Highly integrated analyte detection devices

Abstract

The present invention discloses a highly integrated analyte detection device, in which a battery cavity is arranged in a transmitter module, and the cavity shell includes an upper cover and a lower shell, the upper cover and the circuit board are integrally formed, a diaphragm, an electrolyte, a positive electrode piece, a negative electrode piece and a conductive piece are arranged in the cavity shell, and an electrolyte insulation layer is arranged inside the cavity shell to form a highly integrated analyte detection device integrating a battery and a circuit board. The shape and size of the analyte detection device are no longer restricted by the shape and size of a button battery. After the battery and the circuit board are integrated, more space is available for the battery and the occupied volume is reduced, thereby meeting the miniaturized design requirements of the analyte detection device.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to the following patent application: PCT patent application filed on May 31, 2021, with application number PCT / CN2021 / 097188. Technical Field

[0003] The present invention mainly relates to the field of medical devices, and in particular to a highly integrated analyte detection device. Background Art

[0004] In a healthy individual, the pancreas automatically monitors blood glucose levels and secretes the necessary insulin and glucagon. However, in diabetics, the pancreas malfunctions, preventing it from producing the necessary insulin. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic function and is a lifelong condition. Currently, medical technology cannot cure diabetes; the only approach is to control the onset and progression of diabetes and its complications by stabilizing blood sugar levels.

[0005] Diabetics need to check their blood sugar before injecting insulin. Currently, most testing methods can continuously monitor blood sugar levels and transmit the data in real time to a remote device for easy viewing. This method is called continuous glucose monitoring (CGM). This method requires a device attached to the skin, with a probe inserted into the subcutaneous tissue fluid to complete the test.

[0006] The analyte detection device in the prior art is powered by a button battery. The shape and size of the analyte detection device are restricted by the shape and size of the button battery, which increases the difficulty of further miniaturization design of the device.

[0007] Therefore, the existing technology urgently needs a highly integrated analyte detection device with a smaller battery size and larger capacity. Summary of the Invention

[0008] An embodiment of the present invention discloses a highly integrated analyte detection device, in which a battery cavity is provided in a transmitter module, and the battery cavity shell is integrally formed with the shell and circuit board of the transmitter module. A diaphragm, electrolyte, positive electrode sheet, negative electrode sheet and conductive sheet are provided in the cavity shell, and an electrolyte insulation layer is also provided inside the cavity shell to form a highly integrated analyte detection device integrating a battery and a circuit board. The shape and size of the analyte detection device are no longer restricted by the shape and size of a button battery. After the battery and the circuit board are integrated, more space is available for the battery and the volume occupied is reduced, thereby meeting the requirements of miniaturized design of the analyte detection device.

[0009] The present invention discloses a highly integrated analyte detection device, comprising: a bottom shell, which is used to be installed on the surface of human skin; a sensor, which is assembled on the bottom shell and is used to detect analyte parameter information in the user's body; a transmitter module, which includes a shell, a circuit board, a transmitter and electrical contacts, the electrical contacts are electrically connected to the sensor, and the transmitter is used to transmit the analyte parameter information to an external device; and a battery cavity located in the transmitter, which includes a cavity shell, a diaphragm, an electrolyte, a positive electrode piece, a negative electrode piece and a conductive piece, and the cavity shell includes an upper cover and a lower shell, and the upper cover and the circuit board are integrally formed.

[0010] According to one aspect of the present invention, the lower housing is integrally formed with the housing of the transmitter module.

[0011] According to one aspect of the present invention, an electrolyte isolation layer is provided inside the cavity shell.

[0012] According to one aspect of the present invention, the electrolyte isolation layer is made of TPE or PET.

[0013] According to one aspect of the present invention, the electrolyte isolation layer is a thin film arranged on the inner wall of the cavity shell.

[0014] According to one aspect of the present invention, the thickness of the electrolyte isolation layer film is 300-500 μm.

[0015] According to one aspect of the present invention, the electrolyte isolation layer is a closed shell independent of the cavity shell.

[0016] According to one aspect of the present invention, the cavity shell material is one of PE, PP, HDPE, PVC, ABS, PMMA, PC, PPS or PU.

[0017] According to one aspect of the present invention, a sealant is applied at the connection between the upper cover and the lower shell.

[0018] According to one aspect of the present invention, the sealant is a hot melt adhesive or a silicone sealant.

[0019] According to one aspect of the present invention, the positive electrode sheet and the negative electrode sheet are electrically connected to the circuit board via the conductive sheet.

[0020] According to one aspect of the present invention, the conductive sheet is fixedly connected to the circuit board via solder or solder paste.

[0021] According to one aspect of the present invention, the analyte detection device further comprises a connector, which comprises at least two conductive regions and one insulating region, wherein the conductive regions and the insulating regions are alternately arranged and serve as an electrical connection medium between the electrical contacts and the sensor.

[0022] Compared with the prior art, the technical solution of the present invention has the following advantages:

[0023] In the highly integrated analyte detection device disclosed in the present invention, a battery cavity is provided in the transmitter, and the battery cavity includes a cavity shell, a diaphragm, an electrolyte, a positive electrode plate, a negative electrode plate and a conductive sheet. An electrolyte isolation layer is also provided inside the cavity shell, forming an integrated structure of battery and circuit board. The shape and size of the analyte detection device are no longer restricted by the shape and size of the button battery shell. The shape and size of the battery cavity can be optimized according to the miniaturization design requirements of the analyte detection device to enhance the user experience.

[0024] Furthermore, the integrated structural design of the battery and circuit board no longer requires the metal shell of the button battery, and can fully utilize the useful space of the detection device. Under the premise that the overall volume of the analyte detection device is reduced, more active substances can be filled in the battery cavity, thereby increasing the power of the battery cavity compared to the button battery, thereby increasing the battery life of the analyte detection device.

[0025] Furthermore, the lower shell of the battery cavity and the shell of the transmitter module are integrally formed, and the upper cover of the battery cavity and the circuit board are integrally formed, forming a good sealed environment in the cavity, which can prevent electrolyte leakage and external air and moisture from entering the cavity shell.

[0026] Furthermore, the electrolyte isolation layer is made of TPE or PET, which can effectively prevent the electrolyte from corroding the cavity shell. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 is a schematic structural diagram of an analyte detection device according to a first embodiment of the present invention;

[0028] Figure 2 Schematic diagram of the three-dimensional structure of the sensor according to the first embodiment of the present invention;

[0029] Figure 3 is a diagram showing the internal structure of a transmitter according to a first embodiment of the present invention;

[0030] Figure 4 XX' cross-sectional structural diagram of the battery cavity according to the first embodiment of the present invention;

[0031] Figure 5 A comparison diagram of electrochemical impedance spectra of the positive electrode sheet according to the first embodiment of the present invention;

[0032] Figure 6a Before installing the sealing ring according to the first embodiment of the present invention Figure 2 C-C' cross-section of the sensor shown;

[0033] Figure 6b After installing the sealing ring according to the first embodiment of the present invention Figure 2 C-C' cross-sectional view of the sensor;

[0034] Figure 6c After installing the sealing ring and the transmitter according to the first embodiment of the present invention Figure 2 C-C' cross-sectional view of the sensor;

[0035] Figure 7 is a schematic structural diagram of an analyte detection device according to a second embodiment of the present invention;

[0036] Figure 8 is a top view of a bottom case according to a second embodiment of the present invention;

[0037] Figure 9a Before installing the sealing ring according to the second embodiment of the present invention Figure 8 Y-Y' cross-sectional view of the bottom shell shown;

[0038] Figure 9b After installing the sealing ring according to the second embodiment of the present invention Figure 8 Y-Y' cross-sectional view of the bottom shell shown;

[0039] Figure 9c After installing the sealing ring and the transmitter according to the second embodiment of the present invention Figure 8 Y-Y' cross-sectional view of the bottom shell shown;

[0040] Figure 10 is a schematic structural diagram of an analyte detection device according to a third embodiment of the present invention;

[0041] Figure 11 is a diagram showing the internal structure of a transmitter module according to a third embodiment of the present invention;

[0042] Figure 12 FIG. 2 is a schematic diagram of the ZZ' cross-sectional structure of a battery cavity according to a third embodiment of the present invention. DETAILED DESCRIPTION

[0043] As mentioned above, the shape and size of the prior art analyte detection device are restricted by the shape and size of the button battery housing, which increases the difficulty of further miniaturization design of the device.

[0044] To solve this problem, the present invention provides a highly integrated analyte detection device. A battery cavity is provided in the transmitter module. The battery cavity includes a cavity shell, a diaphragm, an electrolyte, a positive electrode plate, a negative electrode plate and a conductive sheet. An electrolyte insulation layer is also provided inside the cavity shell to form an integrated structure of battery and circuit board. The shape and size of the analyte detection device are no longer restricted by the shape and size of the button battery shell. The shape and size of the battery cavity can be optimized according to the miniaturization design requirements of the analyte detection device to enhance the user experience.

[0045] Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that unless otherwise specifically stated, the relative arrangement of components and steps, numerical expressions and numerical values ​​set forth in these embodiments should not be construed as limiting the scope of the present invention.

[0046] In addition, it should be understood that for ease of description, the sizes of the various components shown in the drawings are not necessarily drawn according to actual proportional relationships. For example, the thickness, width, length or distance of certain units may be enlarged relative to other structures.

[0047] The following description of exemplary embodiments is merely illustrative and is not intended to limit the present invention, its application, or use in any sense. Technologies, methods, and apparatus known to those skilled in the art may not be discussed in detail herein, but to the extent applicable, such technologies, methods, and apparatuses should be considered part of this specification.

[0048] It should be noted that like reference numerals and letters denote like items in the following figures, and thus, once an item is defined or described in one figure, it will not need to be further discussed in the subsequent figure descriptions.

[0049] First embodiment

[0050] Figure 1 Schematic diagram of the structure of the analyte detection device according to the first embodiment of the present invention.

[0051] The detection device includes a bottom shell 10 , a sensor 11 , a connector 114 , a transmitter 12 and a battery cavity 123 .

[0052] The bottom shell 10 is used to assemble the transmitter 12 and sensor 11, and the detection device is affixed to the skin surface via adhesive tape (not shown). The bottom shell 10 includes a fixing portion and a force-applying portion. The bottom shell 10 is provided with at least one second engaging portion 101. The second engaging portion 101 is used to engage the transmitter 12. Specifically, in this embodiment of the present invention, there are two second engaging portions 101. The two second engaging portions 101 are correspondingly provided on the side walls of the bottom shell 10.

[0053] Here, the fixing portion and the force-applying portion are relative concepts. According to the structural design of the bottom shell 10 and the transmitter 12, the positions of the fixing portion and the force-applying portion can be selected in different ways, which will be described in detail below.

[0054] The transmitter 12 is provided with at least one first engaging portion 121. The first engaging portion 121 corresponds to the second engaging portion 101. The second engaging portion 101 and the first engaging portion 121 engage with each other, allowing the transmitter 12 to be assembled to the bottom housing 10. Obviously, in this embodiment of the present invention, the transmitter 12 is provided with two first engaging portions 121, i.e., two pairs of mutually engaging first engaging portions 121 and second engaging portions 101.

[0055] Here, the first engaging portions 121 and the second engaging portions 101 corresponding to each other means that the number of the first engaging portions 121 and the second engaging portions 101 are equal and the positions of the first engaging portions 121 and the second engaging portions 101 correspond to each other.

[0056] When separating the bottom case 10 from the transmitter 12, the fixing portion is held in place by a finger or other device. Using another finger or other auxiliary device, force is applied to the force-applying portion in one direction. This deactivates the bottom case 10, causing the second engaging portion 101 and the first engaging portion 121 to separate from each other, thereby separating the transmitter 12 from the bottom case 10. This allows the user to separate the bottom case 10 from the transmitter 12 by simply applying force in one direction to the force-applying portion with one finger, making the process easier for the user. After separation, the transmitter can be reused, reducing costs for the user.

[0057] It should be noted here that failure is a conventional concept in the field of engineering materials. After failure, the material loses its original function and the failed part cannot be restored. Since the second engaging portion 101 is part of the bottom shell 10, failure of the bottom shell 10 includes failure of the bottom plate, side wall or second engaging portion 101 of the bottom shell 10. Therefore, the failure mode of the bottom shell 10 includes one or more of the following: fracture of the bottom plate or side wall of the bottom shell 10, damage to the bottom shell 10, fracture of the second engaging portion 101, and plastic deformation of the bottom shell 10. Obviously, after the bottom shell 10 fails, the bottom shell 10 loses the function and effect of engaging the transmitter 12.

[0058] Ways to fix the fixing portion include clamping, supporting, etc., which are not specifically limited here, as long as the conditions for fixing the fixing portion are met.

[0059] Combine Figure 2 As shown in the schematic diagram of the three-dimensional structure of the sensor, the sensor 11 is installed on the bottom shell 10, and includes at least a probe 113 and a connector 114. The probe 113 is used to penetrate the human skin, detect body fluid analyte parameter information, and convert it into an electrical signal. The electrical signal is transmitted to the electrical contact 122 of the transmitter 12 through the connector 114, and the transmitter 12 then transmits the body fluid analyte parameter information to the user.

[0060] In an embodiment of the present invention, connector 114 includes at least two conductive regions and an insulating region. The conductive region and the insulating region serve as electrical conduction and electrical insulation, respectively. The conductive region and the insulating region cannot be separated from each other, that is, the conductive region and the insulating region are each an integral part of connector 114. Connector 114 can only conduct electricity longitudinally through the conductive region, while the insulating region insulates the conductive regions from each other, thus preventing transverse conduction. A single connector 114 serves both electrical conduction and electrical insulation, reducing the complexity of the internal structure of the detection device, making the internal structure more compact, and improving the integration of the detection device.

[0061] Figure 3 is a diagram showing the internal structure of a transmitter according to one embodiment of the present invention; Figure 4 Schematic diagram of the XX' cross-sectional structure of the battery cavity.

[0062] Combined with reference Figure 3 and Figure 4 In this embodiment of the present invention, the battery cavity 123 is located within the transmitter 12. The lower shell 12312 of the battery cavity housing 1231 serves as the transmitter housing 124, forming a good seal to prevent electrolyte leakage and the entry of external air, water droplets, and other debris into the battery cavity 123. In this embodiment of the present invention, the battery cavity 123 is electrically connected to the power supply electrode 1251 of the internal circuit 125 via a wire 126, thereby supplying power to the internal circuit 125.

[0063] The battery chamber 123 includes a chamber shell 1231, a diaphragm 1232, an electrolyte 1233, a positive electrode sheet 1234, a negative electrode sheet 1235 and two tabs 1236. The actual size and proportion of each component are not necessarily the same. Figure 4 The sizes and proportions of the components.

[0064] In an embodiment of the present invention, the material of cavity housing 1231 is one of PE, PP, HDPE, PVC, ABS, PMMA, PC, PPS, or PU. Compared to button batteries with metal housings, the weight of battery cavity 123 using a plastic cavity housing 1231 can be significantly reduced, thereby reducing the overall weight of the analyte detection device and improving the user experience. In a preferred embodiment of the present invention, cavity housing 1231 is divided into an upper cover 12311 and a lower shell 12312. The material of lower shell 12312 is the same as that of transmitter housing 124, facilitating integrated injection molding during processing and improving production efficiency.

[0065] In the embodiment of the present invention, the upper cover 12311 covers the lower shell 12312 to form a sealed chamber space inside, and sealant is applied at the connection between the upper cover 12311 and the lower shell 12312.

[0066] In an embodiment of the present invention, since the cavity shell 1231 made of plastic material, such as PE (polyethylene), PP (polypropylene), and PC (polycarbonate), is easily corroded by the electrolyte, an electrolyte isolation layer 1237 is required to be provided inside the cavity shell 1231.

[0067] In an embodiment of the present invention, the cross-sectional shape of the cavity shell 1231 is not limited to the rectangle shown in the figure, but can also be a circle, an ellipse, a triangle or other irregular shapes. Its three-dimensional structure can make full use of the available space between the emitter 12 and the bottom shell 10 to adapt to the miniaturized design of the analyte detection device.

[0068] In an embodiment of the present invention, the electrolyte isolation layer 1237 can be TPE (butyl rubber) or PET (polyethylene terephthalate). TPE is a thermoplastic elastomer material with strong processability. PET itself serves as a container for the electrolyte and can effectively isolate the electrolyte from corroding the cavity shell and circuit components.

[0069] In the embodiment of the present invention, the electrolyte isolation layer 1237 can be a thin film coated on the inside of the cavity shell 1231 by a deposition method or a solution method, or can be a separate shell.

[0070] In a preferred embodiment of the present invention, electrolyte isolation layer 1237 is a thin film with a thickness of 300-500 μm. If the thickness of electrolyte isolation layer 1237 is too thin, the film material will be soaked and softened by the electrolyte, which will cause film aging over time. If the thickness is too thick, it will occupy space within the chamber. In a more preferred embodiment of the present invention, electrolyte isolation layer 1237 is 400 μm thick.

[0071] In an embodiment of the present invention, the solute of electrolyte 1233 is a lithium salt, such as lithium perchlorate (LiClO4), lithium hexafluorophosphate (LiPF6), or lithium tetrafluoroborate (LiBF4). The solvent is one of ethylene carbonate, propylene carbonate, diethyl carbonate, dimethyl carbonate, ethyl methyl carbonate, phosphorus pentafluoride, hydrofluoric acid, diethyl ether, ethylene carbonate, propylene carbonate, or diethyl carbonate. In a preferred embodiment of the present invention, the solvent is an organic solvent, such as one of diethyl ether, ethylene carbonate, propylene carbonate, or diethyl carbonate.

[0072] In the embodiment of the present invention, the main material of the positive electrode plate 1234 is manganese dioxide, and is manufactured by the following manufacturing process:

[0073] ① Screen the electrolytic manganese dioxide, conductive agent, and binder. This can be done using a screen or airflow classifier. Select electrolytic manganese dioxide particles with a particle size of less than 200 μm, place them in a quartz boat, and heat treat them in a sintering furnace at 200°C for 4 hours. The purpose of this step is to cause the electrolytic manganese dioxide to lose some of its bound water, shift the X-ray diffraction peak, reduce the interplanar spacing, and strengthen the Mn-O bonding force, thereby increasing the discharge capacity of the electrolytic manganese dioxide.

[0074] ② After cooling the electrolytic manganese dioxide from step ① to below 60°C, weigh 9g of electrolytic manganese dioxide, 0.5g of a conductive agent with a particle size of less than 200µm, and 0.5g of a binder with a particle size of less than 200µm using an electronic balance. Place the mixture in a grinding dish and stir thoroughly. Then, grind it manually or electrically to obtain 10g of the ground mixture, ensuring that the ground mixture can pass through a 300-mesh (48µm particle size) sieve. This step is intended to ensure uniformity of the mixture and avoid uneven dispersion of the conductive agent and additives.

[0075] In other embodiments of the present invention, the mass ratio of electrolytic manganese dioxide, conductive agent and binder is not limited to the above proportions, and their mass proportions can be 80%-96%, 2%-10% and 2%-10% respectively.

[0076] In a preferred embodiment of the present invention, the conductive agent may be one or more of conductive carbon black, graphite, super P or carbon nanotubes.

[0077] In a preferred embodiment of the present invention, the binder may be one or more of PVDF (polyvinylidene fluoride), polytetrafluoroethylene, and sodium polyacrylate.

[0078] ③ Place the ground mixture in a vacuum oven and heat it to 65°C for 5 hours to dry out any moisture in the mixture and ensure that the sample is dry to obtain a positive electrode mixture.

[0079] ④ Add 10g of NMP (N-methylpyrrolidone) solvent to a dry glass bottle, then slowly add the positive electrode mixture to the glass bottle and stir with a magnetic stirrer for 3 hours to ensure uniform mixing, and obtain a positive electrode slurry with a solid content of 50%. The purpose of this step is to ensure that the components in the positive electrode slurry are evenly dispersed, and the solid content has a certain relationship with the viscosity of the positive electrode slurry. The positive electrode slurry with a solid content of 50% has a better viscosity, and the film forming effect after coating on the substrate is better, which can reduce the phenomenon of powder loss or cracking.

[0080] ⑤ Use a flat coating machine to coat the positive electrode slurry on the surface of the substrate to obtain a conductive layer, and then place the conductive layer and the substrate in a vacuum oven and bake them at 110°C for 12 hours to ensure that the moisture is completely dried.

[0081] In a preferred embodiment of the present invention, the substrate material is one of aluminum foil or nickel foam mesh, with a thickness of 12-18 μm.

[0082] In a more preferred embodiment of the present invention, the base material is aluminum foil with a thickness of 15 μm.

[0083] ⑥ Using an electric vertical roller press to roll the conductive layer and substrate can reduce the overall thickness of the conductive layer and substrate to 180-220μm, resulting in a finished positive electrode sheet. By adjusting the operating parameters of the coating machine and roller press, the thickness of the positive electrode sheet can be controlled, ensuring that the sheet has a high compaction density while also having a relatively complete conductive network, thus meeting the working requirements of high-current pulse discharge.

[0084] Figure 5 The electrochemical impedance spectrum comparison diagram of the positive electrode sheet is shown in FIG. The solid line is the electrochemical impedance curve of the positive electrode sheet α obtained by the process steps of the embodiment of the present invention (dry-wet mixing combined coating method), and the dotted line is the electrochemical impedance curve of the positive electrode sheet β obtained by the process steps of the prior art (tablet pressing and paste coating method). As can be seen from the figure, in R sei In the stage, the curvature of the solid line is smaller than that of the dotted line, indicating that the polarization degree of the positive electrode sheet α is smaller than that of the positive electrode sheet β. Therefore, during high current pulse discharge, the resistance of the positive electrode sheet α is smaller than that of the positive electrode sheet β, which improves the discharge capacity of the battery. ct In the stage, the solid line curvature is still smaller than the dotted line curvature, indicating that the resistance of the positive electrode sheet α is smaller than the resistance of the positive electrode sheet β. This is because under the same environment in the battery, the porosity of the positive electrode sheet α is greater than the porosity of the positive electrode sheet β. The positive electrode sheet α can accommodate more and higher concentration electrolyte, further improving the discharge capacity of the battery under large current pulses.

[0085] In the embodiment of the present invention, the negative electrode plate 1235 is mainly made of lithium-based materials.

[0086] In the embodiment of the present invention, the material of the diaphragm 1232 is PE (polyethylene) or PP (polypropylene), and can be a single layer of PE or PP or three layers of PE or PP.

[0087] In an embodiment of the present invention, one end A of the tab 1236 is fixedly connected to the positive electrode sheet 1234 or the negative electrode sheet 1235. In a preferred embodiment of the present invention, the end A is fixedly connected to the positive electrode sheet 1234 or the negative electrode sheet 1235 by soldering or solder paste.

[0088] In the embodiment of the present invention, the material of the tab 1236 connected to the positive electrode plate is aluminum, and the material of the tab 1236 connected to the negative electrode plate is nickel or copper-plated nickel.

[0089] In an embodiment of the present invention, a through hole is also provided on the side wall of the cavity shell 1231, and the other end B of the pole ear 1236 passes through the through hole from the inside of the cavity shell to the outside of the cavity shell, and insulating glue is coated at the connection between the end B on the outside of the cavity shell and the through hole to achieve a fixed connection between the pole ear 1236 and the cavity shell 1231, and at the same time, the other end B of the pole ear 1236 is also fixedly connected to the end C of the wire 126.

[0090] In the embodiment of the present invention, the other end D of the wire 126 is electrically connected to the internal circuit 125 .

[0091] In a preferred embodiment of the present invention, end B of tab 1236 is fixedly connected to wire 126 by soldering. In a more preferred embodiment of the present invention, a sealing material, such as hot melt adhesive or silicone, is applied to the connection between end B of tab 1236 and end C of wire 126, and the connection between end B of tab 1236 and the through-hole. This can prevent electrolyte from leaking out of battery cavity 123 and causing contamination, and prevent end B of tab 1236 from being exposed on cavity shell 1231, thereby avoiding unnecessary battery discharge.

[0092] Specifically, in the embodiment of the present invention, the processing process of the battery cavity 123 is as follows:

[0093] ① Coat the interior of the upper cover 12311 and the lower shell 12312 with PET or TPE material to a thickness of 300-500 μm, place them in a constant temperature oven at 60-85°C until the coating material is completely dry;

[0094] ② Place the battery cell (including the negative electrode sheet 1235, the negative electrode tab 1236, the separator 1232, the positive electrode sheet 1234, and the positive electrode tab 1236) in the lower shell 12312, and fix one end of the positive and negative electrode tabs 1236 to the through-holes on the side wall of the cavity shell 1231 through solder paste. At the same time, the other ends of the positive and negative electrode tabs 1236 are fixed to the positive and negative electrode sheets respectively through soldering or solder paste;

[0095] ③ The lower housing 12312 is placed statically, and the electrolyte 1233 is injected into the lower housing 12312 using a pipette, and the entire body is moved to a transition chamber for vacuum static state to ensure complete infiltration of the electrolyte, thereby improving the electrochemical performance of the battery cavity;

[0096] ④ After the lower shell 12312 has been left to stand, the upper cover 12311 is closed, and sealant is applied to the joint to maintain the sealing and obtain a complete battery cavity.

[0097] Continue to refer to Figure 1The electrical contact 122 forms an electrical connection with the connector 114. A groove 131 is provided on the sensor bottom shell 111 and around the connector 114 for placing a sealing ring 130. The contour of the sealing ring is consistent with the contour of the groove. The groove 131 and the sealing ring 130 form a waterproof structure to provide waterproof protection for the electrical connection between the transmitter 12 and the sensor 11.

[0098] In other embodiments of the present invention, the sealing ring profile may be inconsistent with the groove profile. For example, the groove may be square, circular, arc-shaped or a combination thereof, and the corresponding sealing ring may be circular, arc-shaped, square or a combination thereof.

[0099] To better understand the waterproof principle of the waterproof structure composed of the groove 131 and the sealing ring 130, refer to Figure 6a 、 Figure 6b 、 Figure 6c .

[0100] Figure 6a Before installing the sealing ring 130, Figure 2 In the C-C' cross-sectional view of sensor 11, groove 131 is provided on sensor base 111, surrounding probe 113 and conductive silicone 114. Probe 113 is divided into an internal portion 113b and an external portion 113a. External portion 113a is bent or curved toward the upper end of sensor base 111 and lies flat on the sensor base 111. Figure 6b After installing the sealing ring 130, Figure 2 In the C-C' cross-sectional view of sensor 11, the contour of sealing ring 130 is consistent with the contour of groove 131. Sealing ring 130 fits tightly into groove 131, probe 13, and connector 114. Furthermore, the upper end surface of sealing ring 130 is slightly higher than the upper end surface of connector 114. "Slightly higher" here means that the upper end surface of sealing ring 130 is 0 to 5 mm higher than the upper end surface of connector 114, preferably 1 mm. Figure 6c After installing the sealing ring 130 and the transmitter 12, Figure 2 In the C-C' cross-sectional view of the sensor 11 shown, the electrical contact 122 contacts the connector 114, and the transmitter housing contacts the upper surface of the sealing ring 130. It is foreseeable that the transmitter housing 12, the sealing ring 130, and the groove 131 can form a sealed chamber 132, within which the probe body portion 113a, the connector 114, and the electrical contact 122 are located. When the detection device is submerged in water, water droplets are blocked by the transmitter housing 12, the sealing ring 130, and the groove 131 and cannot enter the chamber 132, thereby providing waterproof protection for the electrical connection area between the electrical contact 122 and the connector 114.

[0101] In other embodiments of the present invention, the size of the sealing ring is slightly larger than the size of the groove, so that the sealing ring 130 can be more tightly installed in the groove 131 and is not easy to fall off, and the edge of the sealing ring 130 can form a more closed contact with the groove 131, achieving more ideal waterproof protection.

[0102] In other embodiments of the present invention, a sealing ring (not shown in the figure) can also be added below the external part 113a of the probe body and above the sensor bottom shell 111 to form a waterproof structure together with the sealing ring and groove above the external part 113a of the probe body, which can better prevent water droplets from entering the electrical connection area and achieve better waterproof effect.

[0103] In other embodiments of the present invention, the sealing ring material is preferably insulating rubber. Since rubber is a flexible material and has a certain compressive elasticity, when the transmitter 12 is installed on the bottom shell 10, there is a certain extrusion force on the sealing ring 130, which can better maintain the close contact between the sealing ring 130 and the transmitter 12 shell, prevent water droplets from entering the electrical connection area, and avoid causing short circuits and current intensity disturbances.

[0104] Second embodiment

[0105] Figure 7 This is a schematic structural diagram of the analyte detection device according to the second embodiment of the invention.

[0106] The detection device includes a bottom shell 20 , a sensor 11 , a connector 114 , a transmitter 22 and a battery cavity 203 .

[0107] Combine Figure 2 As shown in the schematic diagram of the three-dimensional structure of the sensor, the sensor 11 is installed on the bottom shell 20, and includes at least a probe 113 and a connector 114. The probe 113 is used to penetrate the human skin, detect body fluid analyte parameter information, and convert it into an electrical signal. The electrical signal is transmitted to the electrical contact 122 of the transmitter 12 through the connector 114, and the transmitter 12 then transmits the body fluid analyte parameter information to the user.

[0108] In an embodiment of the present invention, connector 114 includes at least two conductive regions and an insulating region. The conductive region and the insulating region serve as electrical conduction and electrical insulation, respectively. The conductive region and the insulating region cannot be separated from each other, that is, the conductive region and the insulating region are each an integral part of connector 114. Connector 114 can only conduct electricity longitudinally through the conductive region, while the insulating region insulates the conductive regions from each other, thus preventing transverse conduction. A single connector 114 serves both electrical conduction and electrical insulation, reducing the complexity of the internal structure of the detection device, making the internal structure more compact, and improving the integration of the detection device.

[0109] In other embodiments of the present invention, a line 11 connecting the two second engaging portions 202 divides the bottom housing 20 into a side A and a side B. The side A is provided with a force-applying portion, and the side B is provided with a fixing portion.

[0110] In the embodiment of the present invention, the fixing portion and the force-applying portion are relative concepts. According to the structural design of the bottom shell 20 and the transmitter 22, the positions of the fixing portion and the force-applying portion can be selected in different ways.

[0111] Therefore, in the embodiment of the present invention, the process of separating the bottom shell 20 and the transmitter 22 is as follows: fix the fixing portion on the B side with one finger, and use another finger to apply a force F to the force-applying portion in one direction to disable the second engaging portion 202, thereby separating the second engaging portion 202 from the first engaging portion 221, and separating the transmitter 22 from the bottom shell 20.

[0112] It should be noted that the embodiment of the present invention does not limit the position of the second engaging portion 202 . For example, the two second engaging portions 202 can be disposed on the bottom plate of the bottom shell 20 . No specific limitation is made here.

[0113] The embodiment of the present invention does not impose any specific limitation on the shape of the top view of the detection device, and the shape may also be a rounded rectangle, a rectangle, a circle, an ellipse or other shapes.

[0114] The battery cavity 203 is used to power the transmitter and is located on the bottom housing 20. This allows the battery cavity 203 to be replaced each time the bottom housing 20 is replaced. Since the transmitter 22 no longer requires a battery, it can be reused, reducing the cost of replacing the transmitter 22. Furthermore, the bottom housing 20 always uses a new, high-performance battery cavity, ensuring the transmitter 22 maintains high performance.

[0115] Preferably, in the embodiment of the present invention, the top of the battery cavity 203 is flush with the top of the emitter 22, which can reduce the thickness of the detection device.

[0116] The battery cavity 203 can directly serve as a force application portion, so the battery is placed on the A side of the I1. Since the battery cavity 203 is relatively large, it is easier for the user to apply force to the battery cavity 203 as a force application portion, thus optimizing the user's operation steps.

[0117] Figure 8 FIG. 2 is a top view of the bottom case 20 according to one embodiment of the present invention.

[0118] Since the battery cavity 203 needs to supply power to the transmitter 22, in an embodiment of the present invention, the bottom shell 20 is also provided with at least two elastic conductors 204. The electrical contacts 223 of the transmitter 22 are electrically connected to the positive and negative poles of the battery respectively through the elastic conductors 204, forming an electrical connection area. The battery cavity 203 supplies power to the transmitter through the elastic conductors 204 and the electrical contacts 223. Once water droplets enter the electrical connection area, a short circuit will occur, causing unstable power supply to the battery cavity 203 and fluctuations in the current intensity received by the transmitter 22. This may cause the transmitter 22 to receive the body fluid analyte parameter information from the probe 113 and the transmitted parameter information to jump, affecting the reliability of the analyte detection device. Therefore, the electrical connection area needs to be waterproofed. The waterproof structure of the electrical connection area includes a groove 207 and a sealing ring 205.

[0119] To better understand the waterproof principle of the waterproof structure composed of the groove 207 and the sealing ring 205, as well as the structure of the battery chamber, refer to Figure 9a 、 Figure 9b 、 Figure 9c .

[0120] Figure 9a Before installing the sealing ring 205, Figure 8 In the Y-Y' cross-sectional view of the bottom shell 20 shown in FIG. 2 , the battery chamber 203 is composed of a chamber shell 2031, an electrolyte isolation layer 2032, a diaphragm 2033, an electrolyte 2034, a positive electrode sheet 2035, a negative electrode sheet 2035' and a tab 2036. The actual size and proportion of each component are not necessarily the same. Figure 8 The sizes and proportions of the components.

[0121] In an embodiment of the present invention, the material of the cavity shell 2031 is one of PE, PP, HDPE, PVC, ABS, PMMA, PC, PPS or PU. Compared with a button battery with a metal shell, the weight of the battery cavity 203 with a plastic cavity shell 2031 can be greatly reduced, thereby reducing the overall weight of the analyte detection device and improving the user experience.

[0122] In an embodiment of the present invention, the cavity shell 2031 is divided into an upper cover body 20311 and a lower shell body 20312. The upper cover body 20311 covers the lower shell body 20312 to form a closed chamber space inside. Sealant is coated at the connection between the upper cover body 20311 and the lower shell body 20312.

[0123] In a preferred embodiment of the present invention, the material of the cavity shell 2031 is consistent with that of the bottom shell 20, which facilitates integral injection molding during processing and improves production efficiency.

[0124] In an embodiment of the present invention, the cross-sectional shape of the cavity shell 2031 is not limited to the rectangle shown in the figure, but can also be a circle, an ellipse, a triangle or other irregular shapes. Its three-dimensional structure can make full use of the available space between the emitter 12 and the bottom shell 10 to adapt to the miniaturized design of the analyte detection device.

[0125] In the embodiment of the present invention, since the cavity housing 2031 made of a plastic material, such as PE (polyethylene), PP (polypropylene), or PC (polycarbonate), is easily corroded by the electrolyte, an electrolyte isolation layer 2032 is required to be coated on the interior of the cavity housing 2031. In the embodiment of the present invention, the electrolyte isolation layer 2032 can be TPE (butyl rubber) or PET (polyethylene terephthalate). TPE is a thermoplastic elastomer material with strong processability. PET itself serves as a container for the electrolyte and can effectively isolate the cavity housing and circuit components from corrosion caused by the electrolyte.

[0126] In the embodiment of the present invention, the electrolyte isolation layer 2032 may be a thin film coated on the inside of the cavity shell 2031 by a deposition method or a solution method, or may be a separate shell.

[0127] In a preferred embodiment of the present invention, electrolyte isolation layer 2032 is a thin film with a thickness of 300-500 μm. If the thickness of electrolyte isolation layer 2032 is too thin, the film material will be soaked and softened by the electrolyte, which will cause film aging over time. If the thickness is too thick, it will occupy space within the chamber. In a more preferred embodiment of the present invention, the thickness of electrolyte isolation layer 2032 is 400 μm.

[0128] In an embodiment of the present invention, the solute of electrolyte 2034 is a lithium salt, such as lithium perchlorate (LiClO4), lithium hexafluorophosphate (LiPF6), or lithium tetrafluoroborate (LiBF4), and the solvent is ethylene carbonate, propylene carbonate, diethyl carbonate, dimethyl carbonate, ethyl methyl carbonate, phosphorus pentafluoride, hydrofluoric acid, diethyl ether, ethylene carbonate, propylene carbonate, or diethyl carbonate. In a preferred embodiment of the present invention, the solvent is an organic solvent, such as diethyl ether, ethylene carbonate, propylene carbonate, or diethyl carbonate.

[0129] In the embodiment of the present invention, the main material of the positive electrode plate 2035 is manganese dioxide, and is manufactured by the following manufacturing process:

[0130] ① Screen the electrolytic manganese dioxide, conductive agent, and binder. This can be done using a screen or airflow classifier. Select electrolytic manganese dioxide particles with a particle size of less than 200 μm, place them in a quartz boat, and heat treat them in a sintering furnace at 200°C for 4 hours. The purpose of this step is to cause the electrolytic manganese dioxide to lose some of its bound water, shift the X-ray diffraction peak, reduce the interplanar spacing, and strengthen the Mn-O bonding force, thereby increasing the discharge capacity of the electrolytic manganese dioxide.

[0131] ② After cooling the electrolytic manganese dioxide from step ① to below 60°C, weigh 9g of electrolytic manganese dioxide, 0.5g of a conductive agent with a particle size of less than 200µm, and 0.5g of a binder with a particle size of less than 200µm using an electronic balance. Place the mixture in a grinding dish and stir thoroughly. Then, grind it manually or electrically to obtain 10g of the ground mixture, ensuring that the ground mixture can pass through a 300-mesh (48µm particle size) sieve. This step is intended to ensure uniformity of the mixture and avoid uneven dispersion of the conductive agent and additives.

[0132] In other embodiments of the present invention, the mass ratio of electrolytic manganese dioxide, conductive agent and binder is not limited to the above proportions, and their mass proportions can be 80%-96%, 2%-10% and 2%-10% respectively.

[0133] In a preferred embodiment of the present invention, the conductive agent may be one or more of conductive carbon black, graphite, super P or carbon nanotubes.

[0134] In a preferred embodiment of the present invention, the binder may be one or more of PVDF (polyvinylidene fluoride), polytetrafluoroethylene, and sodium polyacrylate.

[0135] ③ Place the ground mixture in a vacuum oven and heat it to 65°C for 5 hours to dry out any moisture in the mixture and ensure that the sample is dry to obtain a positive electrode mixture.

[0136] ④ Add 10g of NMP (N-methylpyrrolidone) solvent to a dry glass bottle, then slowly add the positive electrode mixture to the glass bottle and stir with a magnetic stirrer for 3 hours to ensure uniform mixing, and obtain a positive electrode slurry with a solid content of 50%. The purpose of this step is to ensure that the components in the positive electrode slurry are evenly dispersed, and the solid content has a certain relationship with the viscosity of the positive electrode slurry. The positive electrode slurry with a solid content of 50% has a better viscosity, and the film forming effect after coating on the substrate is better, which can reduce the phenomenon of powder loss or cracking.

[0137] ⑤ Use a flat coating machine to coat the positive electrode slurry on the surface of the substrate to obtain a conductive layer, and then place the conductive layer and the substrate in a vacuum oven and bake them at 110°C for 12 hours to ensure that the moisture is completely dried.

[0138] In a preferred embodiment of the present invention, the substrate material is one of aluminum foil or nickel foam mesh, with a thickness of 12-18 μm.

[0139] In a more preferred embodiment of the present invention, the base material is aluminum foil with a thickness of 15 μm.

[0140] ⑥ Using an electric vertical roller press to roll the conductive layer and substrate can reduce the overall thickness of the conductive layer and substrate to 180-220μm, resulting in a finished positive electrode sheet. By adjusting the operating parameters of the coating machine and roller press, the thickness of the positive electrode sheet can be controlled, ensuring that the sheet has a high compaction density while also having a relatively complete conductive network, thus meeting the working requirements of high-current pulse discharge.

[0141] The performance of the positive electrode 2035 obtained by the above steps is Figure 5 The same is shown and will not be repeated here.

[0142] In the embodiment of the present invention, the negative electrode plate 2035 ′ is mainly made of lithium-based materials.

[0143] In the embodiment of the present invention, the material of the diaphragm 2033 is PE (polyethylene) or PP (polypropylene), and can be a single layer of PE or PP or three layers of PE or PP.

[0144] In an embodiment of the present invention, the positive electrode material of the battery tab 2036 is aluminum, and the negative electrode material is nickel or nickel-plated copper.

[0145] In an embodiment of the present invention, tab 2036 includes a conductive contact 20361 and a conductive sheet 20362. One end A of conductive contact 20361 is fixedly connected to positive electrode sheet 2035 or negative electrode sheet 2035'. In a preferred embodiment of the present invention, end A is fixedly connected to positive electrode sheet 2035 or negative electrode sheet 2035' using solder or solder paste.

[0146] In this embodiment of the present invention, a through-hole is further provided on the side wall of the cavity shell 2031. The other end B of the conductive contact 20361 passes through the through-hole from the interior of the cavity shell to the exterior of the cavity shell. Sealant is applied to the connection between the end B on the outside of the cavity shell and the through-hole to achieve a fixed connection between the tab 2036 and the cavity shell 2031. In a preferred embodiment of the present invention, the end B of the conductive contact 20361 is fixedly connected to the cavity shell 2031 via solder.

[0147] In the embodiment of the present invention, one end C of the conductive sheet 20362 is fixedly connected to the end B of the conductive contact 20361 .

[0148] In an embodiment of the present invention, insulating sealing materials, such as hot melt adhesive or silicone, are also coated at the fixed connection between the end C of the conductive sheet 20362 and the end B of the conductive contact 20361, and at the connection between the end B of the electrical contact 20361 and the through hole. On the one hand, this prevents the electrolyte 2034 from leaking through the through hole to the outside of the cavity shell 2031 and causing pollution; on the other hand, it prevents the end B of the tab 2036 from being exposed on the cavity shell 2031, thereby avoiding unnecessary battery discharge.

[0149] Specifically, in the embodiment of the present invention, the processing process of the battery cavity 203 is as follows:

[0150] ① Coat the interior of the upper cover 20311 and the lower shell 20312 with PET or TPE material to a thickness of 300-500 μm, place them in a constant temperature oven at 60-85°C until the coating material is completely dry;

[0151] ② Fix the battery cell (including the negative electrode sheet 2035', the negative electrode tab 2036, the diaphragm 2033, the positive electrode sheet 2035, and the positive electrode tab 2036) in sequence in the lower shell 20312, and fix one end of the positive and negative electrode tabs 2036 to the through-holes on the side wall of the cavity shell 2031 through solder paste. At the same time, the other ends of the positive and negative electrode tabs 2036 are fixedly connected to the positive and negative electrode sheets respectively through soldering or solder paste;

[0152] ③ The lower housing 20312 is placed in a static state, and the electrolyte 2034 is injected into the lower housing 20312 using a pipette, and the entire body is moved to a transition chamber for vacuum static state to ensure complete infiltration of the electrolyte, thereby improving the electrochemical performance of the battery cavity;

[0153] ④ After the lower shell 20312 has been left to stand, the upper cover 20311 is closed, and sealant is applied to the joint to maintain the sealing and obtain a complete battery cavity.

[0154] In this embodiment of the present invention, the other end D of the conductive sheet 20362 extends outside the battery cavity 203 to the groove 207 and covers the bottom surface of the groove 207. The elastic conductor 204 is located in the center of the groove 207, with one end fixed to the end D of the conductive sheet 20362. The conductive sheet 20362 connected to the positive electrode sheet 2035 is the positive electrode, and the conductive sheet 20362 connected to the negative electrode sheet 2035' is the negative electrode.

[0155] In a preferred embodiment of the present invention, the elastic conductor 204 is a conductive spring.

[0156] Figure 9b After installing the sealing ring 205, Figure 8In the Y-Y' cross-sectional view of the bottom shell 20 shown in the figure, the sealing ring 205 is located on the upper end surface of the groove 207. Its contour is consistent with the contour of the groove and can enclose the elastic conductor 204. The upper end surface of the sealing ring 205 is slightly higher than the upper end surface of the groove 207. Here, "slightly higher" means that the upper end surface of the sealing ring 205 is 0 to 5 mm higher than the upper end surface of the groove 207, preferably 1 mm. Figure 9c After installing the sealing ring 205 and the transmitter 22, Figure 8 In the YY' cross-sectional view of the bottom housing 20 shown, the transmitter power electrode 223 contacts the elastic conductor 204 to obtain electrical energy from the battery chamber 203, and the housing of the transmitter 22 contacts the upper surface of the sealing ring 205. It is foreseeable that the transmitter 22 housing, the sealing ring 205, the groove 207, and the conductive sheet 20362 form a sealed chamber 210, and the transmitter power electrode 223 and the elastic conductor 204 are located within the sealed chamber 210. When the detection device is immersed in water, water droplets are blocked by the transmitter 22 housing, the sealing ring 205, and the groove 207 and cannot enter the chamber 210, thereby forming waterproof protection for the electrical connection area of ​​the transmitter power electrode 223, the elastic conductor 204, and the conductive sheet 20362.

[0157] In other embodiments of the present invention, the size of the sealing ring is slightly larger than the size of the groove, so that the sealing ring 205 can be more tightly installed in the groove 207 and is not easy to fall off, and the edge of the sealing ring 205 can form a more closed contact with the groove 207, achieving more ideal waterproof protection.

[0158] In other embodiments of the present invention, the elastic conductor 204 is an elastic conductive material that can be electrically connected to the transmitter power electrode 223, for example, it can be a conductive spring or a conductive spring. When the transmitter 22 is installed on the bottom shell 20, the transmitter power electrode 223 squeezes the elastic conductor 204, so that the elastic conductor 204 is continuously compressed and maintains elastic force. In this way, the elastic conductor 204 can maintain continuous close contact with the transmitter power electrode 223, ensuring that the battery cavity 203 supplies stable electrical energy to the transmitter 22.

[0159] In other embodiments of the present invention, the sealing ring is preferably made of insulating rubber. Since rubber is a flexible material with a certain degree of compressive elasticity, when the transmitter 22 is mounted on the bottom housing 20, a certain squeezing force is exerted on the sealing ring 205. This can better maintain close contact between the sealing ring 205 and the transmitter 22 housing, preventing water droplets from entering the electrical connection area, thereby avoiding short circuits and current intensity disturbances.

[0160] In the embodiment of the present invention, the waterproof structure of the sensor 11 and the conductive electrode 222 of the transmitter 22 is the same as that of the first embodiment, and will not be described again.

[0161] Third embodiment

[0162] Figure 10 Schematic diagram of the three-dimensional structure of the analyte detection device according to the third embodiment of the present invention.

[0163] The detection device includes a bottom housing 30 , a sensor 11 , a connector 114 , a transmitter module 32 and a battery cavity 323 .

[0164] The bottom shell 30 is used to assemble the transmitter module 32 and sensor 11, and the detection device is affixed to the skin surface via adhesive tape (not shown). The bottom shell 30 includes a fixing portion and a force-applying portion. The bottom shell 30 is provided with at least one second engaging portion 301. The second engaging portion 301 is used to engage the transmitter module 32. Specifically, in this embodiment of the present invention, there are two second engaging portions 301. The two second engaging portions 301 are correspondingly provided on the side walls of the bottom shell 30.

[0165] Here, the fixing portion and the force-applying portion are relative concepts. Depending on the structural design of the bottom housing 30 and the transmitter module 32, the positions of the fixing portion and the force-applying portion can be selected in different ways, which will be described in detail below.

[0166] The transmitter module 32 is provided with at least one first engaging portion 321. The first engaging portion 321 corresponds to the second engaging portion 301. The second engaging portion 301 and the first engaging portion 321 engage with each other, allowing the transmitter module 32 to be assembled to the base housing 30. Obviously, in this embodiment of the present invention, the transmitter module 32 is provided with two first engaging portions 321, i.e., two pairs of mutually engaging first engaging portions 321 and second engaging portions 301.

[0167] Here, the first engaging portion 321 corresponds to the second engaging portion 301 , which means that the number of the first engaging portion 321 and the second engaging portion 301 are equal and their positions correspond.

[0168] When separating the bottom case 30 from the transmitter module 32, the fixing portion is held in place by a finger or other device. Using another finger or other auxiliary device, force is applied to the force-applying portion in one direction. This deactivates the bottom case 30, causing the second engaging portion 301 and the first engaging portion 321 to separate, thereby separating the transmitter module 32 from the bottom case 30. This allows the user to separate the bottom case 30 from the transmitter module 32 by simply applying force in one direction with one finger, making the process easier for the user. After separation, the transmitter can be reused, reducing costs for the user.

[0169] It should be noted that failure is a common concept in the field of engineering materials. After failure, the material loses its original function and the failed part cannot be restored. Since the second engaging portion 301 is part of the bottom shell 30, failure of the bottom shell 30 includes failure of the bottom plate, side wall, or second engaging portion 301 of the bottom shell 30. Therefore, failure modes of the bottom shell 30 include one or more of the following: fracture of the bottom plate or side wall of the bottom shell 30, damage to the bottom shell 30, fracture of the second engaging portion 301, and plastic deformation of the bottom shell 30. Obviously, after failure of the bottom shell 30, the bottom shell 30 loses its function and role of engaging the transmitter module 32.

[0170] Ways to fix the fixing portion include clamping, supporting, etc., which are not specifically limited here, as long as the conditions for fixing the fixing portion are met.

[0171] Combine Figure 2 As shown in the schematic diagram of the three-dimensional structure of the sensor, the sensor 11 is installed on the bottom shell 30, and includes at least a probe 113 and a connector 114. The probe 113 is used to penetrate the human skin, detect body fluid analyte parameter information, and convert it into an electrical signal. The electrical signal is transmitted to the electrical contact 322 of the transmitter module 32 through the connector 114, and the transmitter module 32 then transmits the body fluid analyte parameter information to the user.

[0172] In an embodiment of the present invention, connector 114 includes at least two conductive regions and an insulating region. The conductive region and the insulating region serve as electrical conduction and electrical insulation, respectively. The conductive region and the insulating region cannot be separated from each other, that is, the conductive region and the insulating region are each an integral part of connector 114. Connector 114 can only conduct electricity longitudinally through the conductive region, while the insulating region insulates the conductive regions from each other, thus preventing transverse conduction. A single connector 114 serves both electrical conduction and electrical insulation, reducing the complexity of the internal structure of the detection device, making the internal structure more compact, and improving the integration of the detection device.

[0173] Figure 11 is an internal structural diagram of a transmitter according to a third embodiment of the present invention; Figure 12 Schematic diagram of the Z-Z' cross-sectional structure of the battery cavity.

[0174] Combined with reference Figure 11 and Figure 12 In the embodiment of the present invention, the battery cavity 323 is located in the transmitter module 32, the upper cover 32311 of the battery cavity shell 3231 is the circuit board 325, and the lower shell 32312 is the shell 324 of the transmitter module, so as to form a good seal to prevent electrolyte leakage and prevent external air, water droplets and other debris from entering the battery cavity 323.

[0175] In the embodiment of the present invention, the battery chamber 323 includes a chamber shell 3231, a diaphragm 3232, an electrolyte 3233, a positive electrode sheet 3234, a negative electrode sheet 3235 and a conductive sheet 3237. The actual size and proportion of each component are not necessarily equal to Figure 12 The sizes and proportions of the components.

[0176] In the embodiment of the present invention, the battery cavity 323 is electrically connected to the power electrode 3251 of the circuit board 325 via the conductive sheet 3237 to supply power to the internal circuit 325 .

[0177] In an embodiment of the present invention, the material of the cavity shell 3231 is one of PE, PP, HDPE, PVC, ABS, PMMA, PC, PPS or PU. Compared with a button battery with a metal shell, the weight of the battery cavity 323 with a plastic cavity shell 3231 can be greatly reduced, thereby reducing the overall weight of the analyte detection device and improving the user experience.

[0178] In an embodiment of the present invention, the cavity shell 3231 is divided into an upper cover body 32311 and a lower shell body 32312. The upper cover body 32311 is a part of the circuit board 325. The positive electrode plate 3234 and the negative electrode plate 3235 are electrically connected to the power electrode 3251 of the circuit board 325 through the conductive plate 3237, thereby realizing a closed loop of the battery cavity 323. The battery cavity 323 can provide electrical energy for the circuit board 325.

[0179] In the embodiment of the present invention, the lower housing 32312 is a cavity shell independent of the transmitter module housing 324 .

[0180] In other embodiments of the present invention, the material of the lower shell 32312 is consistent with the material of the shell 324 of the transmitter module, which facilitates one-piece injection molding during processing and improves production efficiency.

[0181] In the embodiment of the present invention, the upper cover 32311 covers the lower shell 32312 to form a sealed chamber space inside, and sealant is applied at the connection between the upper cover 32311 and the lower shell 32312.

[0182] In the embodiment of the present invention, the sealant is hot melt adhesive or silicone.

[0183] In an embodiment of the present invention, since the cavity shell 3231 made of plastic material, such as PE (polyethylene), PP (polypropylene), and PC (polycarbonate), is easily corroded by the electrolyte, an electrolyte isolation layer 3236 is required to be provided inside the cavity shell 3231 .

[0184] In an embodiment of the present invention, the cross-sectional shape of the cavity shell 3231 is not limited to the rectangle shown in the figure, but can also be a circle, an ellipse, a triangle or other irregular shapes. Its three-dimensional structure can make full use of the available space between the emitter module 32 and the bottom shell 30 to adapt to the miniaturized design of the analyte detection device.

[0185] In an embodiment of the present invention, the electrolyte isolation layer 3237 can be TPE (butyl rubber) or PET (polyethylene terephthalate). TPE is a thermoplastic elastomer material with strong processability. PET itself serves as a container for the electrolyte and can effectively isolate the electrolyte from corroding the cavity shell and circuit components.

[0186] In the embodiment of the present invention, the electrolyte isolation layer 3237 can be a thin film coated on the inside of the cavity shell 3231 by a deposition method or a solution method, or can be a closed shell independent of the cavity shell.

[0187] In a preferred embodiment of the present invention, electrolyte isolation layer 3237 is a thin film with a thickness of 300-500 μm. If the thickness of electrolyte isolation layer 3237 is too thin, the film material will be soaked and softened by the electrolyte, which will cause film aging over time. If the thickness is too thick, it will occupy space within the chamber. In a more preferred embodiment of the present invention, the thickness of electrolyte isolation layer 3237 is 400 μm.

[0188] In an embodiment of the present invention, the solute of electrolyte 3233 is a lithium salt, such as lithium perchlorate (LiClO4), lithium hexafluorophosphate (LiPF6), or lithium tetrafluoroborate (LiBF4), and the solvent is ethylene carbonate, propylene carbonate, diethyl carbonate, dimethyl carbonate, ethyl methyl carbonate, phosphorus pentafluoride, hydrofluoric acid, diethyl ether, ethylene carbonate, propylene carbonate, or diethyl carbonate. In a preferred embodiment of the present invention, the solvent is an organic solvent, such as diethyl ether, ethylene carbonate, propylene carbonate, or diethyl carbonate.

[0189] In the embodiment of the present invention, the main material of the positive electrode plate 3234 is manganese dioxide, and is manufactured by the following manufacturing process:

[0190] ① Screen the electrolytic manganese dioxide, conductive agent, and binder. This can be done using a screen or airflow classifier. Select electrolytic manganese dioxide particles with a particle size of less than 200 μm, place them in a quartz boat, and heat treat them in a sintering furnace at 200°C for 4 hours. The purpose of this step is to cause the electrolytic manganese dioxide to lose some of its bound water, shift the X-ray diffraction peak, reduce the interplanar spacing, and strengthen the Mn-O bonding force, thereby increasing the discharge capacity of the electrolytic manganese dioxide.

[0191] ② After cooling the electrolytic manganese dioxide from step ① to below 60°C, weigh 9g of electrolytic manganese dioxide, 0.5g of a conductive agent with a particle size of less than 200µm, and 0.5g of a binder with a particle size of less than 200µm using an electronic balance. Place the mixture in a grinding dish and stir thoroughly. Then, grind it manually or electrically to obtain 10g of the ground mixture, ensuring that the ground mixture can pass through a 300-mesh (48µm particle size) sieve. This step is intended to ensure uniformity of the mixture and avoid uneven dispersion of the conductive agent and additives.

[0192] In other embodiments of the present invention, the mass ratio of electrolytic manganese dioxide, conductive agent and binder is not limited to the above proportions, and their mass proportions can be 80%-96%, 2%-10% and 2%-10% respectively.

[0193] In a preferred embodiment of the present invention, the conductive agent may be one or more of conductive carbon black, graphite, super P or carbon nanotubes.

[0194] In a preferred embodiment of the present invention, the binder may be one or more of PVDF (polyvinylidene fluoride), polytetrafluoroethylene, and sodium polyacrylate.

[0195] ③ Place the ground mixture in a vacuum oven and heat it to 65°C for 5 hours to dry out any moisture in the mixture and ensure that the sample is dry to obtain a positive electrode mixture.

[0196] ④ Add 10g of NMP (N-methylpyrrolidone) solvent to a dry glass bottle, then slowly add the positive electrode mixture to the glass bottle and stir with a magnetic stirrer for 3 hours to ensure uniform mixing, and obtain a positive electrode slurry with a solid content of 50%. The purpose of this step is to ensure that the components in the positive electrode slurry are evenly dispersed, and the solid content has a certain relationship with the viscosity of the positive electrode slurry. The positive electrode slurry with a solid content of 50% has a better viscosity, and the film forming effect after coating on the substrate is better, which can reduce the phenomenon of powder loss or cracking.

[0197] ⑤ Use a flat coating machine to coat the positive electrode slurry on the surface of the substrate to obtain a conductive layer, and then place the conductive layer and the substrate in a vacuum oven and bake them at 110°C for 12 hours to ensure that the moisture is completely dried.

[0198] In a preferred embodiment of the present invention, the substrate material is one of aluminum foil or nickel foam mesh, with a thickness of 12-18 μm.

[0199] In a more preferred embodiment of the present invention, the base material is aluminum foil with a thickness of 15 μm.

[0200] ⑥ Using an electric vertical roller press to roll the conductive layer and substrate can reduce the overall thickness of the conductive layer and substrate to 180-220μm, resulting in a finished positive electrode sheet. By adjusting the operating parameters of the coating machine and roller press, the thickness of the positive electrode sheet can be controlled, ensuring that the sheet has a high compaction density while also having a relatively complete conductive network, thus meeting the working requirements of high-current pulse discharge.

[0201] The performance of the positive electrode 3035 obtained by the above steps is Figure 5 The same is shown and will not be repeated here.

[0202] In the embodiment of the present invention, the negative electrode plate 3235 is mainly made of lithium-based materials.

[0203] In the embodiment of the present invention, the material of the diaphragm 3232 is PE (polyethylene) or PP (polypropylene), which can be a single layer of PE or PP or three layers of PE or PP. Specifically, in the embodiment of the present invention, the processing flow of the battery chamber 323 is as follows:

[0204] ① Coat the interior of the upper cover 32311 and the lower shell 32312 with PET or TPE material to a thickness of 300-500 μm, place them in a constant temperature oven at 60-85°C until the coating material is completely dry;

[0205] ② Place the battery cell (including the negative electrode sheet 3235, the separator 3232, the positive electrode sheet 3234, and the conductive sheet 3237) in the lower housing 32312, and fix one end of the conductive sheet 3237 to the positive electrode sheet 3234 or the negative electrode sheet 3235 using solder paste or solder;

[0206] ③ The lower housing 32312 is placed in a static state, and the electrolyte 3233 is injected into the lower housing 32312 using a pipette, and the entire body is moved to a transition chamber for vacuum static state to ensure complete infiltration of the electrolyte, thereby improving the electrochemical performance of the battery cavity;

[0207] ④ After the lower housing 32312 has rested, close the upper cover 32311 (circuit board 315). Secure the other end of the conductive sheet 3237 to the power supply electrode 3151 of the circuit board 315 using solder paste or tin. Apply sealant to the joint to maintain a tight seal and complete the battery cavity. The sealant can be hot melt adhesive or silicone.

[0208] In summary, the present invention provides a highly integrated analyte detection device, in which a battery cavity is arranged in a transmitter module, and the cavity shell includes an upper cover body and a lower shell body, the upper cover body and the circuit board are integrally formed, and a diaphragm, an electrolyte, a positive electrode plate, a negative electrode plate and a conductive plate are arranged in the cavity shell, and an electrolyte insulation layer is also provided inside the cavity shell to form a highly integrated analyte detection device integrating a battery and a circuit board. The shape and size of the analyte detection device are no longer restricted by the shape and size of the button battery. After the battery and the circuit board are integrated, the battery has more available space and occupies a smaller volume, which meets the miniaturization design requirements of the analyte detection device.

[0209] Although some specific embodiments of the present invention have been described in detail by way of example, it should be understood by those skilled in the art that the above examples are for illustration only and are not intended to limit the scope of the present invention. It should be understood by those skilled in the art that modifications may be made to the above embodiments without departing from the scope and spirit of the present invention. The scope of the present invention is defined by the appended claims.

Claims

1. A highly integrated analyte detection device, characterized in that: include: A bottom shell, the bottom shell being used to be installed on the surface of human skin; A sensor, mounted on the bottom shell, for detecting analyte parameter information in a user's body; A transmitter module, comprising a housing, a circuit board, a transmitter, and electrical contacts, wherein the electrical contacts are electrically connected to the sensor, and the transmitter is used to transmit the analyte parameter information to an external device; and A battery cavity is located in the transmitter module, and the battery cavity includes a cavity shell, a diaphragm, an electrolyte, a positive electrode sheet, a negative electrode sheet and a conductive sheet. The cavity shell includes an upper cover and a lower shell, and the upper cover is integrally formed with the circuit board.

2. The highly integrated analyte detection device according to claim 1, characterized in that: The lower shell is integrally formed with the shell of the transmitter module.

3. The highly integrated analyte detection device according to claim 1 or 2, characterized in that: An electrolyte isolation layer is provided inside the cavity shell.

4. The highly integrated analyte detection device according to claim 3, characterized in that: The electrolyte isolation layer is made of TPE or PET.

5. The highly integrated analyte detection device according to claim 4, characterized in that: The electrolyte isolation layer is a thin film coated on the inner wall of the cavity shell.

6. The highly integrated analyte detection device according to claim 5, characterized in that: The electrolyte isolation layer film thickness is 300-500um.

7. The highly integrated analyte detection device according to claim 4, characterized in that: The electrolyte isolation layer is a closed shell independent of the cavity shell.

8. The highly integrated analyte detection device according to claim 1 or 2, characterized in that: The material of the cavity shell is one of PE, PP, HDPE, PVC, ABS, PMMA, PC, PPS or PU.

9. The highly integrated analyte detection device according to claim 1 or 2, characterized in that: Sealant is applied at the connection between the upper cover and the lower shell.

10. The highly integrated analyte detection device according to claim 9, characterized in that: The sealant is hot melt adhesive or silicone.

11. The highly integrated analyte detection device according to claim 1 or 2, characterized in that: The positive electrode sheet and the negative electrode sheet are electrically connected to the circuit board through the conductive sheet.

12. The highly integrated analyte detection device according to claim 11, characterized in that: The conductive sheet is fixedly connected to the circuit board through solder or solder paste.

13. The highly integrated analyte detection device according to claim 1 or 2, characterized in that: The analyte detection device further includes a connector, which includes at least two conductive areas and one insulating area. The conductive areas and the insulating areas are alternately arranged and used as an electrical connection medium between the electrical contacts and the sensor.

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