CN114391839B

CN114391839B - Body surface attachment unit and assembly method thereof

Info

Publication number: CN114391839B
Application number: CN202111529186.6A
Authority: CN
Inventors: 钱成; 张仕文
Original assignee: Diascience Medical Co Ltd
Current assignee: Diascience Medical Co Ltd
Priority date: 2021-12-14
Filing date: 2021-12-14
Publication date: 2024-09-13
Anticipated expiration: 2041-12-14
Also published as: CN114391839A; WO2023108944A1

Abstract

The present invention provides a body surface attachment unit and an assembly method thereof, wherein the body surface attachment unit comprises a housing, and a sensor electrode and a needle assembly attached to the housing, wherein the needle assembly is configured to guide the in vivo portion of the sensor electrode into the subcutaneous tissue of a host, and further comprises an electronic component, wherein the electronic component is installed in the housing after the sensor electrode and the needle assembly are sterilized by radiation, and the sensor electrode is electrically connected to the electronic component. The present invention can avoid harming the electronic component when the sensor electrode is sterilized by radiation, and the body surface attachment unit is more compact.

Description

Body surface attachment unit and method of assembling the same

Technical Field

The invention relates to the technical field of medical instruments, in particular to a body surface attachment unit and an assembly method thereof.

Background

Some physiological diseases have long disease course and prolonged illness, and certain physiological parameters of a host need to be monitored in real time so as to be better tracked and treated. Such as diabetes, requires real-time monitoring of the host's blood glucose. Accurate blood glucose self-monitoring is a key for realizing good blood glucose control, is beneficial to evaluating the degree of glucose metabolic disturbance of diabetics, and makes a blood glucose reducing scheme, and simultaneously reflects the blood glucose reducing treatment effect and guides the adjustment of the treatment scheme.

Currently, the most widely used blood glucose meter is available on the market, and the patient needs to collect finger peripheral blood by himself to measure the blood glucose level at that time. However, this method has the following drawbacks: 1. the condition of the blood glucose level change between two measurements cannot be known, and a patient may miss blood glucose peaks and valleys, so that complications are caused, and irreversible injury is caused to the patient; 2. the finger tips puncture and blood sampling for many times every day causes great pain to diabetics. In order to overcome the above-mentioned drawbacks, it is necessary to provide a method for continuously monitoring the blood sugar of a patient, which is convenient for the patient to know his or her blood sugar status in real time and to take countermeasures accordingly in time, so as to effectively control the illness state, prevent complications and obtain higher quality of life.

In response to the above-mentioned needs, the skilled person has developed a continuous blood glucose monitoring system capable of being implanted into subcutaneous tissue to continuously monitor subcutaneous blood glucose, the system applies a body surface attachment unit to the surface of the skin of a host through an implanter, a sensor electrode attached to the body surface attachment unit is penetrated into the subcutaneous tissue, the sensor electrode generates an electric signal when an interstitial fluid of a patient and glucose in the body react, the electric signal is converted into blood glucose readings through an electronic component, and the blood glucose readings are transmitted to a wireless receiver every 1 to 5 minutes, and corresponding blood glucose data and a formation map are displayed on the wireless receiver for reference of the patient and a doctor.

Existing continuous blood glucose monitoring systems attach sensor electrodes to a body surface attachment unit in a pre-connection manner and pre-connect with electronic components on the body surface attachment unit, which are vulnerable to damage when the sensor electrodes are subjected to radiation sterilization. In addition, electronic components are currently commonly arranged on a PCB board, and this arrangement results in a larger volume of the existing body surface attachment unit, affecting wearing comfort.

Disclosure of Invention

The object of the present invention is to provide a body surface attachment unit and an assembling method thereof, which can avoid damaging electronic components when radiation sterilization is performed on sensor electrodes, and the body surface attachment unit is more compact.

In order to achieve the aim of the invention, the invention adopts the following technical scheme: a body surface attachment unit comprising a housing, and a sensor electrode and needle assembly attached to the housing, the needle assembly configured to guide an in vivo portion of the sensor electrode into the host subcutaneous, and further comprising an electronic component mounted into the housing after the sensor electrode and needle assembly are sterilized by radiation, the sensor electrode being electrically connected to the electronic component.

In the above-described aspect, the housing includes an upper case and a lower case, the outer body portion of the sensor electrode is attached to an upper surface of the lower case, and the inner body portion of the sensor electrode protrudes from a lower surface of the lower case.

In the above technical scheme, the external part of the sensor electrode is stuck on the upper surface of the lower shell through the first conductive part.

In the above technical scheme, the first conductive part comprises two first conductive members, the sensor electrode comprises a reference electrode and a working electrode, one of the first conductive members is electrically connected with the reference electrode, and the other first conductive member is electrically connected with the working electrode.

In the above technical scheme, the first conductive member comprises a conductive cloth adhered to the upper surface of the lower shell and a conductive foam adhered to the conductive cloth, and the outer part of the sensor electrode is positioned between the conductive cloth and the conductive foam.

In the above technical solution, the electronic component includes a first portion and a second portion that are configured in a stacked manner, and a sensor electronic device that is at least partially configured on an upper surface of the first portion, where the first portion is stacked on an external portion of the sensor electrode and is electrically connected to the external portion of the sensor electrode.

In the above technical solution, an electrode signal input terminal is formed on the lower surface of the first portion, and the first portion is electrically connected with the external portion of the sensor electrode through the electrode signal input terminal.

In the above aspect, the sensor electronics includes a battery, a processor, conductive traces, and a wireless communication circuit, the battery being disposed on an upper surface of the first portion.

In the above technical solution, the battery is electrically connected to the first portion and the second portion through the second conductive portion, where the second conductive portion includes one second conductive member disposed on an upper surface of the first portion and another second conductive member disposed on a lower surface of the second portion, and one of the second conductive members is electrically connected to one of the positive electrode and the negative electrode of the battery, and the other of the second conductive members is electrically connected to the other of the positive electrode and the negative electrode of the battery, and the second conductive portion forms a power input terminal of the electronic component.

In the above technical solution, a third conductive portion is further disposed between the first portion and the second portion, and the third conductive portion includes one third conductive member disposed on an upper surface of the first portion and another third conductive member disposed on a lower surface of the second portion.

In the above technical solution, the first portion and the second portion of the electronic component are flexible circuit boards.

The present invention also provides a method of assembling a body surface attachment unit, comprising attaching a sensor electrode and a needle assembly to a housing of the body surface attachment unit before radiation sterilization of the sensor electrode and the needle assembly, and mounting electronic components into the housing of the body surface attachment unit after radiation sterilization of the sensor electrode and the needle assembly.

In the above technical solution, the electronic component is superimposed on and electrically connected to the external portion of the sensor electrode.

In the above-described aspect, the electronic component is divided into a first portion and a second portion, and the second portion is mounted on the first portion in a stacked manner.

Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:

According to the invention, the electronic component is arranged in the shell of the body surface attachment unit after the sensor electrode and the needle assembly are subjected to radiation sterilization, so that the damage to the electronic component caused by radiation sterilization can be effectively avoided; the electronic component is divided into the first part and the second part which are installed in a stacking mode, the sensor electronic device is clamped between the first part and the second part, the space utilization rate is effectively improved, and therefore the body surface attachment unit is smaller in size; and the electronic component is superimposed on the external portion of the sensor electrode, so that the mounting operation is simplified while ensuring effective electrical connection, and the improvement of the assembly efficiency is facilitated.

Drawings

FIG. 1 is a schematic diagram of a continuous blood glucose monitoring system in accordance with an embodiment of the present invention.

Fig. 2 is a schematic diagram of a continuous blood glucose monitoring system in accordance with an embodiment of the present invention.

Fig. 3 is a cross-sectional view of a body surface attachment unit of an embodiment of the present invention.

Fig. 4 is a schematic view of a body surface attachment unit mounting sensor electrodes and needle assemblies of an embodiment of the present invention.

Fig. 5 is a schematic view of the body surface attachment unit mounting electronic components of the embodiment of the present invention.

Wherein: 100. a host; 200. a body surface attachment unit; 210. a sensor electrode; 211. a reference electrode; 212. a working electrode; 220. a release layer; 230. a housing; 231. an upper housing; 232. a lower housing; 240. a needle assembly; 241. a puncture needle; 242. a hub; 243. a groove; 250. an electronic component; 251. a first portion; 252. a second portion; 253. a battery; 260. a first conductive portion; 261. a conductive cloth; 262. conducting bubbles; 270. a second conductive portion; 280. a third conductive portion; 300. a receiver; 400. an implanter unit; 500. a cap.

Detailed Description

The following description and examples detail some exemplary embodiments of the disclosed invention. Those skilled in the art will recognize that there are many variations and modifications of the present invention which are encompassed by its scope. Thus, the description of certain exemplary embodiments should not be considered as limiting the scope of the present invention.

Continuous blood glucose monitoring (CGM, continuous Glucose Monitoring) system

Referring to fig. 1, a schematic diagram of a continuous blood glucose monitoring system attached to a host 100 is shown. There is shown 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 by an adhesive layer. The body surface attachment unit 200 houses an electronic component 250 electrically connected to the sensor electrode 210 for transmitting the glucose concentration information monitored by the sensor electrode 210 to the receiver 300, and the receiver 300 may be typically a smart phone, a smart watch, a dedicated device, and the like. In use, the sensor electrode 210 is partially positioned under the skin of the host 100 and in contact with the subcutaneous tissue fluid.

Referring to fig. 2, which is a schematic structural view of a continuous blood glucose monitoring system, the continuous blood glucose monitoring system comprises an implant unit 400, a body surface attachment unit 200 and a cap 500, wherein the body surface attachment unit 200 is preloaded into the cap 500, and then the cap 500 is mounted on the implant unit 400 together, and when in use, the cap 500 is removed from the implant unit 400 by rotating the cap 500, and at the same time, the release layer 220 covering the adhesive layer of the body surface attachment unit 200 is peeled off together with the removal of the cap 500; the open side of the implant unit 400 is then adhered to the skin surface of the host 100, and the body surface attachment unit 200 within the implant unit 400 is applied to the skin surface of the host 100 by operating the implant unit 400, at which time the sensor electrode 210 is partially implanted subcutaneously in the host 100, in contact with the subcutaneous tissue fluid to continuously monitor the glucose concentration in the tissue fluid.

For example, the adhesive layer may be a medical nonwoven tape.

For example, the release layer 220 is a release paper or a release film, and a surface is coated with a release agent.

The body surface attachment unit 200 is described in detail below

Referring to fig. 3, which is a schematic cross-sectional view of the body surface attachment unit 200, the body surface attachment unit 200 includes a housing 230, and a sensor electrode 210 and a needle assembly 240 attached to the housing 230, the needle assembly 240 is configured to guide an in-vivo portion of the sensor electrode 210 into the skin of the host 100, an electronic component 250 is mounted in the housing 230, the electronic component 250 is mounted in the housing 230 after the sensor electrode 210 and the needle assembly 240 are sterilized by radiation, and the sensor electrode 210 is electrically connected to the electronic component 250.

The casing 230 includes an upper casing 231 and a lower casing 232, the upper casing 231 and the lower casing 232 may be fastened and fixed via a buckle, in order to improve the tightness of the casing 230, a rubber sealing ring may be configured at the connection between the upper casing 231 and the lower casing 232, and on this basis, a sealing glue may be coated at the connection between the upper casing 231 and the lower casing 232, so as to further improve the tightness of the casing 230, and prevent water vapor from entering the casing 230.

The sensor electrode 210 includes an in-vivo portion representing a portion that is introduced subcutaneously into the host 100 and in contact with subcutaneous tissue fluid, and an in-vitro portion representing a portion that is exposed subcutaneously to the host 100 and attached into the housing 230.

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

For the pre-sterilization stage, please refer to fig. 4, which includes mounting the sensor electrode 210 and the needle assembly 240 to the lower housing 232, wherein the outer portion of the sensor electrode 210 is adhered to the upper surface of the lower housing 232 by the first conductive part 260, and the inner 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, and the sensor electrode 210 includes a reference electrode 211 and a working electrode 212, wherein one first conductive member is electrically connected to the reference electrode 211, and the other first conductive member is electrically connected to the working electrode 212.

For example, the first conductive member includes a conductive cloth 261 attached to a double-sided adhesive tape on an upper surface of the lower case 232 and a conductive foam 262 attached to the conductive cloth 261, and an outer portion of the sensor electrode 210 is positioned between the conductive cloth 261 and the conductive foam 262 such that the outer portion of the sensor electrode 210 is wrapped by the conductive cloth 261 and the conductive foam 262 to form a good electrical connection.

Needle assembly 240 includes a lancet 241 and a hub 242, hub 242 being disposed at the blunt portion of lancet 241, the sidewall of lancet 241 being formed with a slot 243 extending to the sharp portion of lancet 241, the inner body portion of sensor electrode 210 being embedded into lancet 241 via slot 243 so as to be guided subcutaneously into host 100 following movement of lancet 241.

After the sensor electrode 210 and the needle assembly 240 are mounted to the lower housing 232, the lower housing 232 with the sensor electrode 210 and the needle assembly 240 is subjected to radiation sterilization, at which time the radiation sterilization does not harm the electronic components 250 since the electronic components 250 are not mounted.

For the post-sterilization stage, see fig. 3 and 5, the electronic component 250 includes a first portion 251 and a second portion 252, with sensor electronics at least partially located on the first portion 251, for example, the sensor electronics including a battery 253, a processor, conductive traces, and wireless communication circuitry. In one embodiment, the battery 253, the processor, and the wireless communication circuitry are all located on the first portion 251, with a portion of the conductive traces being located on the first portion 251 and a portion of the conductive traces being located on the second portion 252.

When the electronic part 250 is mounted, the first part 251 is first mounted on the upper surface of the lower case 232, the electrode signal input terminal is formed on the lower surface of the first part 251, and when the first part 251 is mounted on the upper surface of the lower case 232, the electrode signal input terminal is electrically connected with 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 portion 251 is installed, the second portion 252 is installed to the second portion 252 in a stacked manner. The battery 253 is mounted to the upper surface of the first portion 251 so as to be sandwiched by the first portion 251 and the second portion 252. The battery 253 is electrically connected with the electronic component 250 through the second conductive part 270, wherein the second conductive part 270 includes one second conductive member disposed on the upper surface of the first portion 251 and another second conductive member disposed on the lower surface of the second portion 252. In one embodiment, one second conductive member is electrically connected to one of the positive and negative electrodes of the battery 253, the other second conductive member is electrically connected to the other of the positive and negative electrodes of the battery 253, and the second conductive portion 270 constitutes a power input terminal of the electronic component 250.

A third conductive portion 280 is further disposed between the first portion 251 and the second portion 252, the third conductive portion 280 including one third conductive member disposed on an upper surface of the first portion 251 and another third conductive member disposed on a lower surface of the second portion 252. When the second portion 252 is mounted to the first portion 251, the two third conductive members abut each other. To this end, a complete electrical connection is achieved between the first portion 251 and the second portion 252, thereby forming a complete blood glucose signal transmission loop between the sensor electrode 210, the first portion 251 and the second portion 252. The third conductive part 280 functions to support the first part 251 and the second part 252 in addition to the function of electrical connection, and by the two third conductive members of the third conductive part 280 abutting each other, the second part 252 can be made almost parallel to the first part 251 when laminated to the first part 251.

The second conductive member and the third conductive member are made of conductive foam.

In other embodiments, conductive foam of the present invention may also be replaced with, for example, conductive rubber, conductive metal dome, conductive metal probe, and the like.

To reduce the thickness of the body surface attachment unit 200 of the present invention, the first portion 251 and the second portion 252 of the electronic component 250 may employ, for example, flexible circuit boards.

When the second part 252 is mounted, the upper housing 231 is mounted to the lower housing 232, and at this time, the upper housing 231 and the lower housing 232 perform a pressing action on the first part 251 and the second part 252, and since the conductive foam is made of an elastic conductive material such as conductive foam and can be compressed, the conductive foam can be compressed by the pressing action of the upper housing 231 and the lower housing 232, thereby improving the stability and effectiveness of the electrical connection. Finally, the body surface attachment unit 200 is mounted in the cap 500.

The foregoing description provides the best mode contemplated for carrying out the present invention, as well as the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains to make and use the same. However, the invention is susceptible to fully equivalent modifications and alternative constructions from the above description. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed. On the contrary, the invention covers all modifications and alternative constructions falling within the spirit and scope of the invention as generally expressed by the following claims, which particularly point out and distinctly define the subject matter of the invention. While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative and not restrictive.

Unless otherwise defined, all terms (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art and are not intended to be limited to one of ordinary skill in the art to which this application belongs unless explicitly defined herein. It should be noted that the use of a particular term when describing certain disclosed features or aspects should not be taken to imply that the term is being redefined herein to be restricted to including any disclosed features or aspects with which that term is associated. The terms and phrases used in the present application and variations thereof, particularly in the appended claims, should be construed in an open-ended, and not limiting sense, unless expressly stated otherwise. As an example of the foregoing, the term "comprising" shall mean "including but not limited to" or the like.

Furthermore, while the foregoing has been described in some detail by way of illustration and example for purposes of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be practiced. Therefore, the description and examples should not be considered as limiting the scope of the invention to the particular embodiments and examples described herein, but rather as covering all modifications and alternatives falling within the true scope and spirit of the invention.

Claims

1. A body surface attachment unit, comprising a housing, and a sensor electrode and a needle assembly attached to the housing, wherein the needle assembly is configured to guide the body portion of the sensor electrode into the subcutaneous tissue of a host, characterized in that: it also comprises an electronic component having an electrode signal input terminal, wherein the electronic component is installed in the housing after the sensor electrode and the needle assembly are sterilized by radiation, and the sensor electrode is electrically connected to the electronic component;

The housing comprises an upper housing and a lower housing, the external portion of the sensor electrode is attached to the upper surface of the lower housing via a first conductive portion, the internal portion of the sensor electrode extends out of the lower surface of the lower housing, and the electronic component is installed between the upper housing and the lower housing;

The upper housing and the lower housing exert a pressing force that causes the electronic component and the first conductive part to press against each other, thereby causing the electrode signal input terminal to be electrically connected to the first conductive part;

After the sensor electrode and the needle assembly are mounted on the lower housing, the lower housing with the sensor electrode and the needle assembly is sterilized by radiation, and then the electronic components are mounted to the lower housing, and then the upper housing is mounted to the lower housing.

2 . The body surface attachment unit according to claim 1 , wherein the external part of the sensor electrode is adhered to the upper surface of the lower shell via the first conductive part. 3 .

3. The body surface attachment unit according to claim 2 is characterized in that: the first conductive part includes two first conductive components, the sensor electrode includes a reference electrode and a working electrode, one of the first conductive components is electrically connected to the reference electrode, and the other first conductive component is electrically connected to the working electrode.

4. The body surface attachment unit according to claim 3 is characterized in that: the first conductive component includes a double-sided adhesive conductive cloth pasted on the upper surface of the lower shell and a conductive foam pasted on the conductive cloth, and the extracorporeal part of the sensor electrode is positioned between the conductive cloth and the conductive foam.

5. The body surface attachment unit according to claim 1 is characterized in that the electronic component includes a first part, a second part and a sensor electronic device at least partially configured on the upper surface of the first part in a stacked configuration, and the first part is superimposed on the extracorporeal part of the sensor electrode and is electrically connected to the extracorporeal part of the sensor electrode.

6 . The body surface attachment unit according to claim 5 , wherein the 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.

7. The body surface attachment unit according to claim 5, characterized in that the sensor electronic device includes a battery, a processor, conductive traces and a wireless communication circuit, and the battery is configured on the upper surface of the first part.

8. The body surface attachment unit according to claim 7 is characterized in that: the battery is electrically connected to the first part and the second part respectively through the second conductive part, the second conductive part includes a second conductive component arranged on the upper surface of the first part and another second conductive component arranged on the lower surface of the second part, wherein one second conductive component is electrically connected to one of the positive and negative poles of the battery, and the other second conductive component is electrically connected to the other of the positive and negative poles of the battery, and the second conductive part constitutes a power input terminal of the electronic component.

9. The body surface attachment unit according to claim 5 is characterized in that a third conductive part is also arranged between the first part and the second part, and the third conductive part includes a third conductive component arranged on the upper surface of the first part and another third conductive component arranged on the lower surface of the second part.

10 . The body surface attachment unit according to claim 5 , wherein the first part and the second part of the electronic component are flexible circuit boards.

11. A method for assembling a body surface attachment unit according to any one of claims 1 to 10, characterized in that it comprises:

The sensor electrode and needle assembly are attached to the housing of the body surface attachment unit before radiation sterilization of the sensor electrode and needle assembly, and the electronic components are installed in the housing of the body surface attachment unit after radiation sterilization of the sensor electrode and needle assembly.

12 . The method for assembling a body surface attachment unit according to claim 11 , wherein the electronic component is superimposed on the external part of the sensor electrode and is electrically connected to the external part of the sensor electrode.

13. The method for assembling a body surface attachment unit according to claim 11, characterized in that the electronic component is divided into a first part and a second part, and the second part is mounted on the first part in a stacked manner.