WO2023108944A1

WO2023108944A1 - Body surface attachment unit and assembly method therefor

Info

Publication number: WO2023108944A1
Application number: PCT/CN2022/082920
Authority: WO
Inventors: 钱成; 张仕文
Original assignee: 苏州百孝医疗科技有限公司
Priority date: 2021-12-14
Filing date: 2022-03-25
Publication date: 2023-06-22
Also published as: CN114391839A

Abstract

A body surface attachment unit (200) and an assembly method therefor. The body surface attachment unit (200) comprises: a housing (230); a sensor electrode (210) and a needle assembly (240) which are attached to the housing (230); and an electronic component (250). The needle assembly (240) is configured to guide an in-vivo portion of the sensor electrode (210) into the skin of a subject (100). The electronic component (250) is mounted in the housing (230), and the sensor electrode (210) is electrically connected to the electronic component (250).

Description

Body surface attachment unit and assembly method thereof

This application claims priority to a Chinese patent application with a filing date of December 14, 2021 and application number 202111529186.6, 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 body surface attachment unit and an assembly method thereof.

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 glucose. The sensor electrode on the unit is then pierced into the subcutaneous tissue, and the sensor electrode undergoes an oxidation reaction with the glucose in the patient's interstitial fluid, and an electrical signal is formed during the reaction, which is converted into a blood glucose reading through electronic components, and is read every 1 -Transmit the blood glucose readings to the wireless receiver in 5 minutes, display the corresponding blood glucose data and form a graph on the wireless receiver for reference by patients and doctors.

The continuous blood glucose monitoring system in the related art attaches the sensor electrodes to the body surface attachment unit in a pre-connected manner and pre-connects with the electronic components on the body surface attachment unit. The body surface attachment unit with this structure Electronic components are easily compromised during radiation sterilization of the sensor electrodes. In addition, electronic components are generally arranged on a PCB board in the related art, which leads to a large volume of the body surface attachment unit and affects wearing comfort.

Contents of the invention

The present application provides a body surface attachment unit and an assembly method thereof, which can avoid damage to electronic components during radiation sterilization of sensor electrodes, and the volume of the body surface attachment unit is smaller.

An embodiment of the present application provides a body surface attachment unit, including a housing; a sensor electrode attached to the housing and a needle assembly, the needle assembly is configured to guide the body part of the sensor electrode into the subcutaneous of the host; and electronic components, the electronic components are installed in the casing, and the sensor electrodes are electrically connected to the electronic components.

An embodiment of the present application also provides a method for assembling a body surface attachment unit, including attaching the sensor electrodes and the needle assembly to the body surface attachment before performing radiation sterilization on the sensor electrodes and the needle assembly. Mounting the electronic components into the housing of the body surface attachment unit after radiation sterilizing the sensor electrodes and the needle assembly.

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 cross-sectional view of a body surface attachment unit according to an embodiment of the present application.

Fig. 4 is a schematic diagram of installing a sensor electrode and a needle assembly on a body surface attachment unit according to an embodiment of the present application.

FIG. 5 is a schematic diagram of installing electronic components on the 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, reference electrode; 212, working electrode; 220, release layer; 230, shell; 231, upper shell; 232, lower shell Body; 240, needle assembly; 241, puncture needle; 242, hub; 243, slot; 250, electronic component; 251, first part; 252, second part; 253, battery; 260, first conductive part; 261, conductive Cloth; 262, conductive bubble; 270, second conductive part; 280, third conductive part; 300, receiver; 400, implanter unit; 500, cap.

Detailed ways

This embodiment provides a continuous glucose monitoring (CGM, Continuous Glucose Monitoring) system, please refer to FIG. 1 , which is a schematic diagram of a continuous 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 electronic component 250 electrically connected to the sensor electrode 210. The electronic component 250 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, a smart Watches, special equipment 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, which is a schematic structural diagram of a continuous blood glucose monitoring system. The continuous blood glucose monitoring system includes an implanter unit 400, a body surface attachment unit 200 and a cap 500. The body surface attachment unit 200 is preinstalled on the cap. 500, then follow the cap 500 to be installed on the implanter unit 400. When in use, the cap 500 is removed from the implanter unit 400 by turning the cap 500. At the same time, the body surface attachment unit 200 is covered. The release layer 220 on the adhesive layer will be peeled off together with the removal of the cap 500; then the opening side of the implanter unit 400 is attached to the skin surface of the host 100, and the implanter unit 400 is operated to place the implanter The body surface attachment unit 200 in the unit 400 is applied to the skin surface of the host 100. At this time, 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.

In one embodiment, the adhesive layer can be medical non-woven adhesive tape.

In one embodiment, the release layer 220 is a release paper or a release film, and a layer of release agent is coated on the surface.

The body surface attachment unit 200 will be described in detail below, please refer to FIG. 3 . FIG. 3 is a schematic cross-sectional view of the body surface attachment unit 200. The sensor electrode 210 and the needle assembly 240, the needle assembly 240 is configured to guide the body part of the sensor electrode 210 into the host 100 subcutaneously, the electronic component 250 is installed in the housing 230, the electronic component 250 is irradiated at the sensor electrode 210 and the needle assembly 240 After being sterilized and installed in the housing 230 , the sensor electrodes 210 are electrically connected to the electronic components 250 .

The casing 230 includes an upper casing 231 and a lower casing 232. The upper casing 231 and the lower casing 232 can be connected and fixed by buckles. A rubber sealing ring is arranged at the position, and a sealant can also be applied at the junction of the upper housing 231 and the lower housing 232 on this basis to further improve the sealing performance of the housing 230 and prevent water vapor from entering the housing 230 .

The sensor electrode 210 includes an internal part, which refers to a part introduced into the subcutaneous area of the host 100 and contacts the subcutaneous tissue fluid, and an extracorporeal part, which refers to a part exposed outside the skin of the host 100 and attached to the housing 230 .

The assembly of the body surface attachment unit 200 of the present application includes two stages: a pre-sterilization stage and a post-sterilization stage.

For the pre-sterilization stage, please refer to FIG. 4, including installing the sensor electrode 210 and the needle assembly 240 on the lower housing 232, wherein the extracorporeal part of the sensor electrode 210 is pasted on the lower housing 232 by the first conductive part 260. On the upper surface, the inner body portion of the sensor electrode 210 protrudes from the lower surface of the lower housing 232 .

In one embodiment, the first conductive part 260 includes two first conductive members, the sensor electrode 210 includes a reference electrode 211 and a working electrode 212, one of the first conductive members is electrically connected to the reference electrode 211, and the other first conductive member is electrically connected to the reference electrode 211. A conductive member is electrically connected to the working electrode 212 .

For example, the first conductive member includes a double-sided adhesive conductive cloth 261 pasted on the upper surface of the lower housing 232 and a conductive foam 262 pasted on the conductive cloth 261, and the extracorporeal part of the sensor electrode 210 is positioned on the conductive cloth 261. Between the conductive cloth 261 and the conductive foam 262 , so that the external part of the sensor electrode 210 is wrapped by the conductive cloth 261 and the conductive foam 262 to form a good electrical connection.

The needle assembly 240 includes a puncture needle 241 and a hub 242. The hub 242 is disposed on the blunt portion of the puncture needle 241. A groove 243 extending to the sharp portion of the puncture needle 241 is formed on the side wall of the puncture needle 241. The internal body part of the sensor electrode 210 The puncture needle 241 is inserted into the puncture needle 241 through the groove 243 so as to be guided into the host 100 subcutaneously following the movement of the puncture needle 241 .

After the sensor electrodes 210 and the needle assembly 240 are installed on the lower housing 232, the lower housing 232 with the sensor electrodes 210 and the needle assembly 240 is sterilized by radiation. Sterilization does not harm the electronic component 250 .

For the post-sterilization phase, see FIGS. 3 and 5 , the electronics 250 includes a first part 251 and a second part 252 on which the sensor electronics are at least partially located, for example, the sensor electronics include a battery 253, a processor , conductive traces and wireless communication circuits. In one embodiment, the battery 253 , the processor, and the wireless communication circuit are located on the first part 251 , some of the conductive traces are located on the first part 251 , and some of the conductive traces are located on the second part 252 .

When installing the electronic component 250, first install the first part 251 on the upper surface of the lower case 232, and an electrode signal input terminal is formed on the lower surface of the first part 251, when the first part 251 is installed on the upper surface of the lower case 232 On the surface, the electrode signal input terminal is electrically connected to the first conductive part 260, so that the subcutaneous glucose concentration information of the host 100 monitored by the sensor electrode 210 is transmitted to the first part 251 via the first conductive part 260 and the electrode signal input terminal. After the first part 251 is mounted, the second part 252 is mounted to the first part 251 in a stacked manner. The battery 253 is mounted on the upper surface of the first part 251 so as to be sandwiched by the first part 251 and the second part 252 . The battery 253 is electrically connected to the electronic component 250 through the second conductive part 270, wherein the second conductive part 270 includes a second conductive member arranged on the upper surface of the first part 251 and a second conductive member arranged on the lower surface of the second part 252 Another second conductive member. In one embodiment, one second conductive member is electrically connected to one of the positive pole and the negative pole of the battery 253, another second conductive member is electrically connected to the other of the positive pole and the negative pole of the battery 253, and the second conductive part 270 constitutes a power input terminal of the electronic component 250 .

A third conductive part 280 is also arranged between the first part 251 and the second part 252, and the third conductive part 280 includes a third conductive member arranged on the upper surface of the first part 251 and a third conductive member arranged on the lower surface of the second part 252. another third conductive member on the When the second part 252 is mounted on the first part 251, the two third conductive members abut each other. So far, a complete circuit connection has been realized between the first part 251 and the second part 252 , thereby forming a complete blood glucose signal transmission loop between the sensor electrode 210 , the first part 251 and the second part 252 . In addition to the role of electrical connection, the third conductive part 280 also plays the role of supporting the first part 251 and the second part 252. The two third conductive members of the third conductive part 280 abut against each other, so that the second The portion 252 is almost parallel to the first portion 251 when laminated onto the first portion 251 .

The above-mentioned second conductive member and third conductive member adopt conductive foam.

In other implementation manners, for example, conductive rubber, conductive metal shrapnel, conductive metal probes, etc. may also be used instead of the conductive foam in this embodiment.

In order to reduce the thickness of the body surface attachment unit 200 of this embodiment, the first part 251 and the second part 252 of the electronic component 250 may, for example, use a flexible circuit board.

After the second part 252 is installed, the upper case 231 is installed on the lower case 232. At this time, the upper case 231 and the lower case 232 exert a pressing effect on the first part 251 and the second part 252, Since the electrical connection of the present application adopts the elastic conductive material such as conductive foam, and the conductive foam can be compressed, the extrusion of the upper casing 231 and the lower casing 232 can make the conductive foam Compression, thereby improving the stability and effectiveness of the electrical connection. Finally, it is enough to install the body surface attachment unit 200 into the cap 500 .

In the present application, by installing the electronic component 250 into the housing 230 of the body surface attachment unit 200 after the sensor electrode 210 and the needle assembly 240 are sterilized by radiation, the damage to the electronic component 250 caused by radiation sterilization can be effectively avoided; The component 250 is divided into a first part 251 and a second part 252 installed in a stacked manner, and the sensor electronics are sandwiched between the first part 251 and the second part 252, which effectively improves space utilization, so that the body surface attachment unit 200 The volume is smaller; and the electronic component 250 is superimposed on the extracorporeal part of the sensor electrode 210, which simplifies the installation operation while ensuring effective electrical connection, and is conducive to improving assembly efficiency.

Claims

A body surface attachment unit, comprising:

shell;

a sensor electrode and a needle assembly attached to the housing, the needle assembly configured to introduce an internal body portion of the sensor electrode subcutaneously into a host; and

an electronic component, the electronic component is installed in the housing, and the sensor electrodes are electrically connected to the electronic component.
The body surface attachment unit according to claim 1, wherein: the housing includes an upper case and a lower case, the extracorporeal part of the sensor electrode is attached to the upper surface of the lower case, the sensor The inner body portion of the electrode protrudes from the lower surface of the lower housing.
The body surface attaching unit according to claim 2, further comprising a first conductive part: the extracorporeal part of the sensor electrode is pasted on the upper surface of the lower case via the first conductive part.
The body surface attachment unit according to claim 3, wherein: the first conductive part includes two first conductive members, the sensor electrode includes a reference electrode and a working electrode, one of the first conductive members and The reference electrode is electrically connected, and the other first conductive member is electrically connected to the working electrode.
The body surface attachment unit according to claim 4, wherein: the first conductive member comprises a double-sided adhesive conductive cloth pasted on the upper surface of the lower case and a conductive bubble pasted on the conductive cloth Cotton, the extracorporeal part of the sensor electrode is positioned between the conductive cloth and the conductive foam.
The body surface attachment unit of claim 1, wherein the electronic component comprises a first portion, a second portion, and sensor electronics disposed at least partially on an upper surface of the first portion in a stacked arrangement, the first portion superimposed on and electrically connected to the extracorporeal portion of the sensor electrode.
The body surface attaching unit according to claim 6, wherein an electrode signal input terminal is formed on the lower surface of the first part, and the first part is electrically connected to the extracorporeal part of the sensor electrode via the electrode signal input terminal. sexual connection.
The body surface attachment unit of claim 6, wherein the sensor electronics includes a battery, a processor, conductive traces and wireless communication circuitry, the battery being disposed on an upper surface of the first portion.
The body surface attachment unit according to claim 8, further comprising a second conductive part and a battery, the battery is respectively electrically connected to the first part and the second part through the second conductive part, the The second conductive part includes a second conductive member arranged on the upper surface of the first part and another second conductive member arranged on the lower surface of the second part, wherein one of the second conductive members electrically connected to one of the positive and negative electrodes of the battery, the other second conductive member is electrically connected to the other of the positive and negative electrodes of the battery, and the second conductive part constitutes the electronic component power input terminals.
The body surface attachment unit according to claim 6, further comprising a third conductive part disposed between the first part and the second part, the third conductive part includes a A third conductive member on the surface and another third conductive member disposed on the lower surface of the second portion.
The body surface attachment unit of claim 6, wherein said first portion and said second portion of said electronic component are flexible circuit boards.
A method for assembling a body surface attachment unit, comprising:

attaching the sensor electrode and needle assembly to the housing of the body surface attachment unit prior to radiation sterilizing the sensor electrode and needle assembly, and

After radiation sterilizing the sensor electrodes and needle assembly, the electronics are mounted into the housing of the body surface attachment unit.
The method for assembling the body surface attachment unit according to claim 12, wherein: the electronic component is superimposed on the extracorporeal part of the sensor electrode and electrically connected with the extracorporeal part of the sensor electrode.
The method of assembling the body surface attaching unit according to claim 12, wherein the electronic part is divided into a first part and a second part, and the second part is mounted on the first part in a stacked manner.