WO2024119564A1 - 一种持续血糖监测器灭菌组件及灭菌方法 - Google Patents

一种持续血糖监测器灭菌组件及灭菌方法 Download PDF

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Publication number
WO2024119564A1
WO2024119564A1 PCT/CN2022/143255 CN2022143255W WO2024119564A1 WO 2024119564 A1 WO2024119564 A1 WO 2024119564A1 CN 2022143255 W CN2022143255 W CN 2022143255W WO 2024119564 A1 WO2024119564 A1 WO 2024119564A1
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WIPO (PCT)
Prior art keywords
sterilization
sensor
skin
skin fixing
fixing seat
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PCT/CN2022/143255
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English (en)
French (fr)
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
Original Assignee
江苏鱼跃凯立特生物科技有限公司
浙江凯立特医疗器械有限公司
江苏跃凯生物技术有限公司
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Application filed by 江苏鱼跃凯立特生物科技有限公司, 浙江凯立特医疗器械有限公司, 江苏跃凯生物技术有限公司 filed Critical 江苏鱼跃凯立特生物科技有限公司
Publication of WO2024119564A1 publication Critical patent/WO2024119564A1/zh

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  • the present application belongs to the field of medical equipment technology, and specifically relates to a continuous blood glucose monitor sterilization component and a sterilization method.
  • a biosensor is an instrument that is sensitive to bioactive substances and converts the perceived concentration of bioactive substances into electrical signals for detection.
  • glucose sensors are a more common type of biosensor.
  • CGM continuous glucose monitoring
  • CGM products require a puncture needle and a sensor pin to pierce the human skin to test blood sugar.
  • the biological enzymes on the sensor produce an electrochemical reaction with the subcutaneous tissue fluid, which is converted into an electrical signal and converted into a blood sugar value to the user. Since the product has a part that pierces the human skin, the product needs to be sterilized before leaving the factory to avoid the risk of infection to the user caused by pathogenic bacteria on the product.
  • Monitoring components generally include sensors and electronic units (transmitters), and the two often require different sterilization methods.
  • gas sterilization is generally used, such as ethylene oxide gas sterilization. Since the biological enzymes on the sensor will react chemically with gases such as ethylene oxide, affecting the activity of the biological enzymes and thus affecting the monitoring accuracy, the sensor cannot be sterilized by gas sterilization, and radiation sterilization is used. At the same time, radiation sterilization is likely to affect the circuit of the transmitter, so the sensor and transmitter need to be sterilized separately.
  • the monitoring components are often assembled before sterilization, and then sterilized in two different ways respectively.
  • radiation sterilization and gas sterilization utilize radiation and gas for sterilization respectively, it is often difficult to effectively isolate the radiation and gas, resulting in varying degrees of damage to the biological enzymes on the sensor and the circuits of the transmitter; or the sensor and the transmitter are sterilized separately, and when used, the user manually installs the transmitter to electrically connect it to the sensor, which increases the complexity of the user's operation.
  • CGM products have higher sterilization requirements for the front-end components that are in direct contact with the skin (such as the skin fixing seat, half-wall needle, etc.), and lower sterilization requirements for the rear-end booster components.
  • CGM products are often sterilized as a whole after assembly, which not only leads to poor sterilization effects on the front-end components, but also makes the whole machine larger and the cost of sterilization higher.
  • the present application provides a continuous blood glucose monitor sterilization component and sterilization method to solve at least one of the above-mentioned technical problems.
  • a continuous blood glucose monitor sterilization component includes a sensor and a skin mount, a cover shell and a connecting seat.
  • the skin mount is provided with a through hole
  • the cover shell cooperates with the lower part of the skin mount to form a closed chamber
  • one end of the sensor is fixed to the skin mount
  • the other end extends downward into the closed chamber after passing through the through hole of the skin mount
  • a skin mount installation cavity is provided in the connecting seat
  • the connecting seat is also provided with an installation port for installing the sensor electronic unit on the skin mount.
  • a snap-fitting position is also provided on the outer side of the connecting seat and/or the inner side of the cover shell to snap-fit and fix the cover shell to the connecting seat.
  • the sterilization assembly also includes an auxiliary needle assembly, and the connecting seat is also provided with a hook portion to connect the connecting seat with the auxiliary needle assembly.
  • the sterilization component also includes a puncture component, which includes a needle body and a needle seat.
  • the needle body extends downward into the closed chamber after passing through the through hole, and the sensor is at least partially nested inside the needle body.
  • the connecting seat and/or the needle seat is provided with a first sealing portion capable of sealing the through hole.
  • the cover shell comprises an outer shell and an inner shell which are sleeved together.
  • the inner shell is arranged at the lower part of the skin fixing seat, and a second sealing part is arranged between the inner shell and the skin fixing seat.
  • At least part of the outer shell surrounds the outer periphery of the connecting seat.
  • One of the outer shell and the connecting seat is provided with a fixing protrusion, and the other is provided with a clamping position, which has a guide section and a locking section connected to each other so that the outer shell and the connecting seat are rotatably engaged.
  • the side wall of the connecting seat is provided with a plurality of elastic ribs.
  • a support column is also arranged in the outer shell, and the support column can abut against the lower side of the skin fixing seat.
  • the sterilization assembly further comprises a sensor electronic unit, the sensor comprises a coupling portion located in the installation port, the coupling portion is provided with a first contact, the sensor electronic unit has a second contact, and the first contact and the second contact can be coupled and connected.
  • the present application also discloses a sterilization method for a continuous blood glucose monitor, comprising the following steps: subjecting a first sterilization unit to a first sterilization treatment, wherein the first sterilization unit comprises a cover shell, a connecting seat and a puncture assembly, a sensor and a skin fixing seat are installed in the installation cavity formed by the connecting seat, the connecting seat is also provided with an installation port, the skin fixing seat cooperates with the cover shell to form a closed chamber, the skin fixing seat is provided with a through hole, one end of the sensor is fixed to the skin fixing seat, and the other end extends downward through the through hole into the closed chamber, at least a portion of the puncture assembly extends downward through the through hole into the closed chamber, and at least a portion of the sensor is nested inside the puncture assembly; subjecting a second sterilization unit to a second sterilization treatment, wherein the second sterilization unit comprises the first sterilization unit and a sensor electronic unit, and the sensor electronic unit is installed on the skin fixing seat through the installation port.
  • the second sterilization unit also includes an auxiliary needle assembly, which is connected to the connecting seat.
  • the present application fixes the skin holder in the connecting seat, and the cover shell cooperates with the skin holder to form a closed chamber, and the connecting seat is provided with an installation port, so that the sensor and the sensor electronic unit can be separately installed on the skin holder, thereby achieving step-by-step sterilization.
  • the sensor can be first fixed to the skin holder, and the sensor can be sterilized by radiation. At this time, since the sensor electronic unit has not been installed on the skin holder, the radiation will not affect its circuit.
  • the cover shell is fixed to the connecting seat. At this time, the cover shell cooperates with the skin holder to form a closed chamber.
  • the sensor's contact pin is located in the closed chamber, and the closed chamber is isolated from the external environment.
  • the sensor electronic unit is installed to the skin holder through the installation port, and then the sensor electronic unit is sterilized by gas.
  • the gas cannot enter the closed chamber, so it will not affect the biological enzyme on the sensor contact pin.
  • the present application connects the skin fixing seat, sensor and other parts with high sterilization requirements into one component through the connecting seat.
  • the component needs to be sent to the sterilization chamber for sterilization, without sterilizing the rear-end parts of the monitor, thereby greatly reducing the volume of the sterilization component and saving sterilization costs.
  • the sterilization efficiency and effect are improved.
  • a snap-in position is further provided on the outer side of the connecting seat and/or the inner side of the cover shell to snap-fit the cover shell to the connecting seat.
  • the cover shell can not only cooperate with the skin fixing seat to enclose one end of the sensor in a closed chamber to provide a sterile environment for it, but also form support for the skin fixing seat to make the skin fixing seat more firm and prevent the skin fixing seat from falling off before implantation.
  • the cover shell can also limit the moving parts inside the monitor, so that when the cover shell is not removed, it is limited and cannot move, thereby realizing the anti-mistouch function.
  • the user Before use, the user removes the cover shell, and at the same time, the moving parts in the monitor are unlocked to improve the reliability of use.
  • the snap-in fixing method makes the disassembly of the cover shell simpler and more convenient, reduces the difficulty of operation, and improves the user experience.
  • the outer shell surrounds the outer periphery of the connection seat, one of the outer shell and the connection seat is provided with a fixing protrusion, and the other is provided with a snap-fit position, and the snap-fit position has a guide section and a locking section connected to each other, so that the outer shell and the connection seat are rotatably engaged.
  • the overall volume of CGM products tends to be miniaturized, so through the rotation control method, it is more convenient for users to apply force and improve the convenience of use.
  • the side wall of the connecting seat is provided with a plurality of elastic ribs.
  • the cover shell pushes against the elastic ribs to move the elastic ribs toward the skin fixing seat to clamp the skin fixing seat.
  • Part of the area of the cover shell surrounds the outer circumference of the skin fixing seat.
  • the elastic ribs lose the squeezing and reset, that is, expand outward, and loosen the skin fixing seat.
  • the skin fixing seat can be detached from the connecting seat under the adhesive force of the human skin and remain on the skin surface.
  • the present application realizes the unlocking of the skin fixing seat while removing the cover shell, further simplifies the operation steps, and improves the user experience.
  • the present application also discloses a sterilization method for a continuous blood glucose monitor, which divides the sterilization assembly into two sterilization units, and sterilizes the two sterilization units in two different ways in sequence.
  • the first sterilization unit only the sensor is installed on the skin holder, and the sensor electronic unit is not installed.
  • the first sterilization unit is subjected to radiation sterilization, and the sensor is sterilized. Since the sensor electronic unit is not installed on the skin holder, its circuit will naturally not be affected by radiation sterilization.
  • the sensor's contact pin is sealed in a closed chamber, the chamber is isolated from the outside world, and then the sensor electronic unit is installed on the skin holder.
  • the second step of sterilization such as gas sterilization
  • the closed chamber is isolated, the gas will not enter and affect the biological enzyme on the sensor contact pin.
  • the sterilization effect is greatly improved, and the adverse effects of different sterilization methods on the two are avoided to a great extent, the yield rate of the monitor and the monitoring accuracy are improved, and the product performance is guaranteed.
  • FIG1 is a schematic structural diagram of a sterilization assembly according to an embodiment of the present application.
  • FIG2 is a schematic structural diagram of a sterilization assembly in another embodiment of the present application.
  • FIG3 is a cross-sectional view of the sterilization assembly in FIG2 ;
  • FIG4 is a schematic structural diagram of a skin fixing seat according to an embodiment of the present application.
  • FIG5 is a schematic structural diagram of a skin fixing seat according to another embodiment of the present application.
  • FIG6 is a schematic diagram of the internal structure of a skin fixing seat according to an embodiment of the present application.
  • FIG7 is a schematic diagram of the internal structure of a skin fixing seat according to another embodiment of the present application.
  • FIG8 is a schematic diagram of the bottom structure of a skin fixing seat according to an embodiment of the present application.
  • FIG9 is a schematic diagram of the bottom structure of a skin fixing seat according to another embodiment of the present application.
  • FIG10 is a schematic structural diagram of a cover shell according to an embodiment of the present application.
  • FIG11 is a schematic structural diagram of a cover shell in another embodiment of the present application.
  • FIG12 is a schematic structural diagram of a connecting socket according to an embodiment of the present application.
  • FIG13 is a schematic structural diagram of a connecting socket in another embodiment of the present application.
  • FIG14 is a schematic structural diagram of a limiting structure in one embodiment of the present application.
  • FIG15 is a schematic structural diagram of a position limiting structure in another embodiment of the present application.
  • FIG16 is a schematic structural diagram of a puncture assembly according to an embodiment of the present application.
  • FIG17 is a schematic structural diagram of a puncture assembly in another embodiment of the present application.
  • FIG18 is a schematic diagram of the internal structure of a monitor according to an embodiment of the present application.
  • FIG19 is a schematic diagram of the structure of the monitor in FIG18;
  • FIG20 is a schematic diagram of the structure of a monitor in another embodiment of the present application.
  • FIG21 is a schematic diagram of the internal structure of the monitor in FIG20 , wherein the cover is not shown;
  • FIG. 22 is a cross-sectional view of the monitor in FIG. 20 .
  • top, bottom, inside, “outside”, “axial”, “circumferential”, etc. indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.
  • the terms “installed”, “connected”, “connected”, “fixed” and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or a communication; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements.
  • installed can be a fixed connection, a detachable connection, or an integral connection
  • it can be a mechanical connection, an electrical connection, or a communication
  • it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements.
  • a continuous blood glucose monitor sterilization component includes a sensor 11 and a skin holder 1, and also includes a cover shell 2 and a connecting seat 5.
  • the skin holder 1 is provided with a through hole 12, and the cover shell 2 cooperates with the lower part of the skin holder 1 to form a closed chamber 23.
  • One end of the sensor 11 is fixed to the skin holder 1, and the other end extends downward through the through hole 12 of the skin holder 1 into the closed chamber 23.
  • a skin holder installation cavity is provided in the connecting seat 5, and the connecting seat 5 is also provided with an installation port 58 for installing the sensor electronic unit 13 on the skin holder 5.
  • the present application does not limit the shape of the cover 2, for example, it can be a split structure or an integrated structure, as long as it can form a closed chamber with the lower part of the skin fixing seat 1.
  • Part of the cover 2 can be connected to the needle-assisting assembly or not.
  • the mounting position 131 for installing the sensor electronic unit 13 is staggered with the through hole 12, and the free end of the sensor 11 passes through the through hole 12.
  • the present application connects the skin fixing base 1, sensor 11 and other components with high sterilization requirements into one component through the connecting base 5.
  • the component needs to be sent to the sterilization chamber for sterilization, without sterilizing the rear-end components of the monitor, thereby greatly reducing the volume of the sterilization component and saving sterilization costs, thereby improving the sterilization efficiency and effect.
  • a snap-fit position is further provided on the outer side of the connecting base 5 and/or the inner side of the cover shell 2 to snap-fit and fix the cover shell 2 to the connecting base 5 .
  • the cover 2 can not only cooperate with the skin holder 1 to enclose one end of the sensor 11 in the closed chamber 23 to provide a sterile environment for it, but also support the skin holder 1 to make the skin holder 1 more firm and prevent the skin holder 1 from falling off before implantation.
  • the cover 2 can also limit the moving parts inside the monitor, so that when the cover 2 is not removed, it is limited and cannot move, thereby realizing the anti-mistouch function.
  • the user removes the cover 2, and at the same time, the moving parts in the monitor are unlocked to improve the reliability of use.
  • the snap-on fixing method makes the removal of the cover 2 simpler and more convenient, reduces the difficulty of operation, and improves the user experience.
  • the connecting seat 5 is connected to the auxiliary needle assembly 7, so that the connecting seat 5 and the auxiliary needle assembly 7 are linked.
  • the auxiliary needle assembly 7 drives the connecting seat 5 to move toward the skin, so that the bottom surface of the skin fixing seat 1 contacts the skin.
  • the bottom surface of the skin fixing seat 1 is provided with an adhesive layer 17, so that the skin fixing seat 1 is bonded and fixed to the skin.
  • the sterilization assembly also includes a puncture assembly 3, the puncture assembly 3 includes a needle body 31 and a needle seat 32, the needle body 31 extends downward into the closed chamber 23 after passing through the through hole 12, and the sensor 11 is at least partially nested inside the needle body 31.
  • the contact needle of the sensor 11 is a flexible structure and cannot directly pierce the skin and enter the subcutaneous tissue, the contact needle of the sensor 11 is nested inside the needle body 31 through the needle body 31, and the skin is pierced by the needle body 31 to implant the contact needle of the sensor 11 into the subcutaneous tissue.
  • the puncture assembly 3 performs a needle withdrawal action to remove the needle body from the human body.
  • the needle body 31 extends into the closed chamber 23 and is in a closed sterile environment together with the contact pin of the sensor 11, ensuring the cleanliness of the needle body 31 and the contact pin of the sensor 11.
  • the needle seat 32 is connected to the auxiliary needle assembly 7, so that the puncture assembly 3 and the auxiliary needle assembly 7 are linked. After the user triggers, the auxiliary needle assembly 7 drives the puncture assembly 3 to move toward the skin to complete the implantation action, providing power for the puncture assembly 3.
  • the needle-assisting assembly 7 drives the puncture assembly 3, the connecting seat 5 and the skin fixing seat 1 to move toward the skin under the help of the spring.
  • the needle body pierces the skin and implants the contact needle of the sensor 11 under the skin to complete the implantation process.
  • the needle withdrawal action of the puncture assembly 3 is triggered, so that the puncture assembly 3 moves away from the skin alone and withdraws from the skin to complete the needle withdrawal operation.
  • the skin fixing seat 1 is adhered and fixed to the skin surface, and the contact needle of the sensor 11 is located under the skin to perform real-time blood sugar monitoring.
  • the present application does not impose any restrictions on the structure of the needle-assisting assembly 7 , and an existing structure may be used, as long as it can drive the connecting seat 5 to move toward the skin and drive the puncture assembly 3 to withdraw the needle.
  • connection seat 5 and/or the needle seat 32 are provided with a first sealing portion 33 capable of sealing the through hole 12 to ensure the sealing of the closed chamber 23.
  • the first sealing portion 33 is preferably a structure made of elastic material, and when the needle seat 32 and the connection seat 5 are pressed against each other, the first sealing portion 33 is squeezed and elastically deformed, thereby sealing the gap between the two.
  • connection seat 5 is further provided with a limiting structure 4 , and the limiting structure 4 can at least limit the puncture assembly 3 from moving out of the through hole 12 .
  • the limiting structure 4 can limit the puncture assembly 3 so that the puncture assembly 3 and the skin holder 1 maintain a stable connection.
  • the puncture assembly 3 seals the through hole 12, and the positions of the two are stable, which helps to ensure the sealing reliability of the through hole 12, thereby ensuring that the closed chamber 23 is isolated from the outside world, ensuring that the sensor 11 and the needle body 31 are in a sterile environment, and at the same time, it also reduces the risk of the puncture assembly 3 and the skin holder 1 being separated, and reduces the risk of damage to the skin holder 1.
  • the limiting structure 3 can limit the movement of the puncture assembly 3, so that when the cover 2 is not removed, the puncture assembly 3 can be prevented from being accidentally touched. Under the restriction of the limiting structure 4, the puncture assembly 3 cannot move and cannot be implanted or withdrawn, thereby improving the working reliability of the monitor and saving costs.
  • the limiting structure 4 has a limiting hole 41, and the limiting hole 41 and the needle seat 32 are both non-circular structures.
  • the limiting hole 41 can rotate relative to the needle seat 32 together with the limiting structure 4.
  • the limiting structure 4 is in an unlocked state.
  • the limiting structure 4 loses the stopper for the needle seat 32, and the puncture assembly 3 can pass through the limiting hole 41.
  • the limiting structure 4 rotates to the point where the limiting hole 41 is misaligned with the needle seat 32, the limiting structure 4 is in a locked state, and the limiting structure 4 forms a stopper for the needle seat 32, so that it cannot pass through the limiting hole 41.
  • a protrusion structure 411 is provided on the inner wall of the limiting hole 41 , and a groove structure is correspondingly provided on the outer wall of the needle seat 32 .
  • the limiting structure 4 rotates synchronously with the cover 2.
  • the cover 2 abuts against the skin fixing seat 1 to form a closed chamber 23, so that the contact pin and the needle body 31 of the sensor 11 are in a closed sterile environment.
  • the cover 2 is removed by rotating, and the contact pin and the needle body 31 of the sensor 11 are exposed, which is convenient for the user to perform the implantation operation.
  • the limiting structure 4 rotates synchronously, thereby unlocking the puncture assembly 3, allowing it to move for implantation, thereby achieving synchronous unlocking of the cover 2 and the puncture assembly 3, and only one step is required to unlock multiple components, which simplifies the operating steps, reduces the cumbersomeness of product use, and greatly improves the user experience.
  • the limiting structure 4 includes a toggle rod 42, and the open end of the cover shell 2 is provided with a mounting groove 211, which is used to engage the toggle rod 42.
  • the cover shell 2 can drive the limiting structure 4 to rotate to change from a locked state to an unlocked state.
  • the open end of the housing 2 surrounds the outer circumference of the skin fixing seat 1, and the toggle rod 42 cooperates with the mounting groove 211 at the open end of the housing 2, and extends radially inwardly along the housing 2 to cooperate with the puncture assembly 3.
  • the two groove walls of the mounting groove 211 are located on both sides of the mounting groove 211 along the circumference of the housing 2, thereby forming a circumferential limit for the toggle rod 42.
  • the mounting groove 211 has an upward opening at the corresponding second position, so that when the user removes the cover 2, the toggle rod 42 can slide out of the opening and disengage from the cover 2, so that the cover 2 is removed, and the toggle rod 42 remains inside the monitor without affecting the operation of the internal components.
  • the sterilization component also includes a guide component for guiding the rotation of the limiting structure 4, the guide component includes a guide groove 43 and a guide slider 51, one of the guide groove 43 and the guide slider 51 is arranged on the limiting structure 4, and the other is arranged on the connecting seat 5.
  • the skin fixing seat 1 is located inside the connecting seat 5, and the limiting structure 4 is located on the top surface of the connecting seat 5.
  • the guide slot 43 and the guide slider 51 cooperate to guide the rotation of the limiting structure 4, thereby improving the reliability of the movement of the limiting structure 4, so that the limiting structure 4 moves along a fixed path, thereby ensuring that the limiting hole 41 overlaps with the needle seat 32 in an unlocked state, and ensuring that the puncture assembly 3 successfully completes the needle withdrawal action.
  • the present embodiment does not specifically limit the structure of the guide assembly.
  • the guide groove 43 is disposed on the limiting structure 4
  • the guide slider 51 is disposed on the top surface of the connecting seat 5 and extends along the circumference of the connecting seat 5 to guide the limiting structure 4 to rotate along the circumference of the connecting seat 5.
  • the guide slot 43 may also be disposed on the connecting seat 5 , and correspondingly, the guide slider 51 may be disposed on the limiting structure 4 , which is not specifically limited here.
  • the limiting structure 4 includes a non-return rib 44, and a non-return protrusion 52 is provided on the cover shell 2 and/or the connecting seat 5.
  • the non-return rib 44 abuts against the non-return protrusion 52 to limit the rotation of the limiting structure 4 from the second position to the first position.
  • the limiting structure 4 rotates to the unlocked state, the limiting structure 4 is restricted in this position under the stopping action of the non-return rib 44 and the non-return protrusion 52, so that it cannot rotate back to the locked state, ensuring that the puncture assembly 3 can successfully complete the needle withdrawal action, ensuring the reliability and safety of the product, further avoiding the product from being reused, and reducing the risk of cross infection.
  • a guide slider 51 is provided on the top surface of the connecting seat 5 , and a non-return protrusion 52 is provided on the guide slider 51 to realize the integration of non-return and guiding functions, so as to achieve multi-purposes, improve the compactness of the internal structure of the monitor, and save costs.
  • 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.
  • the blocking member can abut against the limiting member 45 to limit the limiting structure 4 from continuing to move away from the first position.
  • the cooperation between the limiting member 45 and the blocking member can limit the rotation angle of the limiting structure 4.
  • the puncture assembly 3 is unlocked.
  • the limiting structure 4 cannot continue to rotate, thereby realizing the position locking of the limiting structure 4 and keeping it in the unlocked state. This can prevent the limiting structure 4 from locking the puncture assembly 3 again due to excessive rotation, thereby ensuring that the puncture assembly 3 can successfully complete the needle withdrawal action.
  • the limiting member 45 is a protrusion arranged on the limiting structure 4, and the blocking member is arranged on both sides of the limiting structure 4.
  • the area between the two is the stroke of the limiting structure 4, forming a blocking limit for the limiting structure 4 at two positions.
  • the sterilization assembly also includes a connecting seat 5 for installing the skin fixing seat 1, and a clamping portion 53 is provided on the connecting seat 5, which cooperates with the connecting seat 5 to clamp the limiting structure 4.
  • the pressing part 53 exerts downward pressure on the needle seat 32, pressing the puncture assembly 3 onto the connecting seat 5, thereby fixing the puncture assembly 3.
  • the pressing part 53 is located on at least one side of the limiting structure 4, so that the side wall of the pressing part 53 can form a stop with the limiting structure 4, thereby limiting the rotation amount of the limiting structure 4, that is, the pressing part 53 constitutes the above-mentioned blocking member.
  • the limiting structure 4 is separated from the cover shell 2. Under the action of the clamping portion 53, the limiting structure 4 is still firmly pressed on the connecting seat 5, thereby preventing the limiting structure 4 from moving inside the monitor after losing its limiting function and affecting the operation of other components.
  • the clamping portion 53 is a rib arranged on the top surface of the connecting seat 5 and extending upward.
  • the top of the rib is bent to form a clamping claw.
  • An accommodating space is formed between the clamping claw and the top surface of the connecting seat 5.
  • the limiting structure 4 is placed in the accommodating space, and the clamping claw forms a downward extrusion force on the limiting structure 4.
  • the cover shell 2 includes an outer shell 22 and an inner shell 21 , the inner shell 21 is disposed at the lower part of the skin fixing seat 1 , and a second sealing portion is provided between the inner shell 21 and the skin fixing seat 1 .
  • outer shell 22 and the inner shell 21 may be connected or not connected.
  • the inner shell 21 of the cover shell 2 abuts against the bottom surface of the skin fixing seat 1. On the one hand, it cooperates with the skin fixing seat 1 to form a closed chamber 23, and the second sealing part ensures the sealing of the closed chamber 23. On the other hand, the inner shell 21 can also form an upward supporting force for the skin fixing seat 1, so that the fixation of the skin fixing seat 1 is more stable, preventing the skin fixing seat 1 from falling off before implantation.
  • the present embodiment does not specifically limit the structure of the second sealing portion.
  • the second sealing portion is an annular sealing strip 16 disposed on the bottom surface of the skin fixing seat 1, and the inner shell 21 is also an annular structure, thereby abutting and sealing with the annular sealing strip 16 to form a closed chamber 23 inside.
  • the bottom surface of the skin fixing seat 1 has an adhesive layer 17 , the adhesive layer has a first avoidance area 171 , the second sealing portion is arranged in the first avoidance area 171 , and the abutting end of the inner shell 21 is located in the first avoidance area 171 .
  • the adhesion layer 17 is coated with adhesive, so that after the bottom surface of the skin fixing seat 1 comes into contact with the skin, it will adhere to the skin surface under the action of the adhesive force, while the first avoidance area 171 has no adhesive and is therefore not sticky.
  • the inner shell 21 abuts against the first avoidance area 171, which can prevent the inner shell 21 from adhering to the adhesion layer 17 and causing the colloid to be destroyed when the cover shell 2 is removed, and can also prevent the inner shell 21 from rubbing the colloid when the cover shell 2 and the skin fixing seat 1 rotate relative to each other, causing the adhesion layer 17 to wrinkle, thereby affecting the adhesion effect.
  • a support column 212 is further disposed in the outer shell 22 , and the support column 212 can abut against the lower side of the skin fixing seat 1 .
  • the provision of the support column 212 increases the contact area between the housing 2 and the skin holder 1, and improves the support stability of the housing 2 on the skin holder 1.
  • Fig. 9 and Fig. 10 there are two support columns 212, and the support columns 212 and the inner shell 21 are eccentrically arranged with respect to the cover shell 2, and the connecting line between the three is approximately an isosceles triangle, so as to further improve the supporting stability of the inner shell 21 and the support columns 212 on the skin fixing seat 1, and prevent the skin fixing seat 1 from tilting.
  • At least a partial area of the outer shell 22 surrounds the outer circumference of the connecting seat 5, and one of the outer shell 22 and the connecting seat 5 is provided with a fixing protrusion 54, and the other is provided with a snap-fit position 213, and the snap-fit position 213 has a guide section 2131 and a locking section 2132 that are interconnected to enable the outer shell 22 and the connecting seat 5 to be rotatably engaged.
  • At least a portion of the outer shell 22 surrounds the outer periphery of the connecting seat 5 , one of the fixing protrusion 54 and the engaging position 213 is disposed on the outer periphery of the connecting seat 5 , and the other is disposed on the inner wall of the outer shell 22 .
  • the outer periphery of the connection seat 5 is provided with a fixing protrusion 54
  • the inner wall of the outer shell 22 is provided with a fixing groove to form the said engaging position 213.
  • the fixing protrusion 54 is inserted into the fixing groove from the guide section, and then the cover 2 is rotated so that the fixing protrusion 54 rotates and slides along the fixing groove to the locking section 2132, thereby completing the locking of the cover 2 and the connection seat 5.
  • the cover 2 is rotated in the opposite direction so that the fixing protrusion 54 moves to the guide section 2131, and then the cover 2 is pulled out along the opening direction of the guide section 2131, and then the cover 2 can be removed.
  • the fixing protrusion 54 may also be disposed on the inner wall of the housing 2 , and correspondingly, the engaging position 213 may be disposed on the outer periphery of the connecting seat 5 , which is not specifically limited here.
  • the side wall of the connecting seat 5 is provided with a plurality of elastic ribs 55.
  • the cover shell 2 pushes against the elastic ribs 55 to move the elastic ribs 55 toward the skin fixing seat 1 to clamp the skin fixing seat 1.
  • Part of the area of the cover 2 surrounds the outer periphery of the skin holder 1.
  • the elastic ribs 55 of the connection seat 5 move inward respectively, thereby squeezing the skin holder 1, clamping and fixing the skin holder 1, improving the connection stability of the skin holder 1, and preventing it from falling off.
  • the cover 2 is removed.
  • the elastic ribs 55 lose the squeezing and reset, that is, expand outward, and loosen the skin holder 1.
  • the skin holder 1 can be separated from the connection seat 5 under the action of the bonding force with the human skin and remain on the skin surface.
  • the present application realizes the unlocking of the skin holder 1 while disassembling the cover 2, further simplifying the operation steps and improving the user experience.
  • a fixing rib 551 is provided on the side of the elastic rib position 55 facing the skin fixing seat 1, and a matching groove 14 is provided on the outer periphery of the skin fixing seat 1 corresponding to the elastic rib position 55.
  • the fixing rib 551 extends into the matching groove 14, so that the connecting seat 5 clamps the skin fixing seat 1 more stably, avoiding the circumferential rotation of the skin fixing seat 1 due to vibration or other factors during transportation.
  • the cover shell 2 is removed, the elastic rib position 55 moves outward to reset, and the fixing rib 551 slides out of the matching groove 14.
  • the connecting seat 5 is provided with a through hole 56 , and the through hole 56 is arranged corresponding to the through hole 12 , and at least a portion of the needle seat 32 cooperates with the through hole 56 to limit the rotation of the puncture assembly 3 relative to the connecting seat 5 .
  • the raised structure of the needle seat 32 is located in the through hole 56 to limit the rotation of the puncture assembly 3 relative to the connecting seat 5.
  • the raised structure of the needle seat 32 abuts against the limiting structure 4 so that the needle seat 32 is in a locked state; after the limiting structure 4 is unlocked, the raised structure of the needle seat 32 is disengaged from the limiting structure 4.
  • the puncture assembly 3 retreats, the raised structure of the needle seat 32 can pass through the limiting hole 41 to complete the needle withdrawal action.
  • the sterilization component also includes a sensor electronic unit 13, the sensor 11 includes a coupling portion 18 located in the mounting port 58, the coupling portion 18 is provided with a first contact 181, the sensor electronic unit 13 has a second contact, and the first contact 181 and the second contact can be coupled and connected.
  • the coupling part 18 of the sensor 11 is located in the installation opening 58, so that after the sensor electronic unit 13 is installed on the skin fixing base 1 through the installation opening 58, the coupling of the first contact 181 and the second contact can be completed synchronously, which reduces the operation difficulty, greatly reduces the difficulty of coupling the two, and improves the convenience of assembly.
  • the first contact 181 faces upward, and the second contact is located in the sensor electronic unit 13 and faces downward, so that when the sensor electronic unit 13 is installed, the first contact 181 and the second contact are coupled in the up-and-down direction.
  • first contact 181 faces one side
  • second contact also faces one side and is opposite to the first contact 181, so that when the sensor electronic unit 13 is installed, the first contact 181 and the second contact are laterally coupled.
  • the continuous blood glucose monitor includes a shell 6 and an auxiliary needle assembly 7 placed in the shell 6, and also includes the above-mentioned continuous blood glucose monitor sterilization assembly.
  • the sterilization assembly also includes a puncture assembly 3, and the puncture assembly 3 includes a needle body 31 and a needle seat 32.
  • the needle seat 32 is provided with a snap-in groove 321 and a limiting groove 322.
  • the snap-in groove 321 is used to connect with the auxiliary needle assembly 7, and the limiting groove 322 is used to cooperate with the limiting structure 4.
  • the needle seat 32 is connected to the auxiliary needle assembly 7, so that the puncture assembly 3 and the auxiliary needle assembly 7 are linked. After the user triggers it, the auxiliary needle assembly 7 drives the puncture assembly 3 to move toward the skin to complete the implantation action, providing power for the puncture assembly 3.
  • the connecting seat 5 further has a hook portion 57 for being connected and fixed with the auxiliary needle assembly 7 .
  • the housing 2 comprises a sleeved outer housing 24, an outer housing 22, and an inner housing 21, and the housing 6 is butted against the outer housing 22.
  • the inner housing 21 abuts against the bottom surface of the skin holder 1 to form a closed chamber 23, and the outer housing 24 is butted against the housing 6, enclosing all the components of the monitor in the cavity formed by the two.
  • the housing 6 is provided with a trigger structure 61 , and the user can trigger the monitor by operating the trigger structure 61 to complete the entire implantation and needle withdrawal process.
  • the trigger structure 61 may be a button as shown in FIG. 19 , which is triggered by pressing, or may be a push structure as shown in FIG. 22 , which is triggered by pushing the structure downward.
  • the puncture assembly 3, the skin fixing seat 1 and the connecting seat 5 inside the continuous blood glucose monitor of the present application are all in a locked state, and the user cannot trigger the implantation, which greatly increases the risk of false triggering.
  • the operating method of the continuous blood glucose monitor of the present application is as follows: first, the cover shell 2 is rotated so that the connecting seat 5, the skin fixing seat 1 and the auxiliary needle assembly 7 are rotated synchronously to realize unlocking, and then the cover shell 2 is removed, at which time the contact needle of the sensor 11 and the needle body 31 of the puncture assembly 3 are exposed, and then the open end of the shell 6 is attached to the skin, and the trigger structure 61 is triggered by pressing and other operations.
  • the shell 6 loses the stopper for the auxiliary needle assembly 7, and the auxiliary needle assembly 7 drives the puncture assembly 3, the connecting seat 5 and the skin fixing seat 1 to move toward the skin under the action of the spring assist, and the needle body pierces the skin, and the contact needle of the sensor 11 is implanted under the skin to complete the implantation process, and then the needle withdrawal action of the puncture assembly 3 is triggered, so that the puncture assembly 3 moves away from the skin relative to the auxiliary needle assembly 7 and withdraws from the skin to complete the needle withdrawal operation, and the skin fixing seat 1 is adhered and fixed to the skin surface.
  • the skin fixing seat 1 and the connecting seat 5 are loosened, and the entire implantation process is completed. After the implantation is completed, only the skin fixing seat 1 remains on the skin surface, and the contact needle of the sensor 11 is located under the skin for real-time monitoring.
  • the present application also discloses a sterilization method for a continuous blood glucose monitor, comprising the following steps:
  • the first sterilization unit is subjected to a first sterilization treatment, wherein the first sterilization unit comprises a cover shell 2, a connecting seat 5 and a puncture assembly 3, a sensor 11 and a skin fixing seat 1 are installed in the installation cavity formed by the connecting seat 5, the connecting seat 5 is also provided with an installation port 58, the skin fixing seat 1 cooperates with the cover shell 2 to form a closed chamber 23, the skin fixing seat 1 is provided with a through hole 12, one end of the sensor 11 is fixed to the skin fixing seat 1, and the other end extends downwardly through the through hole 12 into the closed chamber 23, at least a portion of the puncture assembly 3 extends downwardly through the through hole 12 into the closed chamber 23, and at least a portion of the sensor 11 is nested inside the puncture assembly 3;
  • the second sterilization unit is subjected to a second sterilization treatment, wherein the second sterilization unit comprises the first sterilization unit and the sensor electronic unit 13 , and the sensor electronic unit 13 is mounted on the skin fixing base 1 through the mounting opening 58 .
  • the sterilization assembly is divided into two sterilization units, and two different sterilization methods are performed on the two sterilization units in sequence.
  • the first sterilization unit only the sensor 11 is installed on the skin holder 1, and the sensor electronic unit 13 is not installed.
  • the first sterilization unit is subjected to radiation sterilization, and the sensor 11 is sterilized. Since the sensor electronic unit 13 is not installed on the skin holder 1, its circuit will naturally not be affected by radiation sterilization.
  • the contact pin of the sensor 11 is sealed in the closed chamber 23, and the chamber is isolated from the outside world. Then the sensor electronic unit 13 is installed on the skin holder 1.
  • the second step of sterilization such as ethylene oxide gas sterilization, is performed.
  • the closed chamber 23 Since the closed chamber 23 is isolated, the gas will not enter and affect the biological enzyme on the contact pin of the sensor 11. In this way, by installing and sterilizing the sensor 11 and the sensor electronic unit 13 step by step, the sterilization effect is greatly improved, and the adverse effects of different sterilization methods on the two are avoided to a great extent, the yield rate of the monitor and the monitoring accuracy are improved, and the product performance is guaranteed.
  • the second sterilization unit further includes an auxiliary needle assembly 7 , and the auxiliary needle assembly 7 is connected to the connecting seat 5 .
  • the connecting seat 5 is connected to the auxiliary needle assembly 7, so that the auxiliary needle assembly 7 can drive the connecting seat 5 to move toward the skin for implantation, and the skin fixing seat 1 is fixed to the connecting seat 5, so the skin fixing seat 1 will also move accordingly.
  • connection base 5 has a hook portion 57 protruding toward the needle-assisting assembly 7, and the needle-assisting assembly 7 is provided with a card interface, and the hook portion 57 is engaged with the card interface so that the two are engaged and fixed.
  • the needle-assisting assembly 7 is connected to the connection base 5 through the hook portion 57, and the second sterilization process is performed after the second sterilization unit is formed.
  • connecting seat 5 can also be connected to the auxiliary needle assembly 7 in other ways, such as magnetic attraction, etc., which is not specifically limited here.

Landscapes

  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

一种持续血糖监测器灭菌组件及灭菌方法，灭菌组件包括传感器（11）和皮肤固定座（1），还包括罩壳（2）和连接座（5），皮肤固定座（1）设有通孔（12），罩壳（2）与皮肤固定座（1）下部配合并形成封闭腔室（23），传感器（11）一端与皮肤固定座（1）固定，另一端经皮肤固定座（1）的通孔（12）后向下延伸进入封闭腔室（23），连接座（5）内设有皮肤固定座安装腔，连接座（5）还设有用于将传感器电子单元（13）安装于皮肤固定座（1）的安装口（58）。将皮肤固定座（1）固定于连接座（5）内，罩壳（2）与皮肤固定座（1）配合形成封闭腔室（23），传感器（11）与传感器电子单元（13）能够分体安装在皮肤固定座（1）上，从而能够实现分步灭菌，对传感器（11）和传感器电子单元（13）分别进行独立方式的灭菌，使不同的灭菌介质对传感器（11）和传感器电子单元（13）互不干扰，提高灭菌效果。

Description

一种持续血糖监测器灭菌组件及灭菌方法
本申请要求于2022年12月06日提交中国专利局、申请号为202211555748.9、发明名称为“一种持续血糖监测器灭菌组件及灭菌方法”的中国专利申请的优先权,其全部内容通过引用结合在本申请中。
技术领域
本申请属于医疗设备技术领域，具体涉及一种持续血糖监测器灭菌组件及灭菌方法。
背景技术
生物传感器是一种对生物活性物质敏感并将感知的生物活性物质浓度转换为电信号进行检测的仪器。其中，葡萄糖传感器就是较为常见的一类生物传感器。CGM(连续血糖监测)是通过葡萄糖传感器连续地监测皮下组织间液的葡萄糖浓度，而间接反映血糖水平的一种技术手段。CGM产品测试血糖需要有穿刺针和传感器引脚刺破人体皮肤，通过传感器上的生物酶与皮下组织液产生电化学反应，转化成电信号，并通过转化为血糖数值提供给使用者。由于产品具有刺破人体皮肤的部分，因此产品出厂前需要对产品进行灭菌，避免产品上的致病菌引起使用者的感染风险。
监测组件一般包括传感器和电子单元(发射器)，二者往往需要使用不同的灭菌方式，对于发射器部分，一般采用气体杀菌的方式，例如利用环氧乙烷气体灭菌，由于传感器上的生物酶会与环氧乙烷等气体发生化学反应，影响生物酶的活性，进而影响监测准确性，因此无法通过气体灭菌的方式对传感器进行灭菌处理，进而选用辐射灭菌。同时，辐射灭菌又容易对发射器的电路产生影响，因此需要将传感器和发射器分别进行灭菌处理。
现有技术中，灭菌之前往往先将监测组件组装完成，然后再分别进行两种不同方式的灭菌，在灭菌过程中，由于辐射灭菌和气体灭菌分别利用辐射以及气体进行灭菌，往往难以将辐射以及气体进行有效的隔绝，导致传感器上的生物酶以及发射器的电路会受到不同程度的损伤；或将传感器与发射器单独灭菌，待使用时，用户手动将发射器安装使其与传感器电连接，增加了用户的操作复杂度。
此外，CGM产品对于前端与皮肤直接接触的零部件(如皮肤固定座、半壁针等)的灭菌要求较高，而对于后端的助推组件等的灭菌要求较低，但是现有技术中，往往将CGM产品组装后整机进行灭菌，这不仅导致对前端零部件的灭菌效果较差，而且整机机体较大，灭菌的成本较高。
因此，如何对CGM产品前端部分进行有效的灭菌，并且保证两种灭菌方式中不会对传感器和发射器造成影响，成为本领域亟待解决的技术问题。
发明内容
本申请提供了一种持续血糖监测器灭菌组件及灭菌方法，以解决上述技术问题中的至少一个。
本申请所采用的技术方案为：
一种持续血糖监测器灭菌组件，包括传感器和皮肤固定座，还包括罩壳和连接座，皮肤固定座设有通孔，罩壳与皮肤固定座下部配合并形成封闭腔室，传感器一端与皮肤固定座固定，另一端经皮肤固定座的通孔后向下延伸进入封闭腔室，连接座内设有皮肤固定座安装腔，连接座还设有用于将传感器电子单元安装于皮肤固定座的安装口。
连接座外侧和/或罩壳内侧还设有卡接位，以将罩壳与连接座卡接固定。
灭菌组件还包括助针组件，连接座还设有卡勾部，以将连接座与助针组件相连。
灭菌组件还包括穿刺组件，穿刺组件包括针体和针座，针体经通孔后向下延伸进入封闭腔室，传感器至少部分嵌套在针体内部。
连接座和/或针座设有能够密封通孔的第一密封部。
罩壳包括套设的外壳体和内壳体，内壳体设于皮肤固定座下部，且内壳体与皮肤固定座之间设有第二密封部。
外壳体的至少部分区域环绕于连接座的外周，外壳体与连接座二者之一设置有固定凸起，另一设置有卡接位，卡接位具有互相连接的导向段和锁合段，以使外壳体和连接座旋转卡合。
连接座的侧壁设置有多个弹性筋位，罩壳固定于连接座的状态下，罩壳抵顶弹性筋位以使弹性筋位朝向皮肤固定座移动以夹持皮肤固定座。
外壳体内还设置有支撑柱，支撑柱能够与皮肤固定座下方抵接。
灭菌组件还包括传感器电子单元，传感器包括位于安装口内的耦合部，耦合部设置有第一触点，传感器电子单元具有第二触点，第一触点和第二触点能够耦合连接。
本申请还公开了一种用于持续血糖监测器的灭菌方法，包括以下步骤：将第一灭菌单元进行第一灭菌处理，其中，第一灭菌单元包括罩壳、连接座和穿刺组件，连接座形成的安装腔内安装有传感器和皮肤固定座，连接座还设有安装口，皮肤固定座与罩壳配合形成封闭腔室，皮肤固定座设有通孔，传感器一端与皮肤固定座固定，另一端经通孔后向下延伸进入封闭腔室，穿刺组件的至少部分经通孔后向下延伸进入封闭腔室，传感器的至少部分嵌套在穿刺组件内部；将第二灭菌单元进行第二灭菌处理，其中，第二灭菌单元包括第一灭菌单元和传感器电子单元，传感器电子单元通过安装口安装于皮肤固定座。
第二灭菌单元还包括助针组件，助针组件与连接座相连。
由于采用了上述技术方案，本申请所取得的有益效果为：
1.本申请将皮肤固定座固定于连接座内，罩壳与皮肤固定座配合形成封闭腔室，且连接座设置有安装口，使得传感器与传感器电子单元能够分体安装在皮肤固定座上，从而能够实现分步灭菌。具体操作时，可先将传感器固定于皮肤固定座，对传感器进行辐射灭菌，此时由于传感器电子单元还未安装至皮肤固定座，因此辐射不会对其电路造成影响。然后将罩壳固定于连接座，此时罩壳与皮肤固定座配合形成封闭腔室，传感器的触针位于封闭腔室内，且封闭腔室与外界环境隔绝，此时将传感器电子单元通过安装口安装至皮肤固定座，然后对传感器电子单元进行气体灭菌，此时由于传感器的触针位于封闭腔室内，气体无法进入封闭腔室，因此也不会对传感器触针上的生物酶造成影响。
此外，本申请将具有较高灭菌要求的皮肤固定座、传感器等零部件通过连接座连接为一个组件，在灭菌时，仅需要将该组件送入灭菌室进行灭菌，而无需对监测器后端部件灭菌，从而大大减小了灭菌组件的体积，节约了灭菌成本。提高了灭菌效率以及效果。
2.作为本申请的一种优选实施方式，连接座外侧和/或罩壳内侧还设有卡接位，以将罩壳与连接座卡接固定。罩壳不仅能够与皮肤固定座配合将传感器的一端围包在封闭腔室内，为其提供一个无菌环境，而且还能够对皮肤固定座形成支撑，使皮肤固定座更加牢固，防止皮肤固定座在植入前便发生脱落。此外，罩壳还能够对监测器内部的运动部件起到限位作用，使其在罩壳未拆下时，受到限位而无法运动，从而实现防误触功能，用户在使用前，将罩壳拆下，与此同时，监测器内的运动部件完成解锁，提高使用可靠性。同时，卡接固定的方式，使得罩壳的拆卸更加简单方便，降低操作难度，提高使用体验。
3.作为本申请的一种优选实施方式，外壳体的至少部分区域环绕于连接座的外周，外壳体与连接座二者之一设置有固定凸起，另一设置有卡接位，卡接位具有互相连接的导向段和锁合段，以使外壳体和连接座旋转卡合。在实际使用中，CGM产品的整体体积趋于小型化，因此通过转动控制的方式而言，更加方便用户施力，提高使用便捷性。
4.作为本申请的一种优选实施方式，连接座的侧壁设置有多个弹性筋位，罩壳固定于连接座的状态下，罩壳抵顶弹性筋位以使弹性筋位朝向皮肤固定座移动以夹持皮肤固定座。罩壳的部分区域环绕在皮肤固定座的外周，在罩壳未拆卸时，在罩壳的抵顶作用下，连接座的弹性筋位分别向内运动，从而对皮肤固定座形成挤压，将皮肤固定座卡紧固定，提高皮肤固定座的连接稳定性，防止 脱落，在用户进行植入操作时，将罩壳拆下，此时弹性筋位失去挤压而复位，即向外扩张，将皮肤固定座松开，此时皮肤固定座能够在于人体皮肤的粘结力作用下脱离连接座，留在皮肤表面。本申请在拆卸罩壳的同时，实现对皮肤固定座的解锁，进一步简化操作步骤，提高使用体验。
5.本申请还公开了一种用于持续血糖监测器的灭菌方法，以将灭菌组件分为两个灭菌单元，对两个灭菌单元依次进行两种不同方式的灭菌，在第一灭菌单元中，仅将传感器安装至皮肤固定座，而传感器电子单元并未安装，此时对第一灭菌单元进行辐射灭菌，对传感器进行灭菌，由于传感器电子单元并未安装至皮肤固定座，因此自然不会使其电路受到辐射灭菌的影响。对第一灭菌单元灭菌之后，将传感器的触针封闭在封闭腔室内，将该腔室与外界隔绝，然后将传感器电子单元安装至皮肤固定座，此时进行第二步的灭菌，如气体灭菌，由于封闭腔室隔绝，因此气体也不会进入，对传感器触针上的生物酶造成影响。以此通过将传感器、传感器电子单元分步安装并分步灭菌的方式，大大提高了灭菌效果，极大程度的避免了不同灭菌方式对二者产生的不利影响，提高监测器的良品率以及监测准确性，保证产品性能。
附图说明
此处所说明的附图用来提供对本申请的进一步理解，构成本申请的一部分，本申请的示意性实施例及其说明用于解释本申请，并不构成对本申请的不当限定。在附图中：
图1为本申请一种实施方式下的灭菌组件的结构示意图；
图2为本申请另一种实施方式下的灭菌组件的结构示意图；
图3为图2中灭菌组件的剖视图；
图4为本申请一种实施方式下的皮肤固定座的结构示意图；
图5为本申请另一种实施方式下的皮肤固定座的结构示意图；
图6为本申请一种实施方式下的皮肤固定座的内部结构示意图；
图7为本申请另一种实施方式下的皮肤固定座的内部结构示意图；
图8为本申请一种实施方式下的皮肤固定座的底部结构示意图；
图9为本申请另一种实施方式下的皮肤固定座的底部结构示意图；
图10为本申请一种实施方式下的罩壳的结构示意图；
图11为本申请另一种实施方式下的罩壳的结构示意图；
图12为本申请一种实施方式下的连接座的结构示意图；
图13为本申请另一种实施方式下的连接座的结构示意图；
图14为本申请一种实施方式下的限位结构的结构示意图；
图15为本申请另一种实施方式下的限位结构的结构示意图；
图16为本申请一种实施方式下的穿刺组件的结构示意图；
图17为本申请另一种实施方式下的穿刺组件的结构示意图；
图18为本申请一种实施方式下的监测器的内部结构示意图；
图19为图18中监测器的结构示意图；
图20为本申请另一种实施方式下的监测器的结构示意图；
图21为图20中监测器的内部结构示意图，其中罩壳未示出；
图22为图20中监测器的剖视图。
其中：
1皮肤固定座；11传感器；12通孔；13传感器电子单元；131安装位；14配合槽；15隔离部；16环形密封条；17粘附层；171第一避让区；172第二避让区；
2罩壳；21内壳体；211安装槽；212支撑柱；213卡接位；2131导向段；2132锁合段；22外壳体；23封闭腔室；24外罩；
3穿刺组件；31针体；32针座；321卡接槽；322限位槽；33第一密封部；
4限位结构；41限位孔；411凸起结构；42拨动杆；43导向滑槽；44止回筋；45限位件；
5连接座；51导向滑块；52止回凸起；53压紧部；54固定凸起；55弹性筋位；551固定凸筋；56过孔；57卡勾部；58安装口；
6壳体；61触发结构；
7助针组件。
具体实施方式
为了更清楚的阐释本申请的整体构思，下面结合说明书附图以示例的方式进行详细说明。
在下面的描述中阐述了很多具体细节以便于充分理解本申请，但是，本申请还可以采用其他不同于在此描述的其他方式来实施，因此，本申请的保护范围并不受下面公开的具体实施例的限制。
另外，在本申请的描述中，需要理解的是，术语“顶”、“底”、“内”、“外”、“轴向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
在本申请中，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接，还可以是通信；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。
在本申请中，除非另有明确的规定和限定，第一特征在第二特征“上”或“下”可以是第一和第二特征直接接触，或第一和第二特征通过中间媒介间接接触。在本说明书的描述中，参考术语“实施方式”、“实施例”、“一种实施例”、“示例”或“具体示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本申请的至少一个实施例或示例中。在本说明书中，对上述术语的示意性表述不必须针对的是相同的实施例或示例。而且，描述的具体特征、结构、材料或者特点可以在任一个或多个实施例或示例中以合适的方式结合。
如图1至图22所示，一种持续血糖监测器灭菌组件，包括传感器11和皮肤固定座1，还包括罩壳2和连接座5，皮肤固定座1设有通孔12，罩壳2与皮肤固定座1下部配合并形成封闭腔室23，传感器11一端与皮肤固定座1固定，另一端经皮肤固定座1的通孔12后向下延伸进入封闭腔室23，连接座5内设有皮肤固定座安装腔，连接座5还设有用于将传感器电子单元13安装于皮肤固定座5的安装口58。
本申请将皮肤固定座1固定于连接座5内，罩壳2与皮肤固定座1配合形成封闭腔室23，且连接座5设置有安装口58，使得传感器1与传感器电子单元13能够分步依次安装在皮肤固定座1上，从而能够实现分步灭菌。此外，本申请在出厂前将传感器1及传感器电子单元13安装在皮肤固定座1上，形成一体结构，无需使用者在植入操作后再进行传感器电子单元13的组装，更加方便简单，容易操作，提升了用户的使用体验。
具体的，本申请对罩壳2的形状不做限制，例如可以为分体式结构，也可以为一体式结构，只要能与皮肤固定座1下部配合形成封闭腔室即可。罩壳2的部分区域可以与助针组件相连，也可以不相连。
具体操作时，可先将传感器11固定于皮肤固定座1，对传感器11进行辐射灭菌，此时由于传感器电子单元13还未安装至皮肤固定座1，因此辐射不会对其电路造成影响。
然后将罩壳2固定于连接座，此时罩壳2与皮肤固定座1配合形成封闭腔室23，传感器11的触针位于封闭腔室23内，且封闭腔室23与外界环境隔绝，此时将传感器电子单元13通过安装口58安装至皮肤固定座1，然后对传感器电子单元13进行气体灭菌，此时由于传感器11的触针位于封闭腔室23内，气体无法进入封闭腔室23，因此也不会对传感器11触针上的生物酶造成影 响。
如图6、图7所示，用于安装传感器电子单元13的安装位131与通孔12错位布置，传感器11的自由端自通孔12穿出，通孔12和安装位131之间具有隔离部15，使得在灭菌时，可分别对皮肤固定座1的两个区域进行不同方式的灭菌，且不会互相影响。
此外，本申请将具有较高灭菌要求的皮肤固定座1、传感器11等零部件通过连接座5连接为一个组件，在灭菌时，仅需要将该组件送入灭菌室进行灭菌，而无需对监测器后端部件灭菌，从而大大减小了灭菌组件的体积，节约了灭菌成本。提高了灭菌效率以及效果。
作为本申请的一种优选实施方式，连接座5外侧和/或罩壳2内侧还设有卡接位，以将罩壳2与连接座5卡接固定。
罩壳2不仅能够与皮肤固定座1配合将传感器11的一端围包在封闭腔室23内，为其提供一个无菌环境，而且还能够对皮肤固定座1形成支撑，使皮肤固定座1更加牢固，防止皮肤固定座1在植入前便发生脱落。此外，罩壳2还能够对监测器内部的运动部件起到限位作用，使其在罩壳2未拆下时，受到限位而无法运动，从而实现防误触功能，用户在使用前，将罩壳2拆下，与此同时，监测器内的运动部件完成解锁，提高使用可靠性。同时，卡接固定的方式，使得罩壳2的拆卸更加简单方便，降低操作难度，提高使用体验。
在一种优选实施方式中，如图18所示，灭菌组件还包括助针组件7，所述连接座5还设有卡勾部57，以将所述连接座5与所述助针组件7相连。
连接座5与助针组件7相连，使得连接座5与助针组件7实现联动，用户触发后，助针组件7带动连接座5一同向皮肤运动，使皮肤固定座1的底面与皮肤接触，优选的，皮肤固定座1的底面设有粘附层17，从而将皮肤固定座1与皮肤粘结固定。
同时，将传感器电子单元13通过安装口58安装在皮肤固定座1上之后，再通过卡勾部57将连接座5与助针组件7相连，能够降低装配难度，方便操作。可以理解的是，助针组件7下方可以开设有卡槽，以与卡勾部57配合。
在一种优选实施方式中，如图1、图2、图3、图16、图17所示，灭菌组件还包括穿刺组件3，所述穿刺组件3包括针体31和针座32，所述针体31经所述通孔12后向下延伸进入所述封闭腔室23，所述传感器11至少部分嵌套在所述针体31内部。
在使用中，由于传感器11的触针为柔性结构，无法直接刺破皮肤进入皮下，因此通过针体31，将传感器11的触针嵌套在针体31内部，利用针体31刺破皮肤，将传感器11的触针植入皮下，在植入完成后，穿刺组件3进行退针动作，使针体离开人体。
针体31伸入封闭腔室23内，与传感器11的触针一同处于封闭的无菌环境中，保证了针体31和传感器11触针的清洁。优选的，针座32与助针组件7相连，使得穿刺组件3与助针组件7实现联动，用户触发后，助针组件7带动穿刺组件3一同向皮肤运动完成植入动作，为穿刺组件3提供动力。
在植入时，助针组件7带动穿刺组件3、连接座5以及皮肤固定座1一同在弹簧助力作用下向皮肤运动，针体刺破皮肤，将传感器11的触针植入皮下，完成植入过程，然后触发穿刺组件3的退针动作，使得穿刺组件3独自向远离皮肤的方向运动，从皮下退出，完成退针的操作，皮肤固定座1则粘连固定在皮肤表面，传感器11触针位于皮下，进行实时的血糖监测。
本申请对助针组件7的结构不做限制，可使用现有结构，只要能实现带动连接座5向皮肤运动，并实现带动穿刺组件3的退针动作即可。
如图3所示，连接座5和/或针座32设有能够密封通孔12的第一密封部33，以保证封闭腔室23的密封。第一密封部33优选为弹性材料制成的结构，当针座32与连接座5相抵时，第一密封部33受到挤压而发生弹性形变，从而将二者之间的间隙密封。
作为本实施方式下的一种优选实施例，如图1、图2所示，连接座5还设置有限位结构4，限位结构4至少能够限制穿刺组件3从通孔12移出。
限位结构4能够对穿刺组件3进行限位，使穿刺组件3与皮肤固定座1保持稳固的连接，一方面穿刺组件3将通孔12封堵密封，且二者位置稳定，有助于保证通孔12的密封可靠性，从而保证封闭腔室23与外界的隔绝，保证传感器11和针体31的处于无菌环境中，同时也降低了穿刺组件3和皮肤固定座1发生脱离的风险，降低皮肤固定座1损坏的风险。另一方面限位结构3能够限制穿刺组件3的运动，从而在罩壳2未拆下时，实现穿刺组件3的防误触，在限位结构4的限制下，穿刺组件3无法运动进而无法进行植入或退针动作，提高了监测器的工作可靠性，节约了成本。
具体的，如图1、图2、图14至图17所示，限位结构4具有限位孔41，限位孔41与针座32均为非圆形结构，限位孔41能够随限位结构4一起相对于针座32转动，当限位孔41转动至与针座32重合位置处时，限位结构4为解锁状态，此时限位结构4失去对针座32的止挡，穿刺组件3能够自限位孔41穿出。当限位结构4转动至限位孔41与针座32错位时，限位结构4处于锁紧状态，限位结构4对针座32形成止挡，使其无法穿过限位孔41。
在另一种实施例中，如图15所示，限位孔41内壁设有凸起结构411，针座32的外壁对应设置有槽结构，当二者转动至重合时，针座32解锁，当二者错位时，针座32锁紧。
进一步地，限位结构4与罩壳2同步转动。罩壳2在监测器使用之前与皮肤固定座1抵接形成封闭腔室23，使传感器11的触针以及针体31处于封闭的无菌环境中，在使用时，通过转动的方式将罩壳2拆下，此时传感器11触针以及针体31暴露，方便用户进行植入操作。与此同时，在罩壳2拆卸的过程中，限位结构4同步转动，从而将穿刺组件3解除锁定，使其能够运动进行植入操作，以此实现罩壳2和穿刺组件3的同步解锁，只需一步操作实现多个部件的解锁，简化了操作步骤，降低了产品使用的繁琐性，大大提高使用体验。
进一步地，如图1、图2、图10、图11、图14所示，限位结构4包括拨动杆42，罩壳2的开口端设置有安装槽211，安装槽211用于卡合拨动杆42，罩壳2能够带动限位结构4转动以由锁紧状态变为解锁状态。
具体的，如图1、图2所示，罩壳2的开口端环绕于皮肤固定座1的外周，拨动杆42与罩壳2开口端的安装槽211配合，且沿罩壳2的径向向内延伸，与穿刺组件3配合。安装槽211的两槽壁沿罩壳2的周向位于安装槽211的两侧，从而形成对拨动杆42的周向限位，当罩壳2转动时，在安装槽211一侧的槽壁的抵顶作用下，推动拨动杆42随罩壳2同步转动。
更进一步地，如图1、图2、图10、图11所示，安装槽211在对应第二位置处具有朝向上方的开口，以使用户在将罩壳2取下时，拨动杆42能够自开口滑出，与罩壳2脱离，使得罩壳2取下，而拨动杆42则滞留在监测器内部，同时不会对内部各零部件的运行造成影响。
作为本申请的一种优选实施方式，如图2、图12、图14所示，灭菌组件还包括用于导向限位结构4转动的导向组件，导向组件包括导向滑槽43和导向滑块51，导向滑槽43和导向滑块51的二者之一设置在所述限位结构4上，另一设置在连接座5上。
具体的，如图3所示，皮肤固定座1位于连接座5的内部，限位结构4位于连接座5的顶面。导向滑槽43和导向滑块51配合对限位结构4的转动起到导向引导作用，提高限位结构4运动的可靠性，使得限位结构4沿着固定路径运动，从而保证限位孔41与针座32重合处于解锁状态，确保穿刺组件3顺利完成退针动作。
需要说明的是，本实施方式对于导向组件的结构不做具体限定，在一种实施例中，如图12、图14所示，导向滑槽43设置于限位结构4，导向滑块51设置于连接座5的顶面，且沿连接座5的周向延伸，以引导限位结构4沿连接座5的周向转动。
当然，也可以将导向滑槽43设置于连接座5，相对应的，导向滑块51设置于限位结构4，在此不做具体限定。
进一步地，如图2、图12、图14所示，限位结构4包括止回筋44，罩壳2和/或连接座5上设置有止回凸起52，限位结构4由第一位置转动至第二位置时，止回筋44与止回凸起52抵接，以限制限位结构4由第二位置向第一位置转动。
止回筋44与止回凸起52的配合，使得限位结构4的解锁运动为不可逆的操作，一旦限位结构4转动至解锁状态，在止回筋44和止回凸起52的止挡作用下，便将限位结构4限制在该位置，使其无法回转至锁紧状态，确保穿刺组件3顺利完成退针动作，保证产品使用的可靠性以及安全性，进一步避免产品被重复使用，降低交叉感染的风险。
在一种优选示例中，如图12所示，连接座5的顶面设置有导向滑块51，止回凸起52设置于导向滑块51，以实现止回和导向作用的集成，一件多用，提高监测器内部结构紧凑性，节约成本。
作为优选，如图2、图12、图14所示，连接座5及限位结构4的二者之一设置有限位件45，另一设置有阻挡件，当限位结构4由第一位置转动至第二位置时，阻挡件能够抵接限位件45，以限制限位结构4继续向远离第一位置的方向运动。
限位件45和阻挡件配合能够限制限位结构4的转动角度，当限位结构4转动至第二位置时，将穿刺组件3解锁，此时在限位件45和阻挡件的止挡作用下，限位结构4无法继续转动，从而实现限位结构4的位置锁定，使其保持在解锁状态，能够避免因限位结构4转动量过大导致其再次将穿刺组件3锁紧，确保穿刺组件3顺利完成退针动作。
优选的，如图12、图14所示，限位件45为设置于限位结构4上的凸起，阻挡件设置于限位结构4的两侧，二者之间的区域即为限位结构4的行程，对限位结构4在两个位置均形成阻挡限位。
在本申请的一种优选实施方式中，如图1、图2、图12、图13所示，灭菌组件还包括用于安装皮肤固定座1的连接座5，连接座5上设置有压紧部53，压紧部53与连接座5配合，以夹持限位结构4。
压紧部53对针座32形成向下的压力，将穿刺组件3压紧在连接座5上，实现对穿刺组件3的固定。优选的，压紧部53位于限位结构4的至少一侧，从而使压紧部53的侧壁能够与限位结构4形成止挡，从而对限位结构4的转动量进行限制，即压紧部53构成上述的阻挡件。
此外，当罩壳2拆卸后，限位结构4与罩壳2脱离，在压紧部53的作用下，使得限位结构4仍然被牢牢压在连接座5上，从而避免了限位结构4失去限位作用后在监测器内部移动，影响其他零部件的工作。
具体的，如图12、图13所示，压紧部53为设置于连接座5顶面且向上延伸的筋位，筋位的顶部弯曲形成压紧爪，压紧爪与连接座5顶面之间形成容置空间，限位结构4置于容置空间内，压紧爪对限位结构4形成向下的挤压力。
作为本申请的一种优选实施方式，如图3所示，罩壳2包括套设的外壳体22和内壳体21，内壳体21设于皮肤固定座1下部，且内壳体21与皮肤固定座1之间设有第二密封部。
可以理解的是，外壳体22和内壳体21可以相连，也可以不相连。
罩壳2的内壳体21与皮肤固定座1的底面抵接，一方面与皮肤固定座1配合形成封闭腔室23，并且第二密封部保证封闭腔室23的密封性，另一方面，内壳体21还能够对皮肤固定座1形成向上的支撑力，使皮肤固定座1的固定更加稳定，防止在植入之前，皮肤固定座1发生脱落。
需要说明的是，本实施方式对于第二密封部的结构不做具体限定，在一种具体示例中，如图8所示，第二密封部为设置于皮肤固定座1底面的环形密封条16，内壳体21也为环形结构，从而与环形密封条16抵接密封，在内部形成封闭腔室23。
在另一种具体示例中，如图9所示，皮肤固定座1底面具有粘附层17，粘附层开设有第一避让区171，第二密封部设置于第一避让区171内，所述内壳体21的抵接端位于所述第一避让区171内。
可以理解的是，粘附层17涂覆有胶粘剂，使得皮肤固定座1的底面与皮肤接触后，在粘结力作用下，会粘连在皮肤表面，而第一避让区171无胶粘剂，因此不具有粘性，内壳体21与第一避让区171抵接，既能够防止内壳体21与粘附层17发生粘连，导致罩壳2拆下时将胶体破坏，又能够避免罩壳2与皮肤固定座1发生相对转动时，内壳体21对胶体形成揉搓，导致粘附层17起皱，影响粘贴效果。
进一步地，如图10所示，外壳体22内还设置有支撑柱212，支撑柱212能够与皮肤固定座1下方抵接。
支撑柱212的设置增大了罩壳2与皮肤固定座1的接触面积，提高了罩壳2对皮肤固定座1的支撑稳定性。优选的，如图10所示，支撑柱212为两个，以使内壳体21与支撑柱212共同抵顶皮肤固定座1，对皮肤固定座212形成三点支撑。
如图9、图10所示，支撑柱212为两个，支撑柱212和内壳体21均与罩壳2偏心设置，且三者之间的连线呈近似于等腰三角形。以进一步提高内壳体21和支撑柱212对皮肤固定座1的支撑稳定性，防止皮肤固定座1发生倾斜。
作为本实施方式的一种优选实施例，如图10至图13所示，外壳体22的至少部分区域环绕于连接座5的外周，外壳体22与连接座5二者之一设置有固定凸起54，另一设置有卡接位213，卡接位213具有互相连接的导向段2131和锁合段2132，以使外壳体22和连接座5旋转卡合。
具体而言，如图1、图2所示，外壳体22的至少部分区域环绕在连接座5的外周，固定凸起54和卡接位213中的一个设置于连接座5的外周，另一个设置于外壳体22的内壁。
如图10至图13所示，在一种实施例中，连接座5的外周设置有固定凸起54，外壳体22的内壁设置有固定槽构成所述卡接位213，在装配时，将固定凸起54自导向段插入固定槽内，然后转动罩壳2，使固定凸起54沿固定槽转动滑动至锁合段2132，完成罩壳2和连接座5的锁合。相反，将罩壳2沿相反方向转动使固定凸起54运动至导向段2131，然后将罩壳2沿导向段2131的开口方向抽出，即可将罩壳2拆下。
当然，也可以将固定凸起54设置于罩壳2的内壁，相对应的，卡接位213设置于连接座5的外周，在此不做具体限定。
优选的，如图12、图13所示，连接座5的侧壁设置有多个弹性筋位55，罩壳2固定于连接座5的状态下，罩壳2抵顶弹性筋位55以使弹性筋位55朝向皮肤固定座1移动以夹持皮肤固定座1。
罩壳2的部分区域环绕在皮肤固定座1的外周，在罩壳2未拆卸时，在罩壳2的抵顶作用下，连接座5的弹性筋位55分别向内运动，从而对皮肤固定座1形成挤压，将皮肤固定座1卡紧固定，提高皮肤固定座1的连接稳定性，防止脱落，在用户进行植入操作时，将罩壳2拆下，此时弹性筋位55失去挤压而复位，即向外扩张，将皮肤固定座1松开，此时皮肤固定座1能够在与人体皮肤的粘结力作用下脱离连接座5，留在皮肤表面。本申请在拆卸罩壳2的同时，实现对皮肤固定座1的解锁，进一步简化操作步骤，提高使用体验。
优选的，如图12、图13所示，弹性筋位55为多个且沿连接座5的周向间隔设置。
进一步地，如图4、图5、图12、图13所示，弹性筋位55朝向皮肤固定座1的一侧设置有固定凸筋551，皮肤固定座1的外周对应弹性筋位55设置有配合槽14，当弹性筋位55朝向皮肤固定座1运动时，固定凸筋551伸入配合槽14内，使连接座5对皮肤固定座1的夹持更稳定，避免因运输过程中的震动或其他因素而导致皮肤固定座1发生周向转动，当罩壳2拆下时，弹性筋位55向外运动复位，固定凸筋551从配合槽14内滑出。
在本实施方式的另一种实施例中，如图12所示，连接座5开设有过孔56，过孔56与通孔12对应设置，针座32的至少部分区域与过孔56配合，以限制穿刺组件3相对于连接座5转动。
具体的，植入前，针座32的凸起结构位于过孔56内，以限制穿刺组件3相对于连接座5转动，同时，针座32的凸起结构与限位结构4抵接使得针座32处于锁紧状态；限位结构4解锁后，针座32的凸起结构与限位结构4脱离抵接，当穿刺组件3后退时，针座32的凸起结构能够穿过限位孔41以完成退针动作。
作为本申请的一种优选实施方式，如图3、图5、图6、图7所示，灭菌组件还包括传感器电子单元13，传感器11包括位于安装口58内的耦合部18，耦合部18设置有第一触点181，传感器电子单元13具有第二触点，第一触点181和第二触点能够耦合连接。
传感器11的耦合部18位于安装口58内，使得传感器电子单元13通过安装口58安装在皮肤固定座1后，同步能够完成第一触点181和第二触点的耦合，降低操作难度，大大降低了二者耦合的难度，提高装配便捷性。
在一种实施例中，如图7所示，第一触点181朝向上方，第二触点位于传感器电子单元13且朝向下方，以使传感器电子单元13安装完成的同时，第一触点181和第二触点沿上下方向耦合。
在另一种实施例中，第一触点181朝向一侧，第二触点也朝向一侧，且与第一触点181相对，以使传感器电子单元13安装完成时，第一触点181和第二触点横向耦合。
如图18至图22所示，持续血糖监测器包括壳体6以及置于壳体6内的助针组件7，还包括上述的持续血糖监测器灭菌组件，灭菌组件还包括穿刺组件3，穿刺组件3包括针体31和针座32，针座32开设有卡接槽321和限位槽322，卡接槽321用于与助针组件7相连，限位槽322用于与限位结构4相配合。
针座32与助针组件7相连，使得穿刺组件3与助针组件7实现联动，用户触发后，助针组件7带动穿刺组件3一同向皮肤运动完成植入动作，为穿刺组件3提供动力。
如图1、图2、图18所示，连接座5还具有卡勾部57用于与助针组件7卡接固定。
优选的，如图1、图2、图3、图20所示，罩壳2包括套设的外罩24、外壳体22和内壳体21，壳体6和外壳体22对接。内壳体21与皮肤固定座1的底面抵接形成封闭腔室23，外罩24则与壳体6对接，将监测器的所有零部件均围包在二者组成的腔体内。
如图19、图22所示，壳体6设置有触发结构61，用户可通过操作触发结构61对监测器进行触发，完成整个植入以及退针过程。
触发结构61可以为图19中所示的按钮，以通过按压触发，也可以为图22中所示的推动结构，通过向下推动该结构实现触发。
在出厂时，本申请的持续血糖监测器内部的穿刺组件3、皮肤固定座1以及连接座5均处于锁定状态，用户无法触发植入，大大提高了误触发的风险。本申请的持续血糖监测器的操作方法为：首先转动罩壳2，使得连接座5、皮肤固定座1以及助针组件7同步转动实现解锁，然后将罩壳2取下，此时传感器11的触针以及穿刺组件3的针体31暴露，然后将壳体6的开口端贴在皮肤上，通过按压等操作触发触发结构61，此时壳体6失去对助针组件7的止挡，助针组件7带动穿刺组件3、连接座5以及皮肤固定座1一同在弹簧助力作用下向皮肤运动，针体刺破皮肤，将传感器11的触针植入皮下，完成植入过程，然后触发穿刺组件3的退针动作，使得穿刺组件3相对于助针组件7向远离皮肤的方向运动，从皮下退出，完成退针的操作，皮肤固定座1则粘连固定在皮肤表面，同时在将监测器其他部分取走时，皮肤固定座1和连接座5松脱，至此完成植入的整个过程，植入完成后，仅皮肤固定座1保留在皮肤表面，传感器11触针位于皮下，进行实时监测。
本申请还公开了一种用于持续血糖监测器的灭菌方法，包括以下步骤：
将第一灭菌单元进行第一灭菌处理，其中，第一灭菌单元包括罩壳2、连接座5和穿刺组件3，连接座5形成的安装腔内安装有传感器11和皮肤固定座1，连接座5还设有安装口58，皮肤固定座1与罩壳2配合形成封闭腔室23，皮肤固定座1设有通孔12，传感器11一端与皮肤固定座1固定，另一端经通孔12后向下延伸进入封闭腔室23，穿刺组件3的至少部分经通孔12后向下延伸进入封闭腔室23，传感器11的至少部分嵌套在穿刺组件3内部；
将第二灭菌单元进行第二灭菌处理，其中，第二灭菌单元包括第一灭菌单元和传感器电子单元13，传感器电子单元13通过安装口58安装于皮肤固定座1。
以将灭菌组件分为两个灭菌单元，对两个灭菌单元依次进行两种不同方式的灭菌，在第一灭菌单元中，仅将传感器11安装至皮肤固定座1，而传感器电子单元13并未安装，此时对第一灭菌单元进行辐射灭菌，对传感器11进行灭菌，由于传感器电子单元13并未安装至皮肤固定座1，因此自然不会使其电路受到辐射灭菌的影响。对第一灭菌单元灭菌之后，将传感器11的触针封闭在封闭腔室23内，将该腔室与外界隔绝，然后将传感器电子单元13安装至皮肤固定座1，此时进行 第二步的灭菌，如环氧乙烷气体灭菌，由于封闭腔室23隔绝，因此气体也不会进入，对传感器11触针上的生物酶造成影响。以此通过将传感器11、传感器电子单元13分步安装并分步灭菌的方式，大大提高了灭菌效果，极大程度的避免了不同灭菌方式对二者产生的不利影响，提高监测器的良品率以及监测准确性，保证产品性能。
优选的，如图18所示，第二灭菌单元还包括助针组件7，助针组件7与连接座5相连。
连接座5与助针组件7相连，使得助针组件7能够带动连接座5一同朝向皮肤运动，进行植入动作，而皮肤固定座1固定于连接座5，因此皮肤固定座1也会随之运动。
优选的，如图12、图13、图18所示，连接座5具有朝向助针组件7凸出的卡勾部57，助针组件7设有卡接口，卡勾部57与卡接口卡接配合，以使二者卡接固定。将传感器电子单元13安装通过安装口58安装于皮肤固定座1后，再通过卡勾部57将助针组件7与连接座5相连，形成第二灭菌单元后进行第二步灭菌处理。
当然，连接座5也可以通过其他方式与助针组件7相连接，如磁吸等，在此不做具体限定。
本申请中未述及的地方采用或借鉴已有技术即可实现。
本说明书中的各个实施例均采用递进的方式描述，各个实施例之间相同相似的部分互相参见即可，每个实施例重点说明的都是与其他实施例的不同之处。
以上所述仅为本申请的实施例而已，并不用于限制本申请。对于本领域技术人员来说，本申请可以有各种更改和变化。凡在本申请的精神和原理之内所作的任何修改、等同替换、改进等，均应包含在本申请的权利要求范围之内。

Claims (12)

  1. 一种持续血糖监测器灭菌组件，包括传感器和皮肤固定座，其特征在于，
    还包括罩壳和连接座，所述皮肤固定座设有通孔，所述罩壳与所述皮肤固定座下部配合并形成封闭腔室，所述传感器一端与所述皮肤固定座固定，另一端经所述皮肤固定座的通孔后向下延伸进入所述封闭腔室，所述连接座内设有皮肤固定座安装腔，所述连接座还设有用于将传感器电子单元安装于所述皮肤固定座的安装口。
  2. 根据权利要求1所述的持续血糖监测器灭菌组件，其特征在于，
    所述连接座外侧和/或所述罩壳内侧还设有卡接位，以将所述罩壳与所述连接座卡接固定。
  3. 根据权利要求1所述的持续血糖监测器灭菌组件，其特征在于，
    还包括助针组件，所述连接座还设有卡勾部，以将所述连接座与所述助针组件相连。
  4. 根据权利要求1所述的持续血糖监测器灭菌组件，其特征在于，
    还包括穿刺组件，所述穿刺组件包括针体和针座，所述针体经所述通孔后向下延伸进入所述封闭腔室，所述传感器至少部分嵌套在所述针体内部。
  5. 根据权利要求4所述的持续血糖监测器灭菌组件，其特征在于，
    所述连接座和/或所述针座设有能够密封所述通孔的第一密封部。
  6. 根据权利要求1所述的持续血糖监测器灭菌组件，其特征在于，
    所述罩壳包括套设的外壳体和内壳体，所述内壳体设于所述皮肤固定座下部，且所述内壳体与所述皮肤固定座之间设有第二密封部。
  7. 根据权利要求6所述的持续血糖监测器灭菌组件，其特征在于，
    所述外壳体的至少部分区域环绕于所述连接座的外周，所述外壳体与所述连接座二者之一设置有固定凸起，另一设置有卡接位，所述卡接位具有互相连接的导向段和锁合段，以使所述外壳体和所述连接座旋转卡合。
  8. 根据权利要求6所述的持续血糖监测器灭菌组件，其特征在于，
    所述连接座的侧壁设置有多个弹性筋位，所述罩壳固定于所述连接座的状态下，所述罩壳抵顶所述弹性筋位以使所述弹性筋位朝向所述皮肤固定座移动以夹持所述皮肤固定座。
  9. 根据权利要求6所述的持续血糖监测器灭菌组件，其特征在于，
    所述外壳体内还设置有支撑柱，所述支撑柱能够与所述皮肤固定座下方抵接。
  10. 根据权利要求1所述的持续血糖监测器灭菌组件，其特征在于，
    还包括传感器电子单元，所述传感器包括位于所述安装口内的耦合部，所述耦合部设置有第一触点，所述传感器电子单元具有第二触点，所述第一触点和所述第二触点能够耦合连接。
  11. 一种用于持续血糖监测器的灭菌方法，其特征在于，包括以下步骤：
    将第一灭菌单元进行第一灭菌处理，其中，所述第一灭菌单元包括罩壳、连接座和穿刺组件，所述连接座形成的安装腔内安装有传感器和皮肤固定座，所述连接座还设有安装口，所述皮肤固定座与罩壳配合形成封闭腔室，所述皮肤固定座设有通孔，所述传感器一端与皮肤固定座固定，另一端经所述通孔后向下延伸进入封闭腔室，所述穿刺组件的至少部分经所述通孔后向下延伸进入封闭腔室，所述传感器的至少部分嵌套在所述穿刺组件内部；
    将第二灭菌单元进行第二灭菌处理，其中，所述第二灭菌单元包括第一灭菌单元和传感器电子单元，所述传感器电子单元通过所述安装口安装于皮肤固定座。
  12. 根据权利要求11所述的灭菌方法，其特征在于，
    所述第二灭菌单元还包括助针组件，所述助针组件与所述连接座相连。
PCT/CN2022/143255 2022-12-06 2022-12-29 一种持续血糖监测器灭菌组件及灭菌方法 WO2024119564A1 (zh)

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