An analyte level monitoring system

Abstract

The application discloses an analyte level monitoring system, comprising a transmitter mechanism, at least including an implantable skin sensor and a thickness detection unit; an adjustable guide needle mechanism for driving the guide needle to form a cavity for the sensor to extend into; a needle pulling piece; a firing module; according to the skin thickness detected by the thickness detection unit, the guide needle is adjusted to a target extension length, and the transmitter mechanism adjusts the sensor to the target extension length; the locking of the firing module is released, the firing module is lowered with the transmitter mechanism, until the transmitter mechanism is separated from the firing module, the firing module releases the clamping of the needle pulling piece, and the needle pulling piece is reset. The application realizes the purpose of adjusting the implantation depth of the sensor according to the differences of individual skin thickness, so that the sensor is accurately implanted to the target depth, and the accuracy of subsequent subcutaneous monitoring data is ensured.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of continuous glucose monitoring, and particularly relates to an analyte level monitoring system. BACKGROUND

[0002] CGMS refers to implanting a glucose sensor into the subcutaneous tissue of a user, contacting the biosensor implanted in the skin with tissue fluid, generating an electric current signal, and transmitting the generated electric current signal to a fixed receiver fixed on the skin, and the fixed receiver converts the electric current signal into a digital signal, and then converts the digital signal into a blood glucose concentration value. The continuous glucose monitoring system CGMS can provide continuous and comprehensive blood glucose information, which can be metaphorically described as a "blood glucose electrocardiogram". Similar to an electrocardiogram, the CGMS can obtain a blood glucose fluctuation graph of a patient during wearing, and can understand the relationship between food types, exercise types, drug types, mental factors, lifestyles and blood glucose fluctuations of the patient, help to develop an individualized treatment plan, improve treatment compliance, and serve as a visual tool for diabetes treatment.

[0003] The CGMS generally comprises a minimally invasive implantable "needle type" electrochemical glucose sensor based on GOx implanted in the subcutaneous tissue of a human body, a set of wireless or wired signal detection and transmission / recording devices (transmitter), and a processor (usually placed in an App or receiver) for converting the detected electric current signal into a glucose concentration. In general, a needle inserter is also required to implant the sensor into the subcutaneous tissue. The sensor is inserted into the subcutaneous tissue by the needle inserter, and an electric signal is formed when the sensor reacts with the glucose in the tissue fluid of the patient, and the electric signal is converted into a blood glucose reading, which is then transmitted to the receiver by the transmitter. Under the guidance of these data and intuitive graphs, a clinician can comprehensively understand the 24-hour blood glucose fluctuation of a patient, and can inject insulin into the patient in cooperation with an insulin pump if necessary.

[0004] Generally, the working electrode of the CGMS sensor is composed of a surface metal layer, an inner layer, an enzyme layer and an outer membrane. Dissolved oxygen in the interstitial fluid (ISF) and glucose penetrate into the enzyme layer through the outer membrane, the glucose molecules react with the enzyme to produce electrically active reaction products hydrogen peroxide and gluconic acid, the hydrogen peroxide diffuses inward and outward, and the part diffusing inward reaches the electrode surface to form an electrode current. The current is approximately linearly related to the glucose concentration within a certain range, so that the glucose concentration can be converted by the size of the current value.

[0005] At present, except Dexcom company uses flexible noble metal alloy wire as sensor substrate material, other companies basically use flexible substrate material PI or PET, then realize electrode preparation after metalization and patterning, sensor probe is sleeved into semi-closed needle before implantation, under the action of needle holder, semi-closed needle wraps sensor probe into subcutaneous tissue, and then semi-closed needle is also taken out, and sensor probe is successfully implanted into subcutaneous tissue.

[0006] The thickness of subcutaneous tissue can vary greatly due to differences in gender, body part and body mass index. Generally, the thickness of the skin is detected using the property of red light that can penetrate human tissue. Some use ultrasonic detection waves and ultrasonic echo signals to detect skin thickness.

[0007] CGMS can correctly reflect the change of human blood glucose, which is based on the assumption that the glucose concentration in intercellular fluid is very similar to the blood glucose concentration. The basic basis is that the glucose in the interstitial fluid derived from the human capillary blood and the blood glucose show a high correlation. Through the calibration of the reference blood glucose value, the current generated by the biochemical reaction of glucose in the interstitial fluid can be converted into the blood glucose detection value. This requires that the closer the sensor is to the part with rich capillaries, the higher the accuracy. Since the CGMS sensor is usually required to be implanted in the subcutaneous fat layer, different individuals have different body conditions, and the thickness of the fat layer and the richness of the capillaries are different. Human fat usually has white and brown two kinds, among which: white fat accumulates in the subcutaneous tissue, responsible for storing excess energy, also forming unsightly adipose tissue; Brown fat cells contain a large number of mitochondria, and capillaries are rich, so the brown fat part or the junction of white fat and brown fat is the recommended implantation site of CGMS sensor. The adjustment of the implantation depth of the sensor helps to obtain the maximum effective area of the sensor and ensure the sensitivity and accuracy of the sensor.

[0008] At present, the length of the flexible sensor probe and the guide needle implanted in the skin of the patient in some continuous blood glucose monitoring system CGMS (Continuous Glucose Monitoring System) products at home and abroad is not variable, generally implanted in the human skin 5mm. But the thickness of human skin varies from person to person, and the thickness of skin varies with race, age, gender, location, etc. It is not the same, usually 0.5-4mm (not including subcutaneous fat layer), so the depth of the flexible sensor probe and the guide needle implanted in the human body may not match the thickness of the skin of all users, causing some diabetic patients to have a deeper wound and experience a less accurate blood glucose monitoring value. SUMMARY

[0009] In order to overcome the deficiencies of the prior art, the present application provides an analyte level monitoring system, which can accurately adjust the sensor implantation depth and the guide needle implantation depth, accurately monitor blood glucose, and has a simple structure.

[0010] The present application solves the technical problems by adopting the following technical solution: an analyte level monitoring system, comprising:

[0011] A transmitter mechanism, at least comprising a sensor implantable in the skin, and a thickness detection unit for detecting the thickness of the human skin;

[0012] An adjustable guide needle mechanism for driving the guide needle to extend or retract, the guide needle forming a cavity for the sensor to extend into;

[0013] A needle pulling member for clamping or releasing the adjustable guide needle mechanism;

[0014] A firing module axially translatable for clamping or releasing the transmitter mechanism, and for clamping or releasing the needle pulling member;

[0015] According to the thickness of the human skin detected by the thickness detection unit, the guide needle is adjusted to a target extension length, and the transmitter mechanism adjusts the sensor to a target extension length;

[0016] The firing module is unlocked, the firing module with the transmitter mechanism is lowered until the transmitter mechanism is separated from the firing module, the firing module releases the clamping of the needle pulling member, and the needle pulling member is reset.

[0017] Further, the transmitter mechanism further comprises a power device for driving the sensor to extend and retract, which at least comprises a straight tooth section, a transmission rod engageable with the straight tooth section for transmission, and a power source for driving the transmission rod to rotate, when the transmission rod rotates circumferentially, the straight tooth section linearly reciprocates to drive the sensor to extend and retract. The engagement and transmission of the straight tooth section and the transmission rod have good instantaneous transmission accuracy, transmission stability and reverse locking characteristics, and the transmission effect is good.

[0018] Further, the calculation formula of the sensor extension length is movement The sensor fine adjustment is accurate, the implantation depth in the skin is accurate, and the subsequent monitoring value is more accurate.

[0019] Further, the calculation formula of the sensor retraction length is L=n*P, wherein n is the number of revolutions, and P is the pitch.

[0020] Further, the rotation speed of the transmission rod is 15-30 rpm / min or 60-100 rpm / min. The sensor is withdrawn at a relatively fast speed, which can reduce the pain and foreign body sensation of the user, and avoid the pain, bleeding amount and potential infection risk caused by directly pulling the emitter. The extension and retraction speed of the sensor is relatively small, which reduces the pain and foreign body sensation of the user.

[0021] Further, the emitter mechanism further comprises an adjusting mechanism, which at least comprises an adjusting knob, an elastic button arranged on the adjusting knob, and a locking unit, the elastic button extends from a sliding groove of the shell; an external force is applied on the elastic button to switch the locking unit from the locked state to the unlocked state, and the elastic button can move along the sliding groove, and the adjusting knob moves with the sensor to realize extension and retraction.

[0022] The up-down adjustment of the implanted electrode is converted into left-right translation adjustment, so that the thickness of the emitter mechanism does not need to be thickened, the wearing experience is better, the operation is more convenient and reliable, the structure is more light and simple, and the manufacturing cost is relatively reduced.

[0023] Further, the locking unit comprises a fixed sawtooth segment arranged on the shell and a sliding tooth arranged on the adjusting knob, in the locked state, the sliding tooth falls into the fixed sawtooth segment to form engagement, and in the unlocked state, the sliding tooth is separated from the fixed sawtooth segment.

[0024] Further, the sliding groove extends along the length direction of the shell, and a scale area is arranged at the corresponding position of the sliding groove; the length of the sliding groove is 2-10 mm, and the interval of the scale lines of the scale area is 0.04-0.40 mm. The extension and retraction length of the sensor is adjusted according to the scale lines, which is more intuitive, reliable and convenient to operate.

[0025] Further, the inner shell is arranged in the outer shell, the trigger button, and the adjusting knob; the outer shell is formed with an adjusting knob connecting end and a trigger button connecting end, the trigger button is rotatably connected to the trigger button connecting end, the adjusting knob is rotatably connected to the adjusting knob connecting end, and the adjustable guide needle mechanism is connected to the adjusting knob;

[0026] Further, the inner shell comprises an upper body and a lower body, the inner diameter of the lower body is greater than that of the upper body; the firing module inner shell is axially translated, the lower body releases the limitation of the firing module, the emitter mechanism is separated from the firing module, and the limitation of the emitter structure and the clamping of the needle pulling element are released.

[0027] Further, the adjustable guide needle mechanism comprises a movable needle base connected with the adjusting knob, a fixed needle base rotationally connected with the movable needle base, and a guide needle, and rotation of the movable needle base in the circumferential direction can drive the guide needle to move up and down; the movable needle base is internally formed with an internal thread, the guide needle is formed with an external thread, and the fixed needle base is internally formed with a movable needle base cavity; the movable needle base or / and the fixed needle base is formed with a connecting leg to realize axial positioning of the movable needle base and the fixed needle base.

[0028] Further, the transmitter mechanism further comprises a buzzer, and when the blood glucose deviates from the set critical value, the control processor drives the buzzer to emit an alarm sound and sends a signal to the outside world.

[0029] Only by slightly rotating the adjusting knob, the guide needle can move up and down, which is easy to operate and convenient for the user to adjust the implantation length of the guide needle according to the skin measurement thickness, thereby reducing the discomfort of the customer due to the over-deep needle insertion; the implantation depth of the guide needle can be conveniently and quickly adjusted, which cooperates with the accurate implantation of the sensor into the target depth, thereby ensuring the accuracy of the subsequent subcutaneous monitoring data, and the structure is simple and convenient to operate, and the telescopic length of the guide needle is intuitively displayed.

[0030] The beneficial effects of the present application are as follows: 1) the human skin thickness detected by the thickness detection unit realizes the purpose of adjusting the implantation depth of the sensor according to the difference of individual skin thickness, so that the sensor is accurately implanted into the target depth, thereby ensuring the accuracy of the subsequent subcutaneous monitoring data; 2) the design of the adjustable guide needle mechanism can adjust the guide needle with different implantation lengths in production, and then be configured with the corresponding transmitter mechanism, so that it can be set for users of various skin thicknesses and various races; the production line and instrument investment are saved, and the customer demand can be better met in production; 3) the cooperation of the adjustable guide needle mechanism and the adjusting knob can realize the up and down movement of the guide needle only by slightly rotating the adjustable guide needle mechanism or the adjusting knob, which is easy to operate and convenient for the user to adjust the implantation length of the guide needle according to the skin measurement thickness, thereby reducing the discomfort of the customer due to the over-deep needle insertion; 4) through the cooperation with the transmitter mechanism, the guide needle and the sensor can be adjusted according to the physical indicators and needs of the user, so that the discomfort and pain of the user are reduced, and the accuracy of the sensor detection is improved; 5) the design of the internal ribs and grooves of the needle assisting device makes the whole needle implantation process more stable, improves the user experience, and at the same time, the structure is also simpler, which reduces the manufacturing complexity and production cost; 6) the design of the locking bracket and the trigger button avoids the accidental triggering of the user, thereby improving the safety of the needle assisting device. BRIEF DESCRIPTION OF DRAWINGS

[0031] Figure 1 It is an exploded structural schematic view of the needle assisting device of the present application.

[0032] Figure 2 It is a perspective view of the adjusting knob in the present application.

[0033] Figure 3 The top view and front view of the adjusting knob in the present application.

[0034] Figure 4 The schematic diagram of the shell in the present application Figure 1 .

[0035] Figure 5 The schematic diagram of the shell in the present application Figure 2 .

[0036] Figure 6 The schematic diagram of the rotating matching structure of the shell and the adjusting knob in the present application.

[0037] Figure 7 The perspective view of the inner shell in the present application.

[0038] Figure 8 The partial sectional schematic diagram of the inner shell in the present application.

[0039] Figure 9 The perspective view of the trigger button in the present application.

[0040] Figure 10 The perspective view of the locking support in the present application.

[0041] Figure 11 The perspective view of the needle pulling piece in the present application.

[0042] Figure 12 The partial sectional schematic diagram of the needle pulling piece in the present application.

[0043] Figure 13 The sectional view of the adjustable guide needle mechanism in the present application.

[0044] Figure 14 The perspective view of the adjustable guide needle mechanism in the present application.

[0045] Figure 15 The working schematic diagram of the adjustable guide needle mechanism in the present application.

[0046] Figure 16 The partial sectional view of the adjustable guide needle mechanism in the present application.

[0047] Figure 17 The perspective view of the firing module in the present application Figure 1 .

[0048] Figure 18 The perspective view of the firing module in the present application Figure 2 .

[0049] Figure 19 The internal sectional view of the working process (the trigger button is pressed to unlock the firing module) in the present application.

[0050] Figure 20 Internal cross-sectional view of the working process (the firing module moves down) of the present application.

[0051] Figure 21 Internal cross-sectional view of the working process (the firing module releases the limit of the launcher mechanism) of the present application.

[0052] Figure 22 Schematic diagram of rotating the adjusting knob during the use of the present application.

[0053] Figure 23 Schematic diagram of the locking bracket releasing the lock of the trigger button during the use of the present application.

[0054] Figure 24 Schematic diagram of placing to the intended implantation site and pressing the trigger button during the use of the present application.

[0055] Figure 25 Schematic diagram of the launcher mechanism of the present application working on the surface of the skin.

[0056] Figure 26 Perspective view of the launcher mechanism of the present application as a manual adjusting structure Figure 1 .

[0057] Figure 27 Perspective view of the launcher mechanism of the present application as a manual adjusting structure Figure 2 .

[0058] Figure 28 Exploded structural schematic diagram of the launcher mechanism of the present application as a manual adjusting structure.

[0059] Figure 29 Partial cross-sectional schematic diagram of the launcher mechanism of the present application as a manual adjusting structure.

[0060] Figure 30 Partial cross-sectional schematic diagram of the launcher mechanism of the present application as a manual adjusting structure, and the corresponding internal plan view in the locked state.

[0061] Figure 31 Partial cross-sectional schematic diagram of the launcher mechanism of the present application as a manual adjusting structure, and the corresponding internal plan view in the state that the sliding tooth is separated from the fixed sawtooth segment.

[0062] Figure 32 Partial cross-sectional schematic diagram of the launcher mechanism of the present application as a manual adjusting structure, and the corresponding internal plan view in the state that the elastic button moves along the sliding groove.

[0063] Figure 33The transmitter mechanism of the present application is a manual adjustment structure, and the partial sectional view and the corresponding internal plan view of the lock unit in the locked state after the sensor retracts to the target length.

[0064] Figure 34 The transmitter mechanism of the present application is a manual adjustment structure, and the perspective view of the adjustment knob.

[0065] Figure 35 The transmitter mechanism of the present application is a manual adjustment structure, and the perspective view of the bottom shell.

[0066] Figure 36 The transmitter mechanism of the present application is a manual adjustment structure, and the perspective view of the outer shell.

[0067] Figure 37 The transmitter mechanism of the present application is a manual adjustment structure, and the schematic view of the sensor.

[0068] Figure 38 The transmitter mechanism of the present application is a manual adjustment structure, and the schematic view of the visual window.

[0069] Figure 39 The transmitter mechanism of the present application is an exploded structural schematic view of an automatic adjustment structure.

[0070] Figure 40 The transmitter mechanism of the present application is a partial sectional view of an automatic adjustment structure.

[0071] Figure 41 The transmitter mechanism of the present application is a schematic view of the power device when the sensor extends in an automatic adjustment structure.

[0072] Figure 42 The transmitter mechanism of the present application is a schematic view of the plan structure when the sensor extends in an automatic adjustment structure.

[0073] Figure 43 The transmitter mechanism of the present application is a schematic view of the power device when the sensor retracts or withdraws in an automatic adjustment structure.

[0074] Figure 44 The transmitter mechanism of the present application is a schematic view of the plan structure when the sensor retracts or withdraws in an automatic adjustment structure.

[0075] Figure 45 The transmitter mechanism of the present application is an automatic adjustment structure, and the perspective view of the control processor.

[0076] Figure 46 The transmitter mechanism of the present application is an automatic adjustment structure, and the perspective view of the bottom shell.

[0077] Figure 47The transmitter mechanism of the present application is an automatic adjustment structure, and a schematic diagram of the cooperation structure of the sensor and the clamping groove.

[0078] Figure 48 The transmitter mechanism of the present application is an automatic adjustment structure, and a sectional view of the bottom shell.

[0079] Figure 49 The transmitter mechanism of the present application is an automatic adjustment structure, and a schematic diagram of the sensor retracting and extending in the channel.

[0080] Figure 50 The transmitter mechanism of the present application is an automatic adjustment structure, and a schematic diagram of the cooperation of the sensor extension process and the needle helper.

[0081] Figure 51 The transmitter mechanism of the present application is an automatic adjustment structure, and a schematic diagram of the structure of the floating ball pressing sensor.

[0082] Figure 52 The transmitter mechanism of the present application is an automatic adjustment structure, and a schematic diagram of the sensor implanted in the human skin.

[0083] Figure 53 The transmitter mechanism of the present application is an automatic adjustment structure, and a schematic diagram of the sensor length. DETAILED DESCRIPTION

[0084] In order to make the personnel in the technical field better understand the present application scheme, the technical scheme in the embodiment of the application will be described clearly and completely in combination with the drawings in the embodiment of the application. Obviously, the described embodiment is only a part of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by the person skilled in the art without creative labor should belong to the scope of protection of the present application.

[0085] As shown in Figure 1 , an analyte level monitoring system includes an adjustment knob 1000, a housing 2000, an inner housing 3000, a trigger button 4000, a locking bracket 5000, a needle pulling piece 6000, a needle pulling spring 7000, a firing spring 8000, an adjustable guide needle mechanism 9000, a firing module 10000, a transmitter mechanism 11000, and a bottom cover 12000.

[0086] As shown in Figure 2 , 3As shown, the adjusting knob 1000 includes a dial 1001, a toothed cylindrical surface 1002, a limiting step 1003, a connecting end 1004, and an adjusting limiting block 1005. The dial 1001 is marked. Rotating the adjusting knob 1000 by one turn can adjust the length of the guide needle 9001 to extend or retract by 2-8 mm, preferably by 4 mm. The initial value of the adjusting knob of the needle assisting device is 4 mm, and the range of the dial 1001 is 4-8 mm. The toothed cylindrical surface 1002 can increase the friction between the adjusting knob 1000 and the user, facilitating the use of the user. The limiting step 1003 is connected to the shell 2000, and the dial 1001 is connected to the shell 2000. The limiting step 1003 and the dial 1001 limit the axial movement of the adjusting knob 1000 to prevent it from being separated from the shell 2000. The connecting end 1004 is connected to the adjustable guide needle mechanism 9000. A material with high friction can be used to make the connecting end 1004 and the adjustable guide needle mechanism 9000 rotate only under the action of a certain external force. The adjusting limiting block 1005 is connected to the adjusting knob stop block 2004 to limit the rotation of the adjusting knob 1000 to ±360°.

[0087] As shown in Figures 4-6 , the shell 2000 includes an adjusting knob connecting end 2001, a trigger button connecting end 2002, a shell connecting end 2003, and an adjusting knob stop block 2004. The adjusting knob connecting end 2001 is connected to the limiting step 1003 of the adjusting knob 1000. The trigger button connecting end 2002 is connected to the trigger button 2000. The shell connecting end 2003 is connected to the inner shell 3000. The adjusting knob stop block 2004 is connected to the adjusting limiting block 1005 to limit the rotation of the adjusting knob 1000 to only 360 degrees clockwise or counterclockwise, and not to rotate clockwise or counterclockwise all the time.

[0088] As shown in Figure 7 , Figure 8 , the inner shell 3000 includes an inner shell connecting end 3001, an adjusting knob channel 3002, a firing shell channel 3003, a needle removal shell guide groove 3004, a firing spring accommodating groove 3005, a firing shell guide rib 3006, a firing shell guide groove 3007, a pawl stop rib 3008, and a thin wall part 3011. The inner shell connecting end 3001 is connected to the shell connecting end 2003 to realize the assembly of the shell 2000 and the inner shell 3000. The firing shell channel 3003 accommodates part of the firing module 1000 and is connected to the firing module 1000 through the firing shell guide rib 3006 and the firing shell guide groove 3007. The needle removal shell guide groove 3004 can realize smooth needle removal. The pawl stop rib 3008 is connected to the firing module 1000 to release the firing module 1000.

[0089] The inner shell 3000 includes an upper body 3009 and a lower body 3010, the inner diameter of which is larger than the inner diameter of the upper body 3009.

[0090] like Figure 9 As shown, the trigger button 4000 includes a trigger surface 4001, a limiting step 4002, a trigger rod 4003, and a limiting post 4004. The trigger surface 4001 is the user-pressable surface, and the surface of the trigger surface 4001 has protrusions to facilitate user pressing and identification of the trigger button 4000. The trigger surface 4001 and the limiting step 4002 are located at both ends of the trigger button connection end 2002. The trigger rod 4003 is in contact with the firing module 10000. Pressing the trigger surface 4001 causes the trigger rod 4003 to press against the firing module 10000.

[0091] like Figure 10 As shown, the locking bracket 5000 includes a clamp 5001 and a magazine 5002. The clamp 5001 is located at the lower end of the trigger surface 4001 and the upper end of the trigger button connection end 2002, locking the trigger button 4000 to prevent accidental triggering by the user. A protrusion may also be provided on the inner side of the clamp 5001, and a groove may be provided on the limiting post 4004. The protrusion of the clamp 5001 and the groove of the limiting post 4004 cooperate to more efficiently lock the trigger button 4000. The magazine 5002 is U-shaped, V-shaped, or other easy-to-operate shape, allowing the user to squeeze the magazine 5002 with one hand to open the clamp 5001 and unlock the trigger button 4000. At this time, the user can press the trigger button 4000 to fire the firing module 10000.

[0092] like Figure 11 , Figure 12 As shown, the needle removal component 6000 includes a guide rib 6001, a sliding inclined surface 6002, a needle removal spring receiving groove 6003, and a three-jaw buckle 6004. The guide rib 6001 cooperates with the needle removal housing guide groove 3004, allowing the needle removal component 6000 to slide up and down within the needle removal housing guide groove 3004, thus achieving smooth needle insertion and removal. The sliding inclined surface 6002 contacts the firing module 1000. The needle removal spring receiving groove 6003 accommodates the needle removal spring 7000, which is in a charged state in its initial state. The three-jaw buckle 6004 cooperates with the adjustable guide needle mechanism 9000.

[0093] like Figures 13-16As shown, the adjustable guide needle mechanism 9000 includes a guide needle 9001, a movable needle seat 9002, and a fixed needle seat 9003. The guide needle 9001 is an open guide needle. The upper end of the guide needle 9001 is provided with external threads. The middle section is a transition smooth surface. The lower end 9007 is an implantation end. The implantation end has a smooth surface and can accommodate a sensor 11003, i.e., forms a cavity for the sensor 11003 of the transmitter mechanism 11000 to extend into. The movable needle seat 9002 further includes a connecting leg 9005 and internal threads 9008. The end of the fixed needle seat 9003 forms a clamping groove. The connecting leg 9005 extends into the internal clamping groove of the fixed needle seat 9003, so that the movable needle seat 9002 can complete rotation in the fixed needle seat 9003. The fixed needle seat 9003 can also be provided with a connecting leg 9005. The end of the movable needle seat 9002 forms a clamping groove. The connecting leg 9005 extends into the internal clamping groove of the movable needle seat 9002, so that the movable needle seat 9002 can complete rotation in the fixed needle seat 9003. Or both the movable needle seat 9002 and the fixed needle seat 9003 are provided with connecting legs 9005. The ends of the movable needle seat 9002 and the fixed needle seat 9003 are provided with clamping grooves. In this embodiment, the ends of the movable needle seat 9002 and the fixed needle seat 9003 form clamping grooves. The movable needle seat 9002 and the fixed needle seat 9003 are both provided with connecting legs 9005 to realize axial positioning of the movable needle seat 9002 and the fixed needle seat 9003. In this embodiment, the connecting leg 9005 is a ring-shaped arc-shaped protrusion.

[0094] The movable needle seat 9002 is connected with the connecting end 1004. The movable needle seat 9002 and the connecting end 1004 are circular or polygonal structures, which can realize rotation-stopping cooperation. They are paired with each other and have a certain elasticity, which can satisfy the disconnection of the movable needle seat 9002 and the connecting end 1004 when the movable needle seat 9002 is subjected to external force. The internal threads 9008 are matched with the external threads on the upper end of the guide needle 9001. The fixed needle seat 9003 has a notch 9004 on the outer surface and has a fixed needle seat cavity 9006 and a guide needle 9001 middle section accommodating groove 9009 in the interior. The notch 9004 is matched with the three-claw buckle 6004 of the needle pulling member to realize clamping of the adjustable guide needle mechanism 9000. When the movable needle seat 9002 is rotated clockwise or counterclockwise, the guide needle 9001 will move up and down on the movable needle seat cavity 9006 due to the threaded connection relationship between the movable needle seat 9002 and the guide needle 9001, realizing adjustment of the length of the implantation part of the guide needle. The guide needle 9001 middle section accommodating groove 9009 is semicircular or other shapes and is matched with the cross section of the middle section of the guide needle 9001, accommodating only the middle section of the guide needle 9001, limiting the shortest length and the longest length of the guide needle 9001 adjustment, so that the implantation action is more stable.

[0095] As Figure 17 , 18As shown, the firing module 10000 includes a needle removal housing clamping buckle 10001, a needle removal spring receiving groove 10002, a chassis guide groove 10003, an elastic claw 10004, a firing spring receiving groove 10005, a guide limiting groove 10006, a trigger buckle 10007, and a needle passage channel 10008. The pin-pulling housing clamping buckle 10001 engages with the sliding inclined surface 6002 to achieve the non-firing state, fixing and limiting the pin-pulling component 6000; the pin-pulling spring receiving groove 10002 accommodates the pin-pulling spring 7000; the chassis guide groove 10003 and the firing housing guide groove 3007 cooperate to complete the axial limitation of the movement of the firing module 10000; the elastic claw 10004 is connected to the adjustable launcher 11000; the firing spring receiving groove 10005 accommodates the firing spring 8000; the guide limiting groove 10006 and the firing housing The guide ribs 3006 cooperate to axially limit the movement of the firing module 10000, making the implantation process more stable. The trigger latch 10007 contacts the firing housing channel 3003 of the inner shell 3000. When not firing, the trigger latch 10007 locks the top edge of the firing housing channel 3003, locking the firing module 10000 and the inner shell 3000 together. The trigger latch 10007 has a certain elasticity. When the trigger rod 403 pushes the trigger latch 10007 away from the top edge of the firing housing channel 3003, the assist needle device fires. At this time, because the thin-walled portion 3011 of the lower inner wall of the lower body 3010 of the inner shell 3000 relaxes its grip on the elastic claw 10004, it subsequently relaxes its grip on the launcher mechanism 11000.

[0096] The working process of this invention is as follows: Figure 19 As shown, when the trigger button 4000 is pressed, the trigger rod 4003 presses against the trigger latch 10007, and the trigger latch 10007 moves away from the edge of the firing housing channel 3003, thus activating the needle assist device.

[0097] like Figure 20 As shown, the trigger latch 10007 releases the restriction on the inner shell 3000. Driven by the spring force of the firing spring 8000, the firing module 10000 moves downward, and the guide pin mechanism 9000 is also driven downward, separating from the connecting end 1004.

[0098] like Figure 21As shown, when the elastic jaw 10004 of the firing module moves to the thin wall part 3011 of the inner shell 3000, the needle pulling shell clamping buckle 10001 of the firing module moves to the lower body 3010, the elastic jaw 1004 releases the limiting of the transmitter mechanism 11000, so that the transmitter mechanism 11000 is attached to the surface of the human skin, the needle pulling shell clamping buckle 10001 releases the limiting of the needle pulling shell 6000, at this time the elastic force of the needle pulling spring 7000 drives the needle pulling shell 6000 to move upward, the needle pulling action is completed, and the sensor 11003 is smoothly implanted into the human body.

[0099] The use process of the present application is as follows: Figure 22 As shown, according to the skin thickness detected by the thickness detection unit, compared with the initial implantation length, the user adjusts the dial 1001 (clockwise / counter clockwise→increase / decrease), and adjusts the implantation length of the guide needle 9001; after the transmitter mechanism 11000 receives the skin thickness detected by the thickness detection unit, the implantation length of the sensor 11003 is automatically adjusted.

[0100] Alternatively, according to the skin thickness detected by the thickness detection unit, compared with the initial implantation length, the user adjusts the dial 1001 (clockwise / counter clockwise→increase / decrease), and manually adjusts the implantation length of the sensor 11003.

[0101] The above-mentioned thickness detection unit can be built-in in the transmitter mechanism, and is used for sending the detected skin thickness signal to the control processor 004. Of course, the thickness detection unit can also be external to the transmitter mechanism. As shown, Figure 23 The user opens the locking support and the bottom cover.

[0102] As shown, Figure 24 The user places the needle assisting device at the expected implantation site, presses the trigger button 4000, and the needle assisting device is fired.

[0103] As shown, Figure 25 The transmitter mechanism 11000 is attached to the skin surface to start working, and the visible window 002 displays the information of the implantation depth of the sensor 11003 into the human skin, the blood glucose value, the blood glucose monitoring curve, the power, the WiFi / Bluetooth connection, etc. When the sensor 11003 is in the adjusting state, the implantation depth data, the power, the WiFi / Bluetooth connection information of 11003 can also be displayed.

[0104] As shown, Figure 26As shown, the transmitter mechanism 11000 includes an adjustment module 11001, an adhesive paper 11002, a sensor 11003, a visual window 11004, and a housing 11005. The adjustment module 11001 is responsible for controlling and processing the adjustment of the length of the sensor 11003; the adhesive paper 11002 is used to adhere the transmitter mechanism 11000 to the surface of the human body; the sensor 11003 is used to detect the blood glucose signal of the human body and to provide energy; the visual window 11004 is used to display the depth of the sensor 11003 implanted in the skin of the human body, the blood glucose value, the blood glucose monitoring curve, the power, the WiFi / Bluetooth connection, and the like.

[0105] The transmitter mechanism 11000 further includes a buzzer. When the blood glucose is higher or lower than a set threshold value, which can be adjusted by the user according to individual needs, the control processor 004 drives the buzzer to emit an alarm sound to remind the wearer, and also drives the wireless device to send a signal to the cloud, which can be a hospital end or a personal user end, and the like.

[0106] In order to adjust the sensor 11003 to the target extension length in the transmitter mechanism 11000 after detecting the thickness of the human skin by the thickness detection unit, both automatic and manual structures can be adopted.

[0107] When the manual structure is adopted, the adjustment module 11001 is an adjustment mechanism, as shown in Figure 27 , Figure 28 The adjustment mechanism at least includes an adjustment knob 007, an elastic button 0071 provided on the adjustment knob 007, and a locking unit. A sliding groove 0081 is formed on the side wall of the housing 11005, which extends along the length direction of the housing 11005, and the elastic button 0071 extends out of the sliding groove 0081 of the housing 11005.

[0108] More specifically, the locking unit includes a fixed sawtooth segment 0085 provided on the inner side wall of the housing 11005, and a sliding tooth 0070 provided on the adjustment knob 007. The fixed sawtooth segment 0085 extends along the length direction of the housing 11005, which is arranged in the sliding groove 0081 and has a length greater than that of the sliding groove 0081, and the fixed sawtooth segment 0085 is provided with a plurality of sawteeth. In the locked state, the sliding tooth 0070 falls into the fixed sawtooth segment 0085 to form engagement; in the elastic button 0071, the sliding tooth 0070 is separated from the fixed sawtooth segment 0085, i.e. the locking unit is switched from the locked state to the unlocked state, and the elastic button 0071 can move along the sliding groove 0081, and the adjustment knob 007 moves with the sensor to realize extension and contraction.

[0109] In the embodiment, the adjusting knob 007 is in U shape, and the opening end of the adjusting knob 007 is provided with elastic buttons 0071 on both sides, or only one side of the opening end is provided with the elastic buttons 0071. The closed end of the adjusting knob 007 is connected with the control processor 004, and the control processor 004 is provided with a clamping groove 005 which can be connected with the sensor.

[0110] As shown in Figure 34 , Figure 28 , the closed end of the adjusting knob 007 is provided with a recess 0072, and the end of the control processor 004 is formed with a convex part 0041 which can be clamped into the recess 0072, so as to realize the connection of the adjusting knob 007 and the control processor 004. The connection of the adjusting knob 007 and the control processor 004 can also be integrally arranged.

[0111] When the external force is applied on the elastic buttons 0071, the opening end of the adjusting knob 007 will be inwardly contracted, and the side of the control processor 004 is formed with a notch groove 0042, so as to provide sufficient movement space for the opening end of the adjusting knob 007.

[0112] In order to intuitively read the extension length of the sensor, the scale area 0082 is arranged at the corresponding position of the sliding groove 0081. The length of the sliding groove 0081 is 2-10 mm, and preferably 3-5 mm. The interval of the scale lines of the scale area 0082 is 0.04-0.40 mm, and preferably 0.04-0.06 mm. In the embodiment, each sliding scale line corresponds to adjusting 0.05 mm, and the adjusting range is 0-4 mm.

[0113] In order to facilitate assembly, the shell 11005 comprises a bottom shell 008 and an outer shell 0086. The upper edge of the bottom shell 008 is formed with a bottom shell stop 0082, and the lower edge of the outer shell 0086 is formed with an outer shell stop 0014 which is attached to the outer wall of the bottom shell stop 0082, so as to realize the assembly connection of the bottom shell 008 and the outer shell 0086. The outer shell 0086 is connected with a visual window 002 which is connected with the control processor 004 through the flexible wire group 003. The outer shell 0086 is also provided with a needle hole 0012. The lower surface of the outer shell 0086 is connected with a sticking paper.

[0114] The user uses the skin measurement unit to measure the optimal implanting depth at the expected position of the patient. The value displayed by the skin measurement unit has a corresponding relationship with the scale on the transmitter device.

[0115] As shown in Figure 30 , at this time, the fixed sawtooth section 0085 and the sliding tooth 0070 are engaged, the locking unit is in the locked state, the elastic buttons 0071 cannot move relative to the sliding groove 0081, and the length of the implanting electrode 0061 is unchanged.

[0116] As shown in Figure 31As shown, after the doctor presses the elastic buttons 0071 on both sides with fingers, the sliding teeth 0070 disengage from the fixed sawtooth segments 0085, and the sliding teeth 0070 are in mesh with the fixed sawtooth segments 0085, as shown. Figure 32 As shown, the drag adjustment knob 007 is moved to the desired scale in the direction of the arrow, and the elastic buttons 0071 on both sides are released, and the fixed sawtooth segments 0085 and the sliding teeth 0070 are in mesh, as shown. Figure 33 As shown, at this time, the implanted electrode 0061 has been adjusted to the desired depth.

[0117] The sensor length can be adjusted before implantation, or the sensor length can be adjusted after implantation.

[0118] As shown, Figure 38 As shown, when the adjustable transmitter device is in the working state, the display window 002 displays the interface, and the user can directly see the sensor implantation depth, blood glucose value, blood glucose monitoring curve, power, WiFi / Bluetooth connection and other information on the display window 002.

[0119] When the automatic structure is adopted, the transmitter mechanism 11000 includes a power device 3 for driving the sensor to stretch and retract, and a control processor 4.

[0120] The power device 3 is arranged in the shell 11005 and connected to one end of the sensor. Specifically, as shown, Figure 39 、 Figure 40 The power device 3 at least includes a straight tooth segment 31, a transmission rod 32 which can be in mesh transmission with the straight tooth segment 31, and a power source 33 for driving the transmission rod 32 to rotate. When the transmission rod 32 rotates circumferentially, the straight tooth segment 31 linearly reciprocates to drive the sensor to stretch and retract, so as to adjust the implantation depth of the sensor into the skin.

[0121] In this embodiment, the power source 33 is a motor, and the transmission rod 32 is a screw rod. The transmission rod 32 transmits the motion to the control processor 4 by threadingly engaging with the straight tooth segment 31, so as to realize the linear sliding of the control processor 4 in the shell 11005.

[0122] In order to facilitate assembly, the shell 11005 includes a bottom shell 11 and an upper cover 12. The upper cover 12 is connected with a display window 13 which is connected with the control processor 4 through a flexible wire group 45, and is used to display the implantation depth of the sensor, blood glucose value, blood glucose monitoring curve, power, WiFi / Bluetooth connection and other information. As shown, Figure 52 The display window 13 displays that the implantation depth h of the sensor is 6.32 mm.

[0123] The transmission rod 32 is rotationally connected to the bottom shell 11. The bottom shell 11 is provided with a sticker 5 which can be adhered to the skin, and a placement area for placing the control processor 4 is formed in the bottom shell 11. The upper cover 12 is provided with a needle passing window 17 through which a guide needle 6 of a needle holder extends.

[0124] like Figure 48 , Figure 49 As shown, a channel 14 is formed on the bottom shell 11 to limit the range of motion of the sensor. The bend in this channel 14 forms a guide surface 141 that slopes upwards from the outside towards the location of the slot 42. The guide surface 141 facilitates the sensor's downward movement after bending, preventing displacement, by being blocked and guided by the guide surface 141. The position of the channel 14 corresponds vertically to the needle passage window 17 of the needle assist device. Figure 50 As shown, after the sensor is successfully bent through the guide surface 141, the guide needle 6 of the needle aid moves vertically downward to assist the sensor in implanting into the skin. After implantation is completed, the guide needle 6 is withdrawn.

[0125] To ensure the sensor moves vertically downwards, and to make the sensor length calculation more accurate, such as Figure 51 As shown, a mounting groove 15 communicating with the channel 14 is formed on the bottom shell 11. A floating ball 16 is connected in the mounting groove 15. The floating ball 16 extends vertically from the mounting groove 15 and presses the sensor against the side wall of the channel 14.

[0126] like Figure 45 As shown, the control processor 4 includes a circuit board 41, a card slot 42 that can be connected to a sensor, a chip 43, and a mounting bracket 44 for connecting a power supply 441. The aforementioned straight tooth segment 31 is disposed on the side of the circuit board 41. In order to limit the translation distance of the straight tooth segment 31 and to ensure that the movement of the straight tooth segment 31 is smoother, a stroke groove 411 is also provided on the circuit board 41.

[0127] The card slot 42, chip 43, and mounting bracket 44 are soldered onto the circuit board 41, and the sensor head is fixed in the card slot 42. This allows the sensor to slide linearly along with the control processor 4, thereby adjusting the implantation depth of the sensor electrode.

[0128] The control processor 4 will only slide linearly along the stroke groove 411 when the transmission rod 32 rotates, and the control processor 4 has a unidirectional motion characteristic, meaning that the linear sliding of the control processor 4 can only be driven by the rotation of the transmission rod 32. The threaded meshing transmission has good instantaneous transmission accuracy, transmission smoothness accuracy, and reverse locking characteristics.

[0129] When the card slot 42 drives the sensor to make fine adjustments in the skin, through the threaded meshing transmission characteristics, the sensor can not only be pulled out of the skin, but also penetrate the skin at a very low speed (the sensor electrode is protected with a certain sharpness and hardness so that it can pierce the skin), reducing the user's pain and foreign body sensation.

[0130] like Figure 41 , Figure 42As shown, when the transmission rod 32 rotates in the direction of the arrow, it drives the control processor 4 to move in the same direction. The slot 42 on the control processor 4 then drives the sensor to move in the same direction, causing the sensor to extend. At this time, the display window 13 will show the current depth of the sensor in the dermis.

[0131] like Figure 43 , Figure 44 As shown, when the transmission rod 32 rotates in the opposite direction of the arrow, it drives the control processor 4 to move in the opposite direction of the arrow. The slot 42 on the control processor 4 drives the sensor to move in the direction of the arrow, and the sensor retracts or withdraws. At this time, the display window 13 will display the current depth of the sensor in the dermis.

[0132] like Figure 47 As shown, the sensor has a monitoring contact 21 and a charging contact 22. The monitoring contact 21 on the front includes a working electrode and a counter electrode, and may also include a reference electrode. The charging contact 22 on the back is activated when the power supply 441 of the control processor 4 is insufficient. It utilizes endogenous substances in the tissue fluid as fuel, converting the chemical energy in the fuel into electrical energy to supply the control processor 4, including powering the motor of the power source 33. This eliminates the need for battery replacement and extends the transmitter's wearing time. Alternatively, in other embodiments, the charging contact 22 begins using endogenous substances in the tissue fluid as fuel after the sensor is implanted in the human body, converting the chemical energy in the fuel into electrical energy to supply the control processor 4 in the transmitter, including powering the motor of the power source 33, thus extending the transmitter's wearing time. In this technical solution, the sensor may not have a charging contact 22; the working electrode and counter electrode may be located on one side or opposite sides. The application scenarios for when the charging contact 22 functions are defined on the chip 43.

[0133] Chip 43 is responsible for receiving the skin thickness signal, which can be transmitted from the thickness detection unit. Depending on the application scenario, this signal is converted into a pulse signal or rotation speed and finally sent to the power unit 3 to adjust the extension length of the sensor until it is implanted at the target depth. The extension length of the sensor can be detected and transmitted by a metal detector or by a positioning and identification device inside the housing 11005.

[0134] After the user implants the sensor subcutaneously, a metal detector is used to measure the sensor implantation depth, and the sensor implantation depth is shared with chip 43. Alternatively, the transmitter housing has a built-in positioning and identification device that can detect the sensor L inside the housing through infrared or other means. 移动 Specifically, the overall length of the sensor is fixed, and infrared sensors identify the L inside the housing. 移动 The control processor 4 is based on the implantation depth formula L. 植入 =L 总 -L 高-L 横 -L 移动 As shown in Figure 53 L 植入 is calculated and displayed on the display window 13, or the transmitter mechanism 11000 is built-in with a metal detector, which displays the detected sensor implantation depth on the display window 13 of the transmitter mechanism 11000 and feeds back information to the chip 43 to adjust the extension length of the sensor.

[0135] Specifically, the extension length calculation formula of the sensor is movement Wherein the rotation speed of the transmission rod 32 is 15-30 rpm / min, and the step angle a is equivalent to a pulse signal. The above formula is applied to the application scenario of fine adjustment of sensor extension or retraction.

[0136] When the wearing time reaches the set monitoring time, or the power supply 441 is out of power, the control processor 4 sends a signal to the power device 3 to retract the sensor as a whole, and the retraction length calculation formula is L=n*P, wherein n is the number of revolutions, and P is the pitch. The rotation speed of the transmission rod 32 is 60-100 rpm / min.

[0137] The thickness detection unit detects the thickness of the human skin, and transmits the detected skin thickness signal to the transmitter mechanism 11000 through wireless or wired mode. The control processor 4 in the transmitter mechanism 11000 compares the skin thickness with the sensor implantation depth, analyzes the movement L, and calculates the pulse signal y according to the fine adjustment calculation formula since the step angle a, the pitch P, and the movement L are known. Through this formula, the control processor 4 can precisely adjust the compensation for the implantation error.

[0138] When the user completes the blood glucose monitoring and needs to remove the transmitter, the control processor 4 drives the power source 33 to retract according to the above retraction calculation formula. Alternatively, when the wearing time of the transmitter mechanism 11000 reaches the set monitoring time or the battery is out of power (the battery power can be seen on the display window 13), the control processor 4 drives the motor to rotate according to the retraction length calculation formula L=n*P, and the sensor slides linearly through the threaded engagement transmission, realizing the recovery of the sensor. Due to the effect of the adhesive paper, when the battery is out of power, the user needs to manually tear off the adhesive paper and pull out the implanted sensor. When removed, it will pull the skin layer around the implanted part and cause a certain amount of pain and bleeding, which may cause infection and affect the user experience. The technical solution can complete the removal of the implanted sensor without removing the transmitter mechanism 11000, which reduces the amount of pain and bleeding and improves the user's comfort.

[0139] The above detailed description is intended to explain and describe the application, but not to limit the application. Any modification and change within the spirit and scope of the application will be included in the scope of the application.

Claims

1. An analyte level monitoring system, characterized in that... include: The transmitter mechanism includes at least a sensor that can be implanted in the skin and a thickness detection unit for detecting the thickness of human skin; An adjustable guide pin mechanism is used to drive the guide pin to extend or retract, the guide pin forming a cavity into which the sensor extends; A needle-pulling component is used to hold or release the adjustable guide needle mechanism; The firing module is capable of axial translation for clamping or releasing the launcher mechanism, and for clamping or releasing the pin-pulling component; Based on the thickness of human skin detected by the thickness detection unit, the guide pin is adjusted to the target extension length, and the transmitter mechanism adjusts the sensor to the target extension length; Release the firing module from its lock, and the firing module moves down with the transmitter mechanism until the transmitter mechanism is disengaged from the firing module. The firing module then releases its grip on the pin-pulling component, and the pin-pulling component resets. The outer casing includes an inner casing located within the outer casing, a trigger button, and an adjustment knob. The outer casing has an adjustment knob connection end and a trigger button connection end. The trigger button is rotatably connected to the trigger button connection end, and the adjustment knob is rotatably connected to the adjustment knob connection end. The adjustable guide pin mechanism is connected to the adjustment knob. The adjustable guide needle mechanism includes a movable needle seat that can be connected to an adjustment knob, a fixed needle seat that is rotatably connected to the movable needle seat, and a guide needle. Circumferential rotation of the movable needle seat can drive the guide needle to move up and down. The movable needle seat has an internal thread, the guide needle has an external thread, and the fixed needle seat has a movable needle seat cavity. The movable needle seat and / or the fixed needle seat have connecting feet to achieve axial positioning of the movable needle seat and the fixed needle seat. The guide needle and the movable needle seat are threadedly connected. Rotating the movable needle seat causes the guide needle to move up and down in the movable needle seat cavity, thereby adjusting the length of the guide needle implantation portion.

2. The analyte level monitoring system according to claim 1, characterized in that: The transmitter mechanism also includes a power device for driving the sensor to extend and retract, which includes at least a spur tooth section, a transmission rod that can mesh with the spur tooth section, and a power source for driving the transmission rod to rotate. When the transmission rod rotates circumferentially, the spur tooth section reciprocates linearly to drive the sensor to extend and retract.

3. The analyte level monitoring system according to claim 2, characterized in that: The formula for calculating the extension length of the sensor is as follows:

4. The analyte level monitoring system according to claim 2, characterized in that: The formula for calculating the sensor retraction length is L=n*P, where n is the number of revolutions and P is the tooth pitch.

5. The analyte level monitoring system according to claim 3 or 4, characterized in that: The rotational speed of the transmission rod is 15-30 rpm / min or 60-100 rpm / min.

6. The analyte level monitoring system according to claim 1, characterized in that: The transmitter mechanism also includes an adjustment mechanism, which includes at least an adjustment knob, a resilient button disposed on the adjustment knob, and a locking unit, wherein the resilient button extends from a groove in the housing; Applying external force to the elastic button switches the locking unit from the locked state to the unlocked state. The elastic button can move along the slide groove, and the adjustment knob moves with the sensor to achieve extension and retraction.

7. The analyte level monitoring system according to claim 6, characterized in that: The locking unit includes a fixed serrated section on the housing and a sliding tooth on the adjusting knob. In the locked state, the sliding tooth falls into the fixed serrated section to form engagement. In the unlocked state, the sliding tooth disengages from the fixed serrated section.

8. The analyte level monitoring system according to claim 6, characterized in that: The slide extends along the length of the housing, and a scale area is provided at the corresponding position; the length of the slide is 2-10mm, and the spacing between the scale lines in the scale area is 0.04-0.40mm.

9. The analyte level monitoring system according to claim 1, characterized in that: The inner shell includes an upper body and a lower body, the inner diameter of which is larger than that of the upper body; the firing module is axially translated in the inner shell, the lower body releases its restraint on the firing module, and the launcher mechanism disengages from the firing module.

10. The analyte level monitoring system according to claim 1, characterized in that: The transmitter mechanism also includes a buzzer. When blood sugar deviates from the set threshold, the control processor drives the buzzer to emit an alarm sound and send a signal to the outside world.

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