Split analyte monitoring device

Abstract

The invention discloses a split type analyte monitoring device which comprises a first shell and a second shell detachably assembled with the first shell, the first shell is provided with a sensor which can be implanted under the skin of a host to obtain an analyte concentration signal, and a storage module for storing the sensitivity of the sensor, the second shell is provided with an electronic module capable of processing an analyte concentration signal, the first shell comprises a first connecting part, and the second shell comprises a second connecting part capable of being matched with the first connecting part; the second connecting part is matched with the first connecting part in a manner of rotating relative to the first connecting part so as to establish releasable mechanical connection between the first shell and the second shell, and the electronic module is electrically connected with the storage module and the sensor when the second shell is assembled on the first shell. Therefore, the split type analyte monitoring device provided by the invention can improve the assembly convenience.

Description

Technical Field

[0001] This disclosure generally relates to the biomedical engineering industry, and specifically to a split-type analytical monitoring device. Background Technology

[0002] A continuous glucose monitoring (CGM) device is used to monitor glucose concentration in the human body in real time and continuously. Typically, a CGM is picked up by an application device and then applied to the skin surface to achieve real-time and continuous monitoring of glucose concentration in the body's tissue fluid.

[0003] A CGM typically consists of a sensor that acquires a glucose concentration signal and a transmitter that transmits the glucose concentration signal externally. Generally, a CGM can be designed as a separate product (i.e., the sensor and transmitter are assembled in a detachable manner). A separate CGM facilitates the use of different sterilization methods for the sensor and transmitter, and also allows for the reuse of the transmitter, reducing user costs. When using a separate CGM, the sensor is first applied to the skin using an application device, and then the transmitter and sensor are assembled together to obtain a complete CGM.

[0004] In existing technologies, for split-type CGMs, the transmitter and sensor are typically assembled by pressing the transmitter against the skin surface. However, because human muscle or adipose tissue is relatively soft, the sensor may shift or move after being subjected to pressure, making it easy for the transmitter and sensor to not be properly assembled, thus increasing the difficulty of assembling the transmitter and sensor. Summary of the Invention

[0005] This disclosure is made in view of the above-mentioned situation, and its purpose is to provide a split-type analytical substance monitoring device that can improve the ease of assembly.

[0006] Therefore, this disclosure provides a split-type analyte monitoring device, including a first housing and a second housing detachably assembled with the first housing. The first housing is provided with a sensor that can be implanted under the skin of a host to obtain an analyte concentration signal, and a storage module for storing the sensitivity of the sensor. The second housing is provided with an electronic module for processing the analyte concentration signal. The first housing includes a first connecting portion, and the second housing includes a second connecting portion that can cooperate with the first connecting portion. The second connecting portion cooperates with the first connecting portion in a rotatable manner relative to the first connecting portion to establish a releasable mechanical connection between the first housing and the second housing. The electronic module establishes an electrical connection with the storage module and the sensor when the second housing is assembled with the first housing.

[0007] In this disclosure, the second housing is typically assembled onto the first housing after the first housing is applied to the host's skin surface. The second housing is rotated relative to the first housing to engage with the first connecting portion, thereby establishing a releasable mechanical connection between the two housings and completing the assembly of the second housing onto the first housing. In this case, compared to assembling the second housing onto the first housing by pressing it down, which may increase the difficulty of assembly due to the softness of muscle / fat tissue, the force applied by rotating the second housing is not directly towards the host's skin surface, thus avoiding compression / pressing. In other words, the force required to assemble the first and second housings is applied to the analyte monitoring device itself, reducing the influence of external factors such as muscle / fat tissue on the assembly and improving the ease of assembly. Furthermore, by placing the storage module and sensor within the first housing, sensitivity can be bound to the sensor (i.e., the sensitivity data stored in the storage module is integrated with the sensor in the first housing), reducing the possibility of sensor sensitivity loss. In addition, compared to storing sensitivity data in the form of barcodes (such as QR codes), which are prone to loss due to barcode damage, contamination or loss, storing sensitivity data in a storage module can reduce the possibility of sensitivity loss.

[0008] Furthermore, in the split-type analyte monitoring device disclosed herein, optionally, the first connecting portion includes a first profile with a first thread, and the second connecting portion includes a second profile with a second thread. The first thread and the second thread engage to establish a releasable mechanical connection between the first housing and the second housing. In this case, by engaging the first thread and the second thread to screw the first connecting portion to the second connecting portion, thereby establishing a releasable mechanical connection between the first housing and the second housing, the ease of assembly and disassembly of the first housing and the second housing can be improved.

[0009] Furthermore, in the split-type analyte monitoring device disclosed herein, optionally, the first housing includes a first base where the sensor and the storage module are disposed, and a first side portion formed on the periphery of the first base; the second housing includes a second base where the electronic module is disposed, and a second side portion formed on the periphery of the second base; the first profile is located on the first base, and the second profile is located on the second base; or the first profile is located on the first side portion, and the second profile is located on the second side portion. In this case, when the second housing is assembled onto the first housing, the first base, the second base, the first side portion, and the second side portion cooperate to form a receiving space, which can accommodate multiple electronic components (e.g., storage module, power module, and electronic module, etc.). Thus, multiple electronic components of the analyte monitoring device can be protected.

[0010] Additionally, in the split-type analyte monitoring device disclosed herein, a power module may optionally be provided in the first housing. This allows for the provision of electrical energy for the normal operation of the sensor, storage module, and electronic module.

[0011] Additionally, in the split-type analyte monitoring device disclosed herein, optionally, an isolator is provided between the first housing and the second housing. The isolator is configured to seal the electrical connections between the electronic module and the storage module, and between the electronic module and the sensor, when the second housing is assembled onto the first housing. In this case, sealing the electrical connections between the first and second housings with the isolator reduces the possibility of short circuits in the electronic module and storage module due to the infiltration of liquids (e.g., blood, interstitial fluid, or water).

[0012] Additionally, in the split-type analyte monitoring device disclosed herein, optionally, the storage module includes multiple passive devices and is configured to store the sensitivity in binary format through the multiple passive devices. In this case, when the first housing is irradiated for sterilization, compared to storing the sensitivity in a cache (e.g., flash memory), which would result in sensitivity loss due to damage from irradiation sterilization, storing the sensitivity in binary format through multiple passive devices improves the security of the stored data, as irradiation sterilization does not damage the passive devices.

[0013] Furthermore, in the split-type analyte monitoring device disclosed herein, optionally, the first housing includes a first positioning part, and the second housing includes a second positioning part that can cooperate with the first positioning part, wherein the second positioning part engages with the first positioning part when the second housing is assembled onto the first housing. In this case, the tightness of the connection between the first housing and the second housing can be improved, thereby improving the robustness of the assembly of the first housing and the second housing; in addition, by improving the tightness of the connection between the first housing and the second housing, the first housing and the second housing can compress the isolation member, thereby improving the sealing performance of the isolation member.

[0014] Furthermore, in the split-type analyte monitoring device disclosed herein, optionally, the first positioning part is configured to be destructively disengaged from the second positioning part by external forces. In this case, since the first positioning part can only disengage from the second positioning part by being damaged, it serves two purposes: firstly, it reminds the user that the first housing cannot be reused; secondly, it helps to prevent the first housing from being intentionally or unintentionally reused, thereby reducing regulatory risks.

[0015] Furthermore, in the split-type analyte monitoring device disclosed herein, optionally, at least one of the passive components is located in the first positioning part. In this case, when the first positioning part disengages from the second positioning part, the storage module will lose part of the passive component due to the destruction of the first positioning part, making the sensitivity stored in the storage module unusable (i.e., the electronic module will be unable to read the sensitivity), thereby rendering the analyte monitoring device unusable and ensuring that the first housing cannot be reused.

[0016] Additionally, in the split-type analyte monitoring device disclosed herein, optionally, the first housing includes a first base and a first side portion formed on the periphery of the first base, the first side portion surrounding a portion of the periphery of the first base.

[0017] The second housing includes a second base and a second side portion formed around the periphery of the second base. The second side portion surrounds a portion of the periphery of the second base, and the first side portion forms a closed structure with the second side portion when the second housing is assembled onto the first housing. In this configuration, the sides of the analyte monitoring device can be sealed and protected. Furthermore, the second side portion allows the user to stably grip opposite sides of the second housing using the fingers of one hand (e.g., thumb and forefinger), and facilitates the user to apply force along the second side portion to rotate the second housing relative to the first housing, thereby assembling the second housing onto the first housing.

[0018] In addition, in the split-type analyte monitoring device disclosed herein, optionally, the electronic module is configured to acquire the host's physiological parameters based on the sensitivity and the analyte concentration signal.

[0019] According to this disclosure, a split-type analytical substance monitoring device that improves assembly convenience can be provided. Attached Figure Description

[0020] This disclosure will now be explained in further detail with reference to the examples in the accompanying drawings, in which:

[0021] Figure 1 This is a schematic diagram illustrating an application scenario of the analyte monitoring device involved in the examples of this disclosure.

[0022] Figure 2 This is a schematic diagram showing the overall analyte monitoring device involved in the example of this disclosure.

[0023] Figure 3A This is a first-view exploded view showing the analyte monitoring device involved in the example of this disclosure.

[0024] Figure 3B This is a second-view exploded view showing the analyte monitoring device involved in the example of this disclosure.

[0025] Figure 3C This is a third-view exploded view of the analyte monitoring device involved in the example of this disclosure.

[0026] Figure 4 This is a schematic diagram illustrating the sensor involved in the example of this disclosure.

[0027] Figure 5 This is a schematic diagram illustrating the first housing involved in the example of this disclosure.

[0028] Figure 6 This is a schematic diagram illustrating the second housing involved in the example of this disclosure.

[0029] Figure 7A This is a first-view exploded view illustrating a second embodiment of the analyte monitoring device according to the examples of this disclosure.

[0030] Figure 7B This is a second-view exploded view illustrating a second embodiment of the analyte monitoring device according to the examples of this disclosure.

[0031] Figure 8 This is a schematic diagram illustrating the first and second protrusions involved in the examples of this disclosure.

[0032] Explanation of reference numerals in the attached figures:

[0033] 1…Analyte monitoring device, 2…Application device, 3…External device, 10…First housing, 20…Second housing, 12…First base, 12a…First surface, 12b…Second surface, 14…First side, 22…Second base, 24…Second side, 110…Sensor, 112…Implantation part, 114…Connection part, 120…Storage module, 122…Through hole, 130…Power module, 220…Electronic module, 101…First electrical… Contact, 202… second electrical contact, 16… first connecting part, 160… first profile, 162… first thread, 26… second connecting part, 260… second profile, 262… second thread, 18… first positioning part, 180… first protrusion, 182… first vertical surface, 184… first inclined surface, 28… second positioning part, 280… second protrusion, 282… second vertical surface, 284… second inclined surface, 186… flange, 286… bayonet. Detailed Implementation

[0034] The technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this disclosure, and not all embodiments. Based on the embodiments of this disclosure, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this disclosure.

[0035] It should be noted that the terms "first," "second," "third," and "fourth," etc., in this disclosure, claims, and the aforementioned drawings are used to distinguish different objects, not to describe a specific order. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or devices. In the following description, the same reference numerals are used for the same parts, and repeated descriptions are omitted. Additionally, the drawings are merely schematic diagrams, and the scale of the dimensions of the parts or the shape of the parts may differ from the actual figures.

[0036] The split-type analyte monitoring device disclosed herein can be used to monitor the physiological parameters of a host. These physiological parameters can include parameters related to glucose, urea, uric acid, ketone bodies, and a range of amino acid compounds within the host body.

[0037] The split-type analyte monitoring device disclosed herein is a split-type design, comprising multiple detachable and assembleable housings. Before use, the housings can be packaged separately; during use, one housing (e.g., the first housing) can be applied to the host's skin surface, and then another housing (e.g., the second housing) can be rotated relative to the first housing to complete assembly, thus obtaining the complete analyte monitoring device. The split-type analyte monitoring device disclosed herein improves the ease of assembly.

[0038] In some examples, a split-type analyte monitoring device may be simply referred to as an analyte monitoring device, and sometimes it may also be called a monitoring device, detection device, measuring device, monitor, or blood glucose meter, etc.

[0039] In this disclosure, the analyte monitored by the analyte monitoring device may be one or more of the following: glucose, acetylcholine, amylase, bilirubin, cholesterol, human chorionic gonadotropin, creatine kinase, creatine, creatine anhydride, DNA, fructosamine, glutamine, growth hormone, hormone, ketone bodies, lactate, oxygen, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid-stimulating hormone, or troponin.

[0040] The following description uses glucose as an example to illustrate the analyte monitoring device involved in this disclosure. It should be noted that, for other analytes, those skilled in the art can perform analysis on other analytes with slight modifications to the analyte monitoring device used for glucose.

[0041] Figure 1 This is a schematic diagram illustrating an application scenario of the analyte monitoring device 1 involved in the example of this disclosure. Figure 2 This is a schematic diagram of the overall analyte monitoring device 1 involved in the example of this disclosure. Figure 3A This is a first-view exploded view of the analyte monitoring device 1 involved in the example of this disclosure. Figure 3B This is a second-view exploded view showing the analyte monitoring device 1 involved in the example of this disclosure. Figure 3C This is a third-view exploded view of the analyte monitoring device 1 according to the example of this disclosure.

[0042] See in some examples Figure 1 The analyte monitoring device 1 can be picked up by the application device 2 and applied to the host's skin surface. Furthermore, the analyte monitoring device 1 applied to the skin surface can monitor the host's physiological parameters in real time and continuously.

[0043] See in some examples Figure 1The analyte monitoring device 1 can wirelessly transmit physiological parameters to the external device 3. This facilitates the host's acquisition of physiological parameters. Furthermore, the external device 3 can be a mobile smart terminal (such as a smartphone, smartwatch, etc.).

[0044] See in some examples Figure 2 The analyte monitoring device 1 may include a first housing 10 and a second housing 20. The second housing 20 may be detachably assembled with the first housing 10. In some examples, the second housing 20 may be assembled with the first housing 10 after the first housing 10 has been applied to the skin surface of the host. In some examples, the first housing 10 may be picked up and applied to the skin surface of the host by the application device 2.

[0045] See in some examples Figure 3A A sensor 110 and a storage module 120 may be disposed in the first housing 10. The sensor 110 can be used to acquire the analyte concentration signal, and the storage module 120 can store the sensitivity of the sensor 110. In this case, by disposing of the storage module 120 and the sensor 110 in the first housing 10, the sensitivity can be bound to the sensor 110 (that is, the sensitivity data stored in the storage module 120 is integrated with the sensor 110 in the first housing 10), reducing the possibility of sensitivity loss of the sensor 110. In addition, compared with storing sensitivity in the form of barcodes (such as QR codes), which are prone to loss due to barcode damage, contamination or loss, storing sensitivity in the storage module 120 can reduce the possibility of sensitivity loss.

[0046] In some examples, the storage module 120 can be electrically connected to the sensor 110. This allows the storage module 120 to easily acquire the sensitivity of the sensor 110.

[0047] In some examples, the electrical connection between the storage module 120 and the sensor 110 can be a wired electrical connection. That is, the storage module 120 and the sensor 110 can be physically connected to form an electrical connection. This improves the stability of the electrical connection.

[0048] In some examples, the electrical connection between the storage module 120 and the sensor 110 can be a wireless connection. In this case, the number of wires between the storage module 120 and the sensor 110 can be reduced, simplifying the circuit design and making the electrical conduction between the storage module 120 and the sensor 110 more flexible and convenient.

[0049] See in some examples Figure 2 After the first housing 10 is applied to the skin surface of the host, the sensor 110 can be implanted under the skin of the host to obtain the analyte concentration signal (e.g., glucose concentration signal).

[0050] In some examples, sensor 110 may be partially or completely implanted subcutaneously in the host. In some examples, after being implanted subcutaneously, sensor 110 may react with glucose in the subcutaneous interstitial fluid to generate a glucose concentration signal in the host.

[0051] In some examples, the analyte concentration signal can be a current signal characterizing the analyte concentration. For example, taking glucose as an analyte. Sensor 110 can include a working electrode and a counter electrode. A sensing layer including a glucose enzyme can be disposed on the working electrode. When placed under the skin, sensor 110 can generate a current signal by the glucose enzyme on the working electrode reacting with glucose in interstitial fluid or blood through an oxidation-reduction reaction, forming a circuit with the counter electrode. This current signal can represent the host's glucose concentration signal.

[0052] In some examples, analyzing the current signal can yield physiological parameters of the host (such as glucose concentration levels).

[0053] In some examples, storage module 120 may include multiple passive devices, and storage module 120 may be configured to store the sensitivity of sensor 110 in binary format through multiple passive devices. In this case, when the entire first housing 10 is irradiated for sterilization, compared to storing the sensitivity in a cache (e.g., flash memory), which would result in sensitivity loss due to damage from irradiation sterilization, the storage of the sensitivity in binary format through multiple passive devices can improve the security of the stored data since irradiation sterilization does not damage the passive devices.

[0054] In some examples, passive components can be resistors, inductors, or capacitors.

[0055] In some examples, the number of passive components can be matched to the accuracy of the sensitivity. In other words, the required number of passive components can be determined based on the accuracy of the stored sensitivity. In some examples, the accuracy of the sensitivity can refer to the accuracy of the sensitivity data.

[0056] In some examples, preferably, the number of passive devices can be six to eight. This allows the storage module 120 to store higher precision sensitivity. For example, the number of passive devices can be six, seven, or eight.

[0057] In some examples, the first housing 10 can be for single use. In other words, the sensor 110 disposed of in the first housing 10 can be for single use.

[0058] Specifically, the service life of sensor 110 can be a preset number of days (e.g., 7 days, 10 days, or 14 days). When the service life of sensor 110 is exceeded, the activity of glucose enzyme on the working electrode may decrease or the glucose enzyme may detach, resulting in the acquired current signal not accurately reflecting the actual physiological parameters of the host. Therefore, after sensor 110 reaches its service life, the first housing 10 (including sensor 110) needs to be removed from the host's skin surface, and the removed first housing 10 (including sensor 110) will be discarded and cannot be reused.

[0059] See in some examples Figure 3A The first housing 10 may include a first base 12 and a first side portion 14. The first base 12 may be in contact with the skin surface of the host, and the first side portion 14 may be formed on the periphery of the first base 12.

[0060] See in some examples Figure 3A The first base 12 may be equipped with a sensor 110 and a storage module 120. In other words, the sensor 110 and the storage module 120 may be mounted on the first base 12.

[0061] In some examples, the storage module 120 can be mounted inside the first base 12 in a manner that encapsulates it within the first base 12. That is, multiple passive devices can be encapsulated inside the first base 12.

[0062] Additionally, in some examples, the storage module 120 can be mounted to the first base 12 by applying an adhesive sealant. That is, multiple passive devices can be sealed to the surface of the first base 12 with waterproof adhesive.

[0063] Figure 4 This is a schematic diagram illustrating the sensor 110 involved in the example of this disclosure.

[0064] See in some examples Figure 4 The sensor 110 may include an implantation portion 112 and a connection portion 114. The implantation portion 112 may be implanted subcutaneously in a host, and the connection portion 114 may be used for electrical connection with an electronic module 220 (described later).

[0065] See in some examples Figure 3A or Figure 3B The first base 12 may have a through hole 122 through which the implanted portion 112 of the sensor 110 may pass; in addition, the connecting portion 114 of the sensor 110 may extend into the interior of the first base 12.

[0066] See in some examples Figure 3A and Figure 3BThe first base 12 may include a first surface 12a and a second surface 12b. The first surface 12a may be in contact with the skin surface of the host, and the second surface 12b may be opposite to the first surface 12a.

[0067] See in some examples Figure 3A The second surface 12b may be provided with a plurality of raised first electrical contacts 101, and there may be gaps between adjacent first electrical contacts 101.

[0068] In some examples, multiple first electrical contacts 101 can be electrically connected to the sensor 110 and the storage module 120, respectively. Specifically, the connection portion 114 of the sensor 110 extending into the first base 12 can be electrically connected to a portion of the first electrical contacts 101; in addition, the storage module 120 encapsulated inside the first base 12 can be electrically connected to another portion of the first electrical contacts 101.

[0069] Figure 5 This is a schematic diagram illustrating the first housing 10 involved in the example of this disclosure.

[0070] See in some examples Figure 5 The first housing 10 may be equipped with a power module 130. The power module 130 may be configured to provide power to the sensor 110, the storage module 120, and the electronic module 220. This enables the sensor 110, the storage module 120, and the electronic module 220 to operate normally.

[0071] See in some examples Figure 5 The power module 130 can be mounted inside the first base 12 in a manner that encapsulates it within the first base 12. In some examples, the power module 130 encapsulated inside the first base 12 can be electrically connected to a portion of the first electrical contacts 101.

[0072] In some examples, the power module 130 can be a battery. For example, the power module 130 can be a coin cell battery.

[0073] In some examples, when irradiating the sensor 110, the entire first housing 10 can be irradiated for sterilization. It should be noted that the impact of irradiation sterilization on the power module 130 is relatively limited, and at least will not affect the reliability and stability of the power module 130 in supplying power to the sensor 110, storage module 120 and electronic module 220 during the service life of the sensor 110.

[0074] In some examples, the first housing 10 disclosed herein can also be applied to an analyte monitoring device 1 in which multiple housings are assembled by pressing. In some examples, the first housing may also be referred to as a sensor base, sensor housing, or sensor mounting base, etc.

[0075] Figure 6 This is a schematic diagram illustrating the second housing 20 involved in the example of this disclosure.

[0076] See in some examples Figure 6 The second housing 20 may be equipped with an electronic module 220. In some examples, the electronic module 220 may be used to process analyte concentration signals.

[0077] In some examples, electronic module 220 can be configured to process the analyte concentration signal to obtain the host's physiological parameters. Specifically, electronic module 220 can be configured to obtain the host's physiological parameters based on the sensitivity of sensor 110 and the analyte concentration signal. Furthermore, electronic module 220 can also be configured to transmit the host's physiological parameters to an external device wirelessly.

[0078] In some examples, the second housing 20 can be reused. That is, the electronic module 220 disposed in the second housing 20 can be reused. Furthermore, since the power module 130 is disposed in the first housing 10, and the first housing 10 is for single use, in this case, each replacement of the first housing 10 is equivalent to replacing the power supply of the electronic module 220, thereby improving the convenience of replacing the power supply of the electronic module 220.

[0079] In some examples, the second housing 20 may also be referred to as a transmitter housing or a transmitter mount, etc.

[0080] See in some examples Figure 6 The second housing 20 may include a second base 22 and a second side portion 24. The second side portion 24 may be connected to the periphery of the second base 22.

[0081] In some examples, the second side portion 24 can mate with the first side portion 14. Further, see... Figure 3C The side of the analyte monitoring device 1 can be sealed by the cooperation of the second side 24 with the first side 14.

[0082] In some examples, the second side 24 may surround a portion of the periphery of the second base 22 (see [reference]). Figure 3B Additionally, the first side portion 14 may surround a portion of the periphery of the first base 12 (see...). Figure 3A In some examples, the first side 14 can form a closed structure with the second side 24 when the second housing 20 is assembled to the first housing 10 (see [link]). Figure 3C That is, the first side portion 14 can be spliced ​​with the second side portion 10 when the second housing 20 is assembled into the first housing 10 to form a complete side portion, thereby sealing the side of the analyte monitoring device 1.

[0083] In some examples, when the second housing 20 is assembled to the first housing 10, the first base 12, the second base 22, the first side 14, and the second side 24 can cooperate to form a receiving space that can accommodate multiple electronic components (e.g., storage module 120, power module 130, and electronic module 220). This provides protection for the multiple electronic components of the analyte monitoring device 1.

[0084] See in some examples Figure 6 The second base 22 may be provided with an electronic module 220. In other words, the electronic module 220 may be installed on the second base 22. In some examples, the electronic module 220 may be installed on the second base 22 in a manner that encapsulates it inside the second base 22.

[0085] See in some examples Figure 6 The second base 22 may be provided with a plurality of second electrical contacts 202 protruding from its surface. There may be gaps between adjacent second electrical contacts 202. Furthermore, the plurality of second electrical contacts 202 may be used to directly contact the plurality of first electrical contacts 101 to form an electrical connection.

[0086] In some examples, multiple second electrical contacts 202 can be electrically connected to the electronic module 220. Specifically, the electronic module 220, encapsulated within the second base 22, can be electrically connected to multiple second electrical contacts 202.

[0087] In some examples, after the second housing 20 is assembled into the first housing 10, the electronic module 220 can establish electrical connections with the sensor 110, the storage module 120 and the power module 130 respectively through contact between the multiple second electrical contacts 202 and the multiple first electrical contacts 101.

[0088] In some examples, the electronic module 220 can establish an electrical connection with the storage module 120 and the sensor 110 when the second housing 20 is assembled with the first housing 10. In this case, the electronic module 220 can obtain the sensitivity of the sensor 110 from the storage module 120 and the analyte concentration signal from the sensor 110, thereby enabling the electronic module 220 to analyze and process the analyte concentration signal to generate physiological parameters of the host.

[0089] Specifically, after the second housing 20 and the first housing 10 are assembled, the multiple second electrical contacts 202 can directly contact the multiple first electrical contacts 101 to form an electrical connection, thereby enabling the electronic module 220 to form an electrical connection with the storage module 120 and the sensor 110 respectively.

[0090] In some examples, the electronic module 220 can establish an electrical connection with the power module 130 when the second housing 20 is assembled into the first housing 10. Thus, the power module 130 can provide power to the electronic module 220 for analyzing and processing the analyte concentration signal.

[0091] As described above, when the electronic module 220 establishes an electrical connection with the storage module 120, the electronic module 220 can read the sensitivity stored in the storage module 120. In some examples, the electronic module 220 can sequentially access multiple passive devices through multiple first electrical contacts 101 to obtain the sensitivity.

[0092] In some examples, the first housing 10 may be equipped with a switching device electrically connected to the storage module 120, which can be used to switch electrical connections with multiple passive devices. In some examples, the electronic module 220 may be electrically connected to the switching device after the second housing 20 is assembled to the first housing 10. Furthermore, the electronic module 220 may be electrically connected to the storage module 120 via the switching device.

[0093] In some examples, electronic module 220 can sequentially access multiple passive devices in storage module 120 to obtain sensitivity by controlling the switching device. In this case, the number of electrical contacts can be reduced, and the possibility of electronic module 220 failing to accurately obtain sensitivity due to poor contact can be reduced, thereby improving the reliability of electronic module 220 in obtaining sensitivity.

[0094] In some examples, the switching device can be a controllable switching device. For example, the switching device can be a controllable multiplexer, relay, or switch.

[0095] In some examples, the first electrical contact 101 may be resilient (e.g., the first electrical contact 101 may be a spring contact); in other examples, the second electrical contact 202 may be a fixed contact. In this case, after the second housing 20 is assembled to the first housing 10, the first electrical contact 101 and the second electrical contact 202 can form a tight contact, thereby improving the stability of the electrical connection between the first electrical contact 101 and the second electrical contact 202.

[0096] However, this disclosure is not limited to this. In other examples, both the first electrical contact 101 and the second electrical contact 202 can be spring contacts.

[0097] In some examples, the number of second electrical contacts 202 may be the same as the number of first electrical contacts 101.

[0098] See in some examples Figure 3C The first housing 10 may include a first connecting portion 16, and the second housing 20 may include a second connecting portion 26. The second connecting portion 26 may cooperate with the first connecting portion 16.

[0099] In some examples, the second housing 20 can be assembled to the first housing 10 by the second connecting portion 26 engaging with the first connecting portion 16. In some examples, the second connecting portion 26 can engage with the first connecting portion 16 in a rotatable manner relative to the first connecting portion 16. Furthermore, the engagement of the second connecting portion 26 with the first connecting portion 16 can include two connecting portions screwed together, two connecting portions meshing, and two connecting portions latched together.

[0100] In some examples, the second connection 26 can engage with the first connection 26 in a manner that allows rotation relative to the first connection 16 to establish a releasable mechanical connection between the first housing 10 and the second housing 20.

[0101] Specifically, after the first housing 10 is applied to the host's skin surface, the second housing 20 can be rotated relative to the first housing 10 to rotate the second connecting portion 26 relative to the first connecting portion 16. This allows the second connecting portion 26 to engage with the first connecting portion 26 in a rotatable manner relative to the first connecting portion 16 (e.g., screwed connection), thereby establishing a releasable mechanical connection between the first housing 10 and the second housing 20. In this case, compared to assembling the second housing 20 onto the first housing 10 by pressing it down, which might increase the difficulty of assembly due to the softness of muscle / fat tissue, the force applied by rotating the second housing 20 is not directly directed towards the host's skin surface. Therefore, it does not cause compression / pressing to the host's skin surface. In other words, the force required to assemble the first housing 10 and the second housing 20 is applied to the analyte monitoring device 1 itself, thus reducing the influence of external factors such as muscle / fat tissue on the assembly and improving the ease of assembling the first housing 10 and the second housing 20.

[0102] In addition, in this disclosure, compared to assembling the second housing 20 onto the first housing 10 by pressing the second housing 20, the first housing 10 may be squeezed and cause the sensor 110 to be further implanted under the skin, causing discomfort to the user. By rotating the second housing 20 relative to the first housing 10 to complete the assembly of the second housing 20 onto the first housing 10, the user experience can be improved.

[0103] In some examples, the releasable mechanical connection between the first housing 10 and the second housing 20 can be interpreted as follows: the first housing 10 and the second housing 20 form a robust connection that can be easily disassembled without the use of tools or complex operations. Furthermore, the releasable mechanical connection also allows the first housing 10 and the second housing 20 to be assembled and disassembled multiple times.

[0104] In some examples, establishing a releasable mechanical connection between the first housing 10 and the second housing 20 allows the first housing 10 and the second housing 20 to be assembled (e.g., the second housing 20 is assembled to the first housing 10). Additionally, in some examples, establishing a releasable mechanical connection between the first housing 10 and the second housing 20 may also indicate that the first housing 10 and the second housing 20 are assembled.

[0105] In some examples, the first connection 16 may include a first profile 160 having a first thread 162 (see [reference]). Figure 5 The second connecting portion 26 may include a second profile 260 having a second thread 262 (see...). Figure 6 The second thread 262 can mate with the first thread 162.

[0106] In some examples, a releasable mechanical connection can be established between the first housing 10 and the second housing 20 through the engagement of the first thread 162 and the second thread 262. Specifically, by rotating the second connecting portion 26 relative to the first connecting portion 16, the second profile 260 can be screwed onto the first profile 160 through the engagement of the second thread 262 and the first thread 162, thereby establishing a releasable mechanical connection between the first housing 10 and the second housing 20. In this case, the engagement of the first connecting portion 16 with the second connecting portion 262 through the engagement of the first thread 162 and the second thread 262, thereby establishing a releasable mechanical connection between the first housing 10 and the second housing 20, improves the ease of assembly and disassembly of the first housing 10 and the second housing 20.

[0107] In some examples, the pitch of the first thread 162 and the second thread 262 can be from 1 mm to 5 mm. For example, the pitch can be 1 mm, 2 mm, 3 mm, 4 mm or 5 mm.

[0108] In some examples, the rotation angle of the first thread 162 and the second thread 262 can be from 30 degrees to 90 degrees. For example, the rotation angle can be 30 degrees, 45 degrees, 60 degrees, 75 degrees, or 90 degrees. In addition, the rotation angle of the thread can represent the angle by which the thread rotates along the axis.

[0109] In some examples, preferably, the rotation angle between the first thread 162 and the second thread 262 can be 90 degrees. That is, rotating the second connecting portion 26 90 degrees relative to the first connecting portion 16 allows the second housing 20 to be assembled onto the first housing 10. This facilitates confirmation that the first housing 10 and the second housing 20 are assembled.

[0110] In some examples, the first profile 160 may be located at the first base 12 (see...) Figure 5 ), and the second profile 260 may be located on the second base 22 (see Figure 6 In some examples, the first profile 160 located on the first base 12 can be a protruding structure with external threads (i.e., the first protruding structure) (see...). Figure 5 ), and the second profile 260 located on the second base 22 can be a groove structure with internal threads (i.e., the first groove structure) (see Figure 6 ).

[0111] In some examples, the first thread 162 and the second thread 262 can be used to screw the first protrusion structure and the first groove structure together. Specifically, when the first groove structure is aligned with and abuts against the first protrusion structure, the second housing 20 can be rotated relative to the first housing 10, so that the external thread of the first protrusion structure can be screwed into the internal thread of the first groove structure.

[0112] In some examples, the first profile 160 on the first base 12 can be a groove structure with internal threads (i.e., a second groove structure), and the second profile 260 on the second base 22 can be a protrusion structure with external threads (i.e., a second protrusion structure).

[0113] In some examples, the first thread 162 and the second thread 262 can be screwed together as a second protrusion structure and a second groove structure.

[0114] In some examples, multiple first electrical contacts 101 (or second electrical contacts 202) may be located on the top surface of the raised structure. Figure 5 The diagram schematically shows multiple first electrical contacts 101 located on the top surface of the raised structure, and multiple second electrical contacts 202 (or first electrical contacts 101) may be located on the bottom surface of the recessed structure. Figure 6 The diagram schematically shows multiple second electrical contacts 202 located on the bottom surface of the groove structure.

[0115] However, this disclosure is not limited thereto. In other examples, a plurality of first electrical contacts 101 (or second electrical contacts 202) may be located on the side of the raised structure, and a plurality of second contacts (or first electrical contacts 101) may be located on the side of the recessed structure.

[0116] In some examples, the second side 24 may surround a portion of the periphery of the second base 22 (see [reference]). Figure 6 Additionally, the first side portion 14 may surround a portion of the periphery of the first base 12 (see...). Figure 5 In this case, the second side 24 allows the user to stably grip the opposite sides of the second housing 20 with the fingers of one hand (e.g., thumb and forefinger), and allows the user to apply force along the second side 24 to rotate the second housing 20 relative to the first housing 10, thereby assembling the second housing 20 to the first housing 10.

[0117] Figure 7A This is a first-view exploded view showing a second embodiment of the analyte monitoring device 1 according to the examples of this disclosure. Figure 7B This is a second-view exploded view illustrating a second embodiment of the analyte monitoring device 1 according to the examples of this disclosure.

[0118] See in some examples Figure 7A or Figure 7B The first base 12 and the second base 22 can be disc-shaped. Correspondingly, the first side portion 14 and the second side portion 24 can be annular. See some examples. Figure 7A The first profile 160 may be located on the first side 14, and the second profile 260 may be located on the second side 24.

[0119] See in some examples Figure 7A For the disc-shaped first base 12 and second base 22, the first profile 160 located on the first side 14 may have internal threads, and the second profile 260 located on the second side 24 may have external threads.

[0120] In some examples, the first thread 162 and the second thread 262 can be threaded together as internal and external threads. Specifically, when the second side 24 is aligned with and abuts against the first side 14, the second housing 20 is rotated relative to the first housing 10, and the internal thread of the first profile 160 can be threaded together with the external thread of the second profile 260.

[0121] Additionally, in some examples, for the disc-shaped first base 12 and the second base 22, the first profile 160 located on the first side 14 may have external threads, and the second profile 260 located on the second side 24 may have internal threads.

[0122] Additionally, in an example where the first base 12 and the second base 22 are disc-shaped, see... Figure 7A The number of first contours 160 can be multiple (e.g., two), with one first contour 160 located on the first base 12 and the other first contour 160 located on the first side 14. Correspondingly, see [link to relevant documentation]. Figure 7B The number of second profiles 260 can also be two, with one second profile 260 located at the second base 22 and the other second profile 260 located at the second side 24. In this case, screw connections can be formed at the bases of the first housing 10 and the second housing 20, as well as at the sides of the first housing 10 and the second housing 20, thereby improving the firmness of the second housing 20 in assembly with the first housing 10.

[0123] In some examples, an isolator may be provided between the first housing 10 and the second housing 20. The isolator may be configured to seal the electrical connections between the electronic module 220 and the storage module 120, as well as the electrical connections between the electronic module 220 and the sensor 110, when the second housing 20 is assembled with the first housing 10. In this case, sealing the electrical connections between the first housing 10 and the second housing 20 with the isolator can reduce the possibility of short circuits in the electronic module 220 and the storage module 120 due to the infiltration of liquids (such as blood, interstitial fluid, or water).

[0124] In some examples, after the second housing 20 is assembled into the first housing 10, the isolator can seal the electrical connection between the electronic module 220 and the power module 130.

[0125] In some examples, after the second housing 20 is assembled into the first housing 10, the isolator can seal the electrical connections of the plurality of first electrical contacts 101 and the plurality of second electrical contacts 202 to form a watertight seal. This reduces the likelihood of liquids causing short circuits to the electronic module 220, storage module 120, and power module 130 through the electrical contacts.

[0126] In some examples, the spacer can be elastic, and can be compressed by the first housing 10 and the second housing 20 after the second housing 20 is assembled into the first housing 10. This improves the sealing performance of the spacer.

[0127] In some examples, the spacer can be compressed by 0.5 mm to 2.5 mm under the pressure of the first housing 10 and the second housing 20. This further improves the sealing performance of the spacer. For example, the spacer can be compressed by 0.5 mm, 1 mm, 1.5 mm, 2.0 mm, or 2.5 mm.

[0128] In some examples, the spacer can be a sealing ring that forms a sealing area enclosing a plurality of first electrical contacts 101 and a plurality of second electrical contacts 202. For example, the spacer can be a silicone sealing ring or a rubber sealing ring.

[0129] In some examples, the first housing 10 may include a first positioning portion 18 (see...) Figure 5 The second housing 20 may include a second positioning part 28 (see...). Figure 6 The second positioning part 28 can cooperate with the first positioning part 18. In some examples, the cooperation between the second positioning part 28 and the first positioning part 18 can enhance the robustness of the assembly of the second housing 20 and the first housing 10.

[0130] In some examples, the second positioning part 28 can cooperate with the first positioning part 18 when the second housing 20 is assembled to the first housing 10. Furthermore, the cooperation between the second positioning part 28 and the first positioning part 18 can include two positioning parts engaging or two positioning parts being connected by a latch. In this case, the tightness of the connection between the first housing 10 and the second housing 20 can be improved, thereby improving the robustness of the assembly of the first housing 10 and the second housing 20; additionally, by improving the tightness of the connection between the first housing 10 and the second housing 20, the first housing 10 and the second housing 20 can compress the spacer, thereby improving the sealing performance of the spacer.

[0131] In some examples, the second positioning part 28 can engage with the first positioning part 18. In some examples, the second housing 20 can be rotated relative to the first housing 10 to engage the second positioning part 28 with the first positioning part 18.

[0132] In some examples, the second positioning part 28 can engage with the first positioning part 18 when a releasable mechanical connection is established between the first housing 10 and the second housing 20. In some examples, the second positioning part 28 can engage with the first positioning part 18 when the second housing 20 is assembled to the first housing 10. In some examples, the engagement of the second positioning part 28 with the first positioning part 18 confirms that the first housing 10 and the second housing 20 are assembled.

[0133] In some examples, the first positioning part 18 may include a first protrusion 180 located on the first base 12 (see...). Figure 5 The second positioning part 28 may include a second protrusion 280 located on the second base 22 (see...). Figure 6 The second protrusion 280 can fit into the first protrusion 180.

[0134] In some examples, the engagement of the first positioning part 18 and the second positioning part 28 may include the first protrusion 180 abutting against the second protrusion 280. For example, the second housing 20 may be rotated relative to the first housing 10 to make the second protrusion 280 abut against the first protrusion 180, thereby completing the engagement of the second positioning part 28 and the first positioning part 18.

[0135] Figure 8 This is a schematic diagram illustrating the first protrusion 180 and the second protrusion 280 involved in the examples of this disclosure.

[0136] See in some examples Figure 8The first protrusion 180 may include a first vertical surface 182 and a first inclined surface 184. The first vertical surface 182 may be perpendicular to the first base 12, and the first inclined surface 184 may be opposite to the first vertical surface 182. The second protrusion 280 may include a second vertical surface 282 and a second inclined surface 284. The second vertical surface 282 may be perpendicular to the second base 22, and the second inclined surface 284 may be opposite to the second vertical surface 282.

[0137] See in some examples Figure 8 The first protrusion 180 and the second protrusion 280 being attached can be represented as the first vertical surface 182 and the second vertical surface 282 being attached to each other.

[0138] In some examples, the first protrusion 180 may be elastic. Specifically, the first protrusion 180 may deform in a direction perpendicular to the first base 12 under external force. In this case, during the process of the first protrusion 180 and the second protrusion 280 forming a contact, the second protrusion 280 abuts against and presses the first inclined surface 184 of the first protrusion 180 to cause the first protrusion 180 to deform in a direction perpendicular to the first base 12, thereby facilitating the smooth sliding of the second protrusion 280 over the first inclined surface 184 so that the first vertical surface 182 and the second vertical surface 282 are in contact.

[0139] In some examples, the first positioning portion 18 may include a flange 186 located on the first side portion 14 (see Figure 5 The second positioning portion 28 may include a bayonet 286 located on the second side portion 24 and capable of engaging with the flange 186 (see [link]). Figure 6 ).

[0140] Additionally, in some examples, the first positioning portion 18 may include a bayonet 286 located on the first side portion 14, and the second positioning portion 28 may include a flange 186 located on the second side portion 24 and capable of engaging with the bayonet 286.

[0141] In some examples, the engagement of the first positioning part 18 and the second positioning part 28 may include: the flange 186 engaging with the slot 286. For example, the second housing 20 may be rotated relative to the first housing 10 to engage the flange 186 with the slot 286, thereby completing the engagement of the second positioning part 28 with the first positioning part 18.

[0142] In some examples, during the engagement of the first positioning part 18 and the second positioning part 28, the engagement of the first protrusion 180 with the second protrusion 280 and the engagement of the flange 186 with the slot 286 can be completed simultaneously. Specifically, the second housing 20 can be rotated relative to the first housing 10 to make the second protrusion 280 engage with the first protrusion 180 and the flange 186 engage with the slot 286, thereby enabling the second positioning part 28 and the first positioning part 18 to engage.

[0143] In some examples, after the second positioning part 28 engages with the first positioning part 18, the first positioning part 18 can disengage from the second positioning part 28 under external force. Furthermore, after the first positioning part 18 disengages from the second positioning part 28, the first housing 10 and the second housing 20 can be separated by rotating them relative to each other. In this case, by disassembling the first housing 10 and the second housing 20, it is easy to replace the first housing 10, preparing for the assembly of the second housing 20 and another first housing 10.

[0144] In some examples, the first positioning part 18 can be configured to be destructively disengaged from the second positioning part 28 by external force. Specifically, when the first positioning part 18 and the second positioning part 28 are engaged, the first positioning part 18 can be destroyed by external force to disengage from the second positioning part 28. In this case, since the first positioning part 18 must be destroyed to disengage from the second positioning part 28, it serves two purposes: firstly, it reminds the user that the first housing 10 cannot be reused; secondly, it helps to prevent the first housing 10 from being intentionally or unintentionally reused, thereby reducing regulatory risks.

[0145] In some examples, the first positioning part 18 being destroyed by external forces can mean that the first positioning part 18 is detached (or falls off) from the first housing 10 due to external forces.

[0146] In some examples, the first protrusion 180 may include a structure that is easily damaged by external forces (e.g. Figure 5 (The hollow structure shown). This hollow structure can be broken by external force, so that the first protrusion 180 can be detached from the first housing 10, and then the first protrusion 180 can be separated from the second protrusion 280.

[0147] See in some examples Figure 5 At least one passive device may be located in the first positioning part 18. In other words, the first positioning part 18 may be provided with at least one passive device of the storage module 120. In this case, when the first positioning part 18 disengages from the second positioning part 28, the storage module 120 will lose part of the passive device due to the destruction of the first positioning part 18, making the sensitivity stored in the storage module 120 unusable (that is, the electronic module 220 will not be able to read the sensitivity), thereby making the analyte monitoring device 1 unusable, which helps to avoid the first housing 10 being reused and further reduces the risk of supervision.

[0148] See in some examples Figure 5The first protrusion 180 may include a partially hollowed-out structure located on the first base 12. In some examples, at least one passive device may be located in the partially hollowed-out structure.

[0149] 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. A split-type analyte monitoring device, comprising a first housing and a second housing detachably assembled with the first housing, characterized in that, The first housing is equipped with a sensor that can be implanted under the skin of the host to obtain analyte concentration signals, and a storage module for storing the sensitivity of the sensor. The second housing is equipped with an electronic module capable of processing the analyte concentration signal. The first housing includes a first connecting portion, and the second housing includes a second connecting portion that mates with the first connecting portion. The second connecting portion engages with the first connecting portion in a manner that allows rotation relative to the first connecting portion, thereby establishing a releasable mechanical connection between the first housing and the second housing. The electronic module establishes an electrical connection with the storage module and the sensor when the second housing is assembled into the first housing.

2. The split-type analyte monitoring device according to claim 1, characterized in that, The first connecting portion includes a first profile having a first thread, and the second connecting portion includes a second profile having a second thread. The first thread and the second thread engage to establish a releasable mechanical connection between the first housing and the second housing.

3. The split-type analyte monitoring device according to claim 2, characterized in that, The first housing includes a first base on which the sensor and the storage module are disposed, and a first side portion formed on the periphery of the first base. The second housing includes a second base on which the electronic module is disposed, and a second side portion formed on the periphery of the second base. The first profile is located on the first base, and the second profile is located on the second base; or the first profile is located on the first side, and the second profile is located on the second side.

4. The split-type analyte monitoring device according to claim 1, characterized in that, A power module is provided in the first housing.

5. The split-type analyte monitoring device according to claim 1, characterized in that, An isolator is provided between the first housing and the second housing, the isolator being configured to seal the electrical connection between the electronic module and the storage module and the electrical connection between the electronic module and the sensor when the second housing is assembled onto the first housing.

6. The split-type analyte monitoring device according to claim 1, characterized in that, The storage module includes multiple passive devices and is configured to store the sensitivity in binary format through the multiple passive devices.

7. The split-type analyte monitoring device according to claim 6, characterized in that, The first housing includes a first positioning part, and the second housing includes a second positioning part that can cooperate with the first positioning part. The second positioning part engages with the first positioning part when the second housing is assembled onto the first housing.

8. The split-type analyte monitoring device according to claim 7, characterized in that, The first positioning part is configured to be destructively disengaged from the second positioning part by external forces.

9. The split-type analyte monitoring device according to claim 8, characterized in that, At least one of the passive devices is located in the first positioning part.

10. The split-type analyte monitoring device according to claim 1, characterized in that, The first housing includes a first base and a first side portion formed on the periphery of the first base, the first side portion surrounding a portion of the periphery of the first base. The second housing includes a second base and a second side portion formed on the periphery of the second base, the second side portion surrounding a portion of the periphery of the second base. The first side portion forms a closed structure with the second housing when the second housing is assembled into the first housing.

11. The split-type analyte monitoring device according to claim 1, characterized in that, The electronic module is configured to acquire the host's physiological parameters based on the sensitivity and the analyte concentration signal.

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