Highly reliable implantable biosensor assembly and biological information monitoring device

Abstract

The application discloses a high-reliability implantable biosensor assembly and a biological information monitoring device, wherein a shell is provided with a needle passing hole, and a first sealing ring is arranged in the needle passing hole; a sensing section of an implantable sensing electrode extends out of the shell, an implanting needle of a needle assisting assembly is semi-enclosed outside the sensing section, and a barrier is detachably enclosed outside the implanting needle and the sensing section; a lower rubber ring sleeve part of a needle assisting base passes through and is sleeved in the first sealing ring, thereby realizing first clamping positioning of the needle assisting base; an inner wall of the barrier is provided with a lock catch, a lower part of the needle assisting base is provided with a clamping gap, the lock catch is clamped in the clamping gap, thereby realizing second clamping positioning of the needle assisting base; the two clamping positionings of the needle assisting base can obtain high reliability and good sealing performance; the implantable biosensor assembly and a main control circuit are designed in a split type and can be assembled, so that the implantable biosensor assembly can be replaced, the main control circuit assembly can be used for multiple times, and the cost is lower.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of biological information monitoring, in particular to a high-reliability implantable biological sensor assembly and a biological information monitoring device. BACKGROUND

[0002] For the diabetic population, the traditional fingertip blood glucose meter has the disadvantages of invasiveness, limited information, inability to reflect blood glucose fluctuations and early warning, and has not met the needs of some people, especially for type 1 diabetes patients who have real-time transmission requirements for 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 implant assembly of an implantable biological sensor is used to implant the sensor into the subcutaneous tissue of the human body, and the measurement of the blood glucose concentration in the interstitial fluid is a continuous monitoring means available in reality, and its single use life is one to two weeks, greatly reducing the pain caused by the process of continuous fingertip blood sampling and intravenous blood sampling.

[0004] In the prior art, the structure of the transmitter (a device for transmitting monitored biological signals) is small and compact, which helps to improve the wearing experience. In the current integrated product, the transmitter is placed inside the launcher and is in a working or silent state. However, in either of the above ways, the transmitter and the sensor assembly have already completed the electrical connection. In the small size of the transmitter, due to the limitation of the size of the battery, the battery capacity is not large, and the hardware needs to have very low power consumption to meet the shelf life (shelf life, also known as shelf life, or packaging validity period, which is a guarantee and commitment to the quality and efficacy of the product during circulation) requirements. In the current integrated product, the transmitter and the implantable sensing electrode are integrally arranged. Before being implanted into the human body after production, sterilization treatment is required. The sterilization and disinfection require a relatively large packaging box, which occupies a large space and has high cost.

[0005] In the prior art, the implantable biological sensor assembly and the main control circuit of the transmitter are integrally connected. After use, the implantable biological sensor assembly is discarded together with the main control circuit, causing great waste. SUMMARY

[0006] In view of the above, the present application provides a high-reliability implantable biological sensor assembly, which has a small sterilization and disinfection unit, and the implantable biological sensor assembly and the main control circuit are designed in a split type and can be assembled, so that the high-reliability implantable biological sensor assembly can be replaced, and the main control circuit assembly can be used multiple times.

[0007] The implantable biosensor assembly with high reliability comprises a shell, an implantable sensing electrode, a barrier and a needle-assisting assembly, the needle-assisting assembly comprises a needle for implantation and a needle seat, the shell is provided with a needle passing hole, and a first sealing ring is arranged in the needle passing hole;

[0008] A sensing section of the implantable sensing electrode extends out of the shell, the needle for implantation of the needle-assisting assembly is semi-enclosed outside the sensing section, and the barrier is detachably encapsulated outside the needle for implantation and the sensing section;

[0009] A lower rubber ring sleeve portion of the needle seat passes through and is sleeved in the first sealing ring, thereby achieving first clamping positioning of the needle seat;

[0010] An inner wall of the barrier is provided with a lock catch, a lower portion of the needle seat is provided with a clamping gap, the lock catch is clamped in the clamping gap, and second clamping positioning of the needle seat is achieved.

[0011] Preferably, an upper portion of the barrier is provided with two or more rotating clamping buckles, a bottom portion of the shell is provided with rotating clamping slots, the rotating clamping buckles are rotated and clamped in the rotating clamping slots, and assembly of the barrier relative to the shell is achieved;

[0012] While the rotating clamping buckles are rotated and clamped in the rotating clamping slots, the lock catch is rotated and clamped in the clamping gap, and second clamping positioning of the needle seat is achieved.

[0013] Preferably, a head portion of the barrier is provided with a second sealing ring, and the second sealing ring is integrally formed with the barrier by using a two-color injection molding process;

[0014] The second sealing ring is extruded between the head portion of the barrier and the bottom portion of the shell.

[0015] Preferably, the lower portion of the needle seat comprises a vertical guide portion, the needle passing hole comprises a vertical guide section, and the vertical guide portion is gap-fitted or transition-fitted in the vertical guide section, thereby achieving vertical guidance of the needle seat.

[0016] The vertical guide portion is located at an upper portion of the rubber ring sleeve portion.

[0017] Preferably, the clamping gap is arranged on an outer side of the lower portion of the needle seat, the number of the lock catches is two, the two lock catches are symmetrically arranged on the inner wall of the barrier, only one lock catch cooperates with the clamping gap, and the other lock catch is redundant.

[0018] The two lock catches are symmetrically arranged on the inner wall of the barrier, the structure is good in symmetry, and manufacturing is facilitated; only one lock catch cooperates with the clamping gap, and the other lock catch is redundant, the structure is symmetrical and facilitates assembly, and assembly efficiency can be improved.

[0019] Preferably, the head portion of the barrier is provided with two or more clamping buckles, the bottom portion of the shell is provided with clamping slots, the clamping buckles are clamped in the clamping slots, and assembly of the barrier relative to the shell is achieved;

[0020] The clamping buckle is clamped into the clamping slot, and the lock buckle is clamped into the clamping gap, so that the second clamping positioning of the needle holder is realized.

[0021] Preferably, the upper inner side of the barrier is provided with a fifth sealing ring, and the fifth sealing ring is integrally formed with the barrier by a two-color injection molding process.

[0022] The lower stop of the shell extends into the barrier, and the fifth sealing ring is sleeved on the outer side of the lower stop of the shell.

[0023] Preferably, the clamping gap is arranged on the outer side of the lower part of the needle holder, the number of lock buckles is 2, and the 2 lock buckles are symmetrically arranged on the inner wall of the barrier.

[0024] The 2 lock buckles are in the shape of a single-log bridge.

[0025] The 2 lock buckles are in the shape of a single-log bridge and have a certain deformation capacity, and can be elastically locked with the clamping gap.

[0026] Preferably, the number of clamping gaps is 2, and the 2 clamping gaps are symmetrically arranged on the two sides of the lower part of the needle holder.

[0027] The number of lock buckles is 1 group, 1 group of lock buckles includes 2 symmetrically arranged L-shaped extension beams, each L-shaped extension beam is locked in a clamping gap, and the second clamping positioning of the needle holder is realized.

[0028] The number of lock buckles is 2 groups, each group of lock buckles includes 2 front and rear symmetrically (when the barrier is vertically placed, the front and rear are positioned left and right) arranged L-shaped extension beams, and the 2 groups of lock buckles are symmetrically arranged on the two sides of the barrier.

[0029] The two L-shaped extension beams of one group of lock buckles are respectively locked in a clamping gap, and the second clamping positioning of the needle holder is realized.

[0030] Preferably, the spring needle is arranged on the upper part of the shell, and after the spring needle is inserted into the corresponding connecting hole of the implantable biological sensor main control assembly, the implantable biological sensor main control assembly changes from a disconnected state to a connected state.

[0031] The application also provides a biological information monitoring device (also called a transmitter in the industry), which contains an implantable sensing electrode, the implantable sensing electrode is used for being inserted into the subcutaneous part of a human body, the transmitter can obtain physiological parameters of the human body and transmit the obtained physiological parameters of the human body to other receiving devices, and the receiving device can be a special device, a smart mobile terminal (mobile phone) or a remote terminal.

[0032] Preferably, the implantable biosensor master assembly comprises a high-reliability implantable biosensor assembly, the implantable sensing electrode is arranged in the high-reliability implantable biosensor assembly, a part of the shell of the high-reliability implantable biosensor assembly is assembled into the implantable biosensor master assembly, and the high-reliability implantable biosensor assembly provides physiological information parameters to the implantable biosensor master assembly.

[0033] The present application has the advantages that the present application discloses a high-reliability implantable biosensor assembly and a biological information monitoring device, the shell is provided with a needle passing hole, the first sealing ring is arranged in the needle passing hole, the sensing section of the implantable sensing electrode extends out of the shell, the implantation needle of the needle assisting assembly is semi-enclosed outside the sensing section, and the barrier is detachably enclosed outside the implantation needle and the sensing section; the lower rubber ring sleeve part of the needle assisting seat passes through and is sleeved in the first sealing ring, thereby achieving the first clamping positioning of the needle assisting seat; the inner wall of the barrier is provided with a lock catch, the lower part of the needle assisting seat is provided with a clamping gap, the lock catch is clamped in the clamping gap, thereby achieving the second clamping positioning of the needle assisting seat, the needle assisting seat is clamped twice, high reliability and good sealing performance can be achieved, the implantable biosensor assembly and the master control circuit are designed in a split type and can be assembled, the implantable biosensor assembly can be replaced, the master control circuit assembly can be used multiple times, and the cost is lower. BRIEF DESCRIPTION OF DRAWINGS

[0034] The present application will be further described below with reference to the drawings.

[0035] Figure 1 is a structural schematic view of the barrier, the needle assisting seat, the shell and the spring needle of the high-reliability implantable biosensor assembly.

[0036] Figure 2 is a structural schematic view of the barrier of the fourth embodiment of the high-reliability implantable biosensor assembly.

[0037] Figure 3 is a structural schematic view of the first embodiment of the high-reliability implantable biosensor assembly.

[0038] Figure 4 is a structural schematic view of the shell and the needle assisting assembly of the first embodiment of the high-reliability implantable biosensor assembly.

[0039] Figure 5 is a structural schematic view of the implantable sensing electrode of the high-reliability implantable biosensor assembly.

[0040] Figure 6It is a structure schematic view of the high-reliability implantable biosensor assembly and the biological information monitoring device after assembly.

[0041] Figure 7 It is a partial structure schematic view of the third embodiment of the high-reliability implantable biosensor assembly.

[0042] Figure 8 It is a structure schematic view of the high-reliability implantable biosensor assembly and the implantable biosensor main control assembly.

[0043] Figure 9 It is a structure schematic view of the needle assisting assembly of the high-reliability implantable biosensor assembly.

[0044] In the figure:

[0045] 1 - shell; 11 - screw-in clamping groove; 12 - needle passing hole; 121 - first sealing ring; 125 - vertical guide section; 19 - clamping clasp; 3 - implantable sensing electrode; 31 - sensing section; 4 - barrier; 42 - second sealing ring; 43 - screw-in clasp; 45 - lock catch;

[0046] 451 - L-shaped extension beam; 48 - fifth sealing ring; 49 - clamping clasp; 5 - needle assisting assembly; 51 - implanting needle; 52 - needle assisting seat; 521 - rubber ring sleeve joint; 522 - clasp; 523 - vertical guide part; 7 - implantable biosensor main control assembly; 8 - spring needle. DETAILED DESCRIPTION

[0047] The following will be described in combination with the accompanying Figures 1-9 The high-reliability implantable biosensor assembly is further described.

[0048] The present application provides a high-reliability implantable biosensor assembly.

[0049] Embodiment one

[0050] The high-reliability implantable biosensor assembly comprises a shell 1, further comprising an implantable sensing electrode 3, a barrier 4 and a needle assisting assembly 5, the needle assisting assembly 5 comprising an implanting needle 51 and a needle assisting seat 52, the shell 1 is provided with a needle passing hole 12, and the needle passing hole 12 is provided with a first sealing ring 121.

[0051] The sensing section 31 of the implantable sensing electrode 3 extends out of the shell 1, the implanting needle 51 of the needle assisting assembly 5 is half-enclosed outside the sensing section 31, and the barrier 4 is detachably enclosed outside the implanting needle 51 and the sensing section 31.

[0052] The lower rubber ring sleeve part 521 of the needle holder 52 passes through and is sleeved in the first sealing ring 121, to achieve the first clamping positioning of the needle holder 52.

[0053] The inner wall of the barrier 4 is provided with a lock catch 45, and the lower part of the needle holder 52 is provided with a clamping gap 522, the lock catch 45 is clamped in the clamping gap

[0054] 522, to achieve the second clamping positioning of the needle holder 52.

[0055] The two clamping positionings of the needle holder 52 can improve the positioning accuracy and sealing performance of the needle holder, so that the sensing section 31 of the implantable sensing electrode 3 can be stored in a sterile environment for a long time; through the second clamping of the needle holder 52 by the barrier 4, the barrier 4 can also be removed before implantation, and the clamping of the needle holder 52 is released, to facilitate the needle withdrawal action during needle withdrawal.

[0056] In the embodiment, the upper outer side of the barrier 4 is provided with two or more than two rotating buckles 43, the bottom of the shell 1 is provided with a rotating clamping groove 11, the rotating buckle 43 is rotated and clamped in the rotating clamping groove 11, to realize the assembly of the barrier 4 relative to the shell 1.

[0057] The rotating buckle 43 is rotated and clamped in the rotating clamping groove 11 at the same time, and the lock catch 45 is rotated and clamped in the clamping gap 522, to achieve the second clamping positioning of the needle holder 52. Through the rotating and clamping mode, the assembly reliability is high, the assembly tightness is good, and the sealing performance of the assembly is easy to realize.

[0058] Through the structure, the rotating and clamping process is gradually clamped, the slot of the rotating clamping groove 11 gradually becomes smaller, so that the rotating buckle 43 is gradually locked, and the clamping force can be designed according to the needs.

[0059] In the embodiment, the head of the barrier 4 is provided with a second sealing ring 42, and the second sealing ring 42 is integrally formed with the barrier 4 by using a two-color injection molding process; the second sealing ring 42 is extruded between the head of the barrier 4 and the bottom of the shell 1. In the process of rotating and clamping, the second sealing ring 42 plays a role, the structure is reliable, and the sealing performance is high.

[0060] In the embodiment, the lower part of the needle holder 52 includes a vertical guide part 523, the needle hole 12 includes a vertical guide section 125, and the vertical guide part 523 is gap assembled or transition assembled in the vertical guide section 125; the vertical guide part 523 is located in the upper part of the rubber ring sleeve part 521.

[0061] In this embodiment, the spring needle 8 is arranged on the upper part of the shell 1, and after the spring needle 8 is inserted into the corresponding connecting hole of the implantable biosensor master control assembly 7, the implantable biosensor master control assembly 7 changes from the off state to the on state.

[0062] The sensing segment 31 of the implantable sensing electrode 3 extends out of the shell 1, the implantation needle 51 of the needle assembly 5 is half-enclosed outside the sensing segment 31, and the barrier 4 is detachably sealed outside the implantation needle 51 and the sensing segment 31, and the implantation needle 51 is used to assist the sensing segment 31 to penetrate into the subcutaneous tissue of the human body.

[0063] The output pad 32 of the implantable sensing electrode 3 is connected to the assembly chip 2 through the connector 6; the implantable sensing electrode 3 includes a vertical segment and a horizontal segment, the vertical segment is used to penetrate into the subcutaneous tissue of the human body, the output pad 32 is arranged on the horizontal segment, the horizontal segment serves as an adapter, and the number of output pads 32 is generally two or more, including a working electrode and a reference electrode, and can also include a counter electrode and a standby electrode.

[0064] In this embodiment, the connector 6 includes a bottom connecting piece 61 and a circuit board 62, the bottom connecting piece 61 is provided with a clamping groove 611, and the two side walls or one side wall of the clamping groove 611 extends out of a clamping contact head 612;

[0065] The output pad 32 of the implantable sensing electrode 3 is two or more, and the output pad 32 is located on both sides or one side of the adapter segment 33 of the implantable sensing electrode 3; at least part of the adapter segment 33 is located in the clamping groove 611, the clamping contact head 612 is pressed and contacted on the output pad 32; the upper contact of the bottom connecting piece 61 is bonded or welded at the bottom pad of the circuit board 62, and the upper contact is connected to the clamping contact head 612 through the internal lead (internal conductor structure).

[0066] The sensing segment 31 is implanted into the subcutaneous tissue (tissue) of the human body, the assembly chip 2 converts the biological signal collected by the sensing segment 31 into an electrical signal, the electrical signal is a current signal, a resistance signal or an inductance signal, performs first data processing, improves the accuracy and accuracy of measurement, and facilitates subsequent data processing.

[0067] The output pad 32 and the connector 6 are located inside the shell 1, the output terminal of the assembly chip 2 or the external pad 65 of the connector 6 leaks out of the shell 1, and is used to be connected with the master control circuit part of the transmitter.

[0068] The external pad 65 is used for assembly with the implantable biosensor master control assembly 7, the implantable biosensor master control assembly 7 comprising a master control housing 71 and a master control PCBA 72, and the bottom of the master control PCBA 72 is provided with a master control contact bump 721; the master control contact bump 721 is correspondingly connected (or welded or bonded) with the external pad 65 in a press contact manner, after the connection, the master control PCBA 72 enters a communication state and starts to be powered on, before the press contact connection, the master control PCBA 72 is in an open circuit state and does not consume power, thereby the shelf life of the product can be prolonged; after the implantable biosensor master control assembly is assembled with the general implantable biosensor assembly, an implantable monitoring device (transmitter) is formed, the sensing section 31 is implanted subcutaneously in a human body or an animal under the guidance of the implantation needle 51, is used for monitoring biological information and physiological parameters of the human body or the animal, and transmits signals through the master control circuit of the transmitter to a display terminal, an intelligent mobile terminal or a remote terminal.

[0069] Embodiment two

[0070] In this embodiment, the card notch 522 is arranged on the outer side of the lower part of the needle holder 52, the number of the lock catches 45 is two, and the two lock catches 45 are symmetrically arranged on the inner wall of the barrier 4, only one lock catch 45 cooperates with the card notch 522, and the other one is redundant.

[0071] The two lock catches 45 are symmetrically arranged on the inner wall of the barrier 4, and the structure has good symmetry and is convenient to manufacture; only one lock catch 45 cooperates with the card notch 522, and the other one is redundant, the structure is symmetrical and convenient to assemble, and the assembly efficiency can be improved.

[0072] Embodiment three

[0073] In this embodiment, the head of the barrier 4 is provided with two or more than two clamping buckles 49, the bottom of the shell 1 is provided with a clamping card slot 19, the clamping buckle 49 is clamped into the clamping card slot 19, and the assembly of the barrier 4 relative to the shell 1 is realized.

[0074] When the clamping buckle 49 is clamped into the clamping card slot 19, the lock catch 45 is clamped into the card notch 522, and the second clamping positioning of the needle holder 52 is realized.

[0075] In this embodiment, the upper inner side of the barrier 4 is provided with a fifth sealing ring 48, and the fifth sealing ring 48 is integrally formed with the barrier 4 by using a double-color injection molding process.

[0076] The lower stopper of the shell 1 extends into the barrier 4, and the fifth sealing ring 48 is sleeved on the outer side of the lower stopper of the shell 1, and the reliability is high.

[0077] In this embodiment, the card notch 522 is arranged on the outer side of the lower part of the needle holder 52, the number of the lock catches 45 is two, and the two lock catches 45 are symmetrically arranged on the inner wall of the barrier 4, only one lock catch 45 cooperates with the card notch 522, and the other one is redundant.

[0078] The two buckles 45 are in the shape of a single-arch bridge.

[0079] The two buckles 45 are in the shape of a single-arch bridge, have a certain deformation ability, and can be elastically locked in the clamping defects 522.

[0080] Embodiment Four

[0081] In this embodiment, the number of clamping defects 522 is two, and the two clamping defects 522 are symmetrically arranged on both sides of the lower part of the needle holder 52,

[0082] The number of buckles 45 is one group, and the one group of buckles 45 includes two symmetrically arranged L-shaped extension beams 451, each of which is locked at a clamping defect 522 to achieve the second clamping positioning of the needle holder 52; or,

[0083] The number of buckles 45 is two groups, and each group of buckles 45 includes two L-shaped extension beams 451 arranged symmetrically in front and back (the front and back and left and right are positioned when the barrier 4 is placed vertically), and the two groups of buckles 45 are symmetrically arranged on both sides of the barrier 4; the two L-shaped extension beams 451 of one group of buckles 45 are respectively locked at a clamping defect 522 to achieve the second clamping positioning of the needle holder 52; the two L-shaped extension beams 451 of the other group of buckles 45 are redundantly arranged.

[0084] In this embodiment, it also includes a spring needle 8, which is arranged at the upper part of the shell 1, and after the spring needle 8 is inserted into the corresponding connecting hole of the implantable biosensor main control assembly 7, the implantable biosensor main control assembly 7 changes from a disconnected state to a connected state.

[0085] A biological information monitoring device includes an implantable biosensor main control assembly 7, and also includes a high-reliability implantable biosensor assembly, part of the shell 1 is assembled into the implantable biosensor main control assembly 7, and the high-reliability implantable biosensor assembly provides physiological information parameters to the implantable biosensor main control assembly 7.

[0086] A high-reliability implantable biosensor assembly includes a shell 1, and also includes an implantable sensing electrode 3, a barrier 4, and a needle assembly 5, the needle assembly 5 includes an implantable needle 51 and a needle holder 52, the shell 1 is provided with a needle passing hole 12, and the needle passing hole 12 is provided with a first sealing ring 121;

[0087] The sensing section 31 of the implantable sensing electrode 3 extends out of the shell 1, the implantable needle 51 of the needle assembly 5 is semi-enclosed outside the sensing section 31, and the barrier 4 is detachably enclosed outside the implantable needle 51 and the sensing section 31;

[0088] The lower rubber ring sleeve part 521 of the needle holder 52 passes through and is sleeved in the first sealing ring 121 to achieve the first clamping positioning of the needle holder 52;

[0089] The inner wall of the barrier 4 is provided with a lock catch 45, the lower part of the needle holder 52 is provided with a clamping gap 522, the lock catch 45 is clamped at the clamping gap 522, and the second clamping positioning of the needle holder 52 is realized.

[0090] The two clamping positionings of the needle holder 52 can improve the positioning accuracy and sealing performance of the needle holder, so that the sensing section 31 of the implantable sensing electrode 3 can be stored in a sterile environment for a long time; through the second clamping of the needle holder 52 by the barrier 4, the barrier 4 can be removed before implantation, and the clamping of the needle holder 52 is released, which is convenient for the needle withdrawal action.

[0091] In the embodiment, the number of clamping gaps 522 is 2, and the two clamping gaps 522 are symmetrically arranged on both sides of the lower part of the needle holder 52,

[0092] The number of lock catches 45 is 1 group, and the 1 group of lock catches 45 includes two symmetrically arranged L-shaped extension beams 451, each L-shaped extension beam 451 is locked at one clamping gap 522, and the second clamping positioning of the needle holder 52 is realized; or,

[0093] The number of lock catches 45 is 2 groups, each group of lock catches 45 includes two front and rear symmetrically (the front and rear left and right are positioned when the barrier 4 is vertically placed) arranged L-shaped extension beams 451, and the two groups of lock catches 45 are symmetrically arranged on both sides of the barrier 4; the two L-shaped extension beams 451 of one group of lock catches 45 are respectively locked at one clamping gap 522, and the second clamping positioning of the needle holder 52 is realized; the two L-shaped extension beams 451 of the other group of lock catches 45 are redundantly arranged.

[0094] In the embodiment, the spring needle 8 is also included, the spring needle 8 is arranged on the upper part of the shell 1, after the spring needle 8 is inserted into the corresponding connecting hole of the implantable biosensor main control assembly 7, the implantable biosensor main control assembly 7 changes from the open circuit state to the continuous state.

[0095] The above only describes the preferred embodiments of the present application, and it should be pointed out that for ordinary skilled in the art, without departing from the principles of the present application, a number of improvements can also be made, and these improvements should be considered as the protection scope of the present application.

Claims

1. An implantable biosensor assembly with high reliability, comprising a housing (1), characterized in that, It also comprises an implantable sensing electrode (3), a barrier (4) and a needle-assisting assembly (5), the needle-assisting assembly (5) comprising an implanting needle (51) and a needle-assisting seat (52), the shell (1) is provided with a needle passing hole (12), the needle passing hole (12) is provided with a first sealing ring (121) therein; The sensing section (31) of the implantable sensing electrode (3) extends out of the shell (1), the implanting needle (51) of the needle-assisting assembly (5) is semi-enclosed outside the sensing section (31), and the barrier (4) is detachably enclosed outside the implanting needle (51) and the sensing section (31); The implantable sensing electrode (3) comprises a vertical section and a horizontal section, the vertical section is used for piercing into the human body subcutaneously, and the horizontal section serves as an adapter; The lower rubber ring sleeve part (521) of the needle-assisting seat (52) passes through and sleeves in the first sealing ring (121), thereby achieving the first clamping positioning of the needle-assisting seat (52); The inner wall of the barrier (4) is provided with a lock catch (45), the lower part of the needle-assisting seat (52) is provided with a clamping gap (522), the lock catch (45) is clamped at the clamping gap (522), thereby achieving the second clamping positioning of the needle-assisting seat (52); The upper outer side of the barrier (4) is provided with two or more than two rotating buckles (43), the bottom of the shell (1) is provided with a rotating clamping groove (11), the rotating buckles (43) are rotated and clamped in the rotating clamping groove (11), thereby achieving the assembly of the barrier (4) relative to the shell (1); While the rotating buckles (43) are rotated and clamped in the rotating clamping groove (11), the lock catch (45) is rotated and clamped in the clamping gap (522), thereby achieving the second clamping positioning of the needle-assisting seat (52).

2. The high-reliability implantable biosensor assembly of claim 1, wherein the biocompatible material is a biocompatible polymer. The head of the barrier (4) is provided with a second sealing ring (42), the second sealing ring (42) is integrally formed with the barrier (4) by using a two-color injection molding process; The second sealing ring (42) is extruded between the head of the barrier (4) and the bottom of the shell (1).

3. The high-reliability implantable biosensor assembly of claim 1, wherein the biocompatible material is a biocompatible polymer. The lower part of the needle-assisting seat (52) comprises a vertical guide part (523), the needle passing hole (12) comprises a vertical guide section (125), and the vertical guide part (523) is gap-fitted or transition-fitted in the vertical guide section (125); The vertical guide part (523) is located at the upper part of the rubber ring sleeve part (521).

4. The high-reliability implantable biosensor assembly of claim 1, wherein the biocompatible material is a biocompatible polymer. The clamping gap (522) is arranged on the outer side of the lower part of the needle-assisting seat (52), the number of the lock catches (45) is two, and the two lock catches (45) are symmetrically arranged on the inner wall of the barrier (4), only one lock catch (45) cooperates with the clamping gap (522), and the other one is redundant.

5. The high-reliability implantable biosensor assembly of claim 1, wherein the biocompatible material is a biocompatible polymer. The head of the barrier (4) is provided with two or more than two clamping buckles (49), the bottom of the shell (1) is provided with a clamping groove (19), the clamping buckles (49) are clamped in the clamping groove (19), thereby achieving the assembly of the barrier (4) relative to the shell (1); The locking buckle (45) is inserted into the card gap (522) while the clamping buckle (49) is clamped into the clamping slot (19), thereby achieving the second clamping positioning of the needle holder (52).

6. The high-reliability implantable biosensor assembly of claim 5, wherein the biocompatible material is a biocompatible polymer. The upper inner side of the barrier (4) is provided with a fifth sealing ring (48) which is integrally formed with the barrier (4) by a two-color injection molding process. The lower stopper of the shell (1) extends into the barrier (4), and the fifth sealing ring (48) is sleeved on the outer side of the lower stopper of the shell (1).

7. The high-reliability implantable biosensor assembly of claim 6, wherein the biocompatible material is a biocompatible polymer. The card gap (522) is arranged on the outer side of the lower part of the needle holder (52), and the number of the locking buckles (45) is two, and the two locking buckles (45) are symmetrically arranged on the inner wall of the barrier (4), only one locking buckle (45) cooperates with the card gap (522), and the other one is redundant. The two locking buckles (45) are in the shape of a single log bridge.

8. The high-reliability implantable biosensor assembly of claim 6, wherein the biocompatible material is a biocompatible polymer. The number of the card gaps (522) is two, and the two card gaps (522) are symmetrically arranged on both sides of the lower part of the needle holder (52), The number of the locking buckles (45) is one group, and one group of the locking buckles (45) includes two symmetrically arranged L-shaped extension beams (451), each L-shaped extension beam (451) is locked at one card gap (522), thereby achieving the second clamping positioning of the needle holder (52); or, The number of the locking buckles (45) is two groups, each group of the locking buckles (45) includes two L-shaped extension beams (451) which are symmetrically arranged in front and back (the front and back and left and right are used for positioning when the barrier (4) is vertically placed), and the two groups of the locking buckles (45) are symmetrically arranged on both sides of the barrier (4); the two L-shaped extension beams (451) of one group of the locking buckles (45) are respectively locked at one card gap (522), thereby achieving the second clamping positioning of the needle holder (52); the two L-shaped extension beams (451) of the other group of the locking buckles (45) are redundantly arranged.

9. The high-reliability implantable biosensor assembly of claim 1, wherein the biocompatible material is a biocompatible polymer. A spring needle (8) is further included, the spring needle (8) is arranged on the upper part of the shell (1), after the spring needle (8) is inserted into the corresponding connecting hole of the implantable biological sensor main control assembly (7), the implantable biological sensor main control assembly (7) changes from a disconnected state to a connected state.

10. A biological information monitoring apparatus comprising an implantable biological sensor master assembly (7), characterized by The implantable biological sensor assembly with high reliability in any one of claims 1-9 is further included, part of the shell (1) is assembled into the implantable biological sensor main control assembly (7), and the implantable biological sensor assembly with high reliability provides physiological information parameters to the implantable biological sensor main control assembly (7).

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