Secure analyte detection device mounting unit

Abstract

The utility model discloses a safe analyte detection device installation unit, before the installation unit is used, a protective cover is assembled at the near end of a shell to protect an auxiliary needle, the protective cover comprises an outer cover body and an inner cover body, the inner cover body is placed in a concave cavity of the outer cover body and is sealed by label paper, the structure is compact, and the miniaturization design of the installation unit is facilitated.

Description

Technical Field

[0001] The utility model mainly relates to the field of medical devices, and in particular to a safe analyte detection device installation unit. Background Art

[0002] In a healthy individual, the pancreas automatically detects glucose levels in the blood and secretes the necessary insulin and glucagon. However, in diabetics, the pancreas malfunctions, preventing it from producing the necessary insulin. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic function and is a lifelong condition. Currently, medical technology cannot cure diabetes; the only approach is to control the onset and progression of diabetes and its complications by stabilizing blood sugar levels.

[0003] Diabetic patients need to test their blood sugar before injecting insulin into their bodies. Currently, most detection methods can continuously detect blood sugar and send blood sugar data to external devices in real time for users to view. This detection method is called continuous glucose monitoring (CGM). In order to achieve continuous glucose detection, users need to use an auxiliary mounting unit to install the blood sugar analyte detection device on the skin surface. The smaller the size of the mounting unit, the more convenient it is for users to use and the lower the manufacturing cost. Therefore, under the premise that the function of the mounting unit can be realized, it is beneficial to miniaturize the mounting unit while taking into account the safety design.

[0004] Therefore, the prior art urgently needs a more miniaturized and safer analyte detection device installation unit. Utility Model Content

[0005] The utility model discloses an installation unit for an analyte detection device. Before using the installation unit, a protective cover is assembled at the proximal end of a shell to protect an auxiliary needle. The protective cover comprises an outer cover body and an inner cover body. The inner cover body is placed in a concave cavity of the outer cover body and is sealed with label paper. The structure is compact, which is beneficial to the miniaturized design of the installation unit.

[0006] The utility model provides an analyte detection device installation unit, comprising: a shell and an elastic module, a trigger module, a parallel slider module, an auxiliary needle module and an analyte detection device pre-installed in the shell, the auxiliary needle module including an auxiliary needle; and a protective cover releasably connected to the shell, the protective cover including an outer cover body and an inner cover body, the outer cover body including an outer cover body concave cavity, the inner cover body being placed in the outer cover body concave cavity; a label paper is pasted on the proximal end surface of the outer cover body to seal the outer cover body concave cavity.

[0007] According to one aspect of the present invention, the proximal surface of the inner cover body further includes at least two raised semicircular balls.

[0008] According to one aspect of the present invention, the raised semicircular spheres are evenly distributed on the proximal end surface of the inner cover body.

[0009] According to one aspect of the present invention, the outer cover comprises a needle accommodating cavity for accommodating an auxiliary needle before the mounting unit is used.

[0010] According to one aspect of the present invention, the needle accommodating cavity includes a hollow structure, and the inner diameter of the hollow structure of the needle accommodating cavity decreases from the distal end to the proximal end.

[0011] According to one aspect of the present invention, the inner cover includes a needle protection cavity and is used to accommodate the auxiliary needle after the mounting unit is used.

[0012] According to one aspect of the present invention, the needle protection cavity and the needle accommodating cavity share a central axis.

[0013] According to one aspect of the present invention, the inner cover body further includes an assembly structure for establishing an assembly connection with the parallel slider module, the trigger module or the housing, and the assembly structure is correspondingly distributed on the parallel slider module, the trigger module or the housing.

[0014] According to one aspect of the present invention, the inner cover further includes a positioning structure, and the positioning structure is correspondingly distributed on the parallel slider module, the trigger module or the housing.

[0015] According to one aspect of the present invention, after the mounting unit is used, the auxiliary needle module is retracted and at least a portion of the auxiliary needle is exposed outside the housing.

[0016] According to one aspect of the present invention, the length of the auxiliary needle exposed outside the housing is 0 to 5 mm.

[0017] Compared with the existing technology, the technical solution of the utility model has the following advantages:

[0018] In the installation unit of the analyte detection device disclosed by the present utility model, before using the installation unit, a protective cover is assembled at the proximal end of the shell to protect the auxiliary needle. The protective cover includes an outer cover body and an inner cover body. The inner cover body is placed in the concave cavity of the outer cover body and is sealed with label paper. The structure is compact, which is beneficial to the miniaturized design of the installation unit. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 Schematic diagram of the external structure of the installation unit of the analyte detection device according to an embodiment of the present utility model;

[0020] Figure 2a Schematic diagram of the external structure of the housing according to an embodiment of the present utility model;

[0021] Figure 2b This is a schematic structural diagram of a protective cover according to an embodiment of the present utility model;

[0022] Figure 3 This is a schematic diagram of the exploded structure of the installation unit of the analyte detection device according to an embodiment of the present utility model;

[0023] Figure 4 This is a schematic diagram of the internal structure of the housing according to an embodiment of the present utility model;

[0024] Figure 5a This is a structural diagram of the distal end surface of the parallel slider module according to an embodiment of the present utility model;

[0025] Figure 5b This is a structural diagram of the proximal end surface of the parallel slider module according to an embodiment of the present utility model;

[0026] Figure 6 Schematic diagram of the structure of the analyte detection device according to an embodiment of the present utility model;

[0027] Figure 7 This is a structural diagram of an auxiliary needle module according to an embodiment of the present utility model;

[0028] Figure 8 Schematic diagram of the structure of the trigger module according to an embodiment of the present utility model;

[0029] Figure 9 is a top view of a mounting unit according to an embodiment of the present utility model;

[0030] Figure 10a for Figure 9 A cross-sectional structural diagram;

[0031] Figure 10b for Figure 9 Schematic diagram of the cross-section structure of B;

[0032] Figure 10c for Figure 9 Schematic diagram of the C-section structure;

[0033] Figure 11 This is a schematic diagram of the first buckle bending under force according to an embodiment of the present utility model;

[0034] Figure 12 This is a schematic diagram of the exploded structure of the installation unit of the analyte detection device according to an embodiment of the present utility model;

[0035] 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;

[0036] 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;

[0037] Figure 13cThis is a schematic structural diagram of the outer cover according to an embodiment of the present utility model;

[0038] Figure 14 This is a schematic diagram of the state of the installation unit after use according to an embodiment of the utility model;

[0039] Figure 15 This is a schematic diagram of a state where the auxiliary needle of the mounting unit according to an embodiment of the present utility model is retracted;

[0040] Figures 16a-16c This is a schematic diagram of the inner cover as a needle protection structure according to an embodiment of the present utility model;

[0041] Figure 17 Schematic diagram of the cross-sectional structure of the installation unit according to an embodiment of the present utility model;

[0042] Figures 18a-18c This is a schematic diagram of a protective sleeve as a needle protection structure according to an embodiment of the present utility model. DETAILED DESCRIPTION

[0043] As mentioned above, the mounting unit of the prior art analyte detection device cannot take into account both miniaturization and safety.

[0044] In order to solve this problem, the utility model provides an analyte detection device installation unit. Before using the installation unit, a protective cover is assembled at the proximal end of the shell to protect the auxiliary needle. The protective cover includes an outer cover body and an inner cover body. The inner cover body is placed in the concave cavity of the outer cover body and sealed with label paper. The structure is compact, which is beneficial to the miniaturized design of the installation unit.

[0045] 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 of components and steps, numerical expressions and numerical values ​​set forth in these embodiments should not be construed as limiting the scope of the present invention.

[0046] In addition, it should be understood that for ease of description, the sizes of the various components shown in the drawings are not necessarily drawn according to actual proportional relationships. For example, the thickness, width, length or distance of certain units may be enlarged relative to other structures.

[0047] The following description of exemplary embodiments is merely illustrative and does not in any way limit the present invention, its application, or use. Technologies, methods, and devices known to those skilled in the art may not be discussed in detail herein, but where applicable, such technologies, methods, and devices should be considered part of this specification.

[0048] It should be noted that like reference numerals and letters denote like items in the following figures, and thus, once an item is defined or described in one figure, it will not need to be further discussed in the subsequent figure descriptions.

[0049] First embodiment

[0050] 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 internal components. When in use, the end of the mounting unit 100 closest to the user's skin is the proximal end, and the end away 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 components of the housing 101.

[0051] Shell exterior

[0052] Figure 2a This is a schematic diagram of the external structure of the housing of the embodiment of the utility model. Figure 2b The figure is a schematic diagram of the protective cover structure. The protective cover 102 comprises an outer cover 1021, a clamp 1022, and an inner cover 1023. A second opening is provided at the distal end of the outer cover 1021, facing the first opening. At the second opening, the outer cover 1021 and the clamp 1022 are connected by breakable posts 10211, which are spaced at regular intervals between the outer cover 1021 and the clamp 1022. When the outer cover 1021 rotates relative to the clamp 1022, the posts 10211 break, separating the outer cover 1021 from the clamp 1022.

[0053] An internal thread 10212 is provided on the inner side of the outer cover body 1021, and correspondingly, an external thread 10231 is provided on the outer side of the inner cover body 1023. The internal thread 10212 and the external thread 10231 can be matched and connected to connect the outer cover body 1021 and the inner cover body 1023 together and keep them fixed.

[0054] The inner side of the clamp 1022 is provided with a protrusion 10221, and the outer side of the housing 101 is correspondingly 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 inserted into the groove 1011. The outer cover 1021 is first fixed to the inner cover 1023 through threaded engagement, and then connected to the housing 101 via the clamp 1022. The outer cover 1021 and the inner cover 1023 protect, seal, and prevent triggering of the internal structure of the housing 101. The anti-trigger function here will be further explained below.

[0055] In other embodiments of the present invention, the outer cover 1021 and the inner cover 1023 may be fixedly connected by friction fit or snap fit.

[0056] In other embodiments of the present invention, the clamp 1022 and the housing 101 may also be connected by friction fit, snap fit, or thread fit.

[0057] Inside the shell

[0058] Figure 3 This is an exploded schematic diagram of the analyte detection device mounting unit according to an embodiment of the present invention. The dashed lines in the figure indicate the mounting and mating relationships of the various components. The internal components of the analyte detection device mounting unit 100 include a parallel slider module 103, an analyte 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 member 1071 and a second elastic member 1072.

[0059] Figure 4 Schematic diagram of the internal structure of the housing 101 according to an embodiment of the present invention.

[0060] In this embodiment of the utility model, at least two first buckles 1012 are provided in the housing 101. The first buckles 1012 are integrally formed with the housing 101 and protrude toward the proximal end of the housing 101. The first buckles 1012 are made of flexible material, and their ends can be bent or curved toward the outside of the housing 101.

[0061] In a preferred embodiment of the present invention, there are two first buckles 1012 symmetrically distributed inside the housing 101 , with an angular interval of 180° between them.

[0062] In other preferred embodiments of the present invention, the number of first buckles 1012 is three or four, symmetrically distributed inside the housing 101, and the angular intervals between them are 120° or 90°. The number of first buckles 1012 can also be five or more, which is not limited here.

[0063] In the embodiment of the present utility model, at least two limiting grooves 1013 , at least two locking grooves 1014 and one auxiliary needle limiting groove 1015 are further provided in the housing 101 .

[0064] In the embodiment of the present invention, the limiting groove 1013 includes at least two ribs protruding from the inner wall of the housing 101. In a preferred embodiment of the present invention, the ribs are parallel to each other, and a groove is formed between adjacent ribs.

[0065] In other embodiments of the present invention, the limiting groove 1013 is a groove recessed in the inner wall of the housing 101 .

[0066] In the embodiment of the present utility model, the card slot 1014 includes two card slot positions, namely a first card slot position 10141 and a second card slot position 10142. Figure 10a As shown, the first card slot 10141 is closer to the proximal end relative to the second card slot 10142 .

[0067] In a preferred embodiment of the present invention, there are two limiting grooves 1013 and two locking grooves 1014 symmetrically distributed inside the housing 101 , with an angular interval of 180° between them.

[0068] In other preferred embodiments of the present invention, the number of the limiting grooves 1013 and the engaging grooves 1014 is three or four, symmetrically distributed inside the housing 101, and the angular intervals between them are 120° or 90°. The number of the limiting grooves 1013 and the engaging grooves 1014 can also be five or more, without limitation.

[0069] Parallel slider module

[0070] Figure 5a is a structural diagram of the distal end surface of the parallel slider module 103, Figure 5b Schematic diagram of the structure of the proximal end surface of the parallel slider module 103.

[0071] In this embodiment of the present invention, the distal end surface 1031 of the parallel slider module 103 is provided with a distally protruding circular groove 1032. This circular groove 1032 is a hollowed-out cylindrical structure with an inner diameter d1. At least two slider clips 10321 extend distally from the sidewalls of the circular groove 1032. The clip portions of the slider clips 10321 are flat or nearly flat, forming a fixed angle with the horizontal plane, and their extended ends m0 converge at the distal end.

[0072] In the embodiment of the present invention, the slider buckle 10321 is made of a flexible material and can be bent or folded toward the outside of the circular groove 1032 .

[0073] In other embodiments of the present invention, the slider buckle 10321 can be directly provided on the distal end surface of the parallel slider module 103 without the need for a circular groove structure.

[0074] In this embodiment of the present invention, a boss 10322 is provided within the circular groove 1032 at one end near the distal end surface 1031. Boss 10322 is a hollowed-out cylindrical structure with an inner diameter d2, where d1 > d2. The hollowed-out circular groove 1032 and boss 10322 form a through hole 10323 that extends from the distal end surface 1031 to the proximal end surface 1034 of the parallel slider module.

[0075] In a preferred embodiment of the present invention, there are two slider buckles 10321 symmetrically distributed on the side wall of the circular groove 1032 , and the angular interval between the two slider buckles 10321 is 180°.

[0076] In other preferred embodiments of the present invention, the number of slider clips 10321 can be three or four, symmetrically distributed on the sidewalls of the circular groove 1032, with the slider clips 10321 spaced 120° or 90° apart. The number of slider clips 10321 can also be five or more, without limitation.

[0077] Continue to refer to Figure 5a In the embodiment of the present invention, at least two second buckles 1033 are provided on the side of the distal surface 1031 of the parallel slider module 103. The second buckles 1033 are symmetrically distributed on the side of the distal surface 1031, and the angular interval between them is 180°.

[0078] In other embodiments of the present invention, the number of second clips 1033 is three or four, symmetrically distributed along the sides of the distal end surface 1031, with angular intervals of 120° or 90°. The number of second clips 1033 can also be five or more, without limitation. In the mounting unit 100, the second clips 1033 are coupled to the first clips 1012. The position and number of the second clips 1033 are consistent with those of the first clips 1012.

[0079] Reference Figure 5b In an embodiment of the present invention, at least two T-shaped structures 1035 are provided on the side of the proximal surface 1034 of the parallel slider module 103. The vertical portion of the T-shaped structure 1035 is connected to the proximal surface 1034, and the horizontal portion 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.

[0080] In the mounting unit 100, T-shaped structural sliders 10351 are located within the limiting slots 1013 to limit 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 structural sliders 10351 are consistent with the limiting slots 1013. As the parallel slider module 103 slides toward the proximal end, the T-shaped structural sliders 10351 slide within the limiting slots 1013.

[0081] In a preferred embodiment of the present invention, the vertical portion of the T-shaped structure 1035 is made of flexible material, the vertical portion and the horizontal portion are integrally formed, and the horizontal portion can be bent or curved around the vertical portion.

[0082] In other preferred embodiments of the present invention, the vertical part of the T-shaped structure 1035 is made of elastic material, such as a spring, a spring, etc., and the horizontal part is fixedly connected to the vertical part by welding or hot melting, and the horizontal part can also be bent or curved around the vertical part.

[0083] Analyte detection device

[0084] Figure 6 This is a schematic structural diagram of an analyte detection device according to an embodiment of the present utility model.

[0085] Combined with reference Figure 3 In this embodiment of the present invention, the analyte detection device 104 includes a housing 1041, a transmitter (not shown), a sensor 1042, and internal circuitry (not shown) disposed within the housing 1041 and electrically coupled to the sensor. The sensor 1042 is configured to detect analyte parameter information of a user's bodily fluid, transmit the analyte parameter information to the transmitter via the internal circuitry, and then transmit the information to the external device 200.

[0086] In a preferred embodiment of the present invention, before analyte detection device 104 is attached to the user's skin, it transmits signals to external device 200 at a first frequency f1. After attachment to the user's skin, it transmits signals to external device 200 at a second frequency f2, which is greater than first frequency f1. In a further preferred embodiment of the present invention, first frequency f1 is 0 to 12 times / hour, and second frequency f2 is 12 to 3600 times / hour.

[0087] In a more preferred embodiment of the present invention, the first frequency f1 is 0 times / hour, that is, before the analyte detection device 104 is installed on the user's skin surface, no signal is transmitted to the external device 200, which can save power consumption of the analyte detection device 104 before installation.

[0088] In an embodiment of the present invention, the housing 1041 includes an upper housing body 10411 and a lower housing body 10413, and the upper housing body 10411 and the lower housing body 10413 are spliced ​​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 arranged in the internal space, and the external part is electrically coupled to the internal circuit. The internal part is provided with structures such as electrodes and a membrane layer, and piercing the user's subcutaneous tissue can detect analyte parameter information. When the internal part pierces the subcutaneous tissue, it needs to have a correct angle, for example, piercing perpendicular to the skin surface. After the life of the analyte detection device 104 ends, it is removed from the user's skin surface and discarded as a whole.

[0089] In an embodiment of the present invention, the lower outer shell 10413 includes a first through hole 10414 extending therethrough. Correspondingly, on the axis of the first through hole 10414, the upper outer shell 10411 includes a second through hole (not shown in the figure) extending therethrough. The internal part passes through the first through hole 10414 to the outside of the shell to facilitate penetration into the user's subcutaneous tissue.

[0090] In this embodiment of the present invention, the side of the upper outer shell 10411 includes latch holes 10412 corresponding to the T-shaped structure latches 10352. "Corresponding" here means that the position and number of the latch holes 10412 are consistent with those of the T-shaped structure latches 10352. In the installation unit 100, the upper outer shell 10411 is aligned with the proximal end surface 1034, and the T-shaped structure latches 10352 and the latch holes 10412 form a latch connection, thereby securing the analyte detection device 104 to the parallel slider module 103. When the horizontal portion of the T-shaped structure is bent or curved around the vertical portion, the latch connection between the T-shaped structure latches 10352 and the latch holes 10412 is released, and the analyte detection device 104 is separated from the parallel slider module 103. Therefore, in the installation unit 100, the analyte detection device 104 and the parallel slider module 103 are releasably connected.

[0091] Auxiliary needle module

[0092] Figure 7 This is a structural diagram of the auxiliary needle module according to an embodiment of the present utility model.

[0093] In the embodiment of the present invention, the auxiliary needle module 105 includes an auxiliary needle fixing structure 1051 and an auxiliary needle 1052. In the mounting unit 100, the auxiliary needle fixing structure 1051 is located at the distal end, and the auxiliary needle 1052 is located at the proximal end.

[0094] In an embodiment of the present invention, the auxiliary needle fixing structure 1051 includes an auxiliary needle slider 10511 and an auxiliary needle fixing block 10512. The diameter or width of the auxiliary needle slider 10511 is larger than the diameter or width of the auxiliary needle fixing block 10512, forming a convex surface 10513 toward the proximal end.

[0095] In the embodiment of the present invention, the auxiliary needle 1052 includes a fully enclosed needle body 10521 and a semi-enclosed needle body 10522. The fully enclosed needle body 10521 is located between the auxiliary needle fixing block 10512 and the semi-enclosed needle body 10522 and is fixedly connected to the auxiliary needle fixing block 10512. The hollow structure of the semi-enclosed needle body 10522 can be used to accommodate the internal part of the sensor 1042. When the semi-enclosed needle body 10522 is inserted into the user's subcutaneous tissue, the internal part can be inserted into the subcutaneous tissue together with the sensor 1042. When the needle body is retracted, the subcutaneous state of the internal part is not affected.

[0096] In other embodiments of the present invention, the auxiliary needle 1052 only includes a semi-enclosed needle body 10522, that is, the semi-enclosed needle body 10522 is fixedly connected to the auxiliary needle fixing block 10512. This can reduce the material used for the auxiliary needle 1052 and save costs, but it also reduces the rigidity of the auxiliary needle 1052.

[0097] 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 internal portion of the sensor 1042 is located in the semi-enclosed needle body 10522 .

[0098] Trigger Module

[0099] Figure 8 This is a schematic diagram of the structure of the trigger module of an embodiment of the present utility model.

[0100] In this embodiment of the present invention, the trigger module 106 is provided with at least two fixed buckles 1061 corresponding to the first buckle 1012. In the mounting unit 100, the fixed buckles 1061 contact the first buckle 1012 to prevent the first buckle 1012 from bending or folding toward the outside of the housing. The contact between the fixed buckles 1061 and the first buckle 1012 can be point contact, line contact, or surface contact. When the contact is surface contact, the contact surface between the fixed buckles 1061 and the first buckle 1012 forms a fixed angle with the horizontal plane and converges at the proximal end of the mounting unit 100. The number and position of the fixed buckles 1061 are consistent with those of the first buckle 1012.

[0101] In the embodiment of the present invention, at least two latches 1062 are further provided on the trigger module 106. In the mounting unit 100, the latches 1062 are snap-fitted with the slots 1014 to fix the trigger module 106. The number and position of the latches 1062 are consistent with those of the slots 1014. Figure 10a Before the installation unit 100 is used, the ear 1062 is located in the first slot 10141 . At this time, the fixing buckle 1061 is in contact with the first buckle 1012 .

[0102] In this embodiment of the present invention, the trigger module 106 further includes an outer ring 1063, which integrally connects the fixing buckle 1061 and the latch 1062. In the mounting unit 100, the outer ring 1063 is located closer to the proximal end of the latch 1062, positioned at the first opening and protruding from the first opening. When the mounting unit 100 is in use, the outer ring 1063 conforms to the user's skin surface.

[0103] Elastic Module

[0104] Reference Figure 3 The elastic module 107 includes a first elastic member 1071 and a second elastic member 1072 .

[0105] In an embodiment of the present invention, the first elastic member 1071 is located between the parallel slider module 103 and the shell 101, that is, one end of the first elastic member 1071 is located on the distal end surface of the parallel slider module 103, and the other end is located inside the shell 101. In the installation unit 100, the first elastic member 1071 is in a compressed state and can provide elastic force.

[0106] In an embodiment of the present invention, the second elastic member 1072 is located between the parallel slider module 103 and the auxiliary needle module 105, that is, one end of the second elastic member 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 installation unit 100, the second elastic member 1072 is in a compressed state and can provide elastic force.

[0107] In a preferred embodiment of the present invention, the first elastic member 1071 or the second elastic member 1072 is a metal spring.

[0108] In an embodiment of the present invention, the inner ring diameter of the first elastic member 1071 is larger than the outer ring diameter of the circular groove 1032 and the auxiliary needle slider 10511. In the installation unit 100, the first elastic member 1071 is surrounded by the outside of the auxiliary needle slider 10511 and the circular groove 1032, so that the internal space of the installation unit 100 can be fully utilized.

[0109] In an embodiment of the present invention, the outer ring 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 is surrounded by the outside of the auxiliary needle fixing block 10512, so that the internal space of the installation unit 100 can be fully utilized.

[0110] How to use the installation unit

[0111] Figure 9 This is a top view of the installation unit according to an embodiment of the present invention.

[0112] Figure 10a for Figure 9 A cross-sectional structural diagram; Figure 10b for Figure 9 Schematic diagram of the cross-section structure of B; Figure 10c for Figure 9 Schematic diagram of the C-section structure; Figure 11 Schematic diagram of the first buckle bending under force.

[0113] Combined with reference Figure 10a and Figure 10bIn this embodiment of the present invention, the latch 1014 has two latch positions: a first latch position 10141 and a second latch position 10142. Before the mounting unit 100 is used, the trigger module 106 is secured to the housing 101 via the snap fit between the latch 1062 and the first latch position 10141. At this point, the fixed latch 1061 contacts the first latch 1012, preventing the first latch 1012 from bending or folding outward from the housing 101. The fixed latch 1061, the first latch 1012, and the second latch 1033 are located on the same horizontal line. In a preferred embodiment of the present invention, from the inside of the housing 101 to the outside, the second latch 1033, the first latch 1012, and the fixed latch 1061 are located in this order.

[0114] In an embodiment of the present invention, the contact between the fixing buckle 1061 and the first buckle 1012 is one of point contact, line contact or surface contact. When the above contact is surface contact, the extension line m1 of the contact surface converges at the proximal end. This structural design allows the fixing buckle 1061 to slide toward the distal end relative to the first buckle 1012.

[0115] In a preferred embodiment of the present invention, the coupling surface between the second buckle 1033 and the first buckle 1012 is a plane, which forms a fixed angle with the horizontal plane, and the extended ends m2 thereof converge at the proximal end.

[0116] Combined with reference Figure 11 This structural design allows the second buckle 1033 to slide toward the proximal end relative to the first buckle 1012, pushing the first buckle 1012 toward the outside of the shell 101, thereby releasing the coupling state between the first buckle 1012 and the second buckle 1033.

[0117] In an embodiment of the present invention, the first elastic member 1071 is in a compressed state and has elastic potential energy. Its own elastic force gives the parallel module slider 103 a thrust Fr toward the proximal end. The thrust 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. The component force Fsin can push the first buckle 1012 toward the outside of the shell 101 and bend or fold it, thereby releasing the coupling state between the first buckle 1012 and the second buckle 1033.

[0118] In an embodiment of the present invention, when using the mounting unit 100, the outer cover 1021 is rotated to break the column 10211, and the protective cover 102 is separated from the shell 101. The proximal end of the mounting unit 100 is brought close to the user's skin until the outer ring 1063 of the trigger module 106 is in contact with the skin surface. The user presses the shell 101 at the distal end, and the shell 101 slides toward the skin. The trigger module 106 remains stationary, so that the trigger module 106 slides distally relative to the shell 101, and the ear 1062 disengages from the first card slot 10141 and enters the second card slot 10142. At the same time, the fixed buckle 1061 no longer contacts the first buckle 1012. The first buckle 1012 is bent or folded toward the outside of the shell 101 due to the component force Fsin, and the coupling state between the first buckle 1012 and the second buckle 1033 is released.

[0119] In an embodiment of the present invention, after the coupling state is released, the parallel slider module 103 continues to slide toward the proximal end under the elastic force of the first elastic member 1071, while driving the analyte detection device 104 to slide toward the proximal end until the lower outer shell 10413 of the analyte detection device 104 contacts the user's skin surface.

[0120] Reference Figure 10c In the embodiment of the present invention, the slider buckle 10321 is buckled with the auxiliary needle slider 10511. When the first elastic member 1071 pushes the parallel slider module 103 to slide toward the proximal end, it drives the auxiliary needle module 105 to slide toward the proximal end.

[0121] In the embodiment of the present invention, the connection between the slider buckle 10321 and the auxiliary needle slider 10511 is a plane or a nearly plane, which forms a fixed angle with the horizontal plane, and its extension line m3 converges at the distal end. The second elastic member 1072 pushes the auxiliary needle slider 10511 toward the distal end, so the auxiliary needle slider 10511 can push the slider buckle 10321 toward the outside of the housing 101, causing the slider buckle 10321 to bend or bend. The principle is equivalent to Figure 11 .

[0122] In the embodiment of the present invention, in the installation unit 100, the side wall of the auxiliary needle limiting groove 1015 prevents the slider buckle 10321 from bending or curving, and the buckled connection state between the slider buckle 10321 and the auxiliary needle slider 10511 does not change. As the parallel slider module 103 and the auxiliary needle module 105 slide toward the proximal end until the slider buckle 10321 disengages from the auxiliary needle limiting groove 1015, the inner wall of the auxiliary needle limiting groove 1015 no longer prevents the slider buckle 10321 from bending or curving, and the second elastic member 1072 pushes the auxiliary needle slider 10511 toward the distal end. At the same time, the auxiliary needle slider 10511 pushes the slider buckle 10321 to bend or curve outward, and the buckling connection between the slider buckle 10321 and the auxiliary needle slider 10511 is released. The second elastic member 1072 continues to push the auxiliary needle slider 10511 to slide toward the distal end, and finally the auxiliary needle module 105 returns to its initial position, and the auxiliary needle 1052 retracts into the shell 101 to prevent the auxiliary needle 1052 from being exposed outside the shell 101 to avoid unnecessary damage.

[0123] In the embodiment of the present invention, when the slider buckle 10321 is disengaged from the auxiliary needle limiting groove 1015, the semi-enclosed needle body 10522 of the auxiliary needle penetrates into the subcutaneous tissue of the user.

[0124] In an embodiment of the present utility model, in the installation unit 100, the T-shaped structure slider 10351 is located in the limiting groove 1013. The limiting groove 1013 limits the position and direction of the parallel slider module 103 through the T-shaped structure slider 10351 to ensure that the parallel slider module 103 remains perpendicular to its sliding direction, so that the analyte detection device 104 arranged at the front end of the parallel slider module 103 remains perpendicular to its sliding direction, and at the same time, the auxiliary needle 1052 remains parallel to its sliding direction, so that the auxiliary needle 1052 and the part of the sensor body it envelops can penetrate the user's subcutaneous tissue at a vertical angle, thereby reducing the user's pain.

[0125] In an embodiment of the present invention, during the sliding of the parallel slider module 103 toward the proximal end, the T-shaped structure slider 10351 slides in the limiting groove 1013 until it contacts the outer ring 1063 of the trigger module 106. Pushed by 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 structure slider 10351 from continuing to slide toward the proximal end. Therefore, the T-shaped structure slider 10351 bends or folds around the vertical portion, and the buckle connection between the T-shaped structure buckle 10352 and the buckle hole 10412 is released, and the analyte detection device 104 is detached from the parallel slider module 103 so that it can be installed on the user's skin surface.

[0126] In the embodiment of the present invention, when the T-shaped structure slider 10351 contacts the outer ring 1063, the position of the parallel slider module 103 is the predetermined position. At this time, the lower outer shell 10413 of the analyte detection device contacts the user's skin surface.

[0127] In this embodiment of the present invention, the auxiliary needle 1052 sequentially passes through the second through hole and the first through hole 10414, penetrating the analyte detection device 104. Simultaneously, the semi-enclosed needle body 10522 of the auxiliary needle envelops the sensor 1042. As the parallel slider module 103 and the auxiliary needle module 105 slide toward the proximal end, the semi-enclosed needle body 10522 carries the sensor 1042 and penetrates the subcutaneous tissue. After the auxiliary needle 1052 retracts, the internal portion of the sensor 1042 remains subcutaneous, and the retraction of the needle body does not affect the state of the internal portion of the sensor 1042.

[0128] In this embodiment of the present invention, during installation, the user presses the housing 101 distally, applying a proximal force F to the housing 101. This causes the outer ring 1063 of the trigger module 106 to contact the user's skin surface, which in turn applies a force F' opposite to the force F, thereby enabling relative sliding between the trigger module 106 and the housing 101. During the actual installation process, the absolute position of the trigger module 106 remains unchanged, while the housing 101 slides proximally.

[0129] Before performing the installation action, in order to prevent the trigger module 106 from sliding relative to the shell 101, a protective cover 102 is installed at the proximal end of the shell 101. The protective cover 102 surrounds the outside of the outer ring 1063 of the trigger module, which can prevent the installation action from being performed in an incorrect position due to accidental contact with the outer ring 1063, thereby playing an anti-trigger role.

[0130] The distal surface 10232 of the inner cover body 1023 contacts the analyte detection device 104, and the auxiliary needle 1052 and the sensor 1042 extend into the inner cover body groove 10233, which can play a sealing role and prevent external dust, particles and other dirt from contacting the needle body and sensor and causing contamination.

[0131] In the embodiment of the present invention, an adhesive tape (not shown in the figure) is further provided on the lower outer shell 10413 of the analyte detection device for fixing the analyte detection device 104 on the user's skin surface.

[0132] Second embodiment

[0133] In the aforementioned embodiment, after the user uses the installation unit, the auxiliary needle automatically retracts into the shell under the action of the second elastic member to avoid the auxiliary needle causing unnecessary harm to the user. The auxiliary needle is completely retracted into the shell, and sufficient height needs to be reserved in the shell to accommodate the auxiliary needle module, which limits the miniaturization design of the installation unit. In order to further reduce the overall height of the shell of the installation unit and reduce the volume of the installation unit, the embodiment of the present utility model considers reducing the retraction stroke of the auxiliary needle. After the retraction stroke of the auxiliary needle is reduced, the needle tip of the auxiliary needle may be exposed outside the shell of the installation unit, which is unsafe for the user. Therefore, it is also necessary to consider protection measures for the auxiliary needle and design a needle body protection structure for the auxiliary needle.

[0134] Against this background, in some embodiments of the present invention, after a user installs an analyte monitoring device using the mounting unit, the auxiliary needle does not fully retract into the housing, leaving at least a portion of the auxiliary needle, such as the needle tip, exposed outside the housing. The user then attaches a needle protection structure to the mounting unit to protect the exposed needle tip. The specific implementation of the needle protection structure will be described in detail below.

[0135] In the embodiments of the present invention, technical solutions not described are considered to be the same as those in the aforementioned embodiments and will not be described in detail here.

[0136] Figure 12 This is a schematic diagram of the explosion structure of the installation unit of the analyte detection device according to an embodiment of the present utility model. 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 invention. 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 invention. Figure 13c This is a schematic structural diagram of the outer cover of an embodiment of the present utility model.

[0137] Reference Figure 12 In some embodiments of the present invention, the installation unit 200 includes a housing 201 and a protective cover 202. As described above, before installation, the analyte detection device 204 is pre-installed inside the housing 201 and is installed by an elastic module (not shown in the figure, refer to Figure 17 ) is pushed toward the proximal end and installed on the user's skin surface. The protective cover 202 is arranged at the proximal end of the housing 201 and is releasably connected to the housing 201 to protect the various structural components inside the housing 201 before installation.

[0138] Combined with reference Figures 13a to 13cIn some embodiments of the present invention, the protective cover 202 includes an outer cover body 2021, an inner cover body 2023 and a label paper 2024. According to the relative position relationship shown in Figure 13, before installation, the inner cover body 2023 is accommodated in the outer cover body cavity 20214, and the label paper 2024 is used to seal the outer cover body cavity 20214 to seal the inner cover body 2023 in the outer cover body cavity 20214.

[0139] In some embodiments of the present invention, the inner cover 2023 is in a movable state or a 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 does not have a restraining structure on the inner cover 2023 to limit 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, separate the inner cover 2023 and the outer cover 2021, and then remove the inner cover 2023 from the outer cover 2021. In a preferred embodiment of the present invention, in order to facilitate user use, before using the installation unit 200, the inner cover body 2023 is in a movable state relative to the outer cover body 2021, so that the user can remove the inner cover body 2023 from the outer cover body 2021 when using the installation unit 200.

[0140] In some embodiments of the present invention, in order to accommodate the inner cover body 2023 in the outer cover body 2021, the middle part of the outer cover body 2021 protrudes toward the distal end and forms an outer cover body cavity 20214 with a proximal opening. The inner diameter of the outer cover body cavity 20214 is slightly larger than the outer diameter of the inner cover body 2023. For example, a gap of 0.5 to 5 mm is left between the inner wall of the outer cover body cavity 20214 and the outer wall of the inner cover body 2023. At the same time, the depth of the outer cover body cavity 20214 is not less than the height of the inner cover body 2023, so as to prevent the inner cover body 2023 from protruding from the outer cover body cavity 20214, so as to facilitate the label paper 2024 to be pasted on the proximal surface 20215 of the outer cover body 2021, thereby completing the sealing of the outer cover body cavity 20214.

[0141] In some embodiments of the present invention, a plurality of raised semicircular balls 20234 are further provided on the proximal surface 20232 of the inner cover 2023. Before using the mounting unit 200, the inner cover 2023 is accommodated in the outer cover cavity 20214, and the label paper 2024 is adhered to the proximal surface 20215 of the outer cover 2021. The adhesive coating area of ​​the label paper 2024 may exceed the contact area between the label paper 2024 and the outer cover 2021, causing the adhesive coating of the label paper 2024 to contact the proximal surface 20232 of the inner cover 2023, and the inner cover 2023 and the label paper 2024 to adhere. When removing the inner cover 2023, the user has difficulty in tearing off the label paper 2024, and the label paper 2024 may even be damaged when being torn off, and may stick to the inner cover 2023, affecting the user's experience. Based on this, a plurality of raised semicircular balls 20234 are arranged on the proximal surface 20232 of the inner cover body 2023, which contact with the label paper 2024, thereby reducing the contact area between the proximal surface 20232 of the inner cover body 2023 and the label paper 2024, and avoiding the label paper 2024 from adhering to the proximal surface 20232 of the inner cover body 2023 over a large area, making it convenient for users to tear off the label paper 2024.

[0142] In some embodiments of the present invention, the number of the raised semicircular balls 20234 is at least 2, symmetrically or asymmetrically distributed on the proximal surface of the inner cover 2023. Preferably, the raised semicircular balls 20234 are symmetrically and evenly distributed on the proximal surface of the inner cover 2023.

[0143] In some embodiments of the present invention, the label paper 2024 may be printed with information related to the analyte detection device 204, the installation unit 200 and other equipment, such as production batch number, production date, instructions for use, communication connection SN code, trademark, QR code, etc.

[0144] In some embodiments of the present invention, 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 mounted 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 toward the distal end ( Figure 13aThe needle body accommodating cavity 20213 may be a hollow cone or a cone with a visible distal opening. When the needle body accommodating cavity 20213 is a conical structure, its diameter gradually decreases from the distal end to the proximal end. The interior of the needle body accommodating cavity 20213 may be a hollow structure parallel to the external structure, or it may be a hollow structure whose inner diameter decreases from the distal end to the proximal end. The auxiliary needle 2052 shares a central axis with the needle body accommodating cavity 20213, so that the auxiliary needle 2052 can enter the hollow cavity from the distal opening of the needle body accommodating cavity 20213. While the needle body accommodating cavity 20213 protects the auxiliary needle 2052, it effectively utilizes the internal space of the shell 201, making the structure more compact.

[0145] Figure 14 This is a schematic diagram of the state of the installation unit after use according to an embodiment of the utility model.

[0146] Reference Figure 14 In some embodiments of the present invention, the user places the mounting unit 200 on the skin surface, the trigger module 206 contacts the skin, the user applies pressure to the mounting unit 200 from the distal end to the proximal end, and the housing 201 slides proximally relative to the trigger module 206. In the process of the housing 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 to slide proximally together until the analyte detection device 204 contacts the skin surface and the auxiliary needle 2052 penetrates into the subcutaneous tissue.

[0147] Reference Figure 14 In the direction shown, in some embodiments of the present invention, when the parallel slider module 203, the analyte detection device 204, and the auxiliary needle 2052 slide together toward the proximal end, when the proximal surface of the analyte detection device 204 is flush with the proximal surface of the trigger module 206, the analyte detection device 204 contacts the user's skin surface, and the elastic module still exerts a proximal thrust on the parallel slider module 203. 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, and the analyte detection device 204 located at the proximal end of the parallel slider module 203 presses the skin surface. The proximal end of the analyte detection device 204 is provided with an adhesive tape (not shown in the figure). The analyte detection device 204 presses the adhesive tape against the skin surface, which can increase the adhesive effect between the adhesive tape and the skin surface, allowing the analyte detection device 204 to be more firmly adhered to the skin surface.

[0148] In some embodiments of the present invention, as the parallel slider module 203 continues to slide proximally relative to the shell 201, the position of the parallel slider module 203 no longer changes due to the obstruction of the skin surface. If the elastic member in the elastic module still has elastic force that has not been fully released, the elastic module pushes the shell 201 to slide distally relative to the parallel slider module 203, and carries the trigger module 206 away from the skin surface until a height difference h1 is formed between the proximal surface of the trigger module 206 and the proximal surface of the parallel slider module 203, and a pit is formed on the skin surface under the squeezing action of the analyte detection device 204 and the parallel slider module 203.

[0149] In some embodiments of the present invention, as the parallel slider module 203 continues to slide proximally relative to the shell 201, the snap connection between the parallel slider module 203 and the analyte detection device 204 is decoupled. When the relative sliding of the parallel slider module 203 and the shell 201 is terminated, the parallel slider module 203 has been separated from the analyte detection device 204, while the parallel slider module 203 is still confined in the shell 201. At this time, the analyte detection device 204 is in a separated state relative to the shell 201, and the user can lift the shell 201 toward the distal end by hand, and the analyte detection device 204 is adhered to the skin surface with tape.

[0150] In some embodiments of the present invention, when the parallel slider module 203 slides proximally relative to the housing 201 to a first predetermined position, the auxiliary needle module 205 slides proximally relative to the housing to an end point. At this point, the auxiliary needle 2052 penetrates the subcutaneous tissue, and the internal portion of the sensor 2042 is delivered to a predetermined subcutaneous depth. The auxiliary needle module 205 then retracts and slides distally relative to the housing 201 to a second predetermined position.

[0151] Figure 15 This is a schematic diagram of the state where the auxiliary needle of the mounting unit of the embodiment of the utility model is retracted.

[0152] Reference Figure 15 In some embodiments of the present invention, the auxiliary needle module 205 slides distally to a second predetermined position, i.e., the end point of retraction, and the auxiliary needle 2052 exits the subcutaneous space, making it easier for the user to remove the housing 201. After the auxiliary needle 2052 is retracted, the internal part of the sensor 2042 remains subcutaneous.

[0153] In some embodiments of the present invention, after the auxiliary needle 2052 is retracted, a portion of the needle tip is exposed outside the housing 201, such as Figure 15As shown, there is a height difference h2 between the tip of the auxiliary needle 2052 and the proximal end surface of the parallel slider module 203. That is, the length of the auxiliary needle 2052 exposed outside the housing 201 is h2, and the range of h2 is preferably 0.1 to 5 mm. If the exposed length of the auxiliary needle 2052 is too long, the needle tip may remain subcutaneous when retracted, potentially causing damage to the skin or body when the user removes the housing 201.

[0154] In some embodiments of the present invention, after the auxiliary needle 2052 is retracted, a portion of the needle tip is exposed outside the housing 201, rather than being completely retracted into the housing 201. This can reduce the retraction stroke of the auxiliary needle 2052, thereby reducing the overall height of the housing 201, making the installation unit 200 more compact and lighter in weight. At the same time, it can also reduce the material usage of the housing 201, thereby reducing the production cost of the installation unit 200. Figure 15 In the figure, the dotted line represents 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 near the distal end is the final position of the auxiliary needle module 205 before the retraction stroke is reduced, and the position near the proximal end is the final position of the auxiliary needle module 205 after the retraction stroke is reduced.

[0155] In some embodiments of the present invention, reducing the retraction stroke of the auxiliary needle 2052 means reducing the retraction stroke of the auxiliary needle module 205 by the same amount. Figure 15 The reduced retraction stroke of the auxiliary needle module 205 is h3. After the auxiliary needle module 205 reduces the retraction stroke, the overall height of the shell 201 can be reduced. The reduced overall height of the shell 201 can be consistent with the reduced retraction stroke of the auxiliary needle module 205, both of which are h3.

[0156] In some embodiments of the present invention, the auxiliary needle 2052 is exposed outside the housing 201, and the needle tip may cause unnecessary harm to the human body. Therefore, after using the installation unit 200, a needle body protection structure is required to protect the exposed needle tip.

[0157] Figures 16a-16c This is a schematic diagram of the inner cover body serving as a needle protection structure in an embodiment of the present utility model.

[0158] Combined with reference Figures 16a-16c and Figure 13c In some embodiments of the present invention, after using the mounting unit 200, the user can remove the inner cover body 2023 from the outer cover body 2021, and assemble the inner cover body 2023 to the parallel slider module 203, the trigger module 206 or the outer shell 201. A needle protection cavity 20233 is provided on the inner cover body 2023, which can be used to protect the exposed needle tip of the auxiliary needle 2052.

[0159] In some embodiments of the present invention, the inner cover 2023 is assembled with the parallel slider module 203 as an example for description. The inner cover 2023 is a needle protection structure of the present invention. The proximal surface of the parallel slider module 203 is larger than the proximal surface of the trigger module 206 or the housing 201, making it easier to manufacture and assemble the structure.

[0160] In some embodiments of the present invention, referring to Figure 16b In the direction shown, the needle protection cavity 20233 is a hollow cavity that opens toward the distal end. The inner hollow cavity can be used to accommodate the exposed needle tip of the auxiliary needle 2052. The outer surface of the needle protection cavity 20233 can be cylindrical, conical, rectangular, or other irregular three-dimensional structures, without limitation. The inner cavity can be the same or different in shape from the outer surface. Preferably, the inner cavity is cylindrical or conical, and more preferably, the inner cavity is conical, with its inner diameter gradually decreasing from the distal end to the proximal end.

[0161] In some embodiments of the present invention, if the auxiliary needle 20522 is in an off-center position relative to the parallel slider module 203, the needle protection cavity 20233 is also in an off-center position on the inner cover 2023, that is, the auxiliary needle 20522 and the needle protection cavity 20233 share a central axis. Before assembling the outer cover 2021 to the parallel slider module 203, the user must ensure that the distal opening of the needle protection cavity 20233 is aligned with the auxiliary needle 20522 to avoid misalignment between the needle protection cavity 20233 and the auxiliary needle 20522.

[0162] In some embodiments of the present invention, the inner cover 2023 and the parallel slider module 203 are assembled and connected by one or more of the following methods: snaps, hooks, blocks, threads, bolts, Velcro, and glue. Any assembly method that can assemble the inner cover 2023 to the parallel slider module 203 should be included in the scope of protection of the present invention. At least two structures for assembly and 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.

[0163] In some embodiments of the present invention, the assembly structure can be interchanged between the inner cover 2023 and the parallel slider module 203. For example, a hook 20231 is provided on the distal surface of the inner cover 2023, and a corresponding latch hole 2037 is provided on the proximal surface of the parallel slider module 203 for establishing an assembly connection with the hook 20231. In other embodiments of the present invention, the hook 20231 can be provided on the parallel slider module 203, and the corresponding latch hole 2037 can be provided on the inner cover 2023.

[0164] In some embodiments of the present invention, to facilitate user assembly of the inner cover 2023 and to enhance the secure assembly of the inner cover 2023, positioning structures are provided on the inner cover 2023 and the parallel slider module 203. The positioning structures are composed of positioning posts 20232 and positioning holes 2036, with corresponding positions and numbers on the inner cover 2023 and the parallel slider module 203.

[0165] In some embodiments of the present invention, the positioning post 20232 may be located on the distal end surface of the inner cover 2023, in which case the positioning hole 2036 is located on the proximal end surface of the parallel slider module 203. In other embodiments of the present invention, the positioning hole 2036 may be located on the distal end surface of the inner cover 2023, in which case the positioning post 20232 is located on the proximal end surface of the parallel slider module 203.

[0166] In some embodiments of the present invention, the positioning structure is not limited to Figures 16a to 16c The combination of the positioning column 20232 and the positioning hole 2036 shown can also be other types of positioning structures, such as a combination of a slider and a slide groove. All structures involving the positioning function should be included in the protection scope of the present utility model.

[0167] In some embodiments of the present invention, the user holds the inner cover 2023 and the housing 201 by hand and brings them close to each other, aligns the assembly structure and the positioning structure, and then places the auxiliary needle 20522 on the central axis of the needle body protection cavity 20233. Then, by pressing the inner cover 2023 and the housing 201 firmly, the inner cover 2023 can be assembled to the parallel slider module 203. The needle body protection cavity 20233 wraps the auxiliary needle 20522 to seal and protect the exposed needle tip. The schematic diagram of the state where the inner cover 2023 is assembled to the parallel slider module 203 is shown in FIG. Figure 16c shown.

[0168] Figure 17 This is a schematic cross-sectional structural diagram of the installation unit according to an embodiment of the present utility model.

[0169] Reference Figure 17 In some embodiments of the present invention, the elastic module includes a first elastic member 2071, a second elastic member 2072, and a third elastic member 2073. Before using the mounting unit 200, the first elastic member 2071 and the second elastic member 2072 are in a compressed state, and the third elastic member 2073 is in a normal state. After releasing its elastic force, the first elastic member 2071 is used to push the parallel slider module 203 to slide proximally. After releasing its elastic force, the second elastic member 2072 is used to push the auxiliary needle module 205 distally to retract the auxiliary needle 2052. The third elastic member 2073 is used to adjust the retraction stroke of the auxiliary needle module 205.

[0170] In some embodiments of the present invention, a third elastic member 2072 is disposed within the housing 201, with one end contacting the inner side of the housing 201 and the other end facing the auxiliary needle module 205. After the first elastic member 2071 pushes the parallel slider module 203 toward the proximal end and the second elastic member 2072 pushes the auxiliary needle module 205 toward the distal end, the third elastic member 2073 prevents the auxiliary needle module 205 from sliding further distally, limiting its retraction and reducing its retraction travel. Without the third elastic member 2073, when retracting, the auxiliary needle module 205 would slide to the farthest end within the housing 201 until contacting the housing 201. With the third elastic member 2073, the retraction travel of the auxiliary needle module 205, and thus the exposed length of the auxiliary needle 2052 tip, can be adjusted based on the relative elastic forces and lengths of the second and third elastic members 2072 and 2073.

[0171] In some embodiments of the present invention, the reduction amount h3 of the retraction stroke of the auxiliary needle module 205 is equal to the length L of the third elastic member 2073 after the elastic forces of the second elastic member 2072 and the third elastic member 2073 are balanced.

[0172] In some embodiments of the present invention, the initial state of the third elastic member 2073 is normal, uncompressed or unstretched, while the initial state of the second elastic member 2072 is compressed. After the second elastic member 2072 releases its elastic force, the auxiliary needle module 205 is pushed distally by the second elastic member 2072 until the auxiliary needle module 205 contacts the proximal end of the third elastic member 2073 and continues to slide distally under the elastic force of the second elastic member 2072. The third elastic member 2073 is compressed and generates an elastic force under the elastic force of the second elastic member 2072 until the elastic force of the third elastic member 2073 equals the elastic force of the second elastic member 2072, reaching a state of equilibrium, at which point the auxiliary needle module 205 stops sliding distally.

[0173] In some embodiments of the present invention, the second elastic member 2072 and the third elastic member 2073 are springs, whose elastic modulus and initial length are preset before shipment. After the auxiliary needle module 205 is retracted, when the third elastic member 2073 and the second elastic member 2072 have the same elastic force and are in equilibrium, the second elastic member 2072 remains compressed. By adjusting the elastic modulus and initial length of the second and third elastic members 2072, 2073, the length L of the third elastic member 2073 when the second and third elastic members 2072, 2073 reach elastic equilibrium can be controlled, thereby controlling the retraction stroke of the auxiliary needle module 205 and the reduction in retraction stroke h3, ultimately determining the length h2 of the auxiliary needle 2052 tip protruding from the housing 201.

[0174] In some embodiments of the present invention, after the auxiliary needle module 205 stops sliding, the user lifts the shell 201 from the skin surface, and the needle tip of the auxiliary needle 2052 is exposed outside the shell 201, and then assembles the inner cover body 2023 onto the parallel slider module 203. The needle body protection cavity 20233 surrounds and seals the auxiliary needle 2052, and the inner cover body 2023 completes its protection function for the auxiliary needle 2052.

[0175] Figures 18a-18c This is a schematic diagram of the protective sleeve used as a needle protection structure in an embodiment of the utility model.

[0176] Combined with reference Figures 18a-18c In some embodiments of the present invention, the needle protection structure may also be an elastic protective sleeve 20523. After the user has finished using the mounting unit 200, the elastic protective sleeve 20523 may be assembled onto the auxiliary needle 2052 to protect the needle tip exposed outside the housing 201. The specific implementation will be described below.

[0177] by Figure 18b The directions shown are for reference only. In some embodiments of the present invention, the elastic protective sleeve 20523 is a hollow, three-dimensional structure with a distal opening, which is used to accommodate the auxiliary needle 2052. The outer diameter of the auxiliary needle 2052 is set to d3, and the inner diameter of the distal opening of the elastic protective sleeve 20523 is set to d4. The inner diameter d4 is slightly larger than the outer diameter d3 of the auxiliary needle 2052, for example, 0.1 to 2 mm 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 toward the proximal end, 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 to 2 mm. Because the material of the elastic protective sleeve 20523 is elastic, the inner diameter d5 is slightly smaller than the outer diameter d3 of the auxiliary needle 2052. This creates an interference fit between the elastic protective sleeve 20523 and the auxiliary needle 2052, increasing the friction between the auxiliary needle 2052 and the elastic protective sleeve 20523. This allows the elastic protective sleeve 20523 to be fixed relative to the auxiliary needle 2052 after being positioned over the auxiliary needle 2052, preventing it from falling off. That is, the dimensions of the elastic protective sleeve 20523 and the auxiliary needle 2052 are numerically such that d4>d3>d5. The proximal end of the elastic protective sleeve 20523 can be open or closed, and its overall length should be no less than the length h2 of the auxiliary needle 2052 exposed outside the housing 201, for example, 0.1 to 20 mm, so that the elastic protective sleeve 20523 can completely cover the exposed needle tip and protect the auxiliary needle 2052. Preferably, the proximal end of the elastic protective sleeve 20523 is closed to prevent the needle tip of the auxiliary needle 2052 from being exposed from the proximal end of the elastic protective sleeve 20523.

[0178] In some embodiments of the present invention, before the user uses the installation unit 200, the elastic protective cover 20523 can be a structural component independent of the installation unit 200. After using the installation unit 200, the user puts the elastic protective cover 20523 on the auxiliary needle 2052 to form a whole with the installation unit 200.

[0179] In some embodiments of the present invention, 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 and rubber. Any change in the material of the elastic protective sleeve 20523 is included in the scope of protection of the present invention.

[0180] In some embodiments of the present invention, the elastic protective cover 20523 may not be limited to the above 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 in the protection scope of the present utility model.

[0181] To sum up, an embodiment of the utility model discloses an analyte detection device installation unit. Before using the installation unit, a protective cover is assembled at the proximal end of the shell to protect the auxiliary needle. The protective cover includes an outer cover body and an inner cover body. The inner cover body is placed in the concave cavity of the outer cover body and sealed with label paper. The structure is compact, which is beneficial to the miniaturized design of the installation unit.

[0182] Although some specific embodiments of the present invention have been described in detail by way of examples, those skilled in the art will appreciate 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 will appreciate that modifications may 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 installation unit, characterized in that: include: a housing and an elastic module, a trigger module, a parallel slider module, an auxiliary needle module and an analyte detection device pre-installed in the housing, wherein the auxiliary needle module includes an auxiliary needle; and a protective cover releasably connected to the housing, the protective cover comprising an outer cover and an inner cover, the outer cover comprising an outer cover cavity, the inner cover being placed in the outer cover cavity; A label paper is pasted on the proximal end surface of the outer cover to seal the outer cover cavity.

2. The analyte detection device installation unit according to claim 1, characterized in that: The proximal surface of the inner cover body also includes at least two raised semicircular balls.

3. The analyte detection device installation unit according to claim 2, characterized in that: The raised semicircular spheres are evenly distributed on the proximal surface of the inner cover body.

4. The analyte detection device installation unit according to claim 1, characterized in that: The outer cover comprises a needle accommodating cavity for accommodating the auxiliary needle before using the mounting unit.

5. The analyte detection device installation unit according to claim 4, characterized in that: The needle accommodating cavity comprises a hollow structure, and the inner diameter of the hollow structure of the needle accommodating cavity decreases from the distal end to the proximal end.

6. The analyte detection device installation unit according to claim 5, characterized in that: The inner cover includes a needle protection cavity and is used to accommodate the auxiliary needle after the mounting unit is used.

7. The analyte detection device installation unit according to claim 6, characterized in that: The needle protection cavity and the needle accommodating cavity share a central axis.

8. The analyte detection device installation unit according to claim 1, characterized in that: The inner cover body further includes an assembly structure for establishing an assembly connection with the parallel slider module, the trigger module or the housing.

9. The analyte detection device installation unit according to claim 8, characterized in that: The inner cover also includes a positioning structure.

10. The analyte detection device installation unit according to claim 1, characterized in that: After the mounting unit is used, the auxiliary needle module is retracted, and at least a portion of the auxiliary needle is exposed outside the housing.

11. The analyte detection device installation unit according to claim 10, characterized in that: The length of the auxiliary needle exposed outside the shell is 0.1 to 5 mm.

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