WO2023092913A1 - Système de capteur d'analyte transcutané - Google Patents

Système de capteur d'analyte transcutané Download PDF

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Publication number
WO2023092913A1
WO2023092913A1 PCT/CN2022/082904 CN2022082904W WO2023092913A1 WO 2023092913 A1 WO2023092913 A1 WO 2023092913A1 CN 2022082904 W CN2022082904 W CN 2022082904W WO 2023092913 A1 WO2023092913 A1 WO 2023092913A1
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WO
WIPO (PCT)
Prior art keywords
cap
fixing
sensor system
analyte sensor
unit
Prior art date
Application number
PCT/CN2022/082904
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English (en)
Chinese (zh)
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.)
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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 WO2023092913A1 publication Critical patent/WO2023092913A1/fr

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    • 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
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/06—Accessories for medical measuring apparatus

Definitions

  • the present application relates to the technical field of medical devices, for example, to a transdermal analyte sensor system.
  • 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, so as to better track the treatment.
  • 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.
  • the blood glucose meter is the most widely used on the market. Patients need to collect blood from the tip of their finger to measure the blood sugar level at that moment. However, this method has the following defects: 1. It is impossible to know the change of blood glucose level between two measurements, and the patient may miss the peak and valley of blood glucose, which will cause some complications and cause irreversible damage to the patient; 2. Multiple fingertip punctures for blood collection have caused great pain to diabetic patients. 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 and prevent complications, so as to obtain a higher blood sugar level. Quality of Life.
  • the body surface attachment unit of the transdermal analyte sensor system which takes the continuous blood glucose monitoring technology as an example, needs to be attached to the host skin surface through an adhesive layer.
  • the release paper is covered on the adhesive layer, so the release paper needs to be peeled off from the adhesive layer before sensor electrodes are implanted.
  • the release paper is peeled off by hand directly from Since the body surface attachment unit with sensor electrodes needs to be pre-installed in the implanter before implantation, it is easy to cause body surface attachment due to improper operation when tearing off the release paper The unit fell off from the implanter, causing the sensor electrodes to be implanted incorrectly and affecting user experience.
  • the present application provides a transdermal analyte sensor system, which can prevent sensor electrodes from being implanted normally due to peeling off the release paper, thereby improving user experience.
  • a transdermal analyte sensor system comprising an implanter unit; a body surface attachment unit coupled within the implanter unit, the body surface attachment unit comprising a sensor unit configured to detect subcutaneous analyte levels of a host; and Applying the sensor unit to the adhesive layer on the surface of the skin of the host, the adhesive layer is covered with a release layer, the sensor unit includes sensor electrodes, and the implanter unit is configured to insert the a sensor electrode partially implanted under the skin of the host; and a cap coupled to the implanter unit or the sensor unit, the cap being configured to be removable before the implanter unit implants the sensor electrode , and the release layer is configured to be peeled from the adhesive layer when the cap is removed.
  • 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 diagram of an initial state of cap removal according to an embodiment of the present application.
  • FIG. 4 is a schematic diagram of a completed state of cap removal according to an embodiment of the present application.
  • Fig. 5 is a schematic diagram of a release layer arranged in a helical manner according to an embodiment of the present application.
  • Fig. 6 is an exploded view of an assembly in which the release layer is arranged in a spiral manner according to an embodiment of the present invention.
  • Fig. 7 is an assembled cross-sectional view of the release layer arranged in a spiral manner according to an embodiment of the present invention.
  • Fig. 8 is a schematic bottom view of a cap with a release layer arranged in a helical manner according to an embodiment of the present invention.
  • Fig. 9 is a schematic diagram of the arrangement of the release layer in the form of a release fan ring according to an embodiment of the present invention.
  • Fig. 10 is an exploded view of an assembly in which the release layer is arranged in the form of a release fan ring according to an embodiment of the present invention.
  • Fig. 11 is an assembly sectional view of the release layer arranged in the form of a release fan ring according to an embodiment of the present invention.
  • Fig. 12 is a schematic diagram of the bottom of the cap with the release layer arranged in the form of a release fan ring according to an embodiment of the present invention.
  • 100 host; 200, body surface attachment unit; 210, sensor electrode; 220, release layer; 221, fixed part; 222, positioning hole; 223, guide part; 224, cutting line; 225, release Fan ring; 230, sensor unit; 300, receiver; 400, implanter unit; 410, puncture needle; 500, cap; 510, fixing groove; 511, positioning block; 520, positioning plug; 530, sterilization cavity ; 531, hollow column; 532, rubber sealing ring; 540, label.
  • FIG. 1 is a schematic diagram of the continuous glucose monitoring system attached to the host 100 .
  • Fig. 2 shows that the continuous blood glucose monitoring system includes a body surface attachment unit 200 with sensor electrodes 210, and the body surface attachment unit 200 is attached to the skin surface of the 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.
  • the circuit module is configured to send the glucose concentration information monitored by the sensor electrode 210 to the receiver 300.
  • the receiver 300 can usually be a smart phone, smart watch, Special equipment and the like.
  • the sensor electrode 210 is partially located under the skin of the host 100, in contact with the subcutaneous tissue fluid.
  • FIG. 2 is a schematic structural diagram of a continuous blood glucose monitoring system, including an implanter unit 400, a body surface attachment unit 200, and a cap 500.
  • the body surface attachment unit 200 is pre-installed in the cap 500, followed by the cap 500 is installed on the implanter unit 400 together, and during use, the cap 500 is removed from the implanter unit 400 by turning the cap 500, and at the same time, the adhesive layer covering the body surface attachment unit 200
  • the release layer 220 will be peeled off together with the removal of the cap 500; then the opening side of the implanter unit 400 will be attached to the skin surface of the host 100, and the body surface in the implanter unit 400 will be removed by operating the implanter unit 400.
  • the attachment unit 200 is attached to the skin surface of the host 100.
  • the sensor electrode 210 is partially 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.
  • the adhesive layer can be medical non-woven adhesive tape.
  • the release layer 220 is a release paper or a release film, and a layer of release agent is coated on the surface.
  • the peeling method of the release layer 220 will be described in detail below.
  • the present application provides a transdermal analyte sensor system taking a continuous blood glucose monitoring system as an example, including an implanter unit 400 and a body surface attachment unit coupled in the implanter unit 400 200, the body surface attachment unit 200 includes a sensor unit 230 configured to detect the subcutaneous analyte level of the host 100 and an adhesive layer for applying the sensor unit 230 to the skin surface of the host 100, the adhesive layer is covered with a release layer 220, the sensor unit 230 includes the sensor electrode 210, the implanter unit 400 is configured to partially implant the sensor electrode 210 under the skin of the host 100, and the transcutaneous analyte sensor system further includes a device coupled to the implanter unit 400 or the sensor unit 230 The cap 500 is configured to be removable before the implanter unit 400 implants the sensor electrode 210, and the release layer 220 is peeled off from the adhesive layer while the cap 500 is removed.
  • the release layer 220 by coupling the release layer 220 to the cap 500, the release layer 220 can be peeled off when the cap 500 is removed, which is easy to operate and easy to use, and improves user experience.
  • the release layer 220 of the present application is peeled off following the removal of the cap 500, which regulates the peeling operation of the release layer 220 and avoids the body surface attachment unit 200 falling off due to improper operation when peeling off the release layer 220 by hand.
  • the effectiveness of electrode implantation is guaranteed.
  • the implanter unit 400 of the present application includes a puncture needle 410 that guides the sensor electrode 210 into the skin of the host 100.
  • the sensor electrode 210 is partially preset in the puncture needle 410 before implantation, and the puncture needle 410 is implanted in the sensor electrode 210.
  • the sensor electrode 210 is pierced into the skin of the host 100 together.
  • the action of 400 exits the skin of the host 100, at which point the sensor electrodes 210 are left on the skin of the host 100 and continuously monitor the analyte concentration. Please continue to refer to FIG.
  • the ends of the sensor electrodes 210 and puncture needles 410 extend from the side of the adhesive layer of the body surface attachment unit 200. Out, the protruding portion is implanted subcutaneously in the host 100 during implantation. Since the sensor electrode 210 is a flexible sensor electrode 210 with a diameter of 0.28 ⁇ 0.05 mm, and the puncture needle 410 is a fine needle with a diameter of 0.5 ⁇ 0.03 mm, both the sensor electrode 210 and the puncture needle 410 are easily deformed when subjected to external force, for example, tearing the needle with bare hands.
  • the release layer 220 When the release layer 220 is lowered, it is easy for the hand or the release layer 220 to touch the puncture needle 410 due to improper operation, causing the puncture needle 410 to be deformed, and then the sensor electrode 210 cannot be implanted normally, resulting in waste.
  • the release layer 220 when the application removes the cap 500, the release layer 220 is not in contact with the puncture needle 410, and since the release layer 220 is peeled off with the cap 500, the hand will not touch the puncture needle 410 , solve the problem of the deformation of the puncture needle 410 from the root.
  • the cap 500 is configured to be removed in a rotational manner. Referring to FIGS. 3 and 4 , for example, the cap 500 is rotated counterclockwise to separate the cap 500 from the implanter unit 400 , and then the cap 500 is removed along the axial direction of the implanter unit 400 . The following embodiments assume that the cap 500 is removed by rotation.
  • the release layer 220 of the present application is peeled off following the rotation direction of the cap 500, so that the release layer 220 does not contact the puncture needle 410 during the peeling process, avoiding the bending deformation of the puncture needle 410 caused by contact, and further ensuring the electrode The effectiveness of the implant.
  • the rotation direction of the cap 500 is the same as the peeling direction of the release layer 220 .
  • the release layer 220 is configured to be arranged on the adhesive layer in a spiral manner.
  • the release layer 220 will be peeled off sequentially from the edge of the adhesive layer to the middle following the rotation direction of the cap 500, that is, when the cap 500 is rotated, the release layer 220 will be peeled from the edge of the corresponding adhesive layer.
  • the end of the release layer 220 is uncovered, and the uncovered end is called the beginning of the release layer 220 .
  • a fixed portion 221 is configured at the beginning of the release layer 220 , and the release layer 220 is coupled to the cap 500 through the fixed portion 221 .
  • a fixing groove 510 is provided on the cap 500, a positioning hole 222 is disposed on the fixing portion 221, and a positioning block 511 corresponding to the positioning hole 222 is disposed on the inner wall of the fixing groove 510, and the fixing portion 221 is buckled on the positioning block 511 through the positioning hole 222; a positioning plug 520 is also inserted in the fixing groove 510, and the positioning plug 520 is inserted into the fixing groove 510 from the outside of the cap 500 to prevent the fixing part 221 from detaching from the positioning block 511.
  • the fixed part 221 is formed at the beginning of the release layer 220 and is a flexible structure made of the same material as the release layer 220.
  • a guide part 223 is arranged on the fixed part 221.
  • the guide part 223 is a rigid structure, such as hard plastic.
  • the positioning plug 520 is located between the inner wall of the fixing groove 510 facing the positioning block 511 and the fixing portion 221 , thereby preventing the fixing portion 221 from detaching from the positioning block 511 .
  • the guide part 223 is separated from the fixing part 221 after the positioning plug 520 is inserted into the fixing groove 510 .
  • a shearing line 224 is provided between the fixed part 221 and the guide part 223 to make a weak connection between the fixed part 221 and the guide part 223. After the positioning plug 520 is inserted into the fixing groove 510, the guide part 223 is directly cut along the The tangent line 224 can be torn off from the fixing part 221 .
  • the release layer 220 includes two release rings 225 , and the two release rings 225 are spliced together to form a ring-shaped release layer 220 .
  • the two release sector rings 225 are configured to peel off following the rotation direction of the cap 500 .
  • two release fan rings 225 are configured to be adjacent in sequence along the ring direction, that is, the start end of one release fan ring 225 is adjacent to the terminal end of the other release fan ring 225, and the terminal end of one release fan ring 225 Adjacent to the beginning of another release fan ring 225 .
  • the two release sector rings 225 are respectively configured with a fixing portion 221 at their starting ends, and the two release sector rings 225 are respectively coupled to the cap 500 through the respective fixing portions 221 . Similar to the above-mentioned embodiments, please refer to FIGS. 10 to 12 , each fixing portion 221 is provided with a guiding portion 223, and the cap 500 is provided with two fixing grooves 510, and the two guiding portions 223 pass through the two fixing grooves respectively. 510 guides the fastening part 221 into the fastening groove 510 .
  • the coupling manner between the fixing portion 221 and the cap 500 please refer to the above-mentioned embodiments, and details are not repeated here.
  • two fixing grooves 510 need to be provided, and two positioning plugs 520 need to be configured.
  • one of the fixing parts 221 is fixed in one of the fixing slots 510 by one of the positioning plugs 520
  • the other fixing part 221 is fixed in the other fixing slot 510 by another positioning plug 520 .
  • the two positioning plugs 520 are an integral structure.
  • two release fan rings 225 are symmetrically arranged on the adhesive layer with the central point of the ring-shaped release layer 220 as the symmetry center, and this arrangement can ensure two release rings
  • the sector rings 225 are peeled off synchronously, and the adhesive force of the two release sector rings 225 on the adhesive layer is equal, so that the two release sector rings 225 do not touch during the stripping process, thereby avoiding deformation of the puncture needle 410 .
  • a sterilizing cavity 530 is configured in the cap 500, and the sterilizing cavity 530 is configured to accommodate at least the sensor electrode 210 and provide a sealed sterilizing environment for the sensor electrode 210.
  • the sterilization chamber 530 may be defined by a hollow column 531 disposed in the cap 500, and the hollow column 531 is provided with an opening for entering the end of the puncture needle 410 and the sensor electrode 210, and the opening edge of the hollow column 531 is in contact with the end of the sensor electrode 210.
  • the body surface attachment unit 200 is sealed and connected, and the sealing method may be a rubber sealing ring 532 .
  • Analyte levels for the present application may be other indicators than glucose concentration.
  • a label 540 indicating the rotation direction of the cap 500 is pasted on the bottom of the cap 500, and the label 540 can cover the fixing groove 510 on the cap 500, making the bottom of the cap 500 more beautiful.
  • the release layer 220 provided by the present application no matter what implementation mode is used, the center is formed with a through hole for the puncture needle 410 and the sensor electrode 210 to pass through, and by setting the through hole, the release layer 220 is peeled off in a rotating manner , the release layer 220 is not in contact with the puncture needle 410 all the time.

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

Abstract

L'invention concerne un système de capteur d'analyte transcutané, comprenant une unité d'implantation (400) ; une unité de fixation de surface de corps (200) couplée dans l'unité d'implantation (400), l'unité de fixation de surface de corps (200) comprenant une unité de détection (230) pour mesurer un niveau d'analyte sous-cutané d'un hôte (100) et une couche adhésive pour appliquer l'unité de détection (230) sur la surface de la peau de l'hôte (100), une couche de libération (220) recouvrant la couche adhésive, l'unité de détection (230) comprenant une électrode de capteur (210), et l'unité d'implantation (400) étant conçue pour implanter une partie de l'électrode de capteur (210) de manière sous-cutanée dans l'hôte (100) ; et un capuchon (500) couplé à l'unité d'implantation (400) ou l'unité de détection (230), le capuchon (500) étant conçu pour être amovible avant que l'unité d'implantation (400) implante l'électrode de capteur (210), et la couche de libération (220) étant conçue pour être décollée de la couche adhésive lors du retrait du capuchon (500).
PCT/CN2022/082904 2021-11-27 2022-03-25 Système de capteur d'analyte transcutané WO2023092913A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202111428966.1 2021-11-27
CN202111428966.1A CN114391835A (zh) 2021-11-27 2021-11-27 经皮分析物传感器系统

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WO2023092913A1 true WO2023092913A1 (fr) 2023-06-01

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Families Citing this family (1)

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Publication number Priority date Publication date Assignee Title
CN117752333A (zh) * 2022-09-19 2024-03-26 苏州百孝医疗科技有限公司 灵敏度确定方法、植入效果判断方法以及相关设备

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CN114027829A (zh) * 2021-11-22 2022-02-11 普昂(杭州)生命科技有限公司 一种监测用留置单元
CN114146250A (zh) * 2021-11-12 2022-03-08 普昂(杭州)生命科技有限公司 一种具有无菌屏障系统的留置单元、组件及监测系统

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AU2019282729B2 (en) * 2018-06-07 2022-03-17 Abbott Diabetes Care Inc. Focused sterilization and sterilized sub-assemblies for analyte monitoring systems
US20210030319A1 (en) * 2019-08-02 2021-02-04 Bionime Corporation Physiological signal monitoring system for fast assembly

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Publication number Priority date Publication date Assignee Title
US20040199123A1 (en) * 2003-04-01 2004-10-07 Nielsen Jens Egebjerg Infusion device and an adhesive sheet material and a release liner
CN101489604A (zh) * 2006-06-09 2009-07-22 优诺医疗有限公司 安装垫
WO2011039329A1 (fr) * 2009-09-30 2011-04-07 Acarix A/S Pièce adhésive pour la surveillance de signaux acoustiques
US20120296187A1 (en) * 2011-04-29 2012-11-22 Abbott Diabetes Care Inc. Devices and Methods for Obtaining Analyte Sample
US20150182157A1 (en) * 2013-12-30 2015-07-02 CardioCanary, Inc. On-Patient Autonomous Blood Sampler and Analyte Measurement Device
WO2018222010A1 (fr) * 2017-06-02 2018-12-06 주식회사 아이센스 Ensemble applicateur de capteur pour système de surveillance continue de la glycémie
US20210030960A1 (en) * 2019-08-02 2021-02-04 Bionime Corporation Insertion device for a biosensor and insertion method thereof
WO2021177687A1 (fr) * 2020-03-03 2021-09-10 주식회사 아이센스 Dispositif de mesure continue de la glycémie
CN114028648A (zh) * 2021-11-12 2022-02-11 普昂(杭州)生命科技有限公司 一种敷贴式留置系统
CN114146250A (zh) * 2021-11-12 2022-03-08 普昂(杭州)生命科技有限公司 一种具有无菌屏障系统的留置单元、组件及监测系统
CN114027829A (zh) * 2021-11-22 2022-02-11 普昂(杭州)生命科技有限公司 一种监测用留置单元

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