Safe Analyte Detection Device Installation Unit

Abstract

The present invention discloses a safe installation unit for an analyte detection device. Before using the installation unit, the inner cover body is placed in the outer cover body, the outer cover body is assembled at the proximal end of the installation unit, and the auxiliary needle is accommodated in the needle body accommodating cavity of the outer cover body. After using the installation unit, the auxiliary needle is not completely retracted into the shell to reduce the retraction stroke of the auxiliary needle module. At the same time, the inner cover body is assembled to the proximal end of the installation unit, and the auxiliary needle is accommodated in the needle body protection cavity of the inner cover body to protect the auxiliary needle and avoid unnecessary damage, and also make the installation unit more miniaturized.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, and in particular to an analyte testing device mounting unit that is both safe and compact. 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. This detection method is called continuous glucose monitoring (CGM). In order to achieve continuous glucose monitoring, users need to use an auxiliary mounting unit to install a blood sugar analyte testing device on the skin surface. The smaller the size of the mounting unit, the more convenient it is for users to use, and the lower the manufacturing cost. Therefore, under the premise of being able to achieve the function of the mounting unit, the small size 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 when retracted, and the retraction stroke of the auxiliary needle is too long, which limits the overall height of the housing and is not conducive to the small size design of the mounting unit. In order to further miniaturize the mounting unit, in some technical solutions, the retraction stroke of the auxiliary needle is reduced, and the auxiliary needle does not completely enter the housing when retracted, but a part of the needle is exposed outside the housing, so a needle protection structure is needed to protect the exposed needle.

[0004] Therefore, the prior art needs a more compact and safe analyte testing device mounting unit. SUMMARY

[0005] The present application discloses a safe analyte testing device mounting unit. Before using the mounting unit, the inner cover is placed in the outer cover, the outer cover is assembled at the proximal end of the mounting unit, and the auxiliary needle is contained in the needle body containing cavity of the outer cover. After using the mounting unit, the auxiliary needle is not completely retracted into the housing to reduce the retraction stroke of the auxiliary needle module, and the inner cover is assembled at the proximal end of the mounting unit, and the auxiliary needle is contained in the needle body protection cavity of the inner cover to protect the auxiliary needle and avoid unnecessary harm, and the mounting unit can be further miniaturized.

[0006] The application provides an analyte detection device installation unit, comprising: a housing and a spring module, a trigger module, a parallel slider module, an auxiliary needle module and an analyte detection device pre-installed in the housing, the auxiliary needle module comprising an auxiliary needle, the auxiliary needle module being retracted after the installation unit is used, at least a part of the auxiliary needle being exposed outside the housing; and a protective cover releasably connected with the housing, the protective cover comprising an outer cover body and an inner cover body, the inner cover body being located in the outer cover body; the outer cover body comprising a needle body accommodating cavity for accommodating the auxiliary needle before the installation unit is used, the inner cover body comprising a needle body protection cavity for accommodating the auxiliary needle after the installation unit is used; wherein the needle body accommodating cavity and the needle body protection cavity share a central axis when the inner cover body is located in the outer cover body.

[0007] According to an aspect of the application, the outer cover body comprises an outer cover body recess, and the inner cover body is located in the outer cover body recess.

[0008] According to an aspect of the application, a label paper is further included, and the label paper is attached to a proximal end surface of the outer cover body.

[0009] According to an aspect of the application, the proximal end surface of the inner cover body further comprises at least two convex semicircular balls.

[0010] According to an aspect of the application, the convex semicircular balls are uniformly distributed on the proximal end surface of the inner cover body.

[0011] 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.

[0012] According to an aspect of the application, the inner cover body further comprises an assembly structure for establishing an assembly connection with the parallel slider module, the trigger module or the housing.

[0013] According to an aspect of the application, the assembly structure is one or more of a buckle, a clamping hook, a clamping block, a thread, a bolt, a magic tape and glue.

[0014] According to an aspect of the application, the inner cover body further comprises a positioning structure.

[0015] According to an aspect of the application, the length of the auxiliary needle exposed outside the housing is 0.1-5 mm.

[0016] Compared with the prior art, the technical scheme of the application has the following advantages:

[0017] The analyte detection device installation unit disclosed in the application is characterized in that before the installation unit is used, the auxiliary needle is accommodated in the needle body accommodating cavity of the outer cover body, after the installation unit is used, the auxiliary needle is not completely retracted into the shell, so that the retraction stroke of the auxiliary needle module is reduced, meanwhile, the inner cover body is assembled to the proximal end of the installation unit, and the auxiliary needle is accommodated in the needle body protection cavity of the inner cover body, so as to protect the auxiliary needle and avoid unnecessary injury, and the installation unit is further miniaturized.

[0018] 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, the transportation of the installation unit is facilitated, and the label paper can be torn off by the user to take out the inner cover body.

[0019] Further, the inner cover body is provided with a convex semicircular ball structure on the proximal end face, so as to avoid that the inner cover body is pasted with the label paper in a large area and affects the tearing of the label paper from the outer cover body, and the user experience is improved.

[0020] Further, after the installation unit is used, the inner cover body can be assembled and connected with the shell, the parallel sliding block module or the trigger module, and the structure is flexible and changeable according to the design requirement, preferably, the inner cover body is assembled and connected with the parallel sliding block module, and the proximal end face of the parallel sliding block module is large in area and easy to process and assemble.

[0021] Further, the inner cover body is further designed with a positioning structure, so as to facilitate the user to quickly find the relative position of the needle body protection cavity and the auxiliary needle when assembling the inner cover body, so that the auxiliary needle and the needle body protection cavity are on the same axis, the auxiliary needle can smoothly enter the needle body protection cavity, and the positioning of the assembly structure is also facilitated. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1 FIG. 1 is a schematic diagram of the external structure of the analyte detection device installation unit according to the embodiment of the application;

[0023] Figure 2a FIG. 2 is a schematic diagram of the external structure of the shell according to the embodiment of the application;

[0024] Figure 2b FIG. 3 is a schematic diagram of the structure of the protective cover according to the embodiment of the application;

[0025] Figure 3 FIG. 4 is a schematic diagram of the exploded structure of the analyte detection device installation unit according to the embodiment of the application;

[0026] Figure 4 FIG. 5 is a schematic diagram of the internal structure of the shell according to the embodiment of the application;

[0027] Figure 5a FIG. 6 is a schematic diagram of the structure of the distal end face of the parallel sliding block module according to the embodiment of the application;

[0028] Figure 5b Structure diagram of proximal end surface of parallel sliding block module according to embodiments of the present application;

[0029] Figure 6 Structure diagram of analyte detection device according to embodiments of the present application;

[0030] Figure 7 Structure diagram of auxiliary needle module according to embodiments of the present application;

[0031] Figure 8 Structure diagram of trigger module according to embodiments of the present application;

[0032] Figure 9 Top view of mounting unit according to embodiments of the present application;

[0033] Figure 10a Structure diagram of A cross section of Figure 9

[0034] Structure diagram of B cross section of Figure 10b Figure 9 Structure diagram of C cross section of

[0035] Figure 10c Figure 9

[0036] Figure 11 Bending diagram of first buckle under force according to embodiments of the present application;

[0037] Figure 12 Explosion structure diagram of mounting unit of analyte detection device according to embodiments of the present application;

[0038] Figure 13a Separation structure diagram of outer cover and inner cover according to embodiments of the present application;

[0039] Figure 13b Integrated structure diagram of outer cover and inner cover according to embodiments of the present application;

[0040] Figure 13c Structure diagram of outer cover according to embodiments of the present application;

[0041] Figure 14 Structure diagram of mounting unit after use according to embodiments of the present application;

[0042] Figure 15 Structure diagram of auxiliary needle after retraction of mounting unit according to embodiments of the present application;

[0043] Figures 16a-16c Structure diagram of inner cover as needle body protection structure according to embodiments of the present application; ​​​

[0044] Figure 17 A cross-sectional view of a mounting unit according to an embodiment of the present application;

[0045] Figures 18a-18c A schematic view of a protective sleeve as a needle protection structure according to an embodiment of the present application. DETAILED DESCRIPTION

[0046] As mentioned above, in order to make the mounting unit of the prior art analyte detection device more compact, a portion of the needle is exposed outside the housing when the auxiliary needle is retracted, which can cause unnecessary injury and cannot balance the compactness and safety of the mounting unit.

[0047] To solve the problem, the present application provides an analyte detection device mounting unit, before using the mounting unit, the inner cover is placed in the outer cover, the outer cover is assembled at the proximal end of the mounting unit, the auxiliary needle is contained in the needle containing cavity of the outer cover, after using the mounting unit, the auxiliary needle is not completely retracted into the housing, so as to reduce the retraction stroke of the auxiliary needle module, at the same time, the inner cover is assembled at the proximal end of the mounting unit, the auxiliary needle is contained in the needle protection cavity of the inner cover, so as to protect the auxiliary needle and avoid unnecessary injury, and the mounting unit can be more compact.

[0048] 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 of the components and steps, numerical expressions, and numerical values set forth in these embodiments are not to be construed as limiting the scope of the present application unless otherwise specifically stated.

[0049] In addition, it should be understood that the size of each component shown in the drawings is 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.

[0050] 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, its application, or uses. Techniques, methods, and apparatus known to those of ordinary skill in the art can not be discussed in detail herein, but should be understood to be part of the specification, where applicable.

[0051] It should be noted that like reference numerals and letters refer to like items in the following drawings, and therefore, once an item is defined or described in one drawing, it need not be further discussed in subsequent drawings.

[0052] First embodiment

[0053] Figure 1Figure 1 is a schematic diagram of the external structure of an analyte detection device installation unit according to an embodiment of the present application. The external structure of the installation unit 100 comprises a housing 101 and a protective cover 102, and the housing 101 is used to carry internal structural components. The installation unit 100 has a proximal end and a distal end when in use, with the proximal end being closer to the user's skin and the distal end being further away from the skin. A first opening is provided at the proximal end of the housing 101. The protective cover 102 is used to protect, seal and prevent triggering of the internal structure and internal structural components of the housing 101.

[0054] Housing exterior

[0055] Figure 2a Figure 2 is a schematic diagram of the external structure of a housing according to an embodiment of the present application, Figure 2b Figure 3 is a schematic diagram of the structure of a protective cover. The protective cover 102 comprises an outer cover body 1021, a clasp 1022 and an inner cover body 1023. The outer cover body 1021 is provided with a second opening at the distal end, and the second opening faces the first opening. At the second opening, the outer cover body 1021 is connected to the clasp 1022 by breakable columns 10211, which are distributed at regular intervals between the outer cover body 1021 and the clasp 1022. When the outer cover body 1021 is rotated relative to the clasp 1022, the columns 10211 can be broken, and the outer cover body 1021 and the clasp 1022 can be separated.

[0056] 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 together.

[0057] The inner side of the clasp 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 to the inner cover body 1023 by thread cooperation, and then connected to the housing 101 by the clasp 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.

[0058] In other embodiments of the present application, the outer cover body 1021 and the inner cover body 1023 can also be fixedly connected by friction fit or snap fit.

[0059] In other embodiments of the present application, the clasp 1022 and the housing 101 can also be connected by friction fit, snap fit or thread fit.

[0060] Housing interior

[0061] Figure 3An exploded structural schematic view of the analyte detection device mounting unit of the embodiment of the present application is shown in the figure, and the dashed lines represent the mounting and fitting relationship of the structural components. The internal structural 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, wherein the elastic module 107 includes a first elastic component 1071 and a second elastic component 1072.

[0062] Figure 4 An internal structural schematic view of the housing 101 of the embodiment of the present application is shown in the figure.

[0063] In the embodiment of the present application, at least two first buckles 1012 are arranged in the housing 101, and the first buckles 1012 are integrally formed with the housing 101 and protrude towards the proximal end of the housing 101. The first buckles 1012 are made of flexible material, and the distal ends thereof can be bent or curved outwards of the housing 101.

[0064] In the preferred embodiment of the present application, the number of the first buckles 1012 is two, and the first buckles 1012 are symmetrically distributed in the housing 101 with an angular interval of 180° therebetween.

[0065] In other preferred embodiments of the present application, the number of the first buckles 1012 is three or four, and the first buckles 1012 are symmetrically distributed in the housing 101 with an angular interval of 120° or 90° therebetween. The number of the first buckles 1012 can also be five or more, which is not limited herein.

[0066] 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 further arranged in the housing 101.

[0067] 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 the adjacent rib plates.

[0068] In other embodiments of the present application, the limiting grooves 1013 are grooves recessed in the inner wall of the housing 101.

[0069] 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 the figure, wherein the first clamping groove position 10141 is closer to the proximal end relative to the second clamping groove position 10142. Figure 10a

[0070] In the preferred embodiment of the present application, the number of the limiting grooves 1013 and the clamping grooves 1014 is two, and the limiting grooves 1013 and the clamping grooves 1014 are symmetrically distributed in the housing 101 with an angular interval of 180° therebetween.

[0071] ​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.

[0072] Parallel sliding block module

[0073] Figure 5a A structural schematic view of a distal end face of the parallel sliding block module 103, Figure 5b A structural schematic view of a proximal end face of the parallel sliding block module 103.

[0074] In the embodiments 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.

[0075] In the embodiments 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.

[0076] 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.

[0077] In the embodiments 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 which penetrates from the distal end face 1031 to the proximal end face 1034 of the parallel sliding block module.

[0078] In the preferred embodiments 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.

[0079] 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.

[0080] Continuing to refer to Figure 5aIn the embodiment of the present application, the side of the distal end face 1031 of the parallel sliding block 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°.

[0081] 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.

[0082] With reference to Figure 5b In the embodiment of the present application, the side of the proximal end face 1034 of the parallel sliding block 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 sliding block 10351 and a T-shaped structure buckle 10352, the T-shaped structure sliding block 10351 is directed to the outside of the parallel sliding block module 103 and protrudes from the outer ring of the parallel sliding block module 103; the T-shaped structure buckle 10352 is directed to the inside of the parallel sliding block module 103 and protrudes from the inner ring of the parallel sliding block module 103.

[0083] In the installation unit 100, the T-shaped structure sliding block 10351 is located in the limiting groove 1013 to limit the position of the parallel sliding block module 103 and prevent the parallel sliding block module 103 from rotating in the installation unit 100. The number and position of the T-shaped structure sliding block 10351 are consistent with the limiting groove 1013. During the sliding process of the parallel sliding block module 103 to the proximal end, the T-shaped structure sliding block 10351 slides in the limiting groove 1013.

[0084] In the 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.

[0085] 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.

[0086] Analyte detection device

[0087] Figure 6 The structure diagram of the analyte detection device in the embodiment of the present application is shown.

[0088] With reference to Figure 3In the embodiment of the present application, the analyte detection device 104 comprises a housing 1041, a transmitter (not shown in the figure), a sensor 1042, and an internal circuit (not shown in the figure) disposed in the housing 1041 and electrically coupled with 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.

[0089] 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 mounted on the skin surface of the user, and transmits signals to the external device 200 at a second frequency f2 after being mounted 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.

[0090] 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 mounted on the skin surface of the user, which can save the power consumption of the analyte detection device 104 before being mounted.

[0091] 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 in the figure) and an intracorporeal part (not shown in the figure), and the extracorporeal part, the transmitter, and the internal circuit are disposed in the internal space, and the extracorporeal part is electrically coupled with the internal circuit. The intracorporeal part is provided with electrodes, film layers, and other structures, and can be used to 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.

[0092] 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 in the figure) corresponding to the first through hole 10414 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.

[0093] 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.

[0094] Auxiliary needle module

[0095] Figure 7 The auxiliary needle module of the embodiment of the present application is shown in the structural diagram.

[0096] 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.

[0097] 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 towards the proximal end.

[0098] 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 is inserted into the user's subcutaneous tissue, the in-vivo part is also inserted 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.

[0099] 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.

[0100] 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.

[0101] Trigger module

[0102] Figure 8 The structure diagram of the trigger module of the embodiment of the present application.

[0103] 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 shell. 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.

[0104] 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 buckled 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. For a better understanding of the clamping ears 1062, reference is made to the clamping grooves 1014. Figure 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.

[0105] 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 adheres to the surface of the skin of a user when the installation unit 100 is used.

[0106] Elastic module

[0107] For a better understanding of the elastic module 107, reference is made to the elastic module 106. Figure 3 , the elastic module 107 includes a first elastic member 1071 and a second elastic member 1072.

[0108] In the embodiment of the present application, the first elastic member 1071 is located between the parallel sliding block module 103 and the shell 101, i.e., one end of the first elastic member 1071 is located on the distal end surface of the parallel sliding block module 103, and the other end is located in the shell 101. In the installation unit 100, the first elastic member 1071 is in a compressed state and can provide elastic force.

[0109] 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.

[0110] In the preferred embodiment of the present application, the first elastic member 1071 or the second elastic member 1072 is a metal spring.

[0111] In the embodiment of the present application, the inner diameter of the first elastic member 1071 is larger than the outer diameter of the circular groove 1032 and the auxiliary needle slider 10511, 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.

[0112] In the embodiment of the present application, the outer diameter of the second elastic member 1072 is larger than the outer diameter of the auxiliary needle fixed block 10512 and the inner diameter of the boss 10322, and 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.

[0113] Method for using the installation unit

[0114] Figure 9 It is a top view of the installation unit of the embodiment of the present application.

[0115] Figure 10a It is a schematic view of the A cross-sectional structure of Figure 9 Figure 10b It is a schematic view of the B cross-sectional structure of Figure 9 Figure 10c It is a schematic view of the C cross-sectional structure of Figure 9 Figure 11 It is a schematic view of the first buckle bending under stress.

[0116] For reference Figure 10a and Figure 10b ​​​In the embodiment of the present application, the card slot 1014 is provided with two card slot positions, a first card slot position 10141 and a second card slot position 10142. Before the installation unit 100 is used, the trigger module 106 is fixed on the shell 101 by the card ear 1062 and the snap of the first card slot position 10141, at this time, the fixed snap 1061 is in contact with the first snap 1012, preventing the first snap 1012 from bending or folding outwards of the shell 101, and the fixed snap 1061, the first snap 1012 and the second snap 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 snap 1033, the first snap 1012 and the fixed snap 1061 in sequence.

[0117] In the embodiment of the present application, the contact between the fixed snap 1061 and the first snap 1012 is one of point contact, line contact or surface contact, when the contact is surface contact, the extension line m1 of the contact surface converges at the proximal end, and this structure design can make the fixed snap 1061 slide towards the distal end relative to the first snap 1012.

[0118] In the preferred embodiment of the present application, the coupling surface between the second snap 1033 and the first snap 1012 is a plane, which forms a fixed angle with the horizontal plane, and the extension end m2 converges at the proximal end.

[0119] In combination with reference Figure 11 This structure design can make the second snap 1033 slide towards the proximal end relative to the first snap 1012, push the first snap 1012 outwards of the shell 101, and thus release the coupling state between the first snap 1012 and the second snap 1033.

[0120] In the embodiment of the present application, the first elastic member 1071 is in a compressed state, has elastic potential energy, and its own elastic force gives the parallel module slider 103 a pushing force Fr towards the proximal end, which acts on the first snap 1012 through the coupling surface between the second snap 1033 and the first snap 1012, and generates a component force Fsin perpendicular to the plane of the first snap 1012, which can push the first snap 1012 outwards of the shell 101 to bend or fold, and thus release the coupling state between the first snap 1012 and the second snap 1033.

[0121] In the embodiment of the present application, when the mounting unit 100 is used, the outer cover 1021 is rotated, the stand 10211 is broken, the protective cover 102 is separated from the shell 101, the proximal end of the mounting unit 100 is close to the skin of the user, until the outer ring 1063 of the trigger module 106 is attached to the surface of the skin, the user presses the shell 101 at the distal end, the shell 101 slides towards the skin, the trigger module 106 remains stationary, so that the trigger module 106 slides distally 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 clasp 1061 is no longer in contact with the first clasp 1012. The first clasp 1012 is bent or folded outwardly of the shell 101 due to the component force Fsin, and the coupling state of the first clasp 1012 and the second clasp 1033 is released.

[0122] In the embodiment of the present application, after the coupling state is released, the parallel slider module 103 continues to slide proximally under the elastic force of the first elastic member 1071, and drives the analyte detection device 104 to slide proximally until the lower outer shell 10413 of the analyte detection device 104 is in contact with the surface of the skin of the user.

[0123] Referring to Figure 10c In the embodiment of the present application, the slider clasp 10321 is clasp-connected with the auxiliary needle slider 10511, and when the first elastic member 1071 pushes the parallel slider module 103 to slide proximally, the auxiliary needle module 105 is driven to slide proximally together.

[0124] In the embodiment of the present application, the connection between the slider clasp 10321 and the auxiliary needle slider 10511 is a plane or an approximately plane, the plane 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 slider 10511 is towards the distal end, so that the auxiliary needle slider 10511 can push the slider clasp 10321 outwardly of the shell 101, so that the slider clasp 10321 is bent or folded, and the principle is equivalent to Figure 11 .

[0125] In the embodiment of the present application, in the installation unit 100, the side wall of the auxiliary needle limiting groove 1015 prevents the bending or buckling of the slider buckle 10321, and the buckle connection state of the slider buckle 10321 and the auxiliary needle slider 10511 does not change. With the sliding of the parallel slider module 103 and the auxiliary needle module 105 to the proximal end, until the slider buckle 10321 is separated from the auxiliary needle limiting groove 1015, the inner wall of the auxiliary needle limiting groove 1015 no longer prevents the bending or buckling of the slider buckle 10321, the second elastic member 1072 pushes the auxiliary needle slider 10511 to the distal end, and at the same time the auxiliary needle slider 10511 pushes the slider buckle 10321 to bend or buckle outward, the buckle connection of the slider buckle 10321 and the auxiliary needle slider 10511 is released, the second elastic member 1072 continues to push the auxiliary needle slider 10511 to slide to 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.

[0126] In the embodiment of the present application, when the slider buckle 10321 is separated from the auxiliary needle limiting groove 1015, the semi-enclosed needle body 10522 of the auxiliary needle pierces the user's subcutaneous tissue.

[0127] In the embodiment of the present application, in the installation unit 100, the T-shaped structure slider 10351 is located in the limiting groove 1013, and 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 and its sliding direction are perpendicular, so that the analyte detection device 104 arranged at the front end of the parallel slider 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.

[0128] In the embodiment of the present application, during the sliding of the parallel slider module 103 to 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, and 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 structure slider 10351 from continuing to slide to the proximal end, so the T-shaped structure slider 10351 bends or buckles around the vertical part, the buckle connection of the T-shaped structure buckle 10352 and the clamping 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 user's skin.

[0129] In the embodiment of the present application, when the T-shaped structure slider 10351 contacts the outer ring 1063, the parallel slider module 103 is at a predetermined position, at this time, the lower outer shell 10413 of the analyte detection device contacts the skin surface of the user.

[0130] In the embodiment of the present application, the auxiliary needle 1052 sequentially passes through the second through hole and the first through hole 10414, and penetrates the analyte detection device 104, and the semi-enclosed needle body 10522 of the auxiliary needle encloses the sensor 1042. During the sliding of the parallel slider module 103 and the auxiliary needle module 105 towards the proximal end, the semi-enclosed needle body 10522 carries the sensor 1042 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.

[0131] 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, and apply a proximal force F to the shell 101, so that the outer ring 1063 of the trigger module 106 contacts the skin surface of the user, and the skin of the user gives the outer ring 1063 a force F' opposite to the force F, thereby realizing 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 towards the proximal end.

[0132] 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 outer ring 1063 of the trigger module, and can prevent the installation action from being performed at an incorrect position due to accidental contact with the outer ring 1063, thereby preventing triggering.

[0133] The distal end 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 groove 10233, which can play a sealing role to prevent dust, particles and other contaminants from contacting the needle body and the sensor, thereby preventing pollution.

[0134] 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 to the skin surface of the user.

[0135] Second embodiment

[0136] 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 miniaturized 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 embodiments of the present application consider 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.

[0137] 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 embodiments of the needle body protection structure will be described in detail below.

[0138] In the embodiments of the present application, the technical solutions not described are considered the same as the foregoing embodiments, and will not be described here.

[0139] Figure 12 The exploded structural diagram of the analyte detection device installation unit of the embodiments of the present application is shown. Figure 13a The separation structural diagram of the outer cover body and the inner cover body of the embodiments of the present application is shown. Figure 13b The integrated structural diagram of the outer cover body and the inner cover body of the embodiments of the present application is shown. Figure 13c The structural diagram of the outer cover body of the embodiments of the present application is shown.

[0140] Referring to Figure 12 In some embodiments of the present application, the installation unit 200 includes a shell 201 and a protective cover 202. As described before, 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 Figure 17 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.

[0141] Referring to Figures 13a-13c In some embodiments of the present application, the protective cover 202 includes an outer cover body 2021, an inner cover body 2023, and a label paper 2024. According to the relative positional relationship shown in FIG. 13, before installation, the inner cover body 2023 is contained in the outer cover body cavity 20214, and the outer cover body cavity 20214 is sealed with the label paper 2024 to seal the inner cover body 2023 in the outer cover body cavity 20214.

[0142] In some embodiments of the present application, the inner cover 2023 is in a movable state or releasable connection state relative to the outer cover 2021. When the inner cover 2023 is in a movable state relative to the outer cover 2021, the outer cover 2021 has no restraining structure to limit the state of the inner cover 2023 in the outer cover 2021, and the user can directly take out the inner cover 2023 from the outer cover 2021 when needed. When the inner cover 2023 is in a releasable connection state relative to the outer cover 2021, the inner cover 2023 and the outer cover 2021 are fixed together by means of buckling, clamping, threading, magic tape, 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 inner cover 2023 and the outer cover 2021 are separated. In the preferred embodiment of the present application, in order to facilitate the user to use, before using the installation unit 200, the inner cover 2023 is in a movable state relative to the outer cover 2021, which is convenient for the user to take out the inner cover 2023 from the outer cover 2021 when using the installation unit 200.

[0143] In some embodiments of the present application, in order to be able to accommodate 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 0.5-5mm 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, so as to facilitate the label paper 2024 to be pasted on the proximal end face 20215 of the outer cover 2021, and to complete the sealing of the outer cover cavity 20214.

[0144] 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 recess 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 can exceed the contact area of the label paper 2024 and the outer cover 2021, causing the adhesive coating of the label paper 2024 to contact 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 can be broken and adhered 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 contact 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 can avoid the label paper 2024 being adhered to the proximal end surface 20232 of the inner cover 2023 in a large area, facilitating the user to tear off the label paper 2024.

[0145] 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.

[0146] 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 lot number, production date, usage instructions, communication connection SN code, trademark, two-dimensional code, and the like, can be printed on the label paper 2024.

[0147] 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 with a distal end opening. Figure 13a It can be seen that the distal end opening is a hollow circular cone or circular truncated cone with a distal end opening. When the needle accommodating cavity 20213 is a circular truncated cone structure, its diameter gradually decreases from the distal end to the proximal end. The inside 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.

[0148] Figure 14 Figure 6 is a schematic diagram of the installation unit after use in accordance with an embodiment of the present application.

[0149] Referring to Figure 14 In some embodiments of the present 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 relative to the trigger module 206 to the proximal end, and in the process of the shell 201 sliding relative to the trigger module 206 to the proximal end, 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 to the proximal end together, until the analyte detection device 204 is in contact with the skin surface, and the auxiliary needle 2052 penetrates into the subcutaneous tissue.

[0150] Referring to Figure 14 In some embodiments of the present application, in the process of the parallel slider module 203, the analyte detection device 204 and the auxiliary needle 2052 sliding to the proximal end in the direction shown, 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 end pushing force on the parallel slider module 203, the parallel slider module 203 continues to slide relative to the shell 201 to the proximal end, carrying the analyte detection device 204 and the auxiliary needle 2052, and the analyte detection device 204 located at the proximal end of the parallel slider module 203 extrudes 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 extrudes 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.

[0151] In some embodiments of the present application, in the process of the parallel slider module 203 continuing to slide relative to the shell 201 to the proximal end, due to the blockage of the skin surface, the position of the parallel slider module 203 no longer changes, if the elastic element 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 relative to the parallel slider module 203 to the distal end, 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 extrusion of the analyte detection device 204 and the parallel slider module 203.

[0152] In some embodiments of the present invention, as the parallel slider module 203 continues to slide proximally relative to the shell 201, the snap connection between the parallel slider module 203 and the analyte detection device 204 is decoupled. When the relative sliding of the parallel slider module 203 and the shell 201 is terminated, the parallel slider module 203 has been separated from the analyte detection device 204, while the parallel slider module 203 is still confined in the shell 201. At this time, the analyte detection device 204 is in a separated state relative to the shell 201, and the user can lift the shell 201 toward the distal end by hand, and the analyte detection device 204 is adhered to the skin surface with tape.

[0153] In some embodiments of the present invention, when the parallel slider module 203 slides proximally relative to the housing 201 to a first predetermined position, the auxiliary needle module 205 slides proximally relative to the housing to an end point. At this point, the auxiliary needle 2052 penetrates the subcutaneous tissue, and the internal portion of the sensor 2042 is delivered to a predetermined depth subcutaneously. The auxiliary needle module 205 then retracts and slides distally relative to the housing 201 to a second predetermined position.

[0154] Figure 15 This is a schematic diagram of the state where the auxiliary needle of the mounting unit is retracted according to an embodiment of the present invention.

[0155] Reference Figure 15 In some embodiments of the present invention, after the auxiliary needle module 205 slides distally to a second predetermined position, i.e., the end point of retraction, the auxiliary needle 2052 exits the subcutaneous space, making it easier for the user to remove the housing 201. After the auxiliary needle 2052 is retracted, the internal portion of the sensor 2042 remains subcutaneous.

[0156] In some embodiments of the present invention, after the auxiliary needle 2052 is retracted, a portion of the needle tip is exposed outside the housing 201, such as Figure 15 As shown, there is a height difference h2 between the tip of the auxiliary needle 2052 and the proximal end surface of the parallel slider module 203. That is, the length of the auxiliary needle 2052 exposed outside the housing 201 is h2, and the range of h2 is preferably 0.1 to 5 mm. If the exposed length of the auxiliary needle 2052 is too long, the needle tip may remain subcutaneous when retracted, potentially causing damage to the skin or body when the user removes the housing 201.

[0157] In some embodiments of the present invention, after the auxiliary needle 2052 is retracted, a portion of the needle tip is exposed outside the housing 201, rather than being completely retracted into the housing 201. This can reduce the retraction stroke of the auxiliary needle 2052, thereby reducing the overall height of the housing 201, making the installation unit 200 more compact and lighter in weight. At the same time, it can also reduce the material usage of the housing 201, thereby reducing the production cost of the installation unit 200. Figure 15In some embodiments of the present application, the auxiliary needle module 205 is shown in the state before and after the reduction of the retraction stroke, and the final position of the auxiliary needle module 205 after the retraction stroke is reduced. The position close to the distal end is the final position of the auxiliary needle module 205 before the reduction of the retraction stroke, and the position close to the proximal end is the final position of the auxiliary needle module 205 after the reduction of the retraction stroke.

[0158] 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 reduces the same retraction stroke. Referring to Figure 15 , the auxiliary needle module 205 reduces the retraction stroke by h3, and the overall height of the housing 201 can be reduced after the auxiliary needle module 205 reduces the retraction stroke. The overall height of the housing 201 reduced can be consistent with the retraction stroke reduced by the auxiliary needle module 205, which is h3.

[0159] 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. Therefore, after using the installation unit 200, a needle body protection structure is needed to protect the exposed needle tip.

[0160] Figures 16a-16c The figure shows the inner cover of the embodiment of the present application as a needle body protection structure.

[0161] In combination with the description of Figures 16a-16c and Figure 13c , in some embodiments of the present application, after using the installation unit 200, the user can take out 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.

[0162] 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 of the embodiment of the present application. The proximal end surface of the parallel slider module 203 has a larger area relative to the proximal end surface of the trigger module 206 or the housing 201, and is easier to process and assemble the structure.

[0163] In some embodiments of the present application, referring to the direction shown in Figure 16b , the needle body protection cavity 20233 is a hollow cavity open to the distal end, and the hollow cavity on the inner side 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 structure, which is not limited here. The inner side cavity can be the same or different shape structure as the outer side, and is preferably a cylinder or a cone, and more preferably a cone with a gradually decreasing inner diameter from the distal end to the proximal end.

[0164] 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 body 2023, that is, the auxiliary needle 20522 and the needle body protection cavity 20233 share the same center axis. Before the user assembles the outer cover body 2021 to the parallel slider module 203, the user needs to ensure that the distal end opening of the needle body protection cavity 20233 is aligned with the auxiliary needle 20522, so as to avoid misalignment between the needle body protection cavity 20233 and the auxiliary needle 20522.

[0165] In some embodiments of the present application, the inner cover body 2023 and the parallel slider module 203 are assembled by one or more of buckling, clamping, clamping block, thread, bolt, magic tape, glue, etc. Any assembly method that can assemble the inner cover body 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 body 2023 and the parallel slider module 203, and preferably, the assembly structures are symmetrically distributed on the inner cover body 2023 and the parallel slider module 203.

[0166] In some embodiments of the present application, the assembly structures can be interchanged on the inner cover body 2023 and the parallel slider module 203, for example, the clamping hook 20231 is provided on the distal end face of the inner cover body 2023, and the corresponding clamping hole 2037 is provided on the proximal end face of the parallel slider module 203, for establishing assembly connection with the clamping hook 20231. In another embodiment of the present application, the clamping hook 20231 can be provided on the parallel slider module 203, and the corresponding clamping hole 2037 is provided on the inner cover body 2023.

[0167] In some embodiments of the present application, in order to facilitate the user to assemble the inner cover body 2023 and increase the assembly firmness of the inner cover body 2023, a positioning structure is further provided on the inner cover body 2023 and the parallel slider module 203. The positioning structure is composed of a positioning column 20232 and a positioning hole 2036, and the positions and the number of the positioning column 20232 and the positioning hole 2036 on the inner cover body 2023 and the parallel slider module 203 correspond to each other.

[0168] In some embodiments of the present application, the positioning column 20232 can be located on the distal end face of the inner cover body 2023, and at this time, the positioning hole 2036 is located on the proximal end face of the parallel slider module 203. In another embodiment of the present application, the positioning hole 2036 can be located on the distal end face of the inner cover body 2023, and at this time, the positioning column 20232 is located on the proximal end face of the parallel slider module 203.

[0169] In some embodiments of the present application, the positioning structure is not limited to Figures 16a-16cThe combination of the positioning column 20232 and the positioning hole 2036 shown can also be other types of positioning structures, such as the combination of a slider and a sliding groove, and any structure involving positioning functions shall be included in the protection scope of the present application.

[0170] 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 to align 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 presses the inner cover 2023 and the shell 201 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 .

[0171] Figure 17 The cross-sectional structure diagram of the installation unit of the embodiments of the present application.

[0172] 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.

[0173] In some embodiments of the present application, the third elastic member 2072 is arranged in the shell 201, one end of which abuts against the inner side of the shell 201, and the other end of which faces 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, thereby limiting the retraction of the auxiliary needle module 205 to reduce the retraction stroke. If the third elastic member 2073 is not arranged, the auxiliary needle module 205 will slide to the farthest end inside the shell 201 until it abuts against the shell 201 when retracted. After the third elastic member 2073 is arranged, 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 can be adjusted.

[0174] 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 after the elastic forces of the second elastic member 2072 and the third elastic member 2073 are balanced.

[0175] In some embodiments of the present application, the initial state of the third elastic member 2073 is the normal state, i.e. not compressed or stretched, and the initial state of the second elastic member 2072 is the compressed state. After the elastic force of the second elastic member 2072 is released, the auxiliary needle module 205 is pushed by the second elastic member 2072 to the distal end until the auxiliary needle module 205 contacts the proximal end of the third elastic member 2073 and continues to slide to the distal end under the elastic force of the second elastic member 2072. The third elastic member 2073 is compressed and generates an elastic force under the elastic force of the second elastic member 2072 until the elastic force of the third elastic member 2073 is the same as that of the second elastic member 2072, and the auxiliary needle module 205 stops sliding to the distal end.

[0176] In some embodiments of the present application, the second elastic member 2072 and the third elastic member 2073 are springs, and their elastic modulus and initial length are pre-set before leaving the factory. When the elastic force of the third elastic member 2073 is the same as that of the second elastic member 2072 and the third elastic member 2073 is in the balanced state 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 shell 201 is determined.

[0177] In some embodiments of the present application, after the auxiliary needle module 205 stops sliding, the user takes the shell 201 away from 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 the protection function of the auxiliary needle 2052.

[0178] Figures 18a-18c The schematic view of the protective sleeve as the needle body protection structure in some embodiments of the present application is shown in FIG. 8.

[0179] For reference Figures 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, and the specific implementation will be described below.

[0180] by Figure 18b The illustrated orientation is for reference only. In some embodiments of the present invention, the elastic protective sleeve 20523 is a hollow, three-dimensional structure with a distal opening, which is used to accommodate the auxiliary needle 2052. The outer diameter of the auxiliary needle 2052 is set to d3, and the inner diameter of the distal opening of the elastic protective sleeve 20523 is set to d4. The inner diameter d4 is slightly larger than the outer diameter d3 of the auxiliary needle 2052, for example, 0.1 to 2 mm larger, to facilitate user alignment of the auxiliary needle 2052 and the distal opening of the elastic protective sleeve 20523. From the distal opening of the elastic protective sleeve 20523 toward the proximal end, its inner diameter gradually decreases until it reaches d5. The inner diameter d5 is slightly smaller than the outer diameter d3 of the auxiliary needle 2052, for example, by 0.1 to 2 mm. Because the material of the elastic protective sleeve 20523 is elastic, the inner diameter d5 is slightly smaller than the outer diameter d3 of the auxiliary needle 2052. This creates an interference fit between the elastic protective sleeve 20523 and the auxiliary needle 2052, increasing the friction between the auxiliary needle 2052 and the elastic protective sleeve 20523. This allows the elastic protective sleeve 20523 to be fixed relative to the auxiliary needle 2052 after being positioned over the auxiliary needle 2052, preventing it from falling off. That is, the dimensions of the elastic protective sleeve 20523 and the auxiliary needle 2052 are numerically such that d4>d3>d5. The proximal end of the elastic protective sleeve 20523 can be open or closed, and its overall length should be no less than the length h2 of the auxiliary needle 2052 exposed outside the housing 201, for example, 0.1 to 20 mm, so that the elastic protective sleeve 20523 can completely cover the exposed needle tip and protect the auxiliary needle 2052. Preferably, the proximal end of the elastic protective sleeve 20523 is closed to prevent the needle tip of the auxiliary needle 2052 from being exposed from the proximal end of the elastic protective sleeve 20523.

[0181] In some embodiments of the present invention, before the user uses the installation unit 200, the elastic protective cover 20523 can be a structural component independent of the installation unit 200. After using the installation unit 200, the user puts the elastic protective cover 20523 on the auxiliary needle 2052 to form a whole with the installation unit 200.

[0182] In some embodiments of the present invention, since the elastic protective sleeve 20523 needs to have a certain degree of elasticity to achieve an interference fit with the auxiliary needle 2052, the elastic protective sleeve 20523 can be made of elastic materials such as silicone and rubber. Any change in the material of the elastic protective sleeve 20523 is within the scope of protection of the present invention.

[0183] In some embodiments of the present invention, the elastic protective cover 20523 may not be limited to the above and Figures 18a-18c The straight strip structure shown can also be other three-dimensional structures, such as a sphere, a cone, or other irregular three-dimensional structures. Any shape change of the elastic protective cover 20523 should be included in the protection scope of the present invention.

[0184] In summary, the embodiment of the present application discloses a safe analyte detection device mounting unit, before using the mounting unit, the inner cover is placed in the outer cover, the outer cover is assembled at the proximal end of the mounting unit, the auxiliary needle is accommodated in the needle body accommodating cavity of the outer cover, after using the mounting unit, the auxiliary needle is not completely retracted into the shell, so as to reduce the retraction stroke of the auxiliary needle module, and meanwhile, the inner cover is assembled at the proximal end of the mounting unit, the auxiliary needle is accommodated in the needle body protection cavity of the inner cover, so as to protect the auxiliary needle and avoid unnecessary injury, and the mounting unit can be further miniaturized.

[0185] Although some specific embodiments of the present application have been described in detail by examples, those skilled in the art should understand that the above examples are only for illustration, but 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

1. An analyte detection device installation unit, characterized in that: include: a housing and an elastic module, a trigger module, a parallel slider module, an auxiliary needle module, and an analyte detection device pre-installed in the housing, wherein the elastic module includes a first elastic member, a second elastic member, and a third elastic member; before using the installation unit, the first elastic member and the second elastic member are in a compressed state, and the third elastic member is in a normal state; the auxiliary needle module includes an auxiliary needle; after using the installation unit, the second elastic member pushes the auxiliary needle module to retract, and the auxiliary needle module abuts against the third elastic member and compresses the third elastic member until the second elastic member and the third elastic member reach a balanced state, at which point at least a portion of the auxiliary needle is exposed outside the housing to reduce the retraction stroke of the auxiliary needle module, thereby reducing the overall height of the housing; and a protective cover releasably connected to the housing, the protective cover comprising an outer cover and an inner cover, the inner cover being located within the outer cover; The outer cover comprises a needle accommodating cavity for accommodating the auxiliary needle before the mounting unit is used, and the inner cover comprises a needle protection cavity for accommodating the auxiliary needle after the mounting unit is used; wherein, the retraction stroke of the auxiliary needle module is adjusted according to the elastic modulus and initial length of the second elastic member and the third elastic member, thereby adjusting the length of the auxiliary needle exposed outside the housing; Wherein, when the inner cover is located in the outer cover, the needle accommodating cavity and the needle protection cavity share a central axis.

2. The analyte detection device installation unit according to claim 1, characterized in that: The outer cover comprises an outer cover cavity, and the inner cover is located in the outer cover cavity.

3. The analyte detection device installation unit according to claim 2, characterized in that: It also includes label paper, which is pasted on the proximal end surface of the outer cover.

4. The analyte detection device installation unit according to claim 3, characterized in that: The proximal surface of the inner cover body also includes at least two raised semicircular balls.

5. The analyte detection device installation unit according to claim 4, characterized in that: The raised semicircular spheres are evenly distributed on the proximal surface of the inner cover body.

6. The analyte detection device installation unit according to claim 1, characterized in that: The needle accommodating cavity comprises a hollow structure, and the inner diameter of the hollow structure of the needle accommodating cavity decreases from the distal end to the proximal end.

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

8. The analyte detection device installation unit according to claim 7, characterized in that: The assembly structure is one or more of a buckle, a hook, a block, a thread, a bolt, a Velcro, and glue.

9. The analyte detection device installation unit according to claim 7, characterized in that: The inner cover also includes a positioning structure.

10. The analyte detection device installation unit according to claim 1, characterized in that: The length of the auxiliary needle exposed outside the shell is 0.1-5 mm.

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