sensors 3042, and different electrodes 30423, such as working electrode, reference electrode and counter electrode, may be provided on different sensors 3042 respectively.

[0240] Reference Figure 15c In some embodiments of the present invention, the substrate 30421 is not bent along the XY zigzag line, but is installed in the analyte detection device 304 in a straight line shape. The pin 30422 is located in the X region as the external part, electrically connected to the circuit board 3044 via the dielectric 3043. The electrode 30423 is located in the Y region as the internal part, percutaneously inserted subcutaneously to detect analyte parameters in body fluids. The external and internal parts share a common axis.

[0241] Reference Figure 15d In some embodiments of the present invention, the substrate 30421 can be bent along the XY zigzag line to form a "7" shape (bent type) and installed in the analyte detection device 304. The pin 30422 is located in the X region as the external part, which is laid flat on the circuit board 3044 and electrically connected to it. The external part can be adhered to the circuit board 3044 with insulating adhesive, thus fixing the sensor 3042 in the analyte detection device 304. The electrode 30423 is located in the Y region as the internal part, which is inserted percutaneously into the subcutaneous tissue to detect analyte parameters in body fluids. The external part is perpendicular or approximately perpendicular to the internal part; for example, the angle between the external and internal parts is 50° to 90°. Preferably, the angle between the external and internal parts is 90°, so that when installing the analyte detection device 304, the internal part can be inserted subcutaneously with a substantially perpendicular angle to the skin surface.

[0242] In some embodiments of the present invention, the substrate 30421 of the sensor 3042 is planar, with an external portion length of 0.5-20 mm, an internal portion length of 0.5-100 mm, and a thickness of 0.01-5 mm. In other embodiments of the present invention, the substrate 30421 is cylindrical, with an external portion length of 0.5-20 mm, an internal portion length of 0.5-100 mm, and a diameter of 0.01-5 mm. In this embodiment, the cylindrical shape of the substrate 30421 can be a hollow cylinder, a solid cylinder, or a hollow semi-enclosed cylinder, and is not limited thereto.

[0243] In some embodiments of the present invention, electrode 30423 may be referenced. Figure 6h Arranged on the outer surface of substrate 30421, or refer to Figure 6j It is embedded in the substrate 30421, and there are no restrictions on this.

[0244] In some embodiments of the present invention, dielectric 3043 refers to a material including conductive region 30431 and insulating region 30432, wherein conductive region 30431 enables pin 30422 to establish an electrical connection with circuit board 3044, and insulating region 30432 insulates the conductive paths between different pins 30422 and circuit board 3044 from each other.

[0245] In some embodiments of the present invention, the dielectric 3043 can be a spaced-apart conductive elastic element, such as a conductive metal spring or a conductive metal sheet, where the insulating region 30432 is the air between the conductive regions 30431. In other embodiments of the present invention, the dielectric 3043 can be a strip of adhesive with the conductive regions 30431 and the insulating regions 30432 spaced-apart. Conductive metal particles are incorporated into the insulating material of the adhesive strip to form a continuous conductive strip, which serves as the conductive region 30431. The conductive regions 30431 and the insulating regions 30432 are spaced apart on the adhesive strip. The adhesive strip itself has insulating properties, serving as an insulating strip to insulate the conductive regions 30431 from each other, forming the insulating region 30432. For example, a conductive zebra strip, such as a cubic conductive zebra strip, can achieve multi-path conductivity on adjacent or opposite surfaces, with insulation between the multiple conductive paths achieved by the adhesive strip itself. Of course, conductive zebra strips can be designed into other three-dimensional shapes, such as triangular prisms, spheres, Π shapes, etc., to adapt to different installation sizes, installation methods, and electrical connection and insulation requirements.

[0246] Figure 15e , Figure 15f and Figure 15g for Figure 15a A schematic diagram of the r-r' cross-sectional structure, in Figure 15e , Figure 15f and Figure 15g The internal structure of the analyte detection device 304 has been simplified, such as the electronic components on the circuit board, and the transmitter and battery inside the analyte detection device 304.

[0247] Reference Figure 15e In some embodiments of the present invention, taking the analyte detection device 304 using a bent sensor 3042 as an example, the X region (external part) of the sensor 3042 is laid flat on the circuit board 3044, and the pin 30422 is electrically connected to the conductive contact 30441 on the circuit board 3044 through the dielectric (conductive zebra strip) 3043. At the same time, the external part of the sensor 3042 is attached to the circuit board 3044 with insulating glue to fix the sensor 3042.

[0248] by Figure 15eFor reference, the external part of the sensor 3042 is located on the upper side of the circuit board 3044, while the internal part is bent in the direction of puncture. Therefore, the circuit board 3044 needs to avoid the internal part of the sensor 3042. For example, by designing a through hole 30442 on the circuit board 3044 for the internal part of the sensor 3042 to pass through, or by designing the side of the circuit board 3044 facing the internal part of the sensor 3042 as a concave arc shape to avoid the internal part of the sensor 3042.

[0249] In other embodiments of the present invention, the following continues... Figure 15e With the direction shown as a reference, the external part of the sensor 3042 can also be located on the lower side of the circuit board 3044. In this case, the pin 30422 will be located above the external part of the sensor 3042 to be electrically connected to the circuit board 3044 located above the external part.

[0250] Reference Figure 15f In some embodiments of the present invention, taking the analyte detection device 304 using a linear sensor 3042 as an example, the pins 30422 on the X region (external part) of the sensor 3042 are electrically connected to the conductive contacts 30441 on the circuit board 3044 through a dielectric (conductive zebra strip) 3043. Simultaneously, the external part of the sensor 3042 is fixed to the circuit board 3044, thus securing the sensor 3042. Specifically, a through hole 30442 is provided on the circuit board 3044, and the external part of the sensor 3042 is placed inside the through hole 30442. The sides of the external part are fixed to the inner wall of the through hole 30442 by means of insulating adhesive, forming a fixing structure 30443 on the inner wall of the through hole 30442. In the analyte detection device 304, the linear sensor 3042 is arranged substantially perpendicularly to the circuit board 3044, so that during installation, the sensor 3042 can be vertically inserted percutaneously into the subcutaneous tissue.

[0251] In other embodiments of the present invention, the analyte detection device 304 using a linear sensor 3042 is continued as an example, referring to... Figure 15g The external portion is fixed to the lower surface of the circuit board 3044 by means of insulating adhesive, forming a fixing structure 30443. In this embodiment of the invention, the circuit board 3044 does not need to have through holes, reducing the difficulty of the manufacturing process.

[0252] Reference Figure 15hIn some embodiments of the present invention, taking the analyte detection device 304 using a linear sensor 3042 as an example, a through hole 30442 is provided on the circuit board 3044. The external part of the sensor 3042 passes through the through hole 30442 until it abuts against the upper outer shell 30411, and is fixed to the upper outer shell 30411 by means of adhesive bonding, forming a fixing structure 30414 on the outer shell 3041. Compared to Figure 15f and Figure 15g The embodiment described, in which the sensor 3042 is fixed to the circuit board 3044, allows the sensor 3042 to pass through the circuit board 3044 rather than be fixed to it. This reduces the impact of the sensor 3042 on the circuit board 3044, ensures the operational reliability of the electronic components on the circuit board 3044, and consequently ensures the reliability of the analyte detection device 304.

[0253] In the above Figures 15f to 15h In the described embodiments, since the linear sensors 3042 are all arranged perpendicularly to the circuit board 3044, the conductive and insulating areas of the dielectric 3043 need to be bent in order to establish an electrical connection between the pins 30422 and the conductive contacts 30441.

[0254] Combined with reference Figure 15c In some embodiments of the present invention, the pins 30422 are arranged side by side and spaced apart along the axial direction in the external part, and the electrodes 30423 are arranged side by side and spaced apart along the axial direction in the internal part. This can maximize the utilization of the surface area of ​​the arc-shaped base 30421 to ensure that the pins 30422 have sufficient area to contact the dielectric 3043, and that the electrodes 30423 have sufficient area to contact the body fluid.

[0255] In some embodiments of the present invention, the length of the in vitro portion is 0.5-20 mm, the length of the in vivo portion is 0.5-100 mm, and the diameter of the 30421 substrate is 0.01-5 mm. In a preferred embodiment of the present invention, the length of the in vitro portion is 1-5 mm, the length of the in vivo portion is 5-20 mm, and the diameter of the 30421 substrate is 1-3 mm.

[0256] In some embodiments of the present invention, after the analyte detection device 304 has reached the end of its service life, the user removes the analyte detection device 304 from the skin surface, exposing the internal portion of the rigid substrate. The self-penetrating sensor 3042 also requires protective measures to avoid unnecessary harm to the user or other personnel. Corresponding protective measures can be referred to... Figure 6m and Figure 6n The described embodiments will not be repeated in the "Second Embodiment".

[0257] Trigger module In the "Second Embodiment", the structure of the trigger module 306 is the same as that in the "First Embodiment", and will not be repeated here. Please refer to [the relevant documentation]. Figure 8 The described embodiments.

[0258] Elastic module Reference Figure 12 Since the sensor 304 can puncture the skin autonomously, no auxiliary needle or other structure is needed, and the corresponding auxiliary needle retraction structure can also be omitted. In the "Second Embodiment", the elastic module 307 includes only one elastic element 3071.

[0259] In some embodiments of the present invention, the elastic element 3071 is located between the parallel slider module 303 and the housing 301, that is, one end of the elastic element 3071 is located on the far end face of the parallel slider module 303, and the other end is located inside the housing 301. Before using the mounting unit 300, the elastic element 3071 is in a compressed state and can provide elastic force.

[0260] In a preferred embodiment of the present invention, the elastic element 3071 is a metal spring.

[0261] In some embodiments of the present invention, the elastic element 3071 is taken as a metal spring. (Refer to reference...) Figure 14a In the mounting unit 300, the proximal end of the elastic element 3071 is placed inside or outside the circular groove 3032 of the parallel slider 303. The circular groove 3032 is used to position the elastic element 3071 to prevent the proximal end of the elastic element 3071 from losing its predetermined position before ejection, which would cause the elastic element 3071 to bend and lose its elasticity, thus affecting the use of the mounting unit 300.

[0262] How to use the installation unit In the "Second Embodiment," the changes to the structural components of the mounting unit 300 are the same as those in the "First Embodiment," and will not be repeated here. The differences are described below.

[0263] Combined with reference Figure 12 , Figure 14b , Figure 15aIn some embodiments of the present invention, when using the installation unit 300, the user first separates the protective cover 302 from the housing 301, then places the installation unit 300 on the skin surface and presses the housing 301 to trigger ejection. At this time, the trigger module 306 is pressed into the housing 301, the elastic element 3071 releases its elastic force, and pushes the parallel slider module 303 to slide within the housing 301. The parallel slider module 303 carries the analyte detection device 304 and moves it proximally until the internal part of the sensor 3042 abuts against the skin surface. The elastic element 3071 continues to release its elastic force, pushing the parallel slider module 303. Under the elastic force of the elastic element 3071, the sensor 3042 pierces the skin and enters the subcutaneous tissue. When it reaches the predetermined position, the elastic force of the elastic element 3071 is released, the parallel slider module 303 stops sliding, the T-shaped structure buckle 30352 and the buckle connection of the buckle hole 30412 are released, the analyte detection device 304 disengages from the parallel slider module 303, and the adhesive tape 3046 adheres to the skin surface, fixing the analyte detection device 304 relative to the skin. Afterwards, the user removes the installation unit 300, and the installation unit 300 is no longer in use.

[0264] Third Embodiment Figure 16 This is a schematic diagram illustrating the use of the analyte detection device according to the third embodiment of the present invention.

[0265] Reference Figure 16 In some embodiments of the present invention, the analyte detection device 404 still uses a rigid substrate sensor 4042, which can be autonomously inserted subcutaneously via percutaneous puncture. The analyte detection device 404 no longer requires the assistance of a mounting unit for installation; the user can simply press it with their finger, as described below.

[0266] In some embodiments of the present invention, since the analyte detection device 404 no longer requires the use of a mounting unit, and no mounting unit is provided to protect the analyte detection device 404 at the time of manufacture, the rigid substrate sensor 4042 may cause unnecessary harm to the user before using the analyte detection device 404. Therefore, the protective device of the sensor 4042 can be mounted on the analyte detection device 404 and shipped with the analyte detection device 404. The protective device must be removed before using the analyte detection device 404, which will be described in detail below.

[0267] For details of the protective device plan, please refer to Figure 6m , Figure 6n The details and their corresponding descriptions will not be repeated here.

[0268] In the "Third Embodiment", the structure of the analyte detection device 404 is the same as that in the "Second Embodiment", and will not be described again here.

[0269] In the "Third Embodiment", for technical solutions not described in detail, please refer to the "First Embodiment" and the "Second Embodiment".

[0270] Analyte detection device installation method In some embodiments of the present invention, Figure 6m Taking the protective cap as an example of a protective device for sensor 4042, when installing the analyte detection device 404, the user must first remove the protective cap and peel off the release paper 4047 to expose the adhesive side of the tape 4046. The tape 4046 should be placed with the adhesive side facing the skin, and the tip of sensor 4042 should touch the skin surface. The user should press the upper outer shell 40411 of the analyte detection device with their hand. When the pressure is sufficient, the rigid sensor 4042 can pierce the skin and enter subcutaneously, completing the installation of the analyte detection device 404. Afterward, the upper outer shell 40411 or the tape 4046 can be pressed to ensure a sufficiently firm bond between the tape 4046 and the skin. After the analyte detection device 404 reaches the end of its service life, the user should remove the analyte detection device 404 from the skin surface and then reattach the protective cap to the analyte detection device 404.

[0271] In some embodiments of the present invention, Figure 6n Taking the protective housing shown as a protective device for sensor 4042 as an example, when installing the analyte detection device 404, the user needs to remove the analyte detection device 404 from the protective housing first. Therefore, a protective housing cover should be used as the sealing structure. After removing the analyte detection device 404, the user first peels off the release paper 4047, exposing the adhesive side of the adhesive tape 4046, and places the adhesive side of the adhesive tape 4046 towards the skin, with the tip of the sensor 4042 against the skin surface. The user presses the upper outer shell 40411 of the analyte detection device with their hand. When the pressing pressure is sufficient, the rigid sensor 4042 can pierce the skin and enter subcutaneously, completing the installation of the analyte detection device 404. Afterwards, the user can continue to press the upper outer shell 40411 or the adhesive tape 4046 to ensure that the adhesive tape 4046 adheres firmly to the skin. After the analyte detection device 404 reaches the end of its service life, the user removes the analyte detection device 404 from the skin surface and then places the analyte detection device 404 back into the protective housing.

[0272] In some embodiments of the present invention, the analyte detection device 404 may not be equipped with a protective device when it leaves the factory, and its packaging itself can, to a certain extent, prevent the rigid sensor 4042 from causing unnecessary harm to the user.

[0273] In summary, this invention discloses a sensor protection device for an analyte detection apparatus. The sensor substrate of the analyte detection apparatus is made of a rigid material. During the user's daily activities, the rigid substrate will not bend or shift with muscle peristalsis. After the sensor is inserted percutaneously into the subcutaneous tissue, the sensor on the rigid substrate can remain in its predetermined detection position, ensuring the detection reliability of the analyte detection apparatus. At the same time, the protection device can protect the rigid sensor, avoiding unnecessary harm to the user and improving the user experience.

[0274] While specific embodiments of the invention have been described in detail by way of examples, those skilled in the art should understand that the above examples are for illustrative purposes only and are not intended to limit the scope of the invention. Those skilled in the art should understand that modifications can be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.

Claims

1. A sensor guard for an analyte detection device, the sensor guard comprising: The analyte detection device includes: shell; The sensor is used to detect parameter information of the body fluid analyte; A transmitter, used to send the analyte parameter information to an external device; A circuit board and a battery are disposed within the housing, the circuit board being electrically coupled to the sensor, and the battery being used to provide power to the analyte detection device; Adhesive tape, the adhesive tape being used to attach the analyte detection device to the skin surface; The sensor includes a substrate, pins, electrodes, and wires. The substrate is made of a rigid material and includes an external portion and an internal portion. The pins are disposed on the external part of the body and are used for electrical connection with the circuit board; The electrode is disposed in the body portion and is used to be inserted percutaneously into the subcutaneous tissue to contact body fluids and obtain the analyte parameter information in the body fluids. The wire is disposed on the substrate for electrically connecting the pin and the electrode; and A protective device, which, after the analyte detection device has been used, serves at least to contain the in vivo portion.

2. The sensor guard for an analyte testing device of claim 1, wherein, The rigid material includes at least medical-grade stainless steel, or pure metals such as titanium, tantalum, and niobium, or their alloys.

3. The sensor guard for an analyte testing device of claim 2, wherein, The stiffness of the substrate is not less than 1 N / mm.

4. The sensor protection device for an analyte detection apparatus according to claim 1, characterized in that, The protective device is a protective cap made of elastic material. After the analyte detection device has been used, the protective cap can be operatively assembled with the analyte detection device.

5. The sensor protection device for an analyte detection apparatus according to claim 4, characterized in that, The protective cap is a solid three-dimensional structure, and the internal part is left inside the protective cap after being punctured.

6. The sensor protection device for an analyte detection apparatus according to claim 4, characterized in that, The protective cap includes a cavity for enclosing the internal portion.

7. The sensor protection device for an analyte detection apparatus according to claim 6, characterized in that, The length of the protective cap is not less than the length of the internal portion that protrudes outside the analyte detection device.

8. The sensor protection device for an analyte detection apparatus according to claim 7, characterized in that, The cavity is open on one side facing the analyte detection device and closed on the opposite side.

9. The sensor protection device for an analyte detection apparatus according to claim 7, characterized in that, The length of the cavity is not less than the length of the portion of the body that protrudes outside the analyte detection device.

10. The sensor protection device for an analyte detection apparatus according to claim 6, characterized in that, The inner diameter of the cavity is smaller than the outer diameter of the inner part, and when the cavity encloses the inner part, the cavity and the inner part are interference-fitted.

11. The sensor protection device for an analyte detection apparatus according to claim 4, characterized in that, The protective cap is affixed to the adhesive tape to achieve assembly of the protective cap with the analyte detection device.

12. The sensor protection device for an analyte detection apparatus according to claim 11, characterized in that, The protective cap is coated with an adhesive material on its surface facing the analyte detection device.

13. The sensor protection device for an analyte detection apparatus according to claim 12, characterized in that, The protective cap is made of one of the following materials: plastic, foam, or sponge.

14. The sensor protection device for an analyte detection apparatus according to claim 1, characterized in that, The protective device is a protective shell, which includes a protective shell cavity and an encapsulation structure. After the analyte detection device is used, it is placed inside the protective shell cavity. The inner diameter of the protective shell cavity is larger than the outer diameter of the analyte detection device. The encapsulation structure encapsulates the analyte detection device inside the protective shell cavity to prevent it from detaching from the protective shell cavity.

15. The sensor protection device for an analyte detection apparatus according to claim 14, characterized in that, It also includes a positioning post, which is used to abut against the lower outer shell to prevent the sensor from interfering with the cavity of the protective shell.

16. The sensor protection device for an analyte detection apparatus according to claim 15, characterized in that, The height of the positioning post is not less than the length of the inner part that protrudes from the lower outer shell.

17. The sensor protection device for an analyte detection apparatus according to claim 14, wherein the encapsulation structure is a beveled buckle disposed on the cavity of the protective shell, the beveled buckle abutting against the upper outer shell.

18. The sensor protection device for an analyte detection apparatus according to claim 17, characterized in that, The inclined snap fastener is an inclined surface that gradually thins towards the inside of the cavity of the protective shell.

19. The sensor protection device for an analyte detection apparatus according to claim 18, characterized in that, The inner diameter of the inclined buckle is smaller than the outer diameter of the analyte detection device.

20. The sensor protection device for an analyte detection apparatus according to claim 19, characterized in that, The inner diameter of the inclined buckle is 0.1 to 1 mm smaller than the outer diameter of the analyte detection device.

21. The sensor protection device for an analyte detection apparatus according to claim 18, characterized in that, The protective shell is made of one of the following materials: elastic plastic, elastic steel, foam adhesive, or sponge.

22. The sensor protection device for an analyte detection apparatus according to claim 15, characterized in that, The encapsulation structure is a protective cover, and the protective cover is operably and fixedly connected to the protective shell.

23. The sensor protection device for an analyte detection apparatus according to claim 22, characterized in that, The method of fixing the protective cover to the protective shell includes at least one of the following: threaded, adhesive, or snap-fit.

24. The sensor protection device for an analyte detection apparatus according to claim 22, characterized in that, One side of the protective cover is connected to the protective shell via a movable bolt, and the protective cover can rotate or slide relative to the protective shell around the movable bolt.

25. The sensor protection device for an analyte detection apparatus according to claim 24, characterized in that, The other side of the protective cover can be opened and closed relative to the protective cover.

26. The sensor protection device for an analyte detection apparatus according to claim 25, characterized in that, The connection between the other side of the protective cover and the protective shell includes at least one of adhesive or snap-fit.

27. The sensor protection device for an analyte detection apparatus according to claim 1, characterized in that, When installing the analyte detection device, the analyte detection device is placed on the skin surface with the adhesive side of the adhesive tape facing the skin and the internal part abutting against the skin. The analyte detection device is pressed by hand, and the internal part is inserted percutaneously into the subcutaneous tissue.

28. The sensor protection device for an analyte detection apparatus according to claim 27, characterized in that, The adhesive tape also includes release paper, which is used to protect the adhesive side of the tape before it is applied to the skin.

29. The sensor protection device for an analyte detection apparatus according to claim 1, characterized in that, It also includes an installation unit for mounting the analyte detection device onto the skin surface.

30. The sensor protection device for an analyte detection apparatus according to claim 29, characterized in that, The installation unit includes a housing, a protective cover and a trigger module disposed near the proximal end of the housing, and a parallel slider module and an elastic module disposed inside the housing. The parallel slider module is used to carry the analyte detection device, and the elastic module is used to push the parallel slider module. The elastic module includes an elastic element, and the internal part can be percutaneously inserted into the subcutaneous tissue under the elastic force of the elastic module.

Images