Miniaturized mounting unit of analyte detection apparatus

Abstract

Provided is a miniaturized mounting unit (200) of an analyte detection apparatus. After the mounting unit (200) is used, an auxiliary needle (2052) is not completely retracted into a mounting unit housing (201), to reduce the retraction stroke of the auxiliary needle (2052), thereby reducing the overall height of the mounting unit housing (201), which facilitates the miniaturization of the mounting unit (200), is easy to use for users, and saves production costs.

Description

Miniaturized mounting unit for analyte detection device TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a miniaturized mounting unit for analyte detection device. BACKGROUND

[0002] The pancreas in a normal human body can automatically detect the glucose content in the human blood and automatically secrete the required insulin / glucagon. The pancreas of a diabetic patient is abnormal and cannot normally secrete the required insulin for the human body. Therefore, diabetes is a metabolic disease caused by abnormal function of the human pancreas, and diabetes is a lifelong disease. Current medical technology cannot cure diabetes, and can only control the occurrence and development of diabetes and its complications by stabilizing blood sugar.

[0003] A diabetic patient needs to detect blood sugar before injecting insulin into the body. Most current detection methods can continuously detect blood sugar and send blood sugar data to external devices in real time for users to view, and this detection method is called continuous glucose monitoring (CGM). In order to realize continuous glucose monitoring, the user needs to use an auxiliary mounting unit to install the blood sugar analyte detection device on the skin surface, and the smaller the size of the mounting unit, the more convenient the user uses, and the lower the manufacturing cost. Therefore, under the premise of realizing the function of the mounting unit, the miniaturized design of the mounting unit is beneficial. In the prior art, in order to prevent the auxiliary needle from causing unnecessary harm to the user, the auxiliary needle is completely retracted into the housing, and the retraction stroke of the auxiliary needle is too long, which limits the overall height of the housing, which is not conducive to the miniaturization design of the mounting unit.

[0004] Therefore, the prior art needs a more miniaturized analyte detection device mounting unit.

[0005] SUMMARY

[0006] The present application discloses a miniaturized mounting unit for analyte detection device, after using the mounting unit, the auxiliary needle is not completely retracted into the mounting unit housing, to reduce the retraction stroke of the auxiliary needle, and thereby reduce the overall height of the mounting unit housing, which is conducive to the miniaturization of the mounting unit, is convenient for users to use, and saves production costs.

[0007] The application provides a miniaturized mounting unit of an analyte detection device, comprising: a housing and a spring module, a trigger module, a parallel slider module, an auxiliary needle module and an analyte detection device pre-mounted in the housing; the parallel slider module carries the auxiliary needle module and the analyte detection device, the auxiliary needle module comprises an auxiliary needle; after the trigger module is activated, the spring module pushes the parallel slider module to slide to a first predetermined position relative to the housing, then the auxiliary needle module is retracted, and the auxiliary needle module slides to a second predetermined position relative to the housing; wherein the auxiliary needle pierces into the subcutaneous tissue when the parallel slider module is at the first predetermined position, and at least a part of the auxiliary needle is exposed outside the housing when the auxiliary needle module is at the second predetermined position.

[0008] According to an aspect of the application, the length of the auxiliary needle exposed outside the housing is 0.1-5 mm when the auxiliary needle module is at the second predetermined position.

[0009] According to an aspect of the application, the mounting unit further comprises a protective cover, which is located at the proximal end of the housing and releasably connected with the housing.

[0010] According to an aspect of the application, the protective cover comprises an outer cover body and an inner cover body, and the inner cover body is located in the outer cover body before the mounting unit is used.

[0011] According to an aspect of the application, the outer cover body is releasably connected with the inner cover body.

[0012] According to an aspect of the application, the mounting unit further comprises a label paper, which is attached to the proximal end surface of the outer cover body.

[0013] According to an aspect of the application, the proximal end surface of the inner cover body further comprises at least two convex semicircular balls.

[0014] According to an aspect of the application, the convex semicircular balls are uniformly distributed on the proximal end surface of the inner cover body.

[0015] According to an aspect of the application, the outer cover body comprises a needle body accommodating cavity, which shares a common central axis with the auxiliary needle and is used for accommodating the auxiliary needle before the mounting unit is used.

[0016] According to an aspect of the application, the needle body accommodating cavity comprises a hollow structure, and the inner diameter of the hollow structure of the needle body accommodating cavity decreases from the distal end to the proximal end.

[0017] According to an aspect of the application, the inner cover body comprises a needle body protection cavity, which shares a common central axis with the auxiliary needle and is used for accommodating the auxiliary needle after the mounting unit is used.

[0018] According to an aspect of the application, the inner cover body further comprises an assembly structure, which is used for establishing an assembly connection with the parallel slider module, the trigger module or the housing.

[0019] According to an aspect of the present application, the assembling structure is one or more of a buckle, a clasp, a clamping block, a thread, a bolt, a magic tape, and glue.

[0020] According to an aspect of the present application, the inner cover further comprises a positioning structure.

[0021] According to an aspect of the present application, the elastic protective sleeve further comprises a hollow structure at the distal end thereof, for sleeving the outside of the auxiliary needle after the installation unit is used.

[0022] According to an aspect of the present application, the inner diameter of the hollow structure of the elastic protective sleeve decreases from the distal end to the proximal end.

[0023] According to an aspect of the present application, the inner diameter of the hollow structure of the elastic protective sleeve at the distal end is greater than the outer diameter of the auxiliary needle, and the inner diameter of the hollow structure of the elastic protective sleeve at the proximal end is less than the outer diameter of the auxiliary needle.

[0024] According to an aspect of the present application, the proximal end of the elastic protective sleeve is open or closed.

[0025] According to an aspect of the present application, the length of the elastic protective sleeve is not less than the length of the auxiliary needle exposed outside the shell.

[0026] According to an aspect of the present application, at the first predetermined position, the parallel slider module is closer to the proximal end than the trigger module.

[0027] According to an aspect of the present application, the elastic module comprises at least a first elastic member and a second elastic member, and before the installation unit is used, the first elastic member and the second elastic member are in a compressed state.

[0028] According to an aspect of the present application, the elastic module further comprises a third elastic member, and before the installation unit is used, the third elastic member is in a normal state.

[0029] According to an aspect of the present application, the third elastic member is located between the shell and the auxiliary needle module, for adjusting the length of the auxiliary needle exposed outside the shell.

[0030] According to an aspect of the present application, the third elastic member is a spring.

[0031] Compared with the prior art, the technical scheme of the present application has the following advantages:

[0032] In the installation unit of the analyte detection device disclosed in the present application, after the installation unit is used, the auxiliary needle is not completely retracted into the shell, which can reduce the retraction stroke of the auxiliary needle, thereby reducing the overall height of the installation unit shell, facilitating the miniaturization of the installation unit, facilitating the use of users, and saving production costs.

[0033] Further, the installation unit further comprises a protective cover, the protective cover is composed of an outer cover body and an inner cover body, the outer cover body is used to be assembled at the proximal end of the installation unit before use of the installation unit to protect the components in the shell, and the inner cover body is used to be assembled at the proximal end of the installation unit after use of the installation unit as a needle body protection structure to protect the exposed auxiliary needle and avoid unnecessary harm to the user, thereby improving the safety and reliability of the installation unit.

[0034] Further, the label paper is attached to the proximal end of the protective cover, the proximal end of the protective cover is sealed by the label paper, so that the inner cover body can be stored in the outer cover body, facilitating transportation of the installation unit, and the label paper can be torn off by the user to take out the inner cover body.

[0035] Further, a convex semicircular ball structure is arranged on the proximal end surface of the inner cover body, so as to avoid large-area adhesion of the inner cover body to the label paper and affect tearing of the label paper from the outer cover body, thereby improving user experience.

[0036] Further, after use of the installation unit, the inner cover body can be assembled and connected with the shell, the parallel sliding block module or the trigger module, which is selected according to design requirements, and the structure is flexible and variable, preferably, the inner cover body is assembled and connected with the parallel sliding block module, and the proximal end surface of the parallel sliding block module is large in area and easy to process and assemble.

[0037] Further, a positioning structure is further designed on the inner cover body, so as to facilitate the user to quickly locate the relative position of the needle body protection cavity and the auxiliary needle when assembling the inner cover body, so that the auxiliary needle is on the same axis as the needle body protection cavity, the auxiliary needle can smoothly enter the needle body protection cavity, and the positioning of the assembly structure is also facilitated.

[0038] Further, the needle body protection structure can also be an elastic protective sleeve, after use of the installation unit, the user can set the elastic protective sleeve outside the auxiliary needle to protect the auxiliary needle exposed outside the shell, avoid unnecessary harm to the user, and improve user experience.

[0039] Further, the elastic protective sleeve is in interference fit with the auxiliary needle, and has elasticity, so that the elastic protective sleeve can be reliably set on the auxiliary needle to avoid separation of the elastic protective sleeve from the auxiliary needle.

[0040] Further, the elastic module in the installation unit comprises a first elastic member, a second elastic member and a third elastic member, the third elastic member is located between the shell and the auxiliary needle module, and the retraction stroke of the auxiliary needle can be adjusted according to the initial length and elastic modulus of the third elastic member and the second elastic member, and then the length of the auxiliary needle exposed outside the shell is adjusted. BRIEF DESCRIPTION OF DRAWINGS

[0041] FIG. 1 is a schematic diagram of the external structure of the installation unit of the analyte detection device according to an embodiment of the present application;

[0042] Fig. 2a is a schematic diagram of the external structure of a housing according to an embodiment of the present application;

[0043] Fig. 2b is a schematic diagram of the structure of a protective cover according to an embodiment of the present application;

[0044] Fig. 3 is a schematic diagram of the exploded structure of an analyte detection device mounting unit according to an embodiment of the present application;

[0045] Fig. 4 is a schematic diagram of the internal structure of a housing according to an embodiment of the present application;

[0046] Fig. 5a is a schematic diagram of the structure of the distal end face of a parallel slider module according to an embodiment of the present application;

[0047] Fig. 5b is a schematic diagram of the structure of the proximal end face of a parallel slider module according to an embodiment of the present application;

[0048] Fig. 6 is a schematic diagram of the structure of an analyte detection device according to an embodiment of the present application;

[0049] Fig. 7 is a schematic diagram of the structure of an auxiliary needle module according to an embodiment of the present application;

[0050] Fig. 8 is a schematic diagram of the structure of a trigger module according to an embodiment of the present application;

[0051] Fig. 9 is a top view of a mounting unit according to an embodiment of the present application;

[0052] Fig. 10a is a schematic diagram of the A cross-sectional structure of Fig. 9;

[0053] Fig. 10b is a schematic diagram of the B cross-sectional structure of Fig. 9;

[0054] Fig. 10c is a schematic diagram of the C cross-sectional structure of Fig. 9;

[0055] Fig. 11 is a schematic diagram of the bending of a first clasp under stress according to an embodiment of the present application;

[0056] Fig. 12 is a schematic diagram of the exploded structure of an analyte detection device mounting unit according to an embodiment of the present application;

[0057] Fig. 13a is a schematic diagram of the separation structure of an outer cover body and an inner cover body according to an embodiment of the present application;

[0058] Fig. 13b is a schematic diagram of the integrated structure of an outer cover body and an inner cover body according to an embodiment of the present application;

[0059] Fig. 13c is a schematic diagram of the structure of an outer cover body according to an embodiment of the present application;

[0060] Fig. 14 is a schematic diagram of the state of a mounting unit after use according to an embodiment of the present application;

[0061] Fig. 15 is a schematic diagram of the state of a mounting unit after the retraction of an auxiliary needle according to an embodiment of the present application;

[0062] FIGS. 16a-16c are schematic diagrams of a cap as a needle protection structure according to an embodiment of the present application;

[0063] FIG. 17 is a schematic diagram of a cross-sectional structure of a mounting unit according to an embodiment of the present application;

[0064] FIGS. 18a-18c are schematic diagrams of a protective sleeve as a needle protection structure according to an embodiment of the present application. DETAILED DESCRIPTION

[0065] As described above, the mounting unit structure of the prior art analyte testing device limits the overall height of the housing, which is not conducive to the miniaturization design of the mounting unit.

[0066] To solve this problem, the present application provides an analyte testing device mounting unit, after using the mounting unit, the auxiliary needle is not completely retracted into the housing of the mounting unit, so as to reduce the retraction stroke of the auxiliary needle, thereby reducing the overall height of the housing of the mounting unit, which is conducive to the miniaturization of the mounting unit, facilitates the use of users, and saves the production cost.

[0067] Various exemplary embodiments of the present application will now be described in detail with reference to the accompanying drawings. It should be understood that the relative arrangement, numerical expressions, and values of the components and steps set forth in these embodiments should not be construed as limiting the scope of the present application unless otherwise specifically stated.

[0068] In addition, it should be understood that the sizes of the various components shown in the drawings are not necessarily drawn in accordance with the actual proportional relationship, for example, the thickness, width, length or distance of some units can be enlarged relative to other structures.

[0069] The following description of the exemplary embodiments is merely illustrative in nature and is in no way intended to limit the scope of the application or its application or uses. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art can not be discussed in detail herein, but should be considered part of the specification when applicable.

[0070] It should be noted that similar reference numbers and letters represent similar items in the following drawings, so once an item is defined or described in one drawing, it will not need to be further discussed in subsequent drawings.

[0071] First Embodiment

[0072] Figure 1 is a schematic diagram of the external structure of the analyte detection device installation unit according to an embodiment of the present application. The external structure of the installation unit 100 includes a housing 101 and a protective cover 102, the housing 101 is used to carry the internal structure. The installation unit 100 is used, the end close 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 internal structure components of the housing 101.

[0073] Housing exterior

[0074] Figure 2a is a schematic diagram of the external structure of the housing according to an embodiment of the present application, and Figure 2b is a schematic diagram of the structure of the protective cover. The protective cover 102 includes an outer cover body 1021, a clamp 1022 and an inner cover body 1023. The outer cover body 1021 is provided with a second opening in the distal direction, and the second opening faces the first opening. At the second opening, the outer cover body 1021 is connected with the clamp 1022 through breakable columns 10211, and the columns 10211 are distributed at a certain interval between the outer cover body 1021 and the clamp 1022. When the outer cover body 1021 rotates relative to the clamp 1022, the columns 10211 can be broken, and the outer cover body 1021 and the clamp 1022 are separated.

[0075] The inner side of the outer cover body 1021 is provided with an internal thread 10212, and the outer side of the inner cover body 1023 is provided with an external thread 10231. The internal thread 10212 and the external thread 10231 can be connected to connect and fix the outer cover body 1021 and the inner cover body 1023.

[0076] The inner side of the clamp 1022 is provided with a protrusion 10221, and the outer side of the housing 101 is provided with a groove 1011. The protrusion 10221 can be embedded in the groove 1011. The outer cover body 1021 is first fixed with the inner cover body 1023 through thread cooperation, and then connected with the housing 101 through the clamp 1022. The outer cover body 1021 and the inner cover body 1023 can protect, seal and prevent triggering of the internal structure of the housing 101. The function of preventing triggering will be further described below.

[0077] In other embodiments of the present application, the outer cover body 1021 and the inner cover body 1023 can also be fixedly connected through friction fit or snap fit.

[0078] In other embodiments of the present application, the clamp 1022 and the housing 101 can also be connected through friction fit, snap fit or thread fit.

[0079] Housing interior

[0080] Figure 3 is an exploded view of the analyte detection device mounting unit of the present application, the dashed lines indicate the mounting relationship of the 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, which includes a first elastic member 1071 and a second elastic member 1072.

[0081] Figure 4 is a schematic view of the internal structure of the housing 101 of the present application.

[0082] In the embodiment of the present application, at least two first buckles 1012 are provided in the housing 101, which are integrally formed with the housing 101 and protrude towards the proximal end of the housing 101. The first buckles 1012 are made of flexible material and the ends can be bent or curved outwards of the housing 101.

[0083] In the preferred embodiment of the present application, the number of first buckles 1012 is two, which are symmetrically distributed inside the housing 101 with an angular interval of 180°.

[0084] In other preferred embodiments of the present application, the number of first buckles 1012 is three or four, which are symmetrically distributed inside the housing 101 with an angular interval of 120° or 90°. The number of first buckles 1012 can also be five or more, which is not limited here.

[0085] In the embodiment of the present application, at least two limiting grooves 1013, at least two clamping grooves 1014, and an auxiliary needle limiting groove 1015 are also provided in the housing 101.

[0086] In the embodiment of the present application, the limiting grooves 1013 include at least two rib plates protruding from the inner wall of the housing 101. In the preferred embodiment of the present application, the rib plates are parallel to each other, and a groove is formed between adjacent rib plates.

[0087] In other embodiments of the present application, the limiting grooves 1013 are grooves recessed in the inner wall of the housing 101.

[0088] In the embodiment of the present application, the clamping grooves 1014 include two clamping groove positions, i.e. a first clamping groove position 10141 and a second clamping groove position 10142, as shown in Figure 10a, the first clamping groove position 10141 is closer to the proximal end than the second clamping groove position 10142.

[0089] In the preferred embodiment of the present application, the number of limiting grooves 1013 and clamping grooves 1014 is two, which are symmetrically distributed inside the housing 101 with an angular interval of 180°.

[0090] In other preferred embodiments of the present application, the number of the limiting grooves 1013 and the clamping grooves 1014 is three or four, which are symmetrically distributed inside the shell 101 with an angular interval of 120° or 90°. The number of the limiting grooves 1013 and the clamping grooves 1014 can also be five or more, which is not limited herein.

[0091] Parallel sliding block module

[0092] FIG. 5a is a structural schematic view of a distal end face of the parallel sliding block module 103, and FIG. 5b is a structural schematic view of a proximal end face of the parallel sliding block module 103.

[0093] In an embodiment of the present application, the distal end face 1031 of the parallel sliding block module 103 is provided with a circular groove 1032 protruding towards the distal end, which is a hollow cylindrical structure with an inner diameter of d1. At least two sliding block buckles 10321 protrude towards the distal end on the side wall of the circular groove 1032, the buckle part of the sliding block buckle 10321 is a plane or an approximately plane, and the extended end m0 converges at the distal end with a fixed included angle with the horizontal plane.

[0094] In an embodiment of the present application, the sliding block buckle 10321 is made of flexible material, so it can be bent or folded to the outside of the circular groove 1032.

[0095] In other embodiments of the present application, the sliding block buckle 10321 can be directly provided on the distal end face of the parallel sliding block module 103 without the circular groove structure.

[0096] In an embodiment of the present application, the circular groove 1032 is further provided with a boss 10322 at one end close to the distal end face 1031, which is a hollow cylindrical structure with an inner diameter of d2. It can be understood that d1>d2. The hollow circular groove 1032 and the boss 10322 form a through hole 10323 penetrating from the distal end face 1031 to the proximal end face 1034 of the parallel sliding block module.

[0097] In a preferred embodiment of the present application, the number of the sliding block buckles 10321 is two, which are symmetrically distributed on the side wall of the circular groove 1032 with an angular interval of 180° between each other.

[0098] In other preferred embodiments of the present application, the number of the sliding block buckles 10321 can be three or four, which are symmetrically distributed on the side wall of the circular groove 1032 with an angular interval of 120° or 90° between each other. The number of the sliding block buckles 10321 can also be five or more, which is not limited herein.

[0099] Continuing to refer to FIG. 5a, in an embodiment of the present application, the side of the distal end face 1031 of the parallel slider module 103 is provided with at least two second buckles 1033, which are symmetrically distributed on the side of the distal end face 1031 and have an angular interval of 180°.

[0100] In other embodiments of the present application, the number of the second buckles 1033 is three or four, which are symmetrically distributed on the side of the distal end face 1031 and have an angular interval of 120° or 90°. The number of the second buckles 1033 can also be five or more, which is not limited herein. In the installation unit 100, the second buckles 1033 are coupled with the first buckles 1012. The position and number of the second buckles 1033 are consistent with the first buckles 1012.

[0101] Referring to FIG. 5b, in an embodiment of the present application, the side of the proximal end face 1034 of the parallel slider module 103 is provided with at least two T-shaped structures 1035, the vertical part of the T-shaped structure 1035 is connected to the proximal end face 1034, the horizontal part includes a T-shaped structure slider 10351 and a T-shaped structure buckle 10352, the T-shaped structure slider 10351 is directed to 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 is directed to the inside of the parallel slider module 103 and protrudes from the inner ring of the parallel slider module 103.

[0102] In the installation unit 100, the T-shaped structure slider 10351 is located in the limiting groove 1013 to limit the position of the parallel slider module 103 and prevent the parallel slider module 103 from rotating in the installation unit 100. The number and position of the T-shaped structure slider 10351 are consistent with the limiting groove 1013. During the sliding process of the parallel slider module 103 to the proximal end, the T-shaped structure slider 10351 slides in the limiting groove 1013.

[0103] In a preferred embodiment of the present application, the vertical part of the T-shaped structure 1035 is a flexible material, which is integrally formed with the horizontal part, and the horizontal part can be bent or curved around the vertical part.

[0104] In other preferred embodiments of the present application, the vertical part of the T-shaped structure 1035 is an elastic material, such as a spring, a spring sheet, etc., and the horizontal part is fixedly connected with the vertical part through welding or hot melting process, and the horizontal part can also be bent or curved around the vertical part.

[0105] Analyte detection device

[0106] FIG. 6 is a structural schematic diagram of an analyte detection device according to an embodiment of the present application.

[0107] With reference to FIG. 3, in the embodiment of the present application, the analyte detection device 104 comprises a housing 1041, a transmitter (not shown), a sensor 1042, and an internal circuit (not shown) disposed in the housing 1041 and electrically coupled to the sensor 1042. The sensor 1042 is configured to detect analyte parameter information of a user's body fluid, and transmit the analyte parameter information to the transmitter via the internal circuit, and then transmit the analyte parameter information to the external device 200 via the transmitter.

[0108] In the preferred embodiment of the present application, the analyte detection device 104 transmits signals to the external device 200 at a first frequency f1 before being installed on the skin surface of the user, and transmits signals to the external device 200 at a second frequency f2 after being installed on the skin surface of the user, wherein the second frequency f2 is greater than the first frequency f1. In the further preferred embodiment of the present application, the first frequency f1 is 0-12 times per hour, and the second frequency f2 is 12-3600 times per hour.

[0109] In the more preferred embodiment of the present application, the first frequency f1 is 0 times per hour, i.e., the analyte detection device 104 does not transmit signals to the external device 200 before being installed on the skin surface of the user, which can save the power consumption of the analyte detection device 104 before installation.

[0110] In the embodiment of the present application, the housing 1041 comprises 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 comprises an extracorporeal part (not shown) and an intracorporeal part (not shown), the extracorporeal part, the transmitter, and the internal circuit are disposed in the internal space, and the extracorporeal part is electrically coupled to the internal circuit. The intracorporeal part is provided with electrodes, film layers, and other structures, and can detect analyte parameter information by being inserted into the subcutaneous tissue of the user. When the intracorporeal part is inserted into the subcutaneous tissue, it needs to have a correct angle, for example, perpendicular to the skin surface. After the service life of the analyte detection device 104 ends, the analyte detection device 104 is removed from the skin surface of the user and discarded as a whole.

[0111] In the embodiment of the present application, the lower housing body 10413 comprises a first through hole 10414, and the upper housing body 10411 comprises a second through hole (not shown) on the axis of the first through hole 10414, and the intracorporeal part passes through the first through hole 10414 to the outside of the housing, so as to be inserted into the subcutaneous tissue of the user.

[0112] In the embodiment of the present application, the side of the upper housing 10411 comprises a clamping hole 10412 corresponding to the T-shaped clamping structure 10352, where "corresponding" means that the position and number of the clamping hole 10412 are consistent with the T-shaped clamping structure 10352. In the installation unit 100, the upper housing 10411 is attached to the proximal end surface 1034, the T-shaped clamping structure 10352 is clamped with the clamping hole 10412, and the analyte detection device 104 is fixed on the parallel slide block module 103. When the horizontal part of the T-shaped structure is bent or curved around the vertical part, the clamping connection between the T-shaped clamping structure 10352 and the clamping hole 10412 is released, and the analyte detection device 104 is separated from the parallel slide block module 103. Therefore, in the installation unit 100, the analyte detection device 104 and the parallel slide block module 103 are releasably connected.

[0113] Auxiliary needle module

[0114] FIG. 7 is a structural schematic diagram of the auxiliary needle module in the embodiment of the present application.

[0115] In the embodiment of the present application, the auxiliary needle module 105 comprises an auxiliary needle fixing structure 1051 and an auxiliary needle 1052. In the installation 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.

[0116] In the embodiment of the present application, the auxiliary needle fixing structure 1051 comprises an auxiliary needle slide block 10511 and an auxiliary needle fixing block 10512, and the diameter or width of the auxiliary needle slide block 10511 is greater than that of the auxiliary needle fixing block 10512, forming a convex surface 10513 toward the proximal end.

[0117] In the embodiment of the present application, the auxiliary needle 1052 comprises a fully-enclosed needle body 10521 and a semi-enclosed needle body 10522, and 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 with the auxiliary needle fixing block 10512. The hollow structure of the semi-enclosed needle body 10522 can be used to accommodate the in-vivo part of the sensor 1042, and when the semi-enclosed needle body 10522 pierces into the user's subcutaneous tissue, the in-vivo part is also pierced into the subcutaneous tissue, and when the needle body is retracted, it does not affect the state of the in-vivo part in the subcutaneous tissue.

[0118] In other embodiments of the present application, the auxiliary needle 1052 only comprises a semi-enclosed needle body 10522, i.e., the semi-enclosed needle body 10522 is fixedly connected with the auxiliary needle fixing block 10512, which can reduce the material of the auxiliary needle 1052 and save costs, but at the same time, the rigidity of the auxiliary needle 1052 is also reduced.

[0119] In the installation 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 in-vivo portion of the sensor 1042 is located in the semi-enclosed needle body 10522.

[0120] Trigger module

[0121] FIG. 8 is a structural schematic diagram of the trigger module according to an embodiment of the present application.

[0122] In the embodiment of the present application, the trigger module 106 is provided with at least two fixed buckles 1061 corresponding to the first buckles 1012. In the installation unit 100, the fixed buckles 1061 are in contact with the first buckles 1012 to prevent the first buckles 1012 from being bent or folded outwardly of the housing. The contact between the fixed buckles 1061 and the first buckles 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 buckles 1012 forms a fixed angle with the horizontal plane and converges at the proximal end of the installation unit 100. The number and position of the fixed buckles 1061 are consistent with those of the first buckles 1012.

[0123] In the embodiment of the present application, the trigger module 106 is further provided with at least two clamping ears 1062. In the installation unit 100, the clamping ears 1062 are in clamping cooperation with the clamping grooves 1014 to fix the trigger module 106. The number and position of the clamping ears 1062 are consistent with those of the clamping grooves 1014. In combination with FIG. 10a, before the installation unit 100 is used, the clamping ears 1062 are located in the first clamping groove positions 10141, and at this time, the fixed buckles 1061 are in contact with the first buckles 1012.

[0124] In the embodiment of the present application, the trigger module 106 further includes an outer ring 1063 which connects the fixed buckles 1061 and the clamping ears 1062 into a whole. In the installation unit 100, the outer ring 1063 is located close to the proximal end relative to the clamping ears 1062, is located in and protrudes from the first opening, and in use of the installation unit 100, the outer ring 1063 is in contact with the surface of the skin of a user.

[0125] Elastic module

[0126] Referring to FIG. 3, the elastic module 107 includes a first elastic member 1071 and a second elastic member 1072.

[0127] In the embodiment of the present application, the first elastic member 1071 is located between the parallel sliding block module 103 and the housing 101, i.e., one end of the first elastic member 1071 is located at the distal end surface of the parallel sliding block module 103 and the other end is located in the housing 101, and in the installation unit 100, the first elastic member 1071 is in a compressed state and can provide elastic force.

[0128] In the embodiment of the present application, the second elastic member 1072 is located between the parallel slider module 103 and the auxiliary needle module 105, i.e. 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, and in the installation unit 100, the second elastic member 1072 is in a compressed state and can provide elastic force.

[0129] In the preferred embodiment of the present application, the first elastic member 1071 or the second elastic member 1072 is a metal spring.

[0130] In the embodiment of the present application, the inner diameter of the first elastic member 1071 is greater than the outer diameter of the circular groove 1032 and the auxiliary needle slider 10511, and in the installation unit 100, the first elastic member 1071 surrounds 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.

[0131] In the embodiment of the present application, the outer diameter of the second elastic member 1072 is greater than the outer diameter of the auxiliary needle fixed block 10512 and the inner diameter of the boss 10322, and is smaller than the outer diameter of the auxiliary needle slider 10511 and the inner diameter of the circular groove 1032, so that one end of the second elastic member 1072 is placed in the circular groove 1032 and the other end surrounds the outside of the auxiliary needle fixed block 10512, and the internal space of the installation unit 100 can be fully utilized.

[0132] Method for using the installation unit

[0133] FIG. 9 is a top view of the installation unit according to the embodiment of the present application.

[0134] FIG. 10a is a schematic view of the A cross-sectional structure of FIG. 9; FIG. 10b is a schematic view of the B cross-sectional structure of FIG. 9; FIG. 10c is a schematic view of the C cross-sectional structure of FIG. 9; and FIG. 11 is a schematic view of the bending of the first clasp under stress.

[0135] With reference to FIGS. 10a and 10b, in the embodiment of the present application, the clamping groove 1014 is provided with two clamping groove positions, i.e. a first clamping groove position 10141 and a second clamping groove position 10142. Before use of the installation unit 100, the trigger module 106 is fixed on the shell 101 by clamping the clamping ear 1062 with the first clamping groove position 10141, at this time, the fixed clasp 1061 is in contact with the first clasp 1012, preventing the first clasp 1012 from bending or folding outwardly of the shell 101, and the fixed clasp 1061, the first clasp 1012 and the second clasp 1033 are located on the same horizontal line. In the preferred embodiment of the present application, from inside to outside of the shell 101, they are the second clasp 1033, the first clasp 1012 and the fixed clasp 1061 in sequence.

[0136] In the embodiment of the present application, the contact between the fixed buckle 1061 and the first buckle 1012 is one of point contact, line contact or surface contact, and when the contact is surface contact, the extension line m1 of the contact surface converges at the proximal end. This design can make the fixed buckle 1061 slide to the distal end relative to the first buckle 1012.

[0137] In the preferred embodiment of the present application, 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 extension end m2 converges at the proximal end.

[0138] In combination with reference to FIG. 11, this design can make the second buckle 1033 slide to the proximal end relative to the first buckle 1012, push the first buckle 1012 outward from the shell 101, and thus release the coupling state between the first buckle 1012 and the second buckle 1033.

[0139] In the embodiment of the present application, the first elastic member 1071 is in a compressed state and has elastic potential energy, and its own elastic force gives the parallel module slider 103 a pushing force Fr to the proximal end. The pushing force Fr acts on the first buckle 1012 through the coupling surface between 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 outward from the shell 101 to bend or fold, and thus release the coupling state between the first buckle 1012 and the second buckle 1033.

[0140] In the embodiment of the present application, when the installation unit 100 is used, the rotating outer cover 1021 is broken, the protective cover 102 is separated from the shell 101, the proximal end of the installation unit 100 is close to the user's skin, and the outer ring 1063 of the trigger module 106 is attached to the skin surface. The user presses the shell 101 at the distal end, and the shell 101 slides towards the skin. The trigger module 106 remains stationary, so the trigger module 106 slides to the distal end relative to the shell 101, the clamping ear 1062 is separated from the first clamping groove 10141 and enters the second clamping groove 10142, and the fixed buckle 1061 is no longer in contact with the first buckle 1012. The first buckle 1012 is bent or folded outward from 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.

[0141] In the embodiment of the present application, after the coupling state is released, the parallel slider module 103 continues to slide to the proximal end under the elastic force of the first elastic member 1071, and drives the analyte detection device 104 to slide to the proximal end, until the lower outer shell 10413 of the analyte detection device 104 contacts the skin surface of the user.

[0142] Referring to FIG. 10c, in the embodiment of the application, the sliding block buckle 10321 is buckled with the auxiliary needle sliding block 10511, and when the first elastic member 1071 pushes the parallel sliding block module 103 to slide towards the proximal end, the auxiliary needle module 105 is driven to slide towards the proximal end.

[0143] In the embodiment of the application, the connection between the sliding block buckle 10321 and the auxiliary needle sliding block 10511 is a plane or an approximately plane, which forms a fixed angle with the horizontal plane, and the extension line m3 converges at the distal end. The pushing force of the second elastic member 1072 on the auxiliary needle sliding block 10511 is towards the distal end, so that the auxiliary needle sliding block 10511 can push the sliding block buckle 10321 out of the shell 101, causing the sliding block buckle 10321 to bend or fold, and the principle is equivalent to that of FIG. 11.

[0144] In the embodiment of the application, in the installation unit 100, the side wall of the auxiliary needle limiting groove 1015 prevents the sliding block buckle 10321 from bending or folding, and the buckled connection between the sliding block buckle 10321 and the auxiliary needle sliding block 10511 does not change. As the parallel sliding block module 103 and the auxiliary needle module 105 slide towards the proximal end, until the sliding block buckle 10321 is disengaged from the auxiliary needle limiting groove 1015, the inner wall of the auxiliary needle limiting groove 1015 no longer prevents the sliding block buckle 10321 from bending or folding, the second elastic member 1072 pushes the auxiliary needle sliding block 10511 towards the distal end, at the same time the auxiliary needle sliding block 10511 pushes the sliding block buckle 10321 to bend or fold outwards, the buckled connection between the sliding block buckle 10321 and the auxiliary needle sliding block 10511 is released, the second elastic member 1072 continues to push the auxiliary needle sliding block 10511 to slide towards the distal end, and finally the auxiliary needle module 105 returns to the initial position, the auxiliary needle 1052 is retracted into the shell 101, preventing the auxiliary needle 1052 from being exposed outside the shell 101, and avoiding unnecessary harm.

[0145] In the embodiment of the application, when the sliding block buckle 10321 is disengaged from the auxiliary needle limiting groove 1015, the semi-enclosed needle body 10522 of the auxiliary needle pierces the user's subcutaneous tissue.

[0146] In the embodiment of the application, in the installation unit 100, the T-shaped structure sliding block 10351 is located in the limiting groove 1013, and the limiting groove 1013 limits the position and direction of the parallel sliding block module 103 through the T-shaped structure sliding block 10351, to ensure that the parallel sliding block module 103 and its sliding direction are perpendicular, so that the analyte detection device 104 arranged at the front end of the parallel sliding block module 103 and its sliding direction are perpendicular, and at the same time the auxiliary needle 1052 and its sliding direction are parallel, so that the auxiliary needle 1052 and the envelope sensor body inside it can pierce the user's subcutaneous tissue at a perpendicular angle, reducing the user's pain.

[0147] In the embodiment of the present application, during the sliding of the parallel slider module 103 to the proximal end, the T-shaped slider 10351 slides in the limiting groove 1013 until it contacts the outer ring 1063 of the trigger module 106. Under the pushing of the first elastic member 1071, the parallel slider module 103 continues to slide to the proximal end, while the outer ring 1063 blocks the T-shaped slider 10351 from continuing to slide to the proximal end, so that the T-shaped slider 10351 bends around the vertical part or is bent, the buckle connection between the T-shaped buckle 10352 and the buckle hole 10412 is released, and the analyte detection device 104 is separated from the parallel slider module 103, so that it can be installed on the surface of the skin of the user.

[0148] In the embodiment of the present application, when the T-shaped slider 10351 contacts the outer ring 1063, the position of the parallel slider module 103 is a predetermined position, at which the lower outer shell 10413 of the analyte detection device contacts the surface of the skin of the user.

[0149] In the embodiment of the present application, the auxiliary needle 1052 penetrates the second through hole and the first through hole 10414 in sequence, and penetrates the analyte detection device 104, and at the same time, the semi-enclosing needle body 10522 of the auxiliary needle envelops the sensor 1042. During the sliding of the parallel slider module 103 and the auxiliary needle module 105 to the proximal end, the semi-enclosing needle body 10522 carries the sensor 1042 to penetrate into the subcutaneous tissue, and after the auxiliary needle 1052 is retracted, the in-vivo part of the sensor 1042 remains in the subcutaneous tissue, and the retraction of the needle body does not affect the state of the in-vivo part of the sensor 1042.

[0150] In the embodiment of the present application, when the installation action is performed, the user needs to press the shell 101 at the distal end to apply a force F to the proximal end of the shell 101, the outer ring 1063 of the trigger module 106 contacts the surface of the skin of the user, the skin of the user gives the outer ring 1063 a force F' opposite to the force F, so as to realize the relative sliding of the trigger module 106 and the shell 101. In the actual installation process, the absolute position of the trigger module 106 remains unchanged, and the shell 101 slides to the proximal end.

[0151] Before the installation action is performed, 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, which surrounds the outside of the outer ring 1063 of the trigger module, so as to prevent the installation action from being performed at an incorrect position due to accidental contact with the outer ring 1063, and to prevent triggering.

[0152] The distal end surface 10232 of the inner cover body 1023 contacts the analyte detection device 104, and at the same time, the auxiliary needle 1052 and the sensor 1042 extend into the inner cover groove 10233, which can play a sealing role to prevent dust, particles and other dirt in the external environment from contacting the needle body and the sensor and causing pollution.

[0153] In the embodiment of the present application, the lower outer shell 10413 of the analyte detection device is also provided with adhesive tape (not shown in the figure) for fixing the analyte detection device 104 on the surface of the user's skin.

[0154] Second embodiment

[0155] In the foregoing embodiment, after the user uses the installation unit, the auxiliary needle is automatically retracted into the shell under the action of the second elastic member to avoid unnecessary harm to the user. The auxiliary needle is completely retracted into the shell, and a 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 application 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, protective measures for the auxiliary needle need to be considered, and a needle body protection structure is designed for the auxiliary needle.

[0156] In the above technical background, in some embodiments of the present application, after the user uses the installation unit to install the analyte monitoring device, the auxiliary needle is not completely retracted into the shell, and at least a part of the auxiliary needle, such as the needle tip, is exposed outside the shell. The user assembles the needle body protection structure to the installation unit to protect the exposed needle tip. The specific implementation of the needle body protection structure will be described in detail below.

[0157] In the embodiment of the present application, the technical solutions not described are considered the same as the foregoing embodiments, and will not be described here.

[0158] FIG. 12 is an exploded structural schematic diagram of the analyte detection device installation unit according to an embodiment of the present application. FIG. 13a is a separated structural schematic diagram of the outer cover body and the inner cover body according to an embodiment of the present application. FIG. 13b is an integrated structural schematic diagram of the outer cover body and the inner cover body according to an embodiment of the present application. FIG. 13c is a structural schematic diagram of the outer cover body according to an embodiment of the present application.

[0159] Referring to FIG. 12, in some embodiments of the present application, the installation unit 200 includes a shell 201 and a protective cover 202. As described above, before installation, the analyte detection device 204 is pre-installed inside the shell 201, and during installation, it is pushed to the proximal end by an elastic module (not shown in the figure, refer to FIG. 17) and installed on the surface of the user's skin. The protective cover 202 is arranged at the proximal end of the shell 201 and is releasably connected with the shell 201, and is used to protect the structural members inside the shell 201 before installation.

[0160] With reference to FIGS. 13a-13c, in some embodiments of the present application, the protective cover 202 includes an outer cover 2021, an inner cover 2023, and a label paper 2024. Before installation, the inner cover 2023 is contained in the outer cover cavity 20214, and the label paper 2024 is used to seal the outer cover cavity 20214, so as to seal the inner cover 2023 in the outer cover cavity 20214.

[0161] In some embodiments of the present application, the inner cover 2023 is movable relative to the outer cover 2021 or releasably connected to the outer cover 2021. When the inner cover 2023 is movable relative to the outer cover 2021, the outer cover 2021 does not have a restraining structure to limit the state of the inner cover 2023 in the outer cover 2021. When needed, the user can directly take out the inner cover 2023 from the outer cover 2021. When the inner cover 2023 is releasably connected to the outer cover 2021, the inner cover 2023 and the outer cover 2021 are fixed together by means of buckles, hooks, threads, magic tapes, etc. When needed, the user needs to first release the fixed connection between the inner cover 2023 and the outer cover 2021, and then take out the inner cover 2023 from the outer cover 2021 after the separation of the inner cover 2023 and the outer cover 2021. In the preferred embodiment of the present application, in order to facilitate the user, the inner cover 2023 is movable relative to the outer cover 2021 before the installation unit 200 is used, so as to facilitate the user to take out the inner cover 2023 from the outer cover 2021 when the installation unit 200 is used.

[0162] In some embodiments of the present application, in order to contain the inner cover 2023 in the outer cover 2021, the middle part of the outer cover 2021 protrudes towards the distal end and forms a proximal opening outer cover cavity 20214. The inner diameter of the outer cover cavity 20214 is slightly larger than the outer diameter of the inner cover 2023, for example, there is a gap of 0.5-5 mm between the inner wall of the outer cover cavity 20214 and the outer wall of the inner cover 2023. At the same time, the depth of the outer cover cavity 20214 is not less than the height of the inner cover 2023, so as to avoid the inner cover 2023 protruding from the outer cover cavity 20214, and facilitate the label paper 2024 to be pasted on the proximal end surface 20215 of the outer cover 2021 to seal the outer cover cavity 20214.

[0163] In some embodiments of the present application, a plurality of convex semicircular balls 20234 are arranged on the proximal end surface 20232 of the inner cover 2023. Before the installation unit 200 is used, the inner cover 2023 is accommodated in the recessed cavity 20214 of the outer cover 2021, and the label paper 2024 is attached to the proximal end surface 20215 of the outer cover 2021. The adhesive coating area of the label paper 2024 may exceed the contact area of the label paper 2024 and the outer cover 2021, causing the adhesive coating of the label paper 2024 to come into contact with the proximal end surface 20232 of the inner cover 2023, and the inner cover 2023 to be attached to the label paper 2024. When the inner cover 2023 is removed, the user has difficulty tearing off the label paper 2024, and even when the label paper 2024 is torn off, it may be broken and adhere to the inner cover 2023, affecting the user's experience. Based on this, a plurality of convex semicircular balls 20234 are arranged on the proximal end surface 20232 of the inner cover 2023 to come into contact with the label paper 2024, which can reduce the contact area of the proximal end surface 20232 of the inner cover 2023 and the label paper 2024, and avoid the label paper 2024 from being adhered to the proximal end surface 20232 of the inner cover 2023 in a large area, thereby facilitating the user to tear off the label paper 2024.

[0164] In some embodiments of the present application, the number of convex semicircular balls 20234 is at least two, which are symmetrically or asymmetrically distributed on the proximal end surface of the inner cover 2023. Preferably, the convex semicircular balls 20234 are symmetrically and uniformly distributed on the proximal end surface of the inner cover 2023.

[0165] In some embodiments of the present application, information related to the analyte detection device 204, the installation unit 200, and the like, such as production batch number, production date, usage instructions, communication connection SN code, trademark, two-dimensional code, and the like, can be printed on the label paper 2024.

[0166] In some embodiments of the present application, before the installation unit 200 is used, the protective cover 202 is releasably connected to the shell 201, and the specific use mode has been described in the first embodiment, which will not be repeated here. When the protective cover 202 is installed on the shell 201, the needle accommodating cavity 20213 on the outer cover 2021 can accommodate the auxiliary needle 2052. The needle accommodating cavity 20213 is a hollow circular cone or circular truncated cone opening toward the distal end (the distal end opening can be seen in FIG. 13a). When the needle accommodating cavity 20213 is in the form of a circular cone, its diameter gradually decreases from the distal end to the proximal end. The inner part of the needle accommodating cavity 20213 can be a hollow structure parallel to the external structure, or a hollow structure with a decreasing inner diameter from the distal end to the proximal end. The auxiliary needle 2052 shares the central axis with the needle accommodating cavity 20213, so that the auxiliary needle 2052 can enter the hollow cavity from the distal end opening of the needle accommodating cavity 20213. The needle accommodating cavity 20213 protects the auxiliary needle 2052 while effectively utilizing the internal space of the shell 201, and the structure is more compact.

[0167] Figure 14 is a schematic diagram of the state of the installation unit after use in some embodiments of the application.

[0168] Referring to Figure 14, in some embodiments of the application, the user places the installation unit 200 on the skin surface, the trigger module 206 is in contact with the skin, the user applies pressure to the installation unit 200 from the distal end to the proximal end, the shell 201 slides proximally relative to the trigger module 206, and in the process of the shell 201 sliding proximally relative to the trigger module 206, the trigger module 206 releases the elastic module (not shown in the figure) from the restriction, 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 is in contact with the skin surface and the auxiliary needle 2052 penetrates the subcutaneous tissue.

[0169] Referring to the direction shown in Figure 14, in some embodiments of the application, in the process of the parallel slider module 203, the analyte detection device 204 and the auxiliary needle 2052 sliding proximally together, when the proximal end surface of the analyte detection device 204 is flush with the proximal end surface of the trigger module 206, the analyte detection device 204 is in contact with the skin surface of the user, the elastic module still has a proximal pushing force on the parallel slider module 203, the parallel slider module 203 continues to slide proximally relative to the shell 201 with the analyte detection device 204 and the auxiliary needle 2052, and the analyte detection device 204 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 on the skin surface, which can increase the adhesive effect of the adhesive tape on the skin surface, so that the analyte detection device 204 can be more firmly attached to the skin surface.

[0170] In some embodiments of the application, in the process of the parallel slider module 203 continuing to slide proximally relative to the shell 201, due to the obstruction of the skin surface, the position of the parallel slider module 203 no longer changes, and if the elastic member in the elastic module still has elastic force that is not completely released, at this time 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 the proximal end surface of the trigger module 206 forms a height difference h1 with the proximal end surface of the parallel slider module 203, and the skin surface forms a pit under the pressing action of the analyte detection device 204 and the parallel slider module 203.

[0171] In some embodiments of the present application, during the process of the parallel slider module 203 continuously sliding proximally relative to the housing 201, the snap connection between the parallel slider module 203 and the analyte detection device 204 is decoupled, and when the relative sliding between the parallel slider module 203 and the housing 201 is terminated, the parallel slider module 203 has been completely separated from the analyte detection device 204, while the parallel slider module 203 is still confined in the housing 201, at this time, the analyte detection device 204 is in a separated state relative to the housing 201, and the user can lift the housing 201 distally by hand, and the analyte detection device 204 is adhered to the skin surface by the adhesive tape.

[0172] In some embodiments of the present application, when the parallel slider module 203 slides proximally relative to the housing 201 to the first predetermined position, the auxiliary needle module 205 slides proximally relative to the housing to the terminal position, at this time, the auxiliary needle 2052 penetrates into the subcutaneous tissue, and the in-vivo part of the sensor 2042 is sent to the predetermined depth of the subcutaneous tissue. Subsequently, the auxiliary needle module 205 is retracted and slides distally relative to the housing 201 to the second predetermined position.

[0173] FIG. 15 is a schematic view of the state of the auxiliary needle after retraction of the installation unit according to an embodiment of the present application.

[0174] Referring to FIG. 15, in some embodiments of the present application, after the auxiliary needle module 205 slides distally to the second predetermined position, i.e., the retraction terminal position, the auxiliary needle 2052 exits the subcutaneous tissue, facilitating the user to remove the housing 201. After the auxiliary needle 2052 is retracted, the in-vivo part of the sensor 2042 remains in the subcutaneous tissue.

[0175] In some embodiments of the present application, after the auxiliary needle 2052 is retracted, a part of the needle tip is exposed outside the housing 201, as shown in FIG. 15, the height difference h2 is formed between the needle tip of the auxiliary needle 2052 and the proximal end surface of the parallel slider module 203, i.e., the length of the auxiliary needle 2052 exposed outside the housing 201 is h2, and h2 can be in the range of 0.1-5 mm. If the exposed length of the auxiliary needle 2052 is too long, the needle tip will be left in the subcutaneous tissue during retraction, and the user may be injured when removing the housing 201.

[0176] In some embodiments of the present application, the auxiliary needle 2052 is exposed outside the housing 201 after retraction, instead of being completely retracted into the housing 201, which can reduce the retraction stroke of the auxiliary needle 2052, thus reducing the overall height of the housing 201, making the installation unit 200 more compact and smaller in mass, while also reducing the material usage of the housing 201 and the production cost of the installation unit 200. In FIG. 15, the auxiliary needle module 205 represented by the dashed line represents the final position of the auxiliary needle module 205 after the reduction of the retraction stroke, and the final position of the auxiliary needle module 205 before the reduction of the retraction stroke is closer to the distal end, and the final position of the auxiliary needle module 205 after the reduction of the retraction stroke is closer to the proximal end.

[0177] In some embodiments of the present application, the reduction of the retraction stroke of the auxiliary needle 2052 means that the auxiliary needle module 205 also reduces the same retraction stroke. Referring to FIG. 15, the auxiliary needle module 205 reduces the retraction stroke by h3, and after the reduction of the retraction stroke of the auxiliary needle module 205, the overall height of the housing 201 can be reduced, and the overall height of the housing 201 that is reduced can be consistent with the reduction of the retraction stroke of the auxiliary needle module 205, both being h3.

[0178] In some embodiments of the present application, the auxiliary needle 2052 is exposed outside the housing 201, and the needle tip can cause unnecessary harm to the human body, so after using the installation unit 200, a needle body protection structure is needed to protect the exposed needle tip.

[0179] FIGS. 16a-16c are schematic diagrams of the inner cover as a needle body protection structure in embodiments of the present application.

[0180] Referring to FIGS. 16a-16c and FIG. 13c, in some embodiments of the present application, after using the installation unit 200, the user can remove the inner cover 2023 from the outer cover 2021, and assemble the inner cover 2023 to the parallel slider module 203, the trigger module 206, or the housing 201. The inner cover 2023 is provided with a needle body protection cavity 20233, which can be used to protect the exposed needle tip of the auxiliary needle 2052.

[0181] In some embodiments of the present application, the inner cover 2023 is assembled with the parallel slider module 203 as an embodiment, and the inner cover 2023 is a needle body protection structure in embodiments of the present application. The proximal surface of the parallel slider module 203 has a larger area relative to the proximal surface of the trigger module 206 or the housing 201, and is easier to process and assemble.

[0182] In some embodiments of the present application, referring to the direction shown in FIG. 16b, the needle body protection cavity 20233 is a hollow cavity with a distal opening, and the inner hollow cavity can be used to accommodate the exposed needle tip of the auxiliary needle 2052. The outer side of the needle body protection cavity 20233 can be a cylinder, a cone, a cuboid, or other irregular solid structures, which are not limited herein, and the inner side cavity can be the same or different shape structure as the outer side, preferably, the inner side cavity is a cylinder or a cone, more preferably, the inner side cavity is a cone with a gradually decreasing inner diameter from the distal end to the proximal end.

[0183] In some embodiments of the present application, if the auxiliary needle 20522 is in an eccentric position relative to the parallel slider module 203, the needle body protection cavity 20233 is also in an eccentric position on the inner cover 2023, that is, the auxiliary needle 20522 and the needle body protection cavity 20233 share the same central axis. Before the user assembles the outer cover 2021 to the parallel slider module 203, the user needs to ensure that the distal opening of the needle body protection cavity 20233 is aligned with the auxiliary needle 20522, to avoid misalignment between the needle body protection cavity 20233 and the auxiliary needle 20522.

[0184] In some embodiments of the present application, the inner cover 2023 and the parallel slider module 203 are assembled and connected by one or more of buckles, hooks, blocks, threads, bolts, magic tapes, and glue, and any assembly method that can assemble the inner cover 2023 to the parallel slider module 203 should be included in the protection scope of the present application. At least two assembly structures are provided on the corresponding positions of the inner cover 2023 and the parallel slider module 203, and preferably, the assembly structures are symmetrically distributed on the inner cover 2023 and the parallel slider module 203.

[0185] In some embodiments of the present application, the assembly structures can be interchanged on the inner cover 2023 and the parallel slider module 203, for example, the hooks 20231 are provided on the distal end face of the inner cover 2023, and the corresponding card holes 2037 are provided on the proximal end face of the parallel slider module 203, for establishing assembly connection with the hooks 20231. In other embodiments of the present application, the hooks 20231 can be provided on the parallel slider module 203, and the corresponding card holes 2037 are provided on the inner cover 2023.

[0186] In some embodiments of the present application, in order to facilitate the user to assemble the inner cover 2023 and increase the assembly firmness of the inner cover 2023, positioning structures are further provided on the inner cover 2023 and the parallel slider module 203. The positioning structures are composed of positioning columns 20232 and positioning holes 2036, and the positions and quantities of the positioning structures on the inner cover 2023 and the parallel slider module 203 are corresponding.

[0187] In some embodiments of the present application, the positioning column 20232 is located at the distal end surface of the inner cover 2023, and the positioning hole 2036 is located at the proximal end surface of the parallel slider module 203. In other embodiments of the present application, the positioning hole 2036 is located at the distal end surface of the inner cover 2023, and the positioning column 20232 is located at the proximal end surface of the parallel slider module 203.

[0188] In some embodiments of the present application, the positioning structure is not limited to the combination of the positioning column 20232 and the positioning hole 2036 shown in Figures 16a-16c, but can also be other types of positioning structures, such as the combination of a slider and a sliding groove, and any structure related to the positioning function should be included in the protection scope of the present application.

[0189] In some embodiments of the present application, the user holds the inner cover 2023 and the shell 201 with hands respectively and moves 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, and then presses the inner cover 2023 and the shell 201 with force, so as to assemble the inner cover 2023 to the parallel slider module 203, and the needle body protection cavity 20233 wraps the auxiliary needle 20522 to seal and protect the exposed needle tip. The state diagram of the inner cover 2023 assembled to the parallel slider module 203 is shown in Figure 16c.

[0190] Figure 17 is a cross-sectional structure diagram of the installation unit of an embodiment of the present application.

[0191] Referring to Figure 17, in some embodiments of the present application, the elastic module includes a first elastic member 2071, a second elastic member 2072, and a third elastic member 2073. Before using the installation 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. The first elastic member 2071 is used to push the parallel slider module 203 to slide towards the proximal end after releasing the elastic force, the second elastic member 2072 is used to push the auxiliary needle module 205 towards the distal end to retract the auxiliary needle 2052 after releasing the elastic force, and the third elastic member 2073 is used to adjust the retraction stroke of the auxiliary needle module 205.

[0192] In some embodiments of the present application, the third elastic member 2072 is arranged in the housing 201, one end of which is in contact with the inner side of the housing 201, and the other end of which is directed towards the auxiliary needle module 205. After the first elastic member 2071 pushes the parallel slider module 203 towards the proximal end, and the second elastic member 2072 pushes the auxiliary needle module 205 towards the distal end, the third elastic member 2073 blocks the auxiliary needle module 205 from continuing to slide towards the distal end, limiting the retraction of the auxiliary needle module 205 to reduce the retraction stroke. Without the third elastic member 2073, the auxiliary needle module 205 will slide to the farthest end inside the housing 201 until it contacts the housing 201. With the third elastic member 2073, the retraction stroke of the auxiliary needle module 205 can be adjusted according to the relative elastic force and length of the second elastic member 2072 and the third elastic member 2073, and then the length of the needle tip of the auxiliary needle 2052 exposed outside the housing 201 can be adjusted.

[0193] In some embodiments of the present application, the reduction amount h3 of the retraction stroke of the auxiliary needle module 205 is equivalent to the length L of the third elastic member 2073 when the elastic force of the second elastic member 2072 and the third elastic member 2073 is balanced.

[0194] In some embodiments of the present application, the initial state of the third elastic member 2073 is the normal state, which is not compressed or stretched, and the initial state of the second elastic member 2072 is the compressed state. After the second elastic member 2072 releases the elastic force, the auxiliary needle module 205 is pushed towards the distal end 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 towards the distal end under the elastic force of the second elastic member 2072. The third elastic member 2073 is compressed and generates elastic force under the elastic force of the second elastic member 2072 until the elastic force of the third elastic member 2073 is the same as that of the second elastic member 2072, and the auxiliary needle module 205 stops sliding towards the distal end.

[0195] In some embodiments of the present application, the second elastic member 2072 and the third elastic member 2073 are springs, the elastic modulus and initial length of which are preset before leaving the factory. When the third elastic member 2073 is in the balanced state with the same elastic force as the second elastic member 2072 after the auxiliary needle module 205 is retracted, the second elastic member 2072 is still in the compressed state. By adjusting the elastic modulus and initial length of the second elastic member 2072 and the third elastic member 2073, the length L of the third elastic member 2073 when the elastic force of the second elastic member 2072 and the third elastic member 2073 is balanced can be controlled, and then the retraction stroke of the auxiliary needle module 205 and the reduction amount h3 of the retraction stroke can be controlled, and finally the length h2 of the needle tip of the auxiliary needle 2052 exposed outside the housing 201 can be determined.

[0196] In some embodiments of the present application, after the auxiliary needle module 205 stops sliding, the user takes the shell 201 off the skin surface, the needle tip of the auxiliary needle 2052 is exposed outside the shell 201, and then the inner cover 2023 is assembled to the parallel slider module 203, the needle body protection cavity 20233 surrounds and seals the auxiliary needle 2052, and the inner cover 2023 completes its protection function for the auxiliary needle 2052.

[0197] FIGS. 18a-18c are schematic diagrams of the protective sleeve as a needle body protection structure in embodiments of the present application.

[0198] With reference to FIGS. 18a-18c, in some embodiments of the present application, the needle body protection structure can also be an elastic protective sleeve 20523. After the user uses the installation unit 200, the elastic protective sleeve 20523 can be assembled to the auxiliary needle 2052 to protect the needle tip exposed outside the shell 201, which will be described below in the detailed description.

[0199] With reference to the direction shown in FIG. 18b, in some embodiments of the present application, the elastic protective sleeve 20523 is a hollow three-dimensional structure with a distal opening, and the hollow structure is used to accommodate the auxiliary needle 2052. The outer diameter of the auxiliary needle 2052 is d3, and the inner diameter of the distal opening of the elastic protective sleeve 20523 is d4, which is slightly larger than the outer diameter d3 of the auxiliary needle 2052, for example, 0.1-2 mm larger, to facilitate the user to align the distal opening of the elastic protective sleeve 20523 and the auxiliary needle 2052. From the distal opening of the elastic protective sleeve 20523 to the proximal end, the inner diameter gradually decreases until it decreases to d5, which is slightly smaller than the outer diameter d3 of the auxiliary needle 2052, for example, 0.1-2 mm smaller. 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, so that the elastic protective sleeve 20523 and the auxiliary needle 2052 achieve interference fit, increasing the friction between the auxiliary needle 2052 and the elastic protective sleeve 20523, so that the elastic protective sleeve 20523 can be fixed relative to the auxiliary needle 2052 after being sleeved outside the auxiliary needle 2052 and will not fall off. That is, the elastic protective sleeve 20523 and the auxiliary needle 2052 are in size values, d4>d3>d5. The proximal end of the elastic protective sleeve 20523 can be open or closed, and the overall length thereof should be not less than the length h2 of the auxiliary needle 2052 exposed outside the shell 201, for example, 0.1-20 mm longer, so that the elastic protective sleeve 20523 can completely wrap the exposed needle tip and achieve protection for the auxiliary needle 2052. Preferably, the proximal end of the elastic protective sleeve 20523 is closed, which can prevent the needle tip of the auxiliary needle 2052 from being exposed from the proximal end of the elastic protective sleeve 20523.

[0200] In some embodiments of the present application, the elastic protective sleeve 20523 can be a separate structure from the installation unit 200 before the user uses the installation unit 200, and after the user uses the installation unit 200, the user sets the elastic protective sleeve 20523 on the auxiliary needle 2052 to form an integral whole with the installation unit 200.

[0201] In some embodiments of the present application, since the elastic protective sleeve 20523 needs to have a certain elasticity to achieve interference fit with the auxiliary needle 2052, the elastic protective sleeve 20523 can be made of elastic materials such as silica gel and rubber. Any change in the material of the elastic protective sleeve 20523 should be included in the protection scope of the present application.

[0202] In some embodiments of the present application, the elastic protective sleeve 20523 can not be limited to the straight strip structure shown in the above and in FIGS. 18a-18c, but can also be other three-dimensional structures such as spheres, cones or other irregular three-dimensional structures. Any change in the shape of the elastic protective sleeve 20523 should be included in the protection scope of the present application.

[0203] In summary, the embodiments of the present application disclose a miniaturized installation unit of an analyte detection device. After using the installation unit, the auxiliary needle is not completely retracted into the installation unit housing to reduce the retraction stroke of the auxiliary needle, thereby reducing the overall height of the installation unit housing, which is conducive to the miniaturization of the installation unit, facilitates the use of the user, and saves the production cost.

[0204] Although some specific embodiments of the present application have been described in detail through examples, those skilled in the art should understand that the above examples are only for illustration, not for limiting the scope of the present application. Those skilled in the art should understand that the above embodiments can be modified without departing from the scope and spirit of the present application. The scope of the present application is defined by the appended claims.

Claims

An analyte detection device mounting unit characterized by comprising: Comprise: a shell and a elastic module, a trigger module, a parallel slider module, an auxiliary needle module and an analyte detection device pre-installed in the shell; the parallel slider module carries the auxiliary needle module and the analyte detection device, and the auxiliary needle module comprises an auxiliary needle; after the trigger module is activated, the elastic module pushes the parallel slider module to slide proximally to a first predetermined position relative to the shell, then the auxiliary needle module is retracted, and the auxiliary needle module slides distally to a second predetermined position relative to the shell; wherein the auxiliary needle pierces the subcutaneous tissue when the parallel slider module is at the first predetermined position, and at least a part of the auxiliary needle is exposed outside the shell when the auxiliary needle module is at the second predetermined position. The analyte detection device mounting unit according to claim 1, wherein The length of the auxiliary needle exposed outside the shell is 0.1-5mm when the auxiliary needle module is at the second predetermined position. The analyte detection device mounting unit according to claim 1, wherein Further comprising a protective cover, which is located at the proximal end of the shell and is releasably connected with the shell. The analyte detection device mounting unit according to claim 3, wherein The protective cover comprises an outer cover body and an inner cover body, and the inner cover body is located in the outer cover body before the installation unit is used. The analyte detection device mounting unit according to claim 4, wherein The outer cover body is releasably connected with the inner cover body. The analyte detection device mounting unit according to claim 4, wherein Further comprising a label paper, which is attached to the proximal end surface of the outer cover body. The analyte detection device mounting unit according to claim 6, wherein The proximal end surface of the inner cover body further comprises at least two convex semicircular balls. The analyte detection device mounting unit according to claim 7, wherein The convex semicircular balls are uniformly distributed on the proximal end surface of the inner cover body. The analyte detection device mounting unit according to claim 4, wherein The outer cover body comprises a needle body accommodating cavity, which shares a central axis with the auxiliary needle and is used to accommodate the auxiliary needle before the installation unit is used. The analyte detection device mounting unit according to claim 9, wherein The needle body The hollow structure of the needle body accommodating cavity has a decreasing inner diameter from the distal end to the proximal end. The analyte detection device mounting unit according to claim 9, wherein The inner cover body comprises a needle body protection cavity, which shares a central axis with the auxiliary needle and is used to accommodate the auxiliary needle after the installation unit is used. The analyte detection device mounting unit according to claim 11, wherein The inner cover body further comprises an assembly structure, which is used to establish an assembly connection with the parallel slider module, the trigger module or the shell. The analyte detection device mounting unit according to claim 12, wherein The assembly structure is one or more of buckles, hooks, blocks, threads, bolts, magic tapes and glues. The analyte detection device mounting unit according to claim 13, wherein The inner cover body further comprises a positioning structure. The analyte detection device mounting unit according to claim 9, wherein Further comprising an elastic protective sleeve, the distal end of which comprises a hollow structure, which is used to be sleeved outside the auxiliary needle after the installation unit is used. The analyte detection device mounting unit according to claim 15, wherein The hollow structure of the elastic protective sleeve has a decreasing inner diameter from the distal end to the proximal end. The analyte detection device mounting unit according to claim 16, wherein The inner diameter of the hollow structure of the elastic protective sleeve at the distal end is greater than the outer diameter of the auxiliary needle, and the inner diameter of the hollow structure of the elastic protective sleeve at the proximal end is smaller than the outer diameter of the auxiliary needle. The analyte detection device mounting unit according to claim 15, wherein The proximal end of the elastic protective sleeve is open or closed. The analyte detection device mounting unit according to claim 15, wherein The length of the elastic protective sleeve is not less than the length of the auxiliary needle exposed outside the shell. The analyte detection device mounting unit according to claim 1, wherein In the first predetermined position, the parallel slider module is closer to the proximal end than the trigger module. The analyte detection device mounting unit according to claim 1, wherein The elastic module comprises at least a first elastic member and a second elastic member, and the first elastic member and the second elastic member are in a compressed state before the installation unit is used. The analyte detection device mounting unit according to claim 19, wherein The elastic module further comprises a third elastic member, which is in a normal state before the installation unit is used. The analyte detection device mounting unit according to claim 22, wherein The first Three elastic members are located between the housing and the auxiliary needle module for adjusting the length of the auxiliary needle exposed outside the housing. The analyte detection device mounting unit according to claim 23, wherein The third elastic member is a spring.

Images