Invasive biosensor assembly and bioinformation monitoring apparatus

Abstract

Provided is an invasive biosensor assembly, which comprises a biological electrode (1), a protective cover (2), and a guide needle (3). An annular body (11) and a sensing segment (13) of the biological electrode (1) are integrally arranged, the annular body (11) is pressed between the protective cover (2) and the guide needle (3), and the protective cover (2) is detachably arranged at the lower portion of the guide needle (3). The biological electrode (1) is provided with a first guide needle via hole (12), and the guide needle (3) passes through the first guide needle via hole (12) and extends into the protective cover (2). The sensing segment (13) of the biological electrode (1) is contained in a lower half needle groove (33) of the guide needle (3), and when the guide needle (3) is inserted downwards, the sensing segment (13) is driven to change from a straight state to a downwards extending state. The sensing segment (13) of the biological electrode (1) is located in a sealed cavity formed by the protective cover (2) and the guide needle (3). The biosensor assembly can be quickly produced and quickly replaced, thereby reducing the use cost of consumers.

Description

An invasive biosensor assembly and a bioinformatics monitoring device Technical Field

[0001] This disclosure relates to the field of bioinformatics monitoring technology, and in particular to an invasive biosensor assembly and a bioinformatics monitoring device. Background Technology

[0002] For people with diabetes, traditional finger-prick blood glucose meters have drawbacks such as being invasive, providing limited information, and failing to reflect blood glucose fluctuations or provide early warnings. They no longer meet the needs of some individuals, especially type 1 diabetes patients who require real-time transmission of blood glucose fluctuations and type 2 diabetes patients requiring intensive insulin therapy. Due to the need for continuous blood glucose monitoring, a bioinformatics monitoring device is needed, where a guide needle is implanted under the skin to measure blood glucose concentration in the tissue fluid. This is a practical and continuous monitoring method with a single lifespan of one to two weeks, significantly reducing the pain associated with continuous finger-prick and venous blood sampling. Summary of the Invention

[0003] The main objective of this disclosure is to provide an invasive biosensor assembly and a bioinformatics monitoring device, aiming to solve the technical problem of time-consuming and labor-intensive assembly when producing bioinformatics monitoring devices of different specifications and models.

[0004] To achieve the above objectives, in a first aspect, this disclosure provides an invasive biosensor assembly, comprising:

[0005] Bioelectrodes, protective shields, and guide needles;

[0006] The annular body of the bioelectrode is connected to the sensing segment, and the annular body is pressed between the protective cover and the guide needle.

[0007] The protective cover is detachably disposed at the lower part of the guide needle. The bioelectrode is provided with a first guide needle through hole. The guide needle passes through the first guide needle through hole and extends into the protective cover. The sensing section of the bioelectrode is contained in the groove-shaped needle of the lower half of the guide needle. When the guide needle is inserted downward for assembly, it drives the sensing section from a straight state to a downward extending state. The sensing section of the bioelectrode is located in the sealed cavity formed by the protective cover and the guide needle.

[0008] In some embodiments, the annular body includes a sealing ring, an inner ring structure, and an outer ring structure. The sealing ring is disposed between the inner ring structure and the outer ring structure, and the sealing ring is connected to both the inner ring structure and the outer ring structure. The inner ring structure is connected to at least one sensing segment.

[0009] The inner ring structure is located within the sealed cavity formed by the protective cover and the guide pin.

[0010] In some embodiments, the sensing segment is configured as a single electrode, and the sensing segment includes one of a working electrode, a counter electrode, and a reference electrode; or, the sensing segment is configured as a composite electrode, and the sensing segment includes two or more of a working electrode, a counter electrode, and a reference electrode.

[0011] The sensing segment of each invasive biosensor assembly contains three types of electrodes: working electrode, counter electrode, and reference electrode.

[0012] In some embodiments, at least one surface of the outer ring structure is provided with a signal output electrode contact, which is used to form an electrical connection with an external component; the signal output electrode contact includes a working electrode contact, a counter electrode contact, and a reference electrode contact; the working electrode contact, the counter electrode contact, and the reference electrode contact are respectively connected to the working electrode, the counter electrode, and the reference electrode.

[0013] In some embodiments, the annular body is pressed between the protective cover and the guide pin as follows: a first sealing gasket is provided on the upper part of the protective cover, and a second sealing gasket is provided on the middle part of the guide pin. The first sealing gasket abuts against the bottom of the sealing ring body, and the second sealing gasket abuts against the top of the sealing ring body. The first sealing gasket and the second sealing gasket press the sealing ring body between the first sealing gasket and the second sealing gasket.

[0014] In some embodiments, the centers of the first sealing gasket and the second sealing gasket are located on the same longitudinal axis; the first sealing gasket and the second sealing gasket respectively press against 80% to 100% of the longitudinal projection area of ​​the sealing ring body.

[0015] In some embodiments, the annular body is pressed between the protective cover and the guide pin as follows: the upper part of the protective cover abuts against the bottom of the sealing ring body, the middle part of the guide pin abuts against the top of the sealing ring body, and the upper part of the protective cover and the middle part of the guide pin press the sealing ring body between the protective cover and the guide pin.

[0016] In some embodiments, the annular body of the bioelectrode is an integral structure, and the sealing ring is generally flat and continuous.

[0017] In some embodiments, the sensing segment and the inner ring structure are integrated as one unit, or the sensing segment and the inner ring structure are assembled as a unit.

[0018] In some embodiments, a positioning protrusion is provided in the middle of the guide pin, and the positioning protrusion is inserted into the first guide pin through hole;

[0019] The side wall of the positioning protrusion is provided with a guide groove, which penetrates the side wall and bottom of the positioning protrusion. The grooved needle portion of the guide pin passes through the guide groove and enters the protective cover. The sensing segment enters the protective cover along with the grooved needle of the guide pin.

[0020] In a second aspect, this disclosure provides a bio-information monitoring device, including the invasive biosensor assembly disclosed in the first aspect above. The bio-information monitoring device further includes a flexible circuit board attached to the bioelectrode, and the flexible circuit board is electrically connected to the bioelectrode through a first pad group.

[0021] The bio-information monitoring device also includes a flexible battery attached to the flexible circuit board, and the flexible circuit board is electrically connected to the flexible battery through a second set of pads.

[0022] The flexible battery on the flexible circuit board is provided with a third guide pin through hole and a third guide pin through hole for inserting a guide pin. The guide pin passes through the first guide pin through hole, the third guide pin through hole and the third guide pin through hole.

[0023] In the technical solution provided in this disclosure, the sensing section of the bioelectrode is sealed within the enclosed space formed by the cooperation of the guide needle and the protective cover during the production process. The guide needle, the protective cover, and the bioelectrode form a standard component (the smallest sterilization unit). The standard component only needs to be assembled and produced in a GMP workshop. Subsequent processes, such as attaching flexible circuit boards with openings corresponding to the guide needle and bioelectrode, flexible batteries, and other accessories, can be carried out in a general cleanroom environment. This allows for the rapid manufacture of corresponding models of bioinformation monitoring devices (such as blood glucose meters), meeting the requirements for rapid production and rapid replacement of biosensor components, reducing production costs, and lowering the cost of use for consumers. Attached Figure Description

[0024] One or more embodiments are illustrated by way of example with reference to the accompanying drawings. These illustrations do not constitute a limitation on the embodiments. Elements having the same reference numerals in the drawings are denoted as similar elements. Unless otherwise stated, the figures in the drawings are not to be limited by scale.

[0025] Figure 1 is a schematic diagram of the exploded structure of an embodiment of the invasive biosensor assembly disclosed herein;

[0026] Figure 2 is a schematic diagram of the bioelectrode structure of an embodiment of the invasive biosensor assembly disclosed herein;

[0027] Figure 3 is a schematic diagram of the bioelectrode from another angle of one embodiment of the invasive biosensor assembly of this disclosure;

[0028] Figure 4 is a schematic diagram of the guide pin of an embodiment of the invasive biosensor assembly disclosed herein;

[0029] Figure 5 is a schematic diagram of the assembled structure of the guide needle and bioelectrode of one embodiment of the invasive biosensor assembly of this disclosure.

[0030] Figure 6 is a schematic diagram of the overall structure of one embodiment of the invasive biosensor assembly disclosed herein;

[0031] Figure 7 is a second schematic diagram of the overall structure of an embodiment of the invasive biosensor assembly disclosed herein;

[0032] Figure 8 is a schematic diagram of the guide pin from another angle of one embodiment of the invasive biosensor assembly disclosed herein;

[0033] Figure 9 is a schematic diagram of the structure of the protective cover of an embodiment of the invasive biosensor assembly disclosed herein;

[0034] Figure 10 is a cross-sectional schematic diagram of an embodiment of the invasive biosensor assembly disclosed herein;

[0035] Figure 11 is a cross-sectional schematic diagram of an embodiment of the bioinformatics monitoring device disclosed herein;

[0036] Figure 12 is an exploded view of the structure of an embodiment of the bio-information monitoring device of this disclosure;

[0037] Figure 13 is a schematic diagram of the bioelectrode structure of an embodiment of the invasive biosensor assembly disclosed herein;

[0038] Figure 14 is a schematic diagram of the bioelectrode structure of another embodiment of the invasive biosensor assembly disclosed herein;

[0039] Figure 15 is a schematic diagram of the bioelectrode structure of another embodiment of the invasive biosensor assembly disclosed herein;

[0040] Figure 16 is a schematic diagram of the bioelectrode structure of another embodiment of the invasive biosensor assembly disclosed herein;

[0041] Figure 17 is a schematic diagram of the bioelectrode structure of another embodiment of the invasive biosensor assembly disclosed herein.

[0042] In the diagram: 01-Invasive biosensor assembly; 02-Bioinformation monitoring device; 1-Bioelectrode; 11-Annular body; 111-Sealing ring; 112-Inner ring structure; 113-Outer ring structure; 12-First guide pin through hole; 13-Sensing section; 2-Protective cover; 21-First sealing gasket; 22-Second thread; 221-Clamping notch; 222-Arc segment; 3-Guide pin; 31-Second sealing gasket; 32-Positioning protrusion; 321-Guide groove; 322-First thread; 323-Clamping post; 324-Limiting clamping protrusion; 325-Limiting groove; 33-Groove pin; 4-Flexible circuit board; 5-Flexible battery. Detailed Implementation

[0043] To facilitate understanding of this disclosure, a more detailed description is provided below with reference to the accompanying drawings and specific embodiments. It should be noted that when an element is described as being "fixed to" another element, it can be directly on the other element, or one or more intermediate elements may exist between them. When an element is described as being "connected to" another element, it can be directly connected to the other element, or one or more intermediate elements may exist between them. The terms "vertical," "horizontal," "left," "right," "inner," "outer," and similar expressions used in this specification are for illustrative purposes only. In the description of this disclosure, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating relative importance or implying the number of indicated technical features. Thus, unless otherwise stated, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature; "multiple" means two or more. The term "comprising" and any variations thereof mean non-exclusive inclusion, where one or more other features, integers, steps, operations, units, components, and / or combinations thereof may be present or added.

[0044] Furthermore, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly, for example, as a fixed connection, a detachable connection, or an integral connection; a mechanical connection or an electrical connection; a direct connection or an indirect connection through an intermediate medium, or a connection within two components. All technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The terminology used in this disclosure is for the purpose of describing particular embodiments only and is not intended to limit the scope of this disclosure. The term "and / or" as used in this specification includes any and all combinations of one or more of the associated listed items.

[0045] Furthermore, the technical features involved in the different embodiments of this disclosure described below can be combined with each other as long as they do not conflict with each other.

[0046] To adapt to various usage scenarios, blood glucose meters of different specifications need to be manufactured. Other manufacturers in the market generally use the traditional integrated assembly method in the production process, which has high requirements for the production environment and is time-consuming and labor-intensive.

[0047] To achieve the above objectives, please refer to Figures 1-12, where Figure 1 is a schematic diagram of an invasive biosensor assembly provided in this disclosure. Specifically, an invasive biosensor assembly 01 includes:

[0048] Bioelectrode 1, protective cover 2, and guide needle 3;

[0049] The annular body 11 of the bioelectrode 1 is connected to the sensing section 13, and the annular body 11 is pressed between the protective cover 2 and the guide needle 3.

[0050] The protective cover 2 is detachably installed at the lower part of the guide needle 3. The bioelectrode 1 is provided with a first guide needle through hole 12. The guide needle 3 passes through the first guide needle through hole 12 and extends into the protective cover 2. The sensing section 13 of the bioelectrode 1 is contained in the groove-shaped needle 33 of the lower half of the guide needle 3. When the guide needle 3 is inserted downward, it drives the sensing section 13 from a straight state to a downward extending state. The sensing section 13 of the bioelectrode 1 is located in the sealed cavity formed by the protective cover 2 and the guide needle 3.

[0051] The connection between the ring body 11 and the sensing segment 13 can be an integral connection or an assembly connection. The ring body 11 can be connected to at least one sensing segment 13, two sensing segments 13, or multiple sensing segments 13, to meet the needs of various types of detection substances and detection efficiency.

[0052] GMP (Good Manufacturing Practice) workshops are crucial facilities in industries such as pharmaceuticals, food, and cosmetics, ensuring product quality and production process safety. GMP workshops employ stringent air purification and environmental control measures to ensure that the cleanliness, temperature, humidity, pressure differential, and microbial control of the production environment meet specific standards. GMP workshops are classified into different cleanliness levels, such as Class 100, Class 1000, Class 10,000, and Class 100,000, to meet the production needs of various products. In contrast, ordinary cleanrooms do not have such stringent environmental control requirements, and their environmental conditions may be more relaxed to reduce production costs.

[0053] In the technical solution provided in this disclosure, during the production process, the sensing section 13 of the bioelectrode 1 is sealed within the enclosed space formed by the cooperation of the guide pin 3 and the protective cover 2. This allows the guide pin 3, the protective cover 2, and the bioelectrode 1 to form a standard component (the smallest sterilization unit). The standard component only needs to be assembled and produced in a GMP workshop. Subsequent processes, such as attaching flexible circuit boards 4 with openings corresponding to the guide pin 3 and the bioelectrode 1, flexible batteries, and other accessories, can be produced and assembled in a regular cleanroom environment. This allows for the rapid manufacture of corresponding models of bioinformation monitoring devices (such as continuous glucose meters), meeting the requirements for rapid production and rapid replacement of biosensor components, reducing production costs, and lowering the cost of use for consumers.

[0054] In this embodiment, the annular body 11 includes a sealing ring 111, an inner ring structure 112, and an outer ring structure 113. The sealing ring 111 is disposed between the inner ring structure 112 and the outer ring structure 113, and the sealing ring 111 is connected to the inner ring structure 112 and the outer ring structure 113 respectively. The inner ring structure 112 is connected to at least one sensing segment 13.

[0055] The inner ring structure 112 and the sensing section 13 are located in the sealed cavity formed by the protective cover 2 and the guide pin 3. The specific location can be determined according to the size of the positioning protrusion 32 of the guide pin 3 and the diameter of the inner ring structure 112.

[0056] Specifically, the sealing ring 111 is used to press and connect with the first sealing gasket 21 and the second sealing gasket 31, the inner ring structure 112 is used to connect the sensing section 13, and the outer ring structure 113 is used to connect external components.

[0057] In this embodiment, the sealing ring 111 has an annular width of 0.5~2mm; the inner ring structure 112 has a diameter of 3mm~6mm, the inner ring structure 112 is an irregular structure, and the inner ring structure 112 is connected to at least one sensing segment 13.

[0058] In this embodiment, the sensing segment 13 is a long, thin, needle-shaped structure with a width of 0.1mm to 0.4mm, a thickness of 0.05mm to 0.3mm, and a length of 2mm to 7mm. This allows for wider applicability, such as subcutaneous implantation testing and laboratory testing. It also accommodates a wider range of electrode types; for example, a sensing segment 13 with only one electrode type will be shorter, while a sensing segment 13 with two to three electrode types will be longer.

[0059] In this embodiment, the outer diameter of the outer ring structure 113 is 9mm to 40mm. The outer ring structure 113 is an irregular structure, and its shape includes circles, ellipses, racetrack shapes, etc. The size of the outer ring structure 113 is mainly based on the external size of the product, with wearing comfort as the primary consideration. If the size is too large, it is easy to feel foreign objects when wearing it, reducing the wearing experience.

[0060] In this embodiment, the outer ring structure 113 may be provided with connecting contact points, electrodes or slots, etc., for subsequent assembly testing, structural interconnection and electrical interconnection, etc.

[0061] In this embodiment, the inner ring structure 112 can be composed of the inner ring of the ring body 11 and a portion of the ring body 11 near the inner ring, or it can be the inner ring portion; the outer ring structure 113 can be composed of the outer ring of the ring body 11 and a portion of the ring body 11 near the outer ring, or it can be the outer ring portion.

[0062] In this embodiment, the inner ring structure 112 is connected to at least one sensing segment 13. The inner ring structure 112 can be connected to one sensing segment 13, two sensing segments 13, or three or more sensing segments 13. The number of sensing segments 13 and the coating on the surface of the sensing segments 13 can be adjusted according to the biological information to be detected.

[0063] In this embodiment, a sealing plug is embedded in the lower part of the protective cover 2, and a desiccant accessory is provided on the side of the sealing plug facing inward of the protective cover 2. The sealing plug has the function of preventing external moisture from entering the protective cover 2, and also has the function of maintaining the airtight environment inside the protective cover 2, further improving the airtightness and waterproof performance of the protective cover 2. Since the protective cover 2 and the sealing plug cannot completely isolate external moisture, a desiccant accessory is provided inside the sealing plug. The desiccant accessory can absorb the moisture that enters the protective cover 2, further improving the airtightness and waterproof performance.

[0064] Before assembly in the GMP workshop, the bioelectrode 1 is a flat planar type. After assembly with the guide needle 3 and protective cover 2 in the GMP workshop, the annular body 11 of the bioelectrode 1 is closely attached to the second sealing gasket 31 at the bottom of the needle seat of the guide needle 3 and the first sealing gasket 21 at the top of the protective cover 2. The sensing segment 13 of the bioelectrode 1 extends out along the groove needle 33 of the guide needle 3. At the same time, the sensing segment 13 is wrapped in the needle groove, so that the sensing segment 13 can be implanted into the human skin and come into contact with the blood along with the needle groove of the guide needle 3.

[0065] The sensing segment 13 of the bioelectrode 1 can be used to collect biological information in the blood of humans or animals, such as the blood glucose concentration. The surface of the sensing segment 13 can be coated with bio-identification elements corresponding to the target biological information, such as antibodies, enzymes, DNA probes, etc. If it is necessary to detect the blood glucose concentration, glucose oxidase can be used.

[0066] Please refer to Figures 6 and 7. In this embodiment, the annular body 11 is pressed between the protective cover 2 and the guide pin 3 as follows: a first sealing gasket 21 is provided on the upper part of the protective cover 2, and a second sealing gasket 31 is provided on the middle part of the guide pin 3. The first sealing gasket 21 presses against the bottom of the sealing ring body 111, and the second sealing gasket 31 presses against the top of the sealing ring body 111. The first sealing gasket 21 and the second sealing gasket 31 press the sealing ring body 111 between the first sealing gasket 21 and the second sealing gasket 31.

[0067] The first sealing gasket 21 and the second sealing gasket 31 are made of materials that have the function of isolating water vapor and air and also have a certain degree of elasticity, preferably silicone and rubber.

[0068] The sealing ring 111 of the bioelectrode 1 is fixed between the first sealing gasket 21 and the second sealing gasket 31 by the upper and lower compression, making it difficult for the bioelectrode 1 to shift. At the same time, it isolates external air and moisture from entering the sealed space formed by the protective cover 2 and the guide needle 3, further improving the airtightness of the standard part. Meanwhile, since the first sealing gasket 21 and the second sealing gasket 31 have a certain elasticity, when the first sealing gasket 21 and the second sealing gasket 31 are compressed from the upper and lower, they can be combined more fully and better fix the bioelectrode 1, making it difficult for the bioelectrode 1 to shift.

[0069] In this embodiment, the centers of the first sealing gasket 21 and the second sealing gasket 31 are located on the same longitudinal axis; the first sealing gasket 21 and the second sealing gasket 31 respectively press against 80% to 100% of the longitudinal projection area of ​​the sealing ring body 111.

[0070] The longitudinal projection of the first sealing gasket 21 and the second sealing gasket 31 against the sealing ring 111 can be 80% or 100% of the area, with 100% being the preferred option. This ensures that the longitudinal projections of the first sealing gasket 21 and the second sealing gasket 31 completely overlap, resulting in a larger overlap area on the bioelectrode. This further isolates external air and moisture from entering the sealed space formed by the protective cover 2 and the guide needle 3, thus further improving the airtightness of the standard component. The centers of the first sealing gasket 21 and the second sealing gasket 31 are located on the same longitudinal axis. When the first sealing gasket 21 and the second sealing gasket 31 press against each other from above and below, the centers of gravity of the forces exerted by the first sealing gasket 21 and the second sealing gasket 31 on the bioelectrode 1 coincide, further fixing the bioelectrode 1 and making it less prone to displacement.

[0071] In another embodiment, the annular body 11 is pressed between the protective cover 2 and the guide pin 3 as follows: the upper part of the protective cover 2 presses against the bottom of the sealing ring body 111, the middle part of the guide pin 3 presses against the top of the sealing ring body 111, and the upper part of the protective cover 2 and the middle part of the guide pin 3 press the sealing ring body 111 between the protective cover 2 and the guide pin 3.

[0072] If the contact interfaces of the annular body 11, the protective cover 2, and the guide pin 3 with the annular body 11 are relatively flat, the first sealing gasket 21 and the second sealing gasket 31 may not be required.

[0073] In this embodiment, the annular body 11 of the bioelectrode 1 is a one-piece structure, and the sealing ring 111 is generally flat and continuous. The flatness and continuity of the sealing ring 111 means that its surface is smooth and free of unevenness. This generally flat design facilitates the subsequent tight bonding of the sealing ring 111 with the adhesive, flexible circuit board 4, and flexible battery 5, reducing the risk of air bubbles and ensuring the sealing performance of the invasive biosensor assembly 01 and the device. It is worth noting that due to process limitations, the sealing ring 111 cannot actually be 100% flat. The sealing ring 111 does not have any unevenness or slots (non-through holes), as such features might affect the sealing characteristics.

[0074] In this embodiment, the sensing segment 13 and the inner ring structure 112 are integrally formed, or they are assembled. The assembled configuration can be achieved by adhesive bonding. The integral or assembled configuration can be chosen based on production requirements and the size of the sensing segment 13 of the bioelectrode 1.

[0075] In this embodiment, the sensing section 13 is configured as a single electrode, and the sensing section 13 includes one of a working electrode, a counter electrode, and a reference electrode; or, the sensing section 13 is configured as a composite electrode, and the sensing section 13 includes two or more of the working electrode, counter electrode, and reference electrode. Specifically, the sensing section 13 includes a working electrode and a counter electrode, or the sensing section 13 includes a counter electrode and a reference electrode, or the sensing section 13 includes a working electrode and a reference electrode, or the sensing section 13 includes a working electrode, a counter electrode, and a reference electrode.

[0076] The sensing segment 13 in each invasive biosensor assembly includes three types of electrodes: working electrode, counter electrode, and reference electrode.

[0077] At least one surface of the outer ring structure 113 of the bioelectrode 1 is provided with a signal output electrode contact, which is used to form an electrical connection with an external component. The signal output electrode contact includes a working electrode contact, a counter electrode contact, and a reference electrode contact. The signal output electrode contacts are respectively electrically connected to the main control circuit board, which is provided with a signal transmission module and a power supply. The biological information collected by the sensing segment 13 is sent to an external terminal through the main control circuit board. The terminal is responsible for processing and analyzing the collected biological signals to form biological signal data for user reference.

[0078] In this embodiment, a positioning protrusion 32 is provided in the middle of the guide pin 3. The positioning protrusion 32 is inserted into the first guide pin through hole 12. The positioning protrusion 32 can fix the bioelectrode 1 by inserting into the first guide pin through hole 12, so as to prevent the bioelectrode from shifting and causing the sensing segment 13 to leak into the air, which would cause the sensing segment 13 to be contaminated by water vapor in the air, affecting the accuracy of detecting biological signals, and also posing a risk of reducing safety.

[0079] The side wall of the positioning protrusion 32 is provided with a guide groove 321, which penetrates the side wall and bottom of the positioning protrusion 32. The guide pin 3 passes through the guide groove 321 and enters the protective cover 2. The sensing section 13 enters the protective cover 2 along with the guide pin 3. The guide groove 321 is used to accommodate the guide pin 3 and the sensing section 13.

[0080] In this embodiment, the outer periphery of the positioning protrusion 32 is provided with a first thread 322, and the inner top of the protective cover 2 is provided with a second thread 22. The positioning protrusion 32 is connected to the protective cover 2 through the first thread 322 and the second thread 22.

[0081] Please refer to Figures 8 and 9. In this embodiment, one end of the second thread 22 is provided with a notch 221 and an arc segment 222. The peripheral sidewall of the positioning protrusion 32 is provided with a locking post 323 and a limiting locking protrusion 324. The locking post 323 and the limiting locking protrusion 324 are respectively provided on the upper part of the first thread 322. The sidewall of the locking post 323, the sidewall of the limiting locking protrusion 324 and the outer peripheral side of the positioning protrusion 32 form a limiting groove 325.

[0082] When the second thread 22 slides into the first thread 322, the second thread 22 drives the arc segment 222 to slide past the locking post 323 and lock into the limiting groove 325;

[0083] The limiting protrusion 324 abuts against the side wall of the limiting protrusion 324, and the locking post 323 is engaged in the locking notch 221. The side wall of the limiting protrusion 324 and the locking post 323 restrict the longitudinal movement of the arc segment 222.

[0084] When the second thread 22 slides out of the first thread 322, the second thread 22 drives the notch 221 to slide past the pin 323, and the arc segment 222 slides past the limiting groove 325, the pin 323 and the first thread 322 in sequence.

[0085] The combination of the notch 221, the arc segment 222, the locking post 323, and the limiting locking protrusion 324 ensures that the protective cover 2 and the guide pin 3 are not over-assembled (damaging the bioelectrode 1 by tightening the threads too much) or not assembled in place, thus further improving the efficiency of production assembly.

[0086] In this embodiment, the shape and size of the notch 221 are adapted to the notch 323, and the shape and size of the arc segment 222 are adapted to the limiting groove 325.

[0087] In this embodiment, the cross-section of the retaining post 323 is arc-shaped. The arc-shaped retaining post 323 makes it easier for the arc-shaped segment 222 to slide into the limiting groove 325 and for the retaining post 323 to slide into the retaining notch 221, which facilitates the assembly of standard parts and further improves the efficiency of production assembly.

[0088] The engagement of the first thread 322 and the second thread 22 completes the assembly of the guide needle seat of the guide needle 3 and the protective cover 2, while also fixing the sealing ring 111 of the bioelectrode 1, thereby fixing and sealing the sensing section 13 within the protective cover 2. By controlling parameters such as the pitch and lead of the first thread 322 and the second thread 22, it can be ensured that the guide needle 3 and the protective cover 2 can be further precisely fixed during assembly, while also facilitating assembly and further improving production assembly efficiency.

[0089] In this embodiment, one or more sensing segments 13 can be connected to the inner ring structure 112 of the bioelectrode 1. At the same time, multiple grooved needles 33 are provided at the corresponding positions of the guide needle 3. At least one sensing segment 13 is placed in each grooved needle 33. Each sensing segment 13 can be a single electrode or a composite electrode structure. Multiple sensing segments 13 can be implanted under the skin at one time and can be used for multi-parameter monitoring.

[0090] The sensing segment 13 can be a single-electrode structure, that is, it has only one electrode, such as one of the working electrode, reference electrode, and counter electrode; the sensing segment 13 can be a composite electrode, that is, there are two or more electrodes on one sensing segment 13. The types of electrodes can be repeated or not repeated. For example, one sensing segment 13 has a working electrode and a reference electrode, or a working electrode and a counter electrode, or a reference electrode and a counter electrode, or a working electrode, a reference electrode and a counter electrode, or two / more working electrodes, or two / more reference electrodes, or two / more counter electrodes, or two / more working electrodes, reference electrodes and counter electrodes, etc.

[0091] Please refer to Figures 13-17 for the technical solution regarding multiple sensing segments 13. Assume there is a first sensing segment 13, a second sensing segment 13, and a third sensing segment 13. Of course, the number of sensing segments 13 is ≥1. This example is just one embodiment and does not represent the case where there can only be three sensing segments 13.

[0092] The electrode combination on the first sensing segment 13, the second sensing segment 13, and the third sensing segment 13 is as follows:

[0093] The single-electrode combination mode, where each sensing segment 13 has only one electrode, performs only the simplest function, eliminates concerns about cross-contamination and short circuits between electrodes. Therefore, compared to a composite electrode approach for sensing segment 13, it can be made thinner and shorter, such as 0.1~0.25mm wide and 1~4mm long; conventional composite electrodes are typically over 5mm long and around 0.3mm wide. With smaller and shorter sensing segments, the corresponding guide pin 3 is also thinner and shorter, reducing the risks of implantation pain and bleeding.

[0094] First sensing segment 13: Working electrode (WE);

[0095] Second sensing segment 13: Counter electrode (RE);

[0096] Third sensing segment 13: Reference electrode (CE);

[0097] Composite electrode combination mode

[0098] First sensing segment 13: Working electrode (WE), counter electrode (RE), reference electrode (CE);

[0099] Second sensing segment 13: working electrode (WE1), working electrode (WE2).

[0100] Third sensing segment 13: working electrode (WE3), working electrode (WE4).

[0101] Composite electrode + single electrode combination mode

[0102] First sensing segment 13: counter electrode (RE), reference electrode (CE);

[0103] Second sensing segment 13: Working electrode (WE);

[0104] Third sensing segment 13: Working electrode (WE1);

[0105] The improvement of sensing segment 13 enables the device to measure more types of substances with less resources, improves testing functions, and increases manufacturing costs less.

[0106] One sensing segment 13 can be used as an electrode for multiple materials (WE1, WE2, RE, CE), which is equivalent to making four electrodes on the sensing segment 13 of the fine needle, which is quite complex; the modification is also quite complex, as different materials need to be modified on WE1 and WE2; the precision of the process is very high.

[0107] By setting different electrodes on different sensing segments 13 and using different modifying materials, the process complexity is reduced, the process is not crowded, and the difficulty of the process is not increased, while realizing more functions. The process can be reused, and multiple substances can be measured simultaneously.

[0108] Please refer to Figures 13 to 17. The multiple sensing segments 13 can be arranged in an interdigital pattern, a chrysanthemum-like pattern with the tips pointing towards the center, or a comb-like pattern, etc. The arrangement of the multiple sensing segments 13 needs to be used in conjunction with the corresponding implantation guide needle 3 to achieve the implantation action.

[0109] In this embodiment, the protective cover 2 is a single-port structure with a sealed bottom and an open top; or the bottom sealing structure of the protective cover 2 is achieved by assembling a sealing plug, and a drying block structure can be embedded in the sealing plug to control the humidity conditions inside the sealed cavity.

[0110] Secondly, please refer to Figures 1-12, wherein Figure 12 is a schematic diagram of the structure of a bio-information monitoring device 02 provided in this disclosure, specifically: including the invasive biosensor assembly 01 disclosed in the first aspect above, the bio-information monitoring device 02 also includes a flexible circuit board 4 attached to the bioelectrode 1, and the flexible circuit board 4 is electrically connected to the bioelectrode 1 through a first pad group.

[0111] In this embodiment, the bio-information monitoring device 02 also includes a flexible battery 5 attached to a flexible circuit board 4, and the flexible circuit board 4 is electrically connected to the flexible battery 5 through a second pad group.

[0112] The top of the outer ring structure 113 of the bioelectrode 1 is provided with a counter electrode contact, a working electrode contact, and a reference electrode contact. The counter electrode contact, working electrode contact, and reference electrode contact are used to transmit the biosignals collected by the sensing segment 13 to the flexible circuit board 4 (main control circuit board). The bottom of the flexible circuit board 4 is provided with three electrode conductive contacts that are connected to the counter electrode contact, working electrode contact, and reference electrode contact. The counter electrode contact, working electrode contact, and reference electrode contact are electrically connected to the three electrode conductive contacts through conductive adhesive. The counter electrode contact, working electrode contact, reference electrode contact, and the three electrode conductive contacts constitute the first pad group.

[0113] The shape, size, and spacing of the electrode contacts, working electrode contacts, and reference electrode contacts can be flexibly adjusted according to external components and equipment, reducing the thickness of the bioelectrode 1. At the same time, it can quickly manufacture corresponding models of bioinformation monitoring devices 02 (e.g., continuous glucose monitors), meeting the requirements of rapid production and rapid replacement of biosensor components.

[0114] The top of the flexible circuit board 4 is provided with two power conductive contacts, and the bottom of the flexible battery 5 is provided with two circuit board contacts. The two power conductive contacts and the two circuit board contacts correspond one-to-one, and the two power conductive contacts and the two circuit board contacts are electrically connected one-to-one by conductive adhesive. The two power conductive contacts and the two circuit board contacts constitute the second pad group.

[0115] The counter electrode contact, working electrode contact, and reference electrode contact of the bioelectrode 1, the two power conductive contacts at the top and the three electrode conductive contacts at the bottom of the flexible circuit board 4, and the two circuit board contacts at the bottom of the flexible battery 5 are all planar contacts. Planar design is more conducive to contact reliability and ease of use, and at the same time helps to reduce the thickness of the product.

[0116] In this embodiment, the flexible battery 5 on the flexible circuit board 4 is provided with a second guide pin through hole and a third guide pin through hole for the insertion of the guide pin 3. The guide pin 3 passes through the first guide pin through hole 12, the second guide pin through hole and the third guide pin through hole.

[0117] The combination of the first guide pin through hole 12, the second guide pin through hole and the third guide pin through hole makes the assembly of the flexible circuit board 4, the flexible battery 5, the guide pin 3 and the protective cover 2 simpler, and further improves the efficiency of production assembly.

[0118] After the invasive biosensor component 01 in the bioinformatics monitoring device 02 is mass-produced in a GMP workshop, the assembly of other components of the bioinformatics monitoring device 02 can be carried out in a regular cleanroom, further reducing production costs.

[0119] Double-sided adhesive tape can be applied to the upper and lower parts of the bioelectrode 1 by pressing and attaching. The adhesive tape on the lower part of the bioelectrode 1 is for direct contact with human skin, so that the bioelectrode 1 can be firmly fixed on human skin and maintain continuous monitoring.

[0120] The bioelectrode 1 is connected to the flexible circuit board 4 via double-sided adhesive tape. The double-sided adhesive tape can be provided with three circular holes corresponding to the electrode contacts, working electrode contacts, and reference electrode contacts. Conductive adhesive is applied into the three circular holes to form an electrical connection between the bioelectrode 1 and the flexible circuit board 4. Alternatively, the double-sided adhesive tape can be a conductive adhesive, which has both conductive and adhesive properties, thus forming an electrical connection between the bioelectrode 1 and the flexible circuit board 4.

[0121] The top of the flexible circuit board 4 is also provided with double-sided adhesive tape, which is used to stick the flexible circuit board 4 and the flexible battery 5. The double-sided adhesive tape has two through holes, which can be filled with conductive adhesive so that the two power conductive contacts on the top of the flexible circuit board 4 and the two circuit board contacts on the bottom of the flexible battery 5 can form an electrical connection respectively.

[0122] The flexible battery 5 is then sealed with an external adhesive through a pressing process, so that the flexible battery 5 and the external adhesive wrap the annular body 11 of the flexible circuit board 4 and the bioelectrode 1. The manufacturing process is simple and the manufacturing efficiency is high.

[0123] The above embodiments are only used to illustrate the technical solutions of this disclosure, and are not intended to limit it. Under the concept of this disclosure, the technical features of the above embodiments or different embodiments can also be combined, the steps can be implemented in any order, and there are many other variations of different aspects of this disclosure as described above. For the sake of brevity, they are not provided in detail. Although this disclosure has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. These modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this disclosure.

Claims

1. An invasive biosensor assembly, characterized in that, This component includes: Bioelectrode (1), protective cover (2) and guide needle (3); The annular body (11) of the bioelectrode (1) is connected to the sensing section (13), and the annular body (11) is pressed between the protective cover (2) and the guide needle (3); The protective cover (2) is detachably disposed at the lower part of the guide needle (3). The bioelectrode (1) is provided with a first guide needle through hole (12). The guide needle (3) passes through the first guide needle through hole (12) and extends into the protective cover (2). The sensing section (13) of the bioelectrode (1) is contained in the grooved needle (33) of the lower half of the guide needle (3). When the guide needle (3) is inserted downwards for assembly, it drives the sensing section (13) from a straight state to a downward extending state. The sensing section (13) of the bioelectrode (1) is located in the sealed cavity formed by the protective cover (2) and the guide needle (3). The inner ring structure (112) of the annular body (11) is connected to at least one sensing segment (13), and the inner ring structure (112) is located in the sealed cavity formed by the protective cover (2) and the guide pin (3).

2. The invasive biosensor assembly as described in claim 1, characterized in that, The annular body (11) includes a sealing ring (111), an inner ring structure (112), and an outer ring structure (113). The sealing ring (111) is disposed between the inner ring structure (112) and the outer ring structure (113), and the sealing ring (111) is connected to the inner ring structure (112) and the outer ring structure (113) respectively.

3. The invasive biosensor assembly according to claim 2, characterized in that, At least one surface of the outer ring structure (113) is provided with a signal output electrode contact, which is used to form an electrical connection with an external component; the signal output electrode contact includes a working electrode contact, a counter electrode contact and a reference electrode contact.

4. The invasive biosensor assembly according to claim 1, characterized in that, The annular body (11) of the bioelectrode (1) is an integral structure.

5. The invasive biosensor assembly according to claim 2, characterized in that, The sensing segment (13) and the inner ring structure (112) are integrated into one unit.

6. The invasive biosensor assembly according to claim 2, characterized in that, The sensing segment (13) and the inner ring structure (112) are assembled.

7. The invasive biosensor assembly according to claim 2, characterized in that, The sealing ring (111) is set in a generally flat and continuous manner.

8. The invasive biosensor assembly according to claim 1, characterized in that, The sensing section (13) is configured with a single electrode, and the sensing section (13) includes one of a working electrode, a counter electrode, and a reference electrode; The sensing segment (13) in each invasive biosensor assembly includes three types of electrodes: working electrode, counter electrode, and reference electrode.

9. The invasive biosensor assembly according to claim 1, characterized in that, The sensing section (13) is configured as a composite electrode, and the sensing section (13) includes two or more of the following: working electrode, counter electrode, and reference electrode; The sensing segment (13) in each invasive biosensor assembly includes three types of electrodes: working electrode, counter electrode, and reference electrode.

10. The invasive biosensor assembly according to claim 2, characterized in that, The outer ring structure (113) is an irregular structure, and the shape of the outer ring structure (113) includes at least one of the following: circular, elliptical, and racetrack-shaped.

11. The invasive biosensor assembly according to claim 2, characterized in that, The annular body (11) is pressed between the protective cover (2) and the guide pin (3) as follows: a first sealing gasket (21) is provided on the upper part of the protective cover (2), and a second sealing gasket (31) is provided in the middle part of the guide pin (3). The first sealing gasket (21) presses against the bottom of the sealing ring body (111), and the second sealing gasket (31) presses against the top of the sealing ring body (111). The first sealing gasket (21) and the second sealing gasket (31) press the sealing ring body (111) between the first sealing gasket (21) and the second sealing gasket (31).

12. The invasive biosensor assembly according to claim 11, characterized in that, The centers of the first sealing gasket (21) and the second sealing gasket (31) are located on the same longitudinal axis.

13. The invasive biosensor assembly according to claim 11, characterized in that, The first sealing gasket (21) and the second sealing gasket (31) respectively press against 80% to 100% of the longitudinal projection area of ​​the sealing ring (111).

14. The invasive biosensor assembly according to claim 2, characterized in that, The annular body (11) is pressed between the protective cover (2) and the guide pin (3) as follows: the upper part of the protective cover (2) presses against the bottom of the sealing ring (111), the middle part of the guide pin (3) presses against the top of the sealing ring (111), and the upper part of the protective cover (2) and the middle part of the guide pin (3) press the sealing ring (111) between the protective cover (2) and the guide pin (3).

15. The invasive biosensor assembly according to claim 1, characterized in that, The guide pin (3) is provided with a positioning protrusion (32) in the middle, and the positioning protrusion (32) is inserted into the first guide pin through hole (12).

16. The invasive biosensor assembly according to claim 15, characterized in that, The side wall of the positioning protrusion (32) is provided with a guide groove (321). The guide groove (321) penetrates the side wall and bottom of the positioning protrusion (32). The grooved needle (33) of the guide pin (3) passes through the guide groove (321) and enters the protective cover (2). The sensing section (13) enters the protective cover (2) along with the grooved needle (33) of the guide pin (3).

17. The invasive biosensor assembly according to claim 16, characterized in that, The outer periphery of the positioning protrusion (32) is provided with a first thread (322), and the inner top of the protective cover (2) is provided with a second thread (22). The positioning protrusion (32) is connected to the protective cover (2) through the first thread (322) and the second thread (22).

18. The invasive biosensor assembly according to claim 1, characterized in that, The number of the sensing segments (13) is at least two.

19. The invasive biosensor assembly according to claim 18, characterized in that, The arrangement of the sensing segment (13) on the bioelectrode (1) includes one of the following: interdigitated arrangement, chrysanthemum-like arrangement with the tip pointing towards the center, and comb-like arrangement.

20. A bioinformatics monitoring device, characterized in that, The device includes an invasive biosensor assembly (01) as described in any one of claims 1 to 19, and further includes a flexible circuit board (4) and a flexible battery (5), wherein the flexible circuit board (4) is attached to the bioelectrode (1) and the flexible battery (5) is attached to the flexible circuit board (4); The flexible circuit board (4) is electrically connected to the bioelectrode (1) through the first pad group; The flexible circuit board (4) is electrically connected to the flexible battery (5) through the second pad group; The flexible battery (5) on the flexible circuit board (4) is provided with a second guide pin through hole and a third guide pin through hole, which are used for the insertion of the guide pin (3); the guide pin (3) passes through the first guide pin through hole (12), the third guide pin through hole and the third guide pin through hole.

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