Analyte concentration monitoring system and methods of use

Abstract

The application provides an analyte concentration monitoring system and a use method. The system comprises an implant assembly and a sterilization assembly. The sterilization assembly comprises a sensor electrode and a protective cap. An inner part of the protective cap is formed with a sealed sterilization cavity. An in-vivo part of the sensor electrode is arranged in the sterilization cavity. The protective cap is arranged with a trigger member. The trigger member is configured to be operated to separate the protective cap from the sensor electrode. The sterilization assembly further comprises a holding part. A first locking part is formed between the protective cap and the holding part. The first locking part is configured to prevent the protective cap from rotating relative to the holding part along a first direction. The first locking part is released when the trigger member is operated. The application can avoid separating the protective cap from the sensor electrode in a rotating manner before formal use, especially avoid rotating the protective cap due to misoperation when the protective cap is mounted on the implant, and ensure that the sensor electrode is in a sterile environment before formal use.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an analyte concentration monitoring system and its usage method. Background Technology

[0002] Some physiological conditions require monitoring the concentration of specific analytes in the body; for example, diabetic patients need to monitor their blood glucose levels. Currently, the most commonly used technology is the finger-prick blood glucose meter, where patients collect blood from the fingertip to monitor blood glucose levels. However, this method provides discontinuous monitoring and can cause pain for the patient. To overcome the shortcomings of finger-prick blood glucose meters, a monitoring technology has emerged that allows for continuous subcutaneous blood glucose monitoring via implantation in the subcutaneous tissue. This involves implanting sensor electrodes in the subcutaneous tissue, which generate an electrical signal through an oxidation reaction with the patient's interstitial fluid. This signal is then converted into a blood glucose reading by a transmitter and sent to a wireless receiver for reference by the patient and doctor.

[0003] Sensor electrodes and puncture needles must be sterile when inserted into subcutaneous tissue. Some continuous glucose monitoring systems employ separate sterilization processes to sterilize the sensor electrodes and electronic components, such as radiation sterilization. However, since radiation sterilization can damage the electronic components associated with the sensor electrodes, ethylene oxide is typically used to sterilize the electronic components. Nevertheless, ethylene oxide can damage the chemicals on the sensor electrodes; therefore, integrating the sensor electrodes and electronic components into a single unit complicates the sterilization process.

[0004] These problems can be circumvented by separating the components into sensor units (containing sensor electrodes) and transmitter units (containing electronic components), allowing each component to be individually packaged and sterilized using appropriate sterilization methods. For example, after sterilization, the sensor unit can be housed in a protective cap, forming a sterile cavity between the cap and the sensor unit to accommodate the sensor electrodes. The cap can be rotated to assemble or detach from the sensor unit. This can lead to accidental separation of the cap from the sensor unit before actual use, compromising the sterile environment of the sensor unit and rendering it unusable.

[0005] To address the aforementioned issues, existing analyte concentration monitoring systems only allow the protective cap to rotate relative to the sensor unit after it has been installed on the implanter. This approach only prevents the protective cap from separating from the sensor unit due to misoperation before installation. Even after installation, the protective cap can still separate from the sensor unit due to misoperation. For example, if the protective cap is rotated and separated before intended use, it disrupts the sterile environment of the sensor unit. Currently, there is no effective method to solve this problem. Summary of the Invention

[0006] The purpose of this invention is to provide an analyte concentration monitoring system and method of use, which can avoid separating the protective cap and sensor electrode by rotation before formal use, especially avoiding accidental rotation of the protective cap when it is installed on the implanter, and ensuring that the sensor electrode is in a sterile environment before formal use.

[0007] To achieve the above-mentioned objectives, the technical solution adopted by the present invention is: an analyte concentration monitoring system, comprising an implantation assembly and a sterilization assembly, wherein the sterilization assembly comprises a sensor electrode and a protective cap, the interior of the protective cap forms a sealed sterilization chamber, the internal portion of the sensor electrode is disposed in the sterilization chamber, and the protective cap is provided with a triggering member configured to respond to an operation to separate the protective cap from the sensor electrode.

[0008] In the above technical solution, when the sterilization component is coupled to the implantation component, the triggering component is allowed to be operated to separate the protective cap from the sensor electrode.

[0009] In the above technical solution, the sterilization component further includes a retaining part, and a first locking part is formed between the retaining part and the protective cap. The first locking part is configured to prevent the protective cap from rotating relative to the retaining part along a first direction. When the triggering member is operated, the first locking part is released.

[0010] In the above technical solution, the first locking part includes a first locking member disposed on the retaining part and a second locking member disposed on the protective cap, wherein the first locking member and the second locking member cooperate to lock.

[0011] In the above technical solution, the first locking member and the second locking member are located on the same circumference.

[0012] In the above technical solution, the free end of the first locking member has an elastic tendency to open toward the second locking member.

[0013] In the above technical solution, the free end of the first locking member deflects in a direction away from the second locking member in response to the action of the triggering member.

[0014] In the above technical solution, the triggering component is a button configured on the protective cap.

[0015] In the above technical solution, the button has a guide slope facing the first locking member.

[0016] In the above technical solution, the button is a disposable button configured on the protective cap.

[0017] In the above technical solution, the protective cap has an operating hole for accommodating the button, the operating hole has a first limiting part inside, the button has a second limiting part, and the first limiting part is configured to interlock with the second limiting part when the button is pressed.

[0018] In the above technical solution, the second locking member is an arc-shaped rib extending along the circumference, and a channel is formed between the second locking member and the protective cap for the first locking member to pass through.

[0019] In the above technical solution, the second locking member is an arc-shaped rib that extends inward along both the second direction and the radial direction, and the second direction is the opposite direction to the first direction.

[0020] In the above technical solution, the protective cap is coupled to the implant assembly via a retaining part.

[0021] In the above technical solution, the sterilization component further includes a body surface attachment unit installed inside the protective cap, and a second locking part is formed between the body surface attachment unit and the retaining part. The second locking part is configured to prevent the retaining part from rotating relative to the body surface attachment unit along a first or second direction.

[0022] In the above technical solution, the second locking part includes a plurality of latches distributed circumferentially along the edge of the body surface attachment unit and corresponding latch blocks distributed on the retaining part, wherein the latches and the latch blocks cooperate to lock.

[0023] In the above technical solution, the sterilization component further includes a needle assembly installed on the body surface attachment unit. The needle assembly includes a needle hub and a puncture needle attached to the needle hub. A third locking part is formed between the needle hub and the body surface attachment unit. The third locking part is configured to prevent the needle hub from rotating relative to the body surface attachment unit along a first or second direction.

[0024] In the above technical solution, the third locking part includes a shaped waist formed on the needle seat and a boss with a shaped hole formed on the body surface attachment unit. When the needle assembly is installed on the body surface attachment unit, the shaped waist is embedded into the shaped hole of the boss and locks with the shaped hole.

[0025] In the above technical solution, a fourth locking part is formed between the protective cap and the implant assembly. The fourth locking part is configured to prevent the protective cap from rotating relative to the implant assembly in the second direction and to prevent the protective cap from moving in the direction away from the implant assembly.

[0026] In the above technical solution, the fourth locking part includes a third locking member disposed on the implant assembly and a fourth locking member disposed on the protective cap, wherein the third locking member and the fourth locking member cooperate to lock.

[0027] In the above technical solution, the puncture needle is sleeved on the body part of the sensor electrode and is disposed together with the body part of the sensor electrode in the sterilization chamber.

[0028] The present invention also provides a method of using an analyte concentration monitoring system, including separating the protective cap from the sensor electrode only when the triggering member is operated.

[0029] In the above technical solution, the triggering component is a button, which separates the protective cap from the sensor electrode only when the button is pressed.

[0030] Due to the application of the above-mentioned technical solution, the present invention has the following advantages compared with the prior art: This invention enables the protective cap to be separated from the sensor electrode only when the triggering component is operated, thereby avoiding separation of the protective cap and sensor electrode before formal use. In particular, it can prevent the protective cap from being rotated due to accidental operation when it is installed on the implanter, ensuring that the sensor electrode is in a sterile environment before formal use. Attached Figure Description

[0031] Figure 1 This is a schematic diagram of a continuous blood glucose monitoring system according to an embodiment of the present invention.

[0032] Figure 2 This is a schematic diagram of the continuous blood glucose monitoring system according to an embodiment of the present invention.

[0033] Figure 3 yes Figure 2 A magnified view of a portion of the irregularly shaped hole.

[0034] Figure 4 This is a schematic diagram of the sterilization component structure in the initial state of the triggering component being operated according to an embodiment of the present invention.

[0035] Figure 5 yes Figure 4 A magnified view of a portion of point B in the middle.

[0036] Figure 6 This is a schematic diagram of the sterilization component structure during the operation of the triggering component in an embodiment of the present invention.

[0037] Figure 7 yes Figure 6 A magnified view of a portion of point C.

[0038] Figure 8 This is a schematic diagram of the implanter component according to an embodiment of the present invention.

[0039] Figure 9 This is a schematic diagram of the installation of the implant component and protective cap according to an embodiment of the present invention.

[0040] Wherein: 100, host; 200, body surface attachment unit; 210, sensor electrode; 300, receiver; 400, implant assembly; 500, sterilization assembly; 510, protective cap; 511, operating hole; 512, first limiting part; 520, holding part; 530, first locking part; 531, first locking member; 532, second locking member; 5321, channel; 533, triggering member; 5331, second limiting part; 5332, guide slope; 540, second locking part; 541, bayonet; 542, locking block; 550, needle assembly; 551, needle seat; 552, puncture needle; 560, third locking part; 561, irregular waist; 562, boss; 571, third locking member; 572, fourth locking member; 573, guide groove. Detailed Implementation

[0041] The following description and examples illustrate some exemplary embodiments of the disclosed invention. Those skilled in the art will recognize that many variations and modifications may be made to the embodiments of the invention.

[0042] Continuous Glucose Monitoring (CGM) System Please see Figure 1 This is a schematic diagram of a continuous glucose monitoring system attached to a host 100. The diagram shows a continuous glucose monitoring system including a skin attachment unit 200 with sensor electrodes 210, which is attached to the skin surface of the host 100 via an adhesive layer. The skin attachment unit 200 has a built-in circuit module electrically connected to the sensor electrodes 210, which transmits glucose concentration information monitored by the sensor electrodes 210 to a receiver 300, which can typically be a smartphone, smartwatch, dedicated device, or the like. During use, the sensor electrodes 210 are partially located beneath the skin of the host 100 and are in contact with subcutaneous tissue fluid.

[0043] The sensor electrode 210 includes an internal portion and an external portion. The internal portion refers to the part implanted under the skin of the host 100 and in contact with the subcutaneous tissue fluid, while the external portion refers to the part remaining outside the skin of the host 100. In one embodiment, the external portion of the sensor electrode 210 extends into the body surface attachment unit 200 and is attached to the circuit module to establish an electrical connection with the circuit module.

[0044] Please see Figure 2 and Figure 3This is a schematic diagram of a continuous glucose monitoring system, including an implantation component 400 and a sterilization component 500. After sterilization, the implantation component 400 and the sterilization component 500 are placed in two separate packages. The sterilization component 500 includes a protective cap 510 and a body surface attachment unit 200 with sensor electrodes 210 disposed in the protective cap 510. In use, open both packages separately. When installing the sterilization component 500 onto the implanter component 400, the protective cap 510 of the sterilization component 500 can be removed from the implanter component 400 by rotating it only when the trigger member 533 is pressed. This separates the protective cap 510 from the sensor electrode 210, exposing the sensor electrode 210. Then, attach the end of the implanter component 400 with the opening to the skin surface of the host 100. By operating the implanter component 400, the surface attachment unit 200 is applied to the skin surface of the host 100. At this time, the internal part of the sensor electrode 210 is implanted under the skin of the host 100 and comes into contact with the subcutaneous tissue fluid to continuously monitor the glucose concentration in the tissue fluid. After completing the application of the surface attachment unit 200, remove the implanter component 400, leaving only the surface attachment unit 200 on the skin surface of the host 100.

[0045] The present invention selects rotating the protective cap 510 along a first direction as the optimal solution for separating the protective cap 510 from the sensor electrode 210. However, this is not intended to limit the solution for separating the protective cap 510 from the sensor electrode 210. Other methods for separating the protective cap 510 from the sensor electrode 210 should be understood as approximate solutions to the above-mentioned optimal solution and included within the scope of protection of the present invention. For example, the protective cap 510 can also be separated from the sensor electrode 210 by insertion and removal. The direction of insertion and removal can be along the axial direction, radial direction, or at a certain angle to the axial direction of the sterilization assembly 500.

[0046] The adhesive layer can be, for example, medical nonwoven fabric.

[0047] Please see Figure 4 and Figure 5 This invention provides an analyte concentration monitoring system, taking the aforementioned continuous glucose monitoring system as an example. More particularly, it provides a novel sterilization component 500 structure that improves the removal method of the protective cap 510. This sterilization component 500 allows the protective cap 510 to rotate and separate from the sensor electrode 210 along a first direction only when the trigger member 533 is pressed. In one embodiment, the first direction can be counterclockwise. In one embodiment, the trigger member 533 can be a button.

[0048] Please continue reading Figure 4 and Figure 5The sterilization assembly 500 includes a protective cap 510, a body surface attachment unit 200 disposed in the protective cap 510, a sensor electrode 210 attached to the body surface attachment unit 200, and a holding portion 520 disposed in the protective cap 510. A first locking portion 530 is formed between the holding portion 520 and the protective cap 510. The first locking portion 530 has two working states: a locked state and a released state. When the trigger member 533 is not pressed, the first locking portion 530 is in the locked state; when the trigger member 533 is pressed, the first locking portion 530 is in the released state. When the first locking portion 530 is in the locked state, the first locking portion 530 is configured to prevent the protective cap 510 from rotating relative to the holding portion 520 along a first direction; when the first locking portion 530 is in the released state, the first locking portion 530 is configured to allow the protective cap 510 to rotate along the first direction.

[0049] Please continue reading Figure 4 The first locking part 530 includes a first locking member 531 disposed on the retaining part 520 and a second locking member 532 disposed on the protective cap 510, wherein the first locking member 531 and the second locking member 532 cooperate to lock.

[0050] In one embodiment, the first locking member 531 and the second locking member 532 are located on the same circumference.

[0051] In one embodiment, the free end of the first locking member 531 has an elastic tendency to open toward the second locking member 532, and will return to its original shape after the first locking member 531 is deformed by force.

[0052] In one embodiment, the button has a guide ramp 5332 facing the first locking member 531.

[0053] In one embodiment, the button is a one-time button configured on the protective cap 510, that is, the button cannot be reused after being pressed.

[0054] In one embodiment, the protective cap 510 has an operating hole 511 for accommodating a button, a first limiting portion 512 is formed within the operating hole 511, and a second limiting portion 5331 is formed on the button. The first limiting portion 512 is configured to interlock with the second limiting portion 5331 when the button is pressed. Figure 4 and Figure 5 Before the button is pressed, it is confined within the operating hole 511. A flange may be provided at the opening of the operating hole 511 to prevent the button from disengaging. The first limiting part 512 and the second limiting part 5331 are in a free state. Figure 6 and Figure 7When the button is pressed, the first limiting part 512 locks the second limiting part 5331, forming an interlocking limit. At the same time, since the button has entered the interior of the protective cap 510, the button cannot be operated from inside the protective cap 510. Therefore, the button cannot be reused after being pressed.

[0055] In one embodiment, the second locking member 532 is an arc-shaped rib extending circumferentially, and a channel 5321 is formed between the second locking member 532 and the protective cap 510 for the first locking member 531 to pass through. When the retaining part 520 and the protective cap 510 are installed together, the protective cap 510 is rotated in the second direction. At this time, the first locking member 531 moves along the second locking member 532 into the channel 5321. After passing the second locking member 532, the first locking member 531 returns to its original state and interlocks with the second locking member 532.

[0056] In one embodiment, the first locking member 531 and the second locking member 532 are engaged in the following manner: Figure 4 and Figure 5 When the trigger member 533 is not pressed, if the protective cap 510 is to be rotated in the first direction, the first locking member 531 is located on the movement path of the second locking member 532. At this time, the first locking member 531 and the second locking member 532 are interlocked, and the protective cap 510 cannot be rotated relative to the retaining part 520; please refer to Figure 6 and Figure 7 During the pressing of the trigger member 533, the guide slope 5332 of the trigger member 533 drives the first locking member 531 to move away from the second locking member 532, so that the first locking member 531 and the second locking member 532 are misaligned, thereby allowing the protective cap 510 to rotate relative to the retaining part 520 along the first direction. Then, the protective cap 510 is rotated along the first direction. At this time, the first locking member 531 moves along the channel 5321 to pass the second locking member, and the retaining part 520 and the protective cap 510 are in the unlocked state.

[0057] In one embodiment, the first locking member 531 is a sheet-like elastic plastic piece, the free end of which has an elastic tendency to open toward the second locking member 532.

[0058] Please see Figure 4 The protective cap 510 is coupled to the implanter assembly 400 via the retaining portion 520. For example, the retaining portion 520 has a plurality of hooks extending toward the implanter assembly 400, and the implanter housing or internal components of the implanter have notches corresponding to the hooks. When the sterilization assembly 500 is installed on the implanter assembly 400, the hooks pass through the notches and hook the edges of the notches, thereby coupling the retaining portion 520 to the implanter assembly 400.

[0059] Please continue reading Figure 2 A second locking portion 540 is formed between the body surface attachment unit 200 and the retaining portion 520. The second locking portion 540 is configured to prevent the retaining portion 520 from rotating relative to the body surface attachment unit 200 along a first or second direction. In one embodiment, the second locking portion 540 includes a plurality of slots 541 distributed circumferentially along the edge of the body surface attachment unit 200 and corresponding locking blocks 542 distributed on the retaining portion 520. When the retaining portion 520 is installed on the protective cap 510, the locking blocks 542 are inserted into the slots 541 and engage with the slots 541 to lock.

[0060] Please continue reading Figure 2 The sterilization assembly 500 also includes a needle assembly 550, which includes a needle hub 551 and a puncture needle 552 attached to the needle hub 551. A third locking portion 560 is formed between the needle hub 551 and the body surface attachment unit 200. The third locking portion 560 is configured to prevent the needle hub 551 from rotating relative to the body surface attachment unit 200 along a first or second direction. In one embodiment, the third locking portion 560 includes a shaped waist 561 formed on the needle hub 551 and a boss 562 with a shaped hole formed on the body surface attachment unit 200. When the needle assembly 550 is installed on the body surface attachment unit 200, the shaped waist 561 is inserted into the shaped hole of the boss 562 and engages with the shaped hole for locking.

[0061] Please see Figure 8 and Figure 9 A fourth locking portion is formed between the protective cap 510 and the implant assembly 400. The fourth locking portion is configured to prevent the protective cap 510 from rotating relative to the implant assembly 400 along the second direction and to prevent the protective cap 510 from moving away from the implant assembly 400. The state of the fourth locking portion is closely related to the state of the first locking portion 530. When the first locking portion 530 is in the locked state, the fourth locking portion is also in the locked state; when the first locking portion 530 is in the released state, it allows the fourth locking portion to be switched to the released state. That is, releasing the first locking portion 530 is a prerequisite for releasing the fourth locking portion.

[0062] Please continue reading Figure 8 and Figure 9 The fourth locking part includes a third locking member 571 disposed on the implant assembly 400 and a fourth locking member 572 disposed on the protective cap 510, the third locking member 571 and the fourth locking member 572 cooperating to lock.

[0063] Please continue reading Figure 9In one embodiment, the third locking member 571 and the fourth locking member 572 are coupled as follows: the third locking member 571 includes at least two limiting protrusions disposed on the implant assembly 400, and the fourth locking member 572 includes a limiting groove disposed on the protective cap 510 corresponding to the limiting protrusions. The limiting protrusions and limiting grooves are positioned in conjunction. For example, the limiting grooves are evenly distributed circumferentially on the outer surface of the protective cap 510. To save costs, two limiting grooves and two limiting protrusions are used.

[0064] To facilitate the assembly of the implanter assembly 400 and the protective cap 510, a guide groove 573 is provided at the opening of the limiting groove. For example, the guide groove 573 is connected to the limiting groove through the opening of the limiting groove and is perpendicular to the limiting groove. The opening of the guide groove 573 faces the implanter assembly 400.

[0065] In one embodiment, such as Figure 8 and Figure 9 The third locking member 571 is located on the inner wall of the implant assembly 400, and the protective cap 510 is provided with a flange. The fourth locking member 572 and the guide groove 573 are both located on the flange.

[0066] The first locking part 530, the second locking part 540, the third locking part 560, and the fourth locking part of the present invention cooperate with each other. The release of the first locking part 530 is a prerequisite for the release of the fourth locking part, so that the protective cap 510 can be rotated in the first direction to release the fourth locking part only when the trigger member 533 is pressed to release the first locking part 530. The second locking part 540 ensures that the body surface attachment unit 200 and the holding part 520 are relatively stationary when the protective cap 510 is rotated, and the third locking part 560 ensures that the body surface attachment unit 200 and the needle seat 551 are relatively stationary when the protective cap 510 is rotated. In summary, the cooperation of the second locking part 540 and the third locking part 560 ensures that the holding part 520, the body surface attachment unit 200, and the needle seat 551 are all in a relatively stationary state when the protective cap 510 is rotated. This ensures that when the sterilization assembly 500 is assembled, rotating the protective cap 510 in the second direction causes the first locking part 530 and the second locking part 540 to reach the locked state simultaneously.

[0067] This invention can effectively prevent the sensor electrode 210 and the puncture needle 552 from being exposed due to human operation before the product is officially used, thus preventing the sensor electrode 210 and the puncture needle 552 from being contaminated by bacteria and unable to be used normally.

[0068] The body surface attachment unit 200 and the mounting structure of the body surface attachment unit 200 and the needle assembly 550 involved in this invention have been disclosed in detail in the prior Chinese invention patent application 202111426719.8, therefore, they will not be described again in this invention.

[0069] The foregoing description provides, in such complete, clear, concise, and precise language, the best mode of carrying out the invention, as well as the manner and process of making and using it, so that any person skilled in the art may make and use the invention. However, the invention is readily adaptable to make completely equivalent modifications and substitutions to the foregoing description. Therefore, the invention is not limited to the specific embodiments disclosed. Rather, the invention covers all modifications and substitutions within the spirit and scope of the invention as set forth generally by the following claims, which specifically point out and distinctly define the subject matter of the invention. Although the invention has been illustrated and described in detail in the accompanying drawings and the foregoing description, such illustrations and descriptions should be considered exemplary rather than restrictive.

[0070] Unless otherwise specified, all terms (including technical and scientific terms) are used in their ordinary and customary meaning to those skilled in the art and are not intended to limit any particular or specific meaning, unless expressly defined herein. It should be noted that the use of a particular term when describing certain features or aspects of the disclosure should not imply that the term is redefined herein to include any specific feature or aspect of the disclosure associated with that term. The terms and phrases used in this application, and variations thereof, particularly in the appended claims, are intended to be open-ended rather than restrictive, unless otherwise expressly stated. As an example of the foregoing, the term “comprising” should mean “including, but not limited to” or a similar meaning.

[0071] Furthermore, although the foregoing has been described in detail with the aid of illustrations and examples for the purposes of brevity and understanding, it will be apparent to those skilled in the art that certain variations and modifications can be made. Therefore, the descriptions and examples should not be construed as limiting the scope of the invention to the specific embodiments and examples described herein, but rather encompass all modifications and alternatives that conform to the true scope and spirit of the invention.

Claims

1. An analyte concentration monitoring system, comprising an implantation assembly and a sterilization assembly, the sterilization assembly comprising a sensor electrode and a protective cap, the protective cap having a sealed sterilization chamber formed inside, the internal portion of the sensor electrode being disposed within the sterilization chamber, characterized in that: The protective cap is provided with a trigger member configured to respond to an operation to separate the protective cap from the sensor electrode. When the sterilization assembly is coupled to the implantation assembly, the trigger member is operated to separate the protective cap from the sensor electrode. The sterilization assembly also includes a retaining portion, and a first locking portion is formed between the retaining portion and the protective cap. The first locking portion is configured to prevent the protective cap from rotating relative to the retaining portion along a first direction. The triggering component is a button disposed on the protective cap, and the protective cap has an operating hole for receiving the button. When the button is pressed, the first locking part is released. A first limiting part is formed in the operating hole, and a second limiting part is formed on the button. The first limiting part is configured to interlock with the second limiting part when the button is pressed, thereby limiting the button to the inside of the protective cap.

2. The analyte concentration monitoring system according to claim 1, characterized in that: The first locking part includes a first locking member disposed on the retaining part and a second locking member disposed on the protective cap, wherein the first locking member and the second locking member cooperate to lock.

3. The analyte concentration monitoring system according to claim 2, characterized in that: The first locking member and the second locking member are located on the same circumference.

4. The analyte concentration monitoring system according to claim 2, characterized in that: The free end of the first locking member has an elastic tendency to open toward the second locking member.

5. The analyte concentration monitoring system according to claim 4, characterized in that: The free end of the first locking member deflects away from the second locking member in response to the action of the triggering member.

6. The analyte concentration monitoring system according to claim 5, characterized in that: The button has a guide slope facing the first locking member.

7. The analyte concentration monitoring system according to claim 5, characterized in that: The button is a one-time use button located on the protective cap.

8. The analyte concentration monitoring system according to claim 2, characterized in that: The second locking member is an arc-shaped rib extending circumferentially, and a channel is formed between the second locking member and the protective cap for the first locking member to pass through.

9. The analyte concentration monitoring system according to claim 8, characterized in that: The second locking member is an arc-shaped rib that extends simultaneously along a second direction and a radially inward direction, the second direction being the opposite of the first direction.

10. The analyte concentration monitoring system according to claim 1, characterized in that: The protective cap is coupled to the implant assembly via a retainer.

11. The analyte concentration monitoring system according to claim 1, characterized in that: The sterilization assembly further includes a body surface attachment unit installed inside the protective cap, wherein a second locking portion is formed between the body surface attachment unit and the retaining portion, the second locking portion being configured to prevent the retaining portion from rotating relative to the body surface attachment unit along a first or second direction.

12. The analyte concentration monitoring system according to claim 11, characterized in that: The second locking part includes a plurality of latches distributed circumferentially along the edge of the body surface attachment unit and corresponding latches distributed on the retaining part, wherein the latches and the latches cooperate to lock.

13. The analyte concentration monitoring system according to claim 11, characterized in that: The sterilization assembly further includes a needle assembly mounted on a body surface attachment unit. The needle assembly includes a needle hub and a puncture needle attached to the needle hub. A third locking portion is formed between the needle hub and the body surface attachment unit. The third locking portion is configured to prevent the needle hub from rotating relative to the body surface attachment unit in a first or second direction.

14. The analyte concentration monitoring system according to claim 13, characterized in that: The third locking part includes a shaped waist formed on the needle base and a boss with a shaped hole formed on the body surface attachment unit. When the needle assembly is installed on the body surface attachment unit, the shaped waist is embedded into the shaped hole of the boss and locks in place with the shaped hole.

15. The analyte concentration monitoring system according to claim 13, characterized in that: A fourth locking portion is formed between the protective cap and the implant assembly, the fourth locking portion being configured to prevent the protective cap from rotating relative to the implant assembly in a second direction and to prevent the protective cap from moving in a direction away from the implant assembly.

16. The analyte concentration monitoring system according to claim 15, characterized in that: The fourth locking part includes a third locking member disposed on the implant assembly and a fourth locking member disposed on the protective cap, the third locking member and the fourth locking member cooperating to lock.

17. The analyte concentration monitoring system according to claim 13, characterized in that: The puncture needle is fitted onto the body portion of the sensor electrode and is disposed together with the body portion of the sensor electrode in the sterilization chamber.

18. A method of using an analyte concentration monitoring system, implemented based on the analyte concentration monitoring system according to any one of claims 1 to 17, characterized in that: This includes separating the protective cap from the sensor electrode only when the triggering member is operated.

19. The method of using the analyte concentration monitoring system according to claim 18, characterized in that: The triggering component is a button, which separates the protective cap from the sensor electrode only when the button is pressed.

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