WO2023103228A1

WO2023103228A1 - Continuous glucose monitoring system and method of use thereof

Info

Publication number: WO2023103228A1
Application number: PCT/CN2022/082918
Authority: WO
Inventors: 钱成; 张仕文
Original assignee: 苏州百孝医疗科技有限公司
Priority date: 2021-12-06
Filing date: 2022-03-25
Publication date: 2023-06-15
Also published as: CN114391837A

Abstract

A continuous glucose monitoring system, comprising an implant unit (500) and a body surface attachment unit (200), wherein the implant unit (500) is configured to apply the body surface attachment unit (200) to a skin surface of a host (100). The body surface attachment unit (200) comprises a housing (220), a sensor electrode (210) attached to the housing, and an electronic component (300), wherein the electronic component (300) is installed on the housing (220) of the body surface attachment unit (200) in a detachable manner before the implant unit (500) is applied to the body surface attachment unit (200).

Description

Continuous blood glucose monitoring system and method of use

This application claims priority to a Chinese patent application with a filing date of December 6, 2021 and application number 202111471628.6, the entire contents of which are incorporated herein by reference.

technical field

The present application relates to the technical field of medical devices, for example, to a continuous blood glucose monitoring system and its usage method.

Background technique

For some physiological diseases, 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. 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.

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.

In response to the above needs, technicians have developed 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. For patients and doctors reference.

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.

Contents of the invention

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.

Description of drawings

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.

Among them: 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.

Detailed ways

For the Continuous Glucose Monitoring (CGM, Continuous Glucose Monitoring) system, please refer to FIG. 1 . 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. During use, the sensor electrode 210 is partially located under the skin of the host 100, in contact with the subcutaneous tissue fluid.

Please refer to FIG. 2 , 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 . In one embodiment, in order to reduce the user's assembly operations and prevent the product from being unusable due to improper assembly, the body surface attachment unit 200 can be pre-installed in the implanter unit 500 at the factory end, and then the overall Package. On the premise that the body surface attachment unit 200 is preinstalled in the implanter unit 500 , the needle assembly 510 of the implanter unit 500 may also be preinstalled on the body surface attachment unit 200 . For example, 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. For example, 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.

Referring to FIG. 3 , 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 . Wherein, 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. Wherein, 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. Wherein, the power source 226 may be a button battery, and 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 .

Please continue to refer to FIG. 2 , 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. When using it for the first time, 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. Stick it on the skin surface of the host 100, and then separate the implanter unit 500 from the body surface attachment unit 200. When the sensor electrodes 210 on the body surface attachment unit 200 reach the service life, 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. Please refer to FIG. 4, in order to realize that the electronic component 300 can be installed on the continuous blood glucose monitoring system, 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.

Referring to FIGS. 5 and 6 , 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.

Please continue to refer to FIG. 6, for example, 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. When the carrier 310 of the electronic component 300 is plugged When 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 .

In other embodiments, 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 When the housing 220 of the unit 200 is on, 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. In this embodiment, 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.

The 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.

Claims

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, and the body surface attachment The attachment unit includes a housing, sensor electrodes attached to the housing, and electronic components configured to be detachably mounted to the body before the implanter unit is applied to the body surface. table attached to the housing of the unit.
The continuous blood glucose monitoring system according to claim 1, wherein: said sensor electrode includes an internal body part and an external body part, said internal body part protrudes from the bottom surface of said housing, and said external body part is attached to said body surface attachment The interior of the housing of the unit is electrically connected with the electronic components.
The continuous blood glucose monitoring system according to claim 2, further comprising a first conductive part, the end of the extracorporeal part of the sensor electrode is applied to the inside of the housing through the first conductive part to form an electrode signal output terminal , the electronic component includes an electrode signal input terminal, and the electrode signal output terminal is electrically connected to the electrode signal input terminal.
The continuous blood glucose monitoring system according to claim 3, wherein: the first conductive part is conductive foam.
The continuous blood glucose monitoring system according to claim 1, wherein a power source is disposed inside the housing of the body surface attachment unit, and the power source is electrically connected to the electronic components.
The continuous blood glucose monitoring system according to claim 5, wherein: the inside of the housing of the body surface attachment unit is provided with a power base, and the power supply is installed in the power base.
The continuous blood glucose monitoring system according to claim 5, wherein: the inside of the housing of the body surface attachment unit is attached with a second conductive part, and the second conductive parts are respectively electrically connected to the power supply. The positive pole and the negative pole form a power output terminal, the electronic component includes a power input terminal, and the power output terminal is electrically connected to the power input terminal.
The continuous glucose monitoring system of claim 1, further comprising a needle assembly configured to guide the sensor electrode portion subcutaneously of the host.
The continuous glucose monitoring system of claim 8, wherein the needle assembly is configured to be mounted to the housing of the body surface attachment unit before electronic components are mounted to the housing of the body surface attachment unit superior.
The continuous blood glucose monitoring system of claim 1, wherein the electronic component is configured to be plug-mounted to the housing of the body surface attachment unit.
The continuous blood glucose monitoring system of claim 1, wherein the electronic components are configured to be radially mounted to the housing of the body surface attachment unit.
The continuous blood glucose monitoring system according to claim 1, wherein the electronic component does not contact the sensor electrodes during installation.
A method for using a continuous blood glucose monitoring system, comprising: before the implanter unit is applied to the body surface attachment unit on the skin surface of the host, installing electronic components on the shell of the body surface attachment unit in a detachable manner .
The method of using the continuous blood glucose monitoring system according to claim 13, wherein: before installing the electronic components on the shell of the body surface attachment unit in a detachable manner, the needle assembly is firstly installed on the body surface on the housing of the attachment unit.