CN115770306A

CN115770306A - Continuous blood glucose monitor sterilization assembly and sterilization method

Info

Publication number: CN115770306A
Application number: CN202211555748.9A
Authority: CN
Inventors: 杨凯洪; 张亚南; 支佳佳; 周华龙; 蒲继瑞; 陈�峰; 孙博珍; 施逸琪; 华昊
Original assignee: Jiangsu Yuekai Biotechnology Co ltd; Zhejiang Poctech Corp; Jiangsu Yuyue Kailite Biotechnology Co ltd
Current assignee: Jiangsu Yuekai Biotechnology Co ltd; Zhejiang Poctech Corp; Jiangsu Yuyue Kailite Biotechnology Co ltd
Priority date: 2022-12-06
Filing date: 2022-12-06
Publication date: 2023-03-10
Also published as: WO2024119564A1

Abstract

The application discloses continuous blood sugar monitor sterilization assembly and sterilization method, sterilization assembly includes sensor and skin fixing base, still includes housing and connecting seat, the skin fixing base is equipped with the through-hole, housing and skin fixing base lower part cooperation form the closed cavity, sensor one end is fixed with the skin fixing base, the other end downwardly extending gets into the closed cavity behind the through-hole of skin fixing base, be equipped with skin fixing base installation cavity in the connecting seat, the connecting seat still is equipped with the installing port that is used for installing sensor electronic unit in the skin fixing base. In this application is fixed in the connecting seat with the skin fixing base, the housing forms closed cavity with the cooperation of skin fixing base, and the sensor can be installed on the skin fixing base with the components of a whole that can function independently with sensor electronic unit to can realize sterilizing step by step, carry out the sterilization of independent mode respectively to sensor and sensor electronic unit, make different sterilization medium to sensor and sensor electronic unit mutual noninterference, improve the sterilization effect.

Description

Continuous blood glucose monitor sterilization assembly and sterilization method

Technical Field

The application belongs to the technical field of medical equipment, and particularly relates to a sterilization component and a sterilization method for a continuous blood glucose monitor.

Background

A biosensor is an instrument that is sensitive to a bioactive substance and converts the sensed concentration of the bioactive substance into an electrical signal for detection. Among them, the glucose sensor is a common biosensor. CGM (continuous blood glucose monitoring) is a technical means of indirectly reflecting blood glucose levels by continuously monitoring the glucose concentration of subcutaneous interstitial fluid through a glucose sensor. The CGM product needs a puncture needle and a sensor pin to puncture the skin of a human body when testing blood sugar, generates electrochemical reaction with subcutaneous tissue fluid through biological enzyme on the sensor, converts the electrochemical reaction into an electric signal, and provides the electric signal for a user through converting the electric signal into a blood sugar value. Because the product has a part which punctures the skin of a human body, the product needs to be sterilized before leaving a factory, and the infection risk of a user caused by pathogenic bacteria on the product is avoided.

The monitoring assembly generally comprises a sensor and an electronic unit (emitter), different sterilization modes are often required for the sensor and the electronic unit (emitter), the emitter part is generally sterilized by gas, for example, ethylene oxide gas is used for sterilization, and since the biological enzyme on the sensor can chemically react with gases such as ethylene oxide and the like, the activity of the biological enzyme is influenced, the monitoring accuracy is further influenced, the sensor cannot be sterilized by the gas sterilization mode, and then radiation sterilization is selected. Meanwhile, radiation sterilization easily affects the circuit of the emitter, so that the sensor and the emitter need to be sterilized separately.

In the prior art, before sterilization, the monitoring assembly is often assembled, and then two different sterilization modes are respectively performed, in the sterilization process, because radiation sterilization and gas sterilization are respectively performed by using radiation and gas, the radiation and the gas are often difficult to be effectively isolated, so that circuits of biological enzymes and emitters on the sensor can be damaged in different degrees; or the sensor and the emitter are sterilized separately, and when the device is to be used, a user manually installs the emitter to enable the emitter to be electrically connected with the sensor, so that the operation complexity of the user is increased.

In addition, the CGM product has a high sterilization requirement for the components (such as the skin fixing seat, the half-wall needle, etc.) of which the front end is in direct contact with the skin, and a low sterilization requirement for the boosting assembly, etc. of which the rear end is in direct contact with the skin, but in the prior art, the CGM product is often assembled and then sterilized in the whole machine, which not only results in poor sterilization effect for the components at the front end, but also results in a large whole machine body and high sterilization cost.

Therefore, how to effectively sterilize the front end part of the CGM product and ensure that the sensor and the emitter are not affected in the two sterilization modes becomes a technical problem to be solved in the field.

Disclosure of Invention

The present application provides a continuous blood glucose monitor sterilization assembly and method to address at least one of the above-mentioned technical problems.

The technical scheme adopted by the application is as follows:

the utility model provides a last blood sugar monitor sterilization subassembly, includes sensor and skin fixing base, still includes housing and connecting seat, and the skin fixing base is equipped with the through-hole, and the housing cooperates and forms sealed cavity with skin fixing base lower part, and sensor one end is fixed with the skin fixing base, and the other end downwardly extending gets into sealed cavity behind the through-hole of skin fixing base, is equipped with skin fixing base installation cavity in the connecting seat, and the connecting seat still is equipped with the installing port that is used for installing sensor electronic unit in the skin fixing base.

The outer side of the connecting seat and/or the inner side of the housing are/is also provided with clamping positions so as to clamp and fix the housing and the connecting seat.

The sterilization assembly further comprises a needle assisting assembly, and the connecting seat is further provided with a clamping and hooking part so as to connect the connecting seat and the needle assisting assembly.

The sterilization assembly further comprises a puncture assembly, the puncture assembly comprises a needle body and a needle seat, the needle body extends downwards to enter the closed cavity after passing through the through hole, and the sensor is at least partially nested inside the needle body.

The connecting seat and/or the needle seat are/is provided with a first sealing part capable of sealing the through hole.

The housing comprises an outer housing and an inner housing which are sleeved, the inner housing is arranged at the lower part of the skin fixing seat, and a second sealing part is arranged between the inner housing and the skin fixing seat.

At least part of the area of the outer shell surrounds the periphery of the connecting seat, one of the outer shell and the connecting seat is provided with a fixing bulge, the other one is provided with a clamping position, and the clamping position is provided with a guide section and a locking section which are mutually connected so as to enable the outer shell and the connecting seat to be clamped in a rotating mode.

The side wall of the connecting seat is provided with a plurality of elastic rib positions, and the housing abuts against the elastic rib positions so that the elastic rib positions move towards the skin fixing seat to clamp the skin fixing seat in the state that the housing is fixed on the connecting seat.

Still be provided with the support column in the shell, the support column can with skin fixing base below butt.

The sterilization assembly also includes a sensor electronics unit, the sensor including a coupling portion located within the mounting port, the coupling portion provided with a first contact, the sensor electronics unit having a second contact, the first contact and the second contact capable of coupling.

The present application also discloses a sterilization method for a continuous blood glucose monitor, comprising the steps of: carrying out first sterilization treatment on a first sterilization unit, wherein the first sterilization unit comprises a housing, a connecting seat and a puncture assembly, a sensor and a skin fixing seat are installed in an installation cavity formed by the connecting seat, the connecting seat is also provided with an installation opening, the skin fixing seat is matched with the housing to form a closed cavity, the skin fixing seat is provided with a through hole, one end of the sensor is fixed with the skin fixing seat, the other end of the sensor extends downwards into the closed cavity after passing through the through hole, at least part of the puncture assembly extends downwards into the closed cavity after passing through the through hole, and at least part of the sensor is nested in the puncture assembly; and carrying out second sterilization treatment on the second sterilization unit, wherein the second sterilization unit comprises a first sterilization unit and a sensor electronic unit, and the sensor electronic unit is arranged on the skin fixing seat through a mounting port.

The second sterilization unit also comprises an assistant needle assembly which is connected with the connecting seat.

Due to the adoption of the technical scheme, the beneficial effects obtained by the application are as follows:

1. in this application was fixed in the connecting seat with the skin fixing base, the housing formed closed cavity with the cooperation of skin fixing base, and the connecting seat is provided with the installing port for sensor and sensor electronic unit can the components of a whole that can function independently install on the skin fixing base, thereby can realize the substep sterilization. During specific operation, the sensor can be fixed on the skin fixing seat firstly, the sensor is subjected to radiation sterilization, and at the moment, the sensor electronic unit is not installed on the skin fixing seat, so that the radiation does not influence the circuit of the sensor. Then be fixed in the connecting seat with the housing, the housing forms closed cavity with the cooperation of skin fixing base this moment, the contact pilotage of sensor is located closed cavity, and closed cavity and external environment are isolated, install sensor electronic unit to skin fixing base through the installing port this moment, then carry out gaseous sterilization to sensor electronic unit, because the contact pilotage of sensor is located closed cavity this moment, gaseous unable entering closed cavity, consequently also can not lead to the fact the influence to the biological enzyme on the sensor contact pilotage.

In addition, spare parts such as skin fixing base, sensor that this application will have higher sterilization requirement are connected through the connecting seat and are an subassembly, and when the sterilization, only need send this subassembly into the sterilization room and disinfect, and need not to monitor back end part sterilization to the volume of sterilization subassembly has been reduced greatly, has practiced thrift the sterilization cost. The sterilization efficiency and effect are improved.

2. As a preferred embodiment of the present application, the outer side of the connecting base and/or the inner side of the casing are further provided with a clamping position to clamp and fix the casing and the connecting base. The housing not only can enclose the one end of sensor in closed cavity with the cooperation of skin fixing base, provides an aseptic environment for it, but also can form the support to the skin fixing base, makes the skin fixing base more firm, prevents that the skin fixing base from just taking place to drop before implanting. In addition, the housing can also play a limiting role in moving parts inside the monitor, so that the moving parts can be limited and cannot move when the housing is not detached, the function of preventing mistaken touch is realized, a user detaches the housing before using, meanwhile, the moving parts in the monitor complete unlocking, and the use reliability is improved. Simultaneously, the fixed mode of joint for the dismantlement of housing is simple and convenient more, reduces the operation degree of difficulty, improves and uses experience.

3. As a preferred embodiment of the present application, at least a partial region of the outer casing surrounds the periphery of the connecting seat, one of the outer casing and the connecting seat is provided with a fixing protrusion, and the other is provided with a clamping position, and the clamping position has a guiding section and a locking section which are connected with each other, so that the outer casing and the connecting seat are rotatably clamped. In actual use, the whole volume of the CGM product tends to be miniaturized, so that the force application of a user is facilitated in a rotation control mode, and the use convenience is improved.

4. As a preferred embodiment of the present application, the side wall of the connecting seat is provided with a plurality of elastic rib positions, and the housing abuts against the elastic rib positions so that the elastic rib positions move towards the skin fixing seat to clamp the skin fixing seat when the housing is fixed on the connecting seat. The partial region of housing encircles the periphery at the skin fixing base, when the housing is not dismantled, under the effect of supporting of housing, the elastic rib position of connecting seat is the inward movement respectively, thereby form the extrusion to the skin fixing base, it is fixed with skin fixing base chucking, improve the connection stability of skin fixing base, prevent to drop, when the user implants the operation, pull down the housing, elastic rib position loses the extrusion and resets this moment, outside expansion promptly, loosen the skin fixing base, the skin fixing base can lie in the adhesive force effect of human skin and break away from the connecting seat down this moment, stay on the skin surface. This application when dismantling the housing, realizes the unblock to the skin fixing base, further simplifies the operating procedure, improves and uses experience.

5. The application also discloses a sterilization method for lasting blood glucose monitor to divide into two sterilization units with the subassembly that disinfects, carry out the sterilization of two kinds of different modes to two sterilization units in proper order, in first sterilization unit, only install the sensor to the skin fixing base, and sensor electronic unit does not install, carries out radiation sterilization to first sterilization unit this moment, sterilizes the sensor, because sensor electronic unit does not install to the skin fixing base, consequently does not make its circuit receive the influence of radiation sterilization naturally. After the first sterilization unit is sterilized, the contact pin of the sensor is sealed in the sealed cavity, the cavity is isolated from the outside, then the sensor electronic unit is installed on the skin fixing seat, the second step of sterilization is carried out at the moment, for example, gas sterilization is carried out, and gas can not enter due to the isolation of the sealed cavity, so that the influence on biological enzymes on the contact pin of the sensor is caused. Therefore, the sensor and the sensor electronic unit are installed step by step and sterilized step by step, so that the sterilization effect is greatly improved, the adverse effects of different sterilization modes on the sensor and the sensor electronic unit are greatly avoided, the yield and the monitoring accuracy of the monitor are improved, and the product performance is ensured.

Drawings

The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the application and together with the description serve to explain the application and not to limit the application. In the drawings:

FIG. 1 is a schematic view of a sterilization assembly according to one embodiment of the present disclosure;

FIG. 2 is a schematic diagram of a sterilization assembly according to another embodiment of the present disclosure;

FIG. 3 is a cross-sectional view of the sterilization assembly of FIG. 2;

FIG. 4 is a schematic view of a skin anchor according to an embodiment of the present application;

FIG. 5 is a schematic view of a skin anchor according to another embodiment of the present application;

FIG. 6 is a schematic view of an internal structure of a skin anchor according to an embodiment of the present application;

FIG. 7 is a schematic view of the internal structure of a skin anchor according to another embodiment of the present application;

FIG. 8 is a bottom view of the skin anchor according to one embodiment of the present application;

FIG. 9 is a bottom view of a skin anchor according to another embodiment of the present application;

FIG. 10 is a schematic view of the housing according to an embodiment of the present application;

FIG. 11 is a schematic view of the construction of a housing according to another embodiment of the present application;

fig. 12 is a schematic structural diagram of a connection seat according to an embodiment of the present application;

fig. 13 is a schematic structural view of a connecting socket according to another embodiment of the present application;

FIG. 14 is a schematic structural view of a limiting structure according to an embodiment of the present disclosure;

FIG. 15 is a schematic structural view of a stop structure according to another embodiment of the present disclosure;

FIG. 16 is a schematic structural view of a spike assembly in accordance with one embodiment of the present application;

FIG. 17 is a schematic structural view of a spike assembly in accordance with another embodiment of the present application;

FIG. 18 is a schematic view of the internal structure of a monitor according to an embodiment of the present application;

FIG. 19 is a schematic diagram of the monitor of FIG. 18;

FIG. 20 is a schematic view of a monitor according to another embodiment of the present application;

FIG. 21 is a schematic diagram of the internal structure of the monitor of FIG. 20, with the housing not shown;

fig. 22 is a cross-sectional view of the monitor of fig. 20.

Wherein:

1, fixing a skin seat; 11 a sensor; 12 through holes; 13 a sensor electronics unit; 131 mounting position; 14 mating grooves; 15 a spacer; 16 an annular sealing strip; 17 an adhesion layer; 171 a first avoidance zone; 172 a second avoidance zone;

2, covering a housing; 21 an inner shell; 211 mounting grooves; 212 support column; 213 clamping position; 2131 a guide section; 2132 a locking segment; 22 an outer shell; 23 closing the chamber; 24, a housing;

3 a puncture assembly; 31 needle bodies; 32 needle seats; 321 a clamping groove; 322 a limiting groove; 33 a first seal portion;

4, a limiting structure; 41 a limiting hole; 411 raised structures; 42 a poker bar; 43 a guide chute; 44 a check rib; 45 a stopper;

5 connecting base; 51 guiding the sliding block; 52 a non-return projection; 53 a pressing part; 54 a fixing projection; 55 elastic rib positions; 551 fixing the convex ribs; 56 a via hole; 57 a clamping hook part; 58 mounting ports;

6, a shell; 61 triggering structure;

7, assisting the needle assembly.

Detailed Description

In order to more clearly explain the overall concept of the present application, the following detailed description is given by way of example in conjunction with the accompanying drawings.

In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application, however, the present application may be practiced in other ways than those described herein, and therefore the scope of the present application is not limited by the specific embodiments disclosed below.

In addition, in the description of the present application, it should be understood that the terms "top", "bottom", "inner", "outer", "axial", "circumferential", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be taken as limiting the present invention.

In this application, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can include, for example, fixed connections, removable connections, or integral parts; the connection can be mechanical connection, electrical connection or communication; they may be directly connected or indirectly connected through intervening media, or may be connected through the use of two elements or the interaction of two elements. The specific meanings of the above terms in the present invention can be understood according to specific situations by those of ordinary skill in the art.

In this application, unless expressly stated or limited otherwise, a first feature is "on" or "under" a second feature such that the first and second features are in direct contact, or the first and second features are in indirect contact via an intermediary. In the description herein, references to the description of the terms "implementation," "embodiment," "one embodiment," "example" or "specific example" or the like are intended to mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the application. In this specification, the schematic representations of the terms used above are not necessarily intended to refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

As shown in fig. 1 to 22, a last blood glucose monitor sterilization assembly, including sensor 11 and skin fixing base 1, still include housing 2 and connecting seat 5, skin fixing base 1 is equipped with through-hole 12, housing 2 and the cooperation of 1 lower part of skin fixing base form and seal cavity 23, sensor 11 one end is fixed with skin fixing base 1, the other end passes through-hole 12 of skin fixing base 1 and then downwardly extending goes into to seal cavity 23, be equipped with skin fixing base installation cavity in connecting seat 5, connecting seat 5 still is equipped with and is used for installing sensor electronic unit 13 in the installing port 58 of skin fixing base 5.

In this application is fixed in skin fixing base 1 in connecting seat 5, housing 2 forms closed cavity 23 with the cooperation of skin fixing base 1, and connecting seat 5 is provided with installing port 58 for sensor 1 can install on skin fixing base 1 in proper order step by step with sensor electronic unit 13, thereby can realize the substep sterilization. In addition, this application installs sensor 1 and sensor electronic unit 13 on skin fixing base 1 before leaving the factory, forms integrative structure, need not the user and carries out sensor electronic unit 13's equipment again after implanting the operation, and is convenient simple more, and easy to operate has promoted user's use and has experienced.

Specifically, the shape of the housing 2 is not limited in the present application, and for example, the housing may be a split structure or an integrated structure, as long as the housing can cooperate with the lower portion of the skin fixing base 1 to form a closed cavity. Part of the housing 2 may or may not be connected to the needle assembly.

During specific operation, the sensor 11 can be fixed on the skin fixing seat 1, and the sensor 11 is subjected to radiation sterilization, at this time, because the sensor electronic unit 13 is not yet installed on the skin fixing seat 1, the radiation does not affect the circuit thereof.

Then be fixed in the connecting seat with housing 2, housing 2 forms closed chamber 23 with the cooperation of skin fixing base 1 this moment, the contact pin of sensor 11 is located closed chamber 23, and closed chamber 23 is isolated with external environment, install sensor electronic unit 13 to skin fixing base 1 through installing port 58 this moment, then carry out gaseous sterilization to sensor electronic unit 13, this moment because the contact pin of sensor 11 is located closed chamber 23, gaseous unable entering closed chamber 23, consequently also can not cause the influence to the biological enzyme on the contact pin of sensor 11.

As shown in fig. 6 and 7, the mounting position 131 for mounting the sensor electronic unit 13 is disposed in a staggered manner with respect to the through hole 12, the free end of the sensor 11 penetrates out of the through hole 12, and the isolation portion 15 is disposed between the through hole 12 and the mounting position 131, so that two areas of the skin fixing base 1 can be sterilized in different manners without affecting each other.

In addition, spare parts such as skin fixing base 1, sensor 11 that this application will have higher sterilization requirement are connected through connecting seat 5 and are an subassembly, and when the sterilization, only need send this subassembly into the sterile chamber and disinfect, and need not to disinfect to monitor rear end spare to the volume of sterilization subassembly has been reduced greatly, has practiced thrift the sterilization cost. The sterilization efficiency and effect are improved.

As a preferred embodiment of the present application, a clamping position is further provided outside the connecting seat 5 and/or inside the casing 2, so as to clamp and fix the casing 2 and the connecting seat 5.

Housing 2 not only can enclose the one end of sensor 11 with the cooperation of skin fixing base 1 and enclose in closed cavity 23, provides an aseptic environment for it, but also can form the support to skin fixing base 1, makes skin fixing base 1 more firm, prevents that skin fixing base 1 from just taking place to drop before the implantation. In addition, the housing 2 can also play a limiting role on the moving parts in the monitor, so that the moving parts can be limited and cannot move when the housing 2 is not detached, thereby realizing the function of preventing false touch, detaching the housing 2 before the use of a user, and meanwhile, unlocking the moving parts in the monitor to improve the use reliability. Simultaneously, the fixed mode of joint for the dismantlement of housing 2 is simple and convenient more, reduces the operation degree of difficulty, improves and uses experience.

In a preferred embodiment, as shown in fig. 18, the sterilization assembly further comprises an assistant needle assembly 7, and the connecting seat 5 is further provided with a hook part 57 for connecting the connecting seat 5 and the assistant needle assembly 7.

The connecting seat 5 is connected with the needle assisting assembly 7, so that the connecting seat 5 and the needle assisting assembly 7 are linked, after a user triggers, the needle assisting assembly 7 drives the connecting seat 5 to move towards the skin together, the bottom surface of the skin fixing seat 1 is in contact with the skin, and preferably, the bottom surface of the skin fixing seat 1 is provided with an adhesive layer 17, so that the skin fixing seat 1 is bonded and fixed with the skin.

Meanwhile, after the sensor electronic unit 13 is installed on the skin fixing seat 1 through the installation opening 58, the connecting seat 5 is connected with the needle assisting assembly 7 through the clamping hook part 57, so that the assembly difficulty can be reduced, and the operation is convenient. It will be appreciated that a catch slot may be provided below the needle assembly 7 to cooperate with the catch portion 57.

In a preferred embodiment, as shown in fig. 1, 2, 3, 16 and 17, the sterilization assembly further comprises a puncture assembly 3, the puncture assembly 3 comprises a needle body 31 and a needle seat 32, the needle body 31 extends downwards into the closed chamber 23 after passing through the through hole 12, and the sensor 11 is at least partially nested inside the needle body 31.

In use, because the contact pin of the sensor 11 is a flexible structure and cannot directly pierce the skin to enter the subcutaneous part, the contact pin of the sensor 11 is embedded in the needle body 31 through the needle body 31, the needle body 31 is used for piercing the skin, the contact pin of the sensor 11 is implanted into the subcutaneous part, and after the implantation is finished, the puncture component 3 performs a needle withdrawing action to enable the needle body to leave the human body.

The needle body 31 extends into the closed chamber 23 and is in a closed sterile environment together with the stylus of the sensor 11, ensuring that the needle body 31 and the stylus of the sensor 11 are clean. Preferably, the needle holder 32 is connected with the needle assisting assembly 7, so that the puncture assembly 3 and the needle assisting assembly 7 are linked, and after the user triggers, the needle assisting assembly 7 drives the puncture assembly 3 to move towards the skin together to complete the implantation action, so as to provide power for the puncture assembly 3.

When implanting, the helping hand needle subassembly 7 drives puncture subassembly 3, connecting seat 5 and skin fixing base 1 together are to skin motion under the spring helping hand effect, the needle body punctures skin, implant the contact pin of sensor 11 subcutaneous, accomplish the implantation process, then trigger puncture subassembly 3 move back the needle action, make puncture subassembly 3 alone to the direction motion of keeping away from skin, withdraw from subcutaneous, the operation of accomplishing the needle that moves back, skin fixing base 1 then the adhesion is fixed on the skin surface, 11 contact pins of sensor are located subcutaneous, carry out real-time blood sugar monitoring.

The structure of the needle assisting assembly 7 is not limited by the application, the existing structure can be used, and the needle assisting assembly can be used as long as the connecting seat 5 can be driven to move towards the skin and the needle withdrawing action of the puncture assembly 3 can be realized.

As shown in fig. 3, the connecting socket 5 and/or the needle holder 32 are provided with a first sealing portion 33 capable of sealing the through hole 12 to ensure sealing of the closed chamber 23. The first sealing portion 33 is preferably made of an elastic material, and when the needle seat 32 abuts against the connecting seat 5, the first sealing portion 33 is pressed to be elastically deformed, so that a gap between the two is sealed.

As a preferred example of the present embodiment, as shown in fig. 1 and fig. 2, the connecting seat 5 is further provided with a limiting structure 4, and the limiting structure 4 can at least limit the puncture assembly 3 from being removed from the through hole 12.

Spacing structure 4 can carry on spacingly to puncture set 3, make puncture set 3 and skin fixing base 1 keep being connected firm, on the one hand puncture set 3 is sealed with the shutoff of through-hole 12, and the two stable in position, help guaranteeing the sealing reliability of through-hole 12, thereby guarantee to seal cavity 23 and external isolated, guarantee being in sterile environment of sensor 11 and needle body 31, the risk that puncture set 3 and skin fixing base 1 take place to break away from has also been reduced simultaneously, reduce the risk that skin fixing base 1 damaged. On the other hand, the limiting structure 3 can limit the movement of the puncture component 3, so that when the housing 2 is not detached, the puncture component 3 is prevented from being touched by mistake, and under the limitation of the limiting structure 4, the puncture component 3 can not move, so that implantation or needle withdrawing actions can not be carried out, the working reliability of the monitor is improved, and the cost is saved.

Specifically, as shown in fig. 1, 2, and 14 to 17, the limiting structure 4 has a limiting hole 41, the limiting hole 41 and the needle holder 32 are both non-circular structures, the limiting hole 41 can rotate together with the limiting structure 4 relative to the needle holder 32, when the limiting hole 41 rotates to a position coinciding with the needle holder 32, the limiting structure 4 is in an unlocked state, at this time, the limiting structure 4 loses the stop of the needle holder 32, and the puncture assembly 3 can penetrate out of the limiting hole 41. When the limiting structure 4 rotates to the position of the limiting hole 41 and the needle seat 32, the limiting structure 4 is in a locking state, and the limiting structure 4 forms a stop for the needle seat 32, so that the limiting structure cannot pass through the limiting hole 41.

In another embodiment, as shown in fig. 15, the inner wall of the limiting hole 41 is provided with a convex structure 411, the outer wall of the needle seat 32 is correspondingly provided with a groove structure, when the two are rotated to be overlapped, the needle seat 32 is unlocked, and when the two are dislocated, the needle seat 32 is locked.

Further, the limit structure 4 rotates synchronously with the housing 2. The housing 2 is abutted with the skin fixing seat 1 to form a closed chamber 23 before the monitor is used, so that the contact pin of the sensor 11 and the needle body 31 are in a closed sterile environment, when the monitor is used, the housing 2 is detached in a rotating mode, and at the moment, the contact pin of the sensor 11 and the needle body 31 are exposed, so that the implantation operation of a user is facilitated. Meanwhile, in the process of detaching the housing 2, the limiting structure 4 synchronously rotates, so that the puncture assembly 3 is unlocked, the puncture assembly can move to be implanted, the housing 2 and the puncture assembly 3 are synchronously unlocked, the unlocking of a plurality of parts is realized by only one-step operation, the operation steps are simplified, the complexity of product use is reduced, and the use experience is greatly improved.

Further, as shown in fig. 1, fig. 2, fig. 10, fig. 11, and fig. 14, the limiting structure 4 includes a poke rod 42, an opening end of the housing 2 is provided with an installation groove 211, the installation groove 211 is used for clamping the poke rod 42, and the housing 2 can drive the limiting structure 4 to rotate so as to change from the locking state to the unlocking state.

Specifically, as shown in fig. 1 and 2, the open end of the housing 2 surrounds the periphery of the skin fixing seat 1, and the tap lever 42 is engaged with the mounting groove 211 of the open end of the housing 2, and extends inward along the radial direction of the housing 2 to engage with the puncturing assembly 3. Two cell walls of mounting groove 211 are located the both sides of mounting groove 211 along the circumference of housing 2 to it is spacing to form the circumference of poker rod 42, and when housing 2 rotated, under the effect of supporting of the cell wall of mounting groove 211 one side, promote poker rod 42 and rotate along with housing 2 is synchronous.

Furthermore, as shown in fig. 1, 2, 10 and 11, the mounting groove 211 has an upward opening at a position corresponding to the second position, so that when a user removes the housing 2, the tap rod 42 can slide out of the opening and disengage from the housing 2, so that the housing 2 can be removed, and the tap rod 42 remains inside the monitor without affecting the operation of the internal components.

As a preferred embodiment of the present application, as shown in fig. 2, 12 and 14, the sterilization assembly further includes a guiding assembly for guiding the rotation of the limiting structure 4, the guiding assembly includes a guiding sliding groove 43 and a guiding sliding block 51, one of the guiding sliding groove 43 and the guiding sliding block 51 is disposed on the limiting structure 4, and the other is disposed on the connecting seat 5.

Specifically, as shown in fig. 3, the skin fixing seat 1 is located inside the connecting seat 5, and the limiting structure 4 is located on the top surface of the connecting seat 5. The guide chute 43 and the guide slide block 51 are matched to play a role in guiding and guiding the rotation of the limiting structure 4, so that the movement reliability of the limiting structure 4 is improved, the limiting structure 4 moves along a fixed path, the limiting hole 41 and the needle seat 32 are in an unlocking state in a coincided mode, and the puncture assembly 3 is ensured to smoothly complete the needle withdrawing action.

It should be noted that the structure of the guiding assembly is not limited in the present embodiment, and in an embodiment, as shown in fig. 12 and 14, the guiding sliding groove 43 is disposed on the limiting structure 4, and the guiding sliding block 51 is disposed on the top surface of the connecting seat 5 and extends along the circumferential direction of the connecting seat 5 to guide the limiting structure 4 to rotate along the circumferential direction of the connecting seat 5.

Of course, the guiding sliding groove 43 may also be disposed on the connecting seat 5, and correspondingly, the guiding sliding block 51 is disposed on the limiting structure 4, which is not limited herein.

Further, as shown in fig. 2, 12, and 14, the limiting structure 4 includes a check rib 44, a check protrusion 52 is disposed on the housing 2 and/or the connecting seat 5, and when the limiting structure 4 rotates from the first position to the second position, the check rib 44 abuts against the check protrusion 52 to limit the limiting structure 4 from rotating from the second position to the first position.

Cooperation of non return muscle 44 and protruding 52 of non return for limit structure 4's unblock motion is irreversible operation, in case limit structure 4 rotates to the unlocked state, under the backstop effect of non return muscle 44 and protruding 52 of non return, just with limit structure 4 restriction in this position, make it can't turn round to the locking state, ensure that puncture assembly 3 accomplishes the action of withdrawing the needle smoothly, guarantee reliability and the security that the product used, further avoid the product by used repeatedly, reduce cross infection's risk.

In a preferred example, as shown in fig. 12, the top surface of the connecting base 5 is provided with a guiding slide block 51, and a non-return protrusion 52 is provided on the guiding slide block 51, so that the integration of non-return and guiding functions is realized, the monitor is multipurpose, the internal structure compactness of the monitor is improved, and the cost is saved.

Preferably, as shown in fig. 2, 12 and 14, one of the connecting seat 5 and the limiting structure 4 is provided with a limiting member 45, and the other is provided with a blocking member, when the limiting structure 4 rotates from the first position to the second position, the blocking member can abut against the limiting member 45 to limit the limiting structure 4 to continue moving in a direction away from the first position.

The limiting part 45 and the blocking part are matched to limit the rotation angle of the limiting structure 4, when the limiting structure 4 rotates to the second position, the puncture assembly 3 is unlocked, at the moment, under the stopping effect of the limiting part 45 and the blocking part, the limiting structure 4 cannot continue to rotate, so that the position of the limiting structure 4 is locked, the puncture assembly 3 is kept in an unlocking state, the phenomenon that the puncture assembly 3 is locked again due to the fact that the rotation amount of the limiting structure 4 is too large can be avoided, and the puncture assembly 3 is ensured to smoothly complete the needle withdrawing action.

Preferably, as shown in fig. 12 and 14, the limiting member 45 is a protrusion disposed on the limiting structure 4, the blocking member is disposed on two sides of the limiting structure 4, an area between the two is a stroke of the limiting structure 4, and the blocking limiting member forms a blocking limiting position for the limiting structure 4 at two positions.

In a preferred embodiment of the present application, as shown in fig. 1, fig. 2, fig. 12, and fig. 13, the sterilization assembly further includes a connection seat 5 for mounting the skin fixing seat 1, a pressing portion 53 is provided on the connection seat 5, and the pressing portion 53 cooperates with the connection seat 5 to clamp the limiting structure 4.

The pressing part 53 forms downward pressure on the needle seat 32 to press the puncture assembly 3 on the connecting seat 5, so that the puncture assembly 3 is fixed. Preferably, the pressing portion 53 is located on at least one side of the limiting structure 4, so that a sidewall of the pressing portion 53 can form a stop with the limiting structure 4, thereby limiting the rotation amount of the limiting structure 4, i.e. the pressing portion 53 constitutes the above-mentioned stop.

In addition, dismantle the back when housing 2, limit structure 4 breaks away from with housing 2, under the effect of portion 53 that compresses tightly for limit structure 4 is still firmly pressed on connecting seat 5, thereby has avoided limit structure 4 to lose the inside removal of monitor after the limiting displacement, influences the work of other spare parts.

Specifically, as shown in fig. 12 and 13, the pressing portion 53 is a rib position that is arranged on the top surface of the connecting seat 5 and extends upward, the top of the rib position is bent to form a pressing claw, an accommodating space is formed between the pressing claw and the top surface of the connecting seat 5, the limiting structure 4 is arranged in the accommodating space, and the pressing claw forms a downward extrusion force on the limiting structure 4.

As a preferred embodiment of the present application, as shown in fig. 3, the housing 2 includes an outer housing 22 and an inner housing 21, which are sleeved, the inner housing 21 is disposed at the lower portion of the skin fixing base 1, and a second sealing portion is disposed between the inner housing 21 and the skin fixing base 1.

It will be appreciated that the outer shell 22 and the inner shell 21 may or may not be connected.

Casing 21 and the bottom surface butt of skin fixing base 1 in the housing 2, form closed cavity 23 with the cooperation of skin fixing base 1 on the one hand to the leakproofness of closed cavity 23 is guaranteed to the second sealing, and on the other hand, interior casing 21 can also form ascending holding power to skin fixing base 1, makes skin fixing base 1's fixed more stable, prevents that skin fixing base 1 from taking place to drop before the implantation.

In the present embodiment, the structure of the second sealing portion is not particularly limited, and in a specific example, as shown in fig. 8, the second sealing portion is an annular sealing strip 16 provided on the bottom surface of the skin fixing base 1, and the inner housing 21 is also of an annular structure, and is sealed in contact with the annular sealing strip 16 to form a closed chamber 23 inside.

In another specific example, as shown in fig. 9, the bottom surface of the skin fixing base 1 has an adhesive layer 17, the adhesive layer is provided with a first avoiding region 171, the second sealing portion is disposed in the first avoiding region 171, and the abutting end of the inner housing 21 is located in the first avoiding region 171.

It can be understood that, adhesive layer 17 coating has the adhesive, make the bottom surface and the skin contact back of skin fixing base 1, under the cohesive force effect, can the adhesion on the skin surface, and first dodge district 171 and do not have the adhesive, consequently, do not have viscidity, interior casing 21 and first dodge district 171 butt, can enough prevent that interior casing 21 and adhesive layer 17 from taking place the adhesion, destroy the colloid when leading to housing 2 to pull down, when avoiding housing 2 and skin fixing base 1 to take place relative rotation again, interior casing 21 rubs the colloid formation, lead to adhesive layer 17 to corrugate, the effect is pasted in the influence.

Further, as shown in fig. 10, a support column 212 is further disposed in the outer housing 22, and the support column 212 can abut against the lower side of the skin fixing base 1.

The setting of support column 212 has increased the area of contact of housing 2 with skin fixing base 1, has improved the support stability of housing 2 to skin fixing base 1. Preferably, as shown in fig. 10, there are two support columns 212, so that the inner shell 21 and the support columns 212 jointly prop against the skin fixing base 1 to form a three-point support for the skin fixing base 212.

As shown in fig. 9 and 10, two support columns 212 are provided, the support columns 212 and the inner casing 21 are both eccentrically disposed with respect to the housing 2, and a connection line between the three is approximately an isosceles triangle. So as to further improve the support stability of the inner shell 21 and the support column 212 to the skin fixing seat 1 and prevent the skin fixing seat 1 from inclining.

As a preferred embodiment of the present embodiment, as shown in fig. 10 to 13, at least a partial region of the outer shell 22 surrounds the outer periphery of the connecting socket 5, one of the outer shell 22 and the connecting socket 5 is provided with a fixing protrusion 54, and the other is provided with a locking position 213, and the locking position 213 has a guiding section 2131 and a locking section 2132 connected to each other, so that the outer shell 22 and the connecting socket 5 are rotatably engaged.

Specifically, as shown in fig. 1 and 2, at least a partial region of the outer housing 22 surrounds the outer periphery of the connector holder 5, one of the fixing projection 54 and the catch position 213 is provided on the outer periphery of the connector holder 5, and the other is provided on the inner wall of the outer housing 22.

As shown in fig. 10 to 13, in an embodiment, the outer circumference of the connecting socket 5 is provided with a fixing protrusion 54, the inner wall of the outer casing 22 is provided with a fixing groove to form the locking position 213, and when assembling, the fixing protrusion 54 is inserted into the fixing groove from the guiding section, and then the cover 2 is rotated to make the fixing protrusion 54 rotatably slide to the locking section 2132 along the fixing groove, so as to complete the locking of the cover 2 and the connecting socket 5. Conversely, the cover 2 is removed by rotating the cover 2 in the opposite direction to move the fixing projection 54 to the guide section 2131 and then withdrawing the cover 2 in the opening direction of the guide section 2131.

Of course, the fixing protrusion 54 may be disposed on the inner wall of the housing 2, and correspondingly, the locking position 213 is disposed on the outer periphery of the connecting seat 5, which is not limited in this respect.

Preferably, as shown in fig. 12 and 13, the side wall of the connecting seat 5 is provided with a plurality of elastic rib positions 55, and in a state that the housing 2 is fixed to the connecting seat 5, the housing 2 abuts against the elastic rib positions 55 so that the elastic rib positions 55 move towards the skin fixing seat 1 to clamp the skin fixing seat 1.

The regional periphery that encircles at skin fixing base 1 of housing 2, when housing 2 is not dismantled, under the effect of supporting of housing 2, the inside motion respectively of elastic rib position 55 of connecting seat 5, thereby form the extrusion to skin fixing base 1, it is fixed with 1 chucking of skin fixing base, improve the connection stability of skin fixing base 1, prevent to drop, when the user carries out implantation operation, pull down housing 2, elastic rib position 55 loses the extrusion and resets this moment, outwards expand promptly, loosen skin fixing base 1, skin fixing base 1 can break away from connecting seat 5 under the cohesive force effect with human skin this moment, stay at the skin surface. This application is when dismantling housing 2, realizes the unblock to skin fixing base 1, further simplified operation step, improves and uses experience.

Preferably, as shown in fig. 12 and 13, the plurality of elastic rib locations 55 are arranged at intervals along the circumferential direction of the connecting seat 5.

Further, as shown in fig. 4, fig. 5, fig. 12, and fig. 13, a fixing rib 551 is disposed on one side of the elastic rib 55 facing the skin fixing seat 1, a fitting groove 14 is disposed on the periphery of the skin fixing seat 1 corresponding to the elastic rib 55, when the elastic rib 55 moves toward the skin fixing seat 1, the fixing rib 551 extends into the fitting groove 14, so that the connecting seat 5 can clamp the skin fixing seat 1 more stably, thereby preventing the skin fixing seat 1 from rotating circumferentially due to vibration or other factors during transportation, when the housing 2 is detached, the elastic rib 55 moves outwards to reset, and the fixing rib 551 slides out of the fitting groove 14.

In another embodiment of the present embodiment, as shown in fig. 12, the connection seat 5 is provided with a through hole 56, the through hole 56 is disposed corresponding to the through hole 12, and at least a partial region of the needle seat 32 is engaged with the through hole 56 to limit the rotation of the puncturing assembly 3 relative to the connection seat 5.

Specifically, before implantation, the protruding structure of the needle seat 32 is located in the through hole 56 to limit the puncture assembly 3 to rotate relative to the connecting seat 5, and meanwhile, the protruding structure of the needle seat 32 abuts against the limiting structure 4 to enable the needle seat 32 to be in a locking state; after the limiting structure 4 is unlocked, the protruding structure of the needle seat 32 is separated from the limiting structure 4, and when the puncture assembly 3 retreats, the protruding structure of the needle seat 32 can penetrate through the limiting hole 41 to complete the needle retreating action.

As a preferred embodiment of the present application, as shown in fig. 3, 5, 6, and 7, the sterilization assembly further includes a sensor electronics unit 13, the sensor 11 includes a coupling portion 18 located in the mounting opening 58, the coupling portion 18 is provided with a first contact 181, the sensor electronics unit 13 has a second contact, and the first contact 181 and the second contact can be coupled.

The coupling part 18 of the sensor 11 is located in the mounting port 58, so that the sensor electronic unit 13 can be synchronously coupled with the first contact 181 and the second contact after being mounted on the skin fixing seat 1 through the mounting port 58, the operation difficulty is reduced, the coupling difficulty of the first contact and the second contact is greatly reduced, and the assembly convenience is improved.

In one embodiment, as shown in fig. 7, the first contact 181 is directed upward and the second contact is located at the sensor electronics unit 13 and directed downward, so that the first contact 181 and the second contact are coupled in the up-down direction while the sensor electronics unit 13 is mounted.

In another embodiment, the first contact 181 is oriented to one side and the second contact is oriented to one side and opposite the first contact 181 such that the first contact 181 and the second contact are laterally coupled when the sensor electronics unit 13 is fully installed.

As shown in fig. 18 to 22, the continuous blood glucose monitor comprises a housing 6, a needle assembly 7 disposed in the housing 6, and the sterilization assembly of the continuous blood glucose monitor, wherein the sterilization assembly further comprises a puncture assembly 3, the puncture assembly 3 comprises a needle body 31 and a needle base 32, the needle base 32 is provided with a clamping groove 321 and a limiting groove 322, the clamping groove 321 is used for connecting with the needle assembly 7, and the limiting groove 322 is used for matching with the limiting structure 4.

The needle base 32 is connected with the needle assisting assembly 7, so that the puncture assembly 3 is linked with the needle assisting assembly 7, and after a user triggers the needle assisting assembly 7, the needle assisting assembly 7 drives the puncture assembly 3 to move towards the skin together to complete the implantation action, so as to provide power for the puncture assembly 3.

As shown in fig. 1, 2 and 18, the connecting base 5 further has a hook portion 57 for snap-fastening with the needle assembly 7.

Preferably, as shown in fig. 1, 2, 3 and 20, the housing 2 includes an outer cover 24, an outer shell 22 and an inner shell 21, which are sleeved, and the shell 6 is butted with the outer shell 22. The inner shell 21 is abutted with the bottom surface of the skin fixing seat 1 to form a closed chamber 23, and the outer cover 24 is abutted with the shell 6 to enclose all parts of the monitor in a cavity formed by the inner shell and the skin fixing seat.

As shown in fig. 19 and 22, the housing 6 is provided with a trigger mechanism 61, and the user can trigger the monitor by operating the trigger mechanism 61, so as to complete the whole implantation and needle withdrawal processes.

The trigger structure 61 may be a button as shown in fig. 19 for triggering by pressing, or a push structure as shown in fig. 22 for triggering by pushing the structure downward.

When dispatching from the factory, the inside puncture component 3 of the blood glucose monitor that lasts of this application, skin fixing base 1 and connecting seat 5 all are in the lock-out state, and the user can't trigger the implantation, has improved the risk of false triggering greatly. The operation method of the continuous blood sugar monitor comprises the following steps: firstly, the housing 2 is rotated, so that the connecting seat 5, the skin fixing seat 1 and the needle assisting assembly 7 synchronously rotate to realize unlocking, then the housing 2 is taken down, at the moment, the contact pin of the sensor 11 and the needle body 31 of the puncture assembly 3 are exposed, then the open end of the housing 6 is pasted on the skin, the trigger structure 61 is triggered by pressing and other operations, at the moment, the housing 6 loses the stop of the needle assisting assembly 7, the needle assisting assembly 7 drives the puncture assembly 3, the connecting seat 5 and the skin fixing seat 1 to move towards the skin under the assistance of the spring, the needle body punctures the skin, the contact pin of the sensor 11 is implanted under the skin, the implantation process is completed, then the needle withdrawing action of the puncture assembly 3 is triggered, so that the puncture assembly 3 moves towards the direction far away from the skin relative to the needle assisting assembly 7, the needle withdrawing is withdrawn from the skin, the needle withdrawing operation is completed, the skin fixing seat 1 is adhered and fixed on the surface of the skin, meanwhile, when other parts of the monitor are taken away, the skin fixing seat 1 and the connecting seat 5 are loosened, so far away, the whole implantation process is completed, only the skin fixing seat 1 is kept on the surface of the skin, the sensor 11 is located under the skin, and the contact pin is monitored in real time.

The present application also discloses a sterilization method for a continuous blood glucose monitor, comprising the steps of:

carrying out first sterilization treatment on the first sterilization unit, wherein the first sterilization unit comprises a housing 2, a connecting seat 5 and a puncture component 3, a sensor 11 and a skin fixing seat 1 are installed in an installation cavity formed by the connecting seat 5, the connecting seat 5 is further provided with an installation opening 58, the skin fixing seat 1 is matched with the housing 2 to form a closed cavity 23, the skin fixing seat 1 is provided with a through hole 12, one end of the sensor 11 is fixed with the skin fixing seat 1, the other end of the sensor 11 extends downwards into the closed cavity 23 after passing through the through hole 12, at least part of the puncture component 3 extends downwards into the closed cavity 23 after passing through the through hole 12, and at least part of the sensor 11 is embedded inside the puncture component 3;

and performing a second sterilization treatment on a second sterilization unit, wherein the second sterilization unit comprises the first sterilization unit and the sensor electronic unit 13, and the sensor electronic unit 13 is installed on the skin fixing seat 1 through the installation port 58.

In order to divide into two sterilization units with the subassembly that disinfects, carry out the sterilization of two kinds of different modes to two sterilization units in proper order, in first sterilization unit, only install sensor 11 to skin fixing base 1, and sensor electronic unit 13 does not install, carries out radiation sterilization to first sterilization unit this moment, disinfects sensor 11, because sensor electronic unit 13 does not install to skin fixing base 1, consequently does not make its circuit receive the influence of radiation sterilization naturally. After the first sterilization unit is sterilized, the contact pin of the sensor 11 is sealed in the sealed chamber 23, the chamber is isolated from the outside, and then the sensor electronic unit 13 is mounted on the skin fixing base 1, and then the second sterilization step, such as ethylene oxide gas sterilization, is performed, so that the gas does not enter and affect the bio-enzyme on the contact pin of the sensor 11 because the sealed chamber 23 is isolated. By the adoption of the mode of installing the sensor 11 and the sensor electronic unit 13 step by step and sterilizing step by step, the sterilization effect is greatly improved, adverse effects of different sterilization modes on the sensor and the sensor are greatly avoided, the yield and the monitoring accuracy of the monitor are improved, and the product performance is guaranteed.

Preferably, as shown in fig. 18, the second sterilization unit further comprises an assistant needle assembly 7, and the assistant needle assembly 7 is connected with the connecting base 5.

The connecting seat 5 is connected with the needle assisting assembly 7, so that the needle assisting assembly 7 can drive the connecting seat 5 to move towards the skin together to perform implantation, and the skin fixing seat 1 is fixed on the connecting seat 5, so that the skin fixing seat 1 can move along with the skin fixing seat.

Preferably, as shown in fig. 12, 13 and 18, the connecting seat 5 has a hook portion 57 protruding toward the needle assembly 7, the needle assembly 7 is provided with a clip interface, and the hook portion 57 is clip-fitted with the clip interface to clip-fix the two. After the sensor electronic unit 13 is installed on the skin fixing seat 1 through the installation opening 58, the needle assisting assembly 7 is connected with the connecting seat 5 through the clamping hook part 57 to form a second sterilization unit, and then the second sterilization treatment is carried out.

Of course, the connecting seat 5 can be connected with the needle assisting assembly 7 by other means, such as magnetic attraction, and the like, which is not limited herein.

Where not mentioned in this application, this may be achieved using or taking advantage of existing technology.

The embodiments in the present specification are described in a progressive manner, and the same and similar parts among the embodiments are referred to each other, and each embodiment focuses on the differences from the other embodiments.

The above description is only an example of the present application and is not intended to limit the present application. Various modifications and changes may occur to those skilled in the art to which the present application pertains. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the scope of the claims of the present application.

Claims

1. A sterilization component of a continuous blood sugar monitor comprises a sensor and a skin fixing seat, and is characterized in that,

the skin fixing seat is provided with a through hole, the housing is matched with the lower part of the skin fixing seat to form a closed cavity, one end of the sensor is fixed with the skin fixing seat, the other end of the sensor passes through the through hole of the skin fixing seat and then extends downwards to enter the closed cavity, a skin fixing seat installation cavity is arranged in the connecting seat, and the connecting seat is further provided with an installation opening for installing an electronic unit of the sensor in the skin fixing seat.

2. The continuous blood glucose monitor sterilization assembly of claim 1,

the outer side of the connecting seat and/or the inner side of the housing are/is also provided with a clamping position, so that the housing is clamped and fixed with the connecting seat.

3. The continuous blood glucose monitor sterilization assembly of claim 1,

the needle assembly is characterized by further comprising a needle assisting assembly, wherein the connecting seat is further provided with a clamping and hooking part so as to connect the connecting seat with the needle assisting assembly.

4. The continuous blood glucose monitor sterilization assembly of claim 1,

still include puncture set, puncture set includes needle body and needle file, the needle body warp down extend into behind the through-hole closed chamber, the sensor is at least partially nested inside the needle body.

5. The continuous blood glucose monitor sterilization assembly of claim 4,

6. The continuous blood glucose monitor sterilization assembly of claim 1,

the housing comprises an outer housing and an inner housing which are sleeved, the inner housing is arranged on the lower portion of the skin fixing seat, and a second sealing portion is arranged between the inner housing and the skin fixing seat.

7. The continuous blood glucose monitor sterilization assembly of claim 6,

at least part of the area of the outer shell surrounds the periphery of the connecting seat, one of the outer shell and the connecting seat is provided with a fixing bulge, the other is provided with a clamping position, and the clamping position is provided with a guiding section and a locking section which are mutually connected so that the outer shell and the connecting seat can be rotationally clamped.

8. The continuous blood glucose monitor sterilization assembly of claim 6,

9. The continuous blood glucose monitor sterilization assembly of claim 6,

10. The continuous blood glucose monitor sterilization assembly of claim 1,

the sensor comprises a coupling part positioned in the mounting opening, the coupling part is provided with a first contact, the sensor electronic unit is provided with a second contact, and the first contact and the second contact can be coupled and connected.

11. A method of sterilizing a continuous blood glucose monitor, comprising the steps of:

carrying out first sterilization treatment on a first sterilization unit, wherein the first sterilization unit comprises a housing, a connecting seat and a puncture assembly, a sensor and a skin fixing seat are installed in an installation cavity formed by the connecting seat, the connecting seat is also provided with an installation opening, the skin fixing seat is matched with the housing to form a closed cavity, the skin fixing seat is provided with a through hole, one end of the sensor is fixed with the skin fixing seat, the other end of the sensor downwards extends into the closed cavity after passing through the through hole, at least part of the puncture assembly downwards extends into the closed cavity after passing through the through hole, and at least part of the sensor is embedded in the puncture assembly;

and carrying out second sterilization treatment on a second sterilization unit, wherein the second sterilization unit comprises a first sterilization unit and a sensor electronic unit, and the sensor electronic unit is installed on the skin fixing seat through the installation opening.

12. The sterilization method according to claim 11,

the second sterilization unit further comprises an assistant needle assembly, and the assistant needle assembly is connected with the connecting seat.