Highly reliable invasive biological information monitoring apparatus

Abstract

The present application relates to the technical field of biosensor assemblies, and in particular, to a highly reliable invasive biological information monitoring apparatus. An outer side of a sliding seat is provided with two or more first locking arc-shaped protrusions. An inner wall of a bottom housing is provided with two or more second locking arc-shaped protrusions. The first locking arc-shaped protrusions and the second locking arc-shaped protrusions constitute a locking structure of the sliding seat and the bottom housing. In a locked state, the first locking arc-shaped protrusions are locked at the bottoms of the second locking arc-shaped protrusions. After manufacture and before the implantation: the bottom housing is rotated relative to the sliding seat, such that the first locking arc-shaped protrusions are screwed out from the bottoms of the second locking arc-shaped protrusions, and an electrode sealing sleeve is screwed out from the bottom of a biosensor assembly. The present application solves the problems of anti-trigger sleeve fall-off and thus reduced reliability of the product before implantation, thereby improving the overall reliability of the invasive biological information monitoring apparatus.

Description

A highly reliable invasive bio-information monitoring device Technical Field

[0001] This application relates to the field of biosensor component technology, and in particular to a highly reliable invasive 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 module 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 existing technologies, during factory assembly, the invasive biosensor component and the transmitter's main control circuit are separate units. During pre-implantation assembly, the sliding base and the fixed base cooperate, electrically connecting the invasive biosensor component to the transmitter's main control circuit. The transmitter component is in an untriggered or power-off state, resulting in lower standby power consumption and longer product storage and lifespan. Simultaneously, the structures of the fixed base and sliding base cooperate well during assembly, transportation, and implantation, ensuring high reliability during the implantation of the invasive sensing electrode into the human skin. During pre-implantation assembly, the device relies on an anti-trigger sleeve to separate the invasive biosensor component from the transmitter's main control circuit. The anti-trigger sleeve is removed before use, allowing the invasive biosensor electrode component and the invasive biosensor transmitter component to assemble into the invasive biosensor component. The invasive biosensor component is then ejected via a needle-like ejector, and the bioelectrode is implanted into the human body. However, the above technologies have at least the following problems: during the pre-implantation assembly stage and during product transportation after factory assembly, the anti-trigger sleeve may detach, potentially triggering the needle-like ejector to implant the invasive biosensor component, reducing the product's pre-implantation reliability.

[0005] Therefore, how to reduce false triggering of invasive bio-information monitoring devices and improve their reliability has become an urgent technical problem to be solved. Summary of the Invention

[0006] In view of this, the purpose of this application is to solve the problem of false triggering of invasive bio-information monitoring devices, which reduces the reliability of invasive bio-information monitoring devices, and to provide a highly reliable invasive bio-information monitoring device.

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

[0008] A highly reliable invasive bioinformatics monitoring device includes an upper shell, a bottom shell, and a sliding base;

[0009] The upper shell and the bottom shell are connected by threads; the sliding seat is engaged within the space formed by the upper shell and the bottom shell;

[0010] The inner side of the bottom shell has a second locking arc-shaped protrusion, and the outer side of the sliding seat has a first locking arc-shaped protrusion.

[0011] In the locked state, the upper shell and the bottom shell are connected by threads, and the first locking arc-shaped protrusion is locked at the bottom of the second locking arc-shaped protrusion;

[0012] When unlocked, the bottom shell is rotated open relative to the top shell, and the first locking arc-shaped protrusion rotates out from the bottom of the second locking arc-shaped protrusion.

[0013] Preferably, it also includes a biosensor assembly, the lower part of which is snapped with an electrode sealing sleeve, the lower part of which is snapped into the interior of the bottom shell;

[0014] When unlocked, the bottom shell causes the electrode sealing sleeve to rotate out from the bottom of the biosensor assembly.

[0015] Preferably, the lower part of the electrode sealing sleeve is engaged with the sealing sleeve holder as follows: the sealing sleeve holder includes a support post; the bottom of the electrode sealing sleeve is supported on the upper surface of the support post;

[0016] Two bayonet arms extend from the upper sides of the support column, and the two bayonet arms are arranged opposite each other, with each bayonet arm having a bayonet; two limiting protrusions extend from the outer periphery of the electrode sealing sleeve, and the two limiting protrusions are arranged opposite each other, with the two limiting protrusions respectively locking into the two bayonet slots.

[0017] Preferably, two slot arms extend from the upper sides of the support column, and two opposing vertical protrusions extend from the outer periphery of the electrode sealing sleeve, with the two vertical protrusions respectively engaging with the two slot arms;

[0018] The two slot arms and the two bayonet arms are respectively arranged at intervals.

[0019] Preferably, a sealing plug is provided at the bottom of the electrode sealing sleeve; the sealing plug is placed on the upper surface of the support column.

[0020] Preferably, the bottom of the biosensor assembly is provided with an assembly blind hole, the bottom of which extends out of the assembly blind hole, the upper part of the electrode sealing sleeve is engaged with the inside of the assembly blind hole, and the assembly protrusion is engaged with the inside of the electrode sealing sleeve.

[0021] Preferably, it also includes an electrode pressure plate;

[0022] The assembly protrusion is provided with a concave stop, and the upper part of the electrode pressure plate is provided with a convex stop. The convex stop is engaged with the concave stop, and the electrode pressure plate is engaged with the lower part of the assembly protrusion.

[0023] Preferably, it also includes a guide pin;

[0024] The partial penetration of the assembly blind hole becomes a guide hole, and the guide pin is inserted into the guide hole;

[0025] The lower part of the guide pin is provided with a buckle groove, and part of the edge of the electrode pressure plate protrudes from the edge of the mounting protrusion to form an ear-shaped buckle finger;

[0026] The inner side of the electrode sealing sleeve is provided with two screw-in protrusions;

[0027] 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;

[0028] 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.

[0029] Preferably, the ear-shaped buckle extends upwards from the limiting pin;

[0030] Before leaving the factory, the screw-in protrusion abuts against the limiting pin;

[0031] During pre-implantation assembly, the screw-in card protrudes out of the limiting card post.

[0032] Preferably, the angle between the lower surface of the first locking arc-shaped protrusion and the horizontal plane is α, 0° < α ≤ 30°; the angle between the lower surface of the second locking arc-shaped protrusion and the horizontal plane is β, 0° < β ≤ 30°.

[0033] One end of the first locking arc-shaped protrusion is provided with a first chamfer, and one end of the second locking arc-shaped protrusion is provided with a second chamfer;

[0034] In the locked state, the second chamfer engages with the upper part of the other end of the first locking arc-shaped protrusion;

[0035] The first step before implantation after leaving the factory is to initiate the unlocking process: the second locking arc-shaped protrusion slides along the upper surface of the first locking arc-shaped protrusion; the second locking arc-shaped protrusion disengages from the upper surface of the first locking arc-shaped protrusion, causing the first chamfer to engage with the second chamfer; the second chamfer slides along the first chamfer until the first chamfer and the second chamfer separate, and the second locking arc-shaped protrusion separates from the first locking arc-shaped protrusion.

[0036] Compared with the prior art, the beneficial effects of this application are:

[0037] A locking structure is provided at the connection between the sliding base and the bottom shell. During implantation, the bottom shell is attached to the skin surface, and the bottom shell rotates relative to the sliding base. The bottom shell can move along the locking structure, allowing the internal separation / fitting of the locking structure to switch between the locked state and the separated state between the sliding base and the bottom shell. During the product transportation stage after factory assembly, the locking structure can fix the sliding base between the bottom shell and the top shell, preventing the sliding base from falling off due to external collisions or vibrations and being accidentally triggered. This allows the biosensor component to enter the emission implantation state before the user implants it, improving the reliability of the product during implantation and extending the product's shelf life.

[0038] Through the cooperation of the locking structure and the sealing sleeve holder inside the bottom shell, during assembly before implantation, the sealing sleeve holder can synchronously twist the electrode sealing sleeve when the upper shell and bottom shell rotate relative to each other, causing the electrode sealing sleeve to detach from the biosensor assembly. Continuous rotation of the bottom shell causes the internal separation of the locking structure, allowing the bottom shell to detach from the upper shell, and the sensing electrode and guide needle to protrude from the electrode sealing sleeve in a state ready for implantation into human skin. The cooperation between the locking structure and the bottom shell ensures that the sensing electrode and guide needle are in a stable and sterile state before implantation, improving the safety and reliability of the product before implantation. By calculating the distance the bottom shell moves through the locking structure, the direction and distance of twisting the electrode sealing sleeve can be precisely controlled, improving assembly accuracy. Attached Figure Description

[0039] Figure 1 is a schematic diagram of the overall structure of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment;

[0040] Figure 2 is an exploded view of the overall structure of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment;

[0041] Figure 3 is a schematic cross-sectional view of the structure of a high-reliability invasive bio-information monitoring device disclosed in this embodiment, in a locked state when it leaves the factory.

[0042] Figure 4 is a cross-sectional view of the structure of the bottom shell separating from the sliding seat after rotation during the pre-implantation assembly of a high-reliability invasive bio-information monitoring device disclosed in this embodiment.

[0043] Figure 5 is a schematic diagram of the structure of a biosensor assembly of a high-reliability invasive bioinformation monitoring device disclosed in this embodiment;

[0044] Figure 6 is a schematic diagram of the structure of the upper shell after the electrode sealing sleeve is removed from the lower part of the biosensor assembly during the pre-implantation assembly of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment.

[0045] Figure 7 is a bottom view of the upper shell after the electrode sealing sleeve is removed from the lower part of the biosensor assembly during the pre-implantation assembly of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment.

[0046] Figure 8 is a schematic diagram of the structure of a high-reliability invasive bio-information monitoring device disclosed in this embodiment, in which the sliding seat slides upward relative to the fixed seat to expose the guide needle and sensing electrode during implantation.

[0047] Figure 9 is a top view of the bottom shell after the electrode sealing sleeve is removed from the lower part of the biosensor assembly during the pre-implantation assembly of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment.

[0048] Figure 10 is one of the structural schematic diagrams of the bottom shell of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment;

[0049] Figure 11 is a second schematic diagram of the bottom shell of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment;

[0050] Figure 12 is a top view of the sealing sleeve holder of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment;

[0051] Figure 13 is a schematic diagram of the sealing sleeve holder of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment;

[0052] Figure 14 is a schematic diagram of the sliding seat of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment;

[0053] Figure 15 is a schematic diagram of the structure of the mounting base of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment;

[0054] Figure 16 is a schematic diagram of the structure of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment, showing the sensing electrode snapping onto a biosensor assembly.

[0055] Figure 17 is a schematic diagram of the structure of the electrode pressure plate snapping onto the biosensor assembly of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment.

[0056] Figure 18 is a schematic diagram of the guide needle of a high-reliability invasive bio-information monitoring device disclosed in this embodiment;

[0057] Figure 19 is a schematic diagram of the structure of the electrode sealing sleeve of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment;

[0058] Figure 20 is a schematic diagram of the structure of the electrode plate of a high-reliability invasive bioinformatics monitoring device disclosed in this embodiment;

[0059] Figure 21 is a partial enlarged view of A in Figure 14 disclosed in this embodiment;

[0060] Figure 22 is a partial enlarged view of B in Figure 10 disclosed in this embodiment.

[0061] In the diagram: 01-Locking structure; 1-Upper shell; 11-Sliding seat; 111-First locking arc-shaped protrusion; 1111-First chamfer; 12-Fixing seat; 121-Fixing groove; 1211-Cantilever hook beam; 1212-Clamping block; 2-Bottom shell; 21-Second locking arc-shaped protrusion; 211-Second chamfer; 22-Sealing sleeve holder; 221-Bearing column; 2211-Clamping arm; 22111-Clamping slot; 2212 - Slot arm; 3- Biosensor assembly; 31- Assembly blind hole; 311- Guide hole; 32- Assembly protrusion; 321- Concave stop; 33- Main unit; 34- Sensing electrode; 4- Electrode sealing sleeve; 41- Limiting protrusion; 42- Vertical protrusion; 43- Sealing plug; 44- Screw-in protrusion; 5- Electrode pressure plate; 51- Protruding stop; 52- Ear-shaped snap finger; 53- Limiting post; 6- Guide pin; 61- Undercut groove. Detailed Implementation

[0062] 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.

[0063] 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.

[0064] 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."

[0065] 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.

[0066] To reduce false triggering of invasive bio-information monitoring devices and improve their reliability, this application discloses a highly reliable invasive bio-information monitoring device. Please refer to Figure 1, which shows a highly reliable invasive bio-information monitoring device disclosed in this embodiment, including an upper shell 1, a bottom shell 2, and a sliding seat 11.

[0067] The upper shell 1 and the bottom shell 2 are connected by threads; the sliding seat 11 is inserted into the space formed by the upper shell 1 and the bottom shell 2.

[0068] Please refer to Figures 1 to 9. The inner side of the bottom shell 2 has a second locking arc-shaped protrusion 21, and the outer side of the sliding seat 11 has a first locking arc-shaped protrusion 111.

[0069] Please refer to Figure 3. In the locked state, the upper shell 1 and the bottom shell 2 are connected by threads, and the first locking arc-shaped protrusion 111 is stuck at the bottom of the second locking arc-shaped protrusion 21.

[0070] Please refer to Figure 4. In the unlocked state, the bottom shell 2 is rotated open relative to the upper shell 1, and the first locking arc-shaped protrusion 111 is rotated out from the bottom of the second locking arc-shaped protrusion 21.

[0071] In this embodiment, a biosensor assembly 3 is also included. An electrode sealing sleeve 4 is snapped into the lower part of the biosensor assembly 3, and the lower part of the electrode sealing sleeve 4 is snapped into the inside of the bottom shell 2.

[0072] When unlocked, the bottom shell 2 causes the electrode sealing sleeve 4 to rotate out from the bottom of the biosensor assembly 3.

[0073] Please refer to Figures 10 and 11. The upper shell 1 and the lower shell 2 are connected by threads. The thread helix angle is greater than 0° and less than or equal to 45°. Optionally, the thread helix angle can be 10°, 30°, or 45°. In this embodiment, the thread helix angle is 10°. The axial working distance of the thread structure is greater than or equal to the distance at which the electrode sealing sleeve 4 is inserted into the biosensor assembly 3. Optionally, the axial working distance of the thread structure is equal to the distance at which the electrode sealing sleeve 4 is inserted into the biosensor assembly 3. When the user fixes the upper shell 1 and rotates the lower shell 2 relative to it, when the upper shell 1 and the lower shell 2 are separated, the electrode sealing sleeve 4 and the biosensor assembly 3 are also in a separated state. The biosensor assembly 3 is also in a state that can be implanted into the human body, which improves the reliability of the product.

[0074] Please refer to Figure 5. The biosensor assembly 3 also includes a host 33 and sensing electrodes 34. Some of the sensing electrodes 34 are inserted into the host 33, and some of the sensing electrodes 34 extend out of the lower part of the host 33 and enter the electrode sealing sleeve 4. The biosensor assembly 3 is integrated, which avoids the problem of over-assembly or under-assembly of the sensing electrodes and the main control circuit board / or the host that carries the main control circuit board, thus improving the stability and reliability of the overall product.

[0075] It also includes a fixing seat 12; the fixing seat 12 is inserted into the sliding seat 11; the lower part of the fixing seat 12 is provided with a fixing groove 121, and the upper part of the biosensor assembly 3 is inserted into the fixing groove 121.

[0076] Please refer to Figure 15. Three cantilever hook beams 1211 extend downward from the outer periphery of the lower part of the fixed base 12, and each cantilever hook beam 1211 extends inward from the locking block 1212.

[0077] During assembly before leaving the factory, at least one cantilever hook beam 1211 is pulled outward toward the fixing groove 121, so that the area of ​​the lower part of the fixing groove 121 is larger than the area of ​​the upper part, and the biosensor assembly 3 extends into the lower part of the fixing groove 121 and enters the bottom of the fixing groove 121; at least one cantilever hook beam 1211 is released, at least one cantilever hook beam 1211 springs back and fixes the periphery of the biosensor assembly 3, and the locking block 1212 abuts against the bottom of the biosensor assembly 3;

[0078] In the locked state, the upper part of the biosensor assembly 3 is locked at the bottom of the fixing groove 121, at least one cantilever hook beam 1211 fixes the periphery of the biosensor assembly 3, and the locking block 1212 abuts against the bottom of the biosensor assembly 3.

[0079] During implantation, the biosensor assembly 3 disengages from the fixation slot 121 and the cantilever hook beam 1211 to complete the implantation action.

[0080] The cantilever hook beam 1211 and the locking block 1212 fix the biosensor assembly 3 in the fixing groove 121. During transportation, on the shelf, and in storage, the biosensor assembly 3 can still be stably fixed in the fixing seat 12. When implanted, the bottom shell 2 is rotated. When the bottom shell 2 drives the electrode sealing sleeve 4 to rotate out from the bottom of the biosensor assembly 3, since the fixing seat 12 is fixed inside the upper shell 1, the biosensor assembly 3 can be in a stationary state relative to the fixing seat 12, so that the electrode sealing sleeve 4 can be detached from the bottom of the biosensor assembly 3, which improves the reliability of the product.

[0081] During pre-shipment assembly, the cantilever hook beam 1211 can be pulled to insert the biosensor assembly 3 into the fixing slot 121, which facilitates product assembly and improves production efficiency.

[0082] Please refer to Figures 12 and 13. The bottom of the inner shell 2 extends upward to form a sealing sleeve seat 22, and the lower part of the electrode sealing sleeve 4 is engaged with the sealing sleeve seat 22.

[0083] The first step before implantation after leaving the factory is to unlock the device: the bottom shell 2 rotates the sealing sleeve holder 22, and the sealing sleeve holder 22 rotates the electrode sealing sleeve 4 out from the bottom of the biosensor assembly 3.

[0084] The lower part of the electrode sealing sleeve 4 is engaged with the sealing sleeve holder 22 as follows: the sealing sleeve holder 22 includes a support post 221; the bottom of the electrode sealing sleeve 4 is supported on the upper surface of the support post 221.

[0085] Two bayonet arms 2211 extend from the upper sides of the support column 221. The two bayonet arms 2211 are arranged opposite to each other, and each bayonet arm 2211 is provided with a bayonet 22111. Two limiting protrusions 41 extend from the outer periphery of the electrode sealing sleeve 4. The two limiting protrusions 41 are arranged opposite to each other and are respectively locked in the two bayonet 22111.

[0086] Two slot arms 2212 extend from the upper sides of the support column 221, and two vertical protrusions 42 extend from the outer periphery of the electrode sealing sleeve 4, which are respectively locked in the two slot arms 2212.

[0087] Two slot arms 2212 and two latch arms 2211 are spaced apart. These arms are arranged in a circumferential array on the outer periphery of the electrode sealing sleeve 4. The lines connecting the two slot arms 2212 and the two latch arms 2211 form a 180° angle, and the slot arm 2212 forms a 90° angle with the adjacent latch arm 2211. Positioned on the outer periphery of the bottom of the electrode sealing sleeve 4, the two slot arms 2212 and the two latch arms 2211 enhance the stability of the connection between the electrode sealing sleeve 4 and the support column 221, ensuring a more secure fit of the electrode sealing sleeve 4 to the upper part of the support column 221. During pre-implantation assembly, rotating the bottom shell 2 relative to the upper shell 1 rotates the bottom shell 2, causing the support column 221 to rotate, which in turn rotates the electrode sealing sleeve 4, disengaging the electrode sealing sleeve 4 from the biosensor assembly 3 and facilitating correct assembly of the product before implantation.

[0088] Please refer to Figure 19. A sealing plug 43 is provided at the bottom of the electrode sealing sleeve 4. The sealing plug 43 is placed on the upper surface of the support column 221 and connects the electrode sealing sleeve 4 and the support column 221 through the sealing plug 43. The sealing plug 43 provides freedom for the assembly of the electrode sealing sleeve 4 and provides a certain error range for the assembly of the electrode sealing sleeve 4 and the biosensor assembly 3, reducing the occurrence of over-assembly or improper assembly of the electrode sealing sleeve 4.

[0089] The support column 221 provides an upward thrust to the electrode sealing sleeve 4 and the biosensor assembly 3, making the connection between the electrode sealing sleeve 4 and the biosensor assembly 3 tighter, improving the overall airtightness of the biosensor assembly 3 and enhancing the reliability of the product; at the same time, it makes the connection between the biosensor assembly 3 and the fixing base 12 tighter, improving the stability and reliability of the product assembly.

[0090] The sealing sleeve holder 22 is connected to the bottom shell 2 by screws; the outer periphery of the bottom of the support column 221 extends outward with a fixing piece, which is provided with multiple screw holes arranged in a circumferential array. The bottom shell 2 is provided with an arc-shaped channel, and the arc-shaped channel and the screw holes are connected by multiple self-tapping screws, which improves the connection stability between the sealing sleeve holder 22 and the bottom shell 2.

[0091] The specific assembly process for products before shipment is as follows:

[0092] The first step is the assembly of biosensor component 3:

[0093] Assembly of sensing electrode 34 with host 33: Sensing electrode 34 is fixed to host 33 by electrode pressure plate 5. Part of sensing electrode 34 is inserted into host 33 and part of sensing electrode 34 protrudes from the bottom of host 33. Please refer to Figure 16.

[0094] The guide pin 6 is assembled with the host 33: the guide pin 6 passes through the guide hole 311 and is inserted into the host 33, with part of the guide pin 6 protruding from the bottom of the host 33; part of the sensing electrode 34 enters the lower end of the guide pin 6 through the guide hole 311.

[0095] Electrode sealing sleeve 4 is assembled with the main unit: the sealing plug 43 is inserted into the bottom of the electrode sealing sleeve 4, and the upper part of the electrode sealing sleeve 4 is engaged in the assembly blind hole 31.

[0096] Assembly of main unit 33: The main control circuit board is connected to the battery. The main control circuit board and the battery are inserted into the main unit 33. The sensing electrode 34 is inserted into the electrode clamping structure. The sensing electrode 34 is electrically connected to the main control circuit board through the electrode clamping structure. An adhesive is attached to the bottom of the main unit. The adhesive is used to contact the human skin during implantation.

[0097] The second step is the assembly of the needle assist device:

[0098] Assembly of the fixing seat 12 with the needle-carrying component: The needle-carrying component and the spring are inserted into the upper part of the fixing seat 12. The spring is located inside the needle-carrying component, with the top of the spring pressing against the top of the inside of the needle-carrying component and the lower part of the spring abutting against the upper surface of the fixing seat 12.

[0099] Assembly of fixed seat 12 and sliding seat 11: Fixed seat 12 is sleeved inside sliding seat 11, and sliding seat 11 is slidably disposed relative to fixed seat 12;

[0100] Assembly of the mounting base 12 and the biosensor assembly 3: Pull out the cantilever hook beam 1211 and push the biosensor assembly 3 upward toward the mounting base 12 so that the host 33 is snapped into the mounting groove 121;

[0101] The fixed seat 12 and the sliding seat 11 are assembled with the upper shell 1: the upper part of the fixed seat 12 extends out a snap-fit ​​arm, the snap-fit ​​arm extends outward with a hook post, the upper shell 1 is provided with a snap-fit ​​arm, the hook post is snapped with the snap-fit ​​on the snap-fit ​​arm, so that the fixed seat 12 is fixed inside the upper shell 1, the sliding seat 11 is sleeved inside the upper shell 1, and the sliding seat 11 is slidably disposed inside the upper shell 1.

[0102] The third step is the assembly of the main housing:

[0103] Assembly of upper shell 1 and bottom shell 2: A first sealing ring is fitted on the outer periphery of the lower part of the upper shell 1, the upper shell 1 and the bottom shell 2 are rotatably connected, and the sliding seat 11 and the bottom shell 2 are connected by the locking structure 01.

[0104] Assembly of the bottom shell 2 and the sealing sleeve holder 22: The sealing sleeve holder 22 is fixed to the bottom of the bottom shell 2 by connecting the screw groove and the arc-shaped channel with self-tapping screws. The bottom of the bottom shell 2 is provided with a bearing post through hole, which is located inside the arc-shaped channel. A sealing ring groove is provided between the bearing post through hole and the arc-shaped channel. A second sealing ring is held in the sealing ring groove. The bearing post 221 passes through the bearing post through hole and enters the lower part of the bottom shell 2 to engage with the electrode sealing sleeve 4. The fixing plate and the bottom of the outside of the bottom shell 2 are further sealed with stickers.

[0105] The above is the assembly process before the product leaves the factory.

[0106] During assembly before leaving the factory, the bottom shell 2 and the upper shell 1 are rotatably connected. If the sealing sleeve holder 22 and the bottom shell 2 are integrated, the relative positions of the sealing sleeve holder 22 and the bottom shell 2 cannot be determined. In this application, the sealing sleeve holder 22 and the bottom shell 2 are set separately. After the bottom shell 2 is rotatably connected to the upper shell 1, it is connected by alignment of the annular array screw holes and the arc-shaped channel and self-tapping screws, so that the sealing sleeve holder 22 is assembled inside the bottom shell 2, which can ensure the freedom of assembly.

[0107] The bottom of the biosensor assembly 3 is provided with an assembly blind hole 31, and an assembly protrusion 32 extends from the bottom of the assembly blind hole 31. The upper part of the electrode sealing sleeve 4 is engaged inside the assembly blind hole 31, and the assembly protrusion 32 is engaged inside the electrode sealing sleeve 4.

[0108] It also includes electrode pressure plate 5, please refer to Figure 20;

[0109] The mounting protrusion 32 is provided with a recessed stop 321, and the upper part of the electrode pressure plate 5 is provided with a protruding stop 51. The protruding stop 51 is engaged with the recessed stop 321, and the electrode pressure plate 5 is engaged with the lower part of the mounting protrusion 32. Please refer to Figure 17.

[0110] It also includes the guide pin 6;

[0111] The partial penetration of the blind hole 31 becomes the guide hole 311, and the guide pin 6 is inserted into the guide hole 311;

[0112] Please refer to Figure 18. The lower part of the guide pin 6 is provided with a buckle groove 61, and part of the edge of the electrode pressure plate 5 protrudes from the edge of the mounting protrusion 32 to form an ear-shaped buckle finger 52.

[0113] Two screw-in protrusions 44 are provided on the inner side of the electrode sealing sleeve 4;

[0114] Before leaving the factory, one screw-in protrusion 44 is engaged with the ear-shaped buckle finger 52, and the other screw-in protrusion 44 is engaged with the undercut groove 61;

[0115] During pre-implantation assembly, rotate the electrode sealing sleeve 4, one screw-in protrusion 44 is screwed out from the ear-shaped buckle 52, and the other screw-in protrusion 44 is screwed out from the inverted groove 61.

[0116] The ear-shaped buckle 52 extends upwards to limit the locking post 53;

[0117] Before leaving the factory, screw in the locking protrusion 44 to abut the limiting locking post 53;

[0118] During the pre-implantation assembly, screw in the card protrusion 44 and screw out the limiting card post 53.

[0119] The engagement of the ear-shaped buckle 52, the inverted groove 61 and the screw-in protrusion 44 allows the electrode sealing sleeve 4 to be fixed to the lower part of the main unit 33; the engagement of the inverted groove 61 and the screw-in protrusion 44 allows the guide pin 6 to be fixed at the guide hole 311.

[0120] When the assembly is completed at the factory, the part of the guide needle 6 and part of the sensing electrode 34 to be implanted into the human body are in the electrode sealing sleeve 4, in a sealed and sterile stable state.

[0121] During the pre-implantation assembly, the electrode sealing sleeve 4 peels off the guide needle 6 and sensing electrode 34 to be implanted into the human body. Before the pre-implantation assembly stage, the sensing electrode 34 is in a nearly sterile storage environment and is in a sterile state, which improves the safety of the sensing electrode 34 when it is implanted into the human body.

[0122] The limiting pin 53 is used to limit the distance and direction of the screw-in protrusion 44 into the ear-shaped buckle 52 and the undercut groove 61, thereby improving the stability of the electrode sealing sleeve 4 fixed to the lower part of the host 33 and facilitating the assembly of the electrode sealing sleeve 4.

[0123] The angle between the lower surface of the first locking arc-shaped protrusion 111 and the horizontal plane is α, please refer to Figures 14 and 21, 0° < α ≤ 30°, α can be 5°, 15° or 30°; the angle between the lower surface of the second locking arc-shaped protrusion 21 and the horizontal plane is β, please refer to Figures 10 and 22, 0° < β ≤ 30°, β can be 5°, 15° or 30°; in this embodiment, α and β are both 10°; α and β cause the bottom shell 2 to rotate relative to the sliding seat 11, resulting in a downward displacement, thereby twisting the electrode sealing sleeve 4 off the bottom of the biosensor assembly 3.

[0124] Specifically, the angle between the lower surface of the first locking arc-shaped protrusion 111 and the horizontal plane is α, the angle between the lower surface of the second locking arc-shaped protrusion 21 and the horizontal plane is β, and the angle of the helix angle of the thread between the upper shell 1 and the bottom shell 2 is consistent, so that when the bottom shell 2 is rotated relative to the upper shell 1, the first locking arc-shaped protrusion 111 and the second locking arc-shaped protrusion 21 can be smoothly rotated apart to complete the unlocking action.

[0125] One end of the first locking arc-shaped protrusion 111 is provided with a first chamfer 1111, and one end of the second locking arc-shaped protrusion 21 is provided with a second chamfer 211;

[0126] In the locked state, the second chamfer 211 engages with the upper part of the other end of the first locking arc-shaped protrusion 111;

[0127] The first step before implantation after leaving the factory is to unlock the device: the second locking arc-shaped protrusion 21 slides along the upper surface of the first locking arc-shaped protrusion 111; the second locking arc-shaped protrusion 21 disengages from the upper surface of the first locking arc-shaped protrusion 111, so that the first chamfer 1111 and the second chamfer 211 engage; the second chamfer 211 slides along the first chamfer 1111 until the first chamfer 1111 and the second chamfer 211 separate, and the second locking arc-shaped protrusion 21 separates from the first locking arc-shaped protrusion 111.

[0128] The first chamfer 1111 and the second chamfer 211 make the assembly of the first locking arc-shaped protrusion 111 and the second locking arc-shaped protrusion 21 smoother; during pre-shipment assembly, the first chamfer 1111 and the second chamfer 211 make the second locking arc-shaped protrusion 21 more smoothly assembled on the upper surface of the first locking arc-shaped protrusion 111; during pre-implantation assembly, the first chamfer 1111 and the second chamfer 211 make the second locking arc-shaped protrusion 21 more smoothly slide out from the upper surface of the first locking arc-shaped protrusion 111; the first chamfer 1111 and the second chamfer 211, together with α and β, can limit the direction and distance of relative rotation of the first locking arc-shaped protrusion 111 and the second locking arc-shaped protrusion 21, making the assembly more precise and accurate, and improving the overall reliability of the product.

[0129] A locking structure 01 is provided at the connection between the sliding base 11 and the bottom shell 2. During implantation, the bottom shell 2 adheres to the skin surface and rotates relative to the sliding base 11. The bottom shell 2 can move along the locking structure 01, allowing the internal separation / fitting of the locking structure 01 to switch between the locked state and the separated state between the sliding base 11 and the bottom shell 2. During the product transportation stage after factory assembly, the locking structure 01 can fix the sliding base 11 between the bottom shell 2 and the upper shell, preventing the sliding base 11 from falling off due to external collisions or vibrations and being accidentally triggered. This allows the biosensor component 3 to enter the emission implantation state before the user implants it, improving the reliability of the product during implantation and extending the product's shelf life.

[0130] Through the cooperation of the locking structure 01 and the sealing sleeve holder 22 inside the bottom shell 2, during the assembly before implantation, the sealing sleeve holder 22 can synchronously twist the electrode sealing sleeve 4 when the upper shell and the bottom shell 2 rotate relative to each other, so that the electrode sealing sleeve 4 is detached from the biosensor assembly 3; the continuous rotation of the bottom shell 2 causes the internal separation of the locking structure 01, the bottom shell 2 is detached from the upper shell, and the sensing electrode 34 and the guide needle 6 are exposed through the electrode sealing sleeve 4 in a state that is ready for implantation into human skin; the cooperation of the locking structure 01 and the bottom shell 2 ensures that the sensing electrode 34 and the guide needle 6 are in a stable and sterile state before implantation, improving the safety and reliability of the product before implantation into the human body; by calculating the distance that the bottom shell 2 moves through the locking structure 01, the direction and distance of twisting the electrode sealing sleeve 4 can be precisely controlled, improving the accuracy of assembly.

[0131] 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.

[0132] 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.

[0133] Those skilled in the art will understand that, without conflict, the above-mentioned preferred solutions can be freely combined and superimposed.

[0134] 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 reliable invasive bioinformatics monitoring device, comprising an upper shell (1), a bottom shell (2), and a sliding base (11); characterized in that, The upper shell (1) and the bottom shell (2) are connected by threads; the sliding seat (11) is inserted into the space formed by the upper shell (1) and the bottom shell (2); The bottom shell (2) has a second locking arc-shaped protrusion (21) on its inner side, and the sliding seat (11) has a first locking arc-shaped protrusion (111) on its outer side. In the locked state, the upper shell (1) and the bottom shell (2) are connected by threads, and the first locking arc-shaped protrusion (111) is locked at the bottom of the second locking arc-shaped protrusion (21); When in the unlocked state, the bottom shell (2) is rotated open relative to the top shell (1), and the first locking arc-shaped protrusion (111) is rotated out from the bottom of the second locking arc-shaped protrusion (21); The lower surface of the first locking arc-shaped protrusion (111) has an angle with the horizontal plane, and the lower surface of the second locking arc-shaped protrusion (21) has an angle with the horizontal plane, so that the sliding seat (11) switches between a fixed state and an unlocked state as the upper shell (1) and the bottom shell (2) are separated.

2. The high-reliability invasive bio-information monitoring device as described in claim 1, characterized in that, The angle between the lower surface of the first locking arc-shaped protrusion (111) and the horizontal plane is α, where 0° < α ≤ 30°.

3. The high-reliability invasive bioinformatics monitoring device as described in claim 2, characterized in that, The angle between the lower surface of the second locking arc-shaped protrusion (21) and the horizontal plane is β, where 0° < β ≤ 30°.

4. The high-reliability invasive bio-information monitoring device as described in claim 3, characterized in that, One end of the first locking arc-shaped protrusion (111) is provided with a first chamfer (1111), and one end of the second locking arc-shaped protrusion (21) is provided with a second chamfer (211). In the locked state, the second chamfer (211) engages with the upper part of the other end of the first locking arc-shaped protrusion (111); The first step before implantation after leaving the factory is to initiate the unlocking process: the second locking arc-shaped protrusion (21) slides along the upper surface of the first locking arc-shaped protrusion (111); the second locking arc-shaped protrusion (21) disengages from the upper surface of the first locking arc-shaped protrusion (111), causing the first chamfer (1111) to engage with the second chamfer (211); the second chamfer (211) slides along the first chamfer (1111) until the first chamfer (1111) and the second chamfer (211) separate, and the second locking arc-shaped protrusion (21) separates from the first locking arc-shaped protrusion (111).

5. The high-reliability invasive bioinformatics monitoring device as described in claim 4, characterized in that, The device also includes a biosensor assembly (3), the lower part of which is fitted with an electrode sealing sleeve (4), the lower part of which is fitted into the interior of the bottom shell (2). When unlocked, the bottom shell (2) causes the electrode sealing sleeve (4) to rotate out from the bottom of the biosensor assembly (3).

6. The high-reliability invasive bio-information monitoring device as described in claim 5, characterized in that, The lower part of the electrode sealing sleeve (4) is engaged with the sealing sleeve holder (22) as follows: the sealing sleeve holder (22) includes a support post (221); the bottom of the electrode sealing sleeve (4) is supported on the upper surface of the support post (221); Two bayonet arms (2211) extend from the upper sides of the support column (221), the two bayonet arms (2211) are arranged opposite to each other, and each bayonet arm (2211) is provided with a bayonet (22111); two limiting protrusions (41) extend from the outer periphery of the electrode sealing sleeve (4), the two limiting protrusions (41) are arranged opposite to each other, and the two limiting protrusions (41) are respectively locked at the two bayonet (22111).

7. The high-reliability invasive bio-information monitoring device as described in claim 6, characterized in that, Two slot arms (2212) extend from the upper sides of the support column (221), and two opposing vertical protrusions (42) extend from the outer periphery of the electrode sealing sleeve (4). The two vertical protrusions (42) are respectively locked in the two slot arms (2212). The two slot arms (2212) and the two bayonet arms (2211) are respectively spaced apart.

8. The high-reliability invasive bio-information monitoring device as described in claim 7, characterized in that, The bottom of the electrode sealing sleeve (4) is provided with a sealing plug (43); the sealing plug (43) is placed on the upper surface of the support column (221).

9. The high-reliability invasive bioinformatics monitoring device as described in claim 8, characterized in that, The biosensor assembly (3) has an assembly blind hole (31) at its bottom, and an assembly protrusion (32) extends from the bottom of the assembly blind hole (31). The upper part of the electrode sealing sleeve (4) is engaged inside the assembly blind hole (31), and the assembly protrusion (32) is engaged inside the electrode sealing sleeve (4).

10. The high-reliability invasive bioinformatics monitoring device as described in claim 9, characterized in that, It also includes an electrode pressure plate (5); The assembly protrusion (32) is provided with a concave stop (321), and the upper part of the electrode pressure plate (5) is provided with a convex stop (51). The convex stop (51) is engaged with the concave stop (321), and the electrode pressure plate (5) is engaged with the lower part of the assembly protrusion (32).

11. The high-reliability invasive bio-information monitoring device as described in claim 10, characterized in that, It also includes a guide pin (6); The partial penetration of the assembly blind hole (31) becomes a guide hole (311), and the guide pin (6) is inserted into the guide hole (311); The lower part of the guide pin (6) is provided with a buckle groove (61), and part of the edge of the electrode pressure plate (5) protrudes from the edge of the mounting protrusion (32) to form an ear-shaped buckle finger (52). The inner side of the electrode sealing sleeve (4) is provided with two screw-in protrusions (44); Before leaving the factory, one of the screw-in protrusions (44) is engaged with the ear-shaped buckle (52), and the other screw-in protrusion (44) is engaged with the undercut groove (61); During pre-implantation assembly, the electrode sealing sleeve (4) is rotated, and one of the screw-in protrusions (44) is screwed out from the ear-shaped buckle (52), while the other screw-in protrusion (44) is screwed out from the undercut groove (61).

12. The high-reliability invasive bio-information monitoring device as described in claim 11, characterized in that, The ear-shaped buckle (52) extends upwards to limit the locking post (53); Before leaving the factory, the screw-in protrusion (44) abuts against the limiting post (53); During pre-implantation assembly, the screw-in protrusion (44) is screwed out of the limiting post (53).

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