Analyte sensor fixing device

Abstract

In a mounting unit (100) for an analyte detection device (104), a buckle structure of a parallel slider module (103) is in contact with an annular structure of the analyte detection device (104), so that releasable connection is formed between the parallel slider module (103) and the analyte detection device (104), when the parallel slider module (103) is located at a distal end, the analyte detection device (104) is fixed on the parallel slider module (103), and when the parallel slider module (103) is located at a distal end, the analyte detection device (104) is fixed on the parallel slider module (103). After the parallel sliding block module (103) slides to the near end, the analyte detection device (104) is automatically separated from the parallel sliding block module (103), and the installation unit (100) is simple in structure, high in reliability and convenient to use.

Description

Analyte sensor fixture

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to the following patent application: PCT patent application number PCT / CN2022 / 121280 filed on September 26, 2022. Technical Field

[0003] The present invention mainly relates to the field of medical devices, and in particular to a mounting unit of an analyte detection device. Background Art

[0004] 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.

[0005] Diabetics need to check their blood sugar before injecting insulin. Currently, most testing methods can continuously monitor blood sugar levels and transmit the data in real time to an external device for easy viewing. This method is called continuous glucose monitoring (CGM). This method requires a device attached to the skin, with the sensor inserted into the subcutaneous tissue fluid to perform the test.

[0006] The installation unit structure of the current analyte detection device is complex, the installation process is tedious, the production cost is high, and it also causes inconvenience to users.

[0007] Therefore, the prior art urgently needs an analyte detection device installation unit with a simple structure and easy use.

[0008] Summary of the Invention

[0009] The present invention discloses an installation unit for an analyte detection device. The snap structure of a parallel slider module contacts the annular structure of the analyte detection device, so that a releasable connection is formed between the parallel slider module and the analyte detection device. When the parallel slider module is located at the distal end, the analyte detection device is fixed on the parallel slider module. After the parallel slider module slides to the proximal end, the analyte detection device is automatically separated from the parallel slider module. The installation unit has a simple structure, high reliability, and is easy to use.

[0010] The present invention provides an installation unit for an analyte detection device, including an installation unit, which includes at least a shell, an auxiliary needle and a parallel slider module. When the installation unit is used, the auxiliary needle and the parallel slider module slide from the distal end to the proximal end in the shell, and the analyte detection device is installed on the user's skin surface at the proximal end to obtain in vivo analyte parameter information; wherein, when the parallel slider module is located at the distal end, the snap structure of the parallel slider module contacts the annular structure of the analyte detection device, so that the analyte detection device is fixed on the parallel slider module, and after the parallel slider module slides to the proximal end, the snap structure and the annular structure are released from contact, and the analyte detection device is separated from the parallel slider module.

[0011] According to one aspect of the present invention, an analyte detection device includes an upper outer shell and a lower outer shell.

[0012] According to one aspect of the present invention, the annular structure surrounds the outer side of the upper outer shell and / or the lower outer shell.

[0013] According to one aspect of the present invention, the annular structure surrounds the connection between the upper outer shell and the lower outer shell.

[0014] According to one aspect of the present invention, the upper outer shell and the lower outer shell have different circumferential sizes.

[0015] According to one aspect of the present invention, the circumference of the upper outer shell is larger than that of the lower outer shell, and the buckle structure is in contact with the upper outer shell.

[0016] According to one aspect of the present invention, the circumferential dimension of the upper outer shell is 0.05 to 5 mm larger than the circumferential dimension of the lower outer shell.

[0017] According to one aspect of the present invention, the invention further comprises an inclined transition surface connecting the outer edge of the upper housing and the outer edge of the lower housing, and the snap structure contacts the inclined transition surface.

[0018] According to one aspect of the present invention, the annular structure is an annular groove, and the buckle structure is in contact with the annular groove.

[0019] According to one aspect of the present invention, the buckle structure is a T-shaped buckle.

[0020] According to one aspect of the present invention, the number of T-shaped structural buckles is 3, which are evenly spaced and distributed on the parallel slider module.

[0021] According to one aspect of the present invention, it further includes at least one set of corresponding limiting blocks and limiting holes.

[0022] According to one aspect of the present invention, the limiting block is located on the inner circumference of the parallel slider module, and the limiting hole is located on the outer circumference of the analyte detection device.

[0023] According to one aspect of the present invention, the limiting block is located on the outer circumference of the analyte detection device, and the limiting hole is located on the inner circumference of the parallel slider module.

[0024] According to one aspect of the present invention, the invention further comprises a through hole located on the housing.

[0025] According to one aspect of the present invention, the through hole includes a first through hole located in the lower outer shell and a second through hole located in the upper outer shell, and the first through hole and the second through hole are coaxial.

[0026] According to one aspect of the present invention, when the limiting clamping block is embedded in the limiting clamping hole, the auxiliary needle passes through the first through hole and the second through hole.

[0027] According to one aspect of the present invention, the invention further includes a self-sealing member located on the housing.

[0028] According to one aspect of the present invention, when the limiting clamping block is embedded in the limiting clamping hole, the auxiliary needle passes through the self-sealing component.

[0029] According to one aspect of the present invention, the analyte detection device further comprises a sensor, a transmitter, an internal circuit and a battery, wherein the sensor comprises an internal portion and an external portion, and the external portion, the transmitter, the internal circuit and the battery are located within the housing.

[0030] According to one aspect of the invention, the intracorporeal portion is bent relative to the extracorporeal portion.

[0031] According to one aspect of the invention, the external portion is electrically coupled to the internal circuit.

[0032] According to one aspect of the present invention, it further includes a conductive adhesive strip, through which the external portion is electrically coupled to the internal circuit.

[0033] According to one aspect of the present invention, the conductive rubber strip includes conductive areas and insulating areas that are spaced apart.

[0034] According to one aspect of the present invention, the conductive rubber strip is a rectangular parallelepiped structure.

[0035] According to one aspect of the present invention, the internal body portion and the internal circuit are electrically coupled via at least one structural surface of the conductive adhesive strip.

[0036] According to one aspect of the present invention, it further includes an elastic module and a trigger module. Before the installation unit is used, the elastic module is in a compressed state, and the trigger module is used to prevent the elastic module from releasing elastic force.

[0037] Compared with the prior art, the technical solution of the present invention has the following advantages:

[0038] In the mounting unit of the analyte detection device disclosed in the present invention, the snap structure of the parallel slider module contacts the annular structure of the analyte detection device, thereby realizing a releasable connection between the parallel slider module and the analyte detection device. The structure is simple, easy to process, and highly reliable.

[0039] Furthermore, the annular structure may be an annular groove surrounding the outer edge of the upper outer shell or the lower outer shell, which has a simple structure and is easy to process.

[0040] Furthermore, the annular structure may be a stepped structure formed by the difference in circumferential size between the upper outer shell and the lower outer shell. The stepped structure can be formed without additional processing of the upper outer shell or the lower outer shell, and has a simple structure and is easy to process.

[0041] Furthermore, the stepped structure may be a step structure that changes suddenly from the upper outer shell to the lower outer shell, which has a simple structure and is easy to process.

[0042] Furthermore, the stepped structure also includes an inclined transition surface connecting the outer edge of the upper outer shell to the outer edge of the lower outer shell, which can prevent the upper outer shell and the lower outer shell from detaching due to the user touching the outer edges of the upper outer shell and the lower outer shell during use.

[0043] Furthermore, it also includes a corresponding limit block and limit hole, which are respectively located on the parallel slider module or the analyte detection device. When the analyte detection device is fixed on the parallel slider module, the placement direction of the analyte detection device on the parallel slider module can be guided, so that the auxiliary needle can pass through the through hole or self-sealing component on the analyte detection device, so that the sensor can be enclosed in the auxiliary needle. At the same time, it can also prevent the analyte detection device from rotating and offsetting on the parallel slider module. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] FIG1 is a schematic diagram of the external structure of a mounting unit of an analyte detection device according to an embodiment of the present invention;

[0045] FIG2a is a schematic diagram of the external structure of a housing according to an embodiment of the present invention;

[0046] FIG2 b is a schematic structural diagram of a protective cover according to an embodiment of the present invention;

[0047] FIG3 is a schematic diagram of an exploded structure of an installation unit of an analyte detection device according to an embodiment of the present invention;

[0048] FIG4 is a schematic diagram of the internal structure of a housing according to an embodiment of the present invention;

[0049] FIG5 a is a schematic structural diagram of a distal end surface of a parallel slider module according to an embodiment of the present invention;

[0050] FIG5 b is a schematic structural diagram of the proximal end surface of a parallel slider module according to an embodiment of the present invention;

[0051] FIG5c is a schematic structural diagram of a parallel slider module provided with a limit block according to an embodiment of the present invention;

[0052] 6a-6b are schematic structural diagrams of an analyte detection device according to an embodiment of the present invention;

[0053] FIG6 c is a schematic structural diagram of an analyte detection device fixed on a parallel slider module according to an embodiment of the present invention;

[0054] FIG6d is a schematic diagram of the AA' cross-sectional structure of FIG6a according to an embodiment of the present invention;

[0055] 6e-6h are schematic diagrams showing different usages of the conductive adhesive strip according to an embodiment of the present invention;

[0056] FIG7 a is a schematic structural diagram of an auxiliary needle module according to an embodiment of the present invention;

[0057] FIG7 b is a schematic diagram of a bending sensor according to an embodiment of the present invention;

[0058] FIG7 c is a schematic diagram of an elastic pad being arranged outside the auxiliary needle before installation according to an embodiment of the present invention;

[0059] FIG7 d is a schematic diagram showing an elastic pad being arranged outside the auxiliary needle after the auxiliary needle has penetrated subcutaneously according to an embodiment of the present invention;

[0060] FIG7e is a schematic diagram of an elastic cushion sleeve disposed outside the sensor after the auxiliary needle is retracted according to an embodiment of the present invention;

[0061] FIG7 f is a schematic structural diagram of a solid elastic pad according to an embodiment of the present invention;

[0062] FIG7g is a schematic diagram of a structure in which the elastic pad is hollow according to an embodiment of the present invention;

[0063] FIG7h is a schematic diagram showing a structure in which an elastic pad is embedded in a housing of an analyte detection device according to an embodiment of the present invention;

[0064] FIG8 is a schematic structural diagram of a trigger module according to an embodiment of the present invention;

[0065] FIG9 is a top view of a mounting unit according to an embodiment of the present invention;

[0066] FIG10a is a schematic diagram of the cross-sectional structure of line A in FIG9 ;

[0067] FIG10 b is a schematic diagram of the cross-sectional structure of B in FIG9 ;

[0068] FIG10c is a schematic diagram of the cross-sectional structure of line C in FIG9 ;

[0069] FIG. 11 is a schematic diagram of the bending of the first buckle under force according to an embodiment of the present invention. DETAILED DESCRIPTION

[0070] As mentioned above, the installation unit structure of the analyte detection device in the prior art is complex, the installation process is cumbersome, the production cost is high, and it also causes inconvenience to users.

[0071] In order to solve this problem, the present invention provides an installation unit for an analyte detection device. The snap structure of the parallel slider module contacts the annular structure of the analyte detection device, so that a releasable connection is formed between the parallel slider module and the analyte detection device. When the parallel slider module is located at the distal end, the analyte detection device is fixed on the parallel slider module. After the parallel slider module slides to the proximal end, the analyte detection device is automatically separated from the parallel slider module. The installation unit has a simple structure, high reliability, and is easy to use.

[0072] 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.

[0073] 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.

[0074] The following description of exemplary embodiments is merely illustrative and is not intended to limit the present invention, its application, or use in any sense. Technologies, methods, and apparatus known to those skilled in the art may not be discussed in detail herein, but to the extent applicable, such technologies, methods, and apparatuses should be considered part of this specification.

[0075] 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.

[0076] Figure 1 is a schematic diagram of the external structure of the mounting unit of an analyte detection device according to an embodiment of the present invention. The external structure of mounting unit 100 includes a housing 101 and a protective cover 102. Housing 101 is used to support internal components. When in use, mounting unit 100 is positioned proximally, with the end closest to the user's skin being the proximal end, and the end further from the skin being the distal end. A first opening is provided at the proximal end of housing 101. Protective cover 102 is used to protect, seal, and prevent triggering of the internal structure and components of housing 101.

[0077] Shell exterior

[0078] Figure 2a is a schematic diagram of the external structure of the housing according to an embodiment of the present invention, and Figure 2b is a schematic diagram of the structure of the protective cover. The protective cover 102 includes 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, the second opening facing the first opening. At the second opening, the outer cover 1021 and the clamp 1022 are connected by breakable columns 10211, which are distributed at a certain interval between the outer cover 1021 and the clamp 1022. When the outer cover 1021 rotates relative to the clamp 1022, the columns 10211 can be broken, and the outer cover 1021 and the clamp 1022 can be separated.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] Inside the shell

[0084] Figure 3 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.

[0085] The analyte detection device 104 and the mounting unit 100 are not limited to the matching relationship described in Figure 3. In some embodiments of the present invention, before installation, the analyte detection device 104 is built into the mounting unit 100. When in use, the user removes the mounting unit 100 from the packaging box and can then install the analyte detection device 104 on the surface of human skin. In other embodiments of the present invention, before installation, the analyte detection device 104 and the mounting unit 100 are in a separated state. That is, the user needs to remove the mounting unit 100 and the analyte detection device 104 from the packaging box separately, and then assemble the analyte detection device 104 into the mounting unit 100 before the analyte detection device 104 can be installed on the surface of human skin.

[0086] FIG4 is a schematic diagram of the internal structure of the housing 101 according to an embodiment of the present invention.

[0087] In this embodiment of the present invention, 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.

[0088] 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.

[0089] 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.

[0090] In the embodiment of the present invention, 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 .

[0091] 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.

[0092] In other embodiments of the present invention, the limiting groove 1013 is a groove recessed in the inner wall of the housing 101 .

[0093] In the embodiment of the present invention, the card slot 1014 includes two card slot positions, namely a first card slot position 10141 and a second card slot position 10142 . As shown in FIG10 a , the first card slot position 10141 is closer to the proximal end than the second card slot position 10142 .

[0094] 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.

[0095] 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.

[0096] Parallel slider module

[0097] FIG5a is a schematic structural diagram of the distal end surface of the parallel slider module 103 , FIG5b is a schematic structural diagram of the proximal end surface of the parallel slider module 103 , and FIG5c is a schematic structural diagram of the parallel slider module 103 with a limit block 1036 .

[0098] 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.

[0099] 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 .

[0100] In other embodiments of the present invention, the slider buckle 10321 can be directly disposed on the distal end surface of the parallel slider module 103 without the need for a circular groove structure.

[0101] In this embodiment of the present invention, a boss 10322 is further 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.

[0102] In a preferred embodiment of the present invention, there are two slider clips 10321 symmetrically distributed on the side wall of the circular groove 1032 , and the angular interval between the two slider clips 10321 is 180°.

[0103] 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.

[0104] 5 a , 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°.

[0105] In other embodiments of the present invention, the number of second clips 1033 is three or four, symmetrically distributed on the sides of the distal end surface 1031, and the angular spacing between them is 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.

[0106] Referring to 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.

[0107] 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. During the proximal movement of the parallel slider module 103, the T-shaped structural sliders 10351 slide within the limiting slots 1013.

[0108] In a preferred embodiment of the present invention, the vertical portion of the T-shaped structure 1035 is made of a 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.

[0109] 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.

[0110] 5c , in other embodiments of the present invention, a limit block 1036 is further provided on the inner ring of the parallel slider module 103 . The limit block 1036 is used to limit the analyte detection device 104 and prevent the analyte detection device 104 from rotational displacement, which will be described in detail below.

[0111] Analyte detection device

[0112] Figure 6a is a structural schematic diagram of the analyte detection device 104 according to an embodiment of the present invention, Figure 6b is another structural schematic diagram of the analyte detection device 104 according to an embodiment of the present invention, Figure 6c is a structural schematic diagram of the analyte detection device 104 according to an embodiment of the present invention fixed on the parallel slider module 103, Figure 6d is a structural schematic diagram of the A-A' section of Figure 6a, and Figures 6e to 6h are schematic diagrams of different usage methods of the conductive tape 1043.

[0113] 3 , in an embodiment of the present invention, the analyte detection device 104 includes a housing 1041, a transmitter (not shown), a sensor 1042, a battery (not shown), 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 in 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.

[0114] 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, where the second frequency f2 is greater than the first frequency f1. In a further preferred embodiment of the present invention, the first frequency f1 is 0 to 12 times / hour, and the second frequency f2 is 12 to 3600 times / hour.

[0115] 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.

[0116] 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), and the external part, a transmitter, a battery and an 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.

[0117] 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.

[0118] In other embodiments of the present invention, a self-sealing member is provided on the axis of the internal portion of the upper outer shell 10411. The self-sealing member is initially in a sealed state, possesses a certain degree of elasticity and flexibility, and can be pierced by the auxiliary needle 1052. For example, it is made of silicone, nitrile rubber, etc. In the installation unit 100, the auxiliary needle 1052 pierces the self-sealing member, and the self-sealing member tightly surrounds the sidewall of the auxiliary needle 1052, leaving no gaps or openings. After the installation unit 100 is used, the auxiliary needle 1052 is retracted and separated from the analyte detection device 104. The self-sealing member returns to a sealed state without leaving any openings or through-holes, thereby forming a good seal with the analyte detection device 104.

[0119] In other embodiments of the present invention, a self-sealing component is provided around the internal part of the lower outer shell 10413, the internal part passes through the self-sealing component, and the self-sealing component surrounds the internal part. The self-sealing component can provide sealing protection for the lower outer shell 10413 to prevent blood from being sprayed and immersed into the analyte detection device 104 when the internal part pierces the subcutaneous tissue, and can also achieve a waterproof effect.

[0120] In other embodiments of the present invention, self-sealing components may be provided on both the upper housing 10411 and the lower housing 10413, or on one of them. When a self-sealing component is provided on one of them, a through hole for the auxiliary needle 1052 to pass through is provided on the other housing.

[0121] In the embodiment of the present invention, the self-sealing member located on the lower outer shell 10413 is made of a light-proof material to prevent external light from passing through the self-sealing member to irradiate the interior of the analyte detection device 104 and trigger the photosensitive element.

[0122] In an embodiment of the present invention, the self-sealing member on the upper outer shell 10411 may be made of a light-transmitting material. After the analyte detection device 104 is ejected, external light may pass through the self-sealing member and illuminate the interior of the analyte detection device 104 to trigger the photosensitive element.

[0123] In an embodiment of the present invention, the side of the upper outer shell 10411 includes a latch hole 10412 corresponding to the T-shaped structure latch 10352. Here, "corresponding" means that the position and number of the latch holes 10412 are consistent with those of the T-shaped structure latch 10352. In the installation unit 100, the upper outer shell 10411 is in contact with the proximal end surface 1034, and the T-shaped structure latch 10352 forms a latch connection with the latch hole 10412, 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 latch 10352 and the latch hole 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.

[0124] In the embodiment of the present invention, the latch hole 10412 corresponds to the T-shaped structural latch 10352, so that the analyte detection device 104 can also serve as a positioning function when it is fixed to the parallel slider module 103. The outer shell of the analyte detection device 104 is circular. When the analyte detection device 104 is installed on the parallel slider module 103 before shipment, it is impossible to directly align the first through hole 10414 with the auxiliary needle 1052. Moreover, even if the first through hole 10414 and the auxiliary needle 1052 are aligned during installation, the analyte detection device 104 may still rotate relative to the parallel slider module 103 during subsequent transportation and use, causing the internal portion 1042 to break away from the envelope of the auxiliary needle 1052, thus affecting its use. Therefore, according to the correspondence between the card hole 10412 and the T-shaped structure buckle 10352, on the one hand, the placement position of the analyte detection device 104 on the parallel slider module 103 can be determined, and on the other hand, the analyte detection device can be prevented from rotating and offsetting relative to the parallel slider module 103, thereby improving the user experience.

[0125] In an embodiment of the present invention, the circumferential dimensions of the upper outer shell 10411 and the lower outer shell 10413 are consistent, thereby forming a smooth connecting surface at the junction of the upper outer shell 10411 and the lower outer shell 10413, reducing the possibility of separation of the upper outer shell 10411 and the lower outer shell 10413 due to accidental collision, and ensuring the normal use of the analyte detection device 104.

[0126] In this embodiment of the present invention, an annular groove surrounding the upper outer shell 10411 is provided on the outer side of the upper outer shell 10411. The T-shaped structural buckle 10352 can be inserted into the annular groove to achieve a snap-fit ​​fixation of the analyte detection device 104. After the T-shaped structural buckle 10352 is released from the annular groove, the analyte detection device 104 can be separated from the parallel slider module 103.

[0127] In other embodiments of the present invention, the annular groove may also be provided on the outside of the lower outer shell 10413 , or on the outside of the connection between the upper outer shell 10411 and the lower outer shell 10413 .

[0128] 6b and 6c , in other embodiments of the present invention, the circumferential dimensions of the upper outer shell 10411 and the lower outer shell 10413 are inconsistent. Preferably, the diameter of the upper outer shell 10411 is slightly larger than that of the lower outer shell 10413. For example, the diameter of the upper outer shell 10411 is 0.05 to 5 mm larger than that of the lower outer shell 10413. Thus, the upper outer shell 10411 forms a stepped structure 10415 relative to the lower outer shell 10413. When the analyte detection device 104 is placed on the parallel slider module 103, the upper outer shell 10411 abuts the proximal end surface 1034, and the T-shaped structural buckle 10352 abuts the stepped structure 10415, forming a snap-fit ​​connection. The T-shaped structural buckle 10352 presses the analyte detection device 104 onto the proximal end surface 1034 of the parallel slider module 103 via the stepped structure 10415.

[0129] In some embodiments of the present invention, the stepped structure 10415 may be a stepped structure that abruptly changes from the upper outer shell 10411 to the lower outer shell 10413 (as shown in FIG6 a). When the parallel slider module is located at the distal end, the analyte detection device 104 is fixed to the parallel slider module 103, and the T-shaped structure buckle 10352 contacts the upper outer shell 1411. However, in embodiments of the present invention, after the analyte detection device 104 is mounted on the user's skin surface, the user may touch the outer edge of the stepped structure during use, causing the upper outer shell 10411 to separate from the lower outer shell 10413, exposing the internal components and affecting the reliability of the analyte detection device 104.

[0130] To address potential issues with the aforementioned step structure, in other embodiments of the present invention, the step structure 10415 may further include an inclined transition surface connecting the outer edge of the upper outer shell 10411 to the outer edge of the lower outer shell 10413. The inclined transition surface may be an extension of the housing of the upper outer shell 10411 or an extension of the housing of the lower outer shell 10413. The inclined transition surface may tightly connect the outer edges of the upper and lower outer shells 10411 and 10413. When a user touches the outer edges of the upper and lower outer shells 10411 and 10413 during use, the upper and lower outer shells 10411 and 10413 will not separate, thereby improving the reliability of the analyte detection device. When the parallel slider module is located at the distal end, the analyte detection device 104 is fixed to the parallel slider module 103, and the T-shaped structural buckle 10352 contacts the inclined transition surface.

[0131] Those skilled in the art will appreciate that, regardless of whether the stepped structure 10415 is a step structure or an inclined transition surface, the stepped structure 10415 surrounds the outer side of the housing 1041 and is an annular structure.

[0132] With reference to Figure 5c, in an embodiment of the present invention, the analyte detection device 104 can be fixed on the parallel slider module 103 through the cooperation of the step structure 10415 and the T-shaped structure buckle 10352, but it cannot play the positioning role as described above, that is, it cannot prevent the analyte detection device 104 from rotational displacement. Based on this, it is also necessary to set a limiting card hole 10416 on the shell 1041, and correspondingly, set a limiting card block 1036 on the parallel slider module 103. When the analyte detection device 104 is placed on the parallel slider module 103, the limiting card block 1036 can be embedded in the limiting card hole 10416. On the one hand, the analyte detection device 104 can be placed on the parallel slider module 103 in a predetermined direction. On the other hand, it can prevent the analyte detection device 104 from rotational displacement, ensuring that the auxiliary needle 1052 can pass through the first through hole 10414 or the self-sealing component.

[0133] In an embodiment of the present invention, the number of the limit block 1036 is at least one. Those skilled in the art will know that one limit block 1036 and one corresponding limit hole 10416 can realize the functions of positioning and preventing rotational deviation, but may cause uneven force on the analyte detection device 104. Therefore, it is preferred to set at least two corresponding limit blocks 1036 and limit holes 10416, and the limit blocks 1036 and limit holes 10416 are evenly spaced on the circumference of the parallel slider module 103 and the analyte detection device 104, respectively.

[0134] In a preferred embodiment of the present invention, there are two limit blocks 1036 and two limit holes 10416 , which are symmetrically distributed on the circumference of the parallel slider module 103 and the analyte detection device 104 , respectively.

[0135] In the embodiment of the present invention, the limiting block 1036 is provided on the inner circumference of the parallel slider module 103 , and the limiting hole 10416 is provided on the outer circumference of the housing of the analyte detection device 104 .

[0136] In other embodiments of the present invention, the limiting block 1036 is disposed on the outer circumference of the housing of the analyte detection device 104 , and the limiting hole 10416 is disposed on the inner circumference of the parallel slider module 103 .

[0137] Referring to Figure 6d, Figure 6 shows a schematic diagram of the interior of the analyte detection device 104. As previously described, the analyte detection device 104 includes the internal portion 10421 of the sensor 1042, the conductive adhesive strip 1042, and the internal circuit 1044. Those skilled in the art will appreciate that, in addition to the components described above, the analyte detection device 104 may also include a battery (not shown), a buzzer (not shown), an LED light (not shown), and other components.

[0138] In an embodiment of the present invention, several pins are provided on the internal part 10421, and each pin is connected to the electrode of the external part 10422 through a wire provided on the insulating base of the sensor 1042, and is used to receive current from the internal circuit 1044 and transmit detection current containing analyte parameter information to the internal circuit 1044.

[0139] In some embodiments of the present invention, the internal part 10421 can directly contact the electrical contacts on the internal circuit 1044, but due to size limitations, the pins on the internal part 10421 are distributed relatively closely. If they directly contact the electrical contacts on the internal circuit 1044, some pins may contact the wrong electrical contacts, thereby causing a short circuit or confusion of electrical signals.

[0140] Referring to Figure 6e, in some embodiments of the present invention, the internal part 10421 contacts the electrical contacts on the internal circuit 1044 through the conductive rubber strip 1043. The conductive rubber strip 1043 is composed of conductive areas and insulating areas distributed at intervals. The conductive areas and insulating areas are distributed on the surface of the conductive rubber strip 1043 or penetrate the conductive rubber strip 1043.

[0141] In some embodiments of the present invention, in order to form a good conductive and insulating connection between the internal part 10421 and the internal circuit 1044, and to make the best use of the internal space of the analyte detection device 104, some adjustments and improvements can be made to the relative positions and connection relationships of the sensor 1042, the conductive tape 1043 and the internal circuit 1044.

[0142] In some embodiments of the present invention, the in vivo portion 10421 of the sensor 1042 can be bent or curved relative to the in vitro portion 10422. The bending or curving of the sensor 1042 is to better utilize the internal space of the analyte detection device 104 without affecting its use.

[0143] Continuing with reference to FIG6e , in some embodiments of the present invention, the conductive rubber strip 1043 is in the shape of a rectangular parallelepiped, with the conductive area and the insulating area spaced apart along its length, so there are four usable conductive contact surfaces. The four surfaces of the conductive rubber strip 1043 can be flexibly used according to the actual placement and structural design of the sensor 1042 and the internal circuit 1044 .

[0144] In other embodiments of the present invention, the conductive rubber strip 1043 may also be in a regular shape such as a cylinder, a triangular prism, a sphere, a triangular pyramid, or other irregular shapes.

[0145] Continuing with reference to FIG. 6 d , and using the orientation shown in FIG. 6 d as a reference, in an embodiment of the present invention, the internal circuit 1044 is placed within the analyte detection device 104, and the conductive adhesive strip 1043 is in the shape of a rectangular parallelepiped, with its upper end surface contacting the lower end surface of the internal circuit 1044. This leaves the left, right, and lower end surfaces of the conductive adhesive strip 1043 for contact with the external portion 10421 of the sensor 1042. In FIG. 6 d , the external portion 10421 contacts the left end surface of the conductive adhesive strip 1043. Those skilled in the art will appreciate that the external portion 10421 can also contact the lower or right end surface of the conductive adhesive strip 1043, as shown in FIG. 6 g , thereby effectively achieving current transfer between the sensor 1042 and the internal circuit 1044.

[0146] In order to facilitate understanding of the electrical connection between the internal circuit 1044 , the conductive rubber strip 1043 and the sensor 1042 , the following description will focus only on the above three components and their connection methods.

[0147] 6f , in some embodiments of the present invention, the external portion 10421 is bent relative to the internal portion 10422 , the external portion 10421 contacts the right end surface of the conductive strip 1043 , and the upper end surface of the conductive strip 1043 contacts the lower end surface of the internal circuit 1044 .

[0148] 6h , in some embodiments of the present invention, the lower end surface of the zebra strip 1043 contacts the upper end surface of the internal circuit 1044, and the external portion 10421 contacts the right end surface of the zebra strip 1043. In other embodiments of the present invention, the external portion 10421 is bent or curved relative to the internal portion 10422. In this structure, the external portion 10421 can contact the upper end surface of the conductive rubber strip 1043 without affecting the position and state of the internal portion 10422.

[0149] In other embodiments of the present invention, the analyte detection device 104 is not limited to the above structure. In other embodiments of the present invention, the transmitter is disposed outside the housing 1041 , and the user installs the housing 1041 on the user's skin surface using the installation unit 100 and then installs the transmitter on the housing 1041 .

[0150] In some further embodiments of the present invention, when the transmitter is separated from the housing 1041 , the battery is built into the transmitter.

[0151] In some further embodiments of the present invention, when the transmitter is separated from the housing 1041 , the battery is built into the housing 1041 .

[0152] Auxiliary needle module

[0153] Figure 7a is a schematic diagram of the structure of the auxiliary needle module according to an embodiment of the present invention. Figure 7b is a schematic diagram of the bending of the sensor according to an embodiment of the present invention. Figure 7c is a schematic diagram of the elastic pad being provided on the outside of the auxiliary needle before installation according to an embodiment of the present invention. Figure 7d is a schematic diagram of the elastic pad being provided on the outside of the auxiliary needle after the auxiliary needle is inserted subcutaneously according to an embodiment of the present invention. Figure 7e is a schematic diagram of the elastic pad being provided on the outside of the sensor after the auxiliary needle is retracted according to an embodiment of the present invention. Figure 7f is a schematic diagram of the structure of the elastic pad being solid according to an embodiment of the present invention. Figure 7g is a schematic diagram of the structure of the elastic pad being hollow according to an embodiment of the present invention. Figure 7h is a schematic diagram of the structure of the elastic pad being embedded in the housing of the analyte detection device according to an embodiment of the present invention.

[0154] 7a, in an 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.

[0155] 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 facing the proximal end.

[0156] In this 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 also be inserted into the subcutaneous tissue. When the needle body is retracted, the subcutaneous state of the internal part is not affected.

[0157] 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 at the same time also reduces the rigidity of the auxiliary needle 1052.

[0158] 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 .

[0159] Referring to FIG7b , although ideally, the semi-enclosed needle body 10522 is expected to completely envelop the sensor's internal portion 10422, due to the presence of electrodes (not shown) on the side of the internal portion 10422 proximal to the auxiliary needle 1052, the base of the internal portion 10422 can bend toward the side away from the auxiliary needle 1052, resulting in the condition shown in FIG7b . Furthermore, while the components of the mounting unit 100 in this embodiment of the present invention are relatively small, which reduces weight and improves user convenience, during installation, due to inconsistent component dimensions and tolerances, such as unstable fit between the retaining groove 1013 and the T-shaped structure slider 10351, and between the slider buckle 10321 and the auxiliary needle slider 10511, the auxiliary needle 1052 can experience slight swaying, preventing the semi-enclosed needle body 10522 from maintaining effective parallelism with the sensor's internal portion 10422, potentially allowing the internal portion 10422 to escape the envelopment of the semi-enclosed needle body 10522. Based on the above reasons, the internal part 10422 cannot be effectively penetrated into the subcutaneous tissue along with the semi-enclosed needle body 10522 , thereby reducing the detection reliability of the analyte detection device 104 .

[0160] 7c , in order to solve the above problem, in some embodiments of the present invention, before installation, an elastic pad 108 is sleeved on the outside of the semi-enclosed needle body 10522, and the semi-enclosed needle body 10522 envelops the internal part 10422 of the sensor 1042. The elastic pad 108 can restrain the internal part 10422 in the semi-enclosed needle body 10522, which can prevent the internal part 10422 from bending. At the same time, during the installation process, when the auxiliary needle 1052 swings, the internal part 10422 can be prevented from escaping from the outside of the semi-enclosed needle body 10522, so that the internal part 1422 can be smoothly penetrated into the subcutaneous tissue along with the semi-enclosed needle body 10522, thereby improving the detection reliability of the analyte detection device 104.

[0161] In a preferred embodiment of the present invention, the elastic pad 108 is close to the needle tip end of the semi-enclosed needle body 10522, which can better constrain the internal part 10422 and prevent the internal part 10422 from escaping from the envelope of the semi-enclosed needle body 10522 or bending.

[0162] Referring to Figure 7d, in some embodiments of the present invention, when the installation unit 100 is performing the installation action, the semi-enclosed needle body 10522 carries the internal part 10422 to penetrate the subcutaneous tissue, and the elastic pad 108 remains stationary due to the obstruction of the skin. Therefore, during the process of the semi-enclosed needle body 10522 penetrating the subcutaneous tissue, the elastic pad 108 slides distally relative to the semi-enclosed needle body 10522 until the lower outer shell 10413 of the analyte detection device 104 contacts the skin surface and presses the elastic pad 108.

[0163] Referring to Figure 7e, in some embodiments of the present invention, semi-enclosed needle body 10522, carrying internal portion 10422, penetrates the subcutaneous tissue to a predetermined location and then retracts, leaving internal portion 10422 subcutaneously for detecting analyte parameter information. Analyte detection device 104 is adhered to the skin surface by adhesive tape. Therefore, when semi-enclosed needle body 10522 retracts, elastic pad 108 is blocked by lower outer shell 10413 and remains stationary. Elastic pad 108 slides proximally relative to semi-enclosed needle body 10522 until semi-enclosed needle body 10522 is free of elastic pad 108. The elastic pad 108 is sandwiched between the lower outer shell 10413 and the skin surface. After the semi-enclosed needle body 10522 is fully retracted, the elastic pad 108 shrinks and sleeves on the outside of the internal part 10422 under the action of its own elasticity, pressing and covering the wound caused by the semi-enclosed needle body 10522 piercing the subcutaneous tissue, thereby preventing blood from overflowing from the wound and contaminating the analyte detection device 104. At the same time, it can also prevent external foreign matter from contaminating the wound, thereby improving the healing speed of the wound.

[0164] 7 f , in some embodiments of the present invention, the elastic pad 108 may be a solid structure. After the semi-enclosed needle body 10522 pierces the elastic pad 108 , the elastic pad 108 is sleeved on the outside of the semi-enclosed needle body 10522 .

[0165] 7c and 7g , in some embodiments of the present invention, the elastic pad 108 may be a hollow structure, with the inner diameter d' of the elastic pad 108 being smaller than the outer diameter d of the semi-enclosed needle body 10522. This allows the elastic pad 108 to fit tightly around the outside of the semi-enclosed needle body 10522, thereby preventing the internal portion 10422 from escaping the envelope of the semi-enclosed needle body 10522. In a preferred embodiment of the present invention, the inner diameter d' of the elastic pad 108 is also smaller than the outer diameter of the internal portion 10422. After the semi-enclosed needle body 10522 is retracted, the elastic pad 108 can shrink and fit tightly around the outside of the internal portion 10422, thereby compressing and covering the wound caused by the semi-enclosed needle body 10522 piercing the subcutaneous tissue.

[0166] In some embodiments of the present invention, the thickness of elastic pad 108 is 0.01 to 5 mm. If the elastic pad 108 is too thick, it may increase the pressure of analyte detection device 104 on the skin surface, causing discomfort. If the elastic pad 108 is too thin, it may easily deform and fail to effectively constrain internal portion 10422. In a preferred embodiment of the present invention, the thickness of elastic pad 108 is 0.3 mm.

[0167] Referring to Figure 7h, in some embodiments of the present invention, the first through hole 10414 is sunk into the interior of the lower outer shell 10413. During the installation process, the elastic pad 108 is pressed against the skin surface until the lower outer shell 10413 is pushed into contact with the skin surface. The elastic pad 108 is embedded in the first through hole 10414 and is flush with the lower outer shell 10413. In this way, the elastic pad 108 will not cause additional extrusion on the skin surface, reducing discomfort.

[0168] In some embodiments of the present invention, the elastic pad 108 is made of rubber, silicone, or latex, which has good elasticity and can avoid contamination of the wound.

[0169] Trigger Module

[0170] FIG8 is a schematic structural diagram of a trigger module according to an embodiment of the present invention.

[0171] 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.

[0172] In this embodiment of the present invention, the trigger module 106 is further provided with at least two latches 1062. In the mounting unit 100, the latches 1062 engage with the latch slots 1014 to secure the trigger module 106. The number and position of the latches 1062 are consistent with those of the latch slots 1014. With reference to FIG10a , before the mounting unit 100 is used, the latches 1062 are located in the first latch slot 10141. At this point, the securing latch 1061 contacts the first latch 1012.

[0173] 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 within the first opening and protruding beyond it. When the mounting unit 100 is in use, the outer ring 1063 adheres to the user's skin surface.

[0174] Elastic Module

[0175] 3 , the elastic module 107 includes a first elastic member 1071 and a second elastic member 1072 .

[0176] 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.

[0177] 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.

[0178] In a preferred embodiment of the present invention, the first elastic member 1071 or the second elastic member 1072 is a metal spring.

[0179] 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.

[0180] 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.

[0181] How to use the installation unit

[0182] FIG9 is a top view of the mounting unit according to an embodiment of the present invention.

[0183] Figure 10a is a schematic diagram of the cross-sectional structure of A in Figure 9; Figure 10b is a schematic diagram of the cross-sectional structure of B in Figure 9; Figure 10c is a schematic diagram of the cross-sectional structure of C in Figure 9; and Figure 11 is a schematic diagram of the first buckle bending under force.

[0184] With reference to Figures 10a and 10b , in an embodiment of the present invention, the latch 1014 is provided with 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 of 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 that order.

[0185] 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 move toward the distal end relative to the first buckle 1012.

[0186] 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.

[0187] 11 , this structural design allows the second buckle 1033 to push the first buckle 1012 toward the outside of the shell 101 when it moves proximally relative to the first buckle 1012 , thereby releasing the coupling state between the first buckle 1012 and the second buckle 1033 .

[0188] 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.

[0189] In an embodiment of the present invention, when using the mounting unit 100, the outer cover body 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 moves toward the skin. The trigger module 106 remains stationary, so that the trigger module 106 moves 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.

[0190] In an embodiment of the present invention, after the coupling state is released, the parallel slider module 103 continues to move proximally under the elastic force of the first elastic member 1071, while driving the analyte detection device 104 to move proximally until the lower outer shell 10413 of the analyte detection device 104 contacts the user's skin surface.

[0191] 10c, in an embodiment of the present invention, the slider buckle 10321 is buckled with the auxiliary needle slider 10511, and when the first elastic member 1071 pushes the parallel slider module 103 to move proximally, it drives the auxiliary needle module 105 to move proximally together.

[0192] In this embodiment of the present invention, the connection between slider clip 10321 and auxiliary needle slider 10511 is a flat or nearly flat surface, forming a fixed angle with the horizontal plane, with its extended line m3 converging at the distal end. The second elastic member 1072 exerts a distal thrust on auxiliary needle slider 10511, causing auxiliary needle slider 10511 to push slider clip 10321 outward from housing 101, causing it to bend or flex. The principle behind this is similar to that described in FIG11 .

[0193] 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 move 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 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.

[0194] 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.

[0195] In an embodiment of the present invention, 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 movement direction, and at the same time, the auxiliary needle 1052 remains parallel to its movement 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.

[0196] 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 move toward the proximal end, while the outer ring 1063 blocks the T-shaped structure slider 10351 from continuing to move toward the proximal end. Therefore, the T-shaped structure slider 10351 bends or folds around the vertical portion, and the connection between the T-shaped structure buckle 10352 and the buckle hole 10412 or the annular structure 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.

[0197] 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.

[0198] 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. During the proximal movement of the parallel slider module 103 and the auxiliary needle module 105, the semi-enclosed needle body 10522 carries the sensor 1042 and penetrates the subcutaneous tissue. After the auxiliary needle 1052 is retracted, 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.

[0199] 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 force F, thereby achieving relative movement 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 moves proximally.

[0200] Before performing the installation action, in order to prevent the trigger module 106 from moving 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.

[0201] 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.

[0202] 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 to fix the analyte detection device 104 on the user's skin surface.

[0203] In summary, an embodiment of the present invention discloses an installation unit for an analyte detection device, in which the snap-fit ​​structure of the parallel slider module contacts the annular structure of the analyte detection device, forming a releasable connection between the parallel slider module and the analyte detection device. When the parallel slider module is located at the distal end, the analyte detection device is fixed on the parallel slider module. After the parallel slider module slides to the proximal end, the analyte detection device automatically separates from the parallel slider module. The installation unit has a simple structure, high reliability, and is easy to use.

[0204] Although some specific embodiments of the present invention have been described in detail by way of example, it should be understood by those skilled in the art that the above examples are for illustration only and are not intended to limit the scope of the present invention. It should be understood by those skilled in the art 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. A mounting unit for an analyte detection device, characterized in that: include: an installation unit, the installation unit comprising at least a housing, an auxiliary needle, and a parallel slider module. When the installation unit is used, the auxiliary needle and the parallel slider module slide from a distal end to a proximal end within the housing, and the analyte detection device is installed at the proximal end on the user's skin surface to obtain in vivo analyte parameter information; When the parallel slider module is located at the distal end, the snap structure of the parallel slider module contacts the annular structure of the analyte detection device, so that the analyte detection device is fixed on the parallel slider module, and after the parallel slider module slides to the proximal end, the snap structure is released from contact with the annular structure, and the analyte detection device is separated from the parallel slider module.

2. The mounting unit of the analyte detection device according to claim 1, characterized in that The analyte detection device includes an upper outer shell and a lower outer shell.

3. The mounting unit of the analyte detection device according to claim 2, characterized in that: The annular structure surrounds the outer side of the upper outer shell and / or the lower outer shell.

4. The mounting unit of the analyte detection device according to claim 3, characterized in that: The annular structure surrounds a connection between the upper outer shell and the lower outer shell.

5. The mounting unit of the analyte detection device according to claim 2, wherein: The upper outer shell and the lower outer shell have different circumferential sizes.

6. The mounting unit of the analyte detection device according to claim 5, characterized in that: The circumference of the upper outer shell is larger than that of the lower outer shell, and the buckle structure is in contact with the upper outer shell.

7. The mounting unit of the analyte detection device according to claim 6, characterized in that: The circumferential size of the upper outer shell is 0.05 to 5 mm larger than the circumferential size of the lower outer shell.

8. The mounting unit of the analyte detection device according to claim 5, characterized in that: It also includes an inclined transition surface connecting the outer edge of the upper shell and the outer edge of the lower shell, and the buckle structure is in contact with the inclined transition surface.

9. The mounting unit of the analyte detection device according to claim 3, wherein: The annular structure is an annular groove, and the buckle structure is in contact with the annular groove.

10. The mounting unit of the analyte detection device according to any one of claims 1 to 9, characterized in that: The buckle structure is a T-shaped buckle.

11. The mounting unit of the analyte detection device according to claim 10, characterized in that: The number of the T-shaped structural buckles is 3 and they are evenly spaced and distributed on the parallel slider module.

12. The mounting unit of the analyte detection device according to claim 2, characterized in that: It also includes at least one set of corresponding limit blocks and limit holes.

13. The mounting unit of the analyte detection device according to claim 12, wherein: The limiting block is located on the inner circumference of the parallel slider module, and the limiting hole is located on the outer circumference of the analyte detection device.

14. The mounting unit of the analyte detection device according to claim 12, wherein: The limiting block is located on the outer circumference of the analyte detection device, and the limiting hole is located on the inner circumference of the parallel slider module.

15. The mounting unit of the analyte detection device according to claim 12, wherein: Also included is a through hole located in the housing.

16. The mounting unit of the analyte detection device according to claim 15, characterized in that: The through hole includes a first through hole located in the lower outer shell and a second through hole located in the upper outer shell, and the first through hole and the second through hole are coaxial.

17. The mounting unit of the analyte detection device according to claim 16, characterized in that: When the limiting clamping block is embedded in the limiting clamping hole, the auxiliary needle passes through the first through hole and the second through hole.

18. The mounting unit of the analyte detection device according to claim 12, wherein: Also included is a self-sealing member located on the housing.

19. The mounting unit of the analyte detection device according to claim 18, characterized in that: When the limiting clamping block is embedded in the limiting clamping hole, the auxiliary needle passes through the self-sealing component.

20. The mounting unit of the analyte detection device according to claim 1, wherein: The analyte detection device further comprises a sensor, a transmitter, an internal circuit and a battery, wherein the sensor comprises an internal portion and an external portion, and the external portion, the transmitter, the internal circuit and the battery are located within the housing.

21. The mounting unit of the analyte detection device according to claim 20, characterized in that: The intracorporeal portion is bent relative to the extracorporeal portion.

22. The mounting unit of the analyte detection device according to claim 20, wherein: The external portion is electrically coupled to the internal circuit.

23. The mounting unit of the analyte detection device according to claim 20, characterized in that: It also includes a conductive adhesive strip, through which the external part is electrically coupled to the internal circuit.

24. The mounting unit of the analyte detection device according to claim 23, characterized in that: The conductive rubber strip includes conductive areas and insulating areas that are distributed at intervals.

25. The mounting unit of the analyte detection device according to claim 24, characterized in that: The conductive rubber strip is a rectangular parallelepiped structure.

26. The mounting unit of the analyte detection device according to claim 25, characterized in that: The internal body portion and the internal circuit are electrically coupled via at least one structural surface of the conductive adhesive strip.

27. The mounting unit of the analyte detection device according to claim 1, characterized in that: It also includes an elastic module and a trigger module. Before using the installation unit, the elastic module is in a compressed state, and the trigger module is used to prevent the elastic module from releasing elastic force.

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