A continuous glucose monitor sterilization assembly and method

Abstract

The application discloses a continuous blood glucose monitor sterilization assembly and a sterilization method. The sterilization assembly comprises a sensor and a skin fixing seat, a cover shell and a connecting seat. The skin fixing seat is provided with a through hole. The cover shell is matched with the lower part of the skin fixing seat to form a closed cavity. One end of the sensor is fixed to the skin fixing seat, and the other end of the sensor extends downward into the closed cavity through the through hole of the skin fixing seat. The connecting seat is provided with a skin fixing seat mounting cavity. The connecting seat is also provided with a mounting port for mounting a sensor electronic unit on the skin fixing seat. The skin fixing seat is fixed in the connecting seat. The cover shell is matched with the skin fixing seat to form the closed cavity. The sensor and the sensor electronic unit can be mounted on the skin fixing seat in a split manner, so that step-by-step sterilization can be realized. The sensor and the sensor electronic unit are independently sterilized in different ways, different sterilization media do not interfere with each other, and the sterilization effect is improved.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, specifically relating to a sterilization component and sterilization method for a continuous glucose monitor. Background Technology

[0002] A biosensor is an instrument that is sensitive to bioactive substances and converts the detected concentration of these substances into an electrical signal for detection. Glucose sensors are a common type of biosensor. Continuous glucose monitoring (CGM) is a technology that indirectly reflects blood glucose levels by continuously monitoring the glucose concentration in subcutaneous interstitial fluid using a glucose sensor. CGM products require a needle and sensor pin to puncture the skin to test blood glucose. The bio-enzymes on the sensor react electrochemically with the subcutaneous fluid, converting the signal into an electrical signal, which is then converted into a blood glucose value and provided to the user. Because the product involves puncturing the skin, it must be sterilized before leaving the factory to prevent the risk of infection from pathogens on the product.

[0003] Monitoring components typically include sensors and electronic units (transmitters). These often require different sterilization methods. For the transmitter, gas sterilization, such as using ethylene oxide gas, is generally employed. However, because the enzymes on the sensor react chemically with gases like ethylene oxide, affecting their activity and consequently the monitoring accuracy, gas sterilization is not suitable for the sensor. Therefore, radiation sterilization is chosen instead. Furthermore, radiation sterilization can easily affect the transmitter's circuitry; thus, the sensor and transmitter need to be sterilized separately.

[0004] In existing technologies, the monitoring components are often assembled before sterilization, and then sterilization is carried out in two different ways. During the sterilization process, since radiation sterilization and gas sterilization use radiation and gas respectively, it is often difficult to effectively isolate radiation and gas, which can cause varying degrees of damage to the biological enzymes on the sensor and the circuitry of the transmitter. Alternatively, the sensor and transmitter are sterilized separately, and when needed, the user has to manually install the transmitter and connect it to the sensor, which increases the complexity of the user's operation.

[0005] In addition, CGM products have high sterilization requirements for front-end components that come into direct contact with the skin (such as skin fixation bases and half-wall needles), while the sterilization requirements for back-end booster components are lower. However, in the existing technology, CGM products are often sterilized as a whole after assembly. This not only results in poor sterilization effect on front-end components, but also makes the whole machine larger and the sterilization cost higher.

[0006] Therefore, how to effectively sterilize the front end of CGM products and ensure that neither of the two sterilization methods will affect the sensors and transmitters has become a technical problem that urgently needs to be solved in this field. Summary of the Invention

[0007] This application provides a sterilization component and sterilization method for a continuous glucose monitor to solve at least one of the above-mentioned technical problems.

[0008] The technical solution adopted in this application is as follows:

[0009] A sterilization assembly for a continuous glucose monitor includes a sensor and a skin fixation base, as well as a housing and a connecting base. The skin fixation base has a through hole, and the housing fits with the lower part of the skin fixation base to form a closed chamber. One end of the sensor is fixed to the skin fixation base, and the other end extends downward into the closed chamber through the through hole of the skin fixation base. The connecting base has a skin fixation base mounting cavity and an mounting port for mounting the sensor electronic unit to the skin fixation base.

[0010] The outer side of the connector and / or the inner side of the cover are also provided with snap-fit ​​positions to snap and fix the cover to the connector.

[0011] The sterilization assembly also includes a needle assist assembly, and the connector is provided with a hook to connect the connector to the needle assist assembly.

[0012] The sterilization assembly also includes a puncture assembly, which includes a needle body and a needle hub. The needle body extends downward into a closed chamber through a through-hole, and the sensor is at least partially nested inside the needle body.

[0013] The connector and / or needle seat are provided with a first sealing part capable of sealing the through hole.

[0014] The cover includes an outer shell and an inner shell, the inner shell is located below the skin fixation seat, and a second sealing part is provided between the inner shell and the skin fixation seat.

[0015] At least a portion of the outer casing surrounds the outer periphery of the connector. One of the outer casing and the connector is provided with a fixing protrusion, and the other is provided with a snap-fit ​​position. The snap-fit ​​position has a guide section and a locking section that are connected to each other, so that the outer casing and the connector can be rotated and snapped together.

[0016] The side wall of the connector is provided with multiple elastic ribs. When the cover is fixed to the connector, the cover abuts against the elastic ribs so that the elastic ribs move toward the skin fixation seat to clamp the skin fixation seat.

[0017] The outer shell also contains a support column that can abut against the bottom of the skin fixation seat.

[0018] The sterilization assembly also includes a sensor electronic unit. The sensor includes a coupling part located in the mounting port, the coupling part being provided with a first contact, and the sensor electronic unit having a second contact. The first and second contacts can be coupled together.

[0019] This application also discloses a sterilization method for a continuous glucose monitor, comprising the following steps: performing a first sterilization treatment on a first sterilization unit, wherein the first sterilization unit includes a housing, a connecting seat, and a puncture assembly, a sensor and a skin fixation seat are installed in the mounting cavity formed by the connecting seat, the connecting seat also has an installation port, the skin fixation seat and the housing cooperate to form a closed chamber, the skin fixation seat has a through hole, one end of the sensor is fixed to the skin fixation seat, and the other end extends downward into the closed chamber through the through hole, at least a portion of the puncture assembly extends downward into the closed chamber through the through hole, and at least a portion of the sensor is nested inside the puncture assembly; performing a second sterilization treatment on a second sterilization unit, wherein the second sterilization unit includes the first sterilization unit and a sensor electronic unit, the sensor electronic unit being installed on the skin fixation seat through the installation port.

[0020] The second sterilization unit also includes a needle assist assembly, which is connected to the connector.

[0021] Due to the adoption of the above technical solution, the beneficial effects achieved by this application are as follows:

[0022] 1. This application fixes the skin fixation base within the connecting base. The cover and the skin fixation base cooperate to form a closed chamber, and the connecting base is provided with an installation port, allowing the sensor and the sensor electronic unit to be separately installed on the skin fixation base, thereby achieving stepwise sterilization. In specific operation, the sensor can first be fixed to the skin fixation base and subjected to radiation sterilization. At this time, since the sensor electronic unit has not yet been installed on the skin fixation base, the radiation will not affect its circuitry. Then, the cover is fixed to the connecting base. At this point, the cover and the skin fixation base cooperate to form a closed chamber, and the sensor's probe is located within the closed chamber, which is isolated from the external environment. The sensor electronic unit is then installed onto the skin fixation base through the installation port, and then the sensor electronic unit is subjected to gas sterilization. Since the sensor probe is located within the closed chamber, the gas cannot enter the closed chamber and therefore will not affect the bio-enzymes on the sensor probe.

[0023] Furthermore, this application connects components with high sterilization requirements, such as the skin fixation base and sensor, into a single assembly via a connector. During sterilization, only this assembly needs to be placed in the sterilization chamber, eliminating the need to sterilize the rear-end components of the monitor. This significantly reduces the size of the sterilization assembly and saves sterilization costs, thereby improving sterilization efficiency and effectiveness.

[0024] 2. In a preferred embodiment of this application, a snap-fit ​​position is provided on the outer side of the connector and / or the inner side of the housing to snap the housing and connector together. The housing not only cooperates with the skin fixation base to enclose one end of the sensor within a sealed cavity, providing a sterile environment, but also supports the skin fixation base, making it more secure and preventing it from falling off before implantation. Furthermore, the housing also limits the movement of the internal moving parts of the monitor, preventing them from moving when the housing is not removed, thus preventing accidental touch. Before use, the user removes the housing, and simultaneously, the moving parts inside the monitor unlock, improving reliability. Simultaneously, the snap-fit ​​fixing method makes disassembling the housing simpler and more convenient, reducing operational difficulty and improving the user experience.

[0025] 3. In a preferred embodiment of this application, at least a portion of the outer casing surrounds the outer periphery of the connecting seat. One of the outer casing and the connecting seat has a fixing protrusion, and the other has a snap-fit ​​position. The snap-fit ​​position has a guide section and a locking section connected to each other, allowing the outer casing and the connecting seat to rotate and engage. In practical use, the overall size of CGM products tends to be miniaturized; therefore, using rotation control makes it more convenient for users to apply force, improving ease of use.

[0026] 4. In a preferred embodiment of this application, the sidewall of the connector is provided with multiple elastic ribs. With the cover fixed to the connector, the cover abuts against the elastic ribs, causing the ribs to move towards the skin fixation seat to clamp it. A portion of the cover surrounds the outer periphery of the skin fixation seat. When the cover is not removed, the elastic ribs of the connector move inward under the abutting action of the cover, thereby compressing the skin fixation seat and securing it firmly, improving the connection stability of the skin fixation seat and preventing it from falling off. When the user performs the implantation procedure, the cover is removed. At this time, the elastic ribs lose their compression and reset, i.e., expand outward, releasing the skin fixation seat. The skin fixation seat can then detach from the connector under the adhesive force of the skin and remain on the skin surface. This application unlocks the skin fixation seat simultaneously with the removal of the cover, further simplifying the operation and improving the user experience.

[0027] 5. This application also discloses a sterilization method for a continuous glucose monitor, which divides the sterilization components into two sterilization units. The two sterilization units are sterilized sequentially using two different methods. In the first sterilization unit, only the sensor is installed on the skin fixation base, while the sensor electronic unit is not installed. At this time, the first sterilization unit is subjected to radiation sterilization, and the sensor is sterilized. Since the sensor electronic unit is not installed on the skin fixation base, its circuitry is naturally not affected by radiation sterilization. After sterilizing the first sterilization unit, the sensor's probe is sealed in a closed chamber, isolating the chamber from the outside environment. Then, the sensor electronic unit is installed on the skin fixation base. At this point, the second sterilization step, such as gas sterilization, is performed. Because the closed chamber is isolated, gas will not enter and affect the bio-enzymes on the sensor probe. By installing and sterilizing the sensor and sensor electronic unit step by step, the sterilization effect is greatly improved, and the adverse effects of different sterilization methods on both are largely avoided, improving the monitor's yield and monitoring accuracy, and ensuring product performance. Attached Figure Description

[0028] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings:

[0029] Figure 1 This is a schematic diagram of the structure of a sterilization component according to one embodiment of this application;

[0030] Figure 2 This is a schematic diagram of the sterilization component according to another embodiment of this application;

[0031] Figure 3 for Figure 2 Cross-sectional view of the sterilization component;

[0032] Figure 4 This is a schematic diagram of the skin fixation seat according to one embodiment of this application;

[0033] Figure 5 This is a schematic diagram of the skin fixation seat according to another embodiment of this application;

[0034] Figure 6 This is a schematic diagram of the internal structure of the skin fixation seat according to one embodiment of this application;

[0035] Figure 7 This is a schematic diagram of the internal structure of the skin fixation seat according to another embodiment of this application;

[0036] Figure 8 This is a schematic diagram of the bottom structure of the skin fixation base according to one embodiment of this application;

[0037] Figure 9 This is a schematic diagram of the bottom structure of the skin fixation base according to another embodiment of this application;

[0038] Figure 10 This is a schematic diagram of the structure of the cover according to one embodiment of this application;

[0039] Figure 11 This is a schematic diagram of the structure of the casing according to another embodiment of this application;

[0040] Figure 12 This is a schematic diagram of the structure of the connector according to one embodiment of this application;

[0041] Figure 13 This is a schematic diagram of the connector structure according to another embodiment of this application;

[0042] Figure 14 This is a schematic diagram of the limiting structure according to one embodiment of this application;

[0043] Figure 15 This is a schematic diagram of the limiting structure according to another embodiment of this application;

[0044] Figure 16 This is a schematic diagram of the puncture assembly according to one embodiment of this application;

[0045] Figure 17 This is a schematic diagram of the puncture assembly according to another embodiment of this application;

[0046] Figure 18 This is a schematic diagram of the internal structure of the monitor according to one embodiment of this application;

[0047] Figure 19 for Figure 18 A schematic diagram of the structure of the monitoring device;

[0048] Figure 20 This is a schematic diagram of the monitor according to another embodiment of this application;

[0049] Figure 21 for Figure 20 A schematic diagram of the internal structure of the monitor, where the casing is not shown;

[0050] Figure 22 for Figure 20 Cross-sectional view of the monitor.

[0051] in:

[0052] 1 Skin fixation seat; 11 Sensor; 12 Through hole; 13 Sensor electronic unit; 131 Mounting position; 14 Mating groove; 15 Isolation part; 16 Annular sealing strip; 17 Adhesive layer; 171 First clearance area; 172 Second clearance area;

[0053] 2. Cover; 21. Inner shell; 211. Mounting groove; 212. Support column; 213. Snap-fit ​​position; 2131. Guide section; 2132. Locking section; 22. Outer shell; 23. Enclosed chamber; 24. Outer cover;

[0054] 3. Puncture assembly; 31. Needle body; 32. Needle seat; 321. Snap-fit ​​groove; 322. Limiting groove; 33. First sealing part;

[0055] 4. Limiting structure; 41. Limiting hole; 411. Protruding structure; 42. Actuating rod; 43. Guide groove; 44. Anti-return rib; 45. Limiting component;

[0056] 5 Connecting seat; 51 Guide slider; 52 Anti-return protrusion; 53 Clamping part; 54 Fixing protrusion; 55 Elastic rib; 551 Fixing rib; 56 Through hole; 57 Hook part; 58 Mounting port;

[0057] 6. Housing; 61. Trigger structure;

[0058] 7. Needle-assisting components. Detailed Implementation

[0059] To more clearly illustrate the overall concept of this application, a detailed explanation is provided below with reference to the accompanying drawings.

[0060] Many specific details are set forth in the following description in order to provide a full understanding of this application. However, this application may also be implemented in other ways different from those described herein. Therefore, the scope of protection of this application is not limited to the specific embodiments disclosed below.

[0061] Furthermore, it should be understood in the description of this application that the terms "top", "bottom", "inner", "outer", "axial", "circumferential", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention.

[0062] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection, an electrical connection, or a communication connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0063] In this application, unless otherwise expressly specified and limited, the "above" or "below" of the second feature can mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. In the description of this specification, references to terms such as "implementation," "example," "a particular embodiment," "example," or "specific example," etc., indicate that the specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described can be combined in any suitable manner in one or more embodiments or examples.

[0064] like Figures 1 to 22 As shown, a sterilization component for a continuous glucose monitor includes a sensor 11 and a skin fixation base 1, as well as a housing 2 and a connecting base 5. The skin fixation base 1 has a through hole 12. The housing 2 cooperates with the lower part of the skin fixation base 1 to form a closed chamber 23. One end of the sensor 11 is fixed to the skin fixation base 1, and the other end extends downward into the closed chamber 23 after passing through the through hole 12 of the skin fixation base 1. The connecting base 5 has a skin fixation base mounting cavity and a mounting port 58 for mounting the sensor electronic unit 13 to the skin fixation base 5.

[0065] This application fixes the skin fixation base 1 within the connecting base 5. The cover 2 and the skin fixation base 1 cooperate to form a closed chamber 23. The connecting base 5 is provided with an installation port 58, allowing the sensor 1 and the sensor electronic unit 13 to be installed sequentially on the skin fixation base 1, thereby achieving stepwise sterilization. Furthermore, this application installs the sensor 1 and the sensor electronic unit 13 onto the skin fixation base 1 before leaving the factory, forming an integrated structure. This eliminates the need for the user to assemble the sensor electronic unit 13 after the implantation procedure, making it more convenient, simpler, and easier to operate, thus improving the user experience.

[0066] Specifically, this application does not limit the shape of the housing 2. For example, it can be a split structure or a one-piece structure, as long as it can cooperate with the lower part of the skin fixation seat 1 to form a closed chamber. Parts of the housing 2 can be connected to the needle-assisted assembly or not.

[0067] In practice, the sensor 11 can be fixed to the skin fixation base 1 first, and the sensor 11 can be sterilized by radiation. At this time, since the sensor electronic unit 13 has not yet been installed on the skin fixation base 1, the radiation will not affect its circuit.

[0068] Then, the cover 2 is fixed to the connecting seat. At this time, the cover 2 and the skin fixation seat 1 cooperate to form a closed chamber 23. The stylus of the sensor 11 is located in the closed chamber 23, and the closed chamber 23 is isolated from the external environment. At this time, the sensor electronic unit 13 is installed to the skin fixation seat 1 through the mounting port 58. Then, the sensor electronic unit 13 is sterilized by gas. At this time, since the stylus of the sensor 11 is located in the closed chamber 23, the gas cannot enter the closed chamber 23, so it will not affect the bio-enzymes on the stylus of the sensor 11.

[0069] like Figure 6 , Figure 7 As shown, the mounting position 131 for mounting the sensor electronic unit 13 is staggered with the through hole 12. The free end of the sensor 11 passes through the through hole 12. There is an isolation part 15 between the through hole 12 and the mounting position 131, so that during sterilization, the two areas of the skin fixation seat 1 can be sterilized in different ways without affecting each other.

[0070] Furthermore, this application connects components with high sterilization requirements, such as the skin fixation base 1 and the sensor 11, into a single assembly via the connecting base 5. During sterilization, only this assembly needs to be placed in the sterilization chamber, eliminating the need to sterilize the rear-end components of the monitor. This significantly reduces the size of the sterilization assembly and saves sterilization costs, thereby improving sterilization efficiency and effectiveness.

[0071] In a preferred embodiment of this application, the outer side of the connecting seat 5 and / or the inner side of the cover 2 are also provided with snap-fit ​​positions to snap and fix the cover 2 and the connecting seat 5.

[0072] The housing 2 not only works with the skin fixation base 1 to enclose one end of the sensor 11 within the sealed chamber 23, providing a sterile environment, but also supports the skin fixation base 1, making it more secure and preventing it from falling off before implantation. Furthermore, the housing 2 also limits the movement of the internal moving parts of the monitor, preventing them from moving when the housing 2 is not removed, thus preventing accidental touch. Before use, the user removes the housing 2, simultaneously unlocking the moving parts inside the monitor and improving reliability. At the same time, the snap-fit ​​fixing method makes disassembling the housing 2 simpler and more convenient, reducing operational difficulty and improving the user experience.

[0073] In a preferred embodiment, such as Figure 18 As shown, the sterilization assembly also includes a needle-assisting assembly 7, and the connecting seat 5 is further provided with a hook portion 57 to connect the connecting seat 5 to the needle-assisting assembly 7.

[0074] The connecting seat 5 is connected to the needle-assisting component 7, so that the connecting seat 5 and the needle-assisting component 7 are linked. After the user triggers it, the needle-assisting component 7 drives the connecting seat 5 to move toward the skin, so that the bottom surface of the skin fixation seat 1 contacts the skin. Preferably, the bottom surface of the skin fixation seat 1 is provided with an adhesive layer 17, thereby bonding and fixing the skin fixation seat 1 to the skin.

[0075] Meanwhile, after the sensor electronic unit 13 is installed on the skin fixation base 1 through the mounting port 58, the connecting base 5 is connected to the needle assembly 7 through the hook part 57, which reduces the assembly difficulty and facilitates operation. It is understood that a slot can be opened at the bottom of the needle assembly 7 to cooperate with the hook part 57.

[0076] In a preferred embodiment, such as Figure 1 , Figure 2 , Figure 3 , Figure 16 , Figure 17 As shown, the sterilization assembly also includes a puncture assembly 3, which includes a needle body 31 and a needle hub 32. The needle body 31 extends downward 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.

[0077] In use, since the sensor 11 has a flexible structure, it cannot directly pierce the skin to enter the subcutaneous tissue. Therefore, the sensor 11's sensor is nested inside the needle body 31. The needle body 31 is used to pierce the skin and implant the sensor 11's sensor under the skin. After implantation, the puncture component 3 performs a needle withdrawal action to remove the needle from the human body.

[0078] The needle body 31 extends into the closed chamber 23, where it and the sensor 11's probe are kept in a closed, sterile environment, ensuring the cleanliness of both the needle body 31 and the sensor 11's probe. Preferably, the needle hub 32 is connected to the needle assist component 7, enabling the puncture component 3 and the needle assist component 7 to move together. When triggered by the user, the needle assist component 7 drives the puncture component 3 to move towards the skin to complete the implantation, providing power to the puncture component 3.

[0079] During implantation, the needle-assist component 7 drives the puncture component 3, the connecting seat 5, and the skin fixation seat 1 together to move towards the skin under the assistance of the spring. The needle punctures the skin and implants the sensor 11's probe under the skin, completing the implantation process. Then, the needle withdrawal action of the puncture component 3 is triggered, causing the puncture component 3 to move away from the skin on its own and withdraw from the skin, completing the needle withdrawal operation. The skin fixation seat 1 is then adhered and fixed to the skin surface, and the sensor 11's probe is located under the skin for real-time blood glucose monitoring.

[0080] This application does not limit the structure of the needle-assisting component 7. Existing structures can be used, as long as they can drive the connecting seat 5 to move toward the skin and drive the needle-retracting action of the puncture component 3.

[0081] like Figure 3 As shown, the connecting seat 5 and / or the needle seat 32 are provided with a first sealing part 33 capable of sealing the through hole 12 to ensure the sealing of the closed chamber 23. The first sealing part 33 is preferably made of an elastic material. When the needle seat 32 abuts against the connecting seat 5, the first sealing part 33 is compressed and undergoes elastic deformation, thereby sealing the gap between the two.

[0082] As a preferred embodiment of this implementation, such as Figure 1 , Figure 2 As shown, the connecting seat 5 is also provided with a limiting structure 4, which can at least restrict the puncture component 3 from moving out of the through hole 12.

[0083] The limiting structure 4 can limit the puncture component 3, ensuring a stable connection between the puncture component 3 and the skin fixation seat 1. On one hand, the puncture component 3 seals the through hole 12, and the stable position of both helps ensure the sealing reliability of the through hole 12, thereby ensuring the isolation of the closed chamber 23 from the outside world and ensuring that the sensor 11 and the needle body 31 are in a sterile environment. It also reduces the risk of detachment between the puncture component 3 and the skin fixation seat 1, and reduces the risk of damage to the skin fixation seat 1. On the other hand, the limiting structure 3 can restrict the movement of the puncture component 3, thereby preventing accidental contact when the cover 2 is not removed. Under the restriction of the limiting structure 4, the puncture component 3 cannot move and therefore cannot be implanted or withdrawn, improving the working reliability of the monitor and saving costs.

[0084] Specifically, such as Figure 1 , Figure 2 , Figures 14 to 17 As shown, the limiting structure 4 has a limiting hole 41. Both the limiting hole 41 and the needle seat 32 are non-circular structures. The limiting hole 41 can rotate relative to the needle seat 32 along with the limiting structure 4. When the limiting hole 41 rotates to the position where it coincides with the needle seat 32, the limiting structure 4 is in an unlocked state. At this time, the limiting structure 4 loses its stop on the needle seat 32, and the puncture component 3 can pass through the limiting hole 41. When the limiting structure 4 rotates to the point where the limiting hole 41 and the needle seat 32 are misaligned, the limiting structure 4 is in a locked state. The limiting structure 4 forms a stop on the needle seat 32, preventing it from passing through the limiting hole 41.

[0085] In another embodiment, such as Figure 15 As shown, the inner wall of the limiting hole 41 is provided with a protrusion structure 411, and the outer wall of the needle seat 32 is provided with a corresponding groove structure. When the two rotate to overlap, the needle seat 32 is unlocked, and when the two are misaligned, the needle seat 32 is locked.

[0086] Furthermore, the limiting structure 4 rotates synchronously with the housing 2. Before the monitor is used, the housing 2 abuts against the skin fixation seat 1 to form a closed chamber 23, keeping the sensor 11's stylus and needle body 31 in a closed, sterile environment. During use, the housing 2 is removed by rotation, exposing the sensor 11's stylus and needle body 31 for easy implantation. Simultaneously, during the removal of the housing 2, the limiting structure 4 rotates synchronously, thereby unlocking the puncture component 3 and allowing it to move for implantation. This achieves simultaneous unlocking of the housing 2 and the puncture component 3, enabling the unlocking of multiple components in a single operation, simplifying the process, reducing the complexity of product use, and greatly improving the user experience.

[0087] Furthermore, such as Figure 1 , Figure 2 , Figure 10 , Figure 11 , Figure 14 As shown, the limiting structure 4 includes a lever 42, and the open end of the cover 2 is provided with a mounting groove 211. The mounting groove 211 is used to engage the lever 42, and the cover 2 can drive the limiting structure 4 to rotate to change from a locked state to an unlocked state.

[0088] Specifically, such as Figure 1 , Figure 2 As shown, the open end of the cover 2 surrounds the outer periphery of the skin fixation seat 1. The actuating rod 42 engages with the mounting groove 211 at the open end of the cover 2 and extends radially inward along the cover 2 to engage with the puncture assembly 3. The two groove walls of the mounting groove 211 are located on both sides of the mounting groove 211 along the circumference of the cover 2, thereby forming a circumferential limit on the actuating rod 42. When the cover 2 rotates, the actuating rod 42 is pushed to rotate synchronously with the cover 2 by the abutting action of the groove wall on one side of the mounting groove 211.

[0089] Furthermore, such as Figure 1 , Figure 2 , Figure 10 , Figure 11 As shown, the mounting slot 211 has an upward opening at the corresponding second position, so that when the user removes the cover 2, the lever 42 can slide out of the opening and disengage from the cover 2, allowing the cover 2 to be removed, while the lever 42 remains inside the monitor, without affecting the operation of the internal components.

[0090] As a preferred embodiment of this application, such as Figure 2 , Figure 12 , Figure 14 As shown, the sterilization assembly also includes a guide assembly for rotating the guide limiting structure 4. The guide assembly includes a guide groove 43 and a guide slider 51. One of the guide groove 43 and the guide slider 51 is disposed on the limiting structure 4, and the other is disposed on the connecting seat 5.

[0091] Specifically, such as Figure 3 As shown, the skin fixation 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 groove 43 and the guide slider 51 cooperate to guide the rotation of the limiting structure 4, improve the reliability of the movement of the limiting structure 4, and make the limiting structure 4 move along a fixed path, thereby ensuring that the limiting hole 41 coincides with the needle seat 32 and is in the unlocked state, ensuring that the puncture assembly 3 can smoothly complete the needle withdrawal action.

[0092] It should be noted that this embodiment does not specifically limit the structure of the guide component. In one embodiment, such as... Figure 12 , Figure 14 As shown, the guide groove 43 is provided on the limiting structure 4, and the guide slider 51 is provided on the top surface of the connecting seat 5 and extends along the circumference of the connecting seat 5 to guide the limiting structure 4 to rotate along the circumference of the connecting seat 5.

[0093] Of course, the guide groove 43 can also be set on the connecting seat 5, and the guide slider 51 can be set on the limiting structure 4, without specific limitations.

[0094] Furthermore, such as Figure 2 , Figure 12 , Figure 14 As shown, the limiting structure 4 includes a check rib 44, and a check protrusion 52 is provided on the cover 2 and / or the connecting seat 5. 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 restrict the limiting structure 4 from rotating from the second position to the first position.

[0095] The cooperation between the check rib 44 and the check protrusion 52 makes the unlocking movement of the limiting structure 4 an irreversible operation. Once the limiting structure 4 rotates to the unlocked state, the stop action of the check rib 44 and the check protrusion 52 restricts the limiting structure 4 to that position, preventing it from rotating back to the locked state. This ensures that the puncture component 3 can smoothly complete the needle withdrawal action, guaranteeing the reliability and safety of the product, further preventing the product from being reused, and reducing the risk of cross-infection.

[0096] In a preferred example, such as Figure 12 As shown, the top surface of the connecting seat 5 is provided with a guide slider 51, and the check protrusion 52 is provided on the guide slider 51 to realize the integration of check and guide functions, making one piece serve multiple purposes, improving the compactness of the internal structure of the monitor, and saving costs.

[0097] As a preferred option, such as Figure 2 , Figure 12 , Figure 14 As shown, 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 restrict the limiting structure 4 from continuing to move away from the first position.

[0098] The limiting member 45 and the blocking member work together to limit the rotation angle of the limiting structure 4. When the limiting structure 4 rotates to the second position, the puncture component 3 is unlocked. At this time, under the stopping action of the limiting member 45 and the blocking member, the limiting structure 4 cannot continue to rotate, thereby locking the position of the limiting structure 4 and keeping it in the unlocked state. This can prevent the puncture component 3 from locking again due to excessive rotation of the limiting structure 4, and ensure that the puncture component 3 can smoothly complete the needle withdrawal action.

[0099] Preferred, such as Figure 12 , Figure 14 As shown, the limiting member 45 is a protrusion provided on the limiting structure 4, and the blocking member is provided on both sides of the limiting structure 4. The area between the two is the stroke of the limiting structure 4, which forms a blocking limit on the limiting structure 4 at both positions.

[0100] In a preferred embodiment of this application, such as Figure 1 , Figure 2 , Figure 12 , Figure 13 As shown, the sterilization assembly also includes a connecting seat 5 for mounting the skin fixation seat 1. The connecting seat 5 is provided with a pressing part 53, which cooperates with the connecting seat 5 to clamp the limiting structure 4.

[0101] The clamping part 53 applies downward pressure to the needle seat 32, pressing the puncture assembly 3 onto the connecting seat 5, thereby fixing the puncture assembly 3. Preferably, the clamping part 53 is located on at least one side of the limiting structure 4, so that the side wall of the clamping part 53 can form a stop with the limiting structure 4, thereby limiting the amount of rotation of the limiting structure 4, that is, the clamping part 53 constitutes the aforementioned blocking member.

[0102] Furthermore, when the cover 2 is disassembled, the limiting structure 4 is separated from the cover 2. Under the action of the clamping part 53, the limiting structure 4 is still firmly pressed onto the connecting seat 5, thereby preventing the limiting structure 4 from moving inside the monitor after losing its limiting function and affecting the operation of other components.

[0103] Specifically, such as Figure 12 , Figure 13 As shown, the clamping part 53 is a rib that is provided on the top surface of the connecting seat 5 and extends upward. The top of the rib is bent to form a clamping claw. An accommodating space is formed between the clamping claw and the top surface of the connecting seat 5. The limiting structure 4 is placed in the accommodating space. The clamping claw exerts a downward squeezing force on the limiting structure 4.

[0104] As a preferred embodiment of this application, such as Figure 3 As shown, the cover 2 includes an outer shell 22 and an inner shell 21. The inner shell 21 is located at the lower part of the skin fixation seat 1, and a second sealing part is provided between the inner shell 21 and the skin fixation seat 1.

[0105] It is understandable that the outer shell 22 and the inner shell 21 may or may not be connected.

[0106] The inner shell 21 of the cover 2 abuts against the bottom surface of the skin fixation seat 1. On the one hand, it cooperates with the skin fixation seat 1 to form a closed chamber 23, and the second sealing part ensures the sealing of the closed chamber 23. On the other hand, the inner shell 21 can also provide upward support to the skin fixation seat 1, making the fixation of the skin fixation seat 1 more stable and preventing the skin fixation seat 1 from falling off before implantation.

[0107] It should be noted that this embodiment does not specifically limit the structure of the second sealing part. In one specific example, such as Figure 8 As shown, the second sealing part is an annular sealing strip 16 disposed on the bottom surface of the skin fixation seat 1, and the inner shell 21 is also an annular structure, thereby abutting and sealing with the annular sealing strip 16 to form a closed chamber 23 inside.

[0108] In another specific example, such as Figure 9 As shown, the bottom surface of the skin fixation seat 1 has an adhesive layer 17, the adhesive layer has a first clearance area 171, the second sealing part is disposed in the first clearance area 171, and the abutting end of the inner shell 21 is located in the first clearance area 171.

[0109] Understandably, the adhesive layer 17 is coated with adhesive, so that when the bottom surface of the skin fixation seat 1 comes into contact with the skin, it will adhere to the skin surface under the action of adhesive force. The first clearance area 171 has no adhesive and therefore does not have adhesiveness. The inner shell 21 abuts against the first clearance area 171, which can prevent the inner shell 21 from sticking to the adhesive layer 17 and causing the adhesive to be destroyed when the cover 2 is removed. It can also prevent the inner shell 21 from rubbing the adhesive when the cover 2 and the skin fixation seat 1 rotate relative to each other, which would cause the adhesive layer 17 to wrinkle and affect the bonding effect.

[0110] Furthermore, such as Figure 10 As shown, a support column 212 is also provided inside the outer shell 22, and the support column 212 can abut against the lower part of the skin fixation seat 1.

[0111] The support column 212 increases the contact area between the cover 2 and the skin fixation seat 1, thereby improving the support stability of the cover 2 for the skin fixation seat 1. Preferably, as... Figure 10 As shown, there are two support columns 212, so that the inner shell 21 and the support columns 212 together abut against the skin fixation seat 1, forming a three-point support for the skin fixation seat 212.

[0112] like Figure 9 , Figure 10 As shown, there are two support columns 212. Both the support columns 212 and the inner shell 21 are eccentrically positioned relative to the cover 2, and the line connecting the three forms an approximately isosceles triangle. This is to further improve the support stability of the inner shell 21 and the support columns 212 for the skin fixation seat 1 and prevent the skin fixation seat 1 from tilting.

[0113] As a preferred embodiment of this implementation, such as Figures 10 to 13 As shown, at least a portion of the outer casing 22 surrounds the outer periphery of the connecting seat 5. One of the outer casing 22 and the connecting seat 5 is provided with a fixing protrusion 54, and the other is provided with a snap-fit ​​position 213. The snap-fit ​​position 213 has a guide section 2131 and a locking section 2132 that are connected to each other, so that the outer casing 22 and the connecting seat 5 can be rotated and snapped together.

[0114] Specifically, such as Figure 1 , Figure 2 As shown, at least a portion of the outer casing 22 surrounds the outer periphery of the connector 5, with one of the fixing protrusion 54 and the snap-fit ​​position 213 disposed on the outer periphery of the connector 5 and the other disposed on the inner wall of the outer casing 22.

[0115] like Figures 10 to 13As shown, in one embodiment, the outer periphery of the connecting seat 5 is provided with a fixing protrusion 54, and the inner wall of the outer shell 22 is provided with a fixing groove to form the snap-fit ​​position 213. During assembly, the fixing protrusion 54 is inserted into the fixing groove from the guide section, and then the cover 2 is rotated to make the fixing protrusion 54 slide along the fixing groove to the locking section 2132, thus completing the locking of the cover 2 and the connecting seat 5. Conversely, the cover 2 is rotated in the opposite direction to make the fixing protrusion 54 move to the guide section 2131, and then the cover 2 is pulled out along the opening direction of the guide section 2131 to remove the cover 2.

[0116] Of course, the fixing protrusion 54 can also be set on the inner wall of the cover 2, and the corresponding snap-fit ​​position 213 can be set on the outer periphery of the connecting seat 5. No specific limitation is made here.

[0117] Preferred, such as Figure 12 , Figure 13 As shown, the side wall of the connecting seat 5 is provided with a plurality of elastic ribs 55. When the cover 2 is fixed to the connecting seat 5, the cover 2 abuts against the elastic ribs 55 so that the elastic ribs 55 move toward the skin fixation seat 1 to clamp the skin fixation seat 1.

[0118] A portion of the casing 2 surrounds the outer periphery of the skin fixation seat 1. When the casing 2 is not removed, the elastic ribs 55 of the connecting seat 5 move inward under the pressure of the casing 2, thereby compressing the skin fixation seat 1 and securing it firmly, improving the connection stability of the skin fixation seat 1 and preventing it from falling off. When the user performs the implantation procedure, the casing 2 is removed. At this time, the elastic ribs 55 lose their compression and return to their original position, i.e., they expand outward, releasing the skin fixation seat 1. At this point, the skin fixation seat 1 can detach from the connecting seat 5 under the adhesive force with the human skin and remain on the skin surface. This application unlocks the skin fixation seat 1 while removing the casing 2, further simplifying the operation steps and improving the user experience.

[0119] Preferred, such as Figure 12 , Figure 13 As shown, there are multiple elastic ribs 55, which are spaced apart along the circumference of the connecting seat 5.

[0120] Furthermore, such as Figure 4 , Figure 5 , Figure 12 , Figure 13As shown, a fixing rib 551 is provided on the side of the elastic rib 55 facing the skin fixation seat 1. A mating groove 14 is provided on the outer periphery of the skin fixation seat 1 corresponding to the elastic rib 55. When the elastic rib 55 moves toward the skin fixation seat 1, the fixing rib 551 extends into the mating groove 14, making the clamping of the connecting seat 5 on the skin fixation seat 1 more stable, and preventing the skin fixation seat 1 from rotating circumferentially due to vibration or other factors during transportation. When the cover 2 is removed, the elastic rib 55 moves outward to reset, and the fixing rib 551 slides out of the mating groove 14.

[0121] In another embodiment of this implementation, such as Figure 12 As shown, the connecting seat 5 has a through hole 56, which is correspondingly provided with the through hole 12. At least a portion of the needle seat 32 is engaged with the through hole 56 to restrict the rotation of the puncture assembly 3 relative to the connecting seat 5.

[0122] Specifically, before implantation, the protruding structure of the needle hub 32 is located within the through hole 56 to restrict the rotation of the puncture component 3 relative to the connecting seat 5. At the same time, the protruding structure of the needle hub 32 abuts against the limiting structure 4, so that the needle hub 32 is in a locked state. After the limiting structure 4 is unlocked, the protruding structure of the needle hub 32 disengages from the limiting structure 4. When the puncture component 3 retracts, the protruding structure of the needle hub 32 can pass through the limiting hole 41 to complete the needle retraction action.

[0123] As a preferred embodiment of this application, such as Figure 3 , Figure 5 , Figure 6 , Figure 7 As shown, the sterilization assembly also includes a sensor electronic unit 13. The sensor 11 includes a coupling part 18 located in the mounting port 58. The coupling part 18 is provided with a first contact 181. The sensor electronic unit 13 has a second contact. The first contact 181 and the second contact can be coupled together.

[0124] The coupling part 18 of the sensor 11 is located inside the mounting port 58, so that after the sensor electronic unit 13 is installed on the skin fixation seat 1 through the mounting port 58, the coupling of the first contact 181 and the second contact can be completed simultaneously, reducing the difficulty of operation, greatly reducing the difficulty of coupling the two, and improving the ease of assembly.

[0125] In one embodiment, such as Figure 7 As shown, the first contact 181 faces upward, and the second contact is located in the sensor electronic unit 13 and faces downward, so that the first contact 181 and the second contact are coupled in the vertical direction when the sensor electronic unit 13 is installed.

[0126] In another embodiment, the first contact 181 faces to one side, and the second contact also faces to one side and is opposite to the first contact 181, so that when the sensor electronics unit 13 is installed, the first contact 181 and the second contact are laterally coupled.

[0127] like Figures 18 to 22 As shown, the continuous glucose monitor includes a housing 6 and a needle assembly 7 placed inside the housing 6, as well as the aforementioned continuous glucose monitor sterilization assembly. The sterilization assembly also includes a puncture assembly 3, which includes a needle body 31 and a needle seat 32. The needle seat 32 has a locking groove 321 and a limiting groove 322. The locking groove 321 is used to connect with the needle assembly 7, and the limiting groove 322 is used to cooperate with the limiting structure 4.

[0128] The needle hub 32 is connected to the needle assist component 7, enabling the puncture component 3 and the needle assist component 7 to work together. When the user triggers the device, the needle assist component 7 drives the puncture component 3 to move toward the skin to complete the implantation action, providing power to the puncture component 3.

[0129] like Figure 1 , Figure 2 , Figure 18 As shown, the connector 5 also has a hook portion 57 for engaging and fixing with the needle assembly 7.

[0130] Preferred, such as Figure 1 , Figure 2 , Figure 3 , Figure 20 As shown, the housing 2 includes an outer cover 24, an outer shell 22, and an inner shell 21. The housing 6 and the outer shell 22 are connected. The inner shell 21 abuts against the bottom surface of the skin fixation seat 1 to form a closed cavity 23, while the outer cover 24 is connected to the housing 6, enclosing all the components of the monitor within the cavity formed by the two.

[0131] like Figure 19 , Figure 22 As shown, the housing 6 is provided with a trigger structure 61. The user can trigger the monitor by operating the trigger structure 61 to complete the entire implantation and needle withdrawal process.

[0132] Trigger structure 61 can be Figure 19 The button shown can be triggered by pressing, or it can be used for... Figure 22 The push structure shown is triggered by pushing it downwards.

[0133] At the time of manufacture, the puncture component 3, skin fixation seat 1, and connecting seat 5 inside the continuous glucose monitor of this application are all locked, preventing the user from triggering the implantation and greatly increasing the risk of accidental triggering. The operation method of the continuous glucose monitor of this application is as follows: First, rotate the housing 2 to simultaneously unlock the connecting seat 5, skin fixation seat 1, and needle assist component 7. Then, remove the housing 2, exposing the sensor 11's probe and the needle body 31 of the puncture component 3. Next, place the open end of the housing 6 onto the skin and trigger the trigger structure 61 by pressing or other operations. At this time, the housing 6 loses its restraint on the needle assist component 7, and the needle assist component 7 drives the puncture component 3, connecting seat 5, and skin fixation seat 1 together to move towards the skin under the assistance of a spring. The body punctures the skin and inserts the probe of sensor 11 under the skin, completing the implantation process. Then, the needle withdrawal action of puncture component 3 is triggered, causing puncture component 3 to move away from the skin relative to needle assist component 7 and withdraw from under the skin, completing the needle withdrawal operation. Skin fixation seat 1 is then adhered and fixed to the skin surface. At the same time, when the other parts of the monitor are removed, skin fixation seat 1 and connecting seat 5 are released, thus completing the entire implantation process. After implantation, only skin fixation seat 1 remains on the skin surface, and the probe of sensor 11 is located under the skin for real-time monitoring.

[0134] This application also discloses a sterilization method for a continuous glucose monitor, comprising the following steps:

[0135] The first sterilization unit is subjected to a first sterilization process. The first sterilization unit includes a housing 2, a connecting seat 5, and a puncture assembly 3. A sensor 11 and a skin fixation seat 1 are installed in the mounting cavity formed by the connecting seat 5. The connecting seat 5 is also provided with an installation port 58. The skin fixation seat 1 and the housing 2 cooperate to form a closed chamber 23. The skin fixation seat 1 is provided with a through hole 12. One end of the sensor 11 is fixed to the skin fixation seat 1, and the other end extends downward into the closed chamber 23 through the through hole 12. At least a part of the puncture assembly 3 extends downward into the closed chamber 23 through the through hole 12. At least a part of the sensor 11 is nested inside the puncture assembly 3.

[0136] The second sterilization unit is subjected to a second sterilization process. The second sterilization unit includes the first sterilization unit and the sensor electronic unit 13. The sensor electronic unit 13 is installed on the skin fixation seat 1 through the mounting port 58.

[0137] The sterilization components are divided into two sterilization units, which are then sterilized sequentially using two different methods. In the first sterilization unit, only the sensor 11 is installed onto the skin fixation base 1, while the sensor electronic unit 13 is not installed. Radiation sterilization is then performed on the first sterilization unit, and the sensor 11 is sterilized. Since the sensor electronic unit 13 is not installed onto the skin fixation base 1, its circuitry is not affected by radiation sterilization. After sterilization of the first sterilization unit, the sensor 11's stylus is sealed within a closed chamber 23, isolating the chamber from the outside environment. Then, the sensor electronic unit 13 is installed onto the skin fixation base 1. The second sterilization step, such as ethylene oxide gas sterilization, is then performed. Because the closed chamber 23 provides insulation, the gas will not enter and affect the bio-enzymes on the sensor 11's stylus. By installing and sterilizing the sensor 11 and sensor electronic unit 13 in stages, the sterilization effect is greatly improved, and the adverse effects of different sterilization methods on both are largely avoided. This increases the yield rate and monitoring accuracy of the monitor, ensuring product performance.

[0138] Preferred, such as Figure 18 As shown, the second sterilization unit also includes a needle assist assembly 7, which is connected to the connector 5.

[0139] The connector 5 is connected to the needle-assisting component 7, which allows the needle-assisting component 7 to move the connector 5 toward the skin to perform the implantation action. The skin fixation seat 1 is fixed to the connector 5, so the skin fixation seat 1 will also move accordingly.

[0140] Preferred, such as Figure 12 , Figure 13 , Figure 18 As shown, the connecting seat 5 has a hook portion 57 protruding towards the needle-assisting assembly 7. The needle-assisting assembly 7 has a locking interface, and the hook portion 57 engages with the locking interface to secure the two together. After the sensor electronic unit 13 is installed on the skin fixation seat 1 through the mounting port 58, the needle-assisting assembly 7 is connected to the connecting seat 5 through the hook portion 57 to form the second sterilization unit, and then the second sterilization process is performed.

[0141] Of course, the connector 5 can also be connected to the needle assembly 7 in other ways, such as magnetic attraction, etc., without specific limitations.

[0142] For any parts not mentioned in this application, existing technologies may be used or referenced.

[0143] The various embodiments in this specification are described in a progressive manner. The same or similar parts between the various embodiments can be referred to each other. Each embodiment focuses on describing the differences from other embodiments.

[0144] The above description is merely an embodiment of this application and is not intended to limit the scope of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of the claims of this application.

Claims

1. A continuous blood glucose monitor sterilization assembly, comprising a sensor and a skin mount, characterized in that, a cover and a connecting base are further included, the skin mount is provided with a through hole, the cover is matched with the lower part of the skin mount and forms a closed chamber, one end of the sensor is fixed with the skin mount, and the other end extends downward into the closed chamber through the through hole of the skin mount, the connecting base is provided with a skin mount mounting cavity, and the connecting base is further provided with a mounting port for mounting a sensor electronic unit to the skin mount; the cover is fixed to the connecting base, the sterilization assembly further comprises a needle assisting assembly, the connecting base is further provided with a hook part to connect the connecting base with the needle assisting assembly; a plurality of elastic rib positions are arranged on the side wall of the connecting base, when the cover is not removed, the cover abuts against the elastic rib positions to make the elastic rib positions move towards the skin mount to clamp the skin mount, when the cover is removed, the elastic rib positions expand outward to reset to loosen the skin mount, so that the skin mount can be separated from the connecting base under the adhesion force with the human skin.

2. The continuous blood glucose monitor sterilization assembly according to claim 1, characterized in that, the outer side of the connecting base and / or the inner side of the cover is further provided with a clamping position to clampingly fix the cover with the connecting base.

3. The continuous blood glucose monitor sterilization assembly according to claim 1, characterized in that, a puncture assembly is further included, the puncture assembly comprises a needle body and a needle base, the needle body extends downward into the closed chamber through the through hole, and the sensor is at least partially nested inside the needle body.

4. The continuous blood glucose monitor sterilization assembly according to claim 3, characterized in that, the connecting base and / or the needle base is provided with a first sealing part capable of sealing the through hole.

5. The continuous blood glucose monitor sterilization assembly according to claim 1, characterized in that, the cover comprises a set outer shell and an inner shell, the inner shell is arranged at the lower part of the skin mount, and a second sealing part is arranged between the inner shell and the skin mount.

6. The continuous blood glucose monitor sterilization assembly according to claim 5, characterized in that, at least part of the outer shell surrounds the outer periphery of the connecting base, one of the outer shell and the connecting base is provided with a fixed protrusion, and the other is provided with a clamping position, the clamping position has a guide section and a locking section connected with each other, so that the outer shell and the connecting base are rotationally clamped.

7. The continuous blood glucose monitor sterilization assembly according to claim 5, characterized in that, a support column is further arranged in the outer shell, and the support column can abut against the lower part of the skin mount.

8. The continuous blood glucose monitor sterilization assembly according to claim 1, characterized in that, a sensor electronic unit is further included, the sensor comprises a coupling part arranged in the mounting port, the coupling part is provided with a first contact, the sensor electronic unit has a second contact, and the first contact and the second contact can be coupled and connected.

9. A sterilization method for a continuous glucose monitor, applied to the sterilization assembly of the continuous glucose monitor according to any one of claims 1-8, characterized in that, comprising the following steps: The sterilization assembly comprises a first sterilization unit and a second sterilization unit, the first sterilization unit is subjected to first sterilization treatment, wherein the first sterilization unit comprises a cover, a connecting seat and a puncture assembly, the connecting seat forms an installation cavity in which a sensor and a skin fixing seat are installed, the connecting seat is further provided with an installation opening, the skin fixing seat cooperates with the cover to form a closed cavity, the skin fixing seat is provided with a through hole, one end of the sensor is fixed to the skin fixing seat, the other end of the sensor extends downward into the closed cavity through the through hole, at least part of the puncture assembly extends downward into the closed cavity through the through hole, and at least part of the sensor is nested in the puncture assembly; The second sterilization unit is subjected to second sterilization treatment, wherein the second sterilization unit comprises the first sterilization unit and a sensor electronic unit, and the sensor electronic unit is installed on the skin fixing seat through the installation opening.

10. The sterilization method according to claim 9, characterized in that, The second sterilization unit further comprises a needle assisting assembly, and the needle assisting assembly is connected to the connecting seat.

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