Integrated invasive biosensor assembly

Abstract

The present application relates to the technical field of biosensors. Provided is an integrated invasive biosensor assembly, comprising: a host, wherein the host comprises an upper cover, a lower cover, and a sensing electrode, the upper cover and the lower cover are coupled with each other, and the sensing electrode extends from the lower cover; an electrode sealing sleeve, wherein the electrode sealing sleeve is clipped to the bottom of the lower cover, the sensing electrode is sealed in the electrode sealing sleeve, a lower portion of the lower cover is provided with an assembly blind hole, an assembly limiting column extends out of the lower portion of the lower cover and is located in the assembly blind hole; and an electrode pressing plate. The assembly limiting column is provided with a limiting recess, a limiting protrusion extends from an upper portion of the electrode pressing plate, the limiting protrusion mates with the limiting recess, such that the electrode pressing plate engages with a lower portion of the assembly limiting column, thereby solving the problem of airtightness of the integrated biosensor assembly, improving the overall stability of the invasive biosensor assembly, providing minimum unit protection for the sensing electrode, and reducing the sealing requirements for the external housing and product outer packaging.

Description

An integrated invasive biosensor assembly Technical Field

[0001] This application relates to the field of biosensor technology, and in particular to an integrated invasive biosensor assembly. 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, 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 patents CN115399757A (a high-reliability implantation device for implantable biosensors) and CN116984857A (an assembly and propulsion device for invasive biosensor electrode assemblies), the invasive biosensor assembly and the main control circuit of the transmitter are separate during factory assembly. During pre-implantation assembly, the device relies on an anti-trigger sleeve to control the separation of the invasive biosensor electrode assembly and the invasive biosensor transmitter assembly. During use, the anti-trigger sleeve is removed, and the upper and lower shells are rotated relative to each other, allowing the invasive biosensor electrode assembly and the invasive biosensor transmitter assembly to assemble into the invasive biosensor assembly. The above technologies have at least the following problems: due to the separate design, assembling the invasive biosensor electrode assembly and the invasive biosensor transmitter assembly is difficult, potentially leading to incomplete or over-assembly, reducing product reliability; the sensing electrodes in the biosensor need to be in a sterile environment after electrode modification. In existing products, the sensing electrodes, main shell, etc., need to be sealed and uniformly sterilized, increasing the requirements for product packaging and the production environment, and reducing operational efficiency. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to solve the problem of low hermeticity of biosensor components and to provide an integrated invasive biosensor component.

[0006] To achieve the above objectives, this application provides the following technical solution:

[0007] An integrated invasive biosensor assembly includes a main unit, which includes an upper cover, a lower cover, and a sensing electrode. The upper cover and the lower cover are fastened together, and the sensing electrode extends from the lower cover.

[0008] It also includes an electrode sealing sleeve, which is snapped into the bottom of the lower cover, and the sensing electrode is sealed inside the electrode sealing sleeve.

[0009] Preferably, the lower part of the lower cover is provided with an assembly blind hole, and an assembly pin extends out from the lower part of the lower cover, with the assembly pin located inside the assembly blind hole;

[0010] It also includes an electrode pressure plate; the assembly pin is provided with a concave stop, the upper part of the electrode pressure plate extends out of the convex stop, the convex stop engages with the concave stop, and the electrode pressure plate is placed on the lower part of the assembly pin.

[0011] Preferably, the assembly pin is provided with an electrode slot; the sensing electrode is secured between the electrode slot and the upper part of the electrode pressure plate; the assembly blind hole is partially through-hole to form a guide hole, and the sensing electrode extends out from the guide hole.

[0012] Preferably, the upper part of the electrode pressure plate has two adjacent guide protrusions, the electrode slot is partially provided with a deep protrusion groove, and the guide protrusions are inserted into the protrusion grooves; the sensing electrode passes through the two guide protrusions.

[0013] Preferably, the upper part of the electrode pressure plate extends two opposing mounting protrusions, the mounting post is provided with two mounting slots, the two mounting slots are respectively provided on both sides of the electrode slot, and the two mounting protrusions are respectively engaged in the two mounting slots.

[0014] Preferably, it also includes a guide pin; the guide pin is inserted into the guide hole; the lower part of the guide pin is provided with a buckle groove;

[0015] The edge of the electrode pressure plate protrudes from the edge of the mounting pin to form an ear-shaped snap finger; the inner side of the electrode sealing sleeve is provided with two screw-in protrusions;

[0016] Before leaving the factory, one of the screw-in clip protrusions is engaged with the ear-shaped buckle finger, and the other screw-in clip protrusion is engaged with the undercut groove;

[0017] During pre-implantation assembly, the electrode sealing sleeve is rotated, and one of the screw-in protrusions is screwed out from the ear-shaped buckle, while the other screw-in protrusion is screwed out from the undercut groove.

[0018] Preferably, the upper part of the ear-shaped buckle is provided with an upwardly extending limiting post;

[0019] Before leaving the factory, the screw-in protrusion abuts against the limiting pin;

[0020] During pre-implantation assembly, the screw-in card protrudes out of the limiting card post.

[0021] Preferably, the upper cover is provided with an assembly through hole, and the upper part of the lower cover is provided with an upwardly extending fixing pin, which is engaged in the assembly through hole;

[0022] An annular locking block extends from the upper outer periphery of the guide pin, and the guide hole is disposed through the fixed locking post; the guide pin passes through the assembly through hole and enters the guide hole, and the annular locking block is locked onto the upper part of the fixed locking post.

[0023] Preferably, an annular groove is provided on the upper outer periphery of the guide pin, and the annular groove is located at the lower part of the annular locking block;

[0024] It also includes a first sealing ring, the inner circumference of which is engaged with the annular groove, the guide hole is set with a larger upper part and a smaller lower part, and the outer circumference of the first sealing ring is engaged with the larger upper part of the guide hole.

[0025] Preferably, the upper part of the electrode sealing sleeve is engaged within the assembly blind hole;

[0026] It also includes a second sealing ring;

[0027] The upper surface of the electrode sealing sleeve is provided with a sealing groove, the lower part of the second sealing ring is engaged in the sealing groove, and the upper part of the second sealing ring abuts against the bottom of the assembly blind hole.

[0028] Compared with the prior art, the beneficial effects of this application are:

[0029] (1) The sensing electrodes and circuit boards are assembled as a single unit during manufacturing to form a single biosensor component. This single unit is set up during factory transportation and before implantation into the human body. There is no need to consider the problem of over-assembly or under-assembly of the bioelectrodes and circuit boards / or the transmitter carrying the circuit board, which improves the overall stability of the invasive biosensor component.

[0030] (2) The sensing electrode needs to be in a sterile environment after electrode modification. The electrode protective cover is integrated with the electrode assembly to protect the sensing electrode in the smallest unit, reducing the sealing requirements of the outer shell and product packaging.

[0031] (3) When mass-producing products, only the integrated biosensor component needs to be produced and assembled in a sterile environment. Other parts can be produced and assembled in a normal production environment, which reduces the environmental requirements for production and improves the efficiency of production operations when performing sterile disinfection. Attached Figure Description

[0032] Figure 1 is a schematic diagram of the structure of an integrated invasive biosensor assembly disclosed in this embodiment;

[0033] Figure 2 is an exploded view of an integrated invasive biosensor assembly disclosed in this embodiment;

[0034] Figure 3 is a schematic diagram of the structure of the electrode sealing sleeve of an integrated invasive biosensor assembly disclosed in this embodiment;

[0035] Figure 4 is a schematic diagram of the electrode plate of an integrated invasive biosensor assembly disclosed in this embodiment;

[0036] Figure 5 is a top view of the bottom shell of an integrated invasive biosensor assembly disclosed in this embodiment;

[0037] Figure 6 is a bottom view of the bottom shell of an integrated invasive biosensor assembly disclosed in this embodiment;

[0038] Figure 7 is a schematic diagram of the main unit structure of an integrated invasive biosensor assembly disclosed in this embodiment, after removing the electrode pressure plate and electrode sealing sleeve.

[0039] Figure 8 is a structural schematic diagram from one perspective of the removal of the electrode sealing sleeve during the implantation of an integrated invasive biosensor assembly disclosed in this embodiment.

[0040] Figure 9 is a structural schematic diagram from another perspective of the main unit removing the electrode sealing sleeve during the implantation of an integrated invasive biosensor assembly disclosed in this embodiment.

[0041] Figure 10 is a schematic diagram of the host structure of an integrated invasive biosensor assembly disclosed in this embodiment after the guide pin is removed.

[0042] In the diagram: 1-Main unit; 11-Upper cover; 111-Assembly through hole; 12-Lower cover; 121-Assembly blind hole; 1211-Assembly locking post; 12111-Concave stop; 12112-Electrode slot; 12113-Lower groove; 12114-Assembly slot; 122-Guide hole; 123-Fixing locking post; 13-Main control circuit board; 131-Fixing through hole; 14-Battery; 2-Sensing electrode; 3-Guide pin; 31-Undercut groove; 32-Annular locking block; 33-Annular slot; 331-First sealing ring; 4-Electrode sealing sleeve; 41-Screw-in locking protrusion; 42-Sealing groove; 421-Second sealing ring; 5-Electrode pressure plate; 51-Protruding stop; 52-Guide locking protrusion; 53-Assembly locking protrusion; 54-Ear-shaped buckle; 541-Limiting locking post. Detailed Implementation

[0043] 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.

[0044] 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.

[0045] 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."

[0046] 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.

[0047] To improve the sealing of invasive biosensor components, this application provides an integrated invasive biosensor component. Please refer to Figures 1 and 2. Figure 1 is a structural schematic diagram of an integrated invasive biosensor component disclosed in this embodiment, and Figure 2 is an exploded view of an integrated invasive biosensor component disclosed in this embodiment. This embodiment discloses an integrated invasive biosensor component, including a host 1. The host 1 includes an upper cover 11, a lower cover 12, and a sensing electrode 2. The upper cover 11 and the lower cover 12 are fastened together, and the sensing electrode 2 extends from the lower cover 12.

[0048] It also includes an electrode sealing sleeve 4, which is snapped into the bottom of the lower cover 12, and the sensing electrode 2 is sealed inside the electrode sealing sleeve 4.

[0049] A cavity is formed between the upper cover 11 and the lower cover 12, and the main control circuit board 13 and the battery 14 are placed in the cavity; the battery 14 is placed on the upper part of the main control circuit board 13; the main control circuit board 13 and the battery 14 are electrically connected; the upper surface of the main control circuit board 13 is provided with an electrode clamping structure for clamping the contacts on the sensing electrode 2 so that the sensing electrode 2 and the main control circuit board 13 are electrically connected.

[0050] The lower part of the lower cover 12 is provided with an assembly blind hole 121, and an assembly pin 1211 extends out from the lower part of the lower cover 12. The assembly pin 1211 is located inside the assembly blind hole 121.

[0051] Please refer to Figures 4 and 8, which also include an electrode pressure plate 5; the assembly pin 1211 is provided with a concave stop 12111, the upper part of the electrode pressure plate 5 extends out of the convex stop 51, the convex stop 51 engages with the concave stop 12111, and the electrode pressure plate 5 is placed at the lower part of the assembly pin 1211.

[0052] Please refer to Figures 5 to 8. The mounting post 1211 is provided with an electrode slot 12112. The sensing electrode 2 is held between the electrode slot 12112 and the upper part of the electrode pressure plate 5. The partial through-hole of the mounting blind hole 121 becomes a guide hole 122, from which the sensing electrode 2 extends. The electrode pressure plate 5 and the electrode slot 12112 fix part of the sensing electrode 2 inside the mounting post 1211. Part of the sensing electrode 2 extends into the electrode slot 12112 and enters the cavity between the upper cover 11 and the lower cover 12 to connect with the electrode clamping structure.

[0053] Two adjacent guide protrusions 52 extend from the upper part of the electrode pressure plate 5. The electrode slot 12112 is partially provided with a relatively deep groove 12113, and the guide protrusions 52 are inserted into the groove 12113. The sensing electrode 2 passes through the two guide protrusions 52. The guide protrusions 52 further fix the position of the sensing electrode 2 after it is inserted into the groove 12113, so that the sensing electrode 2 can be connected to the electrode clamping structure more accurately. In addition, during assembly before leaving the factory, when assembling the electrode pressure plate 5 with the assembly pin 1211, the guide protrusions 52 can play an assembly positioning role, making it easier for the electrode pressure plate 5 and the assembly pin 1211 to assemble.

[0054] Two opposing mounting protrusions 53 extend from the upper part of the electrode pressure plate 5. The mounting post 1211 is provided with two mounting slots 12114. The two mounting slots 12114 are respectively located on both sides of the electrode slot 12112. The two mounting protrusions 53 are respectively engaged in the two mounting slots 12114.

[0055] The two mounting protrusions 53 are cylindrical, and the two mounting slots 12114 are cylindrical; the two mounting protrusions 53 are symmetrically arranged relative to the electrode slots 12112.

[0056] Sealing adhesive is applied to the mounting groove 12113, mounting slot 12114 and electrode slot 12112, so that the sensing electrode 2 and the electrode pressure plate 5 are fixed in the mounting post 1211, and the mounting slot 12114, the electrode slot 12112 and the sensing electrode 2 and the electrode pressure plate 5 form a sealed structure.

[0057] It also includes a guide pin 3; the guide pin 3 is inserted into the guide hole 122; the lower part of the guide pin 3 is provided with a buckle groove 31;

[0058] The edge of part of the electrode pressure plate 5 protrudes from the edge of the mounting post 1211 to form an ear-shaped snap finger 54; the inner side of the electrode sealing sleeve 4 is provided with two screw-in protrusions 41, please refer to Figure 3;

[0059] Before leaving the factory, one screw-in locking protrusion 41 is engaged with the ear-shaped buckle 54, and the other screw-in locking protrusion 41 is engaged with the inverted groove 31; the electrode sealing sleeve 4 and the main unit 1 are in a locked state;

[0060] During pre-implantation assembly, the electrode sealing sleeve 4 is rotated, and one screw-in locking protrusion 41 is unscrewed from the ear-shaped snap finger 54, while the other screw-in locking protrusion 41 is unscrewed from the undercut groove 31. The electrode sealing sleeve 4 is in a separated state from the main unit 1.

[0061] The engagement of the ear-shaped buckle 54, the inverted groove 31, and the screw-in latch 41 allows the electrode sealing sleeve 4 to be fixed to the lower part of the lower cover 12; the engagement of the inverted groove 31 and the screw-in latch 41 allows the guide pin 3 to be fixed at the guide hole 122.

[0062] When the assembly is completed at the factory, the part of the guide needle 3 and part of the sensing electrode 2 to be implanted into the human body are in the electrode sealing sleeve 4, in a sealed and sterile stable state.

[0063] During the pre-implantation assembly, the electrode sealing sleeve 4 peels off the guide needle 3 and sensing electrode 2 from the human body to be implanted. Before the pre-implantation assembly stage, the sensing electrode 2 is in a nearly sterile storage environment and is in a sterile state, which improves the safety of the sensing electrode 2 when it is implanted into the human body.

[0064] The upper part of the ear-shaped buckle 54 is provided with an upwardly extending limiting post 541;

[0065] Before leaving the factory, screw in the locking protrusion 41 to abut the limiting locking post 541;

[0066] During the pre-implantation assembly, screw in the card protrusion 41 and screw out the limiting card post 541.

[0067] The limiting pin 541 is used to limit the distance and direction of the screw-in protrusion 41 into the ear-shaped buckle 54 and the undercut groove 31, thereby improving the stability of the electrode sealing sleeve 4 fixed to the lower part of the lower cover 12 and facilitating the assembly of the electrode sealing sleeve 4.

[0068] The upper cover 11 is provided with an assembly through hole 111, and the upper part of the lower cover 12 is provided with an upwardly extending fixing pin 123, which is inserted into the assembly through hole 111.

[0069] The main control circuit board 13 is provided with a fixing through hole 131, and the mounting through hole 111 is snapped into the fixing through hole 131;

[0070] The guide pin 3 extends out of the upper outer periphery of the ring-shaped locking block 32, and the guide hole 122 is disposed in the fixed locking post 123; the guide pin 3 passes through the assembly through hole 111 and enters the guide hole 122, and the ring-shaped locking block 32 is locked in the upper part of the fixed locking post 123.

[0071] An annular groove 33 is provided on the upper outer periphery of the guide pin 3, and the annular groove 33 is located at the lower part of the annular block 32.

[0072] It also includes a first sealing ring 331, the inner circumference of which is engaged with the annular groove 33, the guide hole 122 is set with a larger upper part and a smaller lower part, and the outer circumference of the first sealing ring 331 is engaged with the larger upper part of the guide hole 122.

[0073] The first sealing ring 331, guide needle 3, guide hole 122, electrode pressure plate 5 and electrode sealing sleeve 4 form a tightly sealed space. Before the electrode sealing sleeve 4 is removed and implanted into the human body, the guide needle 3 and sensing electrode 2 are in a stable, sealed and sterile state, which improves the stability and safety of the internal biochemical environment of the integrated invasive biosensor assembly.

[0074] The upper part of the electrode sealing sleeve 4 is engaged in the assembly blind hole 121;

[0075] It also includes a second sealing ring 421;

[0076] The upper surface of the electrode sealing sleeve 4 is provided with a sealing groove 42. The lower part of the second sealing ring 421 is engaged in the sealing groove 42, and the upper part of the second sealing ring 421 is abutted against the bottom of the assembly blind hole 121.

[0077] The first sealing ring 331, the second sealing ring 421, the guide needle 3, the guide hole 122, the electrode pressure plate 5, and the electrode sealing sleeve 4 form a more airtight sealed space, which further improves the safety of the guide needle 3 and the sensing electrode 2 before implantation into the human body, and further improves the stability and safety of the internal biochemical environment of the integrated invasive biosensor assembly.

[0078] The sensing electrode 2 and the main control circuit board 13 are assembled as a single unit during manufacturing to form a single biosensor component. This single unit is used both during factory transportation and before implantation into the human body. It eliminates the need to consider the problems of over- or under-assembly of the sensing electrode 2 and the main control circuit board 13 / or the transmitter carrying the main control circuit board 13, which are separate units in the prior art. This makes the single invasive biosensor component composed of the sensing electrode 2 and the main control circuit board 13 a standard universal component, thus improving the overall stability of the invasive biosensor component.

[0079] Before implantation, the sensing electrode 2 and guide needle 3 are sealed and sterile. When the user uses the invasive biosensor assembly to monitor blood glucose levels, the steps are as follows: First, the user removes the electrode sealing sleeve 4 to expose the tip of the guide needle 3 (see Figure 9). Second, the user peels off the release film under the main unit 1 to expose the double-sided adhesive tape on the lower surface of the main unit 1. Third, with the needle tip facing the skin, the implantation device propels the main unit 1 and guide needle 1 towards the skin, causing the tip of the guide needle 1 to carry the sensing electrode 2 into the skin. The sensing electrode 2 contacts the blood to collect biological signals from the blood, while the main unit 1 is attached to the skin surface with the double-sided adhesive tape. At this time, the sensing electrode 2 is used to collect biological signals from the blood, and the main unit 1 is used to receive biological signals. Fourth, the user removes the guide needle 3, leaving only the sensing electrode 2 partially implanted in the skin (see Figure 10). The electrode sealing sleeve 4 is only removed during assembly before implantation into the human body, reducing the risk of contamination of the sensing electrode 2 and guide needle 3, and improving the stability and safety of the sensing electrode 2 and guide needle 3 before and after implantation into the human body.

[0080] After electrode modification, the sensing electrode 2 needs to be in a sterile environment. The electrode sealing sleeve 4 is integrated with the sensing electrode 2 and the guide needle 3, providing protection for the sensing electrode 2 at the smallest unit level. There is no need to seal the outer shell and product packaging as a whole, which reduces the sealing requirements of the outer shell and product packaging and improves the efficiency of production operations.

[0081] When mass-producing products, only the integrated biosensor component needs to be produced and assembled in a sterile environment, while other parts can be produced and assembled in a normal production environment, reducing the environmental requirements for manufacturing; and improving the efficiency of production operations when performing sterile disinfection.

[0082] 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.

Claims

1. An integrated invasive biosensor assembly, the assembly comprising: Includes a host (1), the host (1) includes an upper cover (11), a lower cover (12) and a sensing electrode (2), the upper cover (11) and the lower cover (12) are fastened to each other; the sensing electrode (2) extends from the lower cover (12); The component is characterized in that it further includes an electrode sealing sleeve (4), which is snapped into the bottom of the lower cover (12), and at least a portion of the sensing electrode (2) extends out of the lower cover (12) and is sealed inside the electrode sealing sleeve (4). The lower part of the lower cover (12) is provided with an assembly blind hole (121), and an assembly pin (1211) is provided in the assembly blind hole (121); The assembly also includes an electrode plate (5), which is snapped into the lower part of the assembly post (1211); The sensing electrode (2) extends from the assembly blind hole (121); Before leaving the factory, the electrode pressure plate (5) is snapped into the electrode sealing sleeve (4); before implantation, the electrode sealing sleeve (4) is unscrewed from the electrode pressure plate (5).

2. The integrated invasive biosensor assembly as described in claim 1, characterized in that, The electrode pressure plate (5) is placed at the lower part of the assembly pin (1211) as follows: the assembly pin (1211) is provided with a concave stop (12111), and the upper part of the electrode pressure plate (5) extends out with a convex stop (51), and the convex stop (51) engages with the concave stop (12111).

3. The integrated invasive biosensor assembly as described in claim 2, characterized in that, The sensing electrode (2) extends out of the assembly blind hole (121) as follows: the assembly pin (1211) is provided with an electrode slot (12112); the sensing electrode (2) is locked between the electrode slot (12112) and the upper part of the electrode pressure plate (5); the assembly blind hole (121) is partially opened to form a guide hole (122), and the sensing electrode (2) extends out from the guide hole (122).

4. The integrated invasive biosensor assembly as described in claim 3, characterized in that, The component also includes a guide pin (3), which is disposed through the upper cover (11) and the lower cover (12); at the time of manufacture, the lower part of the guide pin (3) is engaged with the electrode sealing sleeve (4); before implantation, the electrode sealing sleeve (4) is unscrewed from the guide pin (3).

5. The integrated invasive biosensor assembly as described in claim 4, characterized in that, Before leaving the factory, the electrode pressure plate (5) and the electrode sealing sleeve (4) are engaged as follows: part of the edge of the electrode pressure plate (5) protrudes from the edge of the assembly pin (1211) to form an ear-shaped snap finger (54); two screw-in snap protrusions (41) are provided on the inner side of the electrode sealing sleeve (4); before leaving the factory, one of the screw-in snap protrusions (41) is engaged with the ear-shaped snap finger (54); Before implantation, the electrode sealing sleeve (4) is unscrewed from the electrode pressure plate (5) as follows: Before implantation, rotate the electrode sealing sleeve (4), and one of the screw-in protrusions (41) is unscrewed from the ear-shaped buckle (54).

6. The integrated invasive biosensor assembly as described in claim 5, characterized in that, When the product leaves the factory, the lower part of the guide pin (3) is engaged with the electrode sealing sleeve (4) as follows: the guide pin (3) is engaged in the guide hole (122); the lower part of the guide pin (3) is provided with a back groove (31); before leaving the factory, another screw-in protrusion (41) is engaged in the back groove (31); Before implantation, the electrode sealing sleeve (4) is unscrewed from the guide needle (3) as follows: Before implantation, rotate the electrode sealing sleeve (4), and another screw-in protrusion (41) is unscrewed from the undercut groove (31).

7. The integrated invasive biosensor assembly as described in claim 3, characterized in that, The upper part of the electrode pressure plate (5) has two adjacent guide protrusions (52), and the electrode slot (12112) is partially provided with a deep protrusion groove (12113). The guide protrusions (52) are inserted into the protrusion groove (12113); the sensing electrode (2) passes between the two guide protrusions (52).

8. The integrated invasive biosensor assembly as described in claim 7, characterized in that, The upper part of the electrode pressure plate (5) has two opposing mounting protrusions (53), and the mounting post (1211) is provided with two mounting slots (12114). The two mounting slots (12114) are respectively located on both sides of the electrode slot (12112), and the two mounting protrusions (53) are respectively engaged in the two mounting slots (12114).

9. The integrated invasive biosensor assembly as described in claim 5, characterized in that, The upper part of the ear-shaped buckle (54) is provided with an upwardly extending limiting post (541); Before leaving the factory, the screw-in protrusion (41) abuts against the limiting post (541); Before implantation, the screw-in protrusion (41) is screwed out of the limiting post (541).

10. The integrated invasive biosensor assembly as described in claim 9, characterized in that, The upper cover (11) is provided with an assembly through hole (111), and the upper part of the lower cover (12) is provided with an upwardly extending fixing pin (123), which is inserted into the assembly through hole (111). An annular locking block (32) extends out from the upper outer periphery of the guide pin (3), and the guide hole (122) is disposed through the fixed locking post (123); the guide pin (3) passes through the assembly through hole (111) and enters the guide hole (122), and the annular locking block (32) is locked in the upper part of the fixed locking post (123).

11. The integrated invasive biosensor assembly as described in claim 10, characterized in that, The guide pin (3) has an annular groove (33) on its upper outer periphery, and the annular groove (33) is located at the lower part of the annular block (32). It also includes a first sealing ring (331), the inner circumferential side of the first sealing ring (331) is engaged with the annular groove (33), the guide hole (122) is set with a larger upper part and a smaller lower part, and the outer circumferential side of the first sealing ring (331) is engaged with the larger upper part of the guide hole (122).

12. The integrated invasive biosensor assembly as described in claim 11, characterized in that, The upper part of the electrode sealing sleeve (4) is engaged in the assembly blind hole (121); It also includes a second sealing ring (421); The upper surface edge of the electrode sealing sleeve (4) is provided with a sealing groove (42), the lower part of the second sealing ring (421) is engaged in the sealing groove (42), and the upper part of the second sealing ring (421) is abutted against the bottom of the assembly blind hole (121).

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