WO2023103228A1 - Système de surveillance continue de glycémie et son procédé d'utilisation - Google Patents

Système de surveillance continue de glycémie et son procédé d'utilisation Download PDF

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Publication number
WO2023103228A1
WO2023103228A1 PCT/CN2022/082918 CN2022082918W WO2023103228A1 WO 2023103228 A1 WO2023103228 A1 WO 2023103228A1 CN 2022082918 W CN2022082918 W CN 2022082918W WO 2023103228 A1 WO2023103228 A1 WO 2023103228A1
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WO
WIPO (PCT)
Prior art keywords
body surface
housing
surface attachment
attachment unit
monitoring system
Prior art date
Application number
PCT/CN2022/082918
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English (en)
Chinese (zh)
Inventor
钱成
张仕文
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 WO2023103228A1 publication Critical patent/WO2023103228A1/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 continuous blood glucose monitoring system and its 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, 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.
  • a continuous blood glucose monitoring system that can be implanted into the subcutaneous tissue for continuous monitoring of subcutaneous blood sugar.
  • the system penetrates a sensor electrode into the subcutaneous tissue, and the sensor electrode oxidizes the glucose in the patient's interstitial fluid. , when reacting, an electrical signal will be formed, and the electrical signal will be converted into blood sugar readings through electronic components, and the blood sugar readings will be transmitted to the wireless receiver every 1-5 minutes, and the corresponding blood sugar data will be displayed on the wireless receiver and a map will be formed.
  • the continuous blood glucose monitoring system includes a body surface attachment unit, and the sensor electrodes are attached to the body surface attachment unit in a pre-connected manner and are electrically connected with electronic components integrated in the body surface attachment unit. Since the body surface attachment unit and the sensor electrodes are disposable, they need to be discarded after use, resulting in the electronic components integrated in the body surface attachment unit being discarded together. It can still be used later, therefore, the body surface attachment unit of the sensor electrode pre-connection type in the related art causes waste of electronic components and increases use cost.
  • the present application provides a continuous blood glucose monitoring system and a usage method, which can realize the reusability of electronic components, avoid waste of electronic components, and reduce use costs.
  • An embodiment provides a continuous blood glucose monitoring system comprising an implanter unit and a body surface attachment unit, wherein the implanter unit is configured to apply the body surface attachment unit to a skin surface of a host,
  • the body surface attachment unit includes a housing, sensor electrodes attached to the housing, and electronic components; the electronic components are assembled and detached before the implanter unit is applied to the body surface attachment unit. mounted to the housing of the body surface attachment unit.
  • One embodiment provides a method for using a continuous blood glucose monitoring system, including: before the implanter unit is applied to the body surface attachment unit on the skin surface of the host, installing electronic components on the body surface attachment unit in a detachable manner. connected to the housing of the unit.
  • 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 structural exploded view of a body surface attachment unit according to an embodiment of the present application.
  • FIG. 4 is a schematic diagram of an electronic component installed in a continuous blood glucose monitoring system according to an embodiment of the present application.
  • Fig. 5 is a schematic diagram of an electronic component installed on a body surface attachment unit according to an embodiment of the present application.
  • FIG. 6 is a schematic view from another angle of installing an electronic component to a body surface attachment unit according to an embodiment of the present application.
  • 100 host; 200, body surface attachment unit; 210, sensor electrode; 211, internal body part; 212, external body part; 220, shell; 221, upper shell; 222, lower shell; 223, first conductive 224, power base; 225, second conductive part; 226, power supply; 227, limit hole; 300, electronic component; 310, carrier; 311, connecting arm; 312, limit protrusion; 400, receiver; 500, implanter unit; 510, needle assembly; 520, opening.
  • FIG. 1 shows a schematic diagram of a continuous glucose monitoring system attached to a host 100 .
  • Figures 1-3 show a continuous blood glucose monitoring system comprising a body surface attachment unit 200 with sensor electrodes 210, and the body surface attachment unit 200 is applied to the skin surface of a host 100 through an implanter unit 500.
  • An electronic component 300 is installed on the body surface attachment unit 200, and the electronic component 300 is electrically connected to the sensor electrode 210, and is configured to send the glucose concentration information monitored by the sensor electrode 210 to the receiver 400, and the receiver 400 can usually be a smart phone , smart watches, specialized devices 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 continuous blood glucose monitoring system of the present application includes an implanter unit 500 and a body surface attachment unit 200 , and the implanter unit 500 is configured to apply the body surface attachment unit 200 to the skin surface of the host 100 .
  • the body surface attachment unit 200 can be pre-installed in the implanter unit 500 at the factory end, and then the overall Package.
  • the needle assembly 510 of the implanter unit 500 may also be preinstalled on the body surface attachment unit 200 .
  • the needle assembly 510 can be coupled to the body surface attachment unit 200 while the needle assembly 510 is also held by the internal components of the implanter unit 500, and the needle assembly 510 responds to the internal components of the implanter unit 500. series of actions.
  • the actions of the internal components of the implanter unit 500 in the related art include: 1. Driving the needle assembly 510 to guide the sensor electrode 210 partly into the host 100 subcutaneously; 2. After the sensor electrode 210 is introduced into the host 100 subcutaneously , the drive needle assembly 510 is subcutaneously withdrawn from the host 100 and retracted into the implanter unit 500 .
  • the electronic component 300 of the present application is installed on the body surface attachment unit 200 in a detachable manner, and then is applied to the host skin surface by the implanter unit 500 along with the body surface attachment unit 200 . Before the attachment unit 200 is discarded, the electronic component 300 can be removed from the old body surface attachment unit 200 and installed on a new body surface attachment unit 200 , which can realize the reuse of the electronic component 300 and reduce the use cost.
  • the electronic component 300 of the present application is especially suitable for the body surface attachment unit 200 pre-installed with the sensor electrodes 210 , further suitable for the body surface attachment unit 200 pre-installed with the needle assembly 510 .
  • the body surface attachment unit 200 of the present application is pre-installed on the implanter unit 500, and only the electronic components 300 need to be installed on the pre-installed body surface attachment unit 200 during the implant application operation, reducing The user's assembly operation is guaranteed, and the product cannot be used normally due to improper assembly by the user.
  • the body surface attachment unit 200 includes a housing 220 , sensor electrodes 210 and electronic components 300 , and the sensor electrodes 210 are pre-connected to the housing 220 .
  • the sensor electrode 210 includes an internal body part 211 and an external body part 212.
  • the internal body part 211 represents the part that is introduced into the subcutaneous tissue of the host 100 and is in contact with the subcutaneous tissue fluid.
  • the external part 212 represents the part exposed outside the skin of the host 100.
  • the sensor electrode 210 The extracorporeal part 212 is attached to the inside of the housing 220 of the body surface attachment unit 200 for pre-connection.
  • the housing 220 of the body surface attachment unit 200 may include an upper housing 221 and a lower housing 222, the extracorporeal part 212 of the sensor electrode 210 is attached to the lower housing 222, and the upper housing 221 and the lower housing 222 may be snapped together. Connection, the joint of the upper housing 221 and the lower housing 222 is equipped with a rubber sealing ring (not shown) to improve the sealing of the housing 220 of the body surface attachment unit 200, preventing the housing 220 from entering water; Glue dispensing is performed at the connection between the upper housing 221 and the lower housing 222 to further improve the sealing performance of the housing 220 of the body surface attachment unit 200 .
  • the end of the extracorporeal part 212 of the sensor electrode 210 is applied to the lower housing 222 through the first conductive part 223 to form an electrode signal output terminal.
  • the electronic component 300 includes an electrode signal input terminal, and the electrode signal output terminal is electrically connected to the electrode signal. input terminal.
  • the first conductive part 223 is made of flexible conductive material, for example, conductive foam.
  • the lower housing 222 is also equipped with a power base 224 and a second conductive part 225.
  • a power source 226 is installed in the power base 224.
  • the second conductive part 225 is electrically connected to the positive pole and the negative pole of the power source 226 respectively to form a power output terminal.
  • the electronic component 300 includes a power input terminal, and the power output terminal is electrically connected to the power input terminal.
  • the power source 226 may be a button battery
  • the second conductive part 225 may be a metal conductive sheet.
  • the electronic component 300 is detachably mounted on the housing 220 of the body surface attachment unit 200 before the implanter unit 500 is applied to the body surface attachment unit 200 . That is, the electronic component 300 is installed on the housing 220 of the body surface attachment unit 200 first, and then is applied to the skin surface of the host 100 by the implanter unit 500 together with the housing 220 of the body surface attachment unit 200 .
  • the installation method of the electronic component 300 of the present application is especially suitable for a continuous blood glucose monitoring system in which the body surface attachment unit 200 is pre-installed on the implanter unit 500.
  • This continuous blood glucose monitoring system is packaged
  • the electronic component 300 may be installed or not installed.
  • the continuous blood glucose monitoring system with the electronic component 300 is the situation when it is used for the first time.
  • the continuous blood glucose monitoring system without the electronic component 300 It is a replacement case.
  • you only need to take the continuous blood glucose monitoring system out of the package put the implanter unit 500 close to the skin surface of the host 100, and then operate the implanter unit 500 to apply the body surface attachment unit 200 with the electronic components 300 installed on it.
  • the body surface attachment unit 200 is removed from the skin surface of the host 100, and the electronic component 300 is removed from the shell 220 of the body surface attachment unit 200, and then The electronic component 300 can be loaded into another continuous blood glucose monitoring system without the electronic component 300, and the above-mentioned implantation operation can be repeated. In this way, the electronic component 300 can be reused and the cost of use can be reduced.
  • an opening 520 for inserting the electronic component 300 is formed on the implanter unit 500, and the electronic component 300 is installed on the body surface through the opening 520. Unit 200 on.
  • the electronic component 300 includes a carrier 310 and an electronic circuit (not shown) disposed in the carrier 310 and including a plurality of electronic components.
  • the housing 220 of the body surface attachment unit 200 may be a circular structure, and the carrier 310 of the electronic component 300 may be radially inserted into the housing 220 of the body surface attachment unit 200 from the side of the housing 220 of the body surface attachment unit 200 .
  • a U-shaped connecting arm 311 is formed on the carrier 310 , and the connecting arm 311 is located inside the housing 220 of the body surface attaching unit 200 when the carrier 310 of the electronic component 300 is plugged into the housing 220 of the body surface attaching unit 200 .
  • the electrode signal input terminal and the power input terminal are arranged on the connecting arm 311, and extend into the shell 220 of the body surface attachment unit 200 through the connecting arm 311, so that the electrode signal input terminal is electrically connected with the electrode signal output terminal, and the power input terminal The terminal is electrically connected with the output terminal of the power supply.
  • a position-limiting protrusion 312 is formed under the carrier 310 of the electronic component 300, and a position-limiting hole 227 is formed on the shell 220 of the body surface attachment unit 200.
  • the limit protrusion 312 snaps into the limit hole 227, preventing the carrier 310 of the electronic component 300 from falling off from the shell 220 of the body surface attachment unit 200, but allowing artificial force
  • the carrier 310 of the electronic component 300 is removed from the housing 220 of the body surface attachment unit 200 .
  • the installation and removal of the carrier 310 of the electronic component 300 can also be done in a manner similar to that of an SD card, that is, inserting the carrier 310 of the electronic component 300 into a body surface attachment
  • the carrier 310 of the electronic part 300 is locked; 310 is unlocked and ejected radially outward, and then the carrier 310 of the electronic component 300 can be removed.
  • the installation and removal of the carrier 310 of the electronic component 300 is more convenient and labor-saving, but the structure of the response is relatively complicated, resulting in an increase in cost. Therefore, this embodiment is not a preferred embodiment of the present invention and can be used as a follow-up way of improvement.
  • connection between the carrier 310 of the electronic component 300 and the housing 220 of the body surface attachment unit 200 is equipped with a rubber sealing ring (not shown in the figure) to improve the sealing of the entire assembly and prevent the internal cavity of the body surface attachment unit 200 from body into water.

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  • 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

L'invention concerne un système de surveillance continue de glycémie, comprenant une unité d'implant (500) et une unité de fixation à la surface corporelle (200), l'unité d'implant (500) étant configurée pour appliquer l'unité de fixation à la surface corporelle (200) sur une surface de peau d'un hôte (100). L'unité de fixation à la surface corporelle (200) comprend un boîtier (220), une électrode de capteur (210) fixée au boîtier, et un composant électronique (300), le composant électronique (300) étant installé de manière amovible sur le boîtier (220) de l'unité de fixation à la surface corporelle (200) avant l'application de l'unité d'implant (500) sur l'unité de fixation à la surface corporelle (200).
PCT/CN2022/082918 2021-12-06 2022-03-25 Système de surveillance continue de glycémie et son procédé d'utilisation WO2023103228A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202111471628.6A CN114391837A (zh) 2021-12-06 2021-12-06 持续血糖监测系统及使用方法
CN202111471628.6 2021-12-06

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WO2023103228A1 true WO2023103228A1 (fr) 2023-06-15

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018118061A1 (fr) * 2016-12-22 2018-06-28 Sanvita Medical, Llc Système et procédé de surveillance de glucose en continu
CN109998555A (zh) * 2019-04-30 2019-07-12 苏州百孝医疗科技有限公司 一种受体生理参数测量系统
CN110720930A (zh) * 2019-11-05 2020-01-24 微泰医疗器械(杭州)有限公司 助针器以及包括助针器的医疗系统
CN210009033U (zh) * 2019-04-30 2020-02-04 三诺生物传感股份有限公司 一种分体式动态血糖监测仪结构和动态血糖监测仪
CN213758240U (zh) * 2019-11-05 2021-07-23 微泰医疗器械(杭州)有限公司 医疗系统
CN214231337U (zh) * 2020-12-21 2021-09-21 华东数字医学工程研究院 生物信号监测设备和血糖监测设备
CN113499126A (zh) * 2021-06-28 2021-10-15 苏州百孝医疗科技有限公司 植入器及植入方法
CN114391838A (zh) * 2021-12-14 2022-04-26 苏州百孝医疗科技有限公司 植入器及其使用方法

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018118061A1 (fr) * 2016-12-22 2018-06-28 Sanvita Medical, Llc Système et procédé de surveillance de glucose en continu
CN109998555A (zh) * 2019-04-30 2019-07-12 苏州百孝医疗科技有限公司 一种受体生理参数测量系统
CN210009033U (zh) * 2019-04-30 2020-02-04 三诺生物传感股份有限公司 一种分体式动态血糖监测仪结构和动态血糖监测仪
CN110720930A (zh) * 2019-11-05 2020-01-24 微泰医疗器械(杭州)有限公司 助针器以及包括助针器的医疗系统
CN213758240U (zh) * 2019-11-05 2021-07-23 微泰医疗器械(杭州)有限公司 医疗系统
CN214231337U (zh) * 2020-12-21 2021-09-21 华东数字医学工程研究院 生物信号监测设备和血糖监测设备
CN113499126A (zh) * 2021-06-28 2021-10-15 苏州百孝医疗科技有限公司 植入器及植入方法
CN114391838A (zh) * 2021-12-14 2022-04-26 苏州百孝医疗科技有限公司 植入器及其使用方法

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