WO2024125057A1 - 一种传感器组件、含有该传感器组件的针盒及专用无痛敷贴器 - Google Patents

一种传感器组件、含有该传感器组件的针盒及专用无痛敷贴器 Download PDF

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Publication number
WO2024125057A1
WO2024125057A1 PCT/CN2023/123913 CN2023123913W WO2024125057A1 WO 2024125057 A1 WO2024125057 A1 WO 2024125057A1 CN 2023123913 W CN2023123913 W CN 2023123913W WO 2024125057 A1 WO2024125057 A1 WO 2024125057A1
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WO
WIPO (PCT)
Prior art keywords
needle
shell
transmitter
groove
push rod
Prior art date
Application number
PCT/CN2023/123913
Other languages
English (en)
French (fr)
Inventor
毛建
唐荣俊
刘飞飞
Original Assignee
糖简医疗科技(苏州)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202211597534.8A external-priority patent/CN118216909A/zh
Application filed by 糖简医疗科技(苏州)有限公司 filed Critical 糖简医疗科技(苏州)有限公司
Publication of WO2024125057A1 publication Critical patent/WO2024125057A1/zh

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Definitions

  • the invention relates to a sensor component, a needle box containing the sensor component and a special painless applicator.
  • Blood sugar monitoring is very important for diabetic patients, and blood sugar values help to assess the situation of glucose metabolism disorders in diabetic patients.
  • blood sugar detection can be divided into in vitro detection after blood sampling and real-time detection with implanted blood sugar sensors.
  • in vitro detection after blood sampling to control blood sugar
  • blood must be collected multiple times a day, which puts a heavy burden on the patient's mind and body.
  • due to the limited number of measurements only the blood sugar value at the time of measurement can be provided, which cannot fully reflect the fluctuation of blood sugar value within a day.
  • the trend and direction of blood sugar changes in the measured value are unclear.
  • Dynamic blood sugar detection can effectively solve the above problems.
  • the practical dynamic blood sugar monitoring system can not only give blood sugar values in real time, but also display the trend of blood sugar changes. Combined with the patient's daily life, it can more accurately judge the changes and trends of blood sugar. Therefore, the method of real-time detection using implanted blood sugar sensors is becoming more and more popular.
  • the monitoring probe 1' of the sensor in the glucose monitoring equipment sold on the market is generally made by screen printing, and is a strip-shaped plane structure. When installing, it needs to be bent at a certain angle, about 90°, so that it has an implantation part b' implanted in the human body and a connection part a' connected to the electronic system. After wearing, the monitoring probe with this structure is easy to affect the various coatings thereon because the bent part A'-A' is formed by bending during the later installation. The bent part A'-A' is easy to break during the implantation and wearing process.
  • connection part a' is connected to the external electronic system through the conductive contact crimped thereon, and the conductive contact is pressed flat on the electrode of the connection part a'. If the crimping is not firm, it is easy to cause the implanted part to shake in the body, affecting the wearing comfort, causing large data background noise, and easily affecting the data stability.
  • continuous blood glucose monitoring products generally include a needle aid, a sensor and a transmitter.
  • the transmitter is generally installed in the needle aid. When in use, the user needs to install the needle aid with the transmitter and the sensor together.
  • the needle aid, sensor and transmitter are sold as a set of equipment.
  • the needle aid, sensor and transmitter are disposable products with high cost.
  • the needle aid is used to implant the flexible detection part of the sensor under the skin.
  • the parts of the needle aid in the prior art have a complex structure.
  • two springs are required to realize the entire needle aid process. The pre-compression potential energy of one spring is used for needle delivery, and the pre-compression potential energy of the other spring is used for needle withdrawal; or manpower is used to deliver the hard needle and soft needle into the body.
  • the needle aid process the hard needle stays in the body for about 40-50 milliseconds, and the hard needle stays in the body for a long time, and there will be pain when the hard needle is injected.
  • the needle aid will be directly activated, causing the entire continuous blood glucose monitoring product to fail.
  • the purpose of the present invention is to overcome the defects of the prior art and provide a sensor component in which the monitoring probe is directly designed to be L-shaped, which is not easy to break after being implanted in the human body.
  • the monitoring probe and the conductive silicone are in side contact, the connection is firm, not easy to shake, and the data stability is good.
  • Another object of the present invention is to provide a needle box containing the above-mentioned sensor assembly, which can reliably store the sensor assembly and is convenient to use.
  • Another object of the present invention is to provide a special painless applicator with few parts, simple structure, simple assembly, which can prevent false triggering and make the whole needle-assisting process more stable and reliable; the needle-assisting is achieved by a spiral spring, the whole needle-assisting process is faster, the pain is minimized, and painless needle-assisting is achieved.
  • a technical solution to achieve the above purpose is: a sensor assembly, including a monitoring probe, a sensor waterproof soft glue, a plastic base and a hard needle, wherein:
  • the monitoring probe is connected by a transverse connecting part and a vertical implanting part to form an L shape, and the transverse connecting part has three electrodes, and the three electrodes are respectively located on the front and rear sides of the transverse connecting part;
  • the top of the waterproof soft rubber of the sensor is provided with three conductive silicone mounting holes, the three conductive silicone mounting holes are distributed in a triangle, and a conductive silicone is arranged in each conductive silicone mounting hole;
  • a strip-shaped monitoring probe insertion channel is provided inwardly on the side wall of the sensor waterproof soft rubber, and the monitoring probe insertion channel is located between the three conductive silicone mounting holes, and the monitoring probe insertion channel is connected to the three conductive silicone mounting holes respectively;
  • the transverse connecting portion of the monitoring probe is inserted into the monitoring probe insertion channel, and the three electrodes on the transverse connecting portion are in interference fit contact with the side surfaces of the three conductive silicone rubbers in a one-to-one correspondence;
  • the plastic base is provided with a waterproof soft rubber installation groove and a hard pin insertion hole that passes through from top to bottom;
  • the waterproof soft glue of the sensor is arranged in the waterproof soft glue installation groove, and the vertical implantation part of the monitoring probe is inserted into the hard needle insertion hole;
  • a vertically arranged notch groove is provided on the side wall of the hard needle, and the hard needle is inserted through the hard needle insertion hole and sleeved on the outside of the vertical implantation part of the monitoring probe;
  • a hard needle fixing platform is arranged at the top end of the hard needle, and the hard needle fixing platform is located above the hard needle insertion hole.
  • connection between the needle tip of the hard needle and the groove walls on both sides of the notch groove is in an arc shape.
  • a needle box comprising a needle box bottom shell, a needle box upper shell and the above sensor assembly, wherein:
  • a push piece is vertically arranged on the inner wall of the needle box bottom shell; a hard needle accommodating groove is arranged inside the needle box bottom shell;
  • the needle box upper shell is arranged in the needle box bottom shell, and a sensor assembly installation hole penetrating from top to bottom is opened on the needle box upper shell;
  • the sensor assembly is arranged in the sensor assembly mounting hole, and the lower part of the hard needle of the sensor assembly is inserted into the hard needle accommodating groove.
  • a special painless applicator used to push the sensor assembly in the needle box and implant the vertical implantation part of the monitoring probe of the sensor assembly into the human skin
  • the special painless applicator includes a needle aid and a transmitter assembly arranged in the needle aid
  • the needle aid includes a shell, a spiral spring, a turntable, a button, an unlocking push rod, a sliding guide rail and a transmitter fixing shell, wherein:
  • the shell is composed of a shell A and a shell B to form a hollow cavity structure with an opening at the lower end;
  • a spring mounting circular groove, a guide rail groove and a push rod groove are arranged on the inner wall surface of the A housing, the axial direction of the spring mounting circular groove is perpendicular to the axial direction of the housing, and a fixed shaft is coaxially arranged in the spring mounting circular groove;
  • the guide rail groove is composed of two vertical guide rail grooves, and the two vertical guide rail grooves are arranged on both sides of the radial direction of the spring mounting circular groove;
  • the push rod groove is arranged vertically, and the push rod groove is located between the spring mounting circular groove and one of the vertical guide rail grooves;
  • a button installation groove is provided on the outer wall surface of the A shell, and a push rod sliding hole is provided on one side wall of the A shell;
  • the volute spring is installed in the spring installation circular groove and sleeved on the fixed shaft; the rotating disk is rotatably sleeved on the fixed shaft, and the annular peripheral wall of the rotating disk is located between the volute spring and the groove wall of the spring installation circular groove; the inner end of the volute spring is connected to the fixed shaft; the outer end of the volute spring is connected to the annular peripheral wall of the rotating disk;
  • a turntable boss is arranged on the outer wall surface of the annular peripheral wall of the turntable, and a turntable limiting platform is arranged on the bottom of the turntable;
  • the button is movably arranged in the button installation groove of the A housing, and the rear end of the button passes through the bottom of the button installation groove and extends into the A housing;
  • a button boss is arranged on the inner side wall of the rear end of the button, and in the initial state, the turntable boss is in conflict with the button boss;
  • the front end of the unlocking push rod is inserted into the push rod sliding groove and slides along the push rod sliding groove; one side of the unlocking push rod is inserted into the push rod sliding hole and slides along the push rod sliding hole, and in the initial state, the rear end of the button abuts against the other side of the unlocking push rod;
  • a turntable limiting groove is provided on the front side of the upper portion of the sliding guide rail, and the two sides of the sliding guide rail are inserted into the two vertical guide rail grooves one by one and slide along the corresponding vertical guide rail grooves, and the turntable limiting platform is inserted into the turntable limiting groove;
  • the transmitter fixing shell is coaxially arranged in the housing;
  • the top end of the transmitter fixing shell is connected to the bottom end of the sliding guide rail;
  • the transmitter assembly is arranged in the transmitter fixing shell;
  • a hard pin installation hole is provided at the bottom end of the sliding guide rail, and a hard pin insertion hole which penetrates vertically is provided at the top end of the transmitter fixing shell.
  • the transmitter assembly includes a transmitter housing and a transmitter circuit board assembly disposed in the transmitter housing, wherein:
  • the transmitter housing is formed by connecting an upper housing and a lower housing; a transmitter application adhesive is provided on the bottom end surface of the transmitter housing; a sensor component installation position is provided on the lower housing of the transmitter housing;
  • the transmitter circuit board assembly includes a transmitter circuit board, a Mylar sheet, a button battery, a positive nickel sheet and a negative nickel sheet, wherein the Mylar sheet is arranged at the bottom end of the transmitter circuit board; the button battery is located at the bottom end of the Mylar sheet; the negative nickel sheet is welded to the negative electrode pad of the transmitter circuit board; the positive nickel sheet is welded to the positive electrode pad of the transmitter circuit board, and the positive nickel sheet and the negative nickel sheet are respectively connected to the button battery;
  • the upper shell of the transmitter shell and the transmitter circuit board are respectively provided with hard needle fixing platform through holes;
  • the transmitter application adhesive is provided with a sensor component through hole.
  • the hard needle fixing platform passes through the hard needle fixing platform hole on the transmitter circuit board, the hard needle fixing platform hole on the upper shell of the transmitter shell, and the hard needle socket on the top of the transmitter fixing shell in sequence, and is then clamped in the hard needle mounting hole at the bottom end of the sliding guide rail.
  • a transmitter fixing shell limit platform is provided at the bottom end of the inner wall surface of the shell, and when the needle assisting device is used and pulled out, the transmitter fixing shell limit platform clamps the transmitter fixing shell.
  • a downward indicating arrow is arranged on the side wall of the shell, and the indicating arrow is arranged adjacent to the push rod sliding hole; an indicating groove is arranged at the upper end of the needle box bottom shell, and the indicating groove is arranged adjacent to the push piece.
  • the technical scheme of the sensor assembly, the needle box containing the sensor assembly and the special painless applicator of the present invention is adopted.
  • the monitoring probe in the sensor assembly is directly designed to be L-shaped, which is not easy to break after being implanted in the human body.
  • the monitoring probe and the conductive silicone are in side contact, the connection is firm, not easy to shake, and the data stability is good.
  • the needle box can reliably store the sensor assembly and is convenient to use.
  • the special painless applicator there are few parts, simple structure, simple assembly, which can prevent false triggering, and the whole needle-assisting process is more stable and reliable; the needle-assisting is achieved by a volute spring, the whole needle-assisting process is faster, the pain is minimized to the greatest extent, and painless needle-assisting is achieved.
  • FIG1 is a schematic diagram of the structure of a monitoring probe in a glucose monitoring device in the prior art
  • FIG2 is a three-dimensional structural diagram of a sensor assembly of the present invention.
  • FIG3 is a schematic diagram of the structure of a monitoring probe of a sensor assembly of the present invention.
  • FIG4 is a schematic diagram of the structure of a needle box of the present invention.
  • Fig. 5 is an exploded structural diagram of the needle box of the present invention.
  • Fig. 6 is a cross-sectional view of a needle box of the present invention.
  • Fig. 7 is a top view of the needle box of the present invention.
  • FIG8 is a front view of the dedicated painless applicator of the present invention.
  • FIG. 9 is an exploded structural diagram of the dedicated painless applicator of the present invention.
  • FIG10 is a diagram showing the internal structure of the dedicated painless applicator of the present invention.
  • FIG11 is a cross-sectional view of a dedicated painless applicator of the present invention.
  • FIG12 is a schematic diagram of the installation of the spiral spring of the special painless applicator of the present invention.
  • FIG13 is a schematic diagram of the installation of the turntable of the dedicated painless applicator of the present invention.
  • FIG14 is a schematic diagram of the installation of an unlocking push rod of the special painless applicator of the present invention.
  • FIG15 is a schematic diagram of the limit position of the unlocking push rod and the button
  • FIG16 is a schematic diagram of the installation of the sliding rail of the dedicated painless applicator of the present invention.
  • FIG17 is a schematic diagram of the connection process of the slide rail, the launcher fixing housing and the launcher assembly;
  • FIG18 is a schematic diagram of the structure of the transmitter assembly
  • FIG19 is a schematic diagram of the structure of a transmitter circuit board assembly
  • FIG20 is a schematic diagram of the exploded structure of the transmitter circuit board assembly
  • FIG21 is a schematic diagram of the dedicated painless applicator docking with the sensor assembly in the needle box
  • FIG22 is a cross-sectional view of FIG21
  • FIG23 is a working principle diagram of the dedicated painless applicator of the present invention.
  • FIG24 is a comparison diagram of the turntable limiter of the turntable running in the long turntable limit slot and the arc-shaped turntable limit slot (the rotation angle of the turntable is the same);
  • FIG25 is a comparison diagram of the turntable limiter of the turntable running in the long turntable limit slot and the arc-shaped turntable limit slot (the travel of the sliding guide rail is the same);
  • FIG. 26 is a schematic diagram showing the principle of detecting the retention time of a hard needle.
  • a sensor assembly includes a monitoring probe 201 , a sensor waterproof soft glue 202 , a plastic base 203 and a hard needle 204 .
  • the monitoring probe 201 is connected by a transverse connection part 211 and a vertical implant part 212 in an L shape.
  • the transverse connection part 211 has three electrodes 213, and the three electrodes 213 are respectively located on the front and rear sides of the transverse connection part 211; the top of the connection between the transverse connection part 211 and the vertical implant part 212 has a boss 214 protruding upward.
  • the three electrodes are a reference electrode, a working electrode, and an auxiliary electrode; among the three electrodes, two electrodes are respectively arranged on the front side of the transverse connection part 211 of the monitoring probe 201, and the remaining electrode is arranged on the rear side of the transverse connection part 211 of the monitoring probe 201.
  • Three conductive silicone mounting holes are provided at the top of the sensor waterproof soft glue 202, and the three conductive silicone mounting holes are distributed in a triangle.
  • a conductive silicone 205 is arranged in each conductive silicone mounting hole;
  • a strip-shaped monitoring probe insertion channel is provided inwardly on the side wall of the sensor waterproof soft glue 202, and the monitoring probe insertion channel is located between the three conductive silicone mounting holes, and the monitoring probe insertion channel is connected to the three conductive silicone mounting holes respectively;
  • the transverse connecting part 211 of the monitoring probe 201 is inserted into the monitoring probe insertion channel, and the three electrodes 213 on the transverse connecting part 211 are in one-to-one interference fit contact with the sides of the three conductive silicones 205.
  • the plastic base 203 is provided with a waterproof soft rubber installation groove and a hard needle socket that passes through from top to bottom; the sensor waterproof soft rubber 202 is arranged in the waterproof soft rubber installation groove, and the vertical implantation part 212 of the monitoring probe 201 is inserted into the hard needle socket; a vertically arranged notch groove 241 is provided on the side wall of the hard needle 204, and the hard needle 204 is inserted through the hard needle socket and is sleeved on the outside of the vertical implantation part 212 of the monitoring probe 201; a hard needle fixing platform 242 is provided at the top of the hard needle 204, and the hard needle fixing platform 242 is located above the hard needle socket.
  • connection 243 between the needle tip of the hard needle 204 and the two side walls of the notch groove 241 is in an arc shape.
  • the connection 243 between the needle tip of the traditional hard needle 204 and the two side walls of the notch groove 241 is directly connected at a sharp angle.
  • the arc shape design in the present invention can reduce resistance, reduce puncture force, and reduce pain during puncture.
  • a needle box 300 includes a needle box bottom shell 301, a needle box upper shell 302 and the above-mentioned sensor assembly 200.
  • a push piece 311 is vertically arranged on the inner wall of the needle box bottom shell 301; a hard needle accommodating groove is arranged inside the needle box bottom shell 301; the needle box upper shell 302 is arranged in the needle box bottom shell 301, and a sensor assembly installation hole 321 that passes through from top to bottom is opened on the needle box upper shell 302;
  • the sensor assembly 200 is arranged in the sensor assembly mounting hole 321, and the lower part of the hard needle 204 of the sensor assembly 200 is inserted into the hard needle receiving groove.
  • the upper end opening of the needle box bottom shell 301 is hot-pressed with a sealing aluminum foil 303.
  • An indicating groove 312 is arranged at the upper end of the needle box bottom shell 301, and the indicating groove 312 is arranged adjacent to the push piece 311.
  • the needle box When installing the needle box, first install the sensor assembly into the needle box bottom shell, then install the needle box upper shell into the needle box bottom shell, and check whether the steel needle and the needle box upper shell are assembled in place. Take the sealing aluminum foil 303 and heat press it to the upper opening of the needle box bottom shell.
  • a special painless applicator is used to push the sensor assembly 200 in the needle box 300 and implant the vertical implantation part 212 of the monitoring probe 201 of the sensor assembly 200 into human skin.
  • the special painless applicator includes a needle aid and a transmitter assembly 9 arranged in the needle aid, and the needle aid includes a housing 1, a spiral spring 2, a rotating disk 3, a button 4, an unlocking push rod 5, a sliding guide rail 6 and a transmitter fixing shell 7.
  • the shell 1 is composed of a shell A 11 and a shell B 12, which are combined into a hollow cavity structure with an opening at the lower end; a spring mounting circular groove 13, a guide rail groove and a push rod groove 15 are arranged on the inner wall surface of the shell A 11, the axial direction of the spring mounting circular groove 13 is perpendicular to the axial direction of the shell 1, and a fixed shaft 16 is coaxially arranged in the spring mounting circular groove 13;
  • the guide rail groove is composed of two vertical guide rail grooves 14, and the two vertical guide rail grooves 14 are arranged on both sides of the radial direction of the spring mounting circular groove 13;
  • the push rod groove 15 is arranged vertically, and the push rod groove 15 is located between the spring mounting circular groove 13 and one of the vertical guide rail grooves 14.
  • a button mounting groove is formed on the outer wall surface of the A housing 11 , and a push rod sliding hole 17 is formed on one side wall of the A housing 11 .
  • the spiral spring 2 is installed in the spring installation circular groove 13 and sleeved on the fixed shaft 16; the turntable 3 is rotatably sleeved on the fixed shaft 16, and the annular circumferential wall of the turntable 3 is located between the spiral spring 2 and the groove wall of the spring installation circular groove 13; the inner end of the spiral spring 2 is connected to the fixed shaft 16; the outer end of the spiral spring 2 is connected to the annular circumferential wall of the turntable 3; specifically, the fixed shaft 16 is cylindrical, and a spring inner end snap-in 161 is opened on the wall surface of the fixed shaft 16 along its axial direction, and a spring outer end snap-in 31 is opened on the annular circumferential wall of the turntable 3 along its axial direction; the inner end of the spiral spring 2 is clamped in the spring inner end snap-in 161; the outer end of the spiral spring 2 is clamped in the spring outer end snap-in 31.
  • the pre-compression potential energy of the spiral spring 2 drives the turntable 3 to rotate.
  • the bottom of the turntable 3 is provided with an axial hole 32 and two rotating holes 33, and the two rotating holes 33 are located on both sides of the radial direction of the axial hole 32.
  • the axial hole 32 of the bottom of the turntable is sleeved on the fixed shaft 16.
  • a turntable boss is arranged on the outer wall surface of the annular peripheral wall of the turntable 3 , and a turntable limiting platform 34 is arranged on the bottom of the turntable 3 .
  • the button 4 is movably arranged in the button mounting groove of the A shell 11, and the rear end of the button 4 extends into the A shell 11 through the bottom of the button mounting groove; a button boss 41 is arranged on the inner side wall of the rear end of the button 4, and in the initial state, the turntable boss is in conflict with the button boss 41.
  • the button installation groove is located at the front side of the spring installation circular groove 13, and the groove bottom of the button installation groove partially overlaps with the groove bottom of the spring installation circular groove 13.
  • the groove bottom of the button installation groove is provided with two button through holes;
  • the button 4 includes a button body 43, a short button plug 44 and a long button plug 42, and the short button plug and the long button plug are respectively arranged at the rear end of the button body 43;
  • the short button plug 44 and the long button plug 42 pass through the two button through holes one by one, and the short button plug 43 is located in the fixed shaft 16 after passing through the corresponding button through holes;
  • the button boss 41 is located on the inner side wall of the rear end of the long button plug 42;
  • the groove bottom of the button installation groove is provided with a button spring 19 protruding forward, and the button body 43 contacts the button spring 19.
  • the front end of the unlocking push rod 5 is inserted into the push rod slot 15 and slides along the push rod slot 15; one side of the unlocking push rod 5 is inserted into the push rod sliding hole 17 and slides along the push rod sliding hole 17.
  • the rear end of the button 4 abuts against the other side of the unlocking push rod 5.
  • the unlocking push rod 5 includes a push rod body 51, a push rod front insert 52 arranged at the front end of the push rod body 51, a push rod side insert 53 arranged at the lower part of one side of the push rod body, and a button abutment platform 54 arranged at the upper part of the other side of the push rod body;
  • the push rod front insert 52 is inserted into the push rod slide groove 15 and slides along the push rod slide groove 15;
  • the push rod side insert 53 is inserted into the push rod sliding hole 17 and slides along the push rod sliding hole 17.
  • the rear end of the button long plug column 42 of the button 4 abuts against the front side of the button abutment platform 54.
  • a spring piece 55 is arranged on the front inserting piece 52 of the push rod, and a corrugated strip 151 matching with the spring piece 55 is arranged on the groove wall of the push rod sliding groove 15 .
  • a transversely arranged turntable limit groove 60 is opened on the front side of the upper part of the sliding guide rail 6, and the two sides of the sliding guide rail are inserted into the two vertical guide rail grooves 14 one by one and slide along the corresponding vertical guide rail grooves, and the turntable limit platform 34 is inserted into the turntable limit groove 60; when the turntable 3 rotates, the turntable limit platform 34 in the turntable limit groove 60 pushes the sliding guide rail 6 to move downward and then upward.
  • the transmitter fixing shell 7 is coaxially arranged in the housing 1 ; the top end of the transmitter fixing shell 7 is connected to the bottom end of the sliding guide rail 6 .
  • the sliding guide rail 6 includes a guide rail rear plate 61, a guide rail bottom plate 62 and two guide bars 63.
  • the guide rail rear plate 61 and the guide rail bottom plate 62 are connected in an L shape, and the two guide bars 63 are connected to the two sides of the guide rail rear plate 61 one by one; the turntable limiting groove 60 is horizontally opened in the upper part of the front side surface of the guide rail rear plate 61; the two guide bars 63 of the sliding guide rail 6 are inserted into the two vertical guide rail grooves 14 one by one and slide along the corresponding vertical guide grooves.
  • a transmitter fixing shell slot 621 is provided on the guide rail bottom plate 62 , and a transmitter fixing shell inserting platform 71 is provided on the top of the transmitter fixing shell 7 .
  • the transmitter fixing shell inserting platform 71 is inserted into the transmitter fixing shell slot 621 .
  • a hard needle mounting hole 64 is provided at the bottom end of the sliding guide rail 6, i.e., the guide rail bottom plate 62, and a hard needle insertion hole 72 that passes through the top and bottom is provided at the top of the transmitter fixed shell 7; when the painless applicator is docked with the sensor assembly in the needle box bottom shell, the top end of the hard needle 204 on the sensor assembly passes through the hard needle insertion hole 72 and is stuck in the hard needle mounting hole 64, and when the sliding guide rail 6 moves up and down, it drives the hard needle 204 to move up and down.
  • the transmitter fixed shell 7 is a groove-shaped structure with an opening at the lower end; a transmitter assembly 9 is arranged in the transmitter fixed shell 7.
  • the lower part of the housing 1 is covered with a bottom cover 10.
  • the bottom end of the inner wall surface of the housing 1 is provided with a transmitter fixed shell stopper 18. After the needle aid is used and the needle aid is pulled out, the transmitter fixed shell 7 is stuck by the transmitter fixed shell stopper 18 and remains in the housing 1 and is removed together.
  • the transmitter assembly 9 includes a transmitter housing 91 and a transmitter circuit board assembly 92 disposed in the transmitter housing 91, wherein: the transmitter housing 91 is formed by connecting an upper housing and a lower housing; a transmitter application adhesive 93 is disposed on the bottom surface of the transmitter housing 91; a sensor assembly mounting position is provided on the lower housing of the transmitter housing 91; the transmitter circuit board assembly 92 includes a transmitter circuit board 921, a Mylar sheet 922, a button battery 923, a positive nickel sheet 924 and a negative nickel sheet 925, the Mylar sheet 922 is arranged at the bottom of the transmitter circuit board 921; the button battery 923 is located at the bottom of the Mylar sheet 921; the negative nickel sheet 925 is welded to the negative pad of the transmitter circuit board 921; the positive nickel sheet 924 is welded to the positive pad of the transmitter circuit board 921, and the positive nickel sheet 924 needs to be welded with the button battery 923 by a laser spot wel
  • the transmitter assembly 9 When assembling the transmitter assembly 9, first assemble the transmitter circuit board assembly, and then install the transmitter circuit board assembly into the transmitter housing 91.
  • the upper and lower housings of the transmitter housing 91 are welded together using an ultrasonic welding machine. After welding is completed, the sealing of the ultrasonic welding needs to be checked, and then the transmitter adhesive 93 is applied.
  • a downward indicating arrow is provided on the side wall of the shell 1, and the indicating arrow is arranged adjacent to the push rod sliding hole 17; the indicating groove 312 on the bottom shell of the needle box and the indicating arrow on the side wall of the shell 1 are located on the same side.
  • the direction can be determined according to the indicating groove 312 and the indicating arrow.
  • the sensor assembly 200 passes through the sensor assembly through hole 96 on the transmitter application glue 93 and is inserted into the sensor assembly installation position on the lower part of the transmitter housing 91;
  • the hard needle fixing platform 242 passes through the hard needle fixing platform perforation 95 on the transmitter circuit board 921, the hard needle fixing platform perforation on the upper shell of the transmitter shell 91, and the hard needle plug hole 72 at the top of the transmitter fixing shell 7 in sequence, and is then clamped in the hard needle mounting hole 64 at the bottom end of the sliding guide rail.
  • the push piece 311 on the needle box bottom shell 301 pushes the push rod side plug piece 53 to slide upward along the push rod sliding hole 17, and the entire unlocking push rod 5 moves upward, and the rear end of the button long plug column 42 of the button 4 is disengaged from the button abutment platform 54, the button 4 is unlocked, and then the painless compress connected to the sensor assembly is released.
  • the patch is pressed to a suitable position on the human skin, and then the button 4 is pressed inward, the turntable boss on the annular circumferential wall of the turntable 3 is disengaged from the button boss 41 at the rear end of the button long plug column 42, and the button 4 releases the limit on the turntable 3.
  • the turntable 3 rotates driven by the pre-compression potential energy of the spiral spring 2, and the turntable limit table 34 moves downward first with the rotation of the turntable 4.
  • the turntable limit table 34 in the turntable limit groove 60 moves downward, it pushes the sliding guide rail 6 to move downward, driving the transmitter fixed shell 7 and the hard needle 204 to move downward, pushing the transmitter assembly to move downward, and the hard needle 204 drives the monitoring probe
  • the vertical implantation part 212 of the head 201 is inserted into the skin together.
  • the spiral spring 2 drives the turntable 3 to push the sliding guide 6 to the bottom, the hard needle 204 is completely inserted into the muscle, completing the needle insertion process, and the vertical implantation part 212 of the monitoring probe 201 is implanted into the skin.
  • the turntable 3 continues to rotate, and the turntable limit table 34 drives the sliding guide 6 to move upward.
  • the sliding guide 6 drives the hard needle 204 to pull back upward to complete the recovery of the hard needle 204; then the needle aid of the painless applicator is removed, and the transmitter and sensor are attached to the skin by the transmitter application glue 93 at the bottom of the transmitter assembly.
  • the tops of the three conductive silicone rubbers 205 are in contact with the three electrode contact points 97 on the transmitter circuit board 921 of the transmitter assembly 9, and the button battery 26 supplies power to the transmitter circuit board 921.
  • the monitoring probe 201 monitors blood sugar in the human body, and sends the monitored signal to the external electronic device through the transmitter assembly to achieve blood sugar monitoring.
  • the painless applicator of the present invention has a simpler structure.
  • a sliding guide rail is used instead of a connecting rod to connect the turntable and the transmitter fixed shell.
  • the turntable limit platform 34 on the turntable is inserted into the long turntable limit groove 60 on the sliding guide rail. During the rotation of the turntable, the turntable limit platform 34 is always located in the turntable limit groove 60, making the entire needle-assisting process more stable and reliable.
  • the push rod locks the button to prevent users from accidentally touching the button to open it, which is safer and more practical.
  • the turntable limit groove 60 can be in the shape of a long strip, or can be set to an arc shape protruding upward.
  • FIG. 12 A shows the movement trajectory of the turntable limit platform 34 on the turntable in the long strip turntable limit groove 60 during the downward movement of the sliding guide rail 6
  • FIG. 12 B shows the movement trajectory of the turntable limit platform 34 on the turntable in the arc-shaped turntable limit groove 60 during the downward movement of the sliding guide rail 6.
  • the arc-shaped turntable limit groove 60 can achieve a longer pushing stroke of the sliding guide rail.
  • Figure A shows the movement trajectory of the turntable limit platform 34 on the turntable in the long turntable limit groove 60 during the downward movement of the sliding guide rail 6
  • Figure B shows the movement trajectory of the turntable limit platform 34 on the turntable in the arc-shaped turntable limit groove 60 during the downward movement of the sliding guide rail 6.
  • hard needle retention time test an industrial high-speed camera with product model OSG030-790UMTZ is used to detect the hard needle retention time of commercially available products and the painless applicator of the present invention.
  • the specific experimental method is: the applicator 100 is docked with the needle box, the sensor and the hard needle are installed, and then placed at the front end of the industrial high-speed camera 501.
  • the camera of the industrial high-speed camera 501 and the hard needle movement area are in the same direction, so that the industrial high-speed camera 501 can capture the movement process of the hard needle, and a fill light 502 is installed to illuminate the needle aid to provide sufficient light; during the shooting process, the buttons of the commercially available product and the painless applicator of the present invention are pressed respectively, and the industrial high-speed camera records the movement process of both.
  • the video image is analyzed by software, starting from the movement of the hard needle tip outward to the outlet of the needle aid, and then the hard needle tip returns to the outlet of the needle aid.
  • the number of video image frames between the two is the number of video image frames of the hard needle moving outside the needle aid.
  • the number of video image frames of the hard needle moving outside the needle aid is divided by the average frame rate of the high-speed camera during the test to obtain the movement time of the hard needle outside the needle aid, which is the retention time of the hard needle.
  • the average frame rate of the high-speed camera is 2277fps (2277 frames per second)
  • the average frame rate of the high-speed camera is 2696fps (2696 frames per second)
  • the average hard needle retention time of the painless applicator of the present invention is 4.45 milliseconds, and the hard needle retention time of the commercially available needle aid is 48.3 milliseconds.
  • the painless applicator of the present invention has a shorter hard needle retention time, a shorter retention time, and users have a better use experience.
  • the pain is weaker when the hard needle is injected into the sensor, and the entire needle-assisting process is faster, which reduces the pain to the greatest extent and achieves painless needle-assisting. After the sensor fails, just remove the transmitter and the sensor connected to it.
  • the monitoring probe is directly designed to be L-shaped, which is not easy to break after being implanted in the human body.
  • the monitoring probe and the conductive silicone are in side contact, the connection is firm, not easy to shake, and the data stability is good.
  • the needle box of the present invention can reliably store the sensor assembly and is convenient to use.
  • the special painless applicator of the present invention has few parts, simple structure, and simple assembly, which can prevent false triggering, and the entire needle-assisting process is more stable and reliable; the needle-assisting is achieved by a volute spring, and the entire needle-assisting process is faster, minimizing the pain, and achieving painless needle-assisting.

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Abstract

一种传感器组件（200）、含有传感器组件（200）的针盒（300）及专用无痛敷贴器（100），传感器组件（200）包括监测探头（201）、传感器防水软胶（202）、塑胶底座（203）和硬针（204），监测探头（201）由横向连接部（211）和竖向植入部（212）连接呈L形，监测探头（201）植入人体后不容易发生断裂，监测探头（201）与导电硅胶（205）采用侧面接触，连接牢固，不容易晃动，数据稳定性好。

Description

[根据细则26改正 20.10.2023]一种传感器组件、含有该传感器组件的针盒及专用无痛敷贴器 技术领域
本发明涉及一种传感器组件、含有该传感器组件的针盒及专用无痛敷贴器。
背景技术
血糖的监测对糖尿病患者来说非常重要，血糖值有助于评估糖尿病患者糖代谢紊乱的情况。目前，血糖的检测可以分为采血后体外检测和和植入性血糖传感器实时检测。用采血后体外检测这种方法对血糖进行控制时，必须每天多次采血，对患者的精神和肉体带来沉重的负担，另一方面，由于测量的次数有限，只能提供测量时刻的血糖值，不能完全反映血糖值在一天内的波动情况。同时，由于测量次数的限制，测量值所处的血糖变化趋势和方向不明确，因此根据测量得到的血糖值来调整胰岛素的用量，反而可能增加低血糖症发生的可能性。动态血糖检测可以有效的解决上述问题，实用动态血糖监护系统，不仅可以实时给出血糖值，而且可以显示血糖的变化趋势，与病人的日常生活作息相结合，可以更加准确的判断血糖的变化和趋势，因此使用植入性血糖传感器实时检测的方法越来越普及。
目前能够用于临床的血糖连续监测产品，技术上得到一定程度验证的只有皮下组织内植入的传感器组件，为此，本领域需要将细小、柔软的生物传感器柔性检测部分植入皮下，穿刺管以极快的速度穿入皮下，让痛疼感降到极低，并将传感器电极部分留在皮下，实现连续监测，而传感器皮上部分需要与皮肤固定。
请参阅图1，目前，在市场上销售的葡萄糖监测设备中传感器的监测探头1'，一般是采用丝网印刷方式制作，均为条状平面结构，在安装时，需要弯折一定角度，大约为90°，使其具有植入人体的植入部分b'以及与电子系统相连的连接部分a'，这种结构的监测探头在佩戴后，由于弯折部分A'-A'是后期安装时折弯形成，容易影响其上对的各种涂层，弯折部分A'-A'在植入佩戴过程中容易断裂，连接部分a'通过压接在其上的导电触头外接电子系统，导电触头平压在连接部分a'的电极上，压接不牢固也容易导致植入部分容易在体内晃动影响佩戴的舒适感，造成数据背景噪音大,且容易影响数据稳定性。
而且，血糖连续监测产品一般包括助针器、传感器和发射器，发射器一般安装在助针器内，使用时，需要由用户将安装有发射器的助针器和传感器安装在一起，助针器、传感器和发射器作为一套设备成套出售，助针器、传感器和发射器为一次性产品，成本较高。助针器是用作将传感器的柔性检测部分植入皮下，现有技术中的助针器零件结构复杂，一般需要两个弹簧实现整个助针过程，一个弹簧的预压势能用于送针，另一个弹簧的预压势能用于退针；或者采用人力来把硬针和软针送入体内，用户按压整个助针器，借助较大的人力将传感器的检测部分植入皮肤，再通过助针器内的退针机构退针。使用过程中，常常会存在因人为因素用力过大或过小而为用户带来的不适感；送针和退针需要通过两个机构来完成，助针过程中硬针留体时间约为40-50毫秒，硬针留体时间较长，硬针注入时会有疼痛感。而且用户在使用过程中如果误碰助针器的启动按钮会直接启动助针器工作，进而导致整套血糖连续监测产品失效。
发明内容
本发明的目的是克服现有技术的缺陷，提供一种传感器组件，将监测探头直接设计呈L形，植入人体后不容易发生断裂，监测探头与导电硅胶采用侧面接触，连接牢固，不容易晃动，数据稳定性好。
本发明的另外一个目的是提供一种含有上述传感器组件的针盒，可以可靠存储传感器组件，方便使用。
本发明的还有一个目的是提供一种专用无痛敷贴器，零件少，结构简单，装配简单，可以防止误触发，整个助针过程更加稳定可靠；通过一个涡卷弹簧实现助针，整个助针过程更为快速，最大程度减弱痛感，实现无痛助针。
实现上述目的的一种技术方案是：一种传感器组件，包括监测探头、传感器防水软胶、塑胶底座和硬针，其中：
所述监测探头由横向连接部和竖向植入部连接呈L形，所述横向连接部上具有三个电极，且所述三个电极分别位于所述横向连接部的前、后侧面上；
所述传感器防水软胶的顶端开设有三个导电硅胶安装孔，所述三个导电硅胶安装孔呈三角形分布，每个导电硅胶安装孔内均设置一个导电硅胶；
所述传感器防水软胶的侧壁上向内开设有一个条状的监测探头穿插通道，所述监测探头穿插通道位于所述三个导电硅胶安装孔之间，且所述监测探头穿插通道分别与所述三个导电硅胶安装孔连通；
所述监测探头的横向连接部插入所述监测探头穿插通道内，且所述横向连接部上的三个电极一一对应地与三个导电硅胶的侧面过盈配合接触；
所述塑胶底座上开设有防水软胶安装槽和上下贯通的硬针插孔；
所述传感器防水软胶设置在所述防水软胶安装槽内，所述监测探头的竖向植入部插入在所述硬针插孔内；
所述硬针的侧壁上开设有竖向设置的缺口槽，所述硬针穿插过所述硬针插孔并套在所述监测探头的竖向植入部的外部；
所述硬针的顶端设置有硬针固定台，且硬针固定台位于所述硬针插孔的上方。
上述的一种传感器组件，其中，所述硬针的针尖与所述缺口槽的两侧槽壁的连接处呈弧形状。
实现上述目的的另一种技术方案是：一种针盒，包括针盒底壳、针盒上壳和上述的传感器组件，其中：
所述针盒底壳的内壁上竖向设置有推片；所述针盒底壳的内部设置有硬针容纳槽；
所述针盒上壳设置在所述针盒底壳内，且所述针盒上壳上开设有上下贯通的传感器组件安装孔；
所述传感器组件设置在所述传感器组件安装孔内，且所述传感器组件的硬针的下部插入在所述硬针容纳槽内。
上述的一种针盒，其中，所述针盒底壳的上端开口热压有封口铝箔。
实现上述目的的第三种技术方案是：一种专用无痛敷贴器，用于推送上述的针盒内的传感器组件，并将所述传感器组件的监测探头的竖向植入部植入人体皮肤，所述专用无痛敷贴器包括助针器和设置在助针器内的发射器组件，所述助针器包括壳体、涡卷弹簧、转盘、按钮、解锁推杆、滑动导轨和发射器固定壳，其中：
所述壳体由A壳体和B壳体组合成呈下端开口的中空腔体结构；
所述A壳体的内壁面上设置有弹簧安装圆槽、导轨滑槽和推杆滑槽，所述弹簧安装圆槽的轴向与所述壳体的轴向相互垂直，所述弹簧安装圆槽内同轴设置有固定轴；所述导轨滑槽由两个竖向导轨滑槽组成，且所述两个竖向导轨滑槽分设在所述弹簧安装圆槽的径向两侧；所述推杆滑槽竖向设置，且所述推杆滑槽位于所述弹簧安装圆槽和其中一个竖向导轨滑槽之间；
所述A壳体的外壁面上开设有按钮安装槽，所述A壳体的一侧壁上开设有推杆滑动孔；
所述涡卷弹簧安装在所述弹簧安装圆槽内，并套在所述固定轴上；所述转盘可转动地套在所述固定轴上，且所述转盘的环形周壁位于所述涡卷弹簧和弹簧安装圆槽的槽壁之间；所述涡卷弹簧的内端与所述固定轴相连；所述涡卷弹簧的外端与所述转盘的环形周壁相连；
所述转盘的环形周壁的外壁面上设置有转盘凸台，所述转盘的盘底设置有转盘限位台；
所述按钮可活动地设置在所述A壳体的按钮安装槽内，所述按钮的后端穿过所述按钮安装槽的槽底延伸至所述A壳体内；所述按钮的后端的内侧壁上设置有按钮凸台，在初始状态，所述转盘凸台与所述按钮凸台相抵触；
所述解锁推杆的前端插入在所述推杆滑槽内并沿所述推杆滑槽滑动；所述解锁推杆的一侧插入在所述推杆滑动孔内并沿所述推杆滑动孔滑动，在初始状态，所述按钮的后端抵触在所述解锁推杆的另一侧；
所述滑动导轨的上部的前侧开有横向设置的转盘限位槽，所述滑动导轨的两侧一一对应地插入在所述两个竖向导轨滑槽内并沿相应的竖向导轨滑槽滑动，所述转盘限位台插入在所述转盘限位槽内；
所述发射器固定壳同轴设置在所述壳体内；
所述发射器固定壳的顶端与所述滑动导轨的底端相连；
所述发射器组件设置在所述发射器固定壳内；
所述滑动导轨的底端开设有硬针安装孔，所述发射器固定壳的顶端开设有上下贯通的硬针插孔。
上述的一种专用无痛敷贴器，其中，所述发射器组件包括发射器壳体和设置在发射器壳体内的发射器电路板组件，其中：
所述发射器壳体由上、下两壳体连接而成；所述发射器壳体的底端面上设置有发射器敷贴胶；所述发射器壳体的下壳体上开设有传感器组件安装位；
所述发射器电路板组件包括发射器电路板、麦拉片、纽扣电池、正极镍片和负极镍片，所述麦拉片设置在所述发射器电路板的底端；所述纽扣电池位于所述麦拉片的底端；所述负极镍片焊接在所述发射器电路板的负极焊盘处；所述正极镍片焊接到所述发射器电路板的正极焊盘处，所述正极镍片和负极镍片分别与所述纽扣电池相连；
所述发射器壳体的上壳体上以及所述发射器电路板上分别开设有硬针固定台穿孔；
所述发射器敷贴胶上开设有传感器组件穿孔。
上述的一种专用无痛敷贴器，其中，在将所述专用无痛敷贴器与所述针盒内的传感器组件对接时，所述传感器组件穿过所述发射器敷贴胶上的传感器组件穿孔后，插入在所述发射器壳体的下部分壳体上的传感器组件安装位；
所述硬针固定台依次穿过所述发射器电路板上的硬针固定台穿孔、所述发射器壳体的上壳体上的硬针固定台穿孔、所述发射器固定壳的顶端的硬针插孔后，卡接在所述滑动导轨的底端的硬针安装孔内。
上述的一种专用无痛敷贴器，其中，在将所述专用无痛敷贴器与所述针盒内的传感器组件对接时，所述针盒底壳的内壁上的推片推动所述解锁推杆的插入在所述推杆滑动孔内的一侧向上滑动，带动整个解锁推杆向上滑动。
上述的一种专用无痛敷贴器，其中，所述壳体的下部盖合有底盖。
上述的一种专用无痛敷贴器，其中，所述壳体的内壁面的底端设置有发射器固定壳限位台，在使用完助针器，拔下助针器时，所述发射器固定壳限位台将所述发射器固定壳卡住。
上述的一种专用无痛敷贴器，其中，所述壳体的侧壁上设置有向下的指示箭头，且所述指示箭头与所述推杆滑动孔相邻设置；所述针盒底壳的上端设置有指示凹槽，且所述指示凹槽与所述推片相邻设置。
采用本发明的传感器组件、含有该传感器组件的针盒及专用无痛敷贴器的技术方案，传感器组件中将监测探头直接设计呈L形，植入人体后不容易发生断裂，监测探头与导电硅胶采用侧面接触，连接牢固，不容易晃动，数据稳定性好。针盒可以可靠存储传感器组件，方便使用。专用无痛敷贴器中，零件少，结构简单，装配简单，可以防止误触发，整个助针过程更加稳定可靠；通过一个涡卷弹簧实现助针，整个助针过程更为快速，最大程度减弱痛感，实现无痛助针。
附图说明
图1为现有技术中的葡萄糖监测设备中的监测探头的结构示意图；
图2为本发明的传感器组件的立体结构图；
图3为本发明的传感器组件的监测探头的结构示意图；
图4为本发明的针盒的结构示意图；
图5为本发明的针盒的分解结构图；
图6为本发明的针盒的剖视图；
图7为本发明的针盒的俯视图；
图8为本发明的专用无痛敷贴器的主视图；
图9为本发明的专用无痛敷贴器的分解结构图
图10为本发明的专用无痛敷贴器的内部结构图；
图11为本发明的专用无痛敷贴器的剖面图；
图12为本发明的专用无痛敷贴器的涡卷弹簧的安装示意图；
图13为本发明的专用无痛敷贴器的转盘的安装示意图；
图14为本发明的专用无痛敷贴器的解锁推杆的安装示意图；
图15为解锁推杆与按钮的限位示意图；
图16为本发明的专用无痛敷贴器的滑动导轨的安装示意图；
图17为滑动导轨、发射器固定壳和发射器组件的连接过程示意图；
图18为发射器组件的结构示意图；
图19为发射器电路板组件的结构示意图；
图20为发射器电路板组件的分解结构示意图；
图21为专用无痛敷贴器与针盒内的传感器组件对接的示意图；
图22为图21的剖视图；
图23为本发明的专用无痛敷贴器的工作原理图；
图24为转盘的转盘限位台在长条状的转盘限位槽和弧形形状的转盘限位槽中运行的比对图(转盘的转动角度相同)；
图25为转盘的转盘限位台在长条状的转盘限位槽和弧形形状的转盘限位槽中运行的比对图(滑动导轨的行程相同)；
图26为硬针留体时间检测原理图。
具体实施方式
为了使本技术领域的技术人员能更好地理解本发明的技术方案，下面结合附图对其具体实施方式进行详细地说明：
请参阅图2和图3，本发明的实施例，一种传感器组件，包括监测探头201、传感器防水软胶202、塑胶底座203和硬针204。
监测探头201由横向连接部211和竖向植入部212连接呈L形，横向连接部211上具有三个电极213，且三个电极213分别位于横向连接部211的前、后侧面上；横向连接部211和竖向植入部212的连接处的顶端具有向上凸出的凸台214。三个电极分别为参比电极、工作电极和辅助电极；三个电极中，其中两个电极分别设置在监测探头201的横向连接部211的前侧面，剩余一个电极设置在监测探头201的横向连接部211的后侧面。
传感器防水软胶202的顶端开设有三个导电硅胶安装孔，三个导电硅胶安装孔呈三角形分布，每个导电硅胶安装孔内均设置一个导电硅胶205；传感器防水软胶202的侧壁上向内开设有一个条状的监测探头穿插通道，监测探头穿插通道位于三个导电硅胶安装孔之间，且监测探头穿插通道分别与三个导电硅胶安装孔连通；监测探头201的横向连接部211插入监测探头穿插通道内，且横向连接部211上的三个电极213一一对应地与三个导电硅胶205的侧面过盈配合接触。
塑胶底座203上开设有防水软胶安装槽和上下贯通的硬针插孔；传感器防水软胶202设置在防水软胶安装槽内，监测探头201的竖向植入部212插入在硬针插孔内；硬针204的侧壁上开设有竖向设置的缺口槽241，硬针204穿插过硬针插孔并套在监测探头201的竖向植入部212的外部；硬针204的顶端设置有硬针固定台242，且硬针固定台242位于硬针插孔的上方。硬针204的针尖与缺口槽241的两侧槽壁的连接处243呈弧形状,传统的硬针204的针尖与缺口槽241的两侧槽壁的连接处243直接呈尖角连接，与传统的硬针结构相比，在硬针204带着监测探头201的竖向植入部212插入人体过程中，本发明中的该弧形状设计可以减少阻力，减少穿刺力道，降低穿刺过程中的疼痛感。
本发明的传感器组件，在装配时，先取监测探头201，装入传感器防水软胶202，再将三个导电硅胶205装入传感器防水软胶202中，然后将钢针套在监测探头201的竖向植入部212外部，接着将钢针和传感器防水软胶202一起装入塑胶底座203中即可。安装完成后需要检查各零件是否装配到位。
请参阅图4、图5、图6和图7，一种针盒300，包括针盒底壳301、针盒上壳302和上述的传感器组件200。针盒底壳301的内壁上竖向设置有推片311；针盒底壳301的内部设置有硬针容纳槽；针盒上壳302设置在针盒底壳301内，且针盒上壳302上开设有上下贯通的传感器组件安装孔321；
传感器组件200设置在传感器组件安装孔321内，且传感器组件200的硬针204的下部插入在硬针容纳槽内。针盒底壳301的上端开口热压有封口铝箔303。在针盒底壳301的上端设置有指示凹槽312，且指示凹槽312与推片311相邻设置。
针盒在安装时，先将传感器组件，装入针盒底壳，然后将针盒上壳装入针盒底壳，检查钢针和针盒上壳等是否装配到位。取封口铝箔303，热压到针盒底壳上端开口。
请参阅图8至图17，一种专用无痛敷贴器，用于推送上述的针盒300内的传感器组件200，并将传感器组件200的监测探头201的竖向植入部212植入人体皮肤。专用无痛敷贴器包括助针器和设置在助针器内的发射器组件9，助针器包括壳体1、涡卷弹簧2、转盘3、按钮4、解锁推杆5、滑动导轨6和发射器固定壳7。
壳体1由A壳体11和B壳体12组合成呈下端开口的中空腔体结构；A壳体11的内壁面上设置有弹簧安装圆槽13、导轨滑槽和推杆滑槽15，弹簧安装圆槽13的轴向与壳体1的轴向相互垂直，弹簧安装圆槽13内同轴设置有固定轴16；导轨滑槽由两个竖向导轨滑槽14组成，且两个竖向导轨滑槽14分设在弹簧安装圆槽13的径向两侧；推杆滑槽15竖向设置，且推杆滑槽15位于弹簧安装圆槽13和其中一个竖向导轨滑槽14之间。
A壳体11的外壁面上开设有按钮安装槽，A壳体11的一侧壁上开设有推杆滑动孔17。
涡卷弹簧2安装在弹簧安装圆槽13内，并套在固定轴16上；转盘3可转动地套在固定轴16上，且转盘3的环形周壁位于涡卷弹簧2和弹簧安装圆槽13的槽壁之间；涡卷弹簧2的内端与固定轴16相连；涡卷弹簧2的外端与转盘3的环形周壁相连；具体地，固定轴16呈圆筒状，固定轴16的壁面上沿其轴向开设有弹簧内端卡口161，转盘3的环形周壁上沿其轴向开设有弹簧外端卡口31；涡卷弹簧2的内端卡在弹簧内端卡口161内；涡卷弹簧2的外端卡在弹簧外端卡口31内。涡卷弹簧2的预压势能推动转盘3转动。
转盘3的盘底开设有轴孔32和两个转孔33，两个转孔33位于轴孔32的径向两侧，转盘的盘底的轴孔32套在固定轴16上。在安装时，将转盘旋转工具的两个凸台卡在两个转孔33中，可以旋转转盘3，进而旋转涡卷弹簧2，使得涡卷弹簧2的预压势能达到合适强度，足以实现送针和退针。
转盘3的环形周壁的外壁面上设置有转盘凸台，转盘3的盘底设置有转盘限位台34。
按钮4可活动地设置在A壳体11的按钮安装槽内，按钮4的后端穿过按钮安装槽的槽底延伸至A壳体11内；按钮4的后端的内侧壁上设置有按钮凸台41，在初始状态，转盘凸台与按钮凸台41相抵触。
具体地，按钮安装槽位于弹簧安装圆槽13的前侧，按钮安装槽的槽底与弹簧安装圆槽13的槽底部分重合。按钮安装槽的槽底开设有两个按钮穿孔；按钮4包括按钮本体43、按钮短插柱44和按钮长插柱42，按钮短插柱和按钮长插柱分别设置在按钮本体43的后端；按钮短插柱44和按钮长插柱42一一对应地穿过两个按钮穿孔，且按钮短插柱43穿过相应的按钮穿孔后位于固定轴16内；按钮凸台41位于按钮长插柱42的后端的内侧壁上；按钮安装槽的槽底设置有向前凸出的按钮弹片19，按钮本体43与按钮弹片19相接触，在按压按钮4时，按钮长插柱42带动按钮凸台41向后运动，转盘凸台与按钮凸台41脱离，转盘3在涡卷弹簧2的作用下可以旋转。
解锁推杆5的前端插入在推杆滑槽15内并沿推杆滑槽15滑动；解锁推杆5的一侧插入在推杆滑动孔17内并沿推杆滑动孔17滑动，在初始状态，按钮4的后端抵触在解锁推杆5的另一侧。
具体地，解锁推杆5包括推杆本体51、设置在推杆本体51的前端的推杆前插片52、设置在推杆本体的一侧的下部的推杆侧插片53以及设置在推杆本体的另一侧的上部的按钮抵触台54；推杆前插片52插入在推杆滑槽15内并沿推杆滑槽15滑动；推杆侧插片53插入在推杆滑动孔17内并沿推杆滑动孔17滑动，在初始状态，按钮4的按钮长插柱42的后端抵触在按钮抵触台54的前侧，即使使用者误碰按钮4，由于解锁推杆5的按钮抵触台54的抵触作用，也无法推动按钮向后运动。在使用时，装有传感器的针盒底壳上具有推片，在将无痛敷贴器与针盒底壳内的传感器对接时，推片推动推杆侧插片53沿推杆滑动孔17向上滑动，同时，推杆前插片52沿推杆滑槽15向上运动起到导向作用，整个解锁推杆5向上运动，按钮4的按钮长插柱42的后端与按钮抵触台54相脱离，按钮4解锁，可以向后按动按钮4。
推杆前插片52上设置有弹片55，推杆滑槽15的槽壁上设置有与弹片55相适配的波纹条151。
滑动导轨6的上部的前侧开有横向设置的转盘限位槽60，滑动导轨的两侧一一对应地插入在两个竖向导轨滑槽14内并沿相应的竖向导轨滑槽滑动，转盘限位台34插入在转盘限位槽60内；在转盘3转动时，转盘限位槽60内的转盘限位台34推动滑动导轨6向下运动再向上运动。
发射器固定壳7同轴设置在壳体1内；发射器固定壳7的顶端与滑动导轨6的底端相连。
具体地，滑动导轨6包括导轨后板61、导轨底板62和两个导条63，导轨后板61和导轨底板62连接呈L型，两个导条63一一对应地连接在导轨后板61的两侧；转盘限位槽60横向开设在导轨后板61的前侧面的上部；滑动导轨6的两个导条63一一对应地插入在两个竖向导轨滑槽14内并沿相应的竖向导轨滑槽滑动。
导轨底板62上开设有发射器固定壳插槽621，发射器固定壳7的顶端设置有发射器固定壳插台71，发射器固定壳插台71插接在发射器固定壳插槽621内。
滑动导轨6的底端即导轨底板62上开设有硬针安装孔64，发射器固定壳7的顶端开设有上下贯通的硬针插孔72；在将无痛敷贴器与针盒底壳内的传感器组件对接时，传感器组件上的硬针204的顶端穿过硬针插孔72后卡在硬针安装孔64内，滑动导轨6上下运动时，带动硬针204上下运动。
发射器固定壳7呈下端开口的槽状结构；发射器固定壳7内设置有发射器组件9。壳体1的下部盖合有底盖10。壳体1的内壁面的底端设置有发射器固定壳限位台18，在使用完助针器，拔下助针器时，发射器固定壳7被发射器固定壳限位台18卡住，留在壳体1内，一起取下。
请参阅图18、图19和图20，发射器组件9包括发射器壳体91和设置在发射器壳体91内的发射器电路板组件92，其中：发射器壳体91由上、下两壳体连接而成；发射器壳体91的底端面上设置有发射器敷贴胶93；发射器壳体91的下壳体上开设有传感器组件安装位；发射器电路板组件92包括发射器电路板921、麦拉片922、纽扣电池923、正极镍片924和负极镍片925，麦拉片922设置在发射器电路板921的底端；纽扣电池923位于麦拉片921的底端；负极镍片925焊接在发射器电路板921的负极焊盘处；正极镍片924焊接到发射器电路板921的正极焊盘处，正极镍片924需要与纽扣电池923用激光点焊机先焊接好；正极镍片924和负极镍片925分别与纽扣电池923相连，纽扣电池923为发射器电路板921供电。发射器壳体91的上壳体上以及发射器电路板921上分别开设有硬针固定台穿孔95；发射器敷贴胶93上开设有传感器组件穿孔96。发射器电路板921上具有三个电极接触点97。
在组装发射器组件9时，先组装好发射器电路板组件，然后将发射器电路板组件装入发射器壳体91中，发射器壳体91的上、下两壳体是用超声波焊接机焊接在一起。焊接完成需要检查超声波焊接的密封性，然后贴发射器敷贴胶93。
壳体1的侧壁上设置有向下的指示箭头，且指示箭头与推杆滑动孔17相邻设置；针盒底壳的上的指示凹槽312与壳体1的侧壁上指示箭头位于同一侧，在插接针盒时，根据指示凹槽312和指示箭头可以判断方向。
本发明的无痛敷贴器，在装配时，先将按钮4装入A壳体11。再将涡卷弹簧2装入A壳体11。接着将转盘3装入A壳体11。利用转盘旋转工具插入转盘的转孔并适当往上提，将转盘3带动涡卷弹簧2顺时针转动2圈后卡住。取解锁推杆5装入A壳体11，并往下推到底。然后将发射器固定壳7装入滑动导轨6的底端。将发射器组件9装入发射器固定壳7内；检查所有卡扣是否装到位。再将连接好的滑动导轨6/发射器固定壳7和发射器组件9装入敷贴器A壳体11中，检查各部件是否装到位。然后将B壳体12卡接在A壳体11上，检查所有卡扣是否装到位。最后将底盖10盖在壳体1的下部，并检查所有卡扣是否装到位。整个装配过程简单，不需要借助热熔工艺即可装配各零件。
请参阅图21、图22和图23，本发明的无痛敷贴器，在使用时，取下底盖10，撕开针盒底壳301上的封口铝箔303，将含有传感器组件200的针盒底壳301安装在壳体1的下部，向下压壳体1，将无痛敷贴器100与针盒底壳301内的传感器组件200对接，这一对接过程中，传感器组件200穿过发射器敷贴胶93上的传感器组件穿孔96后，插入在发射器壳体91的下部分壳体上的传感器组件安装位内；硬针固定台242依次穿过发射器电路板921上的硬针固定台穿孔95、发射器壳体91的上壳体上的硬针固定台穿孔、发射器固定壳7的顶端的硬针插孔72后，卡接在滑动导轨的底端的硬针安装孔64内，同时针盒底壳301上的推片311推动推杆侧插片53沿推杆滑动孔17向上滑动，整个解锁推杆5向上运动，按钮4的按钮长插柱42的后端与按钮抵触台54相脱离，按钮4解锁，然后将对接上传感器组件的无痛敷贴器压到人体皮肤的合适位置，然后向内按压按钮4，转盘3的环形周壁上的转盘凸台与按钮长插柱42的后端的按钮凸台41脱离，按钮4解除对转盘3的限位，转盘3在涡卷弹簧2的预压势能驱动下旋转，转盘限位台34随着转盘4的转动先向下运动，转盘限位槽60内的转盘限位台34向下运动时推动滑动导轨6向下运动，带动发射器固定壳7和硬针204向下运动，推动发射器组件向下运动，且硬针204带动监测探头201的竖向植入部212一起扎入皮肤，当涡卷弹簧2带动转盘3推动滑动导轨6到最底端，此时硬针204完全扎入肌肉，完成扎针过程，将监测探头201的竖向植入部212植入皮肤，转盘3继续旋转，转盘限位台34带动滑动导轨6将会向上运动，滑动导轨6带动硬针204向上回拉，完成硬针204回收；然后将无痛敷贴器的助针器取下，发射器和传感器依靠发射器组件的底端的发射器敷贴胶93粘贴在皮肤上。三个导电硅胶205的顶端与发射器组件9的发射器电路板921上的三个电极接触点97接触，纽扣电池26为发射器电路板921供电，监测探头201监测人体内的血糖，通过发射器组件将监测到的信号发送给外部电子设备，实现血糖监测。
本发明的无痛敷贴器，结构更为简单，采用滑动导轨代替连杆连接转盘与发射器固定壳，转盘上的转盘限位台34插入在滑动导轨上的长条状的转盘限位槽60内，在转盘转动过程中，转盘限位台34始终位于转盘限位槽60内，使整个助针过程更加稳定可靠；通过解锁推杆锁定按钮，以避免用户误碰按钮开启，更安全与实用。
请参阅图24，转盘限位槽60可以为长条状，也可以设置为向上凸出的弧形形状。图12的A图显示了在滑动导轨6向下运动过程中，转盘上的转盘限位台34在长条状的转盘限位槽60的运动轨迹，B图显示了在滑动导轨6向下运动过程中，转盘上的转盘限位台34在弧形形状的转盘限位槽60的运动轨迹，在转盘转动角度相同∠1＝∠2的情况下，弧形形状的转盘限位槽60可以实现滑动导轨更长的推动行程 h2>h1。
请参阅图25，A图显示了在滑动导轨6向下运动过程中，转盘上的转盘限位台34在长条状的转盘限位槽60的运动轨迹，B图显示了在滑动导轨6向下运动过程中，转盘上的转盘限位台34在弧形形状的转盘限位槽60的运动轨迹，当滑动导轨行程相同h1＝h3的情况下，弧形形状的转盘限位槽60可以让转盘转动角更小，即∠3<∠1，也就是可以以更短的时间完成助针过程。
请参阅图26，硬针留体时间测试：采用品型号OSG030-790UMTZ的工业高速相机检测市售产品和本发明的无痛敷贴器的硬针留体时间，具体实验方法：将敷贴器100与针盒对接，装上传感器与硬针，然后置于工业高速相机501前端，工业高速相机501的摄像头与硬针运动区域在同一方向上，使工业高速相机501能够拍摄到硬针的运动过程，安装上补光灯502照射助针器，以便提供充足的光照；拍摄过程中，分别按下市售产品和本发明的无痛敷贴器的按钮，工业高速相机记录下两者运动过程。拍摄完成后，再通过软件分析视频图像，从硬针针尖向外运动到助针器出口开始，再硬针针尖回到助针器出口为止，计算两者之间视频图像帧数即为硬针在助针器外运动的视频图像帧数，用硬针在助针器外运动的视频图像帧数÷测试时的高速摄像机平均帧率得到硬针在助针器外的运动时间，即为硬针的留体时间,例如：测试市售产品时，高速摄像机的平均帧率2277fps(每秒2277帧)，硬针在助针器外运动平均有110帧，110帧÷2277fps＝48.3ms，经计算可知硬针在助针器外平均运动48.3ms；测试本发明的无痛敷贴器时，高速摄像机平均帧率2696fps(每秒2696帧)，钢针在助针器外运动平均有12帧，12帧÷2696fps＝4.45ms，计算可知钢针在助针器外平均运动4.45ms。经多次测试，本发明的无痛敷贴器，硬针留体时间平均值是4.45毫秒，市售的助针器的硬针留体时间是48.3毫秒，与市售产品相比，本发明的无痛敷贴器，硬针留体时间更短，留体时间更短，用户有更好的使用体验，硬针注入传感器时疼痛感更弱，整个助针过程更为快速，最大程度减弱痛感，实现无痛助针。在传感器失效后，取下发射器和与其相连的传感器即可。
综上所述，本发明的传感器组件中将监测探头直接设计呈L形，植入人体后不容易发生断裂，监测探头与导电硅胶采用侧面接触，连接牢固，不容易晃动，数据稳定性好。本发明的针盒可以可靠存储传感器组件，方便使用。本发明的专用无痛敷贴器中，零件少，结构简单，装配简单，可以防止误触发，整个助针过程更加稳定可靠；通过一个涡卷弹簧实现助针，整个助针过程更为快速，最大程度减弱痛感，实现无痛助针。
本技术领域中的普通技术人员应当认识到，以上的实施例仅是用来说明本发明，而并非用作为对本发明的限定，只要在本发明的实质精神范围内，对以上所述实施例的变化、变型都将落在本发明的权利要求书范围内。

Claims (12)

  1. 一种传感器组件，其特征在于，包括监测探头、传感器防水软胶、塑胶底座和硬针，其中：
    所述监测探头由横向连接部和竖向植入部连接呈L形，所述横向连接部上具有三个电极，且所述三个电极分别位于所述横向连接部的前、后侧面上；
    所述传感器防水软胶的顶端开设有三个导电硅胶安装孔，所述三个导电硅胶安装孔呈三角形分布，每个导电硅胶安装孔内均设置一个导电硅胶；
    所述传感器防水软胶的侧壁上向内开设有一个条状的监测探头穿插通道，所述监测探头穿插通道位于所述三个导电硅胶安装孔之间，且所述监测探头穿插通道分别与所述三个导电硅胶安装孔连通；
    所述监测探头的横向连接部插入所述监测探头穿插通道内，且所述横向连接部上的三个电极一一对应地与三个导电硅胶的侧面过盈配合接触；
    所述塑胶底座上开设有防水软胶安装槽和上下贯通的硬针插孔；
    所述传感器防水软胶设置在所述防水软胶安装槽内，所述监测探头的竖向植入部插入在所述硬针插孔内；
    所述硬针的侧壁上开设有竖向设置的缺口槽，所述硬针穿插过所述硬针插孔并套在所述监测探头的竖向植入部的外部；
    所述硬针的顶端设置有硬针固定台，且硬针固定台位于所述硬针插孔的上方。
  2. 根据权利要求1所述的一种传感器组件，其特征在于，所述硬针的针尖与所述缺口槽的两侧槽壁的连接处呈弧形状。
  3. 一种针盒，其特征在于，包括针盒底壳、针盒上壳和如权利要求1或2所述的传感器组件，其中：
    所述针盒底壳的内壁上竖向设置有推片；所述针盒底壳的内部设置有硬针容纳槽；
    所述针盒上壳设置在所述针盒底壳内，且所述针盒上壳上开设有上下贯通的传感器组件安装孔；
    所述传感器组件设置在所述传感器组件安装孔内，且所述传感器组件的硬针的下部插入在所述硬针容纳槽内。
  4. 根据权利要求3所述的一种针盒，其特征在于，所述针盒底壳的上端开口热压有封口铝箔。
  5. 一种专用无痛敷贴器，用于推送如权利要求3所述的针盒内的传感器组件，并将所述传感器组件的监测探头的竖向植入部植入人体皮肤，所述专用无痛敷贴器包括助针器和设置在助针器内的发射器组件，其特征在于，所述助针器包括壳体、涡卷弹簧、转盘、按钮、解锁推杆、滑动导轨和发射器固定壳，其中：
    所述壳体由A壳体和B壳体组合成呈下端开口的中空腔体结构；
    所述A壳体的内壁面上设置有弹簧安装圆槽、导轨滑槽和推杆滑槽，所述弹簧安装圆槽的轴向与所述壳体的轴向相互垂直，所述弹簧安装圆槽内同轴设置有固定轴；所述导轨滑槽由两个竖向导轨滑槽组成，且所述两个竖向导轨滑槽分设在所述弹簧安装圆槽的径向两侧；所述推杆滑槽竖向设置，且所述推杆滑槽位于所述弹簧安装圆槽和其中一个竖向导轨滑槽之间；
    所述A壳体的外壁面上开设有按钮安装槽，所述A壳体的一侧壁上开设有推杆滑动孔；
    所述涡卷弹簧安装在所述弹簧安装圆槽内，并套在所述固定轴上；所述转盘可转动地套在所述固定轴上，且所述转盘的环形周壁位于所述涡卷弹簧和弹簧安装圆槽的槽壁之间；所述涡卷弹簧的内端与所述固定轴相连；所述涡卷弹簧的外端与所述转盘的环形周壁相连；
    所述转盘的环形周壁的外壁面上设置有转盘凸台，所述转盘的盘底设置有转盘限位台；
    所述按钮可活动地设置在所述A壳体的按钮安装槽内，所述按钮的后端穿过所述按钮安装槽的槽底延伸至所述A壳体内；所述按钮的后端的内侧壁上设置有按钮凸台，在初始状态，所述转盘凸台与所述按钮凸台相抵触；
    所述解锁推杆的前端插入在所述推杆滑槽内并沿所述推杆滑槽滑动；所述解锁推杆的一侧插入在所述推杆滑动孔内并沿所述推杆滑动孔滑动，在初始状态，所述按钮的后端抵触在所述解锁推杆的另一侧；
    所述滑动导轨的上部的前侧开有横向设置的转盘限位槽，所述滑动导轨的两侧一一对应地插入在所述两个竖向导轨滑槽内并沿相应的竖向导轨滑槽滑动，所述转盘限位台插入在所述转盘限位槽内；
    所述发射器固定壳同轴设置在所述壳体内；
    所述发射器固定壳的顶端与所述滑动导轨的底端相连；
    所述发射器组件设置在所述发射器固定壳内；
    所述滑动导轨的底端开设有硬针安装孔，所述发射器固定壳的顶端开设有上下贯通的硬针插孔。
  6. 根据权利要求5所述的一种专用无痛敷贴器，其特征在于，所述发射器组件包括发射器壳体和设置在发射器壳体内的发射器电路板组件，其中：
    所述发射器壳体由上、下两壳体连接而成；所述发射器壳体的底端面上设置有发射器敷贴胶；所述发射器壳体的下壳体上开设有传感器组件安装位；
    所述发射器电路板组件包括发射器电路板、麦拉片、纽扣电池、正极镍片和负极镍片，所述麦拉片设置在所述发射器电路板的底端；所述纽扣电池位于所述麦拉片的底端；所述负极镍片焊接在所述发射器电路板的负极焊盘处；所述正极镍片焊接到所述发射器电路板的正极焊盘处，所述正极镍片和负极镍片分别与所述纽扣电池相连；
    所述发射器壳体的上壳体上以及所述发射器电路板上分别开设有硬针固定台穿孔；
    所述发射器敷贴胶上开设有传感器组件穿孔。
  7. 根据权利要求6所述的一种专用无痛敷贴器，其特征在于，在将所述专用无痛敷贴器与所述针盒内的传感器组件对接时，所述传感器组件穿过所述发射器敷贴胶上的传感器组件穿孔后，插入在所述发射器壳体的下部分壳体上的传感器组件安装位；
    所述硬针固定台依次穿过所述发射器电路板上的硬针固定台穿孔、所述发射器壳体的上壳体上的硬针固定台穿孔、所述发射器固定壳的顶端的硬针插孔后，卡接在所述滑动导轨的底端的硬针安装孔内。
  8. 根据权利要求6所述的一种专用无痛敷贴器，其特征在于，在将所述专用无痛敷贴器与所述针盒内的传感器组件对接时，所述针盒底壳的内壁上的推片推动所述解锁推杆的插入在所述推杆滑动孔内的一侧向上滑动，带动整个解锁推杆向上滑动。
  9. 根据权利要求5所述的一种专用无痛敷贴器，其特征在于，所述壳体的下部盖合有底盖。
  10. 根据权利要求5所述的一种专用无痛敷贴器，其特征在于，所述壳体的内壁面的底端设置有发射器固定壳限位台，在使用完助针器，拔下助针器时，所述发射器固定壳限位台将所述发射器固定壳卡住。
  11. 根据权利要求5所述的一种专用无痛敷贴器，其特征在于，所述壳体的侧壁上设置有向下的指示箭头，且所述指示箭头与所述推杆滑动孔相邻设置；所述针盒底壳的上端设置有指示凹槽，且所述指示凹槽与所述推片相邻设置。
  12. 根据权利要求5所述的一种专用无痛敷贴器，其特征在于，所述转盘限位槽呈长条状或者向上凸出的弧形形状。
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