CN115779124A - Continuous blood glucose monitor sterilization assembly and continuous blood glucose monitor - Google Patents

Continuous blood glucose monitor sterilization assembly and continuous blood glucose monitor Download PDF

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Publication number
CN115779124A
CN115779124A CN202211555749.3A CN202211555749A CN115779124A CN 115779124 A CN115779124 A CN 115779124A CN 202211555749 A CN202211555749 A CN 202211555749A CN 115779124 A CN115779124 A CN 115779124A
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China
Prior art keywords
housing
needle
blood glucose
limiting
monitor
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Pending
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CN202211555749.3A
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Chinese (zh)
Inventor
杨凯洪
张亚南
支佳佳
周华龙
蒲继瑞
陈�峰
孙博珍
施逸琪
华昊
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Jiangsu Yuekai Biotechnology Co ltd
Zhejiang Poctech Corp
Jiangsu Yuyue Kailite Biotechnology Co ltd
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Jiangsu Yuekai Biotechnology Co ltd
Zhejiang Poctech Corp
Jiangsu Yuyue Kailite Biotechnology Co ltd
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Application filed by Jiangsu Yuekai Biotechnology Co ltd, Zhejiang Poctech Corp, Jiangsu Yuyue Kailite Biotechnology Co ltd filed Critical Jiangsu Yuekai Biotechnology Co ltd
Priority to CN202211555749.3A priority Critical patent/CN115779124A/en
Priority to PCT/CN2022/143252 priority patent/WO2024119563A1/en
Publication of CN115779124A publication Critical patent/CN115779124A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08Radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/24Apparatus using programmed or automatic operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26Accessories or devices or components used for biocidal treatment

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Optics & Photonics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

The application discloses last blood glucose monitor sterilization subassembly and last blood glucose monitor, the sterilization subassembly includes the sensor, monitor main part and housing, the monitor main part is equipped with the through-hole, the housing cooperates and forms closed cavity with the monitor main part, sensor one end is located the monitor main part, the other end gets into closed cavity through the through-hole downwardly extending, still include puncture subassembly and limit structure, the puncture subassembly includes needle body and needle file, the needle file is located monitor main part upside, the needle body passes through the through-hole downwardly extending and gets into closed cavity, at least part nestification of sensor is inside the needle body, limit structure can restrict puncture subassembly at least and shift out from the through-hole. Limit structure can carry on spacingly to puncture assembly, makes puncture assembly and monitor main part keep firm being connected, and limit structure can restrict puncture assembly's motion, realizes puncture assembly's mistake proofing and touches, and under limit assembly's restriction, puncture assembly can't move and then can't implant and move back the needle action, has improved operational reliability.

Description

Continuous blood glucose monitor sterilization assembly and continuous blood glucose monitor
Technical Field
The application belongs to the technical field of medical equipment, and particularly relates to a continuous blood glucose monitor sterilization assembly and a continuous blood glucose monitor.
Background
A biosensor is an instrument that is sensitive to a bioactive substance and converts the sensed concentration of the bioactive substance into an electrical signal for detection. Among them, glucose sensors are a common type of biosensor. CGM (continuous blood glucose monitoring) is a technical means of indirectly reflecting blood glucose levels by continuously monitoring the glucose concentration of subcutaneous interstitial fluid through a glucose sensor. The CGM product needs a puncture needle and a sensor pin to puncture the skin of a human body when testing blood sugar, generates electrochemical reaction with subcutaneous tissue fluid through biological enzyme on the sensor, converts the electrochemical reaction into an electric signal, and provides the electric signal for a user through converting the electric signal into a blood sugar value. Because the product has a part which punctures the skin of a human body, the product needs to be sterilized before leaving the factory, and the infection risk of a user caused by pathogenic bacteria on the product is avoided.
The monitoring assembly generally comprises a sensor and an electronic unit (emitter), different sterilization modes are often required for the sensor and the electronic unit (emitter), the emitter part is generally sterilized by gas, for example, ethylene oxide gas is used for sterilization, and since the biological enzyme on the sensor can chemically react with gases such as ethylene oxide and the like, the activity of the biological enzyme is influenced, the monitoring accuracy is further influenced, the sensor cannot be sterilized by the gas sterilization mode, and then radiation sterilization is selected. Meanwhile, radiation sterilization easily affects the circuits of the transmitter, so that the sensor and the transmitter need to be sterilized separately.
In addition, the pjncture needle is direct and human contact equally, need carry out sterilization treatment equally, for improving sterilization efficiency, it makes pjncture needle or sensor receive the pollution once more to reduce after the sterilization in-process of assembling, can assemble the back with the pjncture needle with the monitoring subassembly and sterilize together, however, the assembly back is accomplished to the pjncture needle, relative motion takes place with the monitoring subassembly easily for sealed between the two is destroyed, and then makes aseptic space destroyed, and the bacterium in the outside air can invade pjncture needle and sensor department, makes the two receive the pollution.
Before the implantation operation is carried out, particularly in the product transportation process, relative shaking occurs between the puncture needle and the monitoring assembly, so that the puncture needle and the monitoring assembly are easily separated, the sealing structure between the puncture needle and the monitoring assembly is failed, and the monitoring assembly or the puncture needle is even damaged.
Moreover, to avoid cross infection, CGM products are often disposable products, that is, they fail after completing one-time implantation or withdrawal of the needle, but in the course of product transportation, the product shaking also easily causes false triggering to the puncture needle, resulting in the puncture needle completing implantation or withdrawal of the needle in advance, and further resulting in the product being discarded.
Therefore, how to improve the assembly stability of the puncture needle and the monitoring component, ensure the sterilization effect, and limit the false triggering of the puncture needle becomes a technical problem to be solved urgently in the field.
Disclosure of Invention
The present application provides a continuous blood glucose monitor sterilization assembly and a continuous blood glucose monitor to address at least one of the above technical problems.
The technical scheme adopted by the application is as follows:
the utility model provides a last blood sugar monitor sterilization subassembly, including the sensor, monitor main part and housing, the monitor main part is equipped with the through-hole, the housing cooperates and forms closed cavity with the monitor main part, sensor one end is located the monitor main part, the other end passes through the through-hole downwardly extending and gets into closed cavity, sterilization subassembly still includes puncture subassembly and limit structure, puncture subassembly includes needle body and needle file, the needle file is located monitor main part upside, the needle body passes through the through-hole downwardly extending and gets into closed cavity, at least part nestification of sensor is inside the needle body, limit structure can restrict puncture subassembly at least and shift out from the through-hole.
The limiting structure has a locking state and an unlocking state, the limiting structure can apply force towards the monitor main body to the needle base in the locking state, and the limiting structure stops applying force in the unlocking state.
The limiting structure comprises a limiting hole, at least part of the needle seat is accommodated in the limiting hole, the limiting structure can rotate between a first position and a second position relative to the needle seat, the limiting hole is provided with a first stop structure, and the needle seat is provided with a second stop structure; in the first position, the limiting structure is in a locking state, and the first stop structure is abutted with the second stop structure to limit the needle base to move out of the limiting hole; in the second position, the limiting structure is in an unlocking state, and the first stop structure is separated from the second stop structure in a butting manner, so that the needle seat can be separated from the limiting hole.
The limiting structure further comprises a shifting part, the housing is provided with an installation position, and the installation position is used for accommodating the shifting part, so that the housing can drive the limiting structure to be changed into an unlocking state from a locking state.
The stirring part comprises a stirring rod, the opening end of the housing is provided with a mounting groove, the mounting groove is used for clamping the stirring rod, and the housing can drive the limiting structure to rotate so as to be changed into an unlocking state from a locking state.
The housing comprises an outer housing and an inner housing which are sleeved, and the inner housing is abutted to the lower part of the monitor main body to form a closed chamber.
Monitor main part below is provided with the adhesion layer, and the adhesion layer has been seted up first and has been dodged the district, and the butt end of interior casing is located first dodge the district.
The inside support column that is provided with of shell body, the support column can with the below butt of monitor main part.
Monitor main part below is provided with the adhesion layer, and the adhesion layer has been seted up the second and has been dodged the district, and the butt end of support column is located the second and dodges the district.
The sterilization assembly further comprises a connecting seat used for installing the monitor main body and a guide assembly used for guiding the rotation of the limiting structure, the guide assembly comprises a guide sliding groove and a guide sliding block, one of the guide sliding groove and the guide sliding block is arranged on the limiting structure, and the other guide sliding groove and the guide sliding block are arranged on the connecting seat.
Limiting structure includes the non return muscle, is provided with the non return arch on housing and/or the connecting seat, and when limiting structure rotated to the second position by the primary importance, non return muscle and the protruding butt of non return to restriction limiting structure rotated to the primary importance by the second place.
One of the connecting seat and the limiting structure is provided with a limiting piece, and the other one is provided with a blocking piece, when the limiting structure rotates from a first position to a second position, the blocking piece can be abutted against the limiting piece so as to limit the limiting structure to continue to move towards the direction far away from the first position.
The sterilization assembly further comprises a connecting seat used for installing the monitor main body, a pressing portion is arranged on the connecting seat, and the pressing portion is matched with the connecting seat to clamp the limiting structure.
The limiting structure comprises a limiting hole, at least part of the needle seat is accommodated in the limiting hole, the limiting structure can rotate between a first position and a second position relative to the needle seat, the limiting hole is provided with a first stop structure, and the needle seat is provided with a second stop structure; in the first position, the limiting structure is in a locking state, and the first stop structure is abutted with the second stop structure to limit the needle base to move out of the limiting hole; in the second position, limit structure is in the unblock state, and first only shelves structure breaks away from the butt with the second only shelves structure to make the needle file break away from in the spacing hole.
Part of the area of the cover surrounds the periphery of the connecting seat and is rotationally clamped with the connecting seat.
One of the housing and the connecting seat is provided with a fixing protrusion, the other one of the housing and the connecting seat is provided with a fixing groove, the fixing groove is provided with a guide section and a locking section which are connected with each other, and the housing can rotate relative to the connecting seat so that the fixing protrusion can move to the guide section along the locking section.
The side wall of the connecting seat is provided with a plurality of elastic rib positions, and the housing abuts against the elastic rib positions so that the elastic rib positions move towards the monitor main body to clamp the monitor main body in a state that the housing is fixed on the connecting seat.
The connecting seat has been seted up the via hole, and the via hole corresponds the setting with the through-hole, and at least part region and the via hole cooperation of needle file to restriction puncture subassembly rotates for the connecting seat.
The connecting seat and/or the needle seat are/is provided with a sealing ring.
The application also discloses a last blood glucose monitor, include the casing and arrange the helping hand needle subassembly in the casing in, still include foretell blood glucose monitor sterilization subassembly that lasts, joint groove and spacing groove have been seted up to the needle file, and the joint groove is used for linking to each other with helping the needle subassembly, and the spacing groove is used for cooperateing with limit structure.
The housing comprises an outer housing and an inner housing which are sleeved, and the housing is butted with the outer housing.
Due to the adoption of the technical scheme, the beneficial effects obtained by the application are as follows:
1. the application's housing and monitor main part cooperation form closed cavity, sensor and needle body stretch into to closed cavity in, carry out sterilization process to the one end and the needle body of sensor through the mode of radiation sterilization, the mode of follow-up accessible gas sterilization carries out gas sterilization to the electronic unit in the monitor main part, puncture unit and monitor main part assembly are accomplished the back, seal the through-hole for in the unable closed cavity that gets into of gas, thereby isolated with the sensor with the gas that is used for the sterilization. All the components of the monitor which need to be sterilized are assembled to form a sterilization component, so that the size is smaller, the sterilization is more convenient, and the monitor is assembled with other components of the monitor subsequently to form a complete monitor, namely a CGM product.
In addition, sterilization subassembly still includes limit structure, limit structure can carry on spacingly to puncture subassembly, make puncture subassembly and monitor main part keep firm being connected, on the one hand puncture subassembly is sealed with the through-hole shutoff, and the two position is stable, help guaranteeing the sealing reliability of through-hole, thereby guarantee to seal cavity and external isolated, guarantee being in sterile environment of sensor and needle body, the risk that the emergence of puncture subassembly and monitor main part breaks away from has also been reduced simultaneously, reduce the risk that monitor main part damaged. On the other hand limit structure can restrict the motion of puncture subassembly to realize preventing that puncture subassembly from touching by mistake, under the restriction of limit component, puncture subassembly can't move and then can't implant and move back the needle action, improved the operational reliability of monitor, practiced thrift the cost.
2. As a preferred embodiment of the present application, the limiting structure includes a limiting hole, at least a portion of the needle hub is received in the limiting hole, the limiting structure is capable of rotating between a first position and a second position relative to the needle hub, the limiting hole is provided with a first stop structure, and the needle hub is provided with a second stop structure; in the first position, the limiting structure is in a locking state, and the first stop structure is abutted with the second stop structure to limit the needle base to move out of the limiting hole; in the second position, limit structure is in the unblock state, and first only shelves structure breaks away from the butt with the second only shelves structure to make the needle file break away from in the spacing hole. Limiting structure can rotate the switching that realizes the locking and the unblock state to puncture assembly for the needle file, and in the in-service use, the whole volume of CGM product tends to the miniaturization, consequently through rotation control's mode, convenience of customers application of force more improves the convenience of use. Before leaving the factory, limit structure is in locking state, and it is fixed with puncture structure, makes its unable motion, under this state, can play puncture assembly's the mistake of preventing and touch the effect, prevents in the transportation to and puncture assembly accomplishes implantation or moves back the needle action in advance before the user implants. When the user implants, make it break away from the restriction to the puncture subassembly through rotating limit structure, but the puncture subassembly normal motion this moment to the user can accomplish smoothly and implant the operation.
3. As a preferred embodiment of this application, limit structure includes the non return muscle, is provided with the non return arch on housing and/or the connecting seat, and when limit structure rotated to the second position by primary importance, non return muscle and non return protruding butt to limit structure and rotate to the primary importance by the second place. The bellied cooperation of non return muscle and non return for limit structure's unblock motion is irreversible operation, and in case limit structure rotates to the unblock state, under non return muscle and the bellied backstop effect of non return, just with limit structure restriction in this position, make it unable gyration to the locking state, guarantee reliability and the security that the product used, further avoid the product by used repeatedly, reduce cross infection's risk.
4. As a preferred embodiment of the present application, a partial region of the housing surrounds an outer periphery of the connection seat, and is rotatably engaged with the connection seat. The cover abuts against the monitor main body to form a closed chamber before the monitor is used, so that the contact pin and the needle body of the sensor are in a closed sterile environment, the cover is detached in a rotating mode when the monitor is used, and the contact pin and the needle body of the sensor are exposed, so that a user can conveniently implant the monitor. Meanwhile, in the process of disassembling the housing, the limiting structure synchronously rotates, so that the puncture assembly is unlocked and can move to be implanted, the housing and the puncture assembly are synchronously unlocked, the unlocking of a plurality of parts is realized only by one-step operation, the operation steps are simplified, the complexity of product use is reduced, and the use experience is greatly improved.
5. As a preferred embodiment of the present application, the side wall of the connection seat is provided with a plurality of elastic rib positions, and the cover abuts against the elastic rib positions so that the elastic rib positions move towards the monitor main body to clamp the monitor main body in a state that the cover is fixed to the connection seat. The partial region of housing encircles the periphery at the monitor main part, when the housing is not dismantled, under the effect of supporting of housing, the elastic rib position of monitor main part periphery is inside motion respectively, thereby form the extrusion to the monitor main part, it is fixed with monitor main part chucking, improve the stability of being connected of monitor main part and other parts of monitor, prevent to drop, when the user implants the operation, pull down the housing, elastic rib position loses the extrusion and resets this moment, outside expansion promptly, loosen the monitor main part, the monitor can lie in the adhesive force effect of human skin and break away from the connecting seat down this moment, stay at the skin surface. This application realizes the unblock to the monitor main part when dismantling the housing, further simplified operation step, improves and uses experience.
Drawings
The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the application and together with the description serve to explain the application and not to limit the application. In the drawings:
FIG. 1 is a schematic diagram of a sterilization assembly according to one embodiment of the present disclosure;
FIG. 2 is a schematic view of a sterilization assembly according to another embodiment of the present disclosure;
FIG. 3 is a cross-sectional view of the sterilization assembly of FIG. 2;
FIG. 4 is a schematic view of a monitor body according to an embodiment of the present application;
FIG. 5 is a schematic view of a monitor body according to another embodiment of the present application;
FIG. 6 is a schematic view of the internal structure of a monitor body according to an embodiment of the present application;
FIG. 7 is a bottom view of a monitor body according to an embodiment of the present application;
FIG. 8 is a bottom view of the monitor body according to another embodiment of the present application;
FIG. 9 is a schematic view of a housing according to an embodiment of the present application;
FIG. 10 is a schematic view of the construction of a housing according to another embodiment of the present application;
FIG. 11 is a schematic view of a connecting socket according to an embodiment of the present application;
fig. 12 is a schematic structural view of a connection seat according to another embodiment of the present application;
fig. 13 is a schematic structural diagram of a limiting structure according to an embodiment of the present application;
FIG. 14 is a schematic structural view of a stop structure according to another embodiment of the present disclosure;
FIG. 15 is a schematic structural view of a spike assembly in accordance with one embodiment of the present application;
FIG. 16 is a schematic structural view of a spike assembly in accordance with another embodiment of the present application;
FIG. 17 is a schematic view of the internal structure of a monitor according to an embodiment of the present application;
FIG. 18 is a schematic view of the monitor of FIG. 17;
FIG. 19 is a schematic diagram of a monitor according to another embodiment of the present application;
FIG. 20 is a schematic diagram of the internal structure of the monitor of FIG. 19, with the housing not shown;
fig. 21 is a cross-sectional view of the monitor of fig. 19.
Wherein:
1 a monitor main body; 11 a sensor; 12 through holes; 13 a sensor electronics unit; 131 mounting position; 14 mating grooves; 15 a spacer; 16 an annular sealing strip; 17 an adhesion layer; 171 a first avoidance zone; 172 a second avoidance zone;
2, a housing; 21 an inner shell; 211 installing grooves; 212 support column; 213 fixing grooves; 2131 a guide section; 2132 a locking segment; 22 an outer shell; 23 closing the chamber;
3 a puncture assembly; 31 needle bodies; 32 needle seats; 321 a clamping groove; 322 a limiting groove;
4, a limiting structure; 41 a limiting hole; 411 a raised structure; 42 a poker bar; 43 a guide chute; 44 a check rib; 45 a limiting member;
5 connecting base; 51 guiding the sliding block; 52 a non-return projection; 53 a pressing part; 54 a fixing projection; 55 elastic rib positions; 551 fixing the convex ribs; 56 via holes; 57 clamping the ribs; 58 mounting ports;
6, a shell; 61 triggering structure;
7 assisting the needle assembly.
Detailed Description
In order to more clearly explain the overall concept of the present application, the following detailed description is given by way of example in conjunction with the accompanying drawings.
In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application, however, the present application may be practiced in other ways than those described herein, and therefore the scope of the present application is not limited by the specific embodiments disclosed below.
In addition, in the description of the present application, it is to be understood that the terms "top," "bottom," "inner," "outer," "axial," "radial," "circumferential," and the like are used in the positional or orientational relationship shown in the drawings for the purpose of convenience and simplicity of description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are therefore not to be considered limiting of the present invention.
In this application, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and encompass, for example, both fixed and removable connections or integral parts thereof; the connection can be mechanical connection, electrical connection or communication; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
In this application, unless expressly stated or limited otherwise, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through intervening media. In the description herein, references to the description of the terms "implementation," "embodiment," "one embodiment," "example" or "specific example" or the like are intended to mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the application. In this specification, the schematic representations of the terms used above are not necessarily intended to refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.
As shown in fig. 1 to 21, a sterilization assembly for a continuous blood glucose monitor comprises a sensor 11, a monitor main body 1 and a housing 2, wherein the monitor main body 1 is provided with a through hole 12, the housing 2 is matched with the monitor main body 1 to form a closed chamber 23, one end of the sensor 11 is positioned in the monitor main body 1, the other end of the sensor 11 extends downwards through the through hole 12 to enter the closed chamber 23, the sterilization assembly further comprises a puncture assembly 3 and a limiting structure 4, the puncture assembly 3 comprises a needle body 31 and a needle seat 32, the needle seat 32 is positioned on the upper side of the monitor main body 1, the needle body 32 extends downwards through the through hole 12 to enter the closed chamber 23, at least part of the sensor 11 is nested inside the needle body 31, and the limiting structure 4 at least can limit the puncture assembly 3 from moving out of the through hole 12.
The housing 2 of this application forms closed chamber 23 with the cooperation of monitor main part 1, sensor 11 and needle body 31 stretch into to closed chamber 23 in, the mode through radiation sterilization carries out sterilization process to the one end of sensor 11 and needle body 31, the mode of follow-up accessible gas sterilization carries out gas sterilization to the electronic unit in the monitor main part 1, puncture unit 3 and the assembly completion back of monitor main part 1, seal through-hole 12, make in the unable closed chamber 23 that gets into of gas, thereby with sensor 11 with be used for the gaseous isolated of sterilization. All the components of the monitor which need to be sterilized are assembled to form a sterilization component, so that the size is smaller, the sterilization is more convenient, and the monitor is assembled with other components of the monitor subsequently to form a complete monitor, namely a CGM product.
Specifically, the shape of the casing 2 is not limited in the present application, and may be, for example, a split structure or an integrated structure, as long as the casing can cooperate with the lower portion of the monitor main body 1 to form a closed chamber. Some regions of the housing 2 may or may not be connected to the needle assembly.
In addition, sterilization assembly still includes limit structure 4, limit structure 4 can carry on spacingly to puncture assembly 3, make puncture assembly 3 and monitor main part 1 keep firm being connected, on the one hand puncture assembly 3 seals through-hole 12 shutoff, and the two position is stable, help guaranteeing the sealed reliability of through-hole 12, thereby guarantee to seal cavity 23 and external isolated, guarantee being in sterile environment of sensor 11 and needle body 31, the risk that puncture assembly 3 and monitor main part 1 take place to break away from has also been reduced simultaneously, reduce the risk that monitor main part 1 damaged. On the other hand, when the housing 2 is not taken down, the limiting structure 4 can limit the movement of the puncture component 3, so that the puncture component 3 is prevented from being touched by mistake, and under the limitation of the limiting structure 4, the puncture component 3 can not move and further can not be implanted and withdrawn, thereby improving the working reliability of the monitor and saving the cost.
For example, the puncture assembly 3 is easy to trigger the needle withdrawing movement when the product is vibrated in the transportation process, or the puncture assembly 3 triggers the implantation movement due to the false triggering before the user implants, the limit structure can keep the puncture assembly 3 at the preset position, and the puncture assembly 3 cannot move any way before the unlocking.
It should be noted that the needle withdrawing movement of the puncture set 3 may be triggered manually by the user or automatically after the implantation is completed.
Preferably, the sterilization assembly further comprises a sensor electronics unit 13 for receiving and processing the biological signals monitored by the sensor 11, the sensor electronics unit 13 being removably mounted to the monitor body 1 to enable stepwise sterilization of the sterilization assembly, the closed chamber 23 being sealed after radiation sterilization of the sensor 11, the sensor electronics unit 13 then being mounted to the monitor body 1 and then gas sterilized.
As shown in fig. 6, the mounting position 131 for mounting the sensor electronic unit 13 is disposed in a staggered manner with respect to the through hole 12, the free end of the sensor 11 passes through the through hole 12, and a partition 15 is provided between the through hole 12 and the mounting position 131, so that during sterilization, two regions of the monitor main body 1 can be sterilized in different manners, respectively, without affecting each other.
Further, the limit structure 4 has a locked state in which the limit structure 4 can apply a force to the needle base 32 toward the monitor main body 1 and an unlocked state in which the limit structure 4 stops applying the force.
In the locking state, the limiting structure 4 firmly presses the needle seat 32 on the monitor main body 1, so that the through hole 12 is sealed, the closed chamber 23 is isolated from the external environment, and in the unlocking state, the limiting structure 4 unlocks the needle seat 32, so that the needle seat 32 can move.
It should be noted that the present application does not specifically limit the movement manner of the limiting structure 4, and in one embodiment, as shown in fig. 1 and fig. 2, the limiting structure 4 can rotate relative to the monitor main body 1 to switch between the locking state and the unlocking state. Of course, the limiting structure 4 may also be switched between the two states in other ways, such as translational sliding, etc.
Further, as shown in fig. 2, 13 and 14, the limiting structure 4 includes a limiting hole 41, at least a portion of the needle seat 32 is received in the limiting hole 41, the limiting structure 4 can rotate between a first position and a second position relative to the needle seat 32, the limiting hole 41 is provided with a first stop structure, and the needle seat is provided with a second stop structure; in the first position, the limiting structure 4 is in a locking state, and the first stop structure is abutted with the second stop structure to limit the needle seat 32 to move out of the limiting hole 41; in the second position, the limit structure 4 is in the unlocked state, and the first stop structure is disengaged from the second stop structure, so that the needle seat 32 can be disengaged from the limit hole 41.
Limiting structure 4 can rotate the switching that realizes the locking and the unblock state to puncture assembly 3 for needle file 32, and in the in-service use, the whole volume of CGM product tends to the miniaturization, consequently through rotation control's mode, and convenience of customers application of force more improves the convenience of use. Before leaving the factory, limit structure 4 is in locking state, and is fixed with puncture assembly 3, makes its unable motion, under this state, can play puncture assembly 3 prevent that the mistake from touching the effect, prevents in the transportation to and puncture assembly 3 accomplishes in advance before the user implants or moves back the needle action. When a user implants, the limiting structure 4 is rotated to separate the puncture component 3 from the limitation, and the puncture component 3 can normally move, so that the user can smoothly complete the implantation operation.
In one embodiment, as shown in fig. 2, 13 and 15, the limiting hole 41 and the needle hub 32 are both non-circular structures, the limiting hole 41 can rotate together with the limiting structure 4 relative to the needle hub 32, when the limiting hole 41 rotates to a position coinciding with the needle hub 32, the limiting structure 4 is in an unlocked state, at this time, the limiting structure 4 loses the stop against the needle hub 32, and the puncture assembly 3 can penetrate out of the limiting hole 41. When the limiting structure 4 rotates to a position where the limiting hole 41 is dislocated with the needle seat 32, the limiting structure 4 is in a locking state, and the limiting structure 4 stops the needle seat 32 to prevent the needle seat from passing through the limiting hole 41.
More specifically, as shown in fig. 2, the limiting structure 4 can rotate around the axis of the puncture assembly 3, so that the limiting hole 41 and the needle seat 32 have a dislocation state and an alignment state, so as to reduce the movement space of the limiting structure and prevent the limiting structure from interfering with other parts. Of course, the limiting structure 4 may also rotate around an axis other than the needle seat 32, so that the limiting structure 4 can be close to the needle seat 32 or far away from the needle seat 32 in the rotating process, when the limiting structure rotates towards the direction close to the needle seat 32 and the limiting hole 41 is aligned with the needle seat 32, the needle seat 32 is unlocked, and when the limiting structure rotates towards the direction far away from the needle seat 32 and the limiting hole 41 is misaligned with the needle seat 32, the needle seat 32 is locked.
In another embodiment, as shown in fig. 14, the first stopping structure is a protruding structure 411 disposed on the inner wall of the limiting hole 41, and the outer wall of the needle seat 32 is correspondingly provided with a groove structure, when the two are rotated to overlap, the needle seat 32 is unlocked, and when the two are dislocated, the needle seat 32 is locked.
Preferably, as shown in fig. 2, 9, 10, and 13, the limiting structure 4 further includes a toggle portion, the housing 2 is provided with a mounting position, and the mounting position is used for accommodating the toggle portion, so that the housing 2 can drive the limiting structure 4 to be changed from the locking state to the unlocking state.
Through setting up toggle portion in the installation position, realize limit structure 4 and housing 2's linkage, because limit structure 4 is located inside the monitor, the user can't directly operate limit structure 4, consequently the accessible is controlled housing 2, realizes limit structure 4 state switch, has made things convenient for user's operation.
Further, as shown in fig. 2, 9, 10, and 13, the toggle part includes a toggle rod 42, an opening end of the housing 2 is provided with a mounting groove 211, the mounting groove 211 is used for engaging the toggle rod 42, and the housing 2 can drive the limiting structure 4 to rotate so as to change from the locking state to the unlocking state.
Specifically, as shown in fig. 1 and 2, the open end of the housing 2 surrounds the periphery of the monitor main body 1, and the poke rod 42 is engaged with the mounting groove 211 of the open end of the housing 2 and extends inward in the radial direction of the housing 2 to engage with the puncture assembly 3. Two groove walls of the mounting groove 211 are located at two sides of the mounting groove 211 along the circumferential direction of the housing 2, so as to form circumferential limitation on the poke rod 42, and when the housing 2 rotates, the poke rod 42 is pushed to synchronously rotate along with the housing 2 under the propping action of the groove wall at one side of the mounting groove 211.
Further, as shown in fig. 1, 2, 9 and 10, the mounting groove 211 has an upward opening at a corresponding second position, so that when a user removes the housing 2, the tap rod 42 can slide out of the opening and disengage from the housing 2, so that the housing 2 can be removed, and the tap rod 42 stays inside the monitor without affecting the operation of the internal components.
As a preferred embodiment of the present application, as shown in fig. 2 and 3, the housing 2 includes an outer housing 22 and an inner housing 21, which are sleeved, and the inner housing 21 abuts against a lower portion of the monitor main body 1 to form a closed chamber 23.
The inner casing 21 of the housing 2 is abutted against the bottom surface of the monitor main body 1, on one hand, the inner casing is matched with the monitor main body to form a closed chamber, so that the contact pin of the sensor 11 and the needle body 31 of the puncture component 3 are contained in the sterile environment of the closed chamber 23, on the other hand, the inner casing 21 can also form upward supporting force for the monitor main body 1, so that the monitor main body 1 is more stably fixed, and the monitor main body 1 is prevented from falling off before implantation.
It should be noted that the present embodiment does not specifically limit the structure of the monitor main body 1, and in a specific example, as shown in fig. 7, the bottom surface of the monitor main body 1 is provided with an annular sealing strip 16, and the annular sealing strip 16 is concentrically arranged with the monitor main body 1, and the inner housing 21 is also of an annular structure, so as to be sealed in abutment with the annular sealing strip 16, thereby forming a closed chamber 23 inside.
In another specific example, as shown in fig. 8, an adhesive layer 17 is disposed below the monitor main body 1, the adhesive layer 17 is provided with a first avoidance area 171, and an abutting end of the inner housing 21 is located in the first avoidance area 171.
It can be understood, adhesive layer 17 coating has the adhesive, make monitor main part 1's bottom surface and skin contact back, under the cohesive force effect, can the adhesion at the skin surface, and first dodge district 171 not have the adhesive, consequently do not have viscidity, interior casing 21 with first dodge district 171 butt, can enough prevent that interior casing 21 and adhesive layer 17 from taking place the adhesion, destroy adhesive layer 17 when leading to housing 2 to pull down, when avoiding housing 2 and monitor main part 1 to take place relative rotation again, interior casing forms to rub adhesive layer 17, lead to adhesive layer 17 to corrugate, the effect is pasted in the influence.
Preferably, as shown in fig. 8, the first escape area 171 is arc-shaped and extends along the circumferential direction of the monitor main body 1 to escape the inner housing 21 so that the inner housing 21 does not contact the adhesive layer 17 in the movement path.
In a preferred embodiment, as shown in fig. 9, a support column 212 is provided inside the outer case 22, and the support column 212 can abut on the lower side of the monitor main body 1.
The arrangement of the support column 212 increases the contact area of the cover case 2 and the monitor main body 1, and improves the support stability of the cover case 2 to the monitor main body 1. Preferably, as shown in fig. 9, there are two support columns 212, so that the inner housing 21 and the support columns 212 jointly support against the monitor main body 1 to form a three-point support for the monitor main body 1.
Further, as shown in fig. 8 and 9, an adhesive layer 17 is disposed below the monitor main body 1, a second avoidance area 172 is disposed on the adhesive layer 17, and an abutting end of the supporting column 212 is located in the second avoidance area 172.
The second escape area 172 is also not provided with the adhesive layer 17, so that the support pillar 212 is prevented from rubbing with the adhesive layer 17 during the movement of the cover 2 relative to the monitor main body 1 to affect the adhesion of the adhesive layer 17.
As shown in fig. 8 and 9, two second avoidance areas 172 are provided, and the first avoidance area 171 and the second avoidance area 172 are both disposed eccentrically to the monitor main body 1, and a connection line between the three areas is approximately an isosceles triangle. To further improve the stability of the support of the monitor main body 1 by the inner case 21 and the support pole 212, and to prevent the monitor main body 1 from tilting.
As a preferred embodiment of the present application, as shown in fig. 2 and fig. 2, the sterilization assembly further includes a connection base 5 for mounting the monitor main body 1 and a guide assembly for guiding the rotation of the limit structure 4, the guide assembly includes a guide sliding groove 43 and a guide sliding block 51, one of the guide sliding groove 43 and the guide sliding block 51 is disposed on the limit structure 4, and the other is disposed on the connection base 5.
Preferably, as shown in fig. 12, the connecting base 5 is provided with a mounting opening 58 corresponding to the mounting position of the sensor electronic unit 13 so as to facilitate distributed mounting of the sensor 11 and the sensor electronic unit 13, and after the radiation sterilization of the sensor 11, the sensor electronic unit 13 is mounted to the monitor main body 1 through the mounting opening 58.
Specifically, as shown in fig. 3, the monitor main body 1 is located inside the connection seat 5, and the position-limiting structure 4 is located on the top surface of the connection seat 5. The guide chute 43 and the guide slide block 51 are matched to play a role in guiding and guiding the rotation of the limiting structure 4, so that the movement reliability of the limiting structure 4 is improved, the limiting structure 4 moves along a fixed path, the limiting hole 41 and the needle seat 32 are in an unlocking state in a coincided mode, and the puncture assembly 3 is ensured to smoothly complete the needle withdrawing action.
It should be noted that, the structure of the guiding assembly is not limited in the present embodiment, and in an embodiment, as shown in fig. 11 and 13, the guiding sliding groove 43 is disposed on the limiting structure 4, and the guiding sliding block 51 is disposed on the top surface of the connecting seat 5 and extends along the circumferential direction of the connecting seat 5 to guide the limiting structure 4 to rotate along the circumferential direction of the connecting seat 5.
Of course, the guiding sliding groove 43 may also be disposed on the connecting seat 5, and correspondingly, the guiding sliding block 51 is disposed on the limiting structure 4, which is not limited herein.
Further, as shown in fig. 2, 11, and 13, the limiting structure 4 includes a check rib 44, a check protrusion 52 is disposed on the housing 2 and/or the connecting seat 5, and when the limiting structure 4 rotates from the first position to the second position, the check rib 44 abuts against the check protrusion 52 to limit the limiting structure 4 from rotating from the second position to the first position.
Cooperation of non return muscle 44 and protruding 52 of non return for limit structure 4's unblock motion is irreversible operation, in case limit structure 4 rotates to the unlocked state, under the backstop effect of non return muscle 44 and protruding 52 of non return, just with limit structure 4 restriction in this position, make it can't turn round to the locking state, ensure that puncture assembly 3 accomplishes the action of withdrawing the needle smoothly, guarantee reliability and the security that the product used, further avoid the product by used repeatedly, reduce cross infection's risk.
In a preferred example, as shown in fig. 11, the top surface of the connecting base 5 is provided with a guiding slide block 51, and a non-return protrusion 52 is provided on the guiding slide block 51, so as to realize integration of non-return and guiding functions, thereby achieving multiple purposes, improving the internal structure compactness of the monitor and saving the cost.
Preferably, as shown in fig. 2, 11 and 13, one of the connecting seat 5 and the limiting structure 4 is provided with a limiting member 45, and the other is provided with a blocking member, when the limiting structure 4 rotates from the first position to the second position, the blocking member can abut against the limiting member 45 to limit the limiting structure 4 to continue moving in a direction away from the first position.
The limiting part 45 and the blocking part are matched to limit the rotation angle of the limiting structure 4, when the limiting structure 4 rotates to the second position, the puncture assembly 3 is unlocked, at the moment, under the stopping effect of the limiting part 45 and the blocking part, the limiting structure 4 cannot continue to rotate, the position of the limiting structure 4 is locked, the limiting structure 4 is kept in an unlocking state, and the situation that the puncture assembly 3 is locked again due to the fact that the limiting structure 4 rotates too much can be avoided.
Preferably, as shown in fig. 11 and 13, the limiting member 45 is a protrusion disposed on the limiting structure 4, the blocking member is disposed on two sides of the limiting structure 4, an area between the two is a stroke of the limiting structure 4, and the blocking limiting member 4 is formed to block and limit at two positions.
In a preferred embodiment of the present application, as shown in fig. 1, 2, 11 and 12, the sterilization assembly further includes a connection base 5 for mounting the monitor main body 1, a pressing portion 53 is provided on the connection base 5, and the pressing portion 53 cooperates with the connection base 5 to clamp the position-limiting structure 4.
The pressing part 53 forms downward pressure on the needle seat 32 to press the puncture assembly 3 on the connecting seat 5, so that the puncture assembly 3 is fixed. Preferably, the pressing portion 53 is located on at least one side of the limiting structure 4, so that a sidewall of the pressing portion 53 can form a stop with the limiting structure 4, thereby limiting the rotation amount of the limiting structure 4, i.e. the pressing portion 53 constitutes the above-mentioned stop.
In addition, dismantle the back when housing 2, limit structure 4 breaks away from with housing 2, under the effect of portion 53 that compresses tightly for limit structure 4 is still firmly pressed on connecting seat 5, thereby has avoided limit structure 4 to lose the inside removal of monitor after the limiting displacement, influences the work of other spare parts.
Specifically, as shown in fig. 11 and 12, the pressing portion 53 is a rib position that is arranged on the top surface of the connecting seat 5 and extends upward, the top of the rib position is bent to form a pressing claw, an accommodating space is formed between the pressing claw and the top surface of the connecting seat 5, the limiting structure 4 is arranged in the accommodating space, and the pressing claw forms a downward extrusion force on the limiting structure 4.
Further, the limiting structure 4 includes a limiting hole 41, at least a part of the needle seat 32 is accommodated in the limiting hole 41, the limiting structure 4 can rotate between a first position and a second position relative to the needle seat 32, the limiting hole 41 is provided with a first stop structure, and the needle seat 32 is provided with a second stop structure; in the first position, the limiting structure 4 is in a locking state, and the first stop structure is abutted with the second stop structure to limit the needle seat 32 to move out of the limiting hole 41; in the second position, the limiting structure 4 is in an unlocked state, and the first stop structure is separated from the second stop structure in an abutting manner, so that the needle seat 32 can be separated from the limiting hole 41.
In a preferred embodiment, as shown in fig. 1 and 2, a partial region of the housing 2 surrounds the periphery of the connecting seat 5 and is rotatably engaged with the connecting seat 5.
The housing 2 is abutted with the monitor main body 1 to form a closed chamber 23 before the monitor is used, so that the contact pin of the sensor 11 and the needle body 31 are in a closed sterile environment, when the monitor is used, the housing 2 is detached in a rotating mode, and at the moment, the contact pin of the sensor 11 and the needle body 31 are exposed, so that the implantation operation of a user is facilitated. Meanwhile, in the process of detaching the housing 2, the limiting structure 4 synchronously rotates, so that the puncture assembly 3 is unlocked and can move to be implanted, the housing 2 and the puncture assembly 3 are synchronously unlocked, the unlocking of a plurality of parts is realized only by one-step operation, the operation steps are simplified, the complexity of product use is reduced, and the use experience is greatly improved.
Preferably, as shown in fig. 9 to 12, one of the housing 2 and the connecting socket 5 is provided with a fixing protrusion 54, the other of the housing 2 and the connecting socket 5 is provided with a fixing groove 213, the fixing groove 213 has a guide section 2131 and a locking section 2132 connected with each other, and the housing 2 can rotate relative to the connecting socket 5 so that the fixing protrusion 54 can move to the guide section 2131 along the locking section 2132.
Specifically, as shown in fig. 1 and 2, a partial region of the housing 2 surrounds the outer periphery of the connector holder 5, one of the fixing protrusion 54 and the fixing groove 213 is provided at the outer periphery of the connector holder 5, and the other is provided at the inner wall of the housing 2.
As shown in fig. 9 to 12, in one embodiment, the fixing protrusion 54 is disposed on the outer circumference of the connecting socket 5, the fixing groove 213 is disposed on the inner wall of the housing 2, and when assembling, the fixing protrusion 54 is inserted into the fixing groove 213 from the guiding section 2131, and then the housing 2 is rotated to make the fixing protrusion 54 rotatably slide to the locking section 2132 along the fixing groove 213, thereby completing the locking of the housing 2 and the connecting socket 5. Conversely, the housing 2 is removed by rotating the housing 2 in the opposite direction to move the fixing projection 54 to the guide section 2131 and then withdrawing the housing 2 in the opening direction of the guide section 2131.
Of course, the fixing protrusion 54 may be disposed on the inner wall of the housing 2, and the fixing groove 213 may be disposed on the outer circumference of the connecting seat 5, which is not limited in detail.
As a preferred embodiment of the present embodiment, as shown in fig. 11 and 12, a plurality of elastic rib positions 55 are provided on a side wall of the connection base 5, and in a state where the cover 2 is fixed to the connection base 5, the cover 2 abuts against the elastic rib positions 55 so that the elastic rib positions 55 move toward the monitor main body 1 to clamp the monitor main body 1.
Partial region of housing 2 encircles the periphery at monitor main part 1, when housing 2 is not dismantled, under the effect of propping up of housing 2, the elastic rib position 55 of monitor main part 1 periphery inwards moves respectively, thereby form the extrusion to monitor main part 1, it is fixed with monitor main part 1 chucking, improve the stability of being connected of monitor main part 1 and other parts of monitor, prevent to drop, when the user implants the operation, dismantle housing 2, elastic rib position 55 loses the extrusion and resets this moment, outwards expand promptly, loosen monitor main part 1, monitor main part 1 can lie in human skin's cohesive force effect and break away from connecting seat 5 down at this moment, stay on the skin surface. This application is when dismantling housing 2, realizes the unblock to monitor main part 1, further simplifies the operating procedure, improves and uses experience.
Preferably, as shown in fig. 11 and 12, the plurality of elastic rib locations 55 are arranged at intervals along the circumferential direction of the connecting seat 5.
Furthermore, as shown in fig. 4, 5, 11, and 12, a fixing rib 551 is disposed on one side of the elastic rib 55 facing the monitor main body 1, a fitting groove 14 is disposed on the periphery of the monitor main body 1 corresponding to the elastic rib 55, when the elastic rib 55 moves towards the monitor main body 1 to clamp the monitor main body 1, the fixing rib 551 extends into the fitting groove 14, so that the connecting base 5 can clamp the monitor main body 1 more stably, and when the housing 2 is detached, the elastic rib 55 moves outwards to reset, and the fixing rib 551 slides out of the fitting groove 14.
In another embodiment of the present embodiment, as shown in fig. 11 and 12, the connection seat 5 is provided with a through hole 56, the through hole 56 is disposed corresponding to the through hole 12, and at least a partial region of the needle seat 32 is engaged with the through hole 56 to limit the rotation of the puncture assembly 3 relative to the connection seat 5.
Specifically, before implantation, the second stopping structure of the needle seat 32 is located in the through hole 56 to limit the puncture assembly 3 to rotate relative to the connecting seat 5, and meanwhile, the second stopping structure abuts against the first stopping structure to enable the needle limiting seat 32 to be in a locking state; after the limiting structure 4 is unlocked, the first stop structure and the second stop structure are separated from abutting connection, and when the puncture assembly 3 retreats, the second stop structure can penetrate through the limiting hole 41 to complete the needle withdrawing action.
Preferably, the through hole 56 and the second stopping structure are both non-circular structures, so that the puncture assembly 3 is limited to rotate relative to the connecting seat 5 under the stopping of the edge, and the fixing stability of the puncture assembly 3 is further improved; meanwhile, the noncircular structure of the second stopping structure is easy to be in dislocation butt joint with the limiting hole 41 so as to limit the movement of the puncture assembly. Preferably, connecting seat 5 and/or needle hub 32 are provided with a sealing ring to improve the seal between connecting seat 5 and spike assembly 3 while ensuring the seal of closed chamber 23.
As shown in fig. 17 to 21, the present application further discloses a continuous blood glucose monitor, which comprises a housing 6, an assistant needle assembly 7 disposed in the housing 6, and the continuous blood glucose monitor sterilization assembly, wherein the needle base 32 is provided with a clamping groove 321 and a limiting groove 322, the clamping groove 321 is used for connecting with the assistant needle assembly 7, and the limiting groove 322 is used for matching with the limiting structure 4.
Further, as shown in fig. 14 and 16, the position limiting structure 4 has a position limiting hole 41, and the position limiting groove 322 is engaged with the position limiting hole 41.
The needle seat 32 is connected with the needle assisting assembly 7, so that the puncture assembly 3 and the needle assisting assembly 7 are linked, and after the user triggers the needle assisting assembly 7, the needle assisting assembly 7 drives the puncture assembly 3 to move towards the skin together to complete the implantation action, so as to provide power for the puncture assembly 3.
As shown in fig. 1, 2 and 17, the connecting base 5 further has a snap rib 57 for snap-fastening with the needle assembly 7.
Preferably, as shown in fig. 1, 2 and 19, the housing 2 includes an outer shell 22 and an inner shell 21, which are sleeved, and the shell 6 is butted with the outer shell 22. The inner shell 21 is abutted with the bottom surface of the monitor main body 1 to form a closed chamber 23, and the outer shell 22 is abutted with the shell 6 to enclose all parts of the monitor in a cavity formed by the inner shell and the shell.
As shown in fig. 18 and 21, the housing 6 is provided with a trigger 61, and the user can operate the trigger 61 to trigger the monitor, so as to complete the whole implantation and needle withdrawal process.
The trigger structure 61 may be a button as shown in fig. 18 for triggering by pressing, or a push structure as shown in fig. 21 for triggering by pushing the structure downward.
When leaving the factory, the inside puncture assembly 3 of the continuous blood glucose monitor of this application, monitor main part 1 and connecting seat 5 all are in the locking state, and the user can't trigger the implantation, has improved the risk of false triggering greatly. The operating method of the continuous blood sugar monitor of the application is as follows: firstly, the housing 2 is rotated, so that the connecting seat 5, the monitor main body 1 and the connecting seat 5 synchronously rotate to realize unlocking, then the housing 2 is taken down, at the moment, the contact pin of the sensor 11 and the needle body 31 of the puncture component 3 are exposed, then the open end of the shell 6 is attached to the skin, the trigger structure 61 is triggered through pressing and other operations, at the moment, the shell 6 loses the stop of the needle assisting component 7, the needle assisting component 7 drives the puncture component 3, the connecting seat 5 and the monitor main body 1 to move towards the skin under the action of the spring assisting force, the needle body punctures the skin, the contact pin of the sensor 11 is implanted into the subcutaneous part, the implantation process is completed, then the needle withdrawing action of the puncture component 3 is triggered, the puncture component 3 moves towards the direction far away from the skin relative to the needle assisting component 7, the needle withdrawing operation is completed from the subcutaneous part, the monitor main body 1 is adhered and fixed on the surface of the skin, meanwhile, when other parts of the monitor are taken away, the main body 1 and the connecting seat 5 are loosened, so far away, the whole implantation process is completed, after the implantation is completed, only the main body 1 is remained on the surface of the skin, the sensor 11 is located under the subcutaneous part, and the monitor is monitored in real-time.
Where not mentioned in this application, can be accomplished using or referencing existing technology.
The embodiments in the present specification are described in a progressive manner, and the same and similar parts among the embodiments are referred to each other, and each embodiment focuses on the differences from the other embodiments.
The above description is only an example of the present application and is not intended to limit the present application. Various modifications and changes may occur to those skilled in the art. Any modification, equivalent replacement, improvement or the like made within the spirit and principle of the present application shall be included in the scope of the claims of the present application.

Claims (21)

1. A continuous blood glucose monitor sterilization assembly comprising a sensor, a monitor body having a through hole, and a housing cooperating with the monitor body and forming a closed chamber, the sensor having one end located within the monitor body and another end extending downwardly through the through hole into the closed chamber,
the sterilization assembly further comprises a puncture assembly and a limiting structure, the puncture assembly comprises a needle body and a needle seat, the needle seat is located on the upper side of the monitor main body, the needle body passes through the through hole and extends downwards to enter the closed cavity, at least part of the sensor is nested inside the needle body, and the limiting structure can at least limit the puncture assembly to move out of the through hole.
2. The continuous blood glucose monitor sterilization assembly of claim 1,
the limiting structure has a locking state and an unlocking state, the limiting structure can apply force towards the monitor main body to the needle seat in the locking state, and the limiting structure stops applying force in the unlocking state.
3. The continuous blood glucose monitor sterilization assembly of claim 2,
the limiting structure comprises a limiting hole, at least part of the needle seat is accommodated in the limiting hole, the limiting structure can rotate between a first position and a second position relative to the needle seat, the limiting hole is provided with a first stop structure, and the needle seat is provided with a second stop structure; in the first position, the limiting structure is in a locking state, and the first stop structure is abutted with the second stop structure to limit the needle seat to move out of the limiting hole; in the second position, the limiting structure is in the unlocking state, and the first stop structure is separated from the second stop structure in butt joint, so that the needle seat can be separated from the limiting hole.
4. The continuous blood glucose monitor sterilization assembly of claim 2,
the limiting structure further comprises a shifting part, the housing is provided with an installation position, the installation position is used for accommodating the shifting part, and therefore the housing can drive the limiting structure to be changed from the locking state to the unlocking state.
5. The continuous blood glucose monitor sterilization assembly of claim 4,
the poking part comprises a poking rod, a mounting groove is formed in the open end of the housing and used for clamping the poking rod, and the housing can drive the limiting structure to rotate so that the locking state is changed into the unlocking state.
6. The continuous blood glucose monitor sterilization assembly of claim 4,
the housing comprises an outer housing and an inner housing which are sleeved, wherein the inner housing is abutted to the lower part of the monitor main body to form the closed chamber.
7. The continuous blood glucose monitor sterilization assembly of claim 6,
monitor main part below is provided with the adhesion layer, the adhesion layer has been seted up first district of dodging, the butt end of interior casing is located first dodge the district.
8. The continuous blood glucose monitor sterilization assembly of claim 6,
the inside support column that is provided with of shell body, the support column can with the below butt of monitor main part.
9. The continuous blood glucose monitor sterilization assembly of claim 8,
an adhesive layer is arranged below the monitor main body, a second avoidance area is formed in the adhesive layer, and the abutting end of the supporting column is located in the second avoidance area.
10. The continuous blood glucose monitor sterilization assembly of claim 1,
the monitor is characterized by further comprising a connecting seat for mounting the monitor main body and a guide assembly for guiding the limiting structure to rotate, wherein the guide assembly comprises a guide sliding groove and a guide sliding block, one of the guide sliding groove and the guide sliding block is arranged on the limiting structure, and the other is arranged on the connecting seat.
11. The continuous blood glucose monitor sterilization assembly of claim 10,
the limiting structure comprises a non-return rib, the housing and/or the connecting seat is provided with a non-return protrusion, when the limiting structure rotates to the second position from the first position, the non-return rib is abutted against the non-return protrusion to limit the limiting structure to rotate from the second position to the first position.
12. The continuous blood glucose monitor sterilization assembly of claim 10,
one of the connecting seat and the limiting structure is provided with a limiting part, and the other is provided with a blocking part, when the limiting structure rotates from a first position to a second position, the blocking part can be abutted against the limiting part so as to limit the limiting structure to continue to move towards a direction far away from the first position.
13. The continuous blood glucose monitor sterilization assembly of claim 1,
the monitor is characterized by further comprising a connecting seat used for installing the monitor main body, wherein a pressing part is arranged on the connecting seat, and the pressing part is matched with the connecting seat to clamp the limiting structure.
14. The continuous blood glucose monitor sterilization assembly of claim 13,
the limiting structure comprises a limiting hole, at least part of the needle seat is accommodated in the limiting hole, the limiting structure can rotate between a first position and a second position relative to the needle seat, the limiting hole is provided with a first stop structure, and the needle seat is provided with a second stop structure;
in the first position, the limiting structure is in a locking state, and the first stop structure is abutted with the second stop structure to limit the needle seat to move out of the limiting hole; in the second position, the limiting structure is in an unlocking state, and the first stop structure is separated from the second stop structure in an abutting mode, so that the needle seat can be separated from the limiting hole.
15. The continuous blood glucose monitor sterilization assembly of claim 13,
and part of the area of the housing surrounds the periphery of the connecting seat and is rotationally clamped with the connecting seat.
16. The continuous blood glucose monitor sterilization assembly of claim 15,
the locking device comprises a housing, a connecting seat and a cover, wherein one of the housing and the connecting seat is provided with a fixing protrusion, the other one of the housing and the connecting seat is provided with a fixing groove, the fixing groove is provided with a guide section and a locking section which are connected with each other, the housing can rotate relative to the connecting seat, and therefore the fixing protrusion can move to the guide section along the locking section.
17. The continuous blood glucose monitor sterilization assembly of claim 13,
the side wall of the connecting seat is provided with a plurality of elastic rib positions, and the housing abuts against the elastic rib positions so that the elastic rib positions move towards the monitor main body to clamp the monitor main body in a state that the housing is fixed on the connecting seat.
18. The continuous blood glucose monitor sterilization assembly of claim 13,
the connecting seat is provided with a through hole, the through hole and the through hole are correspondingly arranged, and at least partial region of the needle seat is matched with the through hole so as to limit the puncture assembly to rotate relative to the connecting seat.
19. The continuous blood glucose monitor sterilization assembly of claim 13,
the connecting seat and/or the needle seat are/is provided with a sealing ring.
20. A continuous blood glucose monitor comprising a housing and an assistive needle assembly disposed within the housing,
the continuous blood glucose monitor sterilization assembly of any one of claims 1-19 further comprising the needle hub defining a snap-in groove for coupling with the needle assist assembly and a stop groove for mating with the stop structure.
21. The continuous blood glucose monitor of claim 20,
the housing comprises an outer housing and an inner housing which are sleeved, and the housing is butted with the outer housing.
CN202211555749.3A 2022-12-06 2022-12-06 Continuous blood glucose monitor sterilization assembly and continuous blood glucose monitor Pending CN115779124A (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN202211555749.3A CN115779124A (en) 2022-12-06 2022-12-06 Continuous blood glucose monitor sterilization assembly and continuous blood glucose monitor
PCT/CN2022/143252 WO2024119563A1 (en) 2022-12-06 2022-12-29 Continuous blood glucose monitor sterilization assembly and continuous blood glucose monitor

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202211555749.3A CN115779124A (en) 2022-12-06 2022-12-06 Continuous blood glucose monitor sterilization assembly and continuous blood glucose monitor

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CN114391834A (en) * 2021-11-27 2022-04-26 苏州百孝医疗科技有限公司 Body surface attachment unit
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