Highly sealed invasive biosensing assembly and biological information monitoring apparatus

Abstract

A highly sealed invasive biosensing assembly and a biological information monitoring apparatus. The present invention relates to the technical field of biosensors. The highly sealed invasive biosensing assembly comprises a biosensor, and an electrode-protecting cover is snap-fitted to the lower part of the biosensor. A guide needle is snap-fitted into the biosensor, longitudinally penetrating the biosensor. The biosensor further comprises a sensing electrode and an electrode pressure plate. In a first state, the electrode pressure plate, the lower part of a needle guide seat, and the interior of the electrode-protecting cover form a first closed cavity. In a second state, the electrode-protecting cover is detached from the biosensor, so that at least part of the sensing electrode entering the first closed cavity and at least part of a needle body extend out of the first closed cavity. The invasive biosensing assembly and the biological information monitoring apparatus form a closed space inside the assembly and the apparatus by means of a snap structure and the positional relationship between components during assembly, thereby improving the hermeticity in the assembly and the apparatus, so that the assembly is in a sterile state before being implanted into a human body.

Description

A highly sealed invasive biosensor component and bioinformation monitoring device Technical Field

[0001] This application relates to the field of biosensor technology, and in particular to a highly sealed invasive biosensor component and a bioinformation monitoring device. Background Technology

[0002] For people with diabetes, traditional fingertip blood glucose meters have drawbacks such as being invasive, having limited information, and being unable to reflect blood glucose fluctuations or provide early warnings. They no longer meet the needs of some people, especially type 1 diabetes patients who require real-time transmission of blood glucose fluctuations and type 2 diabetes patients who need intensive insulin therapy.

[0003] Due to the need for continuous blood glucose monitoring, an integrated implantable component of an invasive biosensor is required to implant the sensor into the subcutaneous tissue of the human body. Measuring the blood glucose concentration in the tissue fluid is a practical and continuous monitoring method. Its single lifespan is one to two weeks, which greatly reduces the pain caused by continuous finger-prick and venous blood sampling. Currently, such implantable devices on the market have problems such as complicated operation for users, long implantation time, and easy accidental triggering of the push device, which leads to reduced user compliance (Patient compliance / Treatment compliance, also known as compliance or adherence, refers to the behavior of patients following the doctor's treatment and consistent with the doctor's orders, commonly referred to as patient "cooperation"; the opposite is called non-compliance) and experience.

[0004] In the existing technology, there are at least the following technical problems: When the invasive biosensor component and the main control circuit of the transmitter are assembled at the factory, the main control circuit of the invasive biosensor component and the transmitter both need to be produced in a sterile environment, which is highly dependent on the production environment and reduces the efficiency of mass production; if the main control circuit of the invasive biosensor component and the transmitter are made into one piece, the airtightness of the invasive biosensor component is reduced.

[0005] Therefore, improving the internal airtightness of invasive biosensor components and devices used to place invasive biosensor components, and reducing the requirements of the manufacturing environment, in order to improve the reliability of invasive biosensor components and increase production efficiency, has become an urgent technical problem to be solved. Summary of the Invention

[0006] In view of this, the purpose of the embodiments of this application is to solve the problem of poor internal sealing of invasive biosensor components and devices for placing invasive biosensor components, and to provide an invasive biosensor component with high sealing performance and a bio-information monitoring device.

[0007] To achieve the above objectives, this application provides the following technical solution:

[0008] In a first aspect, this application provides a highly sealed invasive biosensor assembly, including a support structure, an electrode plate, a bioelectrode, a guide needle, and a sealing sleeve; the bioelectrode includes a signal output electrode, a connection section, and a sensing section connected in sequence.

[0009] The electrode pressure plate is pressed against the bottom of the support structure, and part of the connecting section is locked between the support structure and the electrode pressure plate;

[0010] The sealing sleeve is snapped onto the outside of the electrode pressure plate and the guide needle, and the sealing sleeve is sealed at the bottom of the support structure;

[0011] The lower part of the sensing section and the guide pin is sealed within the sealing sleeve; the signal output electrode is disposed on the upper part of the support structure.

[0012] Preferably, the sealing sleeve is sealed at the bottom of the support structure as follows: the support structure is provided with a guide pin through hole, and the guide pin extends out of the lower part of the support structure through the guide pin through hole;

[0013] The lower part of the needle seat of the guide needle is provided with a buckle groove, and part of the edge of the electrode pressure plate extends outward to form an ear-shaped buckle finger. The inner side of the sealing sleeve is provided with two screw-in protrusions; one screw-in protrusion is engaged with the ear-shaped buckle finger, and the other screw-in protrusion is engaged with the buckle groove.

[0014] Preferably, a sealing ring is fitted onto the lower outer side of the needle seat, and the sealing ring is located above the undercut groove;

[0015] The outer side of the sealing ring is press-fitted with the guide pin through hole, and the outer side of the sealing ring is engaged in the guide pin through hole, so that a sealed space is formed between the guide pin through hole, the guide pin and the support structure.

[0016] Preferably, the lower part of the support structure is provided with a first sealing groove, which surrounds the electrode pressure plate, bioelectrode and guide needle;

[0017] The upper part of the sealing sleeve is provided with a first sealing gasket, which is pressed between the first sealing groove and the sealing sleeve, so that a sealed space is formed between the support structure and the sealing sleeve.

[0018] Preferably, a rubber stopper is provided at the lower part of the sealing sleeve;

[0019] The rubber plug is inserted into the bottom inner wall of the sealing sleeve to achieve a detachable sealing structure, with the bottom of the rubber plug partially or completely exposed to the sealing sleeve.

[0020] Preferably, a drying block is provided inside the sealing sleeve, and an installation groove is provided on the upper surface of the rubber stopper, with the drying block embedded in the installation groove.

[0021] Preferably, the support structure is provided with a connecting section through groove, and the bottom of the support structure is provided with an adhesive filling groove. The adhesive filling groove is connected to the connecting section through groove. The electrode pressure plate is pressed against the bottom of the connecting section through groove and the adhesive filling groove, and the connecting section is disposed in the connecting section through groove and the adhesive filling groove.

[0022] Preferably, the upper surface of the electrode pressure plate extends out a snap-fit ​​post, and the lower surface of the support structure is provided with a snap-fit ​​groove, with the snap-fit ​​post and the snap-fit ​​groove having a clearance fit.

[0023] Preferably, the support structure is further provided with an arc-shaped groove, the arc-shaped groove connecting the glue filling groove and the guide pin through hole, and the depth of the arc-shaped groove gradually increases from one end of the glue filling groove to one end of the guide pin through hole;

[0024] The connecting section is provided with a bent section, which connects the connecting section and the sensing section; one end of the bent section connected to the sensing section extends upward with an inclined arm, the upper end of which is bent; the arc-shaped groove holds the bent section.

[0025] In a second aspect, this application provides a highly airtight invasive bio-information monitoring device, including an upper shell, a bottom shell, and a biosensor, wherein the upper shell and the bottom shell are connected by threads; the biosensor includes a highly airtight invasive biosensing component as disclosed in the first aspect above.

[0026] The biosensor is sealed within the upper and lower shells; a second sealing gasket is provided at the lower part of the upper shell, and a second sealing groove is provided at the upper part of the lower shell; the second sealing gasket is embedded in the second sealing groove, thereby forming a sealed space between the upper and lower shells.

[0027] Preferably, it also includes a support base;

[0028] The bottom shell is provided with a through hole, and the support base passes through the through hole and enters the interior of the bottom shell;

[0029] The upper part of the support base is engaged with the lower part of the sealing sleeve, and the fixing piece of the support base is fixedly disposed on the bottom of the outer side of the bottom shell;

[0030] A third sealing groove is provided at the bottom of the outer shell, and a third sealing gasket is provided at the upper part of the fixing plate. The third sealing gasket is pressed into the third sealing groove, so that a sealed space is formed between the upper shell, the bottom shell and the fixing plate.

[0031] Preferably, it further includes an annular drying block, which is disposed at the bottom inside the bottom shell, and the upper part of the support seat passes through the annular drying block; a plurality of cantilever hook beams extend upward from the bottom inside the bottom shell, and the cantilever hook beams hook the annular drying block.

[0032] Compared with the prior art, the beneficial effects of this application are:

[0033] The bioelectrode, support structure, electrode plate, and sealing sleeve are assembled as a single unit during manufacturing to form a highly sealed invasive biosensor component. After uniform sterilization, it can maintain high airtightness. Subsequent assembly of other components such as circuit boards and batteries can be carried out without considering the problem of over- or under-assembly of bioelectrodes and circuit boards / or transmitters carrying circuit boards, thus improving the stability of the invasive biosensor component before and after implantation in the human body.

[0034] The invasive biosensor component forms a sealed space inside, maintaining a sealed and sterile state during manufacturing, transportation, and shelf life, thus improving product stability and safety. When mass-producing invasive biosensor components, only the invasive biosensor component itself needs to be manufactured and assembled in a sterile environment, while other components can be manufactured and assembled in a normal production environment. This reduces the environmental requirements for manufacturing and improves the efficiency of production operations when performing sterile disinfection.

[0035] During factory assembly, the upper shell, bottom shell, and support base form a sealed space. When the product is not in use, the invasive biosensor component is stored in the sealed space. Only during pre-implantation assembly are the upper shell and bottom shell separated to expose the bioelectrode and guide needle to be implanted. The bioelectrode and guide needle are only exposed to the air when the upper shell and bottom shell are separated, which is a very short time. This reduces the risk of contamination of the bioelectrode and guide needle, improves the safety of the bioelectrode and guide needle implanted in the human body, and further enhances the stability and safety of the product. Attached Figure Description

[0036] Figure 1 is an exploded view of a highly sealed invasive biosensor component disclosed in this embodiment;

[0037] Figure 2 is a structural schematic diagram of a highly sealed invasive biosensor component disclosed in this embodiment;

[0038] Figure 3 is a schematic diagram of the structure of a highly sealed invasive biosensor component disclosed in this embodiment after the sealing sleeve is removed;

[0039] Figure 4 is a bottom view of a highly sealed invasive biosensor component disclosed in this embodiment after the sealing sleeve has been removed;

[0040] Figure 5 is a schematic diagram of the structure of a highly sealing invasive biosensor component disclosed in this embodiment, in which the first sealing gasket is located at the lower part of the support structure.

[0041] Figure 6 is a schematic diagram of the sealing sleeve of a highly sealing invasive biosensor component disclosed in this embodiment;

[0042] Figure 7 is a schematic diagram of the guide pin of a highly sealed invasive biosensor component disclosed in this embodiment;

[0043] Figure 8 is a schematic diagram of the electrode plate of a highly sealed invasive biosensor component disclosed in this embodiment;

[0044] Figure 9 is a schematic diagram of the structure of a bioelectrode of a highly sealed invasive biosensor component disclosed in this embodiment;

[0045] Figure 10 is a schematic diagram of the structure of a biosensor in a bioinformation monitoring device disclosed in this embodiment;

[0046] Figure 11 is a schematic diagram of the structure of a bioinformatics monitoring device disclosed in this embodiment;

[0047] Figure 12 is a cross-sectional schematic diagram of a bioinformatics monitoring device disclosed in this embodiment.

[0048] In the diagram: 01-High-sealing invasive biosensor component; 02-High-sealing invasive bioinformation monitoring device; 101-Upper shell; 1011-Second sealing gasket; 102-Bottom shell; 1021-Third sealing groove; 1022-Third sealing gasket; 103-Biosensor; 104-Support base; 1041-Fixing plate; 1-Support structure; 11-Guide pin through hole; 12-First sealing groove; 13-Connecting section through groove; 14-Adhesive. 15-Water filling tank; 16-Arc-shaped groove; 2-Snap-fit ​​groove; 2-Electrode pressure plate; 21-Ear-shaped snap-fit ​​finger; 22-Snap-fit ​​post; 3-Bioelectrode; 31-Connecting section; 311-Bending section; 32-Signal output electrode; 33-Sensing section; 4-Guide pin; 41-Inverted groove; 42-Pin seat; 43-Sealing ring; 5-Sealing sleeve; 51-Screw-in snap-fit ​​protrusion; 52-First sealing gasket; 53-Rubber stopper; 531-Mounting groove; 54-Drying block. Detailed Implementation

[0049] The present application is described below based on embodiments, but the present application is not limited to these embodiments. In the following detailed description of the present application, some specific details are described in detail, but well-known methods, processes, flows, and elements are not described in detail in order to avoid obscuring the substance of the present application.

[0050] Furthermore, those skilled in the art should understand that the accompanying drawings provided herein are for illustrative purposes only and are not necessarily drawn to scale.

[0051] Unless the context explicitly requires it, the words "comprising," "including," and similar terms throughout the specification and claims should be interpreted as encompassing rather than being exclusive or exhaustive; that is, meaning "including but not limited to."

[0052] In the description of this application, it should be understood that the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Furthermore, in the description of this application, unless otherwise stated, "a plurality of" means two or more.

[0053] To address the issue of poor internal sealing in invasive biosensor components and devices for placing them, this application discloses a highly sealed invasive biosensor component and a highly sealed invasive bioinformation monitoring device. Referring to Figures 1 to 9, Figures 1 and 2 illustrate a highly sealed invasive biosensor component disclosed in this embodiment, including a support structure 1, an electrode plate 2, a bioelectrode 3, a guide pin 4, and a sealing sleeve 5. The bioelectrode 3 includes a signal output electrode 32, a connecting section 31, and a sensing section 33 connected in sequence.

[0054] The electrode pressure plate 2 is pressed against the bottom of the support structure 1, and part of the connecting section 31 is stuck between the support structure 1 and the electrode pressure plate 2;

[0055] The sealing sleeve 5 is snapped onto the outside of the electrode pressure plate 2 and the guide pin 4, and the sealing sleeve 5 is sealed at the bottom of the support structure 1.

[0056] The lower part of the sensing section 33 and the guide pin 4 is sealed inside the sealing sleeve 5; the signal output electrode 32 is disposed on the upper part of the support structure 1.

[0057] The interior of the invasive biosensor component 01 forms a sealed space. The support structure 1, the sealing sleeve 5, and the electrode pressure plate 2 form a sealed space. The sensing segment 33 to be implanted and the lower part of the guide needle 4 are sealed in the sealing sleeve 5. The product is in a sealed and sterile state when it leaves the factory, during product transportation, and on the shelf, which improves the stability and safety of the product.

[0058] Mass production of invasive biosensor components requires the integrated biosensor components to be produced and assembled in a sterile environment, while other components can be produced and assembled in a normal production environment. This reduces the environmental requirements for manufacturing and improves the efficiency of production operations when performing sterile disinfection procedures.

[0059] In this embodiment, the sealing sleeve 5 is sealed at the bottom of the support structure 1 as follows: the support structure 1 is provided with a guide pin through hole 11, and the guide pin 4 passes through the guide pin through hole 11 and extends out of the lower part of the support structure 1.

[0060] The lower part of the needle seat 42 of the guide needle 4 is provided with a reverse groove 41, and part of the edge of the electrode pressure plate 2 extends outward to form an ear-shaped buckle 21. The inner side of the sealing sleeve 5 is provided with two screw-in protrusions 51; one screw-in protrusion 51 is engaged with the ear-shaped buckle 21, and the other screw-in protrusion 51 is engaged with the reverse groove 41.

[0061] Before leaving the factory, one screw-in locking protrusion 51 is engaged with the ear-shaped buckle finger 21, and the other screw-in locking protrusion 51 is engaged with the undercut groove 41;

[0062] During pre-implantation assembly, rotate the sealing sleeve 5, one screw-in locking protrusion 51 is screwed out from the ear-shaped buckle 21, and the other screw-in locking protrusion 51 is screwed out from the undercut groove 41.

[0063] In this embodiment, a sealing ring 43 is sleeved on the lower outer side of the needle seat 42, and the sealing ring 43 is located above the undercut groove 41.

[0064] The outer side of the sealing ring 43 is press-fitted with the guide pin through hole 11, and the outer side of the sealing ring 43 is engaged in the guide pin through hole 11, so that a sealed space is formed between the guide pin through hole 11, the guide pin 4 and the support structure 1.

[0065] Specifically, the sealing ring 43 compresses the inner wall of the guide needle through hole 11 and the outer side of the needle seat 42. The lower part of the guide needle 3 and the sensing section 33 are located in the sealed space formed between the guide needle through hole 11, the guide needle 4, the sealing sleeve 5 and the support structure 1, which further improves the internal sealing of the high-sealing invasive biosensor component 01.

[0066] In this embodiment, a first sealing groove 12 is provided at the lower part of the support structure 1, and the first sealing groove 12 surrounds the electrode pressure plate 2, the bioelectrode 3 and the guide needle 4.

[0067] A first sealing gasket 52 is provided on the upper part of the sealing sleeve 5. The first sealing gasket 52 is pressed between the first sealing groove 12 and the sealing sleeve 5, so that a sealed space is formed between the support structure 1 and the sealing sleeve 5. The electrode pressure plate 2, the sensing section 33, and the guide needle 4 are located in the sealed space formed between the support structure 1 and the sealing sleeve 5, which further improves the internal sealing of the high-sealing invasive biosensor component 01.

[0068] The top of the sealing sleeve 5 is provided with a sealing gasket snap-fit ​​groove. The first sealing gasket 52 is partially squeezed into the sealing gasket snap-fit ​​groove, so that the first sealing gasket 52 can be fixed to the top of the sealing sleeve 5. The sealing gasket snap-fit ​​groove can be filled with glue to improve the connection stability of the first sealing gasket 52 to the sealing gasket snap-fit ​​groove, and further improve the sealing performance of the sealed space between the sealing sleeve 5 and the support structure 1.

[0069] The sealing sleeve 5 forms an engaging structure with the ear-shaped snap finger 21 of the electrode pressure plate 2 and the inverted snap groove 41 of the guide needle 4 by screwing in the snap protrusion 51. The engaging structure allows the sealing sleeve 5 to be firmly snapped into the lower part of the support structure 1. At the same time, by squeezing the sealing sleeve 5 upward, the first sealing gasket 52 is squeezed between the sealing gasket snap groove and the first sealing groove 12 of the support structure 1, which further improves the sealing performance of the sealed space between the sealing sleeve 5 and the support structure 1.

[0070] In this embodiment, a rubber stopper 53 is provided at the lower part of the sealing sleeve 5; the rubber stopper 53 can isolate air and moisture.

[0071] The rubber stopper 53 is inserted into the bottom inner wall of the sealing sleeve 5 to achieve a detachable sealing structure. The bottom of the rubber stopper 53 may partially protrude from the sealing sleeve 5. Specifically, the partial protrusion of the bottom of the rubber stopper 53 provides a certain cushioning effect on the sealing sleeve 5. When external force is applied to the bottom of the sealing sleeve 5 during factory assembly or transportation, the soft texture of the rubber stopper 53 can buffer the external force, making the sealing sleeve less prone to damage and the sealing performance less likely to be compromised.

[0072] Meanwhile, during the assembly process, the rubber plug is inserted into the sealing sleeve 5 in the last step of assembling the component. If the component structure in the previous steps is easy to assemble, the component is not likely to be subjected to too much gas pressure. If the rubber plug 53 is not inserted last, the gas inside the sealing sleeve is likely to be squeezed, making assembly difficult. If the rubber plug 53 and the sealing sleeve 5 are an integrated structure, the installation process of the sealing sleeve 5 is more dangerous and may be at risk of breakage and damage, resulting in unsmooth assembly.

[0073] In this embodiment, a drying block 54 is provided inside the sealing sleeve 5, and an installation groove 531 is provided on the upper surface of the rubber stopper 53, into which the drying block 54 is embedded. In actual production, due to the material limitations of the sealing sleeve 5, the sealing sleeve 5 is not absolutely isolated from external gases and liquids. A small amount of gas and liquid may enter the sealed space formed by the sealing sleeve 5 and the support structure 1 through the sealing sleeve 5, contaminating the bioelectrode 3 and the guide needle 4. Placing the drying block 54 inside the sealing sleeve can further absorb moisture, keeping the inside of the sealing sleeve 5 dry, further improving the sealing performance of the sealed space between the sealing sleeve 5 and the support structure 1, and ensuring good internal environmental stability of the component.

[0074] In this embodiment, the support structure 1 is provided with a connecting section through groove 13, and the bottom of the support structure 1 is provided with an adhesive filling groove 14. The adhesive filling groove 14 is connected to the connecting section through groove 13. The electrode pressure plate 2 is pressed below the connecting section through groove 13 and the adhesive filling groove 14. The connecting section 31 is disposed in the connecting section through groove 13 and the adhesive filling groove 14.

[0075] The upper surface of the electrode pressure plate 2 extends out of the snap-fit ​​post 22, and the lower surface of the support structure 1 is provided with a snap-fit ​​groove 16. The snap-fit ​​post 22 and the snap-fit ​​groove 16 are in clearance fit. The snap-fit ​​post 22 and the snap-fit ​​groove 16 are in clearance fit so that the snap-fit ​​groove 16 can be filled with glue. The glue connects the snap-fit ​​post 22 and the snap-fit ​​groove 16.

[0076] Adhesive is filled into the adhesive filling groove 14 and the snap-fit ​​groove 16, filling the gap between the adhesive filling groove 14, the connecting section 31, the electrode pressure plate 2 and the support structure 1. The adhesive is preferably a thick paste-like colloid, such as UV adhesive. The electrode pressure plate 2 is preferably transparent. After filling the adhesive filling groove 14 and the snap-fit ​​groove 16, the electrode pressure plate 2 is irradiated with ultraviolet light. The ultraviolet light penetrates the electrode pressure plate 2 and irradiates the adhesive. The adhesive is cured after irradiation, thereby forming a sealed structure between the support structure 1, the electrode pressure plate 2 and the connecting section 31.

[0077] The connecting section groove 13 can be filled with glue to further cover the gap between the connecting section 31 and the electrode pressure plate 2 and the connecting section groove 13, thereby improving the sealing between the support structure 1, the electrode pressure plate 2 and the connecting section 31.

[0078] In this embodiment, the support structure 1 is also provided with an arc-shaped groove 15, which connects the glue filling groove 14 and the guide needle through hole 11. The depth of the arc-shaped groove 15 gradually increases from one end of the glue filling groove 14 to one end of the guide needle through hole 11.

[0079] The connecting section 31 is provided with a bending section 311, which connects the connecting section 31 and the sensing section 33; one end of the bending section 311 connected to the sensing section 33 extends upward with an inclined arm, and the upper end of the inclined arm is bent; the arc groove 15 holds the bending section 311.

[0080] The curvature of the arc-shaped groove 15 matches the curvature of the inclined arm of the bent section 311. Simultaneously, the arc-shaped groove 15 can be filled with adhesive, forming a sealed structure between the connecting section 31, the arc-shaped groove 15, and the electrode pressure plate 2, further improving the airtightness between the support structure 1, the electrode pressure plate 2, and the connecting section 31. The arc-shaped groove 15 also serves to fix the bent section 311, making the assembly of the bioelectrode 3 smoother.

[0081] Please refer to Figures 1-12. Figure 11 shows a highly sealed invasive bio-information monitoring device, including an upper shell 101, a bottom shell 102, and a biosensor 103. The upper shell 101 and the bottom shell 102 are connected by threads. The biosensor 103 includes a highly sealed invasive biosensing component 01 as disclosed in the above embodiments.

[0082] The biosensor 103 is sealed within the upper shell 101 and the bottom shell 102. A second sealing gasket 1011 is provided at the lower part of the upper shell 101. The second sealing gasket 1011 is pressed against the lower part of the upper shell 101 and the upper inner side of the bottom shell 102, so that a sealed space is formed between the upper shell 101 and the bottom shell 102, which improves the sealing performance of the inside of the high-sealing invasive bio-information monitoring device, thereby further improving the sealing performance of the high-sealing invasive bio-information monitoring device 02.

[0083] In this embodiment, a support base 104 is also included;

[0084] The bottom shell 102 is provided with a through hole, and the support base 104 passes through the through hole and enters the interior of the bottom shell 102;

[0085] The upper part of the support base 104 is snapped into the lower part of the sealing sleeve 5, and the fixing piece 1041 of the support base 104 is fixedly installed on the bottom of the outer side of the bottom shell 102.

[0086] A third sealing groove 1021 is provided at the bottom of the outer shell 102, and a third sealing gasket 1022 is provided on the upper part of the fixing plate 1041. The third sealing gasket 1022 is pressed into the third sealing groove 1021, so that a sealed space is formed between the upper shell 101, the bottom shell 102 and the fixing plate 1041, which improves the sealing performance of the inside of the high-sealing invasive bio-information monitoring device, thereby further improving the sealing performance of the high-sealing invasive bio-information monitoring device 02.

[0087] In this embodiment, an annular drying block is also included. The annular drying block is disposed at the bottom inside the bottom shell 102, and the upper part of the support base 104 passes through the annular drying block. Several cantilever hook beams extend upward from the bottom inside the bottom shell 102, and the cantilever hook beams hook the annular drying block. The annular drying block is fixed inside the bottom shell 102 and surrounds the support base 104. It can absorb water vapor, liquid, etc. that enter the high-sealing invasive bio-information monitoring device 02, thereby further improving the sealing performance of the high-sealing invasive bio-information monitoring device 02.

[0088] The bioelectrode 3, support structure 1, electrode pressure plate 2, and sealing sleeve 4 are assembled as a single unit during manufacturing to form a high-sealing invasive biosensor component 01. After uniform sterilization, it can maintain high sealing performance. When other components such as circuit boards and batteries are assembled later, there is no need to consider the problem of over-assembly or under-assembly of the bioelectrode 3 and circuit board / or the transmitter carrying the circuit board, which improves the stability of the high-sealing invasive biosensor component 01 before and after implantation in the human body.

[0089] The highly sealed invasive bioinformatics monitoring device 02 forms a closed space inside, maintaining a sealed and sterile state during manufacturing, transportation, and shelf placement, thus improving product stability and safety. For mass production, only the highly sealed invasive biosensor component 01 needs to be manufactured and assembled in a sterile environment; other components can be manufactured and assembled in a normal production environment. This reduces the environmental requirements for manufacturing and improves production efficiency during sterilization procedures.

[0090] During factory assembly, the upper shell 101, the bottom shell 102, and the support base 104 form a sealed space. When the product is not in use, the sealed invasive biosensor component 01 is stored in the sealed space. During pre-implantation assembly, the upper shell 101 and the bottom shell 102 are separated to expose the bioelectrode 3 and the guide needle 4 to be implanted. The bioelectrode 3 and the guide needle 4 are only exposed to the air when the upper shell 101 and the bottom shell 102 are separated, which is a very short time. This reduces the risk of contamination of the bioelectrode 3 and the guide needle 4, improves the safety of the bioelectrode 3 and the guide needle 4 when implanted in the human body, and further improves the stability and safety of the product.

[0091] Although embodiments of this application have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of this application, the scope of which is defined by the appended claims and their equivalents.

[0092] It will be understood by those skilled in the art that the above-described preferred solutions can be freely combined and superimposed without conflict. The flowcharts and block diagrams in the accompanying drawings illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of this disclosure. In this regard, each block in a flowchart or block diagram may represent a module, segment, or portion of code containing one or more executable instructions for implementing a specified logical function. It should also be noted that in some alternative implementations, the functions indicated in the blocks may occur in a different order than those indicated in the drawings; for example, two consecutively indicated blocks may actually be executed substantially in parallel, or sometimes in reverse order, depending on the functions involved. It should also be noted that each block in the block diagrams and / or flowcharts, and combinations of blocks in the block diagrams and / or flowcharts, can be implemented using a dedicated hardware-based system that performs the specified function or operation, or using a combination of dedicated hardware and computer instructions. The numbering of each step in this document is for ease of explanation and reference only and is not intended to limit the order of execution. The specific execution order is determined by the technology itself, and those skilled in the art can determine various permissible and reasonable orders based on the technology itself.

[0093] It should be noted that the use of step numbers (letter or number) to refer to certain specific method steps in this application is merely for the purpose of convenience and brevity, and is by no means intended to restrict the order of these method steps. Those skilled in the art will understand that the order of the relevant method steps should be determined by the technology itself and should not be unduly restricted by the existence of step numbers. Those skilled in the art can determine various permissible and reasonable orderings of steps based on the technology itself.

[0094] Those skilled in the art will understand that, without conflict, the above-mentioned preferred solutions can be freely combined and superimposed.

[0095] It should be understood that the above-described embodiments are merely exemplary and not restrictive. Any obvious or equivalent modifications or substitutions made by those skilled in the art regarding the above details without departing from the basic principles of this application shall be included within the scope of the claims of this application.

Claims

1. A highly sealed invasive biosensor component, characterized in that, It includes a support structure (1), an electrode pressure plate (2), a bioelectrode (3), a guide needle (4), and a sealing sleeve (5); the bioelectrode (3) includes a signal output electrode (32), a connection section (31), and a sensing section (33) connected in sequence; The electrode plate (2) is pressed against the bottom of the support structure (1), and part of the connecting section (31) is stuck between the support structure (1) and the electrode plate (2); The sealing sleeve (5) is snapped onto the outside of the electrode pressure plate (2) and the guide pin (4), and the guide pin (4) is disposed through the support structure (1); the electrode pressure plate (2) and the sealing sleeve (5) are detachably fixedly connected, and the guide pin (4) and the sealing sleeve (5) are detachably fixedly connected, so that the sealing sleeve (5) is sealed at the bottom of the support structure (1); The lower part of the sensing section (33) and the guide pin (4) is sealed inside the sealing sleeve (5); the signal output electrode (32) is disposed on the upper part of the support structure (1).

2. The highly sealed invasive biosensor assembly as described in claim 1, characterized in that, The guide pin (4) is configured to pass through the support structure (1) as follows: the support structure (1) is provided with a guide pin through hole (11), and the guide pin (4) passes through the guide pin through hole (11) and extends out of the lower part of the support structure (1).

3. The highly sealed invasive biosensor component as described in claim 2, characterized in that, The electrode pressure plate (2) and the sealing sleeve (5) are detachably fixedly connected as follows: part of the edge of the electrode pressure plate (2) extends outward to form an ear-shaped buckle (21), and the inner side of the sealing sleeve (5) is provided with a screw-in protrusion (51), at least one screw-in protrusion (51) is engaged in the ear-shaped buckle (21).

4. The highly sealed invasive biosensor assembly as described in claim 3, characterized in that, The guide pin (4) and the sealing sleeve (5) are detachably fixedly connected as follows: the lower part of the needle seat (42) of the guide pin (4) is provided with a buckle groove (41), and the inner side of the sealing sleeve (5) is provided with a screw-in protrusion (51), at least one screw-in protrusion (51) is engaged in the buckle groove (41).

5. The highly sealed invasive biosensor assembly as described in claim 4, characterized in that, The lower part of the guide needle (42) is sealed in the sealing sleeve (5) as follows: a sealing ring (43) is sleeved on the lower outer side of the needle seat (42), and the sealing ring (43) is located above the undercut groove (41). The outer side of the sealing ring (43) is press-fitted with the guide pin through hole (11), and the outer side of the sealing ring (43) is engaged in the guide pin through hole (11), so that a sealed space is formed between the guide pin through hole (11), the guide pin (4) and the support structure (1).

6. The highly sealed invasive biosensor assembly as described in claim 1, characterized in that, The lower part of the support structure (1) is provided with a first sealing groove (12), which surrounds the electrode pressure plate (2), bioelectrode (3) and guide needle (4). The upper part of the sealing sleeve (5) is provided with a first sealing gasket (52), which is pressed between the first sealing groove (12) and the sealing sleeve (5), so that a sealed space is formed between the support structure (1) and the sealing sleeve (5).

7. The highly sealed invasive biosensor assembly as described in claim 1, characterized in that, A rubber stopper (53) is provided at the lower part of the sealing sleeve (5); The rubber plug (53) is inserted into the bottom inner wall of the sealing sleeve (5) to achieve a detachable sealing structure, and the bottom of the rubber plug (53) may partially protrude from or not protrude from the sealing sleeve (5).

8. The highly sealed invasive biosensor assembly as described in claim 7, characterized in that, The sealing sleeve (5) is provided with a drying block (54) inside, and the upper surface of the rubber plug (53) is provided with an installation groove (531), and the drying block (54) is embedded in the installation groove (531).

9. The highly sealed invasive biosensor assembly as described in claim 1, characterized in that, The support structure (1) is provided with a connecting section through groove (13), and the bottom of the support structure (1) is provided with an adhesive filling groove (14). The adhesive filling groove (14) is connected to the connecting section through groove (13). The electrode pressure plate (2) is pressed against the bottom of the connecting section through groove (13) and the adhesive filling groove (14). The connecting section (31) is disposed in the connecting section through groove (13) and the adhesive filling groove (14).

10. The highly sealed invasive biosensor assembly as described in claim 9, characterized in that, The glue filling groove (14) and the snap-fit ​​groove (16) can be filled with glue. The glue fills the gap between the glue filling groove (14), the connecting section (31), the electrode pressure plate (2) and the support structure (1) so that the support structure (1), the electrode pressure plate (2) and the connecting section (31) form a sealed structure.

11. The highly hermetic invasive biosensor assembly as described in claim 10, characterized in that, The connecting section through groove (13) can be filled with glue. The glue fills the gap between the connecting section (31) and the electrode pressure plate (2) and the connecting section through groove (13) so that the support structure (1), the electrode pressure plate (2) and the connecting section (31) form a sealed structure.

12. The highly sealed invasive biosensor assembly as described in claim 9, characterized in that, The upper surface of the electrode pressure plate (2) extends out a snap-fit ​​post (22), and the lower surface of the support structure (1) is provided with a snap-fit ​​groove (16), and the snap-fit ​​post (22) and the snap-fit ​​groove (16) are in clearance fit.

13. A highly airtight invasive bio-information monitoring device, characterized in that, The device includes an upper shell (101), a bottom shell (102), and a biosensor (103), wherein the upper shell (101) and the bottom shell (102) are connected by threads; the biosensor (103) includes a highly sealed invasive biosensor assembly (01) as described in any one of claims 1-12; The biosensor (103) is sealed within the upper shell (101) and the bottom shell (102).

14. The highly sealed invasive bio-information monitoring device as described in claim 13, wherein the biosensor (103) is sealed within the upper shell (101) and the bottom shell (102) as follows: a second sealing gasket (1011) is provided at the lower part of the upper shell (101), and the second sealing gasket (1011) is pressed against the lower part of the upper shell (101) and the upper inner side of the bottom shell (102), thereby forming a sealed space between the upper shell (101) and the bottom shell (102).

15. The highly airtight invasive bio-information monitoring device as described in claim 13 or 14, characterized in that, The device also includes a support base (104); The bottom shell (102) is provided with a through hole, and the support base (104) passes through the through hole and enters the interior of the bottom shell (102); The upper part of the support base (104) is engaged with the lower part of the sealing sleeve (5), and the fixing piece (1041) of the support base (104) is fixedly disposed on the bottom of the outer side of the bottom shell (102). The bottom of the outer shell (102) is provided with a third sealing groove (1021), and the upper part of the fixing piece (1041) is provided with a third sealing gasket (1022). The third sealing gasket (1022) is pressed into the third sealing groove (1021), so that a sealed space is formed between the upper shell (101), the bottom shell (102) and the fixing piece (1041).

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