WO2023138571A1 - 经皮分析物传感器系统及使用方法 - Google Patents

经皮分析物传感器系统及使用方法 Download PDF

Info

Publication number
WO2023138571A1
WO2023138571A1 PCT/CN2023/072589 CN2023072589W WO2023138571A1 WO 2023138571 A1 WO2023138571 A1 WO 2023138571A1 CN 2023072589 W CN2023072589 W CN 2023072589W WO 2023138571 A1 WO2023138571 A1 WO 2023138571A1
Authority
WO
WIPO (PCT)
Prior art keywords
cap
locking member
sensor system
analyte sensor
locking
Prior art date
Application number
PCT/CN2023/072589
Other languages
English (en)
French (fr)
Inventor
钱成
Original Assignee
苏州百孝医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 苏州百孝医疗科技有限公司 filed Critical 苏州百孝医疗科技有限公司
Publication of WO2023138571A1 publication Critical patent/WO2023138571A1/zh

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/24—Hygienic packaging for medical sensors; Maintaining apparatus for sensor hygiene
    • A61B2562/247—Hygienic covers, i.e. for covering the sensor or apparatus during use

Definitions

  • the present application relates to the technical field of medical devices, for example, to a transdermal analyte sensor system and usage method.
  • the course of the disease is long and the disease is protracted. It is necessary to monitor certain physiological parameters of the host in real time to better track the treatment. For example, diabetes requires real-time monitoring of the host's blood sugar. Accurate self-monitoring of blood sugar is the key to achieving good blood sugar control. It is helpful to assess the degree of glucose metabolism disorder in diabetic patients, formulate a hypoglycemic plan, reflect the effect of hypoglycemic treatment and guide the adjustment of the treatment plan.
  • blood glucose meters are the most widely used on the market. Patients need to collect blood from the tip of their fingers to measure the blood sugar level at that moment.
  • this method has the following defects: 1. It is impossible to know the change of blood sugar level between two measurements, and the patient may miss the peak and valley of blood sugar, which may cause some complications and cause irreversible damage to the patient; In order to overcome the above defects, it is necessary to provide a method that can continuously monitor the blood sugar of patients, so that patients can know their blood sugar status in real time, and take timely countermeasures accordingly, so as to effectively control the disease, prevent complications, and obtain a higher quality of life.
  • a monitoring technology that can be implanted into the subcutaneous tissue for continuous monitoring of subcutaneous blood sugar.
  • This technology penetrates a sensor electrode into the subcutaneous tissue.
  • the sensor electrode undergoes an oxidation reaction between the interstitial fluid of the patient and the glucose in the body. During the reaction, an electrical signal is formed.
  • the electrical signal is converted into blood sugar readings through the transmitter, and the blood sugar readings are transmitted to the wireless receiver every 1 to 5 minutes.
  • the sensor electrodes and puncture needles are required to be sterile when inserted into the subcutaneous tissue.
  • Some continuous blood glucose monitoring systems use a separate sterilization process to sterilize the sensor electrodes and electronic components.
  • radiation sterilization can be used. Since radiation sterilization will harm the electronic components associated with the sensor electrodes, for example, ethylene oxide is usually used to sterilize the electronic components. However, ethylene oxide can damage the chemicals on the sensor electrodes, so integrating the sensor electrodes and electronics into a single unit complicates the sterilization process.
  • the components can be separated into a sensor unit (containing the sensor electrodes) and a transmitter unit (containing the electronics), so that each component can be packaged and sterilized individually using appropriate sterilization methods.
  • the sensor unit can be stored in a cap after being sterilized, and an aseptic cavity for accommodating the sensor electrodes is formed between the cap and the sensor unit, and the cap and the sensor unit can be assembled or separated by turning the cap, which causes the cap to be mishandled so that the cap and the sensor unit are separated before official use, destroying the aseptic environment of the sensor unit and making the sensor unit unusable.
  • the present application provides a transdermal analyte sensor system and a usage method.
  • the present application provides a transdermal analyte sensor system, including an implanter assembly and a sterilizing assembly, the sterilizing assembly includes a sensor electrode and a cap, a sealed sterilizing cavity is formed in the cap, the body part of the sensor electrode is configured in the sterilizing cavity, and the cap is allowed to separate from the sensor electrode only when the sterilizing assembly is coupled to the implanter assembly so that the sensor electrode leaves the sterilizing cavity.
  • the present application also provides a method of using a transdermal analyte sensor system comprising allowing the cap to be separated from the sensor electrode so that the sensor electrode exits the sterile cavity only when the sterile assembly is coupled to the implanter assembly.
  • Fig. 1 is a schematic diagram of a continuous blood glucose monitoring system according to an embodiment of the present application.
  • Fig. 2 is a schematic structural diagram of a continuous blood glucose monitoring system according to an embodiment of the present application.
  • Fig. 3 is a schematic structural diagram of the sterilization assembly in the initial state of the installation of the holding part according to the embodiment of the present application.
  • Fig. 4 is a schematic structural diagram of the sterilization assembly in the completed state of installation of the holding part according to the embodiment of the present application.
  • Fig. 5 is a schematic cross-sectional view of the installation of the sterilization assembly to the implanter assembly according to the embodiment of the present application.
  • Fig. 6 is a schematic diagram of the limiting protrusion not fitted into the limiting groove according to the embodiment of the present application.
  • Fig. 7 is a schematic diagram of the position-limiting projection of the embodiment of the present application starting to be inserted into the position-limiting groove.
  • Fig. 8 is a schematic diagram of the limiting protrusion fully fitted into the limiting groove according to the embodiment of the present application.
  • CGM Continuous Glucose Monitoring
  • FIG. 1 is a schematic diagram of a continuous blood glucose monitoring system attached to a host 100 .
  • the figure shows a continuous blood glucose monitoring system comprising a body surface attachment unit 200 with sensor electrodes 210 attached to the skin surface of a host 100 through an adhesive layer.
  • the body surface attachment unit 200 has a built-in circuit module electrically connected to the sensor electrode 210, through which the glucose concentration information monitored by the sensor electrode 210 is sent to the receiver 300.
  • the receiver 300 can usually be a smart phone, a smart watch, a dedicated device and the like.
  • the sensor electrode 210 is partially located under the skin of the host 100, in contact with the subcutaneous tissue fluid.
  • the sensor electrode 210 includes an internal part and an external part, wherein the internal part refers to the part that is implanted under the skin of the host 100 and contacts the subcutaneous tissue fluid, and the external part refers to the part left outside the skin of the host 100 .
  • the extracorporeal part of the sensor electrode 210 protrudes into the body surface attachment unit 200 and is attached to the circuit module to establish an electrical connection with the circuit module.
  • FIG. 2 is a schematic structural diagram of a continuous blood glucose monitoring system, including an implanter assembly 400 and a sterilization assembly 500.
  • the implanter assembly 400 and the sterilization assembly 500 are placed in two separate packages after being sterilized.
  • the sterilization assembly 500 includes a cap 510 and a body surface attachment unit 200 with sensor electrodes 210 disposed in the cap 510.
  • the cap 510 When in use, open the two packages respectively, and only when the sterilizing component 500 is installed on the implanter component 400, allow the cap 510 to be removed from the implanter component 400 by turning the cap 510 of the sterilizing component 500, so that the cap 510 is separated from the sensor electrode 210, thereby exposing the sensor electrode 210, and then attach the end with the opening of the implanter component 400 to the skin surface of the host 100, and apply the body surface attachment unit 200 by operating the implanter component 400 Attached to the skin surface of the host 100, at this time, the body part of the sensor electrode 210 is implanted under the skin of the host 100 and is in contact with the subcutaneous tissue fluid to continuously monitor the glucose concentration in the tissue fluid. After the application of the body surface attachment unit 200 is completed, the implanter assembly 400 is removed, and only the body surface attachment unit 200 is placed on the skin surface of the host 100.
  • the present application selects the method of rotating the cap 510 along the first direction as the optimal solution to realize the separation of the cap 510 from the sensor electrode 210, but it does not take this as a limitation to the solution of realizing the separation of the cap 510 from the sensor electrode 210, and the solution of realizing the separation of the cap 510 from the sensor electrode 210 in other ways should be considered
  • the solution is an approximate solution to the above optimal solution and is included in the protection scope of the present application.
  • the cap 510 can be separated from the sensor electrode 210 by plugging and unplugging, and the plugging and unplugging direction can be along the axial or radial direction of the sterilization assembly 500 or at a certain angle to the axial direction.
  • the adhesive layer can be, for example, a medical non-woven adhesive tape.
  • the present application provides a transdermal analyte sensor system taking the above-mentioned continuous blood glucose monitoring system as an example, for example, a new sterilization assembly 500 structure is provided to improve the removal method of the cap 510.
  • the sterilization assembly 500 allows the cap 510 to be separated from the sensor electrode 210 in a rotational manner along the first direction only when it is coupled to the implanter assembly 400.
  • the first direction may be clockwise.
  • the sterilization assembly 500 includes a cap 510, a body surface attachment unit 200 disposed in the cap 510, a sensor electrode 210 attached to the body surface attachment unit 200, and a holding portion 520 disposed in the cap 510.
  • a first locking portion 530 is formed between the holding portion 520 and the cap 510, and the first locking portion 530 includes two working states of a locked state and a released state.
  • the first locking part 530 When the first locking part 530 is in the locked state, the first locking part 530 is configured to prevent the cap 510 from rotating relative to the holding part 520 along the first direction; when the first locking part 530 is in the released state, the first locking part 530 is configured to allow the cap 510 to rotate along the first direction.
  • the first locking part 530 includes a first locking member 531 arranged on the holding part 520 and a second locking member 532 arranged on the cap 510 , and the first locking member 531 and the second locking member 532 are locked together.
  • first locking member 531 is located radially inside the second locking member 532 ; in another embodiment, the first locking member 531 is located radially outside the second locking member 532 .
  • the cooperation between the first locking member 531 and the second locking member 532 is that a step 533 is formed on the second locking member 532.
  • the step 533 on the second locking member 532 will move along the second direction from the base 534 of the first locking member 531 to the free end 535 of the first locking member 531 along with the rotation of the cap 510, so that the first locking member The free end 535 of the 531 abuts against the step 533 , at this time, the installation of the holding part 520 is completed, and the first locking member 531 is locked with the second locking member 532 .
  • FIG. 3 shows a schematic diagram of an initial installation state of the holding part 520
  • FIG. 4 shows a schematic diagram of a completed installation state of the holding part 520 .
  • the second direction may be a counterclockwise direction.
  • the first locking member 531 adopts a sheet-shaped elastic plastic part, and its free end 535 has an elastic tendency to expand towards the second locking member 532 .
  • the free end 535 of the first locking member 531 moves into the step 533 from the end of the second locking member 532 away from the step 533 along the first direction.
  • the second locking member 532 is an arc-shaped rib extending along the circumferential direction, that is, a rib with the same diameter; in another embodiment, the second locking member 532 is an arc-shaped rib extending along the second direction and a radially inward direction, that is, a rib with a reduced diameter. Based on the two implementations, during the movement of the free end 535 of the first locking member 531 , the free end 535 of the first locking member 531 contacts and slides on one side surface of the arc rib.
  • a release member 410 for releasing the first locking portion 530 is formed on the implanter assembly 400 , and the implanter assembly 400 includes an implanter shell and internal components disposed in the implanter shell.
  • the release member 410 is configured on the implant housing; in another embodiment, the release member 410 is configured on the inner member.
  • the surface of the release member 410 facing the first locking member 531 can be a guide slope. By setting the guide slope, it is beneficial for the first locking member 531 to be pushed away by the release member 410 in a linear manner during the process of installing the sterilization assembly 500 to the implanter assembly 400, thereby improving the smoothness of the process of installing the sterilization assembly 500 to the implanter assembly 400.
  • the release member 410 may be a block or a pin or a pin, and its shape is not limited.
  • the cap 510 is coupled to the implanter assembly 400 through the retaining portion 520.
  • the retaining portion 520 is formed with several hooks extending toward the implanter assembly 400, and the implant shell or the internal components of the implanter are formed with holes corresponding to the hooks.
  • a second locking portion 540 is formed between the body surface attachment unit 200 and the holding portion 520 , and the second locking portion 540 is configured to prevent the holding portion 520 from moving relative to the body surface along the first or second direction.
  • the body surface attaching unit 200 rotates.
  • the second locking part 540 includes several bayonet sockets 541 distributed on the edge of the body surface attachment unit 200 in the circumferential direction and bayonet blocks 542 corresponding to the bayonet sockets 541 distributed on the holding part 520 .
  • the main part of the holding part 520 may be a ring-shaped member, but not limited to a ring shape.
  • the ring member On the basis of the ring member, other structures can be added, such as the locking block 542 and the first locking member 531, but not limited thereto.
  • the holding part 520 can be locked with the cap 510 .
  • the holding part 520 can be coupled with the implanter assembly 400 .
  • the retaining portion 520 has been unlocked from the cap 510 .
  • the cap 510 and retaining portion 520 are unlocked, the cap 510 can be removed and the retaining portion 520 remains coupled to the implanter assembly 400 .
  • the locking block 542 is a structure of the holding part 520 , and when the bayonet opening 541 and the locking block 542 are locked together, the holding part 520 can realize the fixing of the body surface attachment unit 200 .
  • the sterilization assembly 500 further includes a needle assembly 550.
  • the needle assembly 550 includes a needle base 551 and a puncture needle 552 attached to the needle base 551.
  • a third locking portion 560 is formed between the needle base 551 and the body surface attachment unit 200.
  • the third locking portion 560 is configured to prevent the needle base 551 from rotating relative to the body surface attachment unit 200 along the first or second direction.
  • the third locking part 560 includes a special-shaped waist 561 formed on the needle base 551 and a boss 562 with a special-shaped hole formed on the body surface attachment unit 200. When the needle assembly 550 is installed on the body surface attachment unit 200, the special-shaped waist 561 is embedded in the special-shaped hole of the boss 562 and locked with the special-shaped hole.
  • a fourth locking portion 570 is formed between the cap 510 and the needle assembly 550, and the fourth locking portion 570 is configured to prevent the cap 510 from rotating relative to the needle hub 551 along the second direction and prevent the cap 510 from moving away from the needle hub 551.
  • the state of the fourth locking portion 570 is closely related to the state of the first locking portion 530 .
  • the fourth locking part 570 is also in the locked state; when the first locking part 530 is in the released state, it is allowed to switch the fourth locking part 570 to the released state. That is, releasing the first locking portion 530 is a prerequisite for releasing the fourth locking portion 570 .
  • the fourth locking part 570 includes a third locking member 571 arranged on the needle hub 551 and a fourth locking member 572 arranged on the cap 510 , and the third locking member 571 and the fourth locking member 572 are locked together.
  • a sleeve 580 defining a sterilization cavity is formed inside the cap 510.
  • the sleeve 580 and the needle seat 551 jointly define a sealed sterilization cavity.
  • the puncture needle 552 and the sensor electrode 210 are sterilized together.
  • a sealing member can be arranged between the sleeve 580 and the needle hub 551 , for example, a rubber sealing ring can be configured on the needle hub 551 , or a rubber sealing ring can be configured at the end of the sleeve 580 .
  • the third locking member 571 and the fourth locking member 572 are matched in such a way that the third locking member 571 includes at least two limiting grooves 5711 arranged on the outer surface of the needle hub 551, the fourth locking member 572 includes a limiting protrusion 5721 corresponding to the limiting groove 5711 arranged at the end of the sleeve 580, and the limiting protrusion 5721 is positioned in cooperation with the limiting groove 5711; the opening of the limiting groove 5711 towards the first direction.
  • the limiting grooves 5711 are distributed on the outer surface of the needle holder 551 at equal intervals along the circumference, and in order to save costs, two limiting grooves 5711 and two limiting protrusions 5721 are selected.
  • a guide groove 573 is provided at the opening of the limiting groove 5711.
  • the guiding groove 573 communicates with the limiting groove 5711 through the opening of the limiting groove 5711 and is perpendicular to the limiting groove 5711.
  • the sterilization assembly 500 when assembling the sterilization assembly 500 , it may be implemented in the order of first installing the body surface attachment unit 200 , then installing the needle assembly 550 , and finally installing the holding part 520 .
  • the extracorporeal part of the sensor electrode 210 is attached into the body surface attaching unit 200 first, and then the body surface attaching unit 200 is installed into the cap 510 .
  • the shaped waist 561 of the needle holder 551 is inserted into the shaped hole of the body surface attachment unit 200, and the puncture needle 552 protrudes from the lower surface of the body surface attachment unit 200 together with the sensor electrode 210 after passing through the shaped hole.
  • the puncture needle 552 protrudes from the lower surface of the body surface attachment unit 200 together with the sensor electrode 210 after passing through the shaped hole.
  • the first locking part 530 , the second locking part 540 , the third locking part 560 and the fourth locking part 570 of the present application cooperate with each other.
  • the release of the first locking part 530 serves as a prerequisite for the release of the fourth locking part 570, so that the first locking part 530 can only be released when the sterilization assembly 500 is mounted on the implanter assembly 400. It is enough to turn the cap 510 in the first direction to release the fourth locking part 570 .
  • the second locking part 540 ensures that the body surface attachment unit 200 and the holding part 520 are relatively stationary when the cap 510 is turned, and the third locking part 560 ensures that the body surface attachment unit 200 and the needle hub 551 are relatively stationary when the cap 510 is turned.
  • the cooperation of the second locking part 540 and the third locking part 560 enables the holding part 520, the body surface attachment unit 200 and the needle hub 551 to be in a relatively stationary state when the cap 510 is turned, which ensures that the assembly is sterilized Turning the cap 510 along the second direction when the assembly 500 makes the first locking part 530 and the second locking part 540 reach the locked state at the same time.
  • This application can effectively prevent the sensor electrode 210 and the puncture needle 552 from being exposed due to the separation of the cap 510 and the needle seat 551 (that is, the sensor electrode 210) due to manual operation before the product is officially used, and prevent the sensor electrode 210 and the puncture needle 552 from being contaminated by bacteria and cannot be used normally.
  • the present application can realize that the cap and the sensor electrode can be separated by rotation only when the sterilized component is coupled to the implanter component, thereby avoiding the separation of the cap and the sensor electrode by rotation before official use, and ensuring that the sensor electrode is in a sterile environment before official use.

Landscapes

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

Abstract

一种经皮分析物传感器系统及使用方法，系统包括植入器组件（400）和灭菌组件（500），灭菌组件（500）包括传感器电极（210）和帽（510），帽（510）内形成有密封的灭菌腔体，传感器电极（210）的体内部分被配置在灭菌腔体中，仅在灭菌组件（500）耦合到植入器组件（400）上时允许帽（510）与传感器电极（210）分离以使得传感器电极（210）离开灭菌腔体。

Description

经皮分析物传感器系统及使用方法
本申请要求在2022年01月20日提交中国专利局、申请号为202210066360.6的中国专利申请的优先权，以上申请的全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，例如涉及一种经皮分析物传感器系统及使用方法。
背景技术
一些生理性的疾病，病程长且病情迁延不愈，需要实时地对宿主的某些生理参数进行监测，以能更好地跟踪治疗。比如糖尿病，需要对宿主血糖进行实时的监测。准确的血糖自我监测，是实现良好血糖控制的关键，有助于评估糖尿病患者糖代谢紊乱的程度，制定降糖方案，同时反映降糖治疗效果并指导对治疗方案的调整。
目前，市面上使用最多的是指血血糖仪，患者需要自行采集手指末梢血来测量该时刻的血糖水平。但这种方法存在以下缺陷：一、无法获知两次测量之间的血糖水平变化情况，患者可能会遗漏血糖峰值和谷值，从而引起一些并发症，对患者造成不可逆的伤害；二、每日多次的指尖穿刺采血，给糖尿病患者造成了很大的痛楚。为克服上述缺陷，需要提供一种能够进行连续监测患者血糖的方法，方便患者实时了解自己的血糖状况，并据此及时采取应对措施，从而有效地控制病情，防止并发症，以获得较高的生活质量。
针对上述需求，技术人员开发了可以植入皮下组织进行持续监测皮下血糖的监测技术，该技术通过在皮下组织刺入一个传感器电极，传感器电极在患者的组织间液与体内葡萄糖发生氧化反应，反应时会形成电信号，通过发射器将电信号转换为血糖读数，并每隔1～5分钟将血糖读数传输到无线接收器上，在无线接收器上显示相应的血糖数据以及形成图谱，供患者及医生参考。
传感器电极和穿刺针在插入皮下组织时要求是无菌的，一些连续血糖监测系统采用单独的灭菌过程以对传感器电极和电子部件进行灭菌，例如可以采用辐射灭菌，由于辐射灭菌会危害与传感器电极相关联的电子部件，因此，通常使用例如环氧乙烷给电子部件灭菌。然而，环氧乙烷会损坏传感器电极上的化学物质，因此，将传感器电极和电子部件集成到一个单元中会使灭菌过程复杂化。
通过将部件分离成传感器单元(包含传感器电极)和发射器单元(包含电子部件)可以绕过这些问题，使得可以使用适当的灭菌方法对每个部件单独地进行包装和灭菌。例如，传感器单元经灭菌后可以被收纳在一帽中，帽与传感器单元之间形成有用于容纳传感器电极的无菌腔体，通过转动帽能够实现帽与传感器单元的装配或分离，这就导致帽会被误操作而使得帽与传感器单元在正式使用前就被分离，破坏了传感器单元的无菌环境，使得传感器单元无法被使用。
发明内容
本申请提供一种经皮分析物传感器系统及使用方法。
本申请提供一种经皮分析物传感器系统，包括植入器组件和灭菌组件，所述灭菌组件包括传感器电极和帽，所述帽内形成有密封的灭菌腔体，所述传感器电极的体内部分被配置在灭菌腔体中，仅在所述灭菌组件耦合到植入器组件上时允许帽与传感器电极分离以使得传感器电极离开灭菌腔体。
本申请还提供一种经皮分析物传感器系统的使用方法，包括仅在所述灭菌组件耦合到植入器组件上时允许将帽与传感器电极分离以使得传感器电极离开灭菌腔体。
附图说明
图1是本申请实施例的连续血糖监测系统的示意图。
图2是本申请实施例的连续血糖监测系统的结构示意图。
图3是本申请实施例的保持部安装的初始状态的灭菌组件结构示意图。
图4是本申请实施例的保持部安装的完成状态的灭菌组件结构示意图。
图5是本申请实施例的灭菌组件安装到植入器组件的剖面示意图。
图6是本申请实施例的限位凸起未装入限位槽的示意图。
图7是本申请实施例的限位凸起开始装入限位槽的示意图。
图8是本申请实施例的限位凸起完全装入限位槽的示意图。
其中：100、宿主；200、体表附接单元；210、传感器电极；300、接收器；400、植入器组件；410、释放构件；500、灭菌组件；510、帽；520、保持部；530、第一锁定部；531、第一锁定构件；532、第二锁定构件；533、台阶；534、基部；535、自由端；540、第二锁定部；541、卡口；542、卡块；550、针组件；551、针座；552、穿刺针；560、第三锁定部；561、异形腰部；562、凸台；570、 第四锁定部；571、第三锁定构件；5711、限位槽；572、第四锁定构件；5721、限位凸起；573、导向槽；580、套管。
具体实施方式
以下描述和例子说明了所公开的申请的一些示例性实施例。本领域技术人员将认识到，本申请实施例可存在许多变化和修改。
连续血糖监测(CGM，Continuous Glucose Monitoring)系统
请参见图1所示，是附接到宿主100上的连续血糖监测系统的示意图。图中示出了包括带有传感器电极210的体表附接单元200的连续血糖监测系统，其通过粘合剂层附接到宿主100的皮肤表面。体表附接单元200内置电性连接到传感器电极210的电路模块，通过电路模块将传感器电极210监测到的葡萄糖浓度信息发送到接收器300，接收器300通常可以为智能电话、智能手表、专用设备和类似物。在使用过程中，传感器电极210部分位于宿主100皮肤的下方，与皮下组织液接触。
传感器电极210包括体内部分和体外部分，其中，体内部分指的是被植入到宿主100皮下与皮下组织液接触的部分，体外部分指的是留置在宿主100皮肤以外的部分。在一种实施方式中，传感器电极210的体外部分伸入体表附接单元200内并附接到电路模块上，以与电路模块建立电性连接。
请参见图2所示，是连续血糖监测系统的结构示意图，包括植入器组件400和灭菌组件500，植入器组件400和灭菌组件500在经过灭菌之后被分别放在两个独立的包装中，灭菌组件500包括帽510和配置在帽510中的带有传感器电极210的体表附接单元200。在使用时，分别打开两个包装，仅在将灭菌组件500安装到植入器组件400上时，允许通过转动灭菌组件500的帽510，将帽510从植入器组件400上移除，使得帽510与传感器电极210分离，从而露出传感器电极210，再将植入器组件400的带有开口的端部贴合到宿主100皮肤表面，通过操作植入器组件400将体表附接单元200敷贴到宿主100皮肤表面，此时，传感器电极210的体内部分被植入宿主100皮下并与皮下组织液接触以持续监测组织液中的葡萄糖浓度，完成体表附接单元200的敷贴操作之后，取下植入器组件400，仅将体表附接单元200留置在宿主100皮肤表面即可。
本申请选择沿着第一方向转动帽510的方式作为实现帽510与传感器电极210分离的最优方案，但是并不会以此作为对实现帽510与传感器电极210分离的方案的限制，以其他方式实现帽510与传感器电极210分离的方案应当被理 解为上述最优方案的近似方案并被包含在本申请的保护范围之内。例如，还可以采用插拔的方式实现帽510与传感器电极210的分离，插拔的方向可以为沿灭菌组件500的轴向或径向或与轴向呈一定角度的方向。
粘合剂层例如可为医用无纺胶布。
请参见图3所示，本申请提供一种以上述连续血糖监测系统为例的经皮分析物传感器系统，例如提供一种对帽510的移除方式进行改进的新的灭菌组件500结构，该灭菌组件500仅在耦合到植入器组件400上时允许帽510沿着第一方向以转动的方式与传感器电极210分离。在一种实施方式中，第一方向可以为顺时针方向。
请继续参见图3和图5所示，灭菌组件500包括帽510、配置在帽510中的体表附接单元200、附接到体表附接单元200上的传感器电极210以及配置在帽510中的保持部520，保持部520与帽510之间形成有第一锁定部530，第一锁定部530包括锁定状态和释放状态两种工作状态。灭菌组件500未安装到植入器组件400上时，第一锁定部530处于锁定状态；灭菌组件500安装到植入器组件400上时，第一锁定部530处于释放状态。当第一锁定部530处于锁定状态时，第一锁定部530被配置为阻止帽510沿着第一方向相对于保持部520转动；当第一锁定部530处于释放状态时，第一锁定部530被配置为允许帽510沿着第一方向转动。
请继续参见图3所示，第一锁定部530包括配置在保持部520上的第一锁定构件531和配置在帽510上的第二锁定构件532，第一锁定构件531与第二锁定构件532配合锁定。
在一种实施方式中，第一锁定构件531位于第二锁定构件532的径向内侧；在另一种实施方式中，第一锁定构件531位于第二锁定构件532的径向外侧。
在一种实施方式中，第一锁定构件531与第二锁定构件532的配合方式为，第二锁定构件532上形成有台阶533，在将保持部520安装到帽510上时，通过沿着第二方向转动帽510，第二锁定构件532上的台阶533会跟随帽510的转动一起沿着第二方向从第一锁定构件531的基部534移动至第一锁定构件531的自由端535，使得第一锁定构件531的自由端535抵接在台阶533中，此时，完成保持部520的安装，第一锁定构件531与第二锁定构件532配合锁定。图3给出了保持部520安装的初始状态的示意，图4给出了保持部520安装的完成状态的示意。在一种实施方式中，第二方向可以为逆时针方向。
在一种实施方式中，第一锁定构件531采用片状的弹性塑料件，其自由端 535具有朝向第二锁定构件532张开的弹性趋势。例如，在第二锁定构件532上的台阶533沿着第二方向从第一锁定构件531的基部534移动至第一锁定构件531的自由端535的过程中，相对地，第一锁定构件531的自由端535会沿着第一方向从第二锁定构件532的远离台阶533的一端移动至台阶533中，在第一锁定构件531的自由端535的移动过程中，第二锁定构件532会提供沿径向推动第一锁定构件531的自由端535的力，在第一锁定构件531的自由端535移动到台阶533处时，第一锁定构件531的自由端535的弹性趋势会克服该力从而使第一锁定构件531的自由端535抵接在台阶533中。
在一种实施方式中，第二锁定构件532为沿周向延伸布置的弧形筋条，即同径筋条；在另一种实施方式中，第二锁定构件532为同时沿着第二方向和径向向内方向延伸布置的弧形筋条，即变径筋条。基于该两种实施方式，在第一锁定构件531的自由端535的移动过程中，第一锁定构件531的自由端535接触弧形筋条的一侧表面并在该表面上滑动。
请参见图5所示，植入器组件400上形成有用于释放第一锁定部530的释放构件410，植入器组件400包括植入器外壳和配置在植入器外壳内的内部构件。在一种实施方式中，释放构件410配置在植入器外壳上；在另一种实施方式中，释放构件410配置在内部构件上。当灭菌组件500安装到植入器组件400上时，释放构件410驱动第一锁定构件531远离第二锁定构件532，使得第一锁定构件531与第二锁定构件532错开，从而使得第一锁定构件531的自由端535脱离台阶533，此时，第一锁定部530处于释放状态，允许帽510沿着第一方向转动。释放构件410上面向第一锁定构件531的面可以为一导向斜面，通过设置导向斜面，有利于在将灭菌组件500安装到植入器组件400的过程中第一锁定构件531被释放构件410以线性的方式推开，提高灭菌组件500安装到植入器组件400的过程的顺畅性。
释放构件410可以是一个块或栓或销，其形状不限制。
请继续参见图5所示，帽510通过保持部520耦接到植入器组件400上，例如，保持部520上形成有若干个朝向植入器组件400延伸出的钩部，植入器外壳或者植入器的内部构件上形成有对应钩部的孔，当灭菌组件500安装到植入器组件400上时，钩部穿过孔并钩住孔的边缘，从而将保持部520耦接到植入器组件400上。
请继续参见图3所示，体表附接单元200与保持部520之间形成有第二锁定部540，第二锁定部540被配置为阻止保持部520沿着第一或第二方向相对于 体表附接单元200转动。在一种实施方式中，第二锁定部540包括沿周向分布在体表附接单元200边缘的若干个卡口541和分布在保持部520上的对应卡口541的卡块542，当保持部520安装到帽510上时，卡块542嵌入卡口541中并与卡口541配合锁定。
在一实施例中，就保持部520而言，保持部520的主体部分可以是一个环状构件，但不限于环状。在环状构件的基础上可以增设其他结构，如卡块542、第一锁定构件531，但不限于此。
通过保持部520可达成以下状态：(1)保持部520可以和帽510锁定在一起。(2)保持部520可以和植入器组件400耦接。在保持部520和植入器组件400耦接时，保持部520已经与帽510解锁。在帽510和保持部520解锁时，帽510可以移除，保持部520保持与植入器组件400的耦接状态。(3)卡块542是保持部520的一个结构，在卡口541和卡块542配合锁定时，保持部520可以实现对体表附接单元200的固定。
请继续参见图3和图5所示，灭菌组件500还包括针组件550，针组件550包括针座551和附接到针座551上的穿刺针552，针座551与体表附接单元200之间形成有第三锁定部560，第三锁定部560被配置为阻止针座551沿着第一或第二方向相对于体表附接单元200转动。在一种实施方式中，第三锁定部560包括形成于针座551上的异形腰部561和形成于体表附接单元200上的带有异形孔的凸台562，针组件550安装到体表附接单元200上时，异形腰部561嵌入到凸台562的异形孔中并与异形孔配合锁定。
请参见图6所示，帽510与针组件550之间形成有第四锁定部570，第四锁定部570被配置为阻止帽510沿着第二方向相对于针座551转动以及阻止帽510沿着远离针座551的方向移动。第四锁定部570的状态与第一锁定部530的状态密切相关。当第一锁定部530处于锁定状态时，第四锁定部570也处于锁定状态；当第一锁定部530处于释放状态时，允许将第四锁定部570转换到释放状态。即释放第一锁定部530是释放第四锁定部570的前提。
请继续参见图6所示，第四锁定部570包括配置在针座551上的第三锁定构件571和配置在帽510上的第四锁定构件572，第三锁定构件571和第四锁定构件572配合锁定。
帽510内形成有限定灭菌腔体的套管580，当第三锁定构件571和第四锁定构件572配合锁定时，套管580和针座551共同限定了密封的灭菌腔体，穿刺针552套接在传感器电极210的体内部分上并与传感器电极210的体内部分一 起被配置在灭菌腔体中，使得穿刺针552与传感器电极210一起经过灭菌处理。为提升灭菌腔体的密封性，可以在套管580和针座551之间配置密封构件，例如，可以在针座551上配置橡胶密封圈，也可以在套管580的端部配置橡胶密封圈。
请继续参见图6所示，在一种实施方式中，第三锁定构件571与第四锁定构件572的配合方式为，第三锁定构件571包括至少两个配置在针座551的外表面上的限位槽5711，第四锁定构件572包括配置在套管580端部的对应限位槽5711的限位凸起5721，限位凸起5721与限位槽5711配合定位；限位槽5711的开口朝向第一方向。例如，限位槽5711沿周向等间隔分布在针座551的外表面上，为节省成本，限位槽5711和限位凸起5721都选用两个。
为方便针座551与帽510的组装，在限位槽5711的开口处还设置有导向槽573，例如，导向槽573经限位槽5711的开口与限位槽5711连通并垂直于限位槽5711，导向槽573的开口朝向帽510。
例如，组装灭菌组件500时，可以按照先安装体表附接单元200、再安装针组件550、最后安装保持部520的顺序来实现。
在安装体表附接单元200时，先将传感器电极210的体外部分附接到体表附接单元200中，然后将体表附接单元200安装到帽510中。
在安装针组件550时，将针座551的异形腰部561嵌入到体表附接单元200的异形孔，穿刺针552穿过异形孔之后和传感器电极210一起从体表附接单元200的下表面伸出，此时，参见图7所示，将套管580上的限位凸起5721对准导向槽573并沿着轴向移动帽510至限位凸起5721到达导向槽573与限位槽5711的转接处。
在安装保持部520时，请继续参见图3所示，将保持部520上的卡块542对准体表附接单元200上的卡口541安装到帽510中；然后，请继续参见图4所示，沿着第二方向转动帽510至第一锁定构件531的自由端535抵接在第二锁定构件532的台阶533中；在沿着第二方向转动帽510的过程中，请参见图8所示，限位凸起5721从导向槽573与限位槽5711的转接处移动至限位槽5711的封闭，并且在第一锁定构件531的自由端535抵接在第二锁定构件532的台阶533中的同时限位凸起5721到达限位槽5711的封闭端。
本申请的第一锁定部530、第二锁定部540、第三锁定部560和第四锁定部570彼此相互配合。第一锁定部530的释放作为第四锁定部570的释放的前提，从而仅在将灭菌组件500安装到植入器组件400上释放第一锁定部530时才能 够沿着第一方向转动帽510以释放第四锁定部570。第二锁定部540确保在转动帽510时体表附接单元200与保持部520相对静止，第三锁定部560确保在转动帽510时体表附接单元200与针座551相对静止，综合而言，第二锁定部540与第三锁定部560的配合实现了在转动帽510时保持部520、体表附接单元200和针座551均处于相对静止状态，这就确保在组装灭菌组件500时沿第二方向转动帽510使得第一锁定部530与第二锁定部540同时到达锁定状态。
本申请能够有效防止在产品正式使用前因人为操作使得帽510与针座551(亦即传感器电极210)分离而导致传感器电极210和穿刺针552裸露在外，防止传感器电极210和穿刺针552受细菌污染而无法正常使用。
本申请中所涉及的体表附接单元200以及体表附接单元200与针组件550的安装结构在中国发明专利202111426719.8中已作了详尽的披露，因此，在本申请中不作赘述。
本申请能够实现仅在将灭菌组件耦接到植入器组件上时允许以转动的方式将帽与传感器电极分离，从而能够避免在正式使用前以转动的方式分离帽与传感器电极，确保传感器电极在正式使用前均处于无菌环境。
上述说明以这样完全、清楚、简明且准确的措辞提供了实施本申请所能想到的最佳模式，以及制造和使用的方式和过程，以便使得本领域任何技术人员制造和使用本申请。然而，本申请易于做出对上述说明进行完全等同的修改和替换构造。因此，本申请并不限于所公开的实施例。相反，在大致由以下的权利要求表述的本申请的精神和范围内，本申请覆盖所有的修改和替换构造，以下的权利要求特别指出且区分地限定了本申请的主题。虽然在附图和前面的说明中对本申请进行了图示和描述，但此类图示和描述应视为示例性的，而不是限制性的。
除非另外限定，否则所有的术语(包括技术和科学术语)取其对于本领域技术人员而言普通且习惯的意义，并且并不用来限制特定或专门的意义，除非在本文中明确地限定。应该指出的是，当描述公开的某些特征或方面时使用特定术语不应当暗指该术语在本文中被重新定义而被限制为包括与该术语相关的任何公开的特定特征或方面。本申请中所用的术语和短语及其变型，尤其在所附的权利要求中，除非另外明确表明，否则应当构成为开放式的而非限制性的。作为前述的例子，术语“包括”应当指的是“包括但不限于”或类似意义。
此外，尽管为了简明和理解的目的已经借助于图示和例子描述了前述内容，但是对于本领域技术人员而言明显的是，可以实施某些变化和改变。因此，描 述和例子不应当看作是将本申请的范围限制为本文所述的特定的实施例和例子，而是还涵盖符合本申请的真实范围和精神的所有修改和替代形式。

Claims (23)

  1. 一种经皮分析物传感器系统，包括植入器组件(400)和灭菌组件(500)，所述灭菌组件(500)包括传感器电极(210)和帽(510)，所述帽(510)内形成有密封的灭菌腔体，所述传感器电极(210)的体内部分被配置在灭菌腔体中，其中：仅在所述灭菌组件(500)耦合到植入器组件(400)上时允许帽(510)与传感器电极(210)分离以使得传感器电极(210)离开灭菌腔体。
  2. 根据权利要求1所述的经皮分析物传感器系统，其中：所述帽(510)被配置为沿着第一方向以转动的方式与传感器电极(210)分离。
  3. 根据权利要求2所述的经皮分析物传感器系统，其中：所述灭菌组件(500)还包括保持部(520)，所述保持部(520)与帽(510)之间形成有第一锁定部(530)，所述第一锁定部(530)被配置为阻止帽(510)沿着第一方向相对于保持部(520)转动，所述第一锁定部(530)设置为在灭菌组件(500)耦合到植入器组件(400)上时被释放。
  4. 根据权利要求3所述的经皮分析物传感器系统，其中：所述第一锁定部(530)包括配置在保持部(520)上的第一锁定构件(531)和配置在帽(510)上的第二锁定构件(532)，所述第一锁定构件(531)与第二锁定构件(532)配合锁定。
  5. 根据权利要求4所述的经皮分析物传感器系统，其中：所述第一锁定构件(531)位于第二锁定构件(532)的径向内侧或径向外侧。
  6. 根据权利要求4所述的经皮分析物传感器系统，其中：所述第二锁定构件(532)上形成有台阶(533)，所述台阶(533)沿着第二方向从第一锁定构件(531)的基部(534)移动至第一锁定构件(531)的自由端(535)使得第一锁定构件(531)的自由端(535)抵接在台阶(533)中。
  7. 根据权利要求6所述的经皮分析物传感器系统，其中：所述第一锁定构件(531)的自由端(535)具有朝向第二锁定构件(532)张开的弹性趋势。
  8. 根据权利要求6所述的经皮分析物传感器系统，其中：所述第二锁定构件(532)为沿周向延伸布置的弧形筋条。
  9. 根据权利要求6所述的经皮分析物传感器系统，其中：所述第二锁定构件(532)为同时沿着第二方向和径向向内方向延伸布置的弧形筋条。
  10. 根据权利要求3所述的经皮分析物传感器系统，其中：所述植入器组件(400)上形成有用于释放第一锁定部(530)的释放构件(410)。
  11. 根据权利要求3所述的经皮分析物传感器系统，其中：所述帽(510)经保持部(520)耦接到植入器组件(400)上。
  12. 根据权利要求3所述的经皮分析物传感器系统，其中：所述灭菌组件 (500)还包括安装到帽(510)内的体表附接单元(200)，所述体表附接单元(200)与保持部(520)之间形成有第二锁定部(540)，所述第二锁定部(540)被配置为阻止保持部(520)沿着第一或第二方向相对于体表附接单元(200)转动。
  13. 根据权利要求12所述的经皮分析物传感器系统，其中：所述第二锁定部(540)包括沿周向分布在体表附接单元(200)边缘的至少一个卡口(541)和分布在保持部(520)上的对应卡口(541)的卡块(542)，所述至少一个卡口(541)与卡块(542)配合锁定。
  14. 根据权利要求12或13所述的经皮分析物传感器系统，其中：所述灭菌组件(500)还包括安装到体表附接单元(200)上的针组件(550)，所述针组件(550)包括针座(551)和附接到针座(551)上的穿刺针(552)，所述针座(551)与体表附接单元(200)之间形成有第三锁定部(560)，所述第三锁定部(560)被配置为阻止针座(551)沿着第一或第二方向相对于体表附接单元(200)转动。
  15. 根据权利要求14所述的经皮分析物传感器系统，其中：所述第三锁定部(560)包括形成于针座(551)上的异形腰部(561)和形成于体表附接单元(200)上的带有异形孔的凸台(562)，所述针组件(550)安装到体表附接单元(200)上时，所述异形腰部(561)嵌入到凸台(562)的异形孔中并与异形孔配合锁定。
  16. 根据权利要求14所述的经皮分析物传感器系统，其中：所述针座(551)与帽(510)之间形成有第四锁定部(570)，所述第四锁定部(570)被配置为阻止帽(510)沿着第二方向相对于针座(551)转动以及阻止帽(510)沿着远离针座(551)的方向移动。
  17. 根据权利要求16所述的经皮分析物传感器系统，其中：所述第四锁定部(570)包括配置在针座(551)上的第三锁定构件(571)和配置在帽(510)上的第四锁定构件(572)，所述第三锁定构件(571)和第四锁定构件(572)配合锁定。
  18. 根据权利要求17所述的经皮分析物传感器系统，其中：所述帽(510)内形成有限定灭菌腔体的套管(580)；
    所述第三锁定构件(571)包括至少两个配置在针座(551)的外表面上的限位槽(5711)，所述第四锁定构件(572)包括配置在套管(580)端部的对应限位槽(5711)的限位凸起(5721)，所述限位凸起(5721)与限位槽(5711)配合定位；
    所述限位槽(5711)的开口朝向第一方向。
  19. 根据权利要求18所述的经皮分析物传感器系统，其中：所述限位槽(5711)沿周向等间隔分布在针座(551)的外表面上。
  20. 根据权利要求14所述的经皮分析物传感器系统，其中：所述穿刺针(552) 套接在传感器电极(210)的体内部分上并与传感器电极(210)的体内部分一起被配置在灭菌腔体中。
  21. 一种经皮分析物传感器系统的使用方法，基于权利要求1～20中任一项所述的经皮分析物传感器系统实现，包括：仅在所述灭菌组件(500)耦合到植入器组件(400)上时允许将帽(510)与传感器电极(210)分离以使得传感器电极(210)离开灭菌腔体。
  22. 根据权利要求21所述的经皮分析物传感器系统的使用方法，还包括：以沿着第一方向转动所述帽(510)的方式将帽(510)与传感器电极(210)分离。
  23. 根据权利要求22所述的经皮分析物传感器系统的使用方法，还包括：在沿着第一方向转动所述帽(510)的过程中释放第四锁定部(570)。
PCT/CN2023/072589 2022-01-20 2023-01-17 经皮分析物传感器系统及使用方法 WO2023138571A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202210066360.6A CN114431855A (zh) 2022-01-20 2022-01-20 经皮分析物传感器系统及使用方法
CN202210066360.6 2022-01-20

Publications (1)

Publication Number Publication Date
WO2023138571A1 true WO2023138571A1 (zh) 2023-07-27

Family

ID=81367093

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2023/072589 WO2023138571A1 (zh) 2022-01-20 2023-01-17 经皮分析物传感器系统及使用方法

Country Status (2)

Country Link
CN (1) CN114431855A (zh)
WO (1) WO2023138571A1 (zh)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114431855A (zh) * 2022-01-20 2022-05-06 苏州百孝医疗科技有限公司 经皮分析物传感器系统及使用方法
CN114680882A (zh) * 2022-06-01 2022-07-01 苏州百孝医疗科技有限公司 分析物浓度监测系统及使用方法
CN115770306A (zh) * 2022-12-06 2023-03-10 江苏鱼跃凯立特生物科技有限公司 一种持续血糖监测器灭菌组件及灭菌方法
CN115844396A (zh) * 2022-12-06 2023-03-28 江苏鱼跃凯立特生物科技有限公司 一种在体血糖监测装置及持续血糖监测器组件

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120303043A1 (en) * 2011-02-28 2012-11-29 Abbott Diabetes Care Inc. Medical Device Inserters and Processes of Inserting and Using Medical Devices
US20170188910A1 (en) * 2015-12-30 2017-07-06 Dexcom, Inc. Transcutaneous analyte sensor systems and methods
CN109310372A (zh) * 2016-04-08 2019-02-05 美敦力泌力美公司 分析物传感器
CN111093472A (zh) * 2017-06-19 2020-05-01 德克斯康公司 施加经皮分析物传感器的施加器和相关制造方法
US20200178899A1 (en) * 2017-06-02 2020-06-11 I-Sens, Inc. Sensor applicator assembly for continuous glucose monitoring system
CN112423664A (zh) * 2018-06-07 2021-02-26 雅培糖尿病护理公司 用于分析物监测系统的聚焦灭菌和已灭菌的子组件
CN213758240U (zh) * 2019-11-05 2021-07-23 微泰医疗器械(杭州)有限公司 医疗系统
CN113827231A (zh) * 2021-11-26 2021-12-24 上海微创生命科技有限公司 用于经皮植入传感器的助针器及医疗装置
CN113842141A (zh) * 2021-11-30 2021-12-28 上海微创生命科技有限公司 植入器、针、传感器底座、发射器组件、灭菌盒及植入系统
CN114431855A (zh) * 2022-01-20 2022-05-06 苏州百孝医疗科技有限公司 经皮分析物传感器系统及使用方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4214274B2 (ja) * 2001-06-11 2009-01-28 アークレイ株式会社 穿刺要素一体装着体
EP1900321A4 (en) * 2005-06-27 2010-09-22 Nat Inst Of Advanced Ind Scien INTEGRATED BIOCAPTOR NEEDLE
US20150157405A1 (en) * 2013-12-05 2015-06-11 Biosense Webster (Israel) Ltd. Needle catheter utilizing optical spectroscopy for tumor identification and ablation
CN206729891U (zh) * 2016-10-28 2017-12-12 三诺生物传感股份有限公司 一种动态血糖仪系统及其传感器
CN113499126B (zh) * 2021-06-28 2022-07-19 苏州百孝医疗科技有限公司 植入器及植入方法

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120303043A1 (en) * 2011-02-28 2012-11-29 Abbott Diabetes Care Inc. Medical Device Inserters and Processes of Inserting and Using Medical Devices
US20170188910A1 (en) * 2015-12-30 2017-07-06 Dexcom, Inc. Transcutaneous analyte sensor systems and methods
CN109310372A (zh) * 2016-04-08 2019-02-05 美敦力泌力美公司 分析物传感器
US20200178899A1 (en) * 2017-06-02 2020-06-11 I-Sens, Inc. Sensor applicator assembly for continuous glucose monitoring system
CN111093472A (zh) * 2017-06-19 2020-05-01 德克斯康公司 施加经皮分析物传感器的施加器和相关制造方法
CN112423664A (zh) * 2018-06-07 2021-02-26 雅培糖尿病护理公司 用于分析物监测系统的聚焦灭菌和已灭菌的子组件
CN213758240U (zh) * 2019-11-05 2021-07-23 微泰医疗器械(杭州)有限公司 医疗系统
CN113827231A (zh) * 2021-11-26 2021-12-24 上海微创生命科技有限公司 用于经皮植入传感器的助针器及医疗装置
CN113842141A (zh) * 2021-11-30 2021-12-28 上海微创生命科技有限公司 植入器、针、传感器底座、发射器组件、灭菌盒及植入系统
CN114431855A (zh) * 2022-01-20 2022-05-06 苏州百孝医疗科技有限公司 经皮分析物传感器系统及使用方法

Also Published As

Publication number Publication date
CN114431855A (zh) 2022-05-06

Similar Documents

Publication Publication Date Title
WO2023138571A1 (zh) 经皮分析物传感器系统及使用方法
WO2023092912A1 (zh) 体表附接单元
CN114391838B (zh) 植入器及其使用方法
WO2023273062A1 (zh) 植入器及植入方法
WO2023273083A1 (zh) 分离式传感器电极固定结构
WO2023092914A1 (zh) 经皮分析物传感器系统
WO2023273078A1 (zh) 传感器底座的固定结构及方法
US11712514B2 (en) Cannulas for systems and methods for delivering microdoses of medication
CA3197901A1 (en) Devices for analyte monitoring
CN217090730U (zh) 灭菌组件
CN219166414U (zh) 一种持续血糖监测器
WO2023092913A1 (zh) 经皮分析物传感器系统
US20230081150A1 (en) Applicators for systems and methods for delivering microdoses of medication
AU2022310377A1 (en) Systems, devices, and methods for analyte monitoring
CN114680882A (zh) 分析物浓度监测系统及使用方法
CN114391837B (zh) 持续血糖监测系统及使用方法
CN219166415U (zh) 一种在体血糖监测装置
CN219167165U (zh) 一种持续血糖监测器灭菌组件及持续血糖监测器
CN215227657U (zh) 电极组件转移装置
CN217090725U (zh) 传感器电极的安装结构
CN215261825U (zh) 传感器底座
WO2024119564A1 (zh) 一种持续血糖监测器灭菌组件及灭菌方法
CN217219010U (zh) 预连接分析物传感器
US11857757B2 (en) Systems and methods for delivering microdoses of medication
WO2024160114A1 (zh) 生理体征检测装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 23742886

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE