Analyte monitoring system

Abstract

This disclosure provides an analyte monitoring system, including a pre-assembled module and an application device. The pre-assembled module includes a body unit and a cap coupled to the body unit. The body unit includes a housing having a receiving space, electronic components located in the receiving space, and a sensor operatively coupled to the electronic components and at least partially implanted in a host to obtain the analyte level of the host. The cap has a mating portion for receiving at least a portion of the sensor and a bottom cap coupled to the application device. The mating portion and the bottom cap are integrally formed. When the cap is coupled to the body unit to form the pre-assembled module, the mating portion is sealed to the housing to form a sealed space for receiving the sensor. The analyte monitoring system is formed by coupling the pre-assembled module to the application device. Therefore, a highly reliable analyte monitoring system can be provided.

Description

Technical Field

[0001] This disclosure relates to the biomedical engineering industry, specifically to an analytical substance monitoring system. Background Technology

[0002] Diabetes is a chronic metabolic disease caused by persistently abnormal blood sugar levels, which can significantly harm human health over the long term. To effectively manage the condition, patients typically need to monitor their blood sugar levels regularly. Continuous Glucose Monitoring (CGM) is a common blood sugar management tool. This system uses a sensor placed under the skin to acquire real-time glucose data from tissue fluid, thereby enabling dynamic tracking and monitoring of blood sugar levels.

[0003] In continuous glucose monitoring systems, to ensure safety, sensors must be sterilized before leaving the factory and then assembled into a dedicated applicator for subcutaneous implantation. The sensor must be sterile before implantation; therefore, a sensor cap is typically used to seal the sensor, forming a sterile module. After sterilization, the module is assembled into the applicator, and then the applicator cap is attached to protect the internal structure. In this case, a connection structure is usually designed between the sensor cap and the applicator cap to allow for user convenience. This connection structure prevents the applicator cap and sensor cap from moving together during assembly, but allows for removal of both together.

[0004] However, in the existing technology, this connection structure is relatively complex, which makes the production and assembly of the continuous glucose monitoring system cumbersome and difficult. Furthermore, the complex connection structure has problems such as structural instability and low reliability, which makes it prone to failure during use, thereby affecting the user experience. Summary of the Invention

[0005] This disclosure is made in view of the above-mentioned state of the prior art, and its purpose is to provide a highly reliable analyte monitoring system.

[0006] To this end, this disclosure provides an analyte monitoring system, including a pre-assembled module and an application device. The pre-assembled module includes an on-body unit and a cap coupled to the on-body unit. The on-body unit includes a housing having a receiving space, electronic components located in the receiving space, and a sensor operatively coupled to the electronic components and at least partially implanted in a host to obtain analyte levels in the host. The cap has a mating portion for receiving at least a portion of the sensor and a bottom cap coupled to the application device. The mating portion is integrally formed with the bottom cap. When the cap is coupled to the on-body unit to form the pre-assembled module, the mating portion is sealed to the housing to form a sealed space for receiving the sensor. The analyte monitoring system is formed by coupling the pre-assembled module to the application device.

[0007] In this disclosure, the cap has a mating part coupled to the body unit and a bottom cover coupled to the application device. The integrated design of the mating part and the bottom cover simplifies the connection structure between them and improves the reliability of the analyte monitoring system during coupling or decoupling compared to a separate design. Furthermore, by first forming a pre-assembled module with a sealed space and then coupling the pre-assembled module to the application device to form the analyte monitoring system, the formation process of the sealed space can be visualized. This facilitates the determination of whether the cap and the body unit are correctly coupled to form a sealed space, reducing the possibility of an unsealed space. Moreover, before coupling the pre-assembled module to the application device, it is possible to confirm in real time whether the sealed space is in a sealed state, reducing the possibility of mis-sealing. Therefore, the analyte monitoring system formed under these conditions has high reliability.

[0008] Additionally, in the analyte monitoring system disclosed herein, optionally, the housing further includes a first housing that can be applied to a host, with at least a portion of the sensor extending beyond the bottom surface of the first housing. This facilitates sensor implantation into the host.

[0009] Additionally, in the analyte monitoring system disclosed herein, optionally, the cap is coupled to the first housing in a manner that allows rotation relative to the first housing. This facilitates the formation of a coupling force between the cap and the first housing.

[0010] Additionally, in the analyte monitoring system disclosed herein, optionally, the housing further includes a second housing that mates with the first housing. The pre-assembled module includes a sterilization module, the electronic components, and the second housing, with the sterilization module formed by a cap sealingly engaging with the first housing. In this case, sterilizing the sensor contributes to the health and safety of the host. Furthermore, the cap sealing with the first housing helps maintain the sterile state of the sensor before use.

[0011] Furthermore, in the analyte monitoring system disclosed herein, optionally, after sterilizing the sterilization module, the electronic components, the second housing, and the sterilization module are assembled to form the pre-assembled module. In this case, by sterilizing the sterilization module first and then coupling the electronic components, it is convenient to select a suitable sterilization method based on the characteristics of the sensor without considering the impact of the sterilization method on the electronic components, thereby facilitating sterilization.

[0012] Additionally, in the analyte monitoring system disclosed herein, optionally, the first housing includes a guide portion, and the cap includes a guided portion, the guide portion cooperating with the guided portion to restrict relative rotation between the cap and the first housing. In this case, the cooperation between the guide portion and the guided portion facilitates coupling of the cap and the first housing in a predetermined manner.

[0013] Additionally, in the analyte monitoring system disclosed herein, optionally, the guide portion has a starting position and an ending position, and the guided portion moves along the guide portion from the starting position to the ending position. In this case, by guiding the guided portion, the movement of the guided portion along a predetermined path can be limited, and excessive rotation of the cap can be suppressed.

[0014] Additionally, in the analyte monitoring system disclosed herein, optionally, the first housing includes a first limiting portion disposed at the termination position, and the guided portion is coupled to the first limiting portion at the termination position. In this case, the coupling of the first limiting portion to the guided portion can prevent the guided portion from moving excessively beyond the termination position, facilitates indication that the cap has moved to the termination position, and also helps maintain the relative position of the cap and the first housing.

[0015] Additionally, in the analyte monitoring system disclosed herein, the analyte monitoring system may optionally include a sharp object that at least partially houses the sensor and is configured to implant at least a portion of the sensor subcutaneously. This facilitates subcutaneous sensor implantation.

[0016] Additionally, in the analyte monitoring system disclosed herein, optionally, the first housing has a first opening, the sharp object has a mating portion, the sharp object extends beyond the bottom surface of the first housing via the first opening, and the mating portion couples with the mating portion to form the sealed space. In this case, by allowing the sharp object to extend beyond the bottom surface of the first housing, it facilitates the sharp object's penetration into the host and helps the portion of the sharp object carrying the sensor extending beyond the bottom surface of the first housing to be implanted subcutaneously.

[0017] Additionally, in the analyte monitoring system disclosed herein, optionally, the joint extends beyond the bottom surface of the first housing. This facilitates coupling between the joint and the mating portion.

[0018] Additionally, in the analyte monitoring system disclosed herein, optionally, the joint and the mating part are coupled by threads. In this case, the threaded structure allows the applied force along the circumference of the sharp object to be converted into a force along the axial direction of the sharp object, thereby enabling a tighter axial coupling between the sharp object and the cap.

[0019] Additionally, in the analyte monitoring system disclosed herein, optionally, the application device includes a housing that can be coupled to the cap, and a receiving portion that can be coupled to the body unit and is movable relative to the housing. When the pre-assembled module is coupled to the application device, the cap is coupled to the housing, and the body unit is coupled to the receiving portion.

[0020] Additionally, in the analyte monitoring system disclosed herein, optionally, the pre-assembled module is movably coupled to the application device via a central axis, the application device having a first assembly feature configured to restrict the pre-assembled module from being received by the application device along its central axis. In this case, the tendency for relative rotation of the components within the pre-assembled module can be suppressed.

[0021] Additionally, in the analyte monitoring system disclosed herein, optionally, the cap has a second mounting feature that mates with the first mounting feature, at least one of the first and second mounting features extending along the central axis of the application device. This facilitates movement of the cap along the central axis of the application device.

[0022] Alternatively, in the analyte monitoring system disclosed herein, the first assembly feature may be a groove, and the second assembly feature may be a protrusion.

[0023] Additionally, in the analyte monitoring system disclosed herein, optionally, the application device has a first engagement feature configured to guide the second assembly feature to decouple the cap from the application device. This allows the cap to move along a predetermined path when decoupled from the application device.

[0024] Additionally, in the analyte monitoring system disclosed herein, optionally, the first engagement feature is a groove or opening formed in the circumferential direction of the application device. In this case, since the first engagement feature extends circumferentially along the application device, the cap can rotate only circumferentially along the application device when decoupled from the application device, without generating relative displacement with respect to the application device in the axial direction.

[0025] Additionally, in the analyte monitoring system disclosed herein, optionally, a decoupling feature is formed at the termination position of the first engagement feature. This decoupling feature is configured to provide a path for decoupling the cap from the application device, and extends along a direction parallel to the central axis of the application device. In this case, the decoupling feature provides an axial decoupling path for the cap, thereby facilitating the decoupling of the cap from the application device.

[0026] Additionally, in the analyte monitoring system disclosed herein, optionally, the application device is configured to apply the body unit to the host after the cap is removed, the cap having a release portion configured to absorb or release the force transmitted to the joint when the joint and the mating part are screwed off. In this case, releasing the force through the release portion can reduce the possibility of damage to components due to excessive interaction forces.

[0027] According to this disclosure, a highly reliable analyte monitoring system can be provided. Attached Figure Description

[0028] This disclosure will now be explained in further detail by way of example only with reference to the accompanying drawings.

[0029] Figure 1A This is a diagram illustrating an application scenario of the analyte monitoring system described in this disclosure.

[0030] Figure 1B This is a cross-sectional view showing the analyte monitoring system involved in the example of this disclosure.

[0031] Figure 2A This is a schematic diagram illustrating the structure of the pre-assembled module involved in the example of this disclosure.

[0032] Figure 2B This is a cross-sectional view showing the pre-assembled module involved in the example of this disclosure.

[0033] Figure 2C It shows Figure 2B A magnified view of region A in the middle.

[0034] Figure 3A This is a schematic diagram illustrating the structure of the sensor involved in the example of this disclosure.

[0035] Figure 3B This is a schematic diagram showing the sensor disposed in the first housing according to an example of this disclosure.

[0036] Figure 3C This is a schematic diagram showing a sealing cap disposed on a first housing according to an example of this disclosure.

[0037] Figure 3D This is a schematic diagram illustrating the structure of the sealing cap involved in the example of this disclosure.

[0038] Figure 3E This is a schematic diagram showing a sharp object disposed in the first housing according to an example of this disclosure.

[0039] Figure 3F This is a schematic diagram illustrating the structure of the sharp object involved in the example of this disclosure.

[0040] Figure 4A This is a schematic diagram illustrating the structure of the cap involved in the example of this disclosure.

[0041] Figure 4B It shows Figure 4A A magnified view of region B in the middle.

[0042] Figure 4C This is a schematic diagram showing the joint and mating parts before coupling, as described in the example of this disclosure.

[0043] Figure 4D This is a schematic diagram showing the coupling of the joint and mating parts involved in the example of this disclosure.

[0044] Figure 5A This is a schematic diagram showing the cap before coupling with the first housing, as described in this disclosure example.

[0045] Figure 5B This is a schematic diagram showing the cap coupled to the first housing as described in the example of this disclosure.

[0046] Figure 6A This is a schematic diagram illustrating the structure of the sterilization module involved in the example of this disclosure.

[0047] Figure 6B This is a cross-sectional view showing the sterilization module involved in the example of this disclosure.

[0048] Figure 7A This is a schematic diagram illustrating the coupling of electronic components to a sterilization module as described in the examples of this disclosure.

[0049] Figure 7B This is a schematic diagram illustrating the structure of the spring and connector involved in the example of this disclosure.

[0050] Figure 8 This is a schematic diagram illustrating the coupling of a second housing to a sterilization module as described in the examples of this disclosure.

[0051] Figure 9 This is a schematic diagram showing the pre-assembled module coupled to the application device as described in the example of this disclosure.

[0052] Figure 10 This is a schematic diagram illustrating the structure of the housing involved in the example of this disclosure.

[0053] Figure 11A This is a schematic diagram showing the first engaging portion and the second engaging portion before they engage, as described in the example of this disclosure.

[0054] Figure 11B This is a schematic diagram showing the engagement of the first engaging part and the second engaging part according to the example of this disclosure. Detailed Implementation

[0055] Hereinafter, preferred embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In the following description, the same reference numerals are used for the same components, and repeated descriptions are omitted. Furthermore, the drawings are merely schematic diagrams, and the proportions of the components or the shapes of the components may differ from actual figures.

[0056] It should be noted that the terms "comprising" and "having" and any variations thereof in this disclosure, such as a process, method, system, product, or device that includes or has a series of steps or units, are not necessarily limited to those steps or units that are explicitly listed, but may include or have other steps or units that are not explicitly listed or that are inherent to such processes, methods, products, or devices.

[0057] It should be noted that in this article, relative position and direction terms such as "above", "facing upward", "below", "facing downward", "up and down direction", "left side", "facing left side", "left side", "facing left side", "right side", "facing right side", "right side", "facing right side", "left and right direction", "front", "facing forward", "back", "facing backward", and "front and back direction" are used with reference to the usual operating posture and should not be considered as restrictive.

[0058] This disclosure provides an analyte monitoring system. The analyte monitoring system can be used to monitor analytes. The analyte monitoring system involved in this disclosure may also be referred to as an analyte monitoring device, analyte monitor, analyte concentration information acquisition device, or biomonitoring device, etc. Furthermore, the sensor involved in the examples of this disclosure may also be referred to as a monitoring probe, sensing probe, or electrode probe, etc.

[0059] In this disclosure, the analyte may be one or more of glucose, acetylcholine, amylase, bilirubin, cholesterol, human chorionic gonadotropin, creatine kinase, creatine, creatine anhydride, DNA, fructosamine, glutamine, growth hormone, hormones, blood ketones, lactate, oxygen, peroxides, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, or troponin. This is merely illustrative; the analyte may also be other substances not shown. In some examples, analyte information may also be referred to as analyte level or physiological information.

[0060] For ease of description, some examples below use glucose as the analyte, and correspondingly, the analyte concentration is the glucose concentration. It should be noted that this does not constitute a limitation of this disclosure, and unless there is a contradiction, the relevant descriptions also apply to other analyte concentrations.

[0061] The analytical substance monitoring system described in this disclosure is illustrated below with reference to the accompanying drawings.

[0062] Figure 1A This is a diagram illustrating an application scenario of the analyte monitoring system 1 as described in this disclosure example. Figure 1B This is a cross-sectional view showing the analyte monitoring system 1 as described in this disclosure example.

[0063] In some examples, the analyte monitoring system 1 can monitor the analyte. For example, it can monitor the analyte concentration. In some examples, the analyte monitoring system 1 can monitor the analyte concentration within the host body.

[0064] See in some examples Figure 1A The analyte monitoring system 1 may include an on-body unit 800. In some examples, the on-body unit 800 may be configured to acquire the analyte concentration of the host.

[0065] In some examples, the body unit 800 can generate analyte information in the body fluid based on the concentration of the analyte in the body fluid. For example, the body unit 800 can react with the analyte in the body fluid and generate analyte information. In this case, by reacting with the analyte in the body fluid, it is convenient to obtain the analyte information. In some examples, the analyte information may include analyte concentration information. For example, the analyte information may be information about the glucose concentration in the body fluid. In some examples, the analyte information may also be analyte content information.

[0066] In some examples, the suprabody unit 800 can be applied to the host. In some examples, the suprabody unit 800 can be located at least partially under the skin of the host. In some examples, the portion of the suprabody unit 800 implanted in the host can be referred to as the implantation site. This facilitates the acquisition of analyte information from the host's subcutaneous tissue.

[0067] See in some examples Figure 1A The analyte monitoring system 1 may include a reading device 900. The reading device 900 can be communicatively connected to the host unit 800. The host unit 800 can transmit acquired analyte information to the reading device 900 (e.g., wirelessly). This facilitates the host's reading and monitoring of its own analyte information.

[0068] In some examples, the analyte monitoring system 1 may include a cap 700 (see [link to documentation]). Figure 1A The cap 700 may be configured to receive at least a portion of the body unit 800. In some examples, the cap 700 may receive an implanted portion of the body unit 800. In some examples, the cap 700 may be coupled to the body unit 800 to receive the body unit 800.

[0069] See in some examples Figure 1B The cap 700 may have a sealed space 710. In some examples, the cap 700 may be sealingly engaged with the suprabody unit 800 to form the sealed space 710. In some examples, the implanted portion of the suprabody unit 800 may be accommodated within the sealed space 710 of the cap 700. In this case, it helps the suprabody unit 800 to be in a sealed space, and for the sterilized sealed space 710, it can also maintain the sterility of the implanted portion, thereby benefiting the safety and health of the host.

[0070] In some examples, the analyte monitoring system 1 may include an application device 1000 (see [reference]). Figure 1A In some examples, the application device 1000 may be configured to apply the body unit 800. In some examples, the application device 1000 may be configured to apply the body unit 800 to the host. That is, the body unit 800 may be applied to the host via the application device 1000. The host can obtain analyte information through the body unit 800 applied to itself.

[0071] In some examples, the analyte monitoring system 1 may include a pre-assembled module. In some examples, the pre-assembled module may be formed by a cap 700 coupled to a body unit 800. That is, the coupled body unit 800 and cap 700 may be referred to as the pre-assembled module. The pre-assembled module may include the body unit 800 and the cap 700.

[0072] In some examples, the pre-assembled module may be coupled to the application device 1000. In some examples, the analyte monitoring system 1 may be formed by coupling the pre-assembled module to the application device 1000. In other words, the analyte monitoring system 1 may include the pre-assembled module and the application device 1000. In some examples, pre-assembly can be understood as completing the coupling between the cap 700 and the body unit 800 before the cap 700 is coupled to the application device 1000.

[0073] In this disclosure, by first forming a pre-assembled module with a sealed space 710, and then coupling the pre-assembled module to the application device 1000 to form an analyte monitoring system 1, the formation process of the sealed space 710 can be visualized. This makes it easier to determine whether the cap 700 and the body unit 800 are correctly coupled to form the sealed space 710, reducing the possibility of the sealed space 710 not being formed. Furthermore, before coupling the pre-assembled module to the application device 1000, it is possible to confirm in real time whether the sealed space 710 is in a sealed state, reducing the possibility of the sealed space 710 being mis-sealed. Thus, the analyte monitoring system 1 formed under these circumstances has high reliability.

[0074] In some examples, when the pre-assembled module is coupled to the application device 1000, the cap 700 may be coupled to the application device 1000. The body unit 800 may also be coupled to the application device 1000.

[0075] In some examples, the application device 1000 may be configured to apply the body unit 800 to the host after the cap 700 has been removed.

[0076] See in some examples Figure 1B The analyte monitoring system 1 may also include a sharp object 270. In some examples, the sharp object 270 may be configured to implant at least a portion (i.e., the implantation portion) of the suprabody unit 800 subcutaneously. This facilitates the implantation of the suprabody unit 800.

[0077] See in some examples Figure 1B The sharp object 270 can be coupled to the body unit 800. In some examples, the sharp object 270 can penetrate the body unit 800 and accommodate the implanted portion.

[0078] See in some examples Figure 1B The sharp object 270 can be coupled to the cap 700. In some examples, the sharp object 270 and the cap 700 can be coupled to form a coupling force. This facilitates the formation of a sealed space 710.

[0079] In some examples, the sharp object 270 can be coupled to the body unit 800 and the cap 700 to form a pre-assembled module. That is, the pre-assembled module may also include the sharp object 270.

[0080] In other examples, the analyte monitoring system 1 may not include the sharp object 270. In some examples, the implant can be made of a rigid material. In this case, the implant can enter the subcutaneous tissue of the host by its own rigidity without the need for other structures to assist implantation, thereby simplifying the structure of the analyte monitoring system 1. Additionally, it facilitates the implant's insertion into the subcutaneous tissue of the host. For ease of description, the following description assumes that the analyte monitoring system 1 includes the sharp object 270, but this should not be construed as limiting the present disclosure; the same description applies equally to cases where the analyte monitoring system 1 does not include the sharp object 270.

[0081] Figure 2A This is a schematic diagram illustrating the structure of the pre-assembled module involved in the example of this disclosure. Figure 2B This is a cross-sectional view showing the pre-assembled module involved in the example of this disclosure. Figure 2C It shows Figure 2B A magnified view of region A in the middle.

[0082] See in some examples Figure 2B The host cell 800 may include a sensor 810. In some examples, the sensor 810 may be configured to acquire analyte information of the host. In some examples, the sensor 810 may be at least partially implanted in the host.

[0083] See in some examples Figure 2A The body unit 800 may include a housing 820. The housing 820 may be attached to the host. In some examples, see [link to example]. Figure 2B The housing 820 may have a receiving space 821. In some examples, the sensor 810 may be disposed in the receiving space 821 of the housing 820. In some examples, the sensor 810 may also extend out of the housing 820. This facilitates the implantation of the sensor 810 into the host.

[0084] In some examples, the body unit 800 may include an electronic component 880. In some examples, the electronic component 880 may be configured to receive analyte information acquired by the sensor 810. In some examples, the electronic component 880 may also be configured to transmit the analyte information to a reading device 900.

[0085] In some examples, electronic component 880 may be operatively coupled to sensor 810. In some examples, electronic component 880 may be located in housing space 821.

[0086] In some examples, the sharp object 270 may be configured to implant at least a portion of the sensor 810 subcutaneously. See also [link to related examples]. Figure 2BThe sharp object 270 can at least partially accommodate the sensor 810. This facilitates the subcutaneous implantation of the sensor 810.

[0087] See in some examples Figure 2B The sharp object 270 can extend beyond the bottom surface of the housing 820. This allows the sharp object 270 to easily accommodate the sensor 810.

[0088] As described above, the cap 700 can be coupled to the body unit 800. See also: [link to example]. Figure 2B The cap 700 may accommodate at least a portion of the sensor 810 (e.g., the implanted portion described above). In some examples, the cap 700 may provide a sealed space 710 for the sensor 810. In some examples, the cap 700 may be sealingly engaged with the housing 820. In some examples, the cap 700 may also accommodate at least a portion of the sharp object 270. In some examples, the cap 700 may also provide a sealed space 710 for the sharp object 270.

[0089] See in some examples Figure 2B The cap 700 may have a mating portion 720. In some examples, the mating portion 720 may accommodate at least a portion of the sensor 810. In some examples, the mating portion 720 may be sealingly engaged with the housing 820. In some examples, when the cap 700 is coupled to the body unit 800 to form a pre-assembled module, the mating portion 720 may be sealingly engaged with the housing 820 to form a sealed space 710 for accommodating the sensor 810. In some examples, the mating portion 720 may also accommodate at least a portion of the sharp object 270.

[0090] See in some examples Figure 2B The cap 700 may include a desiccant 760. In some examples, the desiccant 760 may be located in the sealed space 710. This facilitates keeping the sealed space 710 dry.

[0091] In some examples, the desiccant 760 may be housed within the bottom cover 770 (described later). See also [other examples]. Figure 2B The cap 700 may also include a base plate 772. The base plate 772 may be configured to form a sealed space 710. In some examples, the base plate 772 and the cap 770 may be fixedly connected by one or more methods such as adhesives, ultrasonic welding, etc. This facilitates the sealing of the sealed space 710.

[0092] In some examples, the base plate 772 may be made of a transparent material. In this case, the base plate 772 makes it easy to confirm whether the sensor 810 is in the correct position.

[0093] Figure 3AThis is a schematic diagram illustrating the structure of the sensor 810 involved in the example of this disclosure.

[0094] See in some examples Figure 3A The sensor 810 may include a tail 811. In some examples, the tail 811 may be used for implantation into a host. In some examples, the tail 811 may generate analyte information.

[0095] In some examples, sensor 810 may include contact portion 812 (see Figure 3A In some examples, contact 812 may be configured to connect to electronic component 880. That is, contact 812 may be electrically connected to electronic component 880. In some examples, contact 812 may have electrical contacts.

[0096] See in some examples Figure 3A The contact portion 812 and the tail portion 811 of the sensor 810 can form an angle of 0° to 90°. This facilitates the placement of the tail portion 811 into the first opening 831 or the electrical connection of the contact portion 812 to the electronic component 880 when implanted into the host.

[0097] See in some examples Figure 3A The sensor 810 may include a coupling portion 813. In some examples, the coupling portion 813 may connect the tail portion 811 and the contact portion 812. That is, the tail portion 811, the coupling portion 813, and the contact portion 812 may be connected in sequence. Thus, the analyte information generated by the tail portion 811 can be transmitted to the contact portion 812 through the coupling portion 813.

[0098] Figure 3B This is a schematic diagram showing the sensor 810 disposed in the first housing 830 according to an example of this disclosure.

[0099] See in some examples Figure 2B The outer casing 820 may include a first casing 830. The first casing 830 may be applied to a host. In some examples, the outer casing 820 may also include a second casing 840. In some examples, the second casing 840 may mate with the first casing 830. In some examples, the first casing 830 and the second casing 840 may mate to form a receiving space 821.

[0100] In other examples, the receiving space 821 may also be formed by only one of the first housing 830 or the second housing 840, with the other housing enclosing the receiving space 821.

[0101] In some examples, the second housing 840 can be fixed to the first housing 830. For example, the second housing 840 can be fixed to the first housing 830 by adhesive or welding. This helps to seal the accommodating space 821.

[0102] In some examples, the second housing 840 may also be detachably connected to the first housing 830. For example, the second housing 840 may be detachably connected to the first housing 830 by means of snap-fit, screw-fit, or other detachable means.

[0103] See in some examples Figure 3B The sensor 810 may be disposed in the first housing 830. In some examples, at least a portion of the sensor 810 may extend beyond the bottom surface of the first housing 830. This facilitates the implantation of the sensor 810 into the host.

[0104] See in some examples Figure 3B The first housing 830 may have a first opening 831. In some examples, the sensor 810 may extend beyond the bottom surface of the first housing 830 via the first opening 831. In some examples, a contact portion 812 may be provided in the first housing 830. The tail portion 811 may extend at least partially beyond the bottom surface of the first housing 830 via the first opening 831.

[0105] See in some examples Figure 3B The first housing 830 may include a support portion 832. The support portion 832 may be configured to support at least a portion of the sensor 810. For example, in Figure 3B In this configuration, the support portion 832 may support the connecting portion 813. In some examples, the sensor 810 may extend through the support portion 832 and enter the first opening 831. In some examples, the support portion 832 may be a boss.

[0106] See in some examples Figure 3B The first housing 830 may include a substrate 833. A support portion 832 may be disposed on the substrate 833. In some examples, a first aperture 831 may penetrate through the support portion 832 and the substrate 833.

[0107] See in some examples Figure 3B The first housing 830 may include a fixing portion 838. In some examples, the fixing portion 838 may be configured to fix the sensor 810. In some examples, the fixing portion 838 may fix the contact portion 812. In some examples, the fixing portion 838 may be disposed on the substrate 833.

[0108] See in some examples Figure 3B The fixing portion 838 can be a protrusion formed on the substrate 833. In some examples, there can be two fixing portions 838. In some examples, the two fixing portions 838 can be arranged opposite each other. This facilitates fixing the sensor 810.

[0109] In some other examples, the number of fixing parts 838 may be one. For example, the fixing part 838 may be a fork-shaped structure with a groove. In other examples, the number of fixing parts 838 may be more than two. This allows for more stable fixing of the sensor 810.

[0110] See in some examples Figure 3B The body unit 800 may include a channel 400. In some examples, the channel 400 may extend toward a first aperture 831. In some examples, a sensor 810 may pass through the channel 400 and be located at the first aperture 831. In some examples, a connector 813 may extend through the channel 400.

[0111] See in some examples Figure 3B In some examples, channel 400 may be provided on support portion 832. In some examples, sensor 810 may enter first aperture 831 via channel 400 provided on support portion 832.

[0112] In some examples, the channel 400 may have a fixed size to accommodate the connector 813. The size of the channel 400 may be equal to or similar to the size of the connector 813. This minimizes the gap between the connector 813 and the channel 400, thereby facilitating the formation of a seal in the channel 400.

[0113] In some examples, adhesive can be injected into channel 400 to seal channel 400. This facilitates sealing of sensor 810.

[0114] Figure 3C This is a schematic diagram showing a sealing cap 600 disposed on a first housing 830 according to an example of this disclosure.

[0115] See in some examples Figure 3C The body unit 800 may include a sealing cover 600. The sealing cover 600 may be configured to seal the sensor 810. In some examples, the sealing cover 600 may be disposed on the first housing 830. In some examples, the sealing cover 600 may cover the support portion 832.

[0116] See in some examples Figure 3C The sealing cover 600 can completely cover the support portion 832. In other words, the projection of the sealing cover 600 and the projection of the support portion 832 can completely coincide in the axial direction of the support portion 832. This improves the compactness of the structure and is beneficial for sealing the sensor 810.

[0117] In some examples, the sealing cap 600 may at least partially cover the channel 400. This helps to form a sealing interface at the channel 400, thereby facilitating the sealing of the sensor 810. Additionally, it helps to retain the sensor 810 within the channel 400.

[0118] In some examples, the sealing cap 600 and the support portion 832 can be fixedly connected by one or more methods such as adhesives or ultrasonic welding. This enhances the sealing performance of the sealing cap 600.

[0119] See in some examples Figure 3B The first housing 830 may include an assembly portion 834. In some examples, the assembly portion 834 may be disposed on the support portion 832.

[0120] In other examples, the assembly part 834 may also be disposed on the substrate 833.

[0121] In some examples, the sealing cap 600 may be disposed on the assembly portion 834. In some examples, the sealing cap 600 may mate with the assembly portion 834.

[0122] In some examples, assembly 834 may have bag 8341 (see Figure 3B In some examples, the sealing cap 600 may be received at least partially by the bag 8341. In some examples, an adhesive may be injected into the bag 8341 before the sealing cap 600 is assembled to the assembly 834. This facilitates sealing the interface between the assembly 834 and the sealing cap 600.

[0123] See in some examples Figure 2C A gap may exist between the portion of the sealing cap 600 that receives the bag 8341 and the bottom of the bag 8341. In this case, by leaving a certain flow space for the adhesive between the sealing cap 600 and the bag 8341, it is possible to facilitate the flow of the adhesive to fill the gap between the parts, thereby helping to seal the interface between the assembly 834 and the sealing cap 600.

[0124] See in some examples Figure 3B The bag 8341 can be connected to the channel 400. This allows the adhesive to flow into the channel 400 and seal the channel 400.

[0125] In some examples, the bag 8341 may surround the first opening 831. The bag 8341 may be an annular groove.

[0126] Figure 3D This is a schematic diagram illustrating the structure of the sealing cap 600 involved in the example of this disclosure.

[0127] In some examples, the sealing cap 600 may have a first notch 620 (see Figure 3D In some examples, the first notch 620 may be aligned with the channel 400. In some examples, the first notch 620 may at least partially coincide with the channel 400. This allows the connecting portion 813 to pass through the channel 400.

[0128] In other examples, the channel 400 may also be provided on the sealing cap 600. For example, the channel 400 may be a first notch 620. In some examples, the channel 400 may extend toward the second opening 610. In some examples, the channel 400 may be provided on the side of the sealing cap 600 near the support portion 832.

[0129] See in some examples Figure 3C The first housing 830 may have a first positioning portion 835. In some examples, the sealing cap 600 may have a second positioning portion 650. In some examples, during the assembly of the sealing cap 600 to the assembly portion 834, the first positioning portion 835 may be aligned with the second positioning portion 650. This allows for more accurate assembly of the sealing cap 600 to the assembly portion 834.

[0130] See in some examples Figure 3C The first positioning portion 835 may be disposed on the assembly portion 834. In some examples, the shape of the first positioning portion 835 may be complementary to the shape of the second positioning portion 650. For example, the first positioning portion 835 may be a groove, and the second positioning portion 650 may be a protrusion.

[0131] In other examples, the first positioning part 835 may also be disposed on the substrate 833.

[0132] In some examples, when the first positioning part 835 is aligned with the second positioning part 650, the first notch 620 can be aligned with the connecting part 813. In this case, by aligning the first positioning part 835 and the second positioning part 650, the first notch 620 can be aligned with the connecting part 813, thereby facilitating the assembly of the sealing cover 600.

[0133] See in some examples Figure 3C The first positioning part 835 can abut against the second positioning part 650. In some examples, the first positioning part 835 can abut against the second positioning part 650 in the circumferential direction. This prevents rotation of the sealing cover 600, thereby reducing the risk of damage to the sensor 810 due to rotation of the sealing cover 600.

[0134] Figure 3E This is a schematic diagram showing a sharp object 270 disposed in the first housing 830 according to an example of this disclosure.

[0135] As described above, the sharp object 270 can penetrate the body unit 800. In some examples, the sharp object 270 can penetrate and be disposed within the body unit 800. In some examples, the sharp object 270 can be disposed within the first housing 830 (see [reference]). Figure 3E In some examples, the sharp object 270 may also extend beyond the bottom surface of the first housing 830 via the first orifice 831. In this case, by extending the sharp object 270 beyond the bottom surface of the first housing 830, it is easier for the sharp object 270 to penetrate the host and facilitates the subcutaneous implantation of the portion of the sharp object 270 carrying the sensor 810 extending beyond the bottom surface of the first housing 830.

[0136] See in some examples Figure 3E A sharp object 270 can penetrate the sealing cap 600. See some examples. Figure 3C The sealing cap 600 may have a second opening 610. In some examples, the second opening 610 may be aligned with the first opening 831. In some examples, the second opening 610 may be configured to allow a sharp object 270 to extend through it.

[0137] In some examples, the profile of the first aperture 831 may be the same as the profile of the second aperture 610 (see [reference]). Figure 3B and Figure 3C (or different.) In some examples, at least one of the first aperture 831 and the second aperture 610 may have the same profile as the sharp object 270. Thus, it is possible to suppress unwanted rotation of the sharp object 270.

[0138] In some examples, the analyte monitoring system 1 may include a first sealing element 510 (see [reference]). Figure 3E The first sealing element 510 can be configured to seal the interface between the sharp object 270 and the body unit 800. In some examples, the first sealing element 510 can be disposed between the sharp object 270 and the body unit 800. In some examples, the first sealing element 510 can be disposed between the sharp object 270 and the first housing 830.

[0139] In some examples, the first sealing element 510 can seal the first opening 831. In some examples, the first sealing element 510 can also seal the second opening 610. It is understood that since the sealing cap 600 is sealed to the first housing 830, the first opening 831 and the second opening 610 form a communicating space, sealing the first opening 831 is also equivalent to sealing the second opening 610.

[0140] In some examples, the first sealing element 510 may be made of an elastic material. In some examples, the first sealing element 510 may be made of materials such as silicone resin, thermoplastic elastomer (TPE), polytetrafluoroethylene, or rubber. This improves the sealing performance of the first sealing element 510.

[0141] Figure 3F This is a schematic diagram illustrating the structure of the sharp object 270 involved in the example of this disclosure.

[0142] In some examples, the sharp object 270 may include the first part 277 (see...) Figure 3F In some examples, when the sharp object 270 is disposed on the first housing 830, the first portion 277 may be located at the first opening 831. In some examples, the first portion 277 may have the same or similar contour as the first opening 831. This helps to suppress the shaking of the sharp object 270.

[0143] In some examples, the outline of the first portion 277 can be a non-circular shape. For example, the outline of the first portion 277 can be roughly racetrack-shaped. Alternatively, the outline of the first portion 277 can be polygonal, square, or fan-shaped. In this case, since the outline of the first aperture 831 is the same as the outline of the first portion 277, undesirable rotation of the sharp object 270 within the first aperture 831 can be suppressed.

[0144] In other examples, the outline of the first part 277 can also be circular. In this case, the sharp object 270 can suppress its own rotation through other structures (such as interlocking structures or mating structures).

[0145] In some examples, the sharp object 270 may include a second part 278 (see [link to example]). Figure 3F In some examples, the second portion 278 may be connected to the first portion 277. In some examples, when the sharp object 270 is disposed on the first housing 830, the second portion 278 may be located outside the first opening 831. In some examples, the second portion 278 may be formed with a shape and / or size that does not match the first opening 831. For example, the size of the second portion 278 may be larger than the size of the first opening 831. As another example, the shape of the second portion 278 may be different from the shape of the first opening 831. In this case, the second portion 278 is difficult to enter the first opening 831 due to its mismatch with the first opening 831, thereby limiting the depth to which the sharp object 270 enters the first opening 831.

[0146] In some examples, the first sealing element 510 may be disposed on the second portion 278. In some examples, the first sealing element 510 may be sleeved on the second portion 278. This facilitates the fixation of the first sealing element 510.

[0147] In some examples, the second portion 278 may at least partially abut against the first housing 830 or the sealing cap 600. This facilitates sealing of the first opening 831 or the second opening 610.

[0148] In some examples, the first sealing element 510 can be compressed when the second portion 278 abuts against the first housing 830 or the sealing cap 600. This improves the sealing performance of the first sealing element 510.

[0149] As described above, the cap 700 can be sealingly engaged with the housing 820. See also some examples. Figure 2B The cap 700 can be sealingly engaged with the first housing 830. In some examples, the mating portion 720 can be sealingly engaged with the first housing 830. In some examples, the mating portion 720 can be sealingly engaged with the bottom surface of the first housing 830. In some examples, the mating portion 720 can accommodate a portion of the sensor 810 extending beyond the bottom surface of the first housing 830. In some examples, the mating portion 720 can also accommodate a portion of a sharp object 270 extending beyond the bottom surface of the first housing 830.

[0150] In some examples, the cap 700 and the first housing 830 can be sealed together under the action of a coupling force. In some examples, the cap 700 can be coupled to the first housing 830 in a manner that allows rotation relative to the first housing 830. This facilitates the formation of a coupling force between the cap 700 and the first housing 830.

[0151] As described above, the sharp object 270 can be coupled to the cap 700. In some examples, the sharp object 270 can be threadedly coupled to the cap 700. In this case, the threaded structure allows the applied force along the circumference of the sharp object 270 to be converted into a force along the axial direction of the sharp object 270, thereby making the sharp object 270 more tightly coupled to the cap 700 in the axial direction.

[0152] See in some examples Figure 3F The sharp object 270 may have a joint 274. See some examples. Figure 2B The joint 274 can be coupled to the mating part 720. In some examples, the joint 274 can be coupled to the mating part 720 to form a sealed space 710. In some examples, the joint 274 can be coupled to the mating part 720 via threads. In some examples, the coupling of the joint 274 and the mating part 720 can generate a coupling force to form the sealed space 710.

[0153] See in some examples Figure 2B The joint 274 can extend beyond the bottom surface of the first housing 830. This facilitates coupling of the joint 274 with the mating part 720.

[0154] In other examples, the joint 274 may not extend beyond the bottom surface of the first housing 830.

[0155] In the absence of the sharp object 270 in the analyte monitoring system 1, a threaded structure forming the coupling force can also be provided on the first housing 830. That is, the cap 700 and the first housing 830 can have matching threads. The cap 700 and the first housing 830 can be coupled through the threads.

[0156] Figure 4A This is a schematic diagram illustrating the structure of the cap 700 involved in the example of this disclosure. Figure 4B It shows Figure 4A A magnified view of region B in the middle. Figure 4C This is a schematic diagram showing the joint 274 and mating part 720 before coupling, as described in the example of this disclosure. Figure 4D This is a schematic diagram showing the coupling of the joint 274 and the mating part 720 as described in the example of this disclosure.

[0157] In some examples, the sharp object 270 and the cap 700 can be coupled by relative screwing. In some examples, the joint 274 and the mating part 720 can be coupled by relative screwing.

[0158] See in some examples Figure 3F The joint 274 may have a first engagement structure 2741. In some examples, the first engagement structure 2741 may be a groove. See also [example details omitted]. Figure 4A or Figure 4B The mating part 720 may have a second engagement structure 721. In some examples, the second engagement structure 721 may be an arc-shaped protrusion.

[0159] See in some examples Figure 4C and Figure 4D During the relative twisting of the joint 274 and the mating part 720, the first joint structure 2741 can move along the second joint structure 721 under the restriction or guidance of the second joint structure 721.

[0160] In some examples, when the coupling between the engagement portion 274 and the mating portion 720 is threaded coupling, the first engagement structure 2741 and the second engagement structure 721 can be threads. Let the first engagement structure 2741 be the first thread and the second engagement structure 721 be the second thread.

[0161] In some examples, the angle at which the second thread extends can be a preset angle. In some examples, the preset angle can be 90 degrees. In this case, by coupling the first thread and the second thread, the engaging portion 274 and the mating portion 720 can be coupled after rotating 90 degrees relative to each other. The axial projection of the second thread is arc-shaped, and the angle at which the second thread extends can be understood as the angle corresponding to this arc.

[0162] In some examples, the number of turns of the first and second threads can be adjusted and adapted based on a comprehensive consideration of the tightness of the connection between the sharp object 270 and the cap 700 and the thickness of the first housing 830.

[0163] In some examples, the first and second threads can be herringbone threads. This improves the tightness of the coupling between the joint 274 and the mating part 720.

[0164] In other examples, the first and second threads can also be flat threads.

[0165] See in some examples Figure 4B The mating portion 720 may have a guide groove 723. In some examples, the guide groove 723 may be configured to guide the engagement portion 274 to couple with the mating portion 720. In some examples, the guide groove 723 may extend along the axis of the mating portion 720. This allows the engagement portion 274 to enter the mating portion 720 along its axial direction. In some examples, the axial direction of the mating portion 720 may be vertical.

[0166] In some examples, the guide groove 723 can guide the engagement portion 274 to move to a state ready to rotate relative to the mating portion 720.

[0167] See in some examples Figure 4B The mating portion 720 may have a limiting portion 722. In some examples, the limiting portion 722 may be configured to restrict the mating portion 720 from continuing to rotate relative to the engaging portion 274 after the engaging portion 274 and the mating portion 720 have been rotated relative to each other by a preset angle. In some examples, the guide groove 723 and the limiting portion 722 may be respectively provided at both ends of the second engaging structure 721.

[0168] Figure 5A This is a schematic diagram showing the cap 700 before coupling with the first housing 830, as described in this disclosure example. Figure 5B This is a schematic diagram showing the cap 700 coupled to the first housing 830 as described in this disclosure example.

[0169] As described above, the cap 700 can be coupled to the first housing 830 or the sharp object 270 by relative rotation of the cap 700 to the first housing 830.

[0170] See in some examples Figure 5A or Figure 5B The first housing 830 may include a guide portion 836. The cap 700 may include a guided portion 730. In some examples, the guide portion 836 may cooperate with the guided portion 730. In some examples, the guide portion 836 may cooperate with the guided portion 730 to limit the relative rotation of the cap 700 and the first housing 830. In this case, the cooperation between the guide portion 836 and the guided portion 730 helps to couple the cap 700 and the first housing 830 in a predetermined manner.

[0171] In some examples, the guide portion 836 may be disposed on the side of the first housing 830 near the cap 700. The guided portion 730 may be disposed on the mating portion 720 or the bottom cover 770.

[0172] In some examples, the guide portion 836 may be formed by a recess in the bottom surface of the first housing 830. In some examples, the guide portion 836 may be a groove in the bottom surface of the first housing 830. In some examples, the guided portion 730 may be higher than the mating portion 720 in the axial direction of the mating portion 720. In other words, the guided portion 730 may protrude from the mating portion 720. In this case, when the mating portion 720 engages with the bottom surface of the first housing 830, it facilitates the mating of the guided portion 730 with the recessed guide portion 836.

[0173] In some examples, the guide portion 836 may be arc-shaped. In some examples, the guide portion 836 may have a preset curvature. In some examples, the angle corresponding to the preset curvature may match a preset angle. For example, the angle corresponding to the preset curvature may be equal to the preset angle. It should be noted that since the guided portion 730 has a certain thickness in the guiding direction, the angle corresponding to the preset curvature may also be slightly larger than the preset angle.

[0174] In some examples, the guide portion 836 may have a preset radius. In some examples, the preset radius may match the radius corresponding to the first engagement feature 191 or the second engagement feature. Thus, the coupling between the cap 700 and the cap portion can be simultaneously decoupled when the cap 700 is subsequently decoupled from the application device 1000.

[0175] In some examples, the guide unit 836 may have a starting position. See also [link to example]. Figure 5A Before the cap 700 is coupled to the first housing 830, the guided part 730 can be located at the starting position of the guide part 836.

[0176] In some examples, the guide 836 may have a termination position. See also: Figure 5B After the cap 700 is coupled to the first housing 830, the guided part 730 can be located at the end position of the guide part 836.

[0177] See in some examples Figure 5A and Figure 5B The guided part 730 can move from the starting position to the ending position along the guide part 836. In this case, by guiding the guided part 730 through the guide part 836, the movement of the guided part 730 along a predetermined path can be limited, and excessive rotation of the cap 700 can be suppressed.

[0178] See in some examples Figure 5A or Figure 5B The first housing 830 may include a first limiting portion 837. In some examples, the first limiting portion 837 may be disposed on the guide portion 836 or on an extension of the guide portion 836. In some examples, the first limiting portion 837 may be disposed at the end position of the guide portion 836. The guided portion 730 may be coupled to the first limiting portion 837 at the end position of the guide portion 836. In this case, the coupling of the first limiting portion 837 to the guided portion 730 can prevent the guided portion 730 from moving excessively beyond the end position, facilitates indication that the cap 700 has moved to the end position, and also helps to maintain the relative position of the cap 700 and the first housing 830.

[0179] In some examples, the first limiting portion 837 may be a protrusion. The guided portion 730 may have a groove coupled to the protruding first limiting portion 837.

[0180] In some examples, the first limiting portion 837 may have a ramp that facilitates coupling and decoupling between the first limiting portion 837 and the guided portion 730. In some examples, the ramp may face the guided portion 730. In some examples, the first limiting portion 837 may have two ramps. The two ramps may be located on opposite sides of the first limiting portion 837. Thus, coupling and decoupling between the first limiting portion 837 and the guided portion 730 can be facilitated simultaneously.

[0181] In some examples, the guided portion 730 may also have a slope. This further facilitates the coupling and decoupling of the guided portion 730 from the first limiting portion 837.

[0182] As described above, the guided portion 730 may have a groove that mates with the first limiting portion 837. In some examples, the inclined surface of the guided portion 730 may be formed simultaneously on the inner edge and outer periphery of the groove. In this case, the inclined surface located on the outer periphery of the groove facilitates coupling between the guided portion 730 and the first limiting portion 837, while the inclined surface located on the inner edge of the groove facilitates decoupling between the guided portion 730 and the first limiting portion 837.

[0183] In other examples, the side of the first limiting portion 837 near the starting position of the guide portion 836 may also be a vertical surface. In this case, compared to an inclined surface, it helps to prevent the guided portion 730 from passing over the first limiting portion 837, thereby suppressing excessive rotation.

[0184] In other examples, the guided portion 730 may also have a vertical surface. The vertical surface may be formed on the side of the groove near the starting position of the guide portion 836. In this case, by the engagement of the vertical surface of the guided portion 730 with the vertical surface of the first limiting portion 837, excessive rotation can be further suppressed.

[0185] See in some examples Figure 2B The analyte monitoring system 1 may include a second sealing element 520. The second sealing element 520 may be configured to seal the interface between the cap 700 and the body unit 800. In some examples, the second sealing element 520 may be located between the cap 700 and the body unit 800. In some examples, the second sealing element 520 may be located between the mating portion 720 and the first housing 830.

[0186] In some examples, the second sealing element 520 may seal the first orifice 831. In some examples, the second sealing element 520 may also seal the second orifice 610.

[0187] In some examples, the second sealing element 520 may be made of an elastic material. In some examples, the first sealing element 510 may be made of materials such as silicone resin, thermoplastic elastomer (TPE), polytetrafluoroethylene, or rubber. This improves the sealing performance of the first sealing element 510.

[0188] See in some examples Figure 4CA second sealing element 520 may be disposed on the cap 700. In some examples, the cap 700 may have a first sealing groove 780. In some examples, the second sealing element 520 may be at least partially disposed on the first sealing groove 780. In some examples, the first housing 830 may have a second sealing groove 839. In some examples, the second sealing element 520 may also be at least partially disposed on the second sealing groove 839. Specifically, when the cap 700 is coupled to the first housing 830, the second sealing element 520 may be disposed on both the first sealing groove 780 and the second sealing groove 839.

[0189] In some examples, the second sealing element 520 may be fitted into the first sealing groove 780 of the cap 700 first. In other examples, the second sealing element 520 may be fitted into the second sealing groove 839 of the first housing 830 first.

[0190] In some examples, the dimensions of the first sealing groove 780 and the second sealing groove 839 may be slightly smaller than the dimensions of the second sealing element 520. In other words, when the second sealing element 520 is disposed in the first sealing groove 780 or the second sealing groove 839, the second sealing element 520 may protrude from the first sealing groove 780 or the second sealing groove 839. This allows for more thorough compression of the second sealing element 520, thereby improving its sealing performance.

[0191] In some examples, the depth of the first sealing groove 780 may be greater than the depth of the second sealing groove 839. In this case, when the cap 700 is assembled onto the first housing 830 from below, it helps to prevent the second sealing element 520 from falling off during assembly.

[0192] In some examples, the shape of the second sealing element 520 may be the same as or similar to the contour of the first sealing groove 780 and the second sealing groove 839. In this case, by making the first sealing groove 780 and the second sealing groove 839 have a shape that is closer to the second sealing element 520, the fit between the second sealing element 520 and the first sealing groove 780 and the second sealing groove 839 can be improved, thereby improving the sealing performance of the second sealing element 520.

[0193] In some examples, the second sealing element 520 may be annular. In some examples, at least a portion of the sharp object 270 and the sensor 810 may pass through the second sealing element 520 and enter the mating portion 720.

[0194] As described above, the joint 274 and the mating part 720 can be coupled by threads to form a tension force in the axial direction that tightly couples the sharp object 270 with the cap 700.

[0195] In some examples, the sharp object 270 can apply pressure to the first sealing element 510 under tension. The cap 700 can apply pressure to the second sealing element 520. This improves the sealing performance of both the first and second sealing elements.

[0196] In some examples, the movement of the guided portion 730 along the guided portion 836 and the coupling of the engaging portion 274 and the mating portion 720 (i.e., the movement of the first engaging structure 2741 along the second engaging structure 721) can occur simultaneously. For example, they can start and end simultaneously.

[0197] Specifically, when the guided portion 730 is aligned with and abuts against the starting position of the guide portion 836, the engaging portion 274 can enter the mating portion 720 along the guide groove 723. In some examples, during the relative twisting of the cap 700 and the sharp object 270, the guided portion 730 can move from the starting position of the guide portion 836 along the extending direction of the guide portion 836 to the ending position and couple with the first limiting portion 837, and the engaging portion 274 can move along the second engaging structure 721 to the position abutting against the limiting portion 722. Thus, the sharp object 270 and the cap 700 can be coupled in a preset manner (e.g., moving along a preset path, rotating at a preset angle).

[0198] In some examples, when the guided portion 730 is in the terminated position of the guide portion 836, the body unit 800, the cap 700, and the sharp object 270 can have a desired relative position. In some examples, the desired relative position can be maintained by coupling the guided portion 730 with the first limiting portion 837.

[0199] In some examples, the termination position of the guide 836 can be unique. In this case, there can be a unique intended relative position between the body unit 800, the cap 700, and the sharp point 270. This facilitates proper coupling of the pre-assembled module to the application device 1000 (described later).

[0200] In some examples, the tension generated by the coupling between the sharp object 270 and the cap 700 can form a sealed space 710 that accommodates at least a portion of the sharp object 270 and the sensor 810. In some examples, for the health and safety of the host, the implanted component (e.g., the implanted portion of the superunit 800) needs to be sterilized. Furthermore, after sterilization, the implanted portion of the superunit 800 and the sharp object 270 need to be stored in a sterile space until the cap 700 is removed. In some examples, the sharp object 270 and the sensor 810 accommodated in the sealed space 710 can be sterilized. In some examples, the component being sterilized can be referred to as a sterilization module (or a bacteriostatic module). The sterilization module is described in detail below.

[0201] Figure 6A This is a schematic diagram illustrating the structure of the sterilization module involved in the example of this disclosure. Figure 6B This is a cross-sectional view showing the sterilization module involved in the example of this disclosure.

[0202] In some examples, the pre-assembled module may include a sterilization module. See also: Figure 6B The sterilization module may include sensor 810. In this case, sterilizing sensor 810 can contribute to the health and safety of the host.

[0203] See in some examples Figure 6A The sterilization module may also include a sharp object 270.

[0204] See in some examples Figure 6B The sterilization module may also include a cap 700 and a first housing 830. In some examples, the sterilization module may be formed by the cap 700 being sealed to the first housing 830. In some examples, the cap 700 may be sealed to the first housing 830 to form a sealed space 710. In this case, the sealed engagement of the cap 700 with the first housing 830 helps to keep the sterilized sensor 810 sterile before it is used.

[0205] In some examples, radiation sterilization can be used to sterilize the sensor 810. Radiation sterilization methods can include, for example, electron beam radiation, gamma ray radiation, X-ray radiation, or a combination thereof. This contributes to the health and safety of the host.

[0206] In some examples, at least a portion of the sterilization module (e.g., cap 700) may be made of a material that allows radiation to pass through. This facilitates the sterilization of the sharp object 270 and the sensor 810 sealed within the cap 700. In some examples, suitable materials for making the cap 700 may be non-magnetic metals, thermoplastics, ceramics, rubber, composite materials, or combinations thereof.

[0207] In some examples, the sterilization module can be formed before the pre-assembled module is formed. In some examples, the sterilization module can be sterilized before the pre-assembled module is formed; that is, the sterilization module can be sterilized before it is used to form the pre-assembled module.

[0208] Figure 7A This is a schematic diagram illustrating the coupling of electronic component 880 to a sterilization module as described in this disclosure example. Figure 7B This is a schematic diagram showing the structure of the spring 881 and connector 883 involved in the example of this disclosure.

[0209] As described above, the body unit 800 may include electronic component 880. In some examples, electronic component 880 may be used to form a pre-assembled module. That is, the pre-assembled module may include electronic component 880. See also [link to relevant documentation] for some examples. Figure 7A The electronic component 880 can be coupled to the sterilized module after sterilization. In this case, by sterilizing the sterilization module first and then coupling the electronic component 880, it is convenient to select a suitable sterilization method based on the characteristics of the sensor 810 without considering the impact of the sterilization method on the electronic component 880, thereby facilitating sterilization.

[0210] In some examples, electronic component 880 may be coupled to the first housing 830. In some examples, electronic component 880 may be movable in direction X to couple to the first housing 830. In some examples, electronic component 880 may be electrically connected to a sensor 810 disposed in the first housing 830. In some examples, electronic component 880 may be electrically connected to a contact portion 812.

[0211] In some examples, the electronic component 880 may have space for the sharp object 270 to pass through. Specifically, the electronic component 880 may be designed so that its projection in the X direction does not overlap with the sharp object 270. This facilitates coupling of the electronic component 880 away from the sharp object 270. In some examples, the electronic component 880 may have space pre-reserved in its structure for the sharp object 270 to pass through. For example, holes or slots may be made in the electronic component 880. In other examples, the electronic component 880 may also avoid the sharp object 270 in an offset manner. This facilitates coupling of the electronic component 880 to the first housing 830.

[0212] In some examples, electronic component 880 may include spring 881 (see Figure 7B In some examples, the spring 881 may be configured to connect the conductive contact 812 to the circuit board of the electronic component 880. In some examples, the spring 881 may contact the contact 812. In some examples, the spring 881 may be made of a conductive material. In some examples, there may be one or more springs 881.

[0213] In some examples, the spring 881 can be fixedly connected to the circuit board of the electronic component 880. For example, the spring 881 can be soldered to the circuit board of the electronic component 880. This facilitates the electrical connection between the sensor 810 and the electronic component 880.

[0214] In other examples, the spring 881 may also be fixedly connected to the first housing 830.

[0215] In some examples, electronic component 880 may include connector 883 (see...) Figure 7BConnector 883 can be configured to position spring 881. In some examples, spring 881 can be disposed on connector 883. In some examples, connector 883 can have a first recess. In some examples, the first recess can have a similar profile and size to spring 881. Thus, when connector 883 positions spring 881, it can facilitate fixing the position of spring 881, and when there are multiple springs 881, it can also limit the relative positions between multiple springs 881.

[0216] In some examples, connector 883 may also cover contact portion 812 and fixing portion 838. In some examples, connector 883 may be aligned with contact portion 812 and fixing portion 838.

[0217] In some examples, connector 883 may also have a second recess. In some examples, the second recess may have a similar profile and size to the contact portion 812 and the retaining portion 838. In some examples, the size of the cross-shaped recess may be slightly smaller than that of the contact portion 812 and the retaining portion 838. This allows connector 883 to fit more tightly over the contact portion 812 and the retaining portion 838, and also facilitates the securing of the contact portion 812.

[0218] In other examples, connector 883 may also be fixedly connected to the first housing 830 by adhesive or ultrasonic welding.

[0219] Figure 8 This is a schematic diagram illustrating the coupling of a second housing 840 to a sterilization module as described in the examples of this disclosure.

[0220] As described above, housing 820 may include a second housing 840. In some examples, the second housing 840 may be used to form a pre-assembled module. That is, the pre-assembled module may include the second housing 840. In some examples, the second housing 840 may be coupled to the coupled electronic component 880 and the sterilization module. In some examples, the second housing 840 may be coupled to the first housing 830. In some examples, see [link to relevant documentation]. Figure 8 The second housing 840 can move in the X direction to couple to the first housing 830. This facilitates the placement of the electronic component 880 within the receiving space 821.

[0221] In other examples, the electronic component 880 may be coupled to the second housing 840 first, and then the electronic component 880 and the second housing 840 may be coupled together to the first housing 830.

[0222] See in some examples Figure 8 The second housing 840 may have a third opening 841. The third opening 841 may be configured to allow a sharp object 270 to pass through. This facilitates coupling of the second housing 840 to the sterilization module.

[0223] In some examples, the third aperture 841 can be aligned with the first aperture 831. In some examples, the third aperture 841 can also be aligned with the second aperture 610. In some examples, the axes of the first aperture 831, the second aperture 610, and the third aperture 841 can coincide.

[0224] In some examples, see [reference] Figure 2C The sealing cap 600 may have a fitting portion 640. In some examples, the fitting portion 640 may be located on the side of the sealing cap 600 near the second housing 840. In some examples, the fitting portion 640 may be at least partially embedded in the second housing 840. In some examples, the fitting portion 640 may be at least partially embedded in the third opening 841. This facilitates the fixing of the second housing 840.

[0225] In some examples, the outer edge of the fitting portion 640 may fit against the inner edge of the third aperture 841.

[0226] See in some examples Figure 2C The second housing 840 has a protruding structure 842 disposed on the side of the second housing 840 near the sealing cap 600. In some examples, the sealing cap 600 may have a recessed structure 660 at least partially disposed around the fitting portion 640 and opening toward the second housing 840. In some examples, when the fitting portion 640 is engaged with the third aperture 841, the protruding structure 842 may be at least partially received by the recessed structure 660.

[0227] In some examples, adhesive may be injected into the groove structure 660. In this case, it is convenient to seal the interface between the second housing 840 and the sealing cover 600, thereby facilitating the sealing of the receiving space 821.

[0228] See in some examples Figure 3C The periphery of the groove structure 660 may also have an overflow port 630. In some examples, the overflow port 630 may be formed as a notch. In some examples, the overflow port 630 may be configured to allow excess adhesive to overflow.

[0229] In some examples, there may be a gap between the end of the protrusion 842 near the groove 660 and the bottom of the groove 660. This improves the sealing performance of the adhesive.

[0230] In some examples, the second opening 610 may penetrate the fitting portion 640. This allows a sharp object 270 to pass through the sealing cap 600.

[0231] In some examples, the upper surface of the second housing 840 may be substantially coplanar with the upper surface of the sealing cap 600. In other words, the upper surface of the second housing 840 may be substantially flush with the upper surface of the sealing cap 600. In this case, the overall flatness of the upper surface of the application area can be improved, thereby enabling a simpler sealing of the upper interface (see the sealing method of the upper interface in this article).

[0232] As described above, the sterilized sterilization module, electronic component 880, and second housing 840 can be coupled to form a pre-assembled module. That is, after sterilizing the sterilization module, the electronic component 880, second housing 840, and sterilization module can be assembled to form a pre-assembled module. In this case, by coupling the sterilized sterilization module with the electronic component 880 and second housing 840 to form a pre-assembled module, the assembly of the body unit 800 can be completed at the factory stage, and it is convenient to subsequently assemble the complete body unit 800 into the application device 1000, thereby facilitating user operation.

[0233] As described above, the pre-assembled module can be coupled to the application device 1000. In some examples, the pre-assembled module can also be a coupled body unit 800, a sharp object 270, and a cap 700. In some examples, during the coupling of the pre-assembled module to the application device 1000, the guide portion 730 is moved to the termination position of the guide portion 836, which can give the pre-assembled module multiple components a predetermined relative position. In this case, the predetermined relative position can help align the multiple components of the pre-assembled module with the multiple components of the application device 1000, thereby enabling efficient and quick assembly. In some examples, when the guide portion 730 is in the termination position, the body unit 800 can be aligned with the receiving portion 250. The sharp object 270 can be aligned with the support 280. The second assembly feature 791 of the cap 700 can be aligned with the first assembly feature 194 of the application device 1000.

[0234] In some examples, see [reference] Figure 1B The cap 700 can be coupled to the application device 1000. See some examples. Figure 4A The cap 700 may also have a bottom cover 770. The bottom cover 770 may be coupled to the application device 1000.

[0235] In some examples, the mating part 720 can be integrally formed with the bottom cover 770. In this case, the cap 700 has a mating part 720 coupled to the body unit 800 and a bottom cover 770 coupled to the application device 1000. The integral design of the mating part 720 and the bottom cover 770 simplifies the connection structure between the mating part 720 and the bottom cover 770. Compared with a separate design, it can also improve the reliability of the analyte monitoring system 1 during coupling or decoupling. In addition, the mating part 720 and the bottom cover 770 can move more stably and synchronously, which helps to decouple the cap 700 from the body unit 800 and the application device 1000. The analyte monitoring system 1 with the integrally formed cap 700 is less prone to failure during user operation, which can facilitate user operation and improve the user experience.

[0236] In other examples, the mating part 720 and the bottom cover 770 can also be fixedly connected. For example, the mating part 720 and the bottom cover 770 can be fixedly connected by means of bonding, welding, etc.

[0237] See in some examples Figure 1B The application device 1000 may include a housing 10. In some examples, the housing 10 may be coupled to a cap 700. In some examples, the housing 10 may be coupled to a bottom cover 770. In some examples, the bottom cover 770 may be at least partially embedded in the housing 10. See in some examples Figure 1B The application device 1000 may include a receiving portion 250. In some examples, the receiving portion 250 may be coupled to the body unit 800.

[0238] In some examples, the receiving portion 250 may be movable relative to the housing 10.

[0239] In some examples, when the pre-assembled module is coupled to the application device 1000, the cap 700 may be coupled to the housing 10. The body unit 800 may be coupled to the receiving portion 250.

[0240] See in some examples Figure 1B The application device 1000 may also include a support 280. In some examples, the support 280 may be coupled to a sharp object 270. In some examples, the sharp object 270 may be coupled to the support 280 when the pre-assembled module is coupled to the application device 1000.

[0241] In some examples, the pre-assembled module and the application device 1000 can be coupled by moving relative to each other along a straight line. That is, the pre-assembled module and the application device 1000 can be linearly coupled. In this case, the advantages of the integral molding of the mating part 720 and the bottom cover 770 can be utilized to simplify the structure and improve reliability, while also reducing the possibility of accidental decoupling or damage to the joint 274 and the mating part 720.

[0242] Specifically, since the joint 274 and the mating part 720 are threadedly coupled, during the coupling process between the pre-assembled module and the application device 1000, the tendency for the joint 274 and the mating part 720 to rotate relative to each other should be avoided as much as possible. This reduces the possibility of accidental decoupling of the joint 274 and the mating part 720 (e.g., decoupling before the user operates the cap 700, resulting in contamination of the sealing space 710) or damage to the components due to excessive tightening. When the mating part 720 and the bottom cover 770 are integrally formed, the linear coupling method can suppress the tendency for the joint 274 and the mating part 720 to rotate relative to each other, and also couple the bottom cover 770 with the application device 1000. This allows the advantages of the integral design to be utilized while reducing the possibility of coupling failure of the joint 274 and the mating part 720.

[0243] Figure 9 This is a schematic diagram showing a pre-assembled module coupled to an application device 1000, as illustrated in this disclosure example. Figure 10 This is a schematic diagram illustrating the structure of the housing 10 involved in the example of this disclosure.

[0244] See in some examples Figure 9 The pre-assembled module can be coupled to the application device 1000 by moving along the central axis CA (hereinafter referred to as the central axis CA) or in direction D. In other words, the pre-assembled module can be coupled to the application device 1000 by moving along the central axis CA.

[0245] See in some examples Figure 10 The application device 1000 may have a first assembly feature 194. The first assembly feature 194 may be configured to restrict the pre-assembled module from being received by the application device 1000 along the central axis CA of the application device 1000. In this case, the tendency for the individual components in the pre-assembled module to rotate relative to each other can be suppressed.

[0246] In some examples, the cap 700 may have a second assembly feature 791 (see Figure 4A The second assembly feature 791 can mate with the first assembly feature 194. In some examples, the first assembly feature 194 and the second assembly feature 791 can mate to couple the cap 700 with the application device 1000.

[0247] In some examples, at least one of the first assembly feature 194 and the second assembly feature 791 may extend along the central axis CA of the application device 1000. This facilitates movement of the cap 700 along the central axis CA of the application device 1000. For example, the first assembly feature 194 may be a strip-shaped groove extending along the central axis CA, and the second assembly feature 791 may be a block-shaped protrusion projecting from the surface of the cap 700. As another example, the first assembly feature 194 may be a notch, and the second assembly feature 791 may be a strip-shaped protrusion extending along the central axis CA.

[0248] However, this disclosure is not limited thereto; the first assembly feature 194 and / or the second assembly feature 791 may also extend along a direction having a predetermined angle with the central axis CA. For example, they may extend along a direction having an angle of 10 degrees, 20 degrees, or 30 degrees with the central axis CA.

[0249] In some examples, the first assembly feature 194 may be complementary to the second assembly feature 791. In some examples, the first assembly feature 194 may be a slot (see...). Figure 10 The second assembly feature 791 can be a protrusion (see...). Figure 4A In some examples, the groove may extend along the central axis CA.

[0250] In some examples, the first assembly feature 194 may be provided on the housing 10 of the application device 1000. The second assembly feature 791 may be provided on the bottom cover 770 of the cap 700.

[0251] In some examples, the first assembly feature 194 may have a first engaging portion 1941 (see [reference]). Figure 10 The first engaging portion 1941 can engage with the second assembly feature 791. In some examples, the second assembly feature 791 can have a second engaging portion 7911. In some examples, the second engaging portion 7911 can engage with the first engaging portion 1941. In some examples, when the first engaging portion 1941 engages with the second engaging portion 7911, the pre-assembled module can be coupled to the application device 1000.

[0252] In some examples, the second engaging portion 7911 may be the entire second assembly feature 791. In other examples, the second engaging portion 7911 may be a part of the second assembly feature 791.

[0253] In some examples, the first engaging portion 1941 and the second engaging portion 7911 can be elastic. This facilitates the engagement of the first engaging portion 1941 and the second engaging portion 7911.

[0254] In some examples, the first engaging portion 1941 and the second engaging portion 7911 can press against each other when engaged. In some examples, the first engaging portion 1941 and the second engaging portion 7911 can be offset after pressing against each other and return to their original state. Thus, the first engaging portion 1941 and the second engaging portion 7911 can be engaged.

[0255] Figure 11A This is a schematic diagram showing the first engaging part 1941 and the second engaging part 7911 before they are engaged, as described in the example of this disclosure. Figure 11B This is a schematic diagram showing the engagement of the first engaging part 1941 and the second engaging part 7911 involved in the example of this disclosure.

[0256] See in some examples Figure 11A The first engaging portion 1941 may have a first surface 1942. The second engaging portion 7911 may have a second surface 7912. The second surface 7912 may be opposite to the first surface 1942 or have approximately the same angle of inclination. In some examples, during engagement of the first engaging portion 1941 and the second engaging portion 7911, the first surface 1942 and the second surface 7912 may abut against each other. In some examples, at least one of the first surface 1942 and the second surface 7912 may be inclined to the central axis CA. This facilitates coupling of the cap 700 and the application device 1000 along the central axis CA.

[0257] See in some examples Figure 11B The first engaging portion 1941 may have a third surface 1943. The second engaging portion 7911 may have a fourth surface 7913. In some examples, when the first engaging portion 1941 engages with the second engaging portion 7911, the third surface 1943 abuts against the fourth surface 7913. In some examples, the third surface 1943 and the fourth surface 7913 may be perpendicular to the central axis CA. This helps to maintain the engaging state of the first engaging portion 1941 and the second engaging portion 7911.

[0258] See in some examples Figure 9 The application device 1000 may have a first engagement feature 191. The first engagement feature 191 may be configured to guide a second assembly feature 791. In some examples, the first engagement feature 191 may be configured to guide the second assembly feature 791 to decouple the cap 700 from the application device 1000. This allows the cap 700 to move along a predetermined path when decoupled from the application device 1000.

[0259] See in some examples Figure 10 The first assembly feature 194 may be located at one end of the first engagement feature 191. In some examples, the first assembly feature 194 may be connected to the first engagement feature 191.

[0260] In some examples, the second assembly feature 791 can move under the guidance of the first engagement feature 191. In some examples, the first engagement feature 191 can have a starting position and an ending position. In some examples, the second assembly feature 791 can move from the starting position of the first engagement feature 191 to the ending position to decouple the cap 700 from the application device 1000.

[0261] In some examples, when the pre-assembled module is coupled to the application device 1000, the second assembly feature 791 may be located at the starting position of the first engagement feature 191. In some examples, the first assembly feature 194 may be located at the starting position of the first engagement feature 191.

[0262] See in some examples Figure 10 The application device 1000 may have a second limiting portion 195. The second limiting portion 195 may be configured to limit the position of the second assembly feature 791. In some examples, the second limiting portion 195 may be located at one end of the first engagement feature 191 near the first assembly feature 194. In some examples, the second limiting portion 195 may be located at the starting position of the first engagement feature 191. Thus, it is convenient to hold the second assembly feature 791 at the starting position of the first engagement feature 191.

[0263] See in some examples Figure 10 The second limiting portion 195 may be provided on the housing 10. In some examples, the second limiting portion 195 may be a protrusion.

[0264] In some examples, during the coupling of the pre-assembled module with the application device 1000, the second assembly feature 791 may engage with the first assembly feature 194 to couple with the first engagement feature 191. In some examples, the second assembly feature 791 may move to the starting position of the first engagement feature 191 under the guidance of the first assembly feature 194 and be held in the starting position of the first engagement feature 191 by the second limiting portion 195.

[0265] See in some examples Figure 9The first engagement feature 191 can extend circumferentially along the application device 1000. In this case, since the first engagement feature 191 extends circumferentially along the application device 1000, the cap 700 can rotate only circumferentially along the application device 1000 when decoupled from the application device 1000, without generating relative displacement with respect to the application device 1000 in the axial direction. Specifically, since the engagement portion 274 and the mating portion 720 are threadedly coupled, the engagement portion 274 and the mating portion 720 will generate relative axial movement when decoupled, while the cap 700 and the application device 1000 will not generate relative axial movement when decoupled. This makes different parts of the cap 700 have different motion states. For example, the mating portion 720 tends to move away from the engagement portion 274 when decoupled, while the bottom cover 770 will hinder the movement of the mating portion 720. The hindering effect of the bottom cover 770 on the mating portion 720 makes the mating portion 720 and the engagement portion... 274 requires greater force during decoupling, which reduces the possibility of accidental decoupling between mating part 720 and joint part 274; in addition, before the second assembly feature 791 disengages from the first joint feature 191, the bottom cover 770 continuously applies an obstructive force to the mating part 720. Under the action of the bottom cover 770, the mating part 720 can abut against the joint part 274 or the first housing 830, reducing the possibility of the cap 700 shaking during decoupling, thereby helping to prevent the mating part 720 from affecting the sharp object 270 or the portion of the sensor 810 extending out of the first housing 830 due to shaking.

[0266] See in some examples Figure 9 or Figure 10 The first engagement feature 191 can be an opening. In this case, by having an open first engagement feature 191, it is easy to determine whether the application device 1000 and the cap 700 are in the correct relative position (for example, by determining whether the second assembly feature 791 is at the starting position of the first engagement feature 191 to determine whether the cap 700 is misaligned or whether an unwanted movement has occurred).

[0267] In some examples, the first engagement feature 191 can also be a groove.

[0268] See in some examples Figure 10 The extension direction of the first engagement feature 191 may intersect with the extension direction of the second assembly feature 791. Thus, the cap 700 and the housing 10 can be decoupled in a manner different from coupling the cap 700 to the housing 10.

[0269] In some examples, the extension direction of the first engagement feature 191 may be orthogonal to the extension direction of the second assembly feature 791. This facilitates coupling and decoupling of the cap 700 and the housing 10. However, this disclosure is not limited to this; the extension direction of the first engagement feature 191 may have a preset angle with the extension direction of the second assembly feature 791, such as 60 degrees, 70 degrees, or 80 degrees.

[0270] As described above, the guide portion 836 may have a preset radius. In some examples, the first engagement feature 191 may also have a preset radius. This facilitates the decoupling of the cap 700 from the body unit 800 and the sharp object 270 while simultaneously decoupling the cap 700 from the application device 1000.

[0271] In some examples, the first engagement feature 191 may be formed at the proximal end. In some examples, the first engagement feature 191 may be formed as a groove or opening at the proximal end. For example, it may be formed as an annular groove on the inner wall of the proximal end.

[0272] In some examples, the second assembly feature 791 may be formed on the periphery of the bottom cover 770. This facilitates the engagement of the second assembly feature 791 with the first engagement feature 191. Additionally, it facilitates the decoupling of the cap 700 from the application device 1000 (described later).

[0273] See in some examples Figure 10 A decoupling feature may be formed in the first engagement feature 191. In some examples, the decoupling feature may be configured to provide a path for decoupling the cap 700 from the application device 1000. In some examples, the decoupling feature may be formed at the termination position of the first engagement feature 191.

[0274] In some examples, the second assembly feature 791 can move from the end of the first engagement feature 191 away from the decoupling feature to the end closer to the decoupling feature. In some examples, when the second assembly feature 791 moves to the end of the first engagement feature 191 closer to the decoupling feature, the second assembly feature 791 can enter the decoupling feature. In some examples, the second assembly feature 791 can move away from the application device 1000 along the extension direction of the decoupling feature.

[0275] See in some examples Figure 10 The decoupling feature can extend along a direction parallel to the central axis CA of the application device 1000. In this case, the decoupling feature can provide an axial decoupling path for the cap 700, thereby facilitating the decoupling of the cap 700 from the application device 1000.

[0276] In the integrated cap 700 disclosed herein, the features and structure of the cap 700 are designed to facilitate coupling and decoupling from the application device 1000. The structure of the cap 700 is described below in conjunction with the coupling and decoupling process.

[0277] As described above, the cap 700 can at least partially fit into the application device 1000. In some examples, see [link to relevant documentation]. Figure 4A The cap 700 may have a base 740. See also Figure 1B The base 740 may be fitted into the application device 1000. In some examples, the base 740 may be fitted into the housing 10. In some examples, the base 740 may be part of the bottom cover 770.

[0278] In some examples, the base 740 can be approximately fitted against the inner wall of the housing 10. In other words, the dimensions of the base 740 can be the same as or similar to the dimensions of the inner wall of the housing 10. Thus, when the cap 700 is coupled to the application device 1000, the wobbling of the cap 700 can be suppressed.

[0279] In some examples, ribs 750 may be formed around the base 740 (see...). Figure 4A In some examples, rib 750 may abut against housing 10. In this case, the rib 750 enables the base 740 to form a line contact with housing 10, which reduces the contact area between the base 740 and housing 10, thereby reducing friction between the base 740 and housing 10 and facilitating coupling and decoupling. In some examples, the number of ribs 750 may be one or more.

[0280] In some examples, the body unit 800 and the receiving portion 250 need to be assembled into the application device 1000 in a certain orientation due to at least one of the following reasons: the body unit 800 and the receiving portion 250 are not circular; the center of symmetry of the body unit 800 is not located on the central axis CA; the axis of the body unit 800 is parallel to the central axis CA; the first orifice 831, the second orifice 610, the third orifice 841, and the hole of the receiving portion 250 are not in a central position (e.g., not on the central axis CA); and the engagement of the sharp object 270 with the support 280. In this case, the housing 10 can limit the shaking of the pre-assembled module by the contact between the platform 740 and the housing 10, thereby enabling the pre-assembled module to be coupled to the application device 1000 in the correct orientation.

[0281] See in some examples Figure 9The application device 1000 may have a first indicator 192. The cap 700 may have a second indicator 792. In some examples, before coupling the cap 700 to the application device 1000, the first indicator 192 and the second indicator 792 may be in a first relative position to indicate the correct assembly orientation. After assembly, the first indicator 192 and the second indicator 792 may be in a second relative position to indicate the correct position of the pre-assembled module coupled to the application device 1000.

[0282] The "first relative position" refers to a specific relative state between the two indicators, indicating that the two components are in the correct assembly orientation, but the final assembly is not yet complete. The "second relative position" refers to another specific relative state between the two indicators, indicating that the two components have been assembled to the correct position and the assembly process is complete. These two positions are not limited to specific physical locations, but rather reflect the assembly status of the components through the relative state / position of the indicators. In this case, the relative position indication allows for convenient observation of the assembly orientation during assembly and a direct assessment of whether the components are correctly assembled after assembly, improving the accuracy and efficiency of the assembly process.

[0283] In some examples, the first relative position may refer to the relative position of the first indicator 192 and the second indicator 792 when they are on the same straight line (or their extension directions coincide) before the cap 700 is coupled to the application device 1000 (or the pre-assembled module is coupled to the application device 1000). In some examples, when the first indicator 192 and the second indicator 792 are in the first relative position, the straight line they lie on may be parallel to the central axis CA.

[0284] In some examples, the second relative position may refer to the relative position of the first indicator 192 and the second indicator 792 when they are on the same straight line (or their extension directions coincide) after the cap 700 is coupled to the application device 1000 (or the pre-assembled module is coupled to the application device 1000). In some examples, the first indicator 192 and the second indicator 792 are in the second relative position and the straight line they are on may be parallel to the central axis CA.

[0285] In some examples, the correct assembly orientation may refer to the orientation between the cap 700 (or pre-assembled module) and the application device 1000 when the body unit 800 is aligned with the receiving part 250, the sharp object 270 is aligned with the support 280, the second assembly feature 791 is aligned with the first assembly feature 194, and the first indicator 192 is aligned with the second indicator 792.

[0286] In some examples, the correct position (or correct relative position) may refer to the relative position between the cap 700 (or pre-assembled module) and the application device 1000 when the body unit 800 is coupled to the receiving portion 250 in the intended orientation, the sharp object 270 is coupled to the support 280 in the intended orientation, and the second assembly feature 791 is coupled to the first assembly feature 194 or the first engagement feature 191 in the intended orientation.

[0287] In some examples, when the analyte monitoring system 1 is removed from the packaging box, it can be determined whether the analyte monitoring system 1 has undergone an undesirable morphological change before being used, based on whether the first indicator 192 and the second indicator 792 are aligned.

[0288] In some examples, during the decoupling of the cap 700 from the housing 10, the first indicator 192 and the second indicator 792 can move relative to each other. In some examples, the movement path of the second indicator 792 relative to the first indicator 192 can be an arc, and the angle corresponding to the arc can be equal to a preset angle.

[0289] In some examples, the cap 700 may have a release part 793 (see Figure 4A The release part 793 can be configured to absorb or release force. In some examples, the release part 793 can be configured to absorb or release the force transmitted to the joint 274 when the joint 274 and the mating part 720 are screwed off. In this case, by releasing the force through the release part 793, the possibility of damage to the components due to excessive interaction force can be reduced. Specifically, since the coupling between the joint 274 and the mating part 720 is a threaded coupling, the joint 274 and the mating part 720 will have relative axial movement when decoupled, while the first engagement feature 191 extends circumferentially along the application device 1000. This means that the bottom cover 770 will not have relative axial movement when decoupled from the housing 10. The different motion states of the mating part 720 and the bottom cover 770 cause them to deform due to interaction. By releasing the force through the release part 793, the possibility of damage to the cap 700 can be reduced, and the decoupling of the cap 700 can also be facilitated.

[0290] In some examples, the release part 793 may be located on the bottom cover 770. In some examples, the release part 793 may be located at the connection between the mating part 720 and the bottom cover 770. In some examples, the release part 793 may be a wall of the bottom cover 770 on which the mating part 720 is provided. In some examples, the elasticity of the wall can be changed by changing the thickness of the wall. For example, the elasticity of the wall can be increased (or the wall can be made more deformable) by reducing the thickness of the wall. In this case, since the travel distance of the mating part 720 in the vertical direction is different from that of the bottom cover 770, this causes deformation at the connection between the mating part 720 and the bottom cover 770. By changing the wall thickness to adjust the elasticity of the wall, it is easier for the connection between the mating part 720 and the bottom cover 770 to deform, thereby facilitating the decoupling of the mating part 720 from the connecting part 274.

[0291] In some examples, the wall of the bottom cover 770 can be perpendicular to the direction of movement of the mating part 720 during decoupling. This further facilitates wall deformation.

[0292] In this disclosure, the design of the mating part 720 and the bottom cover 770 being integrally formed simplifies the connection structure between them. Compared to a separate design, this also improves the reliability of the analyte monitoring system 1 during coupling or decoupling. Furthermore, the mating part 720 and the bottom cover 770 can move more stably and synchronously, facilitating the decoupling of the cap 700 from the body unit 800 and the application device 1000. The analyte monitoring system 1 with the integrally formed cap 700 is less prone to failure during user operation, making it easier to use and improving the user experience.

[0293] In summary, according to this disclosure, a highly reliable analyte monitoring system 1 can be provided.

[0294] While the present disclosure has been specifically described above in conjunction with the accompanying drawings and examples, it is to be understood that the foregoing description does not limit the present disclosure in any way. Those skilled in the art can make modifications and variations to the present disclosure as needed without departing from its essential spirit and scope, and all such modifications and variations shall fall within the scope of the present disclosure.

Claims

1. An analyte monitoring system, characterized in that, The assembly includes a pre-assembled module and an application device. The pre-assembled module includes a body unit and a cap coupled to the body unit. The on-body unit includes a housing having a containment space, electronic components located in the containment space, and a sensor operatively coupled to the electronic components and at least partially implanted in the host to obtain the host's analyte levels. The cap has a mating portion for accommodating at least a portion of the sensor, and a bottom cover coupled to the application device, the mating portion being integrally formed with the bottom cover. When the cap is coupled to the body unit to form the pre-assembled module, the mating part is sealed to the housing to form a sealed space to accommodate the sensor, and the analyte monitoring system is formed by the pre-assembled module coupled to the application device.

2. The analyte monitoring system according to claim 1, characterized in that, The housing also includes a first housing that can be applied to a host, with at least a portion of the sensor extending beyond the bottom surface of the first housing.

3. The analyte monitoring system according to claim 2, characterized in that, The cap is coupled to the first housing in a manner that allows it to rotate relative to the first housing.

4. The analyte monitoring system according to claim 3, characterized in that, The housing also includes a second housing that mates with the first housing. The pre-assembled module includes a sterilization module, the electronic components, and the second housing. The sterilization module is formed by the cap sealing and joining the first housing.

5. The analyte monitoring system according to claim 4, characterized in that, After sterilizing the sterilization module, the electronic components, the second housing, and the sterilization module are assembled to form the pre-assembled module.

6. The analyte monitoring system according to claim 3, characterized in that, The first housing includes a guide portion, and the cap includes a guided portion, the guide portion cooperating with the guided portion to restrict relative rotation between the cap and the first housing.

7. The analyte monitoring system according to claim 6, characterized in that, The guide has a starting position and an ending position, and the guided part moves along the guide from the starting position to the ending position.

8. The analyte monitoring system according to claim 7, characterized in that, The first housing includes a first limiting portion disposed at the termination position, and the guided portion is coupled to the first limiting portion at the termination position.

9. The analyte monitoring system according to any one of claims 2 to 8, characterized in that, The analyte monitoring system also includes a sharp object that at least partially houses the sensor and is configured to implant at least a portion of the sensor under the skin.

10. The analyte monitoring system according to claim 9, characterized in that, The first housing has a first opening, the sharp object has a joint, the sharp object extends beyond the bottom surface of the first housing through the first opening, and the joint and the mating part are coupled to form the sealed space.

11. The analyte monitoring system according to claim 10, characterized in that, The joint extends beyond the bottom surface of the first housing.

12. The analyte monitoring system according to claim 10, characterized in that, The joint and the mating part are coupled by threads.

13. The analyte monitoring system according to claim 1, characterized in that, The application device includes a housing that can be coupled to the cap, and a receiving portion that can be coupled to the body unit and is movable relative to the housing. When the pre-assembled module is coupled to the application device, the cap is coupled to the housing, and the body unit is coupled to the receiving portion.

14. The analyte monitoring system according to claim 1, characterized in that, The pre-assembled module is movably coupled to the application device via the central axis of the application device, the application device having a first assembly feature configured to restrict the pre-assembled module to be received by the application device along the central axis of the application device.

15. The analyte monitoring system according to claim 14, characterized in that, The cap has a second assembly feature that mates with the first assembly feature, and at least one of the first assembly feature and the second assembly feature extends along the central axis of the application device.

16. The analyte monitoring system according to claim 15, characterized in that, The first assembly feature is a groove, and the second assembly feature is a protrusion.

17. The analyte monitoring system according to claim 15, characterized in that, The application device has a first engagement feature configured to guide the second assembly feature to decouple the cap from the application device.

18. The analyte monitoring system according to claim 17, characterized in that, The first engagement feature is a groove or opening formed in the circumferential direction of the application device.

19. The analyte monitoring system according to claim 18, characterized in that, A decoupling feature is formed at the terminating position of the first engagement feature, the decoupling feature being configured to provide a path for decoupling the cap from the application device, the decoupling feature extending along a direction parallel to the central axis of the application device.

20. The analyte monitoring system according to claim 12, characterized in that, The application device is configured to apply the body unit to the host after the cap is removed, the cap having a release portion configured to absorb or release the force transmitted to the joint when the joint and the mating portion are screwed off.

Images