Analyte detection device mounting unit and method of use thereof

Abstract

The application discloses an analyte detection device installation unit and a use method thereof. The analyte detection device installation unit comprises a shell, the shell comprising at least two first buckles; a parallel slider module provided with a second buckle corresponding to the first buckle, the first buckle being coupled with the second buckle; an analyte detection device arranged at the front end of the parallel slider module, the analyte detection device comprising an outer shell, an emitter, a sensor and an internal circuit arranged in the outer shell and electrically coupled with the sensor; an auxiliary needle module releasably connected with the parallel slider module and used for puncturing the sensor into the subcutaneous tissue of a user; a trigger module, when moving distally relative to the shell, uncoupling the first buckle and the second buckle to implement an installation action; and an elastic module used for providing an elastic force required for implementing the installation action. When a user uses the installation unit, only needs to adhere the proximal end of the installation unit to the skin surface and press the shell at the distal end, so that the installation of the analyte detection device is completed, and the structure is simple and the use is convenient.

Description

Technical Field

[0001] This invention relates primarily to the field of medical devices, and in particular to an analytical substance detection device mounting unit and its usage method. Background Technology

[0002] In a healthy person, the pancreas automatically detects the glucose level in the blood and secretes the necessary insulin / glucagon. However, in diabetic patients, the pancreas malfunctions and cannot secrete the required insulin. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic function, and it is a lifelong condition. Currently, medical technology cannot cure diabetes; it can only control the occurrence and development of diabetes and its complications by stabilizing blood sugar levels.

[0003] Diabetic patients need to have their blood glucose levels checked before injecting insulin. Currently, most methods can continuously monitor blood glucose and transmit the data in real time to an external device for user viewing; this method is called Continuous Glucose Monitoring (CGM). This method requires a device to be attached to the skin surface, with its sensor penetrating the subcutaneous tissue fluid to complete the measurement. However, current analyte detection devices have complex installation units, cumbersome installation processes, and high production costs, which also makes them inconvenient for users.

[0004] Therefore, there is an urgent need for an analytical analyte detection device installation unit that is simple in structure and easy for users to use. Summary of the Invention

[0005] This invention discloses an analyte detection device mounting unit and its usage method. Before installation, a first latch on the housing is coupled to a second latch on the parallel slider module. The analyte detection device is located at the front end of the parallel slider module. An auxiliary needle module is releasably connected to the parallel slider module. An elastic module provides the elastic force required for the installation action. When the user presses the housing, the trigger module moves distally relative to the housing, thereby releasing the coupling between the first and second latches and performing the installation action. The analyte detection device is installed on the user's skin surface, and the sensor is simultaneously inserted subcutaneously. The analyte detection device mounting unit has a simple structure, is easy to use, and has low production costs.

[0006] The first aspect of the present invention provides an analyte detection device mounting unit, comprising: a housing, the housing including at least two first latches; a parallel slider module, provided with second latches corresponding to the first latches, the second latches being coupled to the first latches; an analyte detection device disposed at the front end of the parallel slider module, the analyte detection device including a housing, an emitter, a sensor, and an internal circuit disposed within the housing and electrically coupled to the sensor; an auxiliary needle module, releasably connected to the parallel slider module, for inserting the sensor subcutaneously into the user; a trigger module, which, when moving distally relative to the housing, releases the coupling between the first latches and the second latches to perform the installation action; and an elastic module for providing the elastic force required to perform the installation action.

[0007] According to one aspect of the invention, the first snap-fit ​​is bendable outward from the housing, and when bent, the first snap-fit ​​is decoupled from the second snap-fit.

[0008] According to one aspect of the invention, the trigger module includes a fixing buckle corresponding to the first buckle, the fixing buckle contacting the first buckle and preventing the first buckle from bending outwards from the housing.

[0009] According to one aspect of the invention, when the trigger module moves distally relative to the housing, the retaining clip cancels contact with the first clip.

[0010] According to one aspect of the invention, the first latch, the second latch, and the fixing latch are located on the same horizontal plane.

[0011] According to one aspect of the invention, the contact between the fixing buckle and the first buckle is one of point contact, line contact, or surface contact.

[0012] According to one aspect of the invention, when the contact between the fixing buckle and the first buckle is a surface contact, the contact surface forms a fixed angle with the horizontal plane and converges at the proximal end.

[0013] According to one aspect of the invention, the coupling point between the first snap and the second snap is a plane.

[0014] According to one aspect of the invention, the plane forms a fixed angle with the horizontal plane and converges at the proximal end.

[0015] According to one aspect of the invention, the first snaps are distributed on the housing at equal angular intervals.

[0016] According to one aspect of the invention, there are two first snaps, which are distributed on the housing at 180° intervals.

[0017] According to one aspect of the invention, during the installation action, the elastic module pushes the parallel slider module and the auxiliary pin module to move proximally.

[0018] According to one aspect of the invention, after the auxiliary needle module moves proximally to a predetermined position, the parallel slider module is disconnected from the auxiliary needle module, and the elastic module pushes the auxiliary needle module back to its initial position.

[0019] According to one aspect of the invention, the front end of the analyte detection device further includes adhesive tape for securing the analyte detection device to the user's skin surface.

[0020] Accordingly, the present invention also discloses a method for using an analyte detection device mounting unit, providing a mounting unit including a housing, a parallel slider module, an auxiliary needle module, an analyte detection device, a trigger module, and an elastic module; the housing includes at least two first latches; the parallel slider module is provided with a second latch corresponding to the first latches, the second latch being coupled to the first latches; the analyte detection device is disposed at the front end of the parallel slider module, the analyte detection device including a housing, an emitter, a sensor, and an internal circuit disposed within the housing and electrically coupled to the sensor; the auxiliary needle module is releasably connected to the parallel slider module for inserting the sensor subcutaneously into the user's skin; the trigger module is positioned relative to the housing. When moving distally, the coupling between the first and second latches is released to perform the installation action; the elastic module provides the elastic force required to perform the installation action; the proximal end of the analyte detection device installation unit is placed against the user's skin surface; the user presses the housing distally, triggering the module to move distally relative to the housing, releasing the coupling between the first and second latches; the elastic module pushes the parallel slider module and the auxiliary needle module proximally to install the analyte detection device on the user's skin surface, while the sensor pierces the user's subcutaneous tissue; the parallel slider module and the auxiliary needle module are disconnected, and the elastic module pushes the auxiliary needle module back to its initial position; the remaining components of the analyte detection device installation unit are removed.

[0021] According to one aspect of the invention, the first snap-fit ​​is bendable outward from the housing, and when bent, the first snap-fit ​​is decoupled from the second snap-fit;

[0022] According to one aspect of the invention, the trigger module includes a fixing buckle corresponding to the first buckle, the fixing buckle contacting the first buckle and preventing the first buckle from bending outwards from the housing.

[0023] According to one aspect of the invention, when the trigger module moves distally relative to the housing, the retaining clip cancels contact with the first clip.

[0024] According to one aspect of the invention, the first latch, the second latch, and the fixing latch are located on the same horizontal plane.

[0025] According to one aspect of the invention, the contact between the fixing buckle and the first buckle is one of point contact, line contact, or surface contact.

[0026] According to one aspect of the invention, when the contact between the fixing buckle and the first buckle is a surface contact, the contact surface forms a fixed angle with the horizontal plane and converges at the proximal end.

[0027] According to one aspect of the invention, the coupling point between the first snap and the second snap is a plane.

[0028] According to one aspect of the invention, the plane forms a fixed angle with the horizontal plane and converges at the proximal end.

[0029] According to one aspect of the invention, the first snaps are distributed on the housing at equal angular intervals.

[0030] According to one aspect of the invention, there are two first snaps, which are distributed on the housing at 180° intervals.

[0031] According to one aspect of the invention, the front end of the analyte detection device further includes adhesive tape for securing the analyte detection device to the user's skin surface.

[0032] Compared with the prior art, the technical solution of the present invention has the following advantages:

[0033] In the analyte detection device installation unit disclosed in this invention, a first latch on the housing is coupled to a second latch on the parallel slider module. The analyte detection device is positioned at the front end of the parallel slider module. An auxiliary needle module is releasably connected to the parallel slider module. When the trigger module moves distally relative to the housing, it releases the coupling between the first and second latches, thereby performing the installation action. An elastic module provides the elastic force required to perform the installation action. During the entire installation process, the user only needs to place the installation unit on the skin surface and press the housing proximally to install the analyte detection device onto the skin surface, while the sensor is simultaneously inserted subcutaneously. The analyte detection device installation unit has a simple structure, is easy to use, and has low production costs.

[0034] Furthermore, the coupling surfaces of the first and second snap fasteners are planar and form a fixed angle with the horizontal plane, converging at the near end. The elastic force of the elastic module on the parallel slider module toward the near end generates a component toward the outside of the housing through the coupling surface of the second and first snap fasteners, allowing the first snap fastener to bend toward the outside of the housing, thereby canceling the coupling between the first and second snap fasteners. The structure is simple.

[0035] Furthermore, the fixing buckle on the trigger module contacts the first buckle, preventing the first buckle from bending outwards from the housing. Therefore, it also prevents the parallel slider module from moving towards the proximal end. When the trigger module moves towards the distal end relative to the housing, the fixing buckle cancels its contact with the first buckle, the first buckle bends outwards from the housing, canceling its coupling with the second buckle. The parallel slider module and the auxiliary pin module move towards the proximal end under the elastic force of the elastic module, performing the installation action. The structure is simple.

[0036] Furthermore, the first buckles are distributed on the housing at equal angular intervals, and correspondingly, the second buckles are distributed on the parallel slider module at equal angular intervals, and the fixing buckles are distributed on the trigger module at equal angular intervals. During use, each module is subjected to uniform force and has good consistency in movement direction, which improves the reliability of the installation unit.

[0037] Furthermore, after the auxiliary needle module moves to the predetermined position proximally, its connection with the parallel slider module is released, and the elastic module pushes the auxiliary needle module back to the initial position, making it convenient to use.

[0038] Accordingly, according to the method of using the analyte detection device installation unit disclosed in this invention, after the installation unit is attached to the user's skin surface, the user presses the housing at the distal end, triggering the module to move distally relative to the housing, releasing the coupling between the first and second latches. The elastic module then pushes the parallel slider module and the auxiliary needle module proximally to install the analyte detection device on the user's skin surface, while the sensor is inserted subcutaneously. Subsequently, the parallel slider module and the auxiliary needle module are disconnected, and the elastic module pushes the auxiliary needle module back to its initial position. The process is simple and enhances the user experience. Attached Figure Description

[0039] Figure 1 This is a schematic diagram of the external structure of the analyte detection device mounting unit according to an embodiment of the present invention;

[0040] Figure 2a This is a schematic diagram of the external structure of the housing according to an embodiment of the present invention;

[0041] Figure 2b This is a schematic diagram of the structure of the protective cover according to an embodiment of the present invention;

[0042] Figure 3 This is an exploded structural diagram of the analytical substance detection device mounting unit according to an embodiment of the present invention;

[0043] Figure 4 This is a schematic diagram of the internal structure of the housing according to an embodiment of the present invention;

[0044] Figure 5a This is a schematic diagram of the structure of the distal end face of the parallel slider module according to an embodiment of the present invention;

[0045] Figure 5b This is a schematic diagram of the near-end face of the parallel slider module according to an embodiment of the present invention;

[0046] Figure 6 This is a schematic diagram of the analyte detection device according to an embodiment of the present invention;

[0047] Figure 7 This is a schematic diagram of the auxiliary needle module according to an embodiment of the present invention;

[0048] Figure 8 This is a schematic diagram of the trigger module according to an embodiment of the present invention;

[0049] Figure 9 This is a top view of the mounting unit according to an embodiment of the present invention;

[0050] Figure 10a for Figure 9 A schematic diagram of the cross-sectional structure at section A;

[0051] Figure 10b for Figure 9 A schematic diagram of the B-section structure;

[0052] Figure 10c for Figure 9 A schematic diagram of the C-section structure;

[0053] Figure 11 This is a schematic diagram of the first buckle being bent under force according to an embodiment of the present invention. Detailed Implementation

[0054] As mentioned above, the existing analytical analyte detection devices have complex installation unit structures, high production costs, are inconvenient to use, and provide a poor user experience.

[0055] To address this issue, the present invention provides an analyte detection device mounting unit. In use, the user attaches the mounting unit to the skin surface, presses the housing at the distal end to release the coupling of the clip, and the analyte detection device is then installed on the user's skin surface, while the sensor is inserted subcutaneously.

[0056] Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that, unless specifically stated otherwise, 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 invention.

[0057] Furthermore, it should be understood that, for ease of description, the dimensions of the various components shown in the accompanying drawings are not necessarily drawn to actual scale; for example, the thickness, width, length, or distance of some units may be enlarged relative to other structures.

[0058] The following description of exemplary embodiments is merely illustrative and is not intended to limit the invention or its application or use in any way. Techniques, methods, and apparatus known to those skilled in the art may not be discussed in detail herein, but where applicable, such techniques, methods, and apparatus should be considered part of this specification.

[0059] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined or described in a figure, it will not need to be discussed further in the subsequent description of the figures.

[0060] Figure 1 This is a schematic diagram of the external structure of the analyte detection device mounting unit according to an embodiment of the present invention. The external structure of the mounting unit 100 includes a housing 101 and a protective cover 102. The housing 101 is used to support the internal structural components. In use, the end of the mounting unit 100 closest to the user's skin is the proximal end, and the end furthest from the skin is the distal end. A first opening is provided at the proximal end of the housing 101. The protective cover 102 is used to protect, seal, and prevent triggering of the internal structure and internal structural components of the housing 101.

[0061] External casing

[0062] Figure 2a This is a schematic diagram of the external structure of the housing according to an embodiment of the present invention. Figure 2b This is a schematic diagram of the protective cover. The protective cover 102 includes an outer cover body 1021, a clamp 1022, and an inner cover body 1023. A second opening is provided at the distal end of the outer cover body 1021, facing the first opening. Through the second opening, the outer cover body 1021 and the clamp 1022 are connected by breakable posts 10211, which are distributed at certain intervals between the outer cover body 1021 and the clamp 1022. When the outer cover body 1021 rotates relative to the clamp 1022, the posts 10211 can be broken, separating the outer cover body 1021 from the clamp 1022.

[0063] The inner side of the outer cover 1021 is provided with an internal thread 10212, and the outer side of the inner cover 1023 is provided with an external thread 10231. The internal thread 10212 and the external thread 10231 can be connected to connect the outer cover 1021 and the inner cover 1023 together and keep them fixed.

[0064] The inner side of the clamp 1022 is provided with a protrusion 10221, and correspondingly, the outer side of the housing 101 is provided with a groove 1011. The groove 1011 surrounds the outer side of the housing to form a circumference, and the protrusion 10221 can be embedded in the groove 1011. The outer cover 1021 is first fixed to the inner cover 1023 by threaded engagement, and then connected to the housing 101 by the clamp 1022. The outer cover 1021 and the inner cover 1023 can protect, seal and prevent triggering of the internal structure of the housing 101. The anti-triggering function will be further explained below.

[0065] In other embodiments of the present invention, the outer cover 1021 and the inner cover 1023 may also be fixedly connected by friction engagement or snap-fit ​​engagement.

[0066] In other embodiments of the present invention, the clamp 1022 and the housing 101 can also be connected by friction fit, snap fit or threaded fit.

[0067] Inside the shell

[0068] Figure 3 This is an exploded structural diagram of the analytical substance detection device mounting unit according to an embodiment of the present invention. The dashed lines in the diagram indicate the installation and fitting relationships of the various structural components. The internal structural components of the analytical substance detection device mounting unit 100 include a parallel slider module 103, an analytical substance detection device 104, an auxiliary needle module 105, a trigger module 106, and an elastic module 107. The elastic module 107 includes a first elastic element 1071 and a second elastic element 1072.

[0069] Figure 4 This is a schematic diagram of the internal structure of the housing 101 in an embodiment of the present invention.

[0070] In this embodiment of the invention, at least two first buckles 1012 are provided inside the housing 101. The first buckles 1012 are integrally formed with the housing 101 and protrude towards the proximal end of the housing 101. The first buckles 1012 are made of flexible material, and their ends can be bent or folded outward from the housing 101.

[0071] In a preferred embodiment of the present invention, there are two first buckles 1012, which are symmetrically distributed inside the housing 101 and are spaced 180° apart from each other.

[0072] In other preferred embodiments of the present invention, the number of first buckles 1012 is three or four, symmetrically distributed inside the housing 101, with an angular interval of 120° or 90° between them. The number of first buckles 1012 may also be five or more, and is not limited herein.

[0073] In this embodiment of the invention, the housing 101 is further provided with at least two limiting grooves 1013, at least two card slots 1014 and an auxiliary pin limiting groove 1015.

[0074] In this embodiment of the invention, the limiting groove 1013 includes at least two ribs protruding from the inner wall of the housing 101. In a preferred embodiment of the invention, the ribs are parallel to each other, and a groove is formed between adjacent ribs.

[0075] In other embodiments of the present invention, the limiting groove 1013 is a groove recessed into the inner wall of the housing 101.

[0076] In this embodiment of the invention, the card slot 1014 includes two card slot positions, namely a first card slot position 10141 and a second card slot position 10142, as follows: Figure 10a As shown, the first card slot 10141 is closer to the proximal end than the second card slot 10142.

[0077] In a preferred embodiment of the present invention, there are two limiting grooves 1013 and two card slots 1014, which are symmetrically distributed inside the housing 101 and are spaced 180° apart from each other.

[0078] In other preferred embodiments of the present invention, the number of limiting grooves 1013 and slots 1014 is three or four, symmetrically distributed inside the housing 101, with an angular interval of 120° or 90° between them. The number of limiting grooves 1013 and slots 1014 may also be five or more, which is not limited here.

[0079] Parallel slider module

[0080] Figure 5a This is a structural schematic diagram of the distal end face of the parallel slider module 103. Figure 5b This is a structural schematic diagram of the near end face of the parallel slider module 103.

[0081] In this embodiment of the invention, the distal end face 1031 of the parallel slider module 103 is provided with a circular groove 1032 protruding distally. The circular groove 1032 is a hollowed-out cylindrical structure with an inner diameter of d1. At least two slider latches 10321 extend distally from the sidewall of the circular groove 1032. The latching part of the slider latch 10321 is a plane or approximately a plane and forms a fixed angle with the horizontal plane. Its extended ends m0 converge at the distal end.

[0082] In this embodiment of the invention, the slider buckle 10321 is made of flexible material, so it can be bent or folded to the outside of the circular groove 1032.

[0083] In other embodiments of the present invention, the slider buckle 10321 can be directly disposed on the far end face of the parallel slider module 103 without the need for a circular groove structure.

[0084] In this embodiment of the invention, a boss 10322 is provided at one end of the circular groove 1032 near the distal end face 1031. The boss 10322 is a hollowed-out cylindrical structure with an inner diameter of d2, where d1 > d2. The hollowed-out circular groove 1032 and the boss 10322 form a through hole 10323, which extends from the distal end face 1031 of the parallel slider module to the proximal end face 1034.

[0085] In a preferred embodiment of the present invention, there are two slider buckles 10321, which are symmetrically distributed on the side wall of the circular groove 1032, and the angle between the two slider buckles 10321 is 180°.

[0086] In other preferred embodiments of the present invention, the number of slider latches 10321 can be three or four, symmetrically distributed on the sidewall of the circular groove 1032, and the angular interval between the slider latches 10321 is 120° or 90°. The number of slider latches 10321 can also be five or more, which is not limited here.

[0087] Continue to refer to Figure 5a In this embodiment of the invention, at least two second buckles 1033 are provided on the side of the distal end face 1031 of the parallel slider module 103. The second buckles 1033 are symmetrically distributed on the side of the distal end face 1031, and the angle interval between them is 180°.

[0088] In other embodiments of the present invention, the number of second snap-fits 1033 is three or four, symmetrically distributed on the side of the distal end face 1031, with an angular interval of 120° or 90° between them. The number of second snap-fits 1033 may also be five or more, without limitation. In the mounting unit 100, the second snap-fits 1033 are coupled to the first snap-fits 1012. The position and number of the second snap-fits 1033 are consistent with those of the first snap-fits 1012.

[0089] Reference Figure 5b In this embodiment of the invention, at least two T-shaped structures 1035 are provided on the side of the proximal end face 1034 of the parallel slider module 103. The vertical part of the T-shaped structure 1035 is connected to the proximal end face 1034, and the horizontal part includes a T-shaped structure slider 10351 and a T-shaped structure buckle 10352. The T-shaped structure slider 10351 faces the outside of the parallel slider module 103 and protrudes from the outer ring of the parallel slider module 103; the T-shaped structure buckle 10352 faces the inside of the parallel slider module 103 and protrudes from the inner ring of the parallel slider module 103.

[0090] In the mounting unit 100, the T-shaped slider 10351 is located within the limiting groove 1013 to restrict the position of the parallel slider module 103 and prevent the parallel slider module 103 from rotating within the mounting unit 100. The number and position of the T-shaped sliders 10351 are consistent with the limiting groove 1013. During the movement of the parallel slider module 103 towards its proximal end, the T-shaped sliders 10351 slide within the limiting groove 1013.

[0091] In a preferred embodiment of the present invention, the vertical part of the T-shaped structure 1035 is made of flexible material, the vertical part and the horizontal part are integrally formed, and the horizontal part can be bent or flexed around the vertical part.

[0092] In other preferred embodiments of the present invention, the vertical part of the T-shaped structure 1035 is made of an elastic material, such as a spring or a sheet, and the horizontal part is fixedly connected to the vertical part by welding or hot melting processes. The horizontal part can also be bent or flexed around the vertical part.

[0093] Analyte detection device

[0094] Figure 6 This is a schematic diagram of the analyte detection device according to an embodiment of the present invention.

[0095] Combined with reference Figure 3 In this embodiment of the invention, the analyte detection device 104 includes a housing 1041, a transmitter (not shown), a sensor 1042, and an internal circuit (not shown) disposed within the housing 1041 and electrically coupled to the sensor. The sensor 1042 is used to detect the analyte parameter information of the user's bodily fluids, and transmits the analyte parameter information to the transmitter through the internal circuit, and then the transmitter sends it to the external device 200.

[0096] In a preferred embodiment of the present invention, before the analyte detection device 104 is installed on the user's skin surface, a signal is transmitted to the external device 200 at a first frequency f1. After installation on the user's skin surface, a signal is transmitted to the external device 200 at a second frequency f2, wherein the second frequency f2 is greater than the first frequency f1. In a further preferred embodiment of the present invention, the first frequency f1 is 0 to 12 times / hour, and the second frequency f2 is 12 to 3600 times / hour.

[0097] In a more preferred embodiment of the present invention, the first frequency f1 is 0 times / hour, that is, before the analyte detection device 104 is installed on the user's skin surface, no signal is transmitted to the external device 200, which can save the power consumption of the analyte detection device 104 before installation.

[0098] In this embodiment of the invention, the outer shell 1041 includes an upper outer shell 10411 and a lower outer shell 10413, which are joined together to form an internal space. The sensor 1042 includes an external part (not shown in the figure) and an internal part (not shown in the figure). The external part, the transmitter, and the internal circuit are disposed in the internal space, and the external part is electrically coupled to the internal circuit. The internal part is provided with electrodes, membranes, and other structures, and can detect analyte parameters by inserting it under the user's skin. When the internal part is inserted under the skin, a correct angle is required, such as perpendicular to the skin surface. After the analyte detection device 104 reaches the end of its lifespan, it is removed from the user's skin surface and discarded as a whole.

[0099] In this embodiment of the invention, the lower outer shell 10413 includes a through first through hole 10414, and correspondingly, on the axis of the first through hole 10414, the upper outer shell 10411 includes a through second through hole (not shown in the figure), and the inner part passes through the first through hole 10414 to the outside of the outer shell so as to be inserted under the user's skin.

[0100] In this embodiment of the invention, the side of the upper outer shell 10411 includes a locking hole 10412 corresponding to the T-shaped structure buckle 10352. Here, "corresponding" means that the position and number of the locking holes 10412 are consistent with the T-shaped structure buckle 10352. In the mounting unit 100, the upper outer shell 10411 is fitted with the proximal end face 1034, and the T-shaped structure buckle 10352 and the locking hole 10412 form a snap-fit ​​connection, and the analyte detection device 104 is fixed on the parallel slider module 103. When the horizontal part of the T-shaped structure bends or flexes around the vertical part, the snap-fit ​​connection between the T-shaped structure buckle 10352 and the locking hole 10412 is released, and the analyte detection device 104 is separated from the parallel slider module 103. Therefore, in the mounting unit 100, the analyte detection device 104 and the parallel slider module 103 are releasable connections.

[0101] Auxiliary needle module

[0102] Figure 7 This is a schematic diagram of the auxiliary needle module according to an embodiment of the present invention.

[0103] In this embodiment of the invention, the auxiliary needle module 105 includes an auxiliary needle fixing structure 1051 and an auxiliary needle 1052. In the mounting unit 100, the auxiliary needle fixing structure 1051 is located at the distal end, and the auxiliary needle 1052 is located at the proximal end.

[0104] In this embodiment of the invention, the auxiliary needle fixing structure 1051 includes an auxiliary needle slider 10511 and an auxiliary needle fixing block 10512. The diameter or width of the auxiliary needle slider 10511 is greater than the diameter or width of the auxiliary needle fixing block 10512, forming a convex surface 10513 facing the proximal end.

[0105] In this embodiment of the invention, the auxiliary needle 1052 includes a fully enclosed needle body 10521 and a semi-enclosed needle body 10522. The fully enclosed needle body 10521 is located between the auxiliary needle fixing block 10512 and the semi-enclosed needle body 10522, and is fixedly connected to the auxiliary needle fixing block 10512. The hollow structure of the semi-enclosed needle body 10522 can be used to accommodate the internal part of the sensor 1042. When the semi-enclosed needle body 10522 is inserted into the user's subcutaneous tissue, the internal part can be inserted into the subcutaneous tissue along with it, and the state of the internal part under the skin is not affected when the needle body is retracted.

[0106] In other embodiments of the present invention, the auxiliary needle 1052 only includes a semi-enclosed needle body 10522, that is, the semi-enclosed needle body 10522 is fixedly connected to the auxiliary needle fixing block 10512. This can reduce the material used in the auxiliary needle 1052 and save costs, but at the same time, it also reduces the rigidity of the auxiliary needle 1052.

[0107] In the mounting unit 100, the auxiliary needle 1052 passes through the second through hole and the first through hole 10414 in sequence, thereby penetrating the analyte detection device 104, and the body part of the sensor 1042 is located in the semi-enclosed needle body 10522.

[0108] Trigger module

[0109] Figure 8 This is a schematic diagram of the trigger module in an embodiment of the present invention.

[0110] In this embodiment of the invention, the trigger module 106 is provided with at least two fixing buckles 1061 corresponding to the first buckle 1012. In the mounting unit 100, the fixing buckles 1061 contact the first buckle 1012 to prevent the first buckle 1012 from bending or folding outwards from the housing. The contact between the fixing buckles 1061 and the first buckle 1012 can be point contact, line contact, or surface contact. When the contact is surface contact, the contact surfaces of the fixing buckles 1061 and the first buckle 1012 form a fixed angle with the horizontal plane and converge at the near end of the mounting unit 100. The number and position of the fixing buckles 1061 are the same as those of the first buckle 1012.

[0111] In this embodiment of the invention, the trigger module 106 is further provided with at least two latches 1062. In the mounting unit 100, the latches 1062 engage with the slots 1014 to secure the trigger module 106. The number and position of the latches 1062 are consistent with those of the slots 1014. (Refer to reference...) Figure 10a Before the installation unit 100 is used, the ear 1062 is located in the first slot 10141, at which time the fixing buckle 1061 is in contact with the first buckle 1012.

[0112] In this embodiment of the invention, the trigger module 106 further includes an outer ring 1063, which connects the aforementioned fixing buckle 1061 and ear 1062 into a whole. In the installation unit 100, the outer ring 1063 is closer to the proximal end relative to the ear 1062, located at the first opening and protruding from the first opening. When using the installation unit 100, the outer ring 1063 fits against the user's skin surface.

[0113] Elastic module

[0114] Reference Figure 3 The elastic module 107 includes a first elastic element 1071 and a second elastic element 1072.

[0115] In this embodiment of the invention, the first elastic element 1071 is located between the parallel slider module 103 and the housing 101, that is, one end of the first elastic element 1071 is located on the far end face of the parallel slider module 103, and the other end is located inside the housing 101. In the mounting unit 100, the first elastic element 1071 is in a compressed state and can provide elastic force.

[0116] In this embodiment of the invention, the second elastic element 1072 is located between the parallel slider module 103 and the auxiliary needle module 105. That is, one end of the second elastic element 1072 is located on the boss 10322 of the parallel slider module 103, and the other end is located on the convex surface 10513 of the auxiliary needle module 105. In the mounting unit 100, the second elastic element 1072 is in a compressed state and can provide elastic force.

[0117] In a preferred embodiment of the present invention, the first elastic element 1071 or the second elastic element 1072 is a metal spring.

[0118] In this embodiment of the invention, the inner diameter of the first elastic member 1071 is larger than the outer diameter of the circular groove 1032 and the auxiliary needle slider 10511. In the mounting unit 100, the first elastic member 1071 surrounds the auxiliary needle slider 10511 and the outer side of the circular groove 1032, which can make full use of the internal space of the mounting unit 100.

[0119] In this embodiment of the invention, the outer diameter of the second elastic member 1072 is larger than the outer diameter of the auxiliary needle fixing block 10512 and the inner diameter of the boss 10322, but smaller than the outer diameter of the auxiliary needle slider 10511 and the inner diameter of the circular groove 1032. Therefore, one end of the second elastic member 1072 is placed in the circular groove 1032, and the other end surrounds the outside of the auxiliary needle fixing block 10512, so that the internal space of the mounting unit 100 can be fully utilized.

[0120] How to use the installation unit

[0121] Figure 9 This is a top view of the installation unit in an embodiment of the present invention.

[0122] Figure 10a for Figure 9 A schematic diagram of the cross-sectional structure at section A; Figure 10b for Figure 9 A schematic diagram of the B-section structure; Figure 10c for Figure 9 A schematic diagram of the C-section structure; Figure 11 This is a schematic diagram of the first buckle bending under stress.

[0123] Combined with reference Figure 10a and Figure 10bIn this embodiment of the invention, the card slot 1014 is provided with two card slot positions: a first card slot position 10141 and a second card slot position 10142. Before the installation unit 100 is used, the trigger module 106 is fixed to the housing 101 by the latch of the first card slot position 10141 through the latch ear 1062. At this time, the fixing latch 1061 is in contact with the first latch 1012, preventing the first latch 1012 from bending or folding outward from the housing 101. The fixing latch 1061, the first latch 1012, and the second latch 1033 are located on the same horizontal line. In a preferred embodiment of the invention, from the inside to the outside of the housing 101, the sequence is the second latch 1033, the first latch 1012, and the fixing latch 1061.

[0124] In this embodiment of the invention, the contact between the fixed buckle 1061 and the first buckle 1012 is one of point contact, line contact or surface contact. When the contact is surface contact, the extension lines m1 of the contact surfaces converge at the proximal end. This structural design allows the fixed buckle 1061 to move towards the distal end relative to the first buckle 1012.

[0125] In a preferred embodiment of the present invention, the coupling surface between the second buckle 1033 and the first buckle 1012 is a plane, which forms a fixed angle with the horizontal plane, and its extended end m2 converges at the proximal end.

[0126] Combined with reference Figure 11 This structural design allows the second latch 1033 to move towards the proximal end relative to the first latch 1012, thereby pushing the first latch 1012 away from the outer side of the housing 101 and releasing the coupling between the first latch 1012 and the second latch 1033.

[0127] In this embodiment of the invention, the first elastic element 1071 is in a compressed state and has elastic potential energy. Its own elastic force gives the parallel module slider 103 a pushing force Fr towards the proximal end. The pushing force Fr acts on the first buckle 1012 through the coupling surface of the second buckle 1033 and the first buckle 1012, and generates a component force Fsin perpendicular to the plane of the first buckle 1012. This component force Fsin can push the first buckle 1012 outward of the housing 101 and bend or fold it, thereby releasing the coupling state between the first buckle 1012 and the second buckle 1033.

[0128] In this embodiment of the invention, when using the installation unit 100, the outer cover 1021 is rotated to break the column 10211, and the protective cover 102 is separated from the housing 101. The proximal end of the installation unit 100 is brought close to the user's skin until the outer ring 1063 of the trigger module 106 is attached to the skin surface. The user presses the housing 101 at the distal end, and the housing 101 moves toward the skin. The trigger module 106 remains stationary, so the trigger module 106 moves distally relative to the housing 101. The ear 1062 disengages from the first slot 10141 and enters the second slot 10142. At the same time, the fixing buckle 1061 no longer contacts the first buckle 1012. The first buckle 1012 bends or folds outward toward the housing 101 due to the component force Fsin, and the coupling state between the first buckle 1012 and the second buckle 1033 is released.

[0129] In this embodiment of the invention, after the coupling is released, the parallel slider module 103 continues to move towards the proximal end under the elastic force of the first elastic element 1071, while simultaneously driving the analyte detection device 104 to move towards the proximal end until the lower outer shell 10413 of the analyte detection device 104 contacts the user's skin surface.

[0130] Reference Figure 10c In this embodiment of the invention, the slider buckle 10321 is buckled to the auxiliary needle slider 10511. When the first elastic element 1071 pushes the parallel slider module 103 to move towards the proximal end, it drives the auxiliary needle module 105 to move towards the proximal end as well.

[0131] In this embodiment of the invention, the connection between the slider latch 10321 and the auxiliary needle slider 10511 is a plane or approximately a plane, which forms a fixed angle with the horizontal plane, and its extension line m3 converges at the distal end. The pushing force of the second elastic element 1072 on the auxiliary needle slider 10511 is directed towards the distal end, so the auxiliary needle slider 10511 can push the slider latch 10321 outward from the housing 101, causing the slider latch 10321 to bend or fold. The principle is equivalent to... Figure 11 .

[0132] In this embodiment of the invention, in the mounting unit 100, the side wall of the auxiliary needle limiting groove 1015 prevents the slider buckle 10321 from bending or twisting, and the buckle connection state between the slider buckle 10321 and the auxiliary needle slider 10511 remains unchanged. As the parallel slider module 103 and the auxiliary needle module 105 move towards the proximal end, until the slider latch 10321 disengages from the auxiliary needle limiting groove 1015, the inner wall of the auxiliary needle limiting groove 1015 no longer prevents the slider latch 10321 from bending or folding. The second elastic element 1072 pushes the auxiliary needle slider 10511 towards the distal end, while the auxiliary needle slider 10511 pushes the slider latch 10321 to bend or fold outward. The latching connection between the slider latch 10321 and the auxiliary needle slider 10511 is released. The second elastic element 1072 continues to push the auxiliary needle slider 10511 towards the distal end. Finally, the auxiliary needle module 105 returns to its initial position, and the auxiliary needle 1052 retracts into the housing 101 to prevent the auxiliary needle 1052 from being exposed outside the housing 101 and to avoid unnecessary damage.

[0133] In this embodiment of the invention, when the slider buckle 10321 disengages from the auxiliary needle limiting groove 1015, the auxiliary needle semi-enclosed needle body 10522 pierces the user's subcutaneous tissue.

[0134] In this embodiment of the invention, in the installation unit 100, the T-shaped slider 10351 is located in the limiting groove 1013. The limiting groove 1013 restricts the position and direction of the parallel slider module 103 through the T-shaped slider 10351 to ensure that the parallel slider module 103 remains perpendicular to its sliding direction. This ensures that the analyte detection device 104 located at the front end of the parallel slider module 103 remains perpendicular to its movement direction, while the auxiliary needle 1052 remains parallel to its movement direction. This allows the auxiliary needle 1052 and the sensor body portion it envelops to pierce the user's subcutaneous tissue at a vertical angle, reducing the user's pain.

[0135] In this embodiment of the invention, during the sliding process of the parallel slider module 103 towards the proximal end, the T-shaped slider 10351 slides within the limiting groove 1013 until it contacts the outer ring 1063 of the trigger module 106. Under the push of the first elastic member 1071, the parallel slider module 103 continues to move towards the proximal end, while the outer ring 1063 blocks the T-shaped slider 10351 from continuing to move towards the proximal end. Therefore, the T-shaped slider 10351 bends or folds around the vertical part, the snap-fit ​​connection between the T-shaped buckle 10352 and the buckle hole 10412 is released, and the analyte detection device 104 is disengaged from the parallel slider module 103, so that it can be installed on the user's skin surface.

[0136] In this embodiment of the invention, when the T-shaped slider 10351 contacts the outer ring 1063, the parallel slider module 103 is in a predetermined position. At this time, the lower outer shell 10413 of the analyte detection device contacts the user's skin surface.

[0137] In this embodiment of the invention, the auxiliary needle 1052 passes sequentially through the second through hole and the first through hole 10414, and penetrates the analyte detection device 104. Simultaneously, the auxiliary needle's semi-enclosed needle body 10522 surrounds the sensor 1042. During the proximal movement of the parallel slider module 103 and the auxiliary needle module 105, the semi-enclosed needle body 10522 carries the sensor 1042 subcutaneously. After the auxiliary needle 1052 retracts, the internal portion of the sensor 1042 remains subcutaneously, and the retraction of the needle body does not affect the state of the internal portion of the sensor 1042.

[0138] In this embodiment of the invention, during installation, the user needs to press the housing 101 at the distal end, applying a force F towards the proximal end to the housing 101. The outer ring 1063 of the trigger module 106 contacts the user's skin surface, and the user's skin applies a force F' to the outer ring 1063 in the opposite direction to the force F, thereby achieving relative movement between the trigger module 106 and the housing 101. During actual installation, the absolute position of the trigger module 106 remains unchanged, while the housing 101 moves towards the proximal end.

[0139] Before installation, to prevent the trigger module 106 from moving relative to the housing 101, a protective cover 102 is installed at the near end of the housing 101. The protective cover 102 surrounds the outer ring 1063 of the trigger module, which can prevent the installation from being performed in the wrong position due to accidental contact with the outer ring 1063, and plays a role in preventing triggering.

[0140] The distal end face 10232 of the inner cover 1023 contacts the analyte detection device 104. At the same time, the auxiliary needle 1052 and the sensor 1042 extend into the groove 10233 of the inner cover, which can play a sealing role to prevent external dust, particles and other dirt from contacting the needle and sensor and causing contamination.

[0141] In this embodiment of the invention, 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 user's skin surface.

[0142] In summary, this invention discloses an analyte detection device installation unit and its usage method. The first latch of the housing is coupled to the second latch of the parallel slider module. When the trigger module moves to the distal end relative to the housing, the coupling between the first and second latches can be released, and the installation action can be performed. When using the installation unit, the user only needs to place the proximal end of the installation unit against the skin surface and press the housing at the distal end to realize the installation of the analyte detection device. The installation unit has a simple structure, is easy to use, and enhances the user experience.

[0143] While specific embodiments of the invention have been described in detail by way of examples, those skilled in the art should understand that the above examples are for illustrative purposes only and are not intended to limit the scope of the invention. Those skilled in the art should understand that modifications can be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.

Claims

1. An analyte detection device mounting unit, characterized in that, include: A housing, the housing comprising at least two first latches; A parallel slider module, wherein the parallel slider module is provided with a second buckle corresponding to the first buckle, and the second buckle is coupled to the first buckle; An analyte detection device is disposed at the front end of the parallel slider module. The analyte detection device includes a housing, an emitter, a sensor, and an internal circuit disposed within the housing and electrically coupled to the sensor. An auxiliary needle module, which is releasably connected to the parallel slider module, is used to insert the sensor under the user's skin. The trigger module, when moving distally relative to the housing, releases the coupling between the first latch and the second latch to perform the installation action; and An elastic module, wherein the elastic module is used to provide the elastic force required to perform the installation action; The first buckle can be bent outwards from the housing. When bent, the first buckle is decoupled from the second buckle. The triggering module includes a fixing buckle corresponding to the first buckle. The fixing buckle contacts the first buckle and prevents the first buckle from bending outwards from the housing.

2. The analyte detection device mounting unit according to claim 1, characterized in that, When the trigger module moves to the distal end relative to the housing, the fixing buckle cancels contact with the first buckle.

3. The analyte detection device mounting unit according to claim 1, characterized in that, The first buckle, the second buckle, and the fixing buckle are located on the same horizontal plane.

4. The analyte detection device mounting unit according to claim 1, characterized in that, The contact between the fixing buckle and the first buckle is one of point contact, line contact, or surface contact.

5. The analyte detection device mounting unit according to claim 4, characterized in that, When the contact between the fixing buckle and the first buckle is a surface contact, the contact surface forms a fixed angle with the horizontal plane and converges at the near end.

6. The analyte detection device mounting unit according to claim 1, characterized in that, The coupling point between the first buckle and the second buckle is a plane.

7. The analyte detection device mounting unit according to claim 6, characterized in that, The plane forms a fixed angle with the horizontal plane and converges at the near end.

8. The analyte detection device mounting unit according to claim 1, characterized in that, The first buckles are distributed on the housing at equal angular intervals.

9. The analyte detection device mounting unit according to claim 8, characterized in that, The first buckle has two parts, which are distributed on the housing at 180° intervals.

10. The analyte detection device mounting unit according to claim 1, characterized in that, During the installation process, the elastic module pushes the parallel slider module and the auxiliary needle module toward the proximal end.

11. The analyte detection device mounting unit according to claim 10, characterized in that, After the auxiliary needle module moves to a predetermined position proximally, the parallel slider module is disconnected from the auxiliary needle module, and the elastic module pushes the auxiliary needle module back to its initial position.

12. The analyte detection device mounting unit according to claim 1, characterized in that, The front end of the analyte detection device also includes adhesive tape, which is used to fix the analyte detection device to the user's skin surface.

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