A small implantable biosensor assembly and bioinformatics monitoring device

Abstract

This invention discloses a small implantable biosensor assembly and a bioinformation monitoring device containing the assembly. The first conductive end of the connecting unit protrudes from the surface of the outer shell for connection with a transmitter, and the second conductive end of the connecting unit is physically connected to the lead electrode of the implantable sensing electrode. The lower part of the implantation needle and the first notch of the auxiliary needle pass through the guide hole of the outer shell from top to bottom, and a first sealing ring is provided between the lower part of the auxiliary needle and the upper part of the outer shell. The implantable sensing section is contained in the V-shaped or U-shaped opening of the lower part of the implantation needle. The outer side of the barrier is detachably engaged with the second buckle at the bottom of the outer shell, and the inner side of the barrier is detachably engaged with the first notch of the needle assembly. The implantable sensing section and the lower part of the implantation needle are sealed in a closed space formed by the barrier, the lower part of the outer shell, and the lower part of the auxiliary needle. This closed space constitutes a sterilization unit, which is small and has high production efficiency.

Description

Technical Field

[0001] This invention relates to the field of bioinformatics monitoring technology, specifically to a small implantable biosensor assembly and a bioinformatics 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 biosensor and its internal components are 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, the small size of the transmitter (the device used to transmit detected biosignals) helps to improve the wearing experience. In current integrated products, the transmitter is either in working or silent state when it is placed inside the transmitter. However, regardless of the method, the transmitter and sensor components have been electrically connected. In the small size of the transmitter, the battery capacity is limited due to the size of the battery. The hardware needs to have extremely low power consumption to meet the shelf life requirements of the product. Shelf life (also known as shelf life or packaging expiration date) is a guarantee and commitment to the quality and efficacy of a product during its circulation period.

[0005] In current integrated products, the transmitter and implantable sensing electrode are integrated. After production and before implantation into the human body, they need to be disinfected and sterilized. The disinfection and sterilization process requires a relatively large packaging box, which takes up a lot of space and is costly. Summary of the Invention

[0006] In view of the above, the present invention provides a small implantable biosensor component with a small sterilization and disinfection unit that requires no power or consumes very little power before implantation into the human body.

[0007] A small implantable biosensor assembly includes a housing, a connection unit, an implantable sensing electrode, an implantable needle, and a barrier. The implantable sensing segment of the implantable sensing electrode extends out of the housing. The implantable sensing segment of the implantable sensing electrode and the lower part of the implantation needle are sealed within a closed space formed by the barrier, the lower part of the housing, and the lower part of the implantable needle. The lead electrode of the implantable sensing electrode is embedded in the housing and connected to the second conductive terminal of the connection unit. The first conductive terminal of the connection unit protrudes from the surface of the housing for connection with a transmitter. The housing is provided with an assembly structure for engaging with the transmitter.

[0008] Preferably, the assembly structure refers to the fifth snap fastener.

[0009] Preferably, there are two second buckles, which are symmetrically arranged at the bottom of the outer shell, and two outer protrusions, which are symmetrically arranged on the outer side of the barrier.

[0010] The barrier is rotated so that the two outer protrusions engage with the second latches to assemble the barrier and the outer shell. At the same time, the inner latch engages with the first notch of the needle-assist component to achieve a reliable seal between the needle-assist component and the outer shell at the first sealing ring. When the barrier is rotated in the opposite direction, the two outer protrusions disengage from the second latches to disassemble the barrier and the outer shell. At the same time, the inner latch disengages from the first notch of the needle-assist component to separate the needle-assist component from the barrier.

[0011] Preferably, the first conductive end of the connection unit protrudes from the surface of the housing for connection with the transmitter, and the second conductive end of the connection unit is physically connected to the lead electrode of the implanted sensing electrode.

[0012] The lower part of the implantation needle of the auxiliary needle and the first notch pass through the guide hole of the outer shell from top to bottom, and a first sealing ring is provided between the lower part of the auxiliary needle and the upper part of the outer shell.

[0013] The lower section of the implantation needle has a V-shaped or concave cross-section, and the implantation sensing segment is contained within the V-shaped or concave opening;

[0014] The outer upper part of the barrier is detachably engaged with the second latch at the bottom of the outer shell, and the inner upper part of the barrier is detachably engaged with the first latch.

[0015] The lower part of the implanted sensing segment and the implantation needle is sealed within a closed space formed by the barrier, the lower part of the outer shell, and the lower part of the needle-assisting component.

[0016] Most of the connecting unit is fixed inside the housing.

[0017] Preferably, the connecting unit includes a connecting piece, a sealing element, and a fixing element. The number of fixing elements is more than one pair, and the number of connecting pieces is more than two pairs. The two fixing elements interlock to lock the connecting pieces in pairs.

[0018] The first end of each pair of connecting pieces extends out of the surface of the outer shell and becomes the first conductive end; the second end of each pair of connecting pieces clamps an output electrode to achieve conductivity, and the second end of each pair of connecting pieces becomes the second conductive end; the sealing element seals the surface of the fixing element, and the fixing element is placed inside the outer shell for fixation.

[0019] Preferably, the outer casing includes an upper casing and a lower casing, and the fastener is disposed between the upper casing and the lower casing;

[0020] An adhesive groove is provided in the lower part of the upper shell, and sealant is applied in the adhesive groove. The lower shell is installed from the bottom of the upper shell, and the protruding ribs of the lower shell are engaged in the adhesive groove.

[0021] Preferably, a QR code printing area is provided on the bottom plane of the lower housing. A QR code is printed in this area. The QR code is used to identify information such as the sensor's UUID (Universally Unique Identifier). This allows for production application traceability or recording of relevant sensor information.

[0022] Preferably, the implantable sensing electrode is shaped like a "7", and the angle between the two sides of the "7" is 90° to 100°.

[0023] Preferably, the lateral portion of the implantable sensing electrode extends from the guide hole, passes through the dispensing groove, and enters between the lower housing and the upper housing, and the portion where the lateral portion intersects with the dispensing groove is sealed with sealant.

[0024] Preferably, the protruding bone position is provided with two adjacent tacks, the adhesive groove is provided with a deeper adhesive sub-groove, the two tacks are inserted into the adhesive sub-groove, and the lateral part of the implantable sensing electrode passes through the two tacks.

[0025] Preferably, a notch is provided at the junction of the horizontal and vertical portions of the implantable sensing electrode, the upper part of the vertical portion is higher than the horizontal portion and protrudes outward as a protruding structure, and the lower part of the vertical portion is the implantable sensing segment.

[0026] The protruding structure is slightly compressed by the inner wall of the groove of the implantation needle, so that the implantation sensing segment does not extend beyond the groove area of ​​the implantation needle under the compression.

[0027] Preferably, the guide hole is a stepped hole, with the upper part of the guide hole being larger and the lower part being smaller. The junction between the upper and lower parts of the guide hole is stepped, and the first sealing ring is located at the step. The first sealing ring is sleeved on the outside of the needle-assisting component.

[0028] Preferably, the needle-assisting component includes a needle-assisting guide and an implantation needle, with the upper part of the implantation needle embedded in the needle-assisting guide;

[0029] The needle guide components, from bottom to top, are: notch setting part, rubber ring sleeve part, guide part, pressure hole part, claw part, and claw blocking part;

[0030] The first notch is set at the notch setting part; the first sealing ring is sleeved on the outside of the rubber ring sleeve part, and the outside of the first sealing ring abuts against the inner wall of the large hole part of the guide hole; the outer wall of the guide part abuts against the inner wall of the large hole part of the guide hole; the lower part of the pressing part presses against the top of the large hole part of the guide hole.

[0031] A bioinformation monitoring device includes a transmitter and a small implantable biosensor assembly; the transmitter is provided with an assembly through-hole, the small implantable biosensor assembly is detachably passed through the assembly through-hole and snapped into the assembly through-hole, and the signal input and output terminals of the transmitter are connected to the first conductive terminal of the connection unit; after the small implantable biosensor assembly is snapped into the assembly through-hole, the transmitter changes from an open circuit state to a closed circuit state.

[0032] Preferably, the small implantable biosensor component is snapped into the component through hole, and at the same time, the spring pin on the outer shell is inserted into the power port of the transmitter, and the entire system circuit of the transmitter changes from a power-off state to a power-on state.

[0033] Preferably, the small implantable biosensor assembly includes a housing, a connection unit, an implantable sensing electrode, a needle attachment, and a barrier, wherein the implantable sensing segment of the implantable sensing electrode extends out of the housing;

[0034] The first conductive end of the connection unit protrudes from the surface of the housing for connection with the transmitter, and the second conductive end of the connection unit is physically connected to the lead electrode of the implanted sensing electrode.

[0035] The lower part of the implantation needle of the auxiliary needle and the first notch pass through the guide hole of the outer shell from top to bottom, and a first sealing ring is provided between the lower part of the auxiliary needle and the upper part of the outer shell.

[0036] The lower section of the implantation needle has a V-shaped or concave cross-section, and the implantation sensing segment is contained within the V-shaped or concave opening;

[0037] The outer upper part of the barrier is detachably engaged with the second latch at the bottom of the outer shell, and the inner upper part of the barrier is detachably engaged with the first latch.

[0038] The lower part of the implanted sensing segment and the implantation needle is sealed within a closed space formed by the barrier, the lower part of the outer shell, and the lower part of the needle-assisting component.

[0039] Most of the connecting unit is fixed inside the housing.

[0040] Preferably, the connecting unit includes a connecting piece, a sealing element, and a fixing element. The number of fixing elements is more than one pair, and the number of connecting pieces is more than two pairs. The two fixing elements interlock to lock the connecting pieces in pairs.

[0041] The first end of each pair of connecting pieces extends out of the surface of the outer shell and becomes the first conductive end; the second end of each pair of connecting pieces clamps an output electrode to achieve conductivity, and the second end of each pair of connecting pieces becomes the second conductive end; the sealing element seals the surface of the fixing element, and the fixing element is placed inside the outer shell for fixation.

[0042] Preferably, the outer casing includes an upper casing and a lower casing, and the fastener is disposed between the upper casing and the lower casing;

[0043] An adhesive groove is provided in the lower part of the upper shell, and sealant is applied in the adhesive groove. The lower shell is installed from the bottom of the upper shell, and the protruding ribs of the lower shell are engaged in the adhesive groove.

[0044] Preferably, the implantable sensing electrode is shaped like a "7", and the angle between the two sides of the "7" is 90° to 100°.

[0045] Preferably, the lateral portion of the implantable sensing electrode extends from the guide hole, passes through the dispensing groove, and enters between the lower housing and the upper housing, and the portion where the lateral portion intersects with the dispensing groove is sealed with sealant.

[0046] Preferably, the protruding bone position is provided with two adjacent tacks, the adhesive groove is provided with a deeper adhesive sub-groove, the two tacks are inserted into the adhesive sub-groove, and the lateral part of the implantable sensing electrode passes through the two tacks.

[0047] Preferably, a notch is provided at the junction of the horizontal and vertical portions of the implantable sensing electrode, the upper part of the vertical portion is higher than the horizontal portion and protrudes outward as a protruding structure, and the lower part of the vertical portion is the implantable sensing segment.

[0048] The protruding structure is slightly compressed by the inner wall of the groove of the implantation needle, so that the implantation sensing segment does not extend beyond the groove area of ​​the implantation needle under the compression.

[0049] Preferably, the guide hole is a stepped hole, with the upper part of the guide hole being larger and the lower part being smaller. The junction between the upper and lower parts of the guide hole is stepped, and the first sealing ring is located at the step. The first sealing ring is sleeved on the outside of the needle-assisting component.

[0050] Preferably, the needle-assisting component includes a needle-assisting guide and an implantation needle, with the upper part of the implantation needle embedded in the needle-assisting guide;

[0051] The needle guide components, from bottom to top, are: notch setting part, rubber ring sleeve part, guide part, pressure hole part, claw part, and claw blocking part;

[0052] The first notch is set at the notch setting part; the first sealing ring is sleeved on the outside of the rubber ring sleeve part, and the outside of the first sealing ring abuts against the inner wall of the large hole part of the guide hole; the outer wall of the guide part abuts against the inner wall of the large hole part of the guide hole; the lower part of the pressing part presses against the top of the large hole part of the guide hole.

[0053] Preferably, the implantable sensing electrode is a double-sided circuit electrode, with a working electrode, a reference electrode, and a counter electrode provided on both sides of the implantable sensing segment. The number of output electrodes is more than three. The working electrode, the reference electrode, and the counter electrode are respectively connected to different output electrodes through the circuit of the implantable sensing electrode. The number of second conductive terminals is more than three. The working electrode, the reference electrode, and the counter electrode are respectively connected to different second conductive terminals on the connection unit 2 through the output electrodes.

[0054] Preferably, the connection unit is provided with three first conductive terminals, three of which correspond to the working electrode, reference electrode, and counter electrode, respectively; the other terminal can be used as the second working electrode WE2 to realize multi-component testing or to wake up the sensor system.

[0055] The beneficial effects of this invention are as follows: A small implantable biosensor assembly includes a shell, a connecting unit, an implantable sensing electrode, an auxiliary needle, and a barrier. The implantable sensing segment of the implantable sensing electrode extends out of the shell and is used for insertion below the skin to collect and monitor biological information. The first conductive end of the connecting unit protrudes from the surface of the shell and can be connected to a transmitter via snap-fit ​​or other methods. Before connection, the transmitter is in an open-circuit state. The second conductive end of the connecting unit physically connects to the lead-out electrode of the implantable sensing electrode via snap-fit, welding, or other methods. The lower part of the implantation needle and the first notch of the auxiliary needle pass through the guide hole of the shell from top to bottom. The guide hole provides vertical guidance and spatial isolation for the implantation needle, achieving a seal. A first sealing ring is provided between the lower part of the needle and the upper part of the outer shell, which separates the lower and upper parts of the implantation needle. The lower part of the implantation needle has a V-shaped or concave cross-section, and the implantation sensing section is contained within the V-shaped or concave opening. The outer side of the upper part of the barrier (protective sleeve, protective shell) is detachably engaged with the second buckle at the bottom of the outer shell, and the inner side of the upper part of the barrier is detachably engaged with the first notch. The implantation sensing section and the lower part of the implantation needle are sealed within the enclosed space formed by the barrier, the lower part of the outer shell, and the lower part of the needle-assisting component. The sealed space constitutes a small sterilization unit. The small size of the sterilization unit can improve production efficiency and reduce production costs. Before implantation into the human body, the transmitter does not require power or consumes very little power, which can improve the shelf life of the transmitter. Attached Figure Description

[0056] The present invention provides a small implantable biosensor assembly in further detail below with reference to the accompanying drawings.

[0057] Figure 1 This is an exploded structural diagram of a small implantable biosensor assembly according to the present invention.

[0058] Figure 2 This is an assembly diagram of a small implantable biosensor assembly according to the present invention.

[0059] Figure 3 This is a schematic diagram of the needle-borne component of a small implantable biosensor assembly according to the present invention.

[0060] Figure 4 This is an exploded structural diagram of the upper housing, second sealing ring, and barrier 6 of a small implantable biosensor assembly according to the present invention.

[0061] Figure 5 This is an exploded structural diagram of a bioinformation monitoring device of the present invention, including a transmitter 10 and a small implantable biosensor assembly.

[0062] Figure 6 This is a schematic diagram of the assembled structure of the upper and lower housings of a small implantable biosensor assembly according to the present invention.

[0063] Figure 7 This is an exploded structural diagram of the upper and lower housings of a small implantable biosensor assembly according to the present invention.

[0064] Figure 8 This is a schematic diagram of the implantable sensing electrode of a small implantable biosensor assembly according to the present invention from one perspective.

[0065] Figure 9 This is a schematic diagram of the connection unit of a small implantable biosensor assembly according to the present invention from one perspective.

[0066] Figure 10 This is a cross-sectional view of a small implantable biosensor assembly according to the present invention.

[0067] Figure 11 This is a schematic diagram of the assembly of a spring needle and a transmitter circuit board of a small implantable biosensor assembly according to the present invention.

[0068] In the picture:

[0069] 1-Outer shell; 11-Upper shell; 111-Dispensing groove; 1111-Dispensing sub-groove; 112-Second buckle; 118-Guide hole;

[0070] 119 - Assembly structure; 12 - Lower housing; 121 - Snap-in; 123 - Protruding bone position; 2 - Connecting unit; 23 - Connecting piece; 231 - First conductive end; 232 - Second conductive end; 24 - Sealing element; 25 - Fixing element; 3 - Implantable sensing electrode; 32 - Notch; 33 - Outlet electrode; 34 - Implantable sensing segment; 341 - Protruding structure; 4 - Needle aid; 41 - Needle aid guide; 411 - Snap-in notch setting part; 4111 - First snap-in notch; 412 - Rubber ring sleeve part; 413 - Guide part; 415 - Pressing hole part; 416 - Claw part; 417 - Claw blocking part; 43 - Implantation needle; 6 - Barrier; 60 - Outer snap-in; 61 - Inner buckle; 7 - First sealing ring; 8 - Second sealing ring; 90 - Third sealing ring; 91 - Fourth sealing ring; 10 - Transmitter; 101 - Component through hole. Detailed Implementation

[0071] The following is in conjunction with the appendix Figures 1-11 The present invention provides a further description of a small implantable biosensor assembly.

[0072] A small implantable biosensor assembly includes a housing 1, and the lower part of the implantable sensing segment 34 of the implantable sensing electrode 3 and the implantation needle 43 are sealed in a closed space formed by a barrier 6, the lower part of the housing 1 and the lower part of the needle 4. The lead electrode 33 of the implantable sensing electrode 3 is embedded in the housing 1 and connected to the second conductive end 232 of the unit 2. The first conductive end 231 of the unit 2 protrudes from the surface of the housing 1 for connection with the transmitter 10. The housing 1 is provided with an assembly structure 119 for engaging with the transmitter 10.

[0073] In this embodiment, the implantable sensing segment 34 of the implantable sensing electrode 3 extends out of the outer shell 1;

[0074] The first conductive end 231 of the connection unit 2 protrudes from the surface of the housing 1 for connection with the transmitter 10, and the second conductive end 232 of the connection unit 2 is physically connected to the lead electrode 33 of the implanted sensing electrode 3.

[0075] The lower part of the implantation needle 43 of the auxiliary needle component 4 and the first notch 4111 pass through the guide hole 118 of the outer shell 1 from top to bottom. A first sealing ring 7 is provided between the lower part of the auxiliary needle component 4 and the upper part of the outer shell 1. The cross-section of the lower part of the implantation needle 43 is V-shaped or concave, and the implantation sensing section 34 is contained in the V-shaped or concave opening.

[0076] The outer side of the upper part of the barrier 6 is detachably engaged with the second buckle 112 at the bottom of the outer shell 1, and the inner side of the upper part of the barrier 6 is detachably engaged with the first notch 4111.

[0077] The lower parts of the implantable sensing segment 34 and the implantation needle 43 are sealed within a closed space formed by the barrier 6, the lower part of the outer shell 1, and the lower part of the needle aid 4.

[0078] In this embodiment, the assembly structure refers to the fifth snap fastener.

[0079] In this embodiment, there are two second buckles 112, which are symmetrically arranged at the bottom of the outer shell 1. There are also two outer protrusions 60, which are symmetrically arranged on the outer side of the barrier 6.

[0080] Rotate the barrier 6, and the two outer protrusions 60 respectively engage with a second buckle 112 to assemble the barrier 6 with the outer shell 1. At the same time, the inner buckle 61 engages with the first notch 4111 of the needle aid 4 to achieve a reliable seal between the needle aid 4 and the outer shell 1 at the first sealing ring 7. Rotate the barrier 6 in the opposite direction, and the two outer protrusions 60 respectively disengage from the second buckle 112 to disassemble the barrier 6 from the outer shell 1. At the same time, the inner buckle 61 disengages from the first notch 4111 of the needle aid 4 to separate the needle aid 4 from the barrier 6.

[0081] By rotating and snapping the barrier 6, both the snapping of the needle aid 4 and the sealing of the implantation sensing section 34 and the implantation needle 43 are achieved, resulting in the smallest sealing unit, which is convenient for sterilization.

[0082] In this embodiment, a second sealing ring 8 is provided between the barrier 6 and the outer shell 1. The second sealing ring 8 and the main body of the barrier 6 are integrally molded using two-color injection molding for easy assembly.

[0083] In this embodiment, most of the connecting unit 2 is fixed inside the outer casing 1.

[0084] In this embodiment, the connecting unit 2 includes a connecting piece 23, a sealing member 24, and a fixing member 25. The number of fixing members 25 is more than one pair, and the number of connecting pieces 23 is more than two pairs. The two fixing members 25 engage with each other to lock the connecting pieces 23 in pairs.

[0085] The first end of each pair of connecting pieces 23 extends out of the surface of the outer shell 1 to become the first conductive end 231; the second end of each pair of connecting pieces 23 clamps an output electrode 33 to achieve conduction, and the second end of each pair of connecting pieces 23 becomes the second conductive end 232. The sealing member 24 is sealed on the surface of the fixing member 25, and the fixing member 25 is placed inside the outer shell 1 for fixation.

[0086] The fasteners 25 are arranged in pairs. The back of the fastener 25 is provided with an insertion post 251 and an insertion hole 252. The insertion post 251 of one fastener 25 is inserted into the insertion hole of the other fastener 25 to achieve mutual snapping of the two fasteners 25.

[0087] The connecting piece 23 is roughly shaped like a left parenthesis "(" and a right parenthesis ")". The connecting pieces 23 are arranged back-to-back, and a pair of fixing pieces 25 can snap one pair of connecting pieces 23 into place. The lead electrode 33 is snapped between the two connecting pieces 23. The connection end of the connecting piece 23 and the lead electrode 23 is the second conductive end 232 of the connecting unit 2, and the other end of the connecting piece 23 protrudes from the fixing piece 25 and becomes the first conductive end 231 of the connecting unit 2.

[0088] The number of lead-out electrodes 33 can be two or more. The two or more lead-out electrodes 33 can be symmetrically arranged on opposite sides of the implantable sensing electrode 3, or they can be arranged asymmetrically. The number of lead-out electrodes 33 can also be two or more pairs, with each pair of lead-out electrodes 33 symmetrically arranged on opposite sides of the implantable sensing electrode 3. Each pair of lead-out electrodes 33 can be a working electrode, a reference electrode, or a counter electrode, or both can be working electrodes, reference electrodes, or counter electrodes.

[0089] In this embodiment, the outer shell 1 includes an upper shell 11 and a lower shell 12, and the fastener 25 is disposed between the upper shell 11 and the lower shell 12;

[0090] An adhesive groove 111 is provided in the lower part of the upper shell 11. Sealing adhesive is applied in the adhesive groove 111. The lower shell 12 is installed from the bottom of the upper shell 11, and the protruding rib 123 of the lower shell 12 is engaged in the adhesive groove 111.

[0091] In this embodiment, a QR code printing area is provided on the bottom plane of the lower housing 12. A QR code is printed in this area. The QR code is used to identify information such as the sensor's UUID (Universally Unique Identifier). This allows for production application traceability, recording of relevant sensor information, and sensor calibration.

[0092] In this embodiment, the implantable sensing electrode 3 is shaped like a "7", and the angle between the two sides of the "7" is 90° to 100°.

[0093] In this embodiment, the lateral portion of the implantable sensing electrode 3 extends from the guide hole 118, passes through the dispensing groove 111, and enters between the lower housing 12 and the upper housing 11. The portion where the lateral portion intersects with the dispensing groove 111 is sealed with sealant.

[0094] In this embodiment, the protruding bone position 123 is provided with two adjacent tacks 121, the dispensing groove 111 is provided with a deeper dispensing sub-groove 1111, the two tacks 121 are inserted into the dispensing sub-groove 1111, and the lateral part of the implanted sensing electrode 3 passes through the two tacks 121.

[0095] In this embodiment, a notch 32 is provided at the junction of the horizontal and vertical portions of the implantable sensing electrode 3. The upper part of the vertical portion protrudes outward from the horizontal portion as a protruding structure 341, and the lower part of the vertical portion is the implantable sensing segment 34.

[0096] The protruding structure 341 is slightly squeezed by the inner wall of the groove of the implantation needle 43, so that the implantation sensing section 34 does not exceed the groove area of ​​the implantation needle 43 under the squeezing action.

[0097] In this embodiment, the guide hole 118 is a stepped hole, with the upper part of the guide hole 118 being larger than the lower part. The junction of the upper and lower parts of the guide hole 118 is stepped. The first sealing ring 7 is located at the step and is sleeved on the outside of the needle-assisting component 4.

[0098] In this embodiment, the needle-assisting component 4 includes a needle-assisting guide 41 and an implantation needle 43, with the upper part of the implantation needle 43 embedded in the needle-assisting guide 41;

[0099] The needle guide 41 consists of, from bottom to top: a notch setting part 411, a rubber ring sleeve part 412, a guide part 413, a pressing hole part 415, a claw part 416, and a claw blocking part 417.

[0100] The first notch 4111 is provided at the notch setting part 411; the first sealing ring 7 is sleeved on the outside of the rubber ring sleeve part 412, and the outside of the first sealing ring 7 abuts against the inner wall of the large hole part of the guide hole 118; the outer wall of the guide part 413 abuts against the inner wall of the large hole part of the guide hole 118; the lower part of the pressing part 415 presses against the top of the large hole part of the guide hole 118.

[0101] In this embodiment, the upper housing 11 is provided with an assembly structure 119, which is used to engage with the transmitter 10.

[0102] In this embodiment, a second sealing ring 8 is provided between the upper part of the barrier 6 and the outer shell 1.

[0103] This component is used in the launching device. The barrier 6 is connected to the bottom protective sleeve of the launching device. By rotating the protective sleeve, the barrier 6 can be rotated relative to the outer shell 1, thereby enabling the barrier 6 to be disassembled relative to the launcher.

[0104] In this embodiment, the first sealing ring 7 and the main body of the outer shell 1 are integrally molded by two-color injection molding, which makes the connection reliable and stable and easy to assemble. The first sealing ring 7 has a certain clamping force on the needle-assisting component 4 and will not pop out easily. Under the action of the spring of the launching device, the needle-assisting component 4 can be pulled out.

[0105] In this embodiment, a third sealing ring 90 and a fourth sealing ring 91 are also included. The third sealing ring 90 is located on the upper circumferential side of the outer shell 1 and serves to seal when assembled with the transmitter 10. The fourth sealing ring 91 is located on the upper circumferential side of the guide hole 118 and serves to seal when assembled with the component through hole 101 of the transmitter 10. The third sealing ring 90 and the fourth sealing ring 91 are integrally molded with the main body of the outer shell 1 using two-color injection molding.

[0106] The present invention also provides a bio-information monitoring device.

[0107] A bioinformation monitoring device includes a transmitter 10 and a small implantable biosensor assembly;

[0108] The transmitter 10 is provided with a component through hole 101. A small implantable biosensor component can be detachably passed through the component through hole 101 and snapped into the component through hole 101. The signal input and output terminals of the transmitter 10 are connected to the first conductive terminal 231 of the connection unit 2.

[0109] After the small implantable biosensor component is snapped into the component through-hole 101, the spring pin 15 on the outer shell 1 is inserted into the power port 102 of the transmitter 10, and the entire system circuit of the transmitter 10 changes from a power-off state to a power-on state. The spring pin 15 can drive the power port 102 to conduct in different ways: ① The walls on both sides of the power port 102 are not fully copper-plated and are in a non-connected state; after the spring pin 15 is inserted, the left and right sides begin to connect; ② A trigger switch is installed inside the power port 102, and power is applied by the spring pin 15 abutting against the trigger switch.

[0110] The power port 102 is located on the circuit board 103 of the transmitter 10.

[0111] In this embodiment, the small implantable biosensor assembly includes a housing 1, a connection unit 2, an implantable sensing electrode 3, an assist needle 4, and a barrier 6, with the implantable sensing segment 34 of the implantable sensing electrode 3 extending out of the housing 1.

[0112] The first conductive end 231 of the connection unit 2 protrudes from the surface of the housing 1 for connection with the transmitter 10, and the second conductive end 232 of the connection unit 2 is physically connected to the lead electrode 33 of the implanted sensing electrode 3.

[0113] The lower part of the implantation needle 43 of the auxiliary needle component 4 and the first notch 4111 pass through the guide hole 118 of the outer shell 1 from top to bottom, and a first sealing ring 7 is provided between the lower part of the auxiliary needle component 4 and the upper part of the outer shell 1.

[0114] The lower section of the implantation needle 43 has a V-shaped or concave cross-section, and the implantation sensing segment 34 is contained within the V-shaped or concave opening;

[0115] The outer side of the upper part of the barrier 6 is detachably engaged with the second buckle 112 at the bottom of the outer shell 1, and the inner side of the upper part of the barrier 6 is detachably engaged with the first notch 4111.

[0116] The lower parts of the implantable sensing segment 34 and the implantation needle 43 are sealed within a closed space formed by the barrier 6, the lower part of the outer shell 1, and the lower part of the needle aid 4.

[0117] Most of the connecting unit 2 is fixed inside the outer casing 1.

[0118] In this embodiment, the connecting unit 2 includes a connecting piece 23, a sealing member 24, and a fixing member 25. The number of fixing members 25 is more than one pair, and the number of connecting pieces 23 is more than two pairs. The two fixing members 25 engage with each other to lock the connecting pieces 23 in pairs.

[0119] The first end of each pair of connecting pieces 23 extends out of the surface of the outer shell 1 to become the first conductive end 231; the second end of each pair of connecting pieces 23 clamps an output electrode 33 to achieve conduction, and the second end of each pair of connecting pieces 23 becomes the second conductive end 232. The sealing member 24 is sealed on the surface of the fixing member 25, and the fixing member 25 is placed inside the outer shell 1 for fixation.

[0120] In this embodiment, the outer shell 1 includes an upper shell 11 and a lower shell 12, and the fastener 25 is disposed between the upper shell 11 and the lower shell 12;

[0121] An adhesive groove 111 is provided in the lower part of the upper shell 11. Sealing adhesive is applied in the adhesive groove 111. The lower shell 12 is installed from the bottom of the upper shell 11, and the protruding rib 123 of the lower shell 12 is engaged in the adhesive groove 111.

[0122] In this embodiment, the implantable sensing electrode 3 is shaped like a "7", and the angle between the two sides of the "7" is 90° to 100°.

[0123] In this embodiment, the lateral portion of the implantable sensing electrode 3 extends from the guide hole 118, passes through the dispensing groove 111, and enters between the lower housing 12 and the upper housing 11. The portion where the lateral portion intersects with the dispensing groove 111 is sealed with sealant.

[0124] In this embodiment, the protruding bone position 123 is provided with two adjacent tacks 121, the dispensing groove 111 is provided with a deeper dispensing sub-groove 1111, the two tacks 121 are inserted into the dispensing sub-groove 1111, and the lateral part of the implanted sensing electrode 3 passes through the two tacks 121.

[0125] In this embodiment, a notch 32 is provided at the junction of the horizontal and vertical portions of the implantable sensing electrode 3. The upper part of the vertical portion protrudes outward from the horizontal portion as a protruding structure 341, and the lower part of the vertical portion is the implantable sensing segment 34.

[0126] The protruding structure 341 is slightly squeezed by the inner wall of the groove of the implantation needle 43, so that the implantation sensing section 34 does not exceed the groove area of ​​the implantation needle 43 under the squeezing action.

[0127] In this embodiment, the guide hole 118 is a stepped hole, with the upper part of the guide hole 118 being larger than the lower part. The junction of the upper and lower parts of the guide hole 118 is stepped. The first sealing ring 7 is located at the step and is sleeved on the outside of the needle-assisting component 4.

[0128] In this embodiment, the needle-assisting component 4 includes a needle-assisting guide 41 and an implantation needle 43, with the upper part of the implantation needle 43 embedded in the needle-assisting guide 41;

[0129] The needle guide 41 consists of, from bottom to top: a notch setting part 411, a rubber ring sleeve part 412, a guide part 413, a pressing hole part 415, a claw part 416, and a claw blocking part 417.

[0130] The first notch 4111 is provided at the notch setting part 411; the first sealing ring 7 is sleeved on the outside of the rubber ring sleeve part 412, and the outside of the first sealing ring 7 abuts against the inner wall of the large hole part of the guide hole 118; the outer wall of the guide part 413 abuts against the inner wall of the large hole part of the guide hole 118; the lower part of the pressing part 415 presses against the top of the large hole part of the guide hole 118.

[0131] In this embodiment, the implantable sensing electrode 3 is a double-sided circuit electrode. The two sides of the implantable sensing segment 34 are provided with a working electrode, a reference electrode, and a counter electrode. The number of output electrodes 34 is more than three. The working electrode, the reference electrode, and the counter electrode are respectively connected to different output electrodes 34 through the circuit of the implantable sensing electrode 3. The number of second conductive terminals 232 is more than three. The working electrode, the reference electrode, and the counter electrode are respectively connected to different second conductive terminals 232 on the connection unit 2 through the output electrodes 33.

[0132] In this embodiment, the connection unit 2 is provided with four first conductive terminals 231, three of which correspond to the working electrode, reference electrode and counter electrode respectively; the other one can be used as the second working electrode WE2 to realize multi-component testing, or for sensor system wake-up.

[0133] After the small implantable biosensor component is snapped into the component through-hole 101, the spring pin 15 on the outer shell 1 is inserted into the power port 102 of the transmitter 10, and the entire system circuit of the transmitter 10 changes from a power-off state to a power-on state. The spring pin 15 can drive the power port 102 to conduct in different ways: ① The walls on both sides of the power port 102 are not fully copper-plated and are in a non-connected state, with both sides in an open circuit state. After the spring pin 15 is inserted, the left and right sides begin to connect; ② A trigger switch is installed inside the power port 102, and power is applied by the spring pin 15 abutting the trigger switch.

[0134] The above description is only a preferred embodiment of the present invention. It should be noted that those skilled in the art can make several improvements without departing from the principle of the present invention, and these improvements should also be considered within the scope of protection of the present invention.

Claims

1. A small implantable biosensor assembly, comprising a housing (1), a connection unit (2), an implantable sensing electrode (3), a needle attachment (4), and a barrier (6), characterized in that, The lower part of the implantation sensing segment (34) of the implantable sensing electrode (3) and the implantation needle (43) of the needle aid (4) are sealed in the sealed space formed by the barrier (6), the lower part of the outer shell (1) and the lower part of the needle aid (4); the lead electrode (33) of the implantable sensing electrode (3) is embedded in the outer shell (1) and connected to the second conductive end (232) of the connecting unit (2); the first conductive end (231) of the connecting unit (2) protrudes from the surface of the outer shell (1) for connection with the transmitter (10); the outer shell (1) is provided with an assembly structure (119) for snapping with the transmitter (10). The implantable sensing segment (34) of the implantable sensing electrode (3) extends out of the outer shell (1); The lower part of the implantation needle (43) of the needle aid (4) and the first notch (4111) of the needle aid (4) pass through the guide hole (118) of the outer shell (1) from top to bottom. A first sealing ring (7) is provided between the lower part of the needle aid (4) and the upper part of the outer shell (1). The lower section of the implantation needle (43) is V-shaped or concave, and the implantation sensing section (34) is contained within the V-shaped or concave opening; The outer side of the upper part of the barrier (6) is detachably engaged with the second buckle (112) at the bottom of the outer shell (1), and the inner side of the upper part of the barrier (6) is detachably engaged with the first notch (4111). There are two second buckles (112), which are symmetrically arranged at the bottom of the outer shell (1). There are two outer protrusions (60), which are symmetrically arranged on the outside of the barrier (6). Rotate the barrier (6), and the two outer protrusions (60) respectively engage with the corresponding second buckles (112) to assemble the barrier (6) and the outer shell (1). At the same time, the inner buckle (61) engages with the first notch (4111) of the needle aid (4) to achieve a reliable seal between the needle aid (4) and the outer shell (1) at the first sealing ring (7). Rotate the barrier (6) in the opposite direction, and the two outer protrusions (60) respectively disengage from the corresponding second buckles (112) to disassemble the barrier (6) and the outer shell (1). At the same time, the inner buckle (61) disengages from the first notch (4111) of the needle aid (4) to separate the needle aid (4) from the barrier (6). The implantable sensing electrode (3) has a notch (32) at the junction of the horizontal and vertical parts. The upper part of the vertical part is higher than the horizontal part and protrudes outward to form a protruding structure (341). The lower part of the vertical part is the implantable sensing segment (34). The protruding structure (341) is slightly squeezed by the inner wall of the groove of the implantation needle (43), so that the implantation sensing section (34) does not exceed the groove area of ​​the implantation needle (43) under the squeezing action.

2. The miniature implantable biosensor assembly as described in claim 1, characterized in that, The connecting unit (2) includes a connecting piece (23), a sealing member (24) and a fixing member (25). The number of fixing members (25) is more than one pair, and the number of connecting pieces (23) is more than two pairs. The two fixing members (25) are fastened together to lock the connecting pieces (23) in pairs. The first end of each pair of connecting pieces (23) extends out of the surface of the outer shell (1) to become the first conductive end (231); the second end of each pair of connecting pieces (23) clamps an output electrode (33) to achieve conduction, and the second end of each pair of connecting pieces (23) becomes the second conductive end (232). The sealing member (24) is sealed on the surface of the fixing member (25), and the fixing member (25) is placed inside the outer shell (1) for fixation.

3. The miniature implantable biosensor assembly as described in claim 2, characterized in that, The outer shell (1) includes an upper shell (11) and a lower shell (12), and the fastener (25) is disposed between the upper shell (11) and the lower shell (12); The lower part of the upper housing (11) is provided with a dispensing groove (111), and sealant is dispensed into the dispensing groove (111). The lower housing (12) is installed from the bottom of the upper housing (11), and the protruding rib (123) of the lower housing (12) is engaged in the dispensing groove (111).

4. The miniature implantable biosensor assembly as described in claim 3, characterized in that, The bottom plane of the lower housing (12) is provided with a QR code printing area for identifying the UUID information of the sensor, which can be used for production application traceability or to record relevant sensor information.

5. The miniature implantable biosensor assembly as described in claim 3, characterized in that, The implantable sensing electrode (3) is shaped like a "7", and the angle between the two sides of the "7" is 90° to 100°.

6. The miniature implantable biosensor assembly as described in claim 5, characterized in that, The lateral portion of the implantable sensing electrode (3) extends from the guide hole (118), passes through the dispensing groove (111), and enters between the lower housing (12) and the upper housing (11). The portion where the lateral portion intersects with the dispensing groove (111) is sealed with sealant.

7. The small implantable biosensor assembly as described in claim 6, characterized in that, The protruding bone position (123) is provided with two adjacent truncations (121), the adhesive groove (111) is provided with a deeper adhesive sub-groove (1111), the two truncations (121) are inserted into the adhesive sub-groove (1111), and the lateral portion of the implantable sensing electrode (3) passes between the two truncations (121).

8. The miniature implantable biosensor assembly as described in claim 1, characterized in that, The needle-assisting component (4) includes a needle-assisting guide (41) and an implantation needle (43), with the upper part of the implantation needle (43) embedded in the needle-assisting guide (41); The needle guide (41) consists of, from bottom to top: a notch setting part (411), a rubber ring sleeve part (412), a guide part (413), a pressing hole part (415), a claw part (416), and a claw blocking part (417). The first notch (4111) is provided at the notch setting part (411); the first sealing ring (7) is sleeved on the outside of the rubber ring sleeve part (412), and the outside of the first sealing ring (7) abuts against the inner wall of the large hole portion of the guide hole (118); the outer wall of the guide part (413) abuts against the inner wall of the large hole portion of the guide hole (118); the lower part of the pressing part (415) presses against the top of the large hole portion of the guide hole (118).

9. The miniature implantable biosensor assembly as described in claim 1, characterized in that, The guide hole (118) is a stepped hole, with the upper part of the guide hole (118) being larger than the lower part. The upper and lower parts of the guide hole (118) are stepped at the junction. The first sealing ring (7) is located at the step and is sleeved on the outside of the needle-assisting component (4).

10. A bio-information monitoring device, comprising a transmitter (10), characterized in that, It also includes the small implantable biosensor assembly as described in any one of claims 1 to 9; The transmitter (10) is provided with a component through hole (101), and the small implantable biosensor component is detachably passed through the component through hole (101) and snapped into the component through hole (101). The signal input and output terminals of the transmitter (10) are connected to the first conductive terminal (231) of the connection unit (2). After the small implantable biosensor assembly is snapped into the assembly through hole (101), the spring pin (15) provided on the housing (1) is inserted into the power hole (102) of the transmitter (10), and the entire system circuit of the transmitter (10) changes from a power-off state to a power-on state.

11. The bioinformatics monitoring device as described in claim 10, characterized in that, The implantable sensing electrode (3) is a double-sided line electrode. The two sides of the implantable sensing section (34) are provided with a working electrode, a reference electrode and a counter electrode. The number of output electrodes (33) is more than three. The working electrode, the reference electrode and the counter electrode are respectively connected to different output electrodes (33) through the lines of the implantable sensing electrode (3). The working electrode, the reference electrode and the counter electrode are respectively connected to the second conductive terminal (232) of the connection unit (2) through the output electrodes (33).

12. The bioinformatics monitoring device as described in claim 11, characterized in that, The connection unit (2) is provided with four second conductive terminals (232), three of which correspond to the working electrode, the reference electrode and the counter electrode respectively; the other terminal is used as the second working electrode WE2 to realize multi-component testing or to wake up the sensor system.

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