Analyte detection device mounting unit with sterile barrier

Abstract

According to the analyte detection device installation unit with the sterile barrier, before installation is carried out, the subcutaneous penetrating part of an auxiliary needle is contained in a needle body containing cavity of an outer cover body, a main sterile barrier is arranged at the contact position of the outer cover body and a first through hole, and therefore after the subcutaneous penetrating part is subjected to directional irradiation sterilization, the auxiliary needle can penetrate through the needle body containing cavity of the outer cover body; the subcutaneous piercing part is located in a closed sterile environment, germs existing in the unsterilized part in the installation unit cannot enter the sterile environment, the subcutaneous piercing part cannot carry germs again after directional sterilization, health of a user cannot be affected, and use safety of the user is guaranteed.

Description

Technical Field

[0001] This utility model mainly relates to the field of medical devices, and in particular to an analyte detection device mounting unit with a sterile barrier. 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 in real time to an external device for user viewing; this method is called Continuous Glucose Monitoring (CGM). This method requires a device to be attached to the skin surface, and an installer inserts a sensor into the subcutaneous tissue fluid to complete the measurement.

[0004] For devices inserted under the skin, maintaining sterility during insertion is crucial; otherwise, it could seriously harm the user's health or even cause safety issues. Current sterilization methods primarily include gas sterilization and irradiation sterilization. Gas sterilization, such as with ethylene oxide, can have risks. The bio-enzymes on the sensor react chemically with the ethylene oxide gas, affecting their activity and thus monitoring accuracy. Large-area irradiation sterilization may damage the sensor's electronic components, necessitating complex shielding systems in the analyte detection system. When using targeted sterilization of the subcutaneous insertion site, the remaining internal components of the mounting unit may not be sterilized, leaving the subcutaneous insertion site at risk of reinfection with pathogens after sterilization.

[0005] Therefore, there is an urgent need in the existing technology for an analytical device installation unit that can prevent the part inserted under the skin from carrying pathogens again after sterilization. Utility Model Content

[0006] This utility model discloses an analyte detection device installation unit with a sterile barrier. Before installation, the subcutaneous part of the auxiliary needle is housed in the needle housing cavity of the outer cover. A main sterile barrier is provided at the contact position between the outer cover and the first through hole. Therefore, after the subcutaneous part is sterilized by directional irradiation, the subcutaneous part is in a closed sterile environment. Bacteria present in the unsterilized part of the installation unit cannot enter this sterile environment. The subcutaneous part will not carry bacteria again after directional sterilization, and will not affect the user's health, thus ensuring the user's safety.

[0007] This utility model provides an analyte detection device installation unit with a sterile barrier, comprising: a housing and an elastic module, a trigger module, a parallel slider module, an auxiliary needle module, and an analyte detection device pre-installed within the housing; the parallel slider module carries the auxiliary needle module and the analyte detection device, the analyte detection device including a sensor, an upper housing and a lower housing, the sensor including an internal part and an external part, the auxiliary needle module including an auxiliary needle and an auxiliary needle fixing structure, the upper housing having a second through hole, the lower housing having a first through hole, the auxiliary needle enveloping the internal part and passing through the second through hole and the first through hole; and a protective cover, the protective cover being releasably connected to the housing, the protective cover including at least an outer cover body, the outer cover body including a needle body receiving cavity, the auxiliary needle and the internal part being received in the needle body receiving cavity before installation; a main sterile barrier is provided at the contact position between the outer cover body and the first through hole.

[0008] According to one aspect of the present invention, the main sterile barrier is a first elastic pad, which is sleeved on the outside of the auxiliary needle.

[0009] According to one aspect of the present invention, the needle body receiving cavity includes a hollow structure, and the inner diameter of the hollow structure of the needle body receiving cavity decreases from the distal end to the proximal end.

[0010] According to one aspect of the present invention, the needle body receiving cavity protrudes from the outer cover, and the first elastic pad is at least partially received within the needle body receiving cavity.

[0011] According to one aspect of the present invention, a first elastic pad receiving groove is provided on the lower outer shell of the analyte detection device, and the first elastic pad is at least partially received in the first elastic pad receiving groove.

[0012] According to one aspect of the present invention, the analyte detection device mounting unit further includes a secondary sterile barrier, which is one or more of a second sterile barrier, a third sterile barrier, and a fourth sterile barrier.

[0013] According to one aspect of the present invention, a second sterile barrier is disposed at the contact position between the auxiliary needle and the second through hole.

[0014] According to one aspect of the present invention, the second sterile barrier is a second elastic pad.

[0015] According to one aspect of the present invention, the upper housing of the analyte detection device is provided with a second elastic pad receiving groove and / or the auxiliary needle fixing structure is provided with a second elastic pad receiving groove, wherein the second elastic pad is at least partially received in the second elastic pad receiving groove.

[0016] According to one aspect of the present invention, a third sterile barrier is disposed between the parallel slider and the analyte detection device.

[0017] According to one aspect of this invention, the third sterile barrier is a sealing ring.

[0018] According to one aspect of the present invention, the upper outer shell of the analyte detection device is provided with a sealing ring receiving groove and / or the near end face of the parallel slider is provided with a sealing ring receiving groove, wherein the sealing ring is at least partially disposed in the sealing ring receiving groove.

[0019] According to one aspect of the present invention, the fourth sterile barrier is a third elastic pad, the two ends of which respectively abut against the second through hole and the first through hole of the analyte detection device.

[0020] According to one aspect of the present invention, the outer cover is provided with a plurality of protrusions, which are symmetrically arranged around the needle receiving cavity.

[0021] According to one aspect of the present invention, the protective cover further includes an inner cover body, which is used to be assembled on the proximal end of the mounting unit after the mounting unit is used.

[0022] According to one aspect of the present invention, the elastic module includes a first elastic element, a second elastic element, and a third elastic element, wherein the third elastic element is located between the housing and the auxiliary needle module.

[0023] Compared with the prior art, the technical solution of this utility model has the following advantages:

[0024] The analytical device installation unit with a sterile barrier disclosed in this utility model has, before installation, a subcutaneous portion of the auxiliary needle housed in the needle housing cavity of the outer cover. A main sterile barrier is provided at the contact position between the outer cover and the first through hole. Therefore, after the subcutaneous portion is sterilized by directional irradiation, the subcutaneous portion is in a closed sterile environment. Bacteria present in the unsterilized portion within the installation unit cannot enter this sterile environment. The subcutaneous portion will not carry bacteria again after directional sterilization, and will not affect the user's health, thus ensuring the user's safety.

[0025] Furthermore, the needle receiving cavity protrudes from the surface of the outer cover, and the first elastic pad is at least partially contained in the needle receiving cavity. On the one hand, this better achieves longitudinal and lateral sealing of the subcutaneous portion, and on the other hand, it increases the distance between the adhesive tape of the analyte detection device and the surface of the outer cover, preventing the adhesive tape from sticking to the analyte detection device.

[0026] Furthermore, a second sterile barrier is provided at the contact position between the auxiliary needle and the second through hole of the analyte detection device to prevent pathogens inside the shell from entering the needle body cavity vertically through the second through hole, thus preventing the subcutaneous part from carrying pathogens.

[0027] Furthermore, a third sterile barrier is provided between the parallel slider and the analyte detection device to prevent pathogens inside the shell from entering the second through hole through the gap between the parallel slider and the analyte detection device, and then entering the needle body cavity vertically through the second through hole, so that the subcutaneous part carries pathogens.

[0028] Furthermore, a fourth sterile barrier is provided inside the analyte detection device. The fourth sterile barrier is a third elastic pad. The upper and lower ends of the third elastic pad abut against the second through hole and the first through hole of the analyte detection device, respectively, to prevent pathogens inside the analyte detection device from entering the needle cavity in the vertical direction through the second through hole, so that the subcutaneous part carries pathogens.

[0029] Furthermore, the lower outer shell of the analyte detection device is also provided with a first elastic pad receiving groove. The first elastic pad can be set in the needle body receiving cavity and / or the first elastic pad receiving groove. On the one hand, it can better achieve longitudinal and transverse sealing of the subcutaneous part. On the other hand, after installation and retraction of the auxiliary needle, the first elastic pad presses on the wound caused by the auxiliary needle to prevent blood from flowing into the interior of the analyte detection device and causing contamination of the analyte detection device, while accelerating wound healing.

[0030] Furthermore, the outer cover surface is provided with multiple protrusions, symmetrically distributed around the needle receiving cavity. On the one hand, this can stably support the analyte detection device and prevent the parallel slider from not properly engaging with the analyte detection device, causing the analyte detection device to fall off. On the other hand, it increases the distance between the adhesive tape of the analyte detection device and the surface of the outer cover, changing the surface contact with the adhesive tape to point contact, thus preventing the adhesive tape from sticking to the analyte detection device.

[0031] Furthermore, the protective cover consists of an outer cover and an inner cover. The outer cover is used to assemble near the end of the installation unit before use to protect the components inside the housing. The inner cover is used to assemble near the end of the installation unit after the tip of the auxiliary needle is exposed outside the housing of the installation unit during use. As a needle protection structure, it protects the exposed auxiliary needle, avoids unnecessary harm to the user, and improves the safety and reliability of the installation unit.

[0032] Furthermore, the elastic module within the mounting unit includes a first elastic element, a second elastic element, and a third elastic element. The third elastic element is located between the housing and the auxiliary pin module. The retraction stroke of the auxiliary pin can be adjusted according to the initial length and elastic modulus of the third and second elastic elements, thereby adjusting the length of the auxiliary pin protruding outside the housing. Attached Figure Description

[0033] Figure 1 This is a schematic diagram of the external structure of the analyte detection device mounting unit according to an embodiment of the present invention;

[0034] Figure 2a This is a schematic diagram of the external structure of the housing according to an embodiment of the present utility model;

[0035] Figure 2b This is a schematic diagram of the structure of the protective cover according to an embodiment of the present utility model;

[0036] Figure 3 This is an exploded structural diagram of the installation unit of the analytical material detection device according to an embodiment of the present invention;

[0037] Figure 4 This is a schematic diagram of the internal structure of the housing according to an embodiment of the present utility model;

[0038] Figure 5a This is a structural schematic diagram of the distal end face of the parallel slider module according to an embodiment of the present invention;

[0039] Figure 5b This is a schematic diagram of the near-end face of the parallel slider module according to an embodiment of the present invention;

[0040] Figure 6 This is a schematic diagram of the analyte detection device according to an embodiment of the present invention;

[0041] Figure 7 This is a schematic diagram of the auxiliary needle module according to an embodiment of the present utility model;

[0042] Figure 8 This is a schematic diagram of the trigger module according to an embodiment of the present utility model;

[0043] Figure 9 This is a top view of the installation unit according to an embodiment of the present utility model;

[0044] Figure 10a for Figure 9 A schematic diagram of the cross-sectional structure at section A;

[0045] Figure 10b for Figure 9 A schematic diagram of the B-section structure;

[0046] Figure 10c for Figure 9 A schematic diagram of the C-section structure;

[0047] Figure 11 This is a schematic diagram of the first buckle under stress and bending according to an embodiment of the present utility model;

[0048] Figure 12 This is an exploded structural diagram of the installation unit of the analytical material detection device according to an embodiment of the present invention;

[0049] Figure 13a This is a schematic diagram of the separation structure of the outer cover and the inner cover according to an embodiment of the present utility model;

[0050] Figure 13b This is a schematic diagram of the integrated structure of the outer cover and the inner cover according to an embodiment of the present utility model;

[0051] Figure 13c This is a schematic diagram of the structure of the outer cover according to an embodiment of the present utility model;

[0052] Figure 14 This is a schematic diagram showing the state of the installation unit after use according to an embodiment of the present utility model;

[0053] Figure 15 This is a schematic diagram showing the state of the auxiliary pin of the installation unit after retraction according to an embodiment of the present invention;

[0054] Figures 16a-16c This is a schematic diagram of the inner cover serving as a protective structure for the needle according to an embodiment of the present invention;

[0055] Figure 17 This is a cross-sectional structural diagram of the installation unit according to an embodiment of the present utility model;

[0056] Figures 18a-18c This is a schematic diagram of the protective sleeve serving as a needle protection structure according to an embodiment of the present utility model;

[0057] Figure 19a This is a cross-sectional structural diagram of the installation unit during sterilization according to an embodiment of the present invention;

[0058] Figure 19b This is a schematic cross-sectional view of the installation unit after sterilization according to an embodiment of the present invention;

[0059] Figure 20 This is a schematic diagram of the structure of the first elastic pad receiving groove provided in the lower shell of the analytical material detection device according to an embodiment of the present invention. Detailed Implementation

[0060] As mentioned earlier, when existing technologies perform targeted sterilization on the subcutaneous insertion portion, there is a risk that the subcutaneous insertion portion may still carry pathogens again after sterilization because other parts inside the installation unit housing are not sterilized.

[0061] To address this issue, this invention provides an analyte detection device installation unit with a sterile barrier. Before installation, the subcutaneous portion of the auxiliary needle is housed within the needle housing cavity of the outer cover. A primary sterile barrier is provided at the contact point between the outer cover and the first through hole. Therefore, after the subcutaneous portion is sterilized by directional irradiation, it remains in a closed sterile environment. Pathogens present in the unsterilized portion within the installation unit cannot enter this sterile environment. The subcutaneous portion will not carry pathogens again after directional sterilization, thus not affecting the user's health and ensuring user safety.

[0062] 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 present invention.

[0063] 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.

[0064] The following description of exemplary embodiments is merely illustrative and is not intended to limit the present 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.

[0065] It should be noted that similar reference numerals 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.

[0066] First Embodiment

[0067] Figure 1 This is a schematic diagram of the external structure of the mounting unit of the analyte detection device according to an 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.

[0068] External casing

[0069] Figure 2a This is a schematic diagram of the external structure of the shell according to an 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.

[0070] 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.

[0071] 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 triggering prevention function will be further explained below.

[0072] In other embodiments of this utility model, the outer cover 1021 and the inner cover 1023 can also be fixedly connected by friction engagement or snap-fit ​​engagement.

[0073] In other embodiments of this utility model, the clamp 1022 and the housing 101 can also be connected by friction fit, snap fit or threaded fit.

[0074] Inside the shell

[0075] Figure 3 This is an exploded structural diagram of the analytical substance detection device mounting unit according to an embodiment of the present invention. The dashed lines in the diagram indicate the installation and fitting relationships of the various structural components. 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.

[0076] Figure 4 This is a schematic diagram of the internal structure of the housing 101 in an embodiment of the present invention.

[0077] In this embodiment 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.

[0078] In a preferred embodiment of this utility model, there are two first buckles 1012, which are symmetrically distributed inside the housing 101 and are spaced 180° apart from each other.

[0079] In other preferred embodiments of this utility model, 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, which is not limited here.

[0080] In this embodiment of the utility model, 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.

[0081] In this embodiment of the 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 invention, the ribs are parallel to each other, and a groove is formed between adjacent ribs.

[0082] In other embodiments of this utility model, the limiting groove 1013 is a groove recessed into the inner wall of the housing 101.

[0083] In this embodiment of the utility model, the card slot 1014 includes two card slot positions, namely the first card slot position 10141 and the second card slot position 10142, as follows: Figure 10a As shown, the first card slot 10141 is closer to the proximal end than the second card slot 10142.

[0084] In a preferred embodiment of this utility model, 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.

[0085] In other preferred embodiments of this utility model, 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.

[0086] Parallel slider module

[0087] 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.

[0088] In this embodiment of the 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 side wall of the circular groove 1032. The latching part of the slider latch 10321 is planar or approximately planar and forms a fixed angle with the horizontal plane. Its extended ends m0 converge at the distal end.

[0089] In this embodiment of the utility model, the slider buckle 10321 is made of flexible material, so it can be bent or folded to the outside of the circular groove 1032.

[0090] In other embodiments of this utility model, the slider buckle 10321 can be directly set on the far end face of the parallel slider module 103 without the need for a circular groove structure.

[0091] In this embodiment of the 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.

[0092] In a preferred embodiment of this utility model, 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°.

[0093] In other preferred embodiments of this utility model, the number of slider buckles 10321 can be three or four, symmetrically distributed on the sidewall of the circular groove 1032, and the angular interval between the slider buckles 10321 is 120° or 90°. The number of slider buckles 10321 can also be five or more, which is not limited here.

[0094] Continue to refer to Figure 5a In this embodiment of the utility model, at least two second buckles 1033 are provided on the side of the far end face 1031 of the parallel slider module 103. The second buckles 1033 are symmetrically distributed on the side of the far end face 1031, and the angle interval between them is 180°.

[0095] In other embodiments of this utility model, the number of second snap fasteners 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 fasteners 1033 may also be five or more, without limitation. In the mounting unit 100, the second snap fasteners 1033 are coupled to the first snap fasteners 1012. The position and number of the second snap fasteners 1033 are consistent with those of the first snap fasteners 1012.

[0096] Reference Figure 5b In this embodiment of the present invention, at least two T-shaped structures 1035 are provided on the side of the near end face 1034 of the parallel slider module 103. The vertical part of the T-shaped structure 1035 is connected to the near 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.

[0097] 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 sliding of the parallel slider module 103 towards its proximal end, the T-shaped sliders 10351 slide within the limiting groove 1013.

[0098] In a preferred embodiment of this utility model, the vertical part of the T-shaped structure 1035 is made of flexible material, and the vertical part and the horizontal part are integrally formed. The horizontal part can be bent or flexed around the vertical part.

[0099] In other preferred embodiments of this utility model, 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.

[0100] Analyte detection device

[0101] Figure 6 This is a schematic diagram of the analyte detection device according to an embodiment of the present invention.

[0102] Combined with reference Figure 3In this embodiment of the invention, the analyte detection device 104 includes a housing 1041, a transmitter (not shown in the figure), a sensor 1042, and an internal circuit (not shown in the figure) disposed within the housing 1041 and electrically coupled to the sensor. 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 through the internal circuit, and then the transmitter sends it to the external device 200.

[0103] In a preferred embodiment of this 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 this utility model, the first frequency f 1 represents 0-12 times / hour, the second frequency. f 2 represents 12 to 3600 times per hour.

[0104] In a more preferred embodiment of this utility model, the first frequency f 1 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.

[0105] In this embodiment of the invention, the outer shell 1041 includes an upper outer shell 10411 and a lower outer shell 10413, which are joined together to form an internal space. The sensor 1042 includes an external part (not shown in the figure) and an internal part (not shown in the figure). The external part, the transmitter, and the internal circuit are disposed in the internal space, and the external part is electrically coupled to the internal circuit. The internal part is provided with electrodes, membranes, and other structures, and can detect analyte parameters by inserting it under the user's skin. When the internal part is inserted under the skin, a correct angle is required, such as 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 surface and discarded as a whole.

[0106] In this embodiment 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.

[0107] In this embodiment of the 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 to the near end face 1034, and the T-shaped structure buckle 10352 and the locking hole 10412 form a locking 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 locking 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.

[0108] Auxiliary needle module

[0109] Figure 7 This is a schematic diagram of the auxiliary needle module in an embodiment of the present invention.

[0110] In this embodiment of the 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.

[0111] In this embodiment of the utility model, 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.

[0112] In this embodiment of the 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.

[0113] In other embodiments of this utility model, 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.

[0114] 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.

[0115] Trigger module

[0116] Figure 8 This is a schematic diagram of the trigger module in an embodiment of the present invention.

[0117] In this embodiment of the 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.

[0118] In this embodiment of the 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 secure 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.

[0119] In this embodiment of the 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 mounting unit 100, the outer ring 1063 is closer to the proximal end relative to the ear 1062, located at the first opening and protruding from the first opening. When using the mounting unit 100, the outer ring 1063 fits against the user's skin surface.

[0120] Elastic module

[0121] Reference Figure 3 The elastic module 107 includes a first elastic element 1071 and a second elastic element 1072.

[0122] In this embodiment 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.

[0123] In this embodiment 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.

[0124] In a preferred embodiment of this utility model, the first elastic element 1071 or the second elastic element 1072 is a metal spring.

[0125] In this embodiment 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.

[0126] In this embodiment 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.

[0127] How to use the installation unit

[0128] Figure 9 This is a top view of the installation unit in an embodiment of the present invention.

[0129] 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.

[0130] Combined with reference Figure 10a and Figure 10bIn this embodiment 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 the 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.

[0131] In this embodiment of the utility model, 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 near end. This structural design allows the fixed buckle 1061 to slide relative to the first buckle 1012 to the far end.

[0132] In a preferred embodiment of this utility model, 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 near end.

[0133] Combined with reference Figure 11 This structural design allows the first buckle 1012 to be pushed away from the outer side of the housing 101 when the second buckle 1033 slides towards the proximal end relative to the first buckle 1012, thereby releasing the coupling between the first buckle 1012 and the second buckle 1033.

[0134] In this embodiment 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.

[0135] In this embodiment of the utility model, when using the installation unit 100, the outer cover 1021 is rotated to break the column 10211, and the protective cover 102 is separated from the housing 101. The proximal end of the installation 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, and the housing 101 slides toward the skin. The trigger module 106 remains stationary, so the trigger module 106 slides distally relative to the housing 101. The ear 1062 disengages from the first slot 10141 and enters the second slot 10142. 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.

[0136] In this embodiment of the present invention, after the coupling is released, the parallel slider module 103 continues to slide towards the proximal end under the elastic force of the first elastic element 1071, while simultaneously driving the analyte detection device 104 to slide towards the proximal end until the lower outer shell 10413 of the analyte detection device 104 contacts the user's skin surface.

[0137] Reference Figure 10c In this embodiment of the utility model, 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 slide towards the proximal end, it drives the auxiliary needle module 105 to slide towards the proximal end as well.

[0138] In this embodiment of the 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 element 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 outward from the housing 101, causing the slider latch 10321 to bend or fold. The principle is equivalent to... Figure 11 .

[0139] In this embodiment of the utility model, in the installation unit 100, the side wall 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 slide 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.

[0140] In this embodiment of the utility model, when the slider buckle 10321 disengages from the auxiliary needle limiting groove 1015, the auxiliary needle semi-encloses the needle body 10522 and pierces the user's subcutaneous tissue.

[0141] In this embodiment 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 sliding direction, while the auxiliary needle 1052 remains parallel to its sliding direction. This allows the auxiliary needle 1052 and the sensor body portion it encloses to pierce the user's subcutaneous tissue at a vertical angle, reducing the user's pain.

[0142] In this embodiment 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 slide toward the proximal end, while the outer ring 1063 blocks the T-shaped slider 10351 from continuing to slide 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.

[0143] In this embodiment 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.

[0144] In this embodiment of the 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 sliding of the parallel slider module 103 and the auxiliary needle module 105 towards the proximal end, 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 does not affect the state of the internal portion of the sensor 1042.

[0145] In this embodiment of the invention, during installation, 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 sliding between the trigger module 106 and the housing 101. During actual installation, the absolute position of the trigger module 106 remains unchanged, while the housing 101 slides towards the proximal end.

[0146] Before installation, to prevent the trigger module 106 from sliding 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.

[0147] 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.

[0148] In this embodiment of the invention, an adhesive tape (not shown in the figure) is also provided on the lower outer shell 10413 of the analyte detection device to fix the analyte detection device 104 to the user's skin surface.

[0149] Second Embodiment

[0150] In the aforementioned embodiments, after the user uses the installation unit, the auxiliary needle automatically retracts into the housing under the action of the second elastic element to avoid causing unnecessary injury to the user. The complete retraction of the auxiliary needle into the housing requires sufficient height within the housing to accommodate the auxiliary needle module, which limits the miniaturization design of the installation unit. To further reduce the overall height of the installation unit's housing and decrease its volume, this embodiment of the invention considers reducing the retraction stroke of the auxiliary needle. However, with a reduced retraction stroke, the needle tip may be exposed outside the installation unit's housing, which is unsafe for the user. Therefore, protective measures for the auxiliary needle must be considered, and a needle body protection structure must be designed for it.

[0151] Against the aforementioned technical background, in some embodiments of this utility model, after the user installs the analyte monitoring device using the mounting unit, the auxiliary needle is not completely retracted into the housing; at least a portion of the auxiliary needle, such as the needle tip, protrudes outside the housing. The user assembles a needle protection structure onto the mounting unit to protect the exposed needle tip. Specific implementations of the needle protection structure will be described in detail below.

[0152] In this embodiment of the utility model, any technical solutions not described are considered to be the same as those in the foregoing embodiments, and will not be repeated here.

[0153] Figure 12 This is an exploded structural diagram of the installation unit of the analytical substance detection device according to an embodiment of this utility model. Figure 13a This is a schematic diagram of the separation structure of the outer cover and the inner cover in an embodiment of the present utility model. Figure 13b This is a schematic diagram of the integrated structure of the outer cover and the inner cover in an embodiment of the present utility model. Figure 13c This is a schematic diagram of the structure of the outer cover of an embodiment of the present utility model.

[0154] Reference Figure 12 In some embodiments of this utility model, the mounting unit 200 includes a housing 201 and a protective cover 202. As mentioned above, before installation, the analyte detection device 204 is pre-installed inside the housing 201. During installation, it is supported by an elastic module (not shown in the figure, see reference). Figure 17 The protective cap 202 is located at the proximal end of the housing 201 and is releasably connected to the housing 201 to protect the internal structural components of the housing 201 before installation.

[0155] Combined with reference Figures 13a-13cIn some embodiments of this utility model, the protective cover 202 includes an outer cover 2021, an inner cover 2023, and a label 2024. According to the relative positional relationship shown in FIG13, before installation, the inner cover 2023 is accommodated in the outer cover cavity 20214, and the label 2024 is used to seal the outer cover cavity 20214 to seal the inner cover 2023 in the outer cover cavity 20214.

[0156] In some embodiments of this utility model, the inner cover 2023 is in a movable or releasable connection state relative to the outer cover 2021. When the inner cover 2023 is in a movable state relative to the outer cover 2021, the outer cover 2021 has no constraint structure to restrict the state of the inner cover 2023 within the outer cover 2021. When needed, the user can directly remove the inner cover 2023 from the outer cover 2021. When the inner cover 2023 is in a releasable connection state relative to the outer cover 2021, the inner cover 2023 and the outer cover 2021 are fixed together by means of buckles, hooks, threads, Velcro, etc. When needed, the user must first release the fixed connection between the inner cover 2023 and the outer cover 2021, and after the inner cover 2023 and the outer cover 2021 are separated, the inner cover 2023 can be removed from the outer cover 2021. In a preferred embodiment of this utility model, in order to facilitate user use, before using the installation unit 200, the inner cover 2023 is in a movable state relative to the outer cover 2021, so that the user can remove the inner cover 2023 from the outer cover 2021 when using the installation unit 200.

[0157] In some embodiments of this utility model, in order to accommodate the inner cover 2023 within the outer cover 2021, the middle portion of the outer cover 2021 protrudes distally, forming a proximal opening outer cover cavity 20214. The inner diameter of the outer cover cavity 20214 is slightly larger than the outer diameter of the inner cover 2023. For example, a gap of 0.5~5mm is left between the inner wall of the outer cover cavity 20214 and the outer wall of the inner cover 2023. At the same time, the depth of the outer cover cavity 20214 is not less than the height of the inner cover 2023, to prevent the inner cover 2023 from protruding beyond the outer cover cavity 20214, so that the label 2024 can be pasted onto the proximal end face 20215 of the outer cover 2021, thus sealing the outer cover cavity 20214.

[0158] In some embodiments of this utility model, a plurality of protruding hemispherical spheres 20234 are further provided on the proximal end face 20232 of the inner cover 2023. Before using the installation unit 200, the inner cover 2023 is accommodated in the cavity 20214 of the outer cover, and the label 2024 is pasted on the proximal end face 20215 of the outer cover 2021. The adhesive coating area of ​​the label 2024 may extend beyond the contact area between the label 2024 and the outer cover 2021, causing the adhesive coating of the label 2024 to contact the proximal end face 20232 of the inner cover 2023. The inner cover 2023 and the label 2024 are stuck together. When removing the inner cover 2023, it is difficult for the user to tear off the label 2024, and the label 2024 may even be damaged when being torn off, sticking to the inner cover 2023, affecting the user's experience. Based on this, multiple raised hemispherical spheres 20234 are provided on the near end face 20232 of the inner cover 2023 to contact the label paper 2024. This reduces the contact area between the near end face 20232 of the inner cover 2023 and the label paper 2024, thus preventing the label paper 2024 from adhering to the near end face 20232 of the inner cover 2023 over a large area, making it easier for users to remove the label paper 2024.

[0159] In some embodiments of this invention, the number of protruding hemispherical spheres 20234 is at least two, symmetrically or asymmetrically distributed on the proximal surface of the inner cover 2023. Preferably, the protruding hemispherical spheres 20234 are symmetrically and uniformly distributed on the proximal surface of the inner cover 2023.

[0160] In some embodiments of this utility model, information related to the analyte detection device 204, the mounting unit 200, and other equipment can be printed on the label paper 2024, such as production batch number, production date, instructions for use, communication connection SN code, trademark, QR code, etc.

[0161] In some embodiments of this utility model, before using the mounting unit 200, the protective cover 202 and the housing 201 can be releasably connected. The specific usage has been described in the first embodiment and will not be repeated here. When the protective cover 202 is installed on the housing 201, the needle receiving cavity 20213 on the outer cover 2021 can accommodate the auxiliary needle 2052. The needle receiving cavity 20213 is an opening facing the distal end. Figure 13aThe needle body receiving cavity 20213 can be a hollow frustum or cone with a visible distal opening. When the cavity is conical, its diameter gradually decreases from the distal to the proximal end. The interior of the needle body receiving cavity 20213 can be a hollow structure parallel to the external structure, or it can be a hollow structure with an inner diameter decreasing from the distal to the proximal end. The auxiliary needle 2052 shares a central axis with the needle body receiving cavity 20213, allowing the auxiliary needle 2052 to enter the hollow cavity from the distal opening of the cavity 20213. The needle body receiving cavity 20213 protects the auxiliary needle 2052 while effectively utilizing the internal space of the shell 201, resulting in a more compact structure.

[0162] Figure 14 This is a schematic diagram showing the state of the installation unit after use in an embodiment of this utility model.

[0163] Reference Figure 14 In some embodiments of this utility model, the user places the installation unit 200 on the skin surface, the trigger module 206 contacts the skin, and the user applies pressure to the installation unit 200 from the distal end to the proximal end. The outer shell 201 slides proximally relative to the trigger module 206. During the process of the outer shell 201 sliding proximally relative to the trigger module 206, the trigger module 206 releases the restriction of the elastic module (not shown in the figure). Under the elastic force of the elastic module, the parallel slider module 203, the analyte detection device 204 and the auxiliary needle 2052 are pushed together to the proximal end until the analyte detection device 204 contacts the skin surface and the auxiliary needle 2052 pierces the subcutaneous tissue.

[0164] Reference Figure 14 In some embodiments of this invention, as shown in the direction indicated, during the process of the parallel slider module 203, the analyte detection device 204, and the auxiliary needle 2052 sliding proximally together, when the proximal surface of the analyte detection device 204 is flush with the proximal surface of the trigger module 206, the elastic module still exerts a proximal pushing force on the parallel slider module 203 while the analyte detection device 204 is in contact with the user's skin surface. The parallel slider module 203, carrying the analyte detection device 204 and the auxiliary needle 2052, continues to slide proximally relative to the housing 201. The analyte detection device 204, located proximally on the parallel slider module 203, presses against the skin surface. An adhesive tape (not shown in the figure) is provided proximally on the analyte detection device 204. Pressing the adhesive tape against the skin surface increases the adhesion between the tape and the skin, allowing the analyte detection device 204 to adhere more firmly to the skin surface.

[0165] In some embodiments of this utility model, as the parallel slider module 203 continues to slide proximally relative to the housing 201, the position of the parallel slider module 203 no longer changes due to the obstruction of the skin surface. If the elastic element in the elastic module still has elastic force that has not been fully released, the elastic module pushes the housing 201 to slide distally relative to the parallel slider module 203, and carries the trigger module 206 away from the skin surface until the proximal end face of the trigger module 206 and the proximal end face of the parallel slider module 203 form a height difference h1. Under the squeezing action of the analyte detection device 204 and the parallel slider module 203, a pit is formed on the skin surface.

[0166] In some embodiments of this utility model, as the parallel slider module 203 continues to slide proximally relative to the housing 201, the snap-fit ​​connection between the parallel slider module 203 and the analyte detection device 204 is decoupled. When the relative sliding between the parallel slider module 203 and the housing 201 terminates, the parallel slider module 203 has been separated from the analyte detection device 204, while the parallel slider module 203 is still confined within the housing 201. At this time, the analyte detection device 204 is in a separated state relative to the housing 201, and the user can lift the housing 201 distally by hand, and the analyte detection device 204 is attached to the skin surface with adhesive tape.

[0167] In some embodiments of this invention, when the parallel slider module 203 slides proximally to a first predetermined position relative to the housing 201, the auxiliary needle module 205 slides proximally to an endpoint relative to the housing. At this point, the auxiliary needle 2052 pierces the subcutaneous tissue, and the internal portion of the sensor 2042 is delivered to a predetermined subcutaneous depth. Subsequently, the auxiliary needle module 205 retracts and slides distally to a second predetermined position relative to the housing 201.

[0168] Figure 15 This is a schematic diagram showing the state of the auxiliary pin of the installation unit after it is retracted in an embodiment of this utility model.

[0169] Reference Figure 15 In some embodiments of this invention, the auxiliary needle module 205 slides distally to a second predetermined position, i.e., after retracting to the endpoint, the auxiliary needle 2052 exits the subcutaneous tissue, facilitating the user to remove the housing 201. After the auxiliary needle 2052 retracts, the internal portion of the sensor 2042 remains subcutaneously.

[0170] In some embodiments of this utility model, after the auxiliary needle 2052 retracts, a section of the needle tip protrudes outside the housing 201, such as... Figure 15As shown, a height difference h2 is formed between the tip of the auxiliary needle 2052 and the proximal end face of the parallel slider module 203. That is, the length of the auxiliary needle 2052 protruding outside the housing 201 is h2, and the range of h2 can be 0.1~5mm. If the protruding length of the auxiliary needle 2052 is too long, the needle tip will remain under the skin when retracted, which may cause injury to the skin or body when the user removes the housing 201.

[0171] In some embodiments of this utility model, after the auxiliary needle 2052 retracts, a portion of its tip protrudes outside the housing 201, rather than being completely retracted into the housing 201. This reduces the retraction stroke of the auxiliary needle 2052, thereby lowering the overall height of the housing 201, making the mounting unit 200 more compact and lighter. It also reduces the material used in the housing 201, lowering the production cost of the mounting unit 200. Figure 15 In the diagram, the dotted lines represent the auxiliary needle module 205 before and after the retraction stroke is reduced, and the final position of the auxiliary needle module 205 after retraction. The position closer to the far end is the final position of the auxiliary needle module 205 before the retraction stroke is reduced, and the position closer to the proximal end is the final position of the auxiliary needle module 205 after the retraction stroke is reduced.

[0172] In some embodiments of this utility model, reducing the retraction stroke of the auxiliary needle 2052 means that the auxiliary needle module 205 reduces the same retraction stroke. (Refer to...) Figure 15 The reduced retraction stroke of the auxiliary needle module 205 is h3. After the reduced retraction stroke of the auxiliary needle module 205, the overall height of the housing 201 can be reduced. The reduced overall height of the housing 201 can be consistent with the reduced retraction stroke of the auxiliary needle module 205, which is h3.

[0173] In some embodiments of this utility model, the auxiliary needle 2052 is exposed outside the housing 201. The needle tip may cause unnecessary harm to the human body. Therefore, after using the installation unit 200, a needle body protection structure is also needed to protect the exposed needle tip.

[0174] Figures 16a-16c This is a schematic diagram of the inner cover serving as a protective structure for the needle in an embodiment of this utility model.

[0175] Combined with reference Figures 16a-16c and Figure 13c In some embodiments of this utility model, after using the installation unit 200, the user can remove the inner cover 2023 from the outer cover 2021. The inner cover 2023 is then assembled onto the parallel slider module 203, the trigger module 206, or the outer shell 201. The inner cover 2023 is provided with a needle protection cavity 20233, which can be used to protect the exposed needle tip of the auxiliary needle 2052.

[0176] In some embodiments of this utility model, the assembly of the inner cover 2023 with the parallel slider module 203 is described as an example. The inner cover 2023 is a needle protection structure of this utility model. The proximal surface of the parallel slider module 203 has a larger area than the proximal surface of the trigger module 206 or the outer shell 201, making it easier to process and assemble.

[0177] In some embodiments of this utility model, reference is made to Figure 16b As shown, the needle protection cavity 20233 is a hollow cavity opening to the distal end, and its inner hollow cavity can be used to accommodate the exposed needle tip of the auxiliary needle 2052. The outer side of the needle protection cavity 20233 can be a cylinder, cone, cuboid, or other irregular three-dimensional structure, without limitation. The inner cavity can be a structure with the same or different shape as the outer side. Preferably, the inner cavity is a cylinder or cone, and more preferably, the inner cavity is a cone, with its inner diameter gradually decreasing from the distal end to the proximal end.

[0178] In some embodiments of this utility model, if the auxiliary needle 20522 is in an eccentric position relative to the parallel slider module 203, the needle body protection cavity 20233 is also in an eccentric position on the inner cover 2023, that is, the auxiliary needle 20522 and the needle body protection cavity 20233 share a central axis. Before assembling the outer cover 2021 onto the parallel slider module 203, the user needs to ensure that the distal opening of the needle body protection cavity 20233 is aligned with the auxiliary needle 20522 to avoid misalignment between the needle body protection cavity 20233 and the auxiliary needle 20522.

[0179] In some embodiments of this utility model, the inner cover 2023 and the parallel slider module 203 are assembled and connected by one or more of the following methods: snap fasteners, hooks, blocks, threads, bolts, Velcro, and adhesive. Any assembly method that can assemble the inner cover 2023 onto the parallel slider module 203 should be included within the scope of protection of this utility model. At least two structures for assembly connection are provided at corresponding positions on the inner cover 2023 and the parallel slider module 203. Preferably, the assembly structures are symmetrically distributed on the inner cover 2023 and the parallel slider module 203.

[0180] In some embodiments of this utility model, the assembly structure can be interchanged on the inner cover 2023 and the parallel slider module 203. For example, a hook 20231 is provided on the distal end face of the inner cover 2023, and a corresponding locking hole 2037 is provided on the proximal end face of the parallel slider module 203 for establishing an assembly connection with the hook 20231. In other embodiments of this utility model, the hook 20231 can be provided on the parallel slider module 203, while the corresponding locking hole 2037 is provided on the inner cover 2023.

[0181] In some embodiments of this utility model, to facilitate user assembly of the inner cover 2023 and increase the assembly firmness of the inner cover 2023, a positioning structure is also provided on the inner cover 2023 and the parallel slider module 203. The positioning structure consists of positioning posts 20232 and positioning holes 2036, and their positions and numbers correspond on the inner cover 2023 and the parallel slider module 203.

[0182] In some embodiments of this invention, the positioning post 20232 may be located on the distal end face of the inner cover 2023, in which case the positioning hole 2036 is located on the proximal end face of the parallel slider module 203. In other embodiments of this invention, the positioning hole 2036 may be located on the distal end face of the inner cover 2023, in which case the positioning post 20232 is located on the proximal end face of the parallel slider module 203.

[0183] In some embodiments of this utility model, the positioning structure is not limited to Figures 16a-16c The combination of positioning post 20232 and positioning hole 2036 shown can also be other types of positioning structures, such as the combination of slider and groove. All structures involving positioning function should be included within the protection scope of this utility model.

[0184] In some embodiments of this utility model, the user holds the inner cover 2023 and the shell 201 close together, aligning them with the assembly and positioning structures. The auxiliary needle 20522 can then be placed on the central axis of the needle protection cavity 20233. By pressing the inner cover 2023 and the shell 201 firmly, the inner cover 2023 is assembled onto the parallel slider module 203. The needle protection cavity 20233 encloses the auxiliary needle 20522, sealing and protecting the exposed needle tip. A schematic diagram of the inner cover 2023 assembled onto the parallel slider module 203 is shown below. Figure 16c As shown.

[0185] Figure 17 This is a cross-sectional structural diagram of the installation unit in an embodiment of the present invention.

[0186] Reference Figure 17 In some embodiments of this utility model, the elastic module includes a first elastic element 2071, a second elastic element 2072, and a third elastic element 2073. Before using the mounting unit 200, the first elastic element 2071 and the second elastic element 2072 are in a compressed state, while the third elastic element 2073 is in a normal state. After releasing its elastic force, the first elastic element 2071 is used to push the parallel slider module 203 to slide proximally; after releasing its elastic force, the second elastic element 2072 is used to push the auxiliary needle module 205 distally to retract the auxiliary needle 2052; and the third elastic element 2073 is used to adjust the retraction stroke of the auxiliary needle module 205.

[0187] In some embodiments of this utility model, a third elastic element 2073 is disposed within the housing 201, with one end abutting against the inner side of the housing 201 and the other end facing the auxiliary needle module 205. After the first elastic element 2071 pushes the parallel slider module 203 to the proximal end and the second elastic element 2072 pushes the auxiliary needle module 205 to the distal end, the third elastic element 2073 prevents the auxiliary needle module 205 from continuing to slide distally, limiting the retraction of the auxiliary needle module 205 to reduce its retraction stroke. If the third elastic element 2073 is not provided, when the auxiliary needle module 205 retracts, it will slide to the farthest end inside the housing 201 until it abuts against the housing 201. With the third elastic element 2073 provided, the retraction stroke of the auxiliary needle module 205 can be adjusted according to the preset relative elasticity and length of the second elastic element 2072 and the third elastic element 2073, thereby adjusting the exposed length of the needle tip of the auxiliary needle 2052.

[0188] In some embodiments of this utility model, the reduction in the retraction stroke of the auxiliary needle module 205, h3, is equivalent to the length L of the third elastic element 2073 after the elastic force of the second elastic element 2072 and the third elastic element 2073 is balanced.

[0189] In some embodiments of this invention, the third elastic element 2073 is initially in a normal state, not compressed or stretched, while the second elastic element 2072 is initially in a compressed state. After the second elastic element 2072 releases its elastic force, the auxiliary needle module 205 is pushed distally by the second elastic element 2072 until it contacts the proximal end of the third elastic element 2073, and continues to slide distally under the elastic force of the second elastic element 2072. The third elastic element 2073 is compressed and generates elastic force under the elastic force of the second elastic element 2072 until the elastic force of the third elastic element 2073 is the same as that of the second elastic element 2072, reaching a state of equilibrium, at which point the auxiliary needle module 205 stops sliding distally.

[0190] In some embodiments of this utility model, the second elastic element 2072 and the third elastic element 2073 are springs, and their elastic modulus and initial length are preset before leaving the factory. After the auxiliary needle module 205 retracts, when the third elastic element 2073 and the second elastic element 2072 have the same elastic force and are in a balanced state, the second elastic element 2072 is still in a compressed state. By adjusting the elastic modulus and initial length of the second elastic element 2072 and the third elastic element 2073, the length L of the third elastic element 2073 when the second elastic element 2072 and the third elastic element 2073 reach elastic force balance can be controlled, thereby controlling the retraction stroke of the auxiliary needle module 205 and the reduction amount h3 of the retraction stroke, and finally determining the length h2 of the auxiliary needle 2052 needle tip protruding from the housing 201.

[0191] In some embodiments of this utility model, after the auxiliary needle module 205 stops sliding, the user picks up the housing 201 from the skin surface, and the needle tip of the auxiliary needle 2052 protrudes outside the housing 201. Then, the inner cover 2023 is assembled onto the parallel slider module 203, and the needle body protection cavity 20233 surrounds and seals the auxiliary needle 2052. The inner cover 2023 completes its protective function for the auxiliary needle 2052.

[0192] Figures 18a-18c This is a schematic diagram of the protective sleeve serving as a protective structure for the needle body in an embodiment of this utility model.

[0193] Combined with reference Figures 18a-18c In some embodiments of this utility model, the needle protection structure can also be an elastic protective sleeve 20523. After the user has finished using the installation unit 200, the elastic protective sleeve 20523 can be assembled onto the auxiliary needle 2052 to protect the needle tip exposed outside the housing 201. Specific implementation methods will be described below.

[0194] by Figure 18b The indicated direction is for reference. In some embodiments of this utility model, the elastic protective sleeve 20523 is a hollow three-dimensional structure with an opening at the distal end. The hollow structure is used to accommodate the auxiliary needle 2052. The outer diameter of the auxiliary needle 2052 is set as d3, and the inner diameter at the distal opening of the elastic protective sleeve 20523 is d4. The inner diameter d4 is slightly larger than the outer diameter d3 of the auxiliary needle 2052, for example, 0.1~2mm larger, to facilitate the user's alignment of the auxiliary needle 2052 and the distal opening of the elastic protective sleeve 20523. From the distal opening of the elastic protective sleeve 20523 towards the proximal opening, its inner diameter gradually decreases until it reaches d5. The inner diameter d5 is slightly smaller than the outer diameter d3 of the auxiliary needle 2052, for example, by 0.1~2mm. Because the material of the elastic protective sleeve 20523 is elastic, the slightly smaller inner diameter d5 compared to the outer diameter d3 of the auxiliary needle 2052 allows for an interference fit between the elastic protective sleeve 20523 and the auxiliary needle 2052. This increases the friction between the auxiliary needle 2052 and the elastic protective sleeve 20523, ensuring that the elastic protective sleeve 20523, after being fitted over the outer side of the auxiliary needle 2052, remains fixed relative to the auxiliary needle 2052 and will not fall off. In other words, in terms of dimensions, the order of the elastic protective sleeve 20523 and the auxiliary needle 2052 is d4 > d3 > d5. The proximal end of the elastic protective sleeve 20523 can be either open or closed. Its overall length should not be less than the length h2 of the auxiliary needle 2052 protruding from the housing 201, for example, a relative length of 0.1~20mm, so that the elastic protective sleeve 20523 can completely cover the exposed needle tip, thereby protecting the auxiliary needle 2052. Preferably, the proximal end of the elastic protective sleeve 20523 is closed, which can prevent the needle tip of the auxiliary needle 2052 from protruding from the proximal end of the elastic protective sleeve 20523.

[0195] In some embodiments of this utility model, before the user uses the installation unit 200, the elastic protective sleeve 20523 can be a structural component independent of the installation unit 200. After using the installation unit 200, the user puts the elastic protective sleeve 20523 on the auxiliary pin 2052 to form an integral unit with the installation unit 200.

[0196] In some embodiments of this utility model, since the elastic protective sleeve 20523 needs to have a certain degree of elasticity to achieve an interference fit with the auxiliary needle 2052, the elastic protective sleeve 20523 can be made of elastic materials such as silicone or rubber. Any change in the material of the elastic protective sleeve 20523 should be included within the protection scope of this utility model.

[0197] In some embodiments of this utility model, the elastic protective sleeve 20523 may not be limited to the above description and... Figures 18a-18c The straight strip structure shown can also be other three-dimensional structures, such as a sphere, a cone, or other irregular three-dimensional structures. Any shape change of the elastic protective sleeve 20523 should be included within the protection scope of this utility model.

[0198] In Example 1, after the subcutaneous portion is sterilized by directional irradiation (i.e., the auxiliary needle and sensor are sterilized by directional irradiation in the vertical direction), a small amount of pathogens remain inside the housing because other parts inside the housing are not sterilized. Since a strict sealing structure is not used between the various components in the vertical direction, if the time between sterilization and the user's use of the analyte detection device installation unit is relatively long, the small amount of pathogens remaining in the housing may cause the subcutaneous portion to re-carry pathogens. In this case, the user's health may be seriously harmed when using the device again.

[0199] Against this background, in some embodiments of the present invention, a sterile barrier is provided in the installation unit to prevent the sterilized subcutaneous insertion portion from re-carrying pathogens. Specific implementation details of the sterile barrier will be provided below.

[0200] In this embodiment of the utility model, any technical solutions not described are considered to be the same as those in the foregoing embodiments, and will not be repeated here.

[0201] Figure 19a This is a cross-sectional structural diagram of the installation unit during sterilization according to an embodiment of the present invention; Figure 19b This is a schematic cross-sectional view of the installation unit after sterilization according to an embodiment of the present invention.

[0202] like Figure 19aAs shown, during directional irradiation sterilization, the irradiation is mainly concentrated in the vertical direction of the auxiliary needle 3052 and the internal part of the sensor 3042. In this embodiment of the invention, in order to prevent the irradiation range from accidentally expanding and affecting other electronic components such as the PCB board in the analyte detection device 304, a metal blocking member 3024 is provided. The metal blocking member 3024 includes a metal blocking member through hole 30241 that cooperates with the needle body receiving cavity 30213 of the outer cover. The metal blocking member through hole 30241 is sleeved on the needle body receiving cavity 30213. That is, during directional irradiation sterilization, the irradiation will only sterilize the subcutaneous part through the metal blocking member through hole 30241, and the irradiation of other parts will be blocked by the metal blocking member 3024 and will not cause damage to other electronic components. The metal blocking component 30241 is only used during irradiation sterilization before leaving the factory and is not provided to the user with the installer. The inner cover 3023 is then fitted onto the outer cover 3021 after sterilization. Figure 19b As shown.

[0203] In Embodiment 1, the auxiliary needle 1052 of the envelope sensor 1042 is housed in the groove 10233 of the inner cover 1023. The analyte detection device 104 and the inner cover 1023 are not sealed. Therefore, after directional sterilization, bacteria present in other unsterilized parts of the housing may enter the groove 10233 of the inner cover 1023 through the gap between the inner cover 1023 and the analyte detection device 104, thereby causing the part to be pierced under the skin to carry bacteria again. Therefore, in this embodiment of the present invention, a first sterile barrier is provided between the analyte detection device 304 and the inner cover. It should be noted that the inner cover 1023 and outer cover 1021 in Embodiment 1 are structurally and functionally equivalent to the outer cover 3021 in this embodiment of the present invention. Therefore, in this embodiment of the present invention, the first sterile barrier is provided between the analyte detection device 304 and the outer cover 3021 to prevent pathogens from entering the subcutaneous portion through the gap between the analyte detection device 304 and the outer cover 3021, ensuring user safety. Specifically, the first sterile barrier is a first elastic pad 308, which is sleeved on the outside of the auxiliary needle 3052 at the contact position between the outer cover 3021 and the first through hole of the analyte detection device 304. In one embodiment of the present invention, the first elastic pad 308 is a solid structure; after the auxiliary needle 3052 pierces the elastic pad, the first elastic pad 308 is sleeved on the outside of the auxiliary needle 3052. When the protective cover and the housing are connected, the protective cover and the first elastic pad 308, and the first elastic pad and the analyte detection device 304 are compressed together. Therefore, the first elastic pad 308 can form a longitudinal and transverse seal between the analyte detection device 304 and the outer cover 3021. Bacteria inside the housing can no longer enter through the gap between the analyte detection device 304 and the outer cover 3021, thereby ensuring that the subcutaneous part is sterile.

[0204] In one embodiment of this utility model, the needle receiving cavity 30213 of the outer cover 3021 protrudes from the outer cover 3021. A portion of the first elastic pad 308 can be embedded into the protruding portion of the needle receiving cavity 30213. When the first elastic pad 308 is compressed, a portion of the first elastic pad 308 is accommodated in the needle receiving cavity 30231, and a portion is between the protrusion 30216 and the analyte detection device 304, such as... Figure 19a and Figure 19b As shown, this design further enables longitudinal and lateral sealing between the analyte detection device 304 and the outer cover 3021. In other embodiments of this invention, when compressed, the first elastic pad 308 is completely contained within the needle receiving cavity 30213.

[0205] The lower outer casing of the analyte detection device 304 is also provided with adhesive tape 3043. When the surface of the outer cover 3021 is flat, that is, when the needle receiving cavity 30213 does not protrude from the outer cover 3021, although there is a first elastic pad 308 between them, the distance between the adhesive tape 3043 and the outer cover 3021 is very small, and the adhesive tape 3043 and the outer cover 3021 can almost be considered to be in surface contact. As a result, the adhesive tape 3043 sticks to the outer cover 3021, affecting the normal use of the installation unit. When the needle receiving cavity 30213 protrudes from the outer cover 3021, the distance between the adhesive tape 3043 and the outer cover 3021 is increased, preventing the adhesive tape 3043 from sticking to the outer cover 3021. Simultaneously, the outer cover 3021 is also provided with multiple protrusions 30216. On one hand, the multiple protrusions 30216 can support the analyte detection device 304; on the other hand, they change the surface contact between the adhesive tape 3043 and the outer cover 3021 into point contact, thereby minimizing the impact of the adhesive tape 312 on the outer cover 3021. The multiple protrusions 30216 are symmetrically arranged around the protrusions on the outer cover 3021 (e.g., ...). Figure 13a As shown in the figure, it can better support the analyte detection device 304.

[0206] In another embodiment of this utility model, the needle receiving cavity 30213 of the outer cover 3021 does not protrude from the surface of the outer cover 3021, such as... Figure 2b The inner cover groove 10233 shown is provided, while the lower outer shell 30413 of the analyte detection device 304 is provided with a first elastic pad receiving groove 304131, as shown. Figure 20As shown, the depth of the first elastic pad receiving groove 304131 is less than the thickness of the first elastic pad 308 after compression, that is, the first elastic pad receiving groove 304131 accommodates part of the first elastic pad 308. Correspondingly, the first through hole 30414 sinks into the interior of the lower outer shell 30413. When the outer cover 3021 and the shell are connected, a lateral and longitudinal seal can also be formed between the outer cover 3021 and the analyte detection device 304. In another embodiment of this utility model, the first elastic pad 308 can also be completely accommodated in the first elastic pad receiving groove 304131, while simultaneously contacting the needle receiving cavity.

[0207] In another embodiment of the present invention, the needle body receiving cavity 30213 protrudes from the outer cover 3021, and the lower outer shell 30413 of the analyte detection device 304 is provided with a first elastic pad receiving groove 304131. The first elastic pad is simultaneously disposed in the needle body receiving cavity 30213 and the first elastic pad receiving groove 304131, and a lateral and longitudinal seal can also be formed between the outer cover 3021 and the analyte detection device 304.

[0208] After the first elastic pad 308 is set, when the auxiliary needle 3052 retracts, the first elastic pad 308 can contract and tightly fit on the outer side of the inner part of the sensor 3042 body to press and cover the wound caused by the auxiliary needle 3052 piercing the subcutaneous tissue, preventing blood from overflowing from the wound and contaminating the analyte detection device 304, ensuring the normal use of the analyte detection device 304, and at the same time preventing foreign objects from contaminating the wound and improving the wound healing speed.

[0209] In some embodiments of this utility model, when the first elastic pad 308 is sleeved on the part of the auxiliary needle 3052 that fully surrounds the needle body, the first elastic pad 308 can be a hollow structure. The inner diameter of the first elastic pad 308 is smaller than the outer diameter of the auxiliary needle 3052, so that the first elastic pad 308 can be tightly sleeved on the outside of the auxiliary needle 3052, so as to prevent the gap between the first elastic pad 308 and the auxiliary needle 3052 from causing the analyte detection device 304 and the outer cover 3021 to be unable to be completely sealed in the longitudinal direction.

[0210] In other embodiments of this utility model, when the first elastic pad 308 is fitted onto the semi-enclosed needle body portion of the auxiliary needle 3052, and the first elastic pad 308 is a hollow structure, a gap may exist between the first elastic pad 308 and the semi-enclosed needle body of the auxiliary needle 3052, resulting in the analyte detection device 304 and the outer cover 3021 not being completely sealed longitudinally. Therefore, a second sterile barrier is also provided, fitted onto the auxiliary needle 3052 at the position where it contacts the second through hole of the outer shell of the analyte detection device 304. The second sterile barrier is a second elastic pad 309, which can be a solid or hollow structure. Preferably, the second elastic pad 309 is a solid structure. Figure 7 The auxiliary needle module includes an auxiliary needle fixing structure and an auxiliary needle. The auxiliary needle fixing structure of the auxiliary needle module compresses the second elastic pad 309 in the longitudinal direction, and achieves a lateral and longitudinal seal at the second through hole position on the outer shell of the auxiliary needle 3052 and the analyte detection device 304, preventing pathogens in the shell from entering the needle body receiving cavity 30213 in the vertical direction through the second through hole, thereby preventing the part inserted into the body from carrying pathogens.

[0211] In another embodiment of this invention, a second elastic pad receiving groove (not shown in the figure) is provided on the upper outer shell of the analyte detection device 304. The depth of the second elastic pad receiving groove is less than the thickness of the second elastic pad 309 after compression. That is, the second elastic pad receiving groove on the upper outer shell accommodates a portion of the second elastic pad 309. Correspondingly, the second through hole sinks into the interior of the upper outer shell, and the auxiliary needle fixing structure of the auxiliary needle module 305 squeezes the second elastic pad 309 longitudinally, achieving a lateral and longitudinal seal at the position of the auxiliary needle 3052 and the second through hole on the upper outer shell of the analyte detection device 304. In another embodiment of this invention, the second elastic pad 309 can also be completely accommodated in the second elastic pad receiving groove of the upper outer shell.

[0212] In another embodiment of this utility model, a second elastic pad receiving groove (not shown in the figure) may also be provided on the auxiliary needle fixing structure to at least partially accommodate the second elastic pad 309. When the upper housing of the analyte detection device 304 and the auxiliary needle fixing structure are both provided with second elastic pad receiving grooves, the second elastic pad 309 is simultaneously accommodated in both second elastic pad receiving grooves.

[0213] Considering that the analyte detection device 304 is mounted in the parallel slider 303 via a snap-fit ​​structure, and there is a gap between the parallel slider 303 and the analyte detection device 304, pathogens inside the housing may enter the second through-hole along this gap, and then enter the needle body receiving cavity 30213 vertically from the second through-hole, thus carrying pathogens into the body. Therefore, in another embodiment of this utility model, a third sterile barrier is provided between the parallel slider 303 and the analyte detection device 304. The third sterile barrier is a sealing ring 310. A sealing ring receiving groove is provided on the proximal end face of the parallel slider 303 and / or a sealing ring receiving groove is provided on the upper outer shell of the analyte detection device 304. The sealing ring 310 is at least partially disposed in the sealing ring receiving groove. Since the analyte detection device 304 will eventually be installed on the user's body, for the sake of the aesthetics of the analyte detection device 304, it is preferable to provide a sealing ring receiving groove on the proximal end face of the parallel slider 303, such as... Figure 19a and 19b As shown.

[0214] Since sterilization is performed only in the vertical direction of the subcutaneous portion during directional irradiation, bacteria may still be present inside the analyte detection device 304. To prevent these bacteria from entering the needle housing cavity 30213 vertically through the second through hole, in one embodiment of this invention, a fourth sterile barrier is provided between the first and second through holes inside the analyte detection device 304. The fourth sterile barrier is a third elastic pad 311, which can be solid or hollow. Preferably, the third elastic pad 311 is solid and is fitted over the outside of the auxiliary needle 3052. The upper and lower ends of the third elastic pad 311 abut against the first and second through holes of the analyte detection device 304, respectively. Therefore, through the fourth sterile barrier, bacteria inside the analyte detection device 304 no longer affect the subcutaneous portion.

[0215] It should be noted that among the first, second, third, and fourth sterile barriers described in this specification, the first sterile barrier is the primary sterile barrier and is a necessary sterile barrier. The second, third, and fourth sterile barriers are secondary sterile barriers, which can be optionally set or not. When a secondary sterile barrier is set, it can be one or more of the second, third, and fourth sterile barriers, all of which can ensure that the subcutaneous insertion part remains sterile after sterilization. The description of the second, third, and fourth barriers does not mean that the second, third, and fourth sterile barriers can only be set sequentially after the first sterile barrier. The ordinal prefix is ​​only used to distinguish different sterile barriers and should not be construed as a limitation on the scope of this utility model.

[0216] In summary, this utility model embodiment discloses an analyte detection device installation unit with a sterile barrier. Before installation, the subcutaneous portion of the auxiliary needle is housed in the needle housing cavity of the outer cover. A main sterile barrier is provided at the contact position between the outer cover and the first through hole. Therefore, after the subcutaneous portion is sterilized by directional irradiation, the subcutaneous portion is in a closed sterile environment. Bacteria present in the unsterilized portion within the installation unit cannot enter this sterile environment. The subcutaneous portion will not carry bacteria again after directional sterilization, and will not affect the user's health, thus ensuring the user's safety.

[0217] While specific embodiments of the present 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 present 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 present invention. The scope of the present invention is defined by the appended claims.

Claims

1. An analyte detection device mounting unit having a sterile barrier, characterized by, The analyte testing device installation unit comprises: a housing and a spring module, a trigger module, a parallel slider module, an auxiliary needle module and an analyte testing device pre-installed in the housing; the parallel slider module carries the auxiliary needle module and the analyte testing device, the analyte testing device comprises a sensor, an upper housing and a lower housing, the sensor comprises an in-vivo part and an in-vitro part, the auxiliary needle module comprises an auxiliary needle and an auxiliary needle fixing structure, the upper housing is provided with a second through hole, the lower housing is provided with a first through hole, the auxiliary needle envelopes the in-vivo part and passes through the second through hole and the first through hole; and a protective cover, the protective cover is releasably connected with the housing, the protective cover at least comprises an outer cover body, the outer cover body comprises a needle body accommodating cavity, before the installation, the auxiliary needle and the in-vivo part are accommodated in the needle body accommodating cavity; a main sterile barrier is arranged at the contact position of the outer cover body and the first through hole.

2. The analyte detection device mounting unit with a sterile barrier of claim 1, wherein, The main sterile barrier is a first elastic pad, the first elastic pad is sleeved outside the auxiliary needle.

3. The analyte detection device mounting unit with a sterile barrier of claim 2, wherein, The needle body accommodating cavity comprises a hollow structure, the inner diameter of the hollow structure decreases from the distal end to the proximal end.

4. The analyte detection device mounting unit with a sterile barrier of claim 3, wherein, The needle body accommodating cavity protrudes from the outer cover body, and the first elastic pad is at least partially accommodated in the needle body accommodating cavity.

5. The analyte detection device mounting unit with a sterile barrier of claim 2, wherein, The lower housing of the analyte testing device is provided with a first elastic pad accommodating groove, and the first elastic pad is at least partially accommodated in the first elastic pad accommodating groove.

6. The analyte detection device mounting unit with a sterile barrier of claim 2, wherein, The analyte testing device installation unit further comprises a secondary sterile barrier, the secondary sterile barrier is one or more of a second sterile barrier, a third sterile barrier and a fourth sterile barrier.

7. The analyte detection device mounting unit with a sterile barrier of claim 6, wherein, The second sterile barrier is arranged at the contact position of the auxiliary needle and the second through hole.

8. The analyte detection device mounting unit with a sterile barrier of claim 7, wherein, The second sterile barrier is a second elastic pad.

9. The analyte detection device mounting unit with a sterile barrier of claim 8, wherein, The upper housing of the analyte testing device is provided with a second elastic pad accommodating groove and / or the auxiliary needle fixing structure is provided with a second elastic pad accommodating groove, and the second elastic pad is at least partially accommodated in the second elastic pad accommodating groove.

10. The analyte detection device mounting unit with a sterile barrier of claim 6, wherein, The third sterile barrier is arranged between the parallel slider and the analyte testing device.

11. The analyte detection device mounting unit with a sterile barrier of claim 10, wherein, The third sterile barrier is a sealing ring.

12. The analyte detection device mounting unit with a sterile barrier of claim 11, wherein, The upper housing of the analyte testing device is provided with a sealing ring accommodating groove and / or the proximal end surface of the parallel slider is provided with a sealing ring accommodating groove, and the sealing ring is at least partially arranged in the sealing ring accommodating groove.

13. The analyte detection device mounting unit with a sterile barrier of claim 6, wherein, The fourth sterile barrier is a third elastic pad, and the two ends of the third elastic pad abut against the second through hole and the first through hole of the analyte testing device respectively.

14. The analyte sensing device mounting unit with a sterile barrier of claim 2, wherein, The outer cover body is provided with a plurality of protrusions, and the plurality of protrusions are symmetrically arranged around the needle body accommodating cavity.

15. The analyte sensing device mounting unit with a sterile barrier of claim 1, wherein, The protective cover further comprises an inner cover body, and the inner cover body is used to be assembled at the proximal end of the installation unit after the installation unit is used.

16. The analyte sensing device mounting unit with a sterile barrier of claim 1, wherein, The spring module comprises a first elastic member, a second elastic member and a third elastic member, and the third elastic member is located between the housing and the auxiliary needle module.

Images