CN114391839A - Body surface attachment unit and method of assembling the same - Google Patents
Body surface attachment unit and method of assembling the same Download PDFInfo
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- CN114391839A CN114391839A CN202111529186.6A CN202111529186A CN114391839A CN 114391839 A CN114391839 A CN 114391839A CN 202111529186 A CN202111529186 A CN 202111529186A CN 114391839 A CN114391839 A CN 114391839A
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Images
Classifications
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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
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- 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
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- 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
Abstract
A body surface attachment unit includes a housing, and a sensor electrode and a needle assembly attached to the housing, the needle assembly being configured to guide an internal portion of the sensor electrode into a subcutaneous region of a host, and an electronic component mounted in the housing after the sensor electrode and the needle assembly are radiation sterilized, the sensor electrode being electrically connected to the electronic component. The invention can avoid damaging the electronic components when the sensor electrodes are subjected to radiation sterilization, and the body surface attachment unit has smaller volume.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a body surface attaching unit and an assembling method thereof.
Background
Some physiological diseases, which have long disease course and prolonged disease duration, need to monitor some physiological parameters of the host in real time to better track the treatment. Such as diabetes, require real-time monitoring of the host blood glucose. Accurate blood sugar self-monitoring is a key for realizing good blood sugar control, is beneficial to evaluating the degree of glucose metabolism disorder of a diabetic patient, formulating a blood sugar reduction scheme, and simultaneously reflecting the blood sugar reduction treatment effect and guiding the adjustment of the treatment scheme.
Currently, most commercially available instruments refer to blood glucose meters, and patients need to collect finger peripheral blood by themselves to measure the blood glucose level at that moment. However, this method has the following drawbacks: firstly, the change of the blood sugar level between two measurements cannot be known, and the peak value and the valley value of the blood sugar can be missed by a patient, so that complications are caused, and irreversible damage is caused to the patient; secondly, the finger tip puncture blood sampling is carried out for a plurality of times every day, which causes great pain for the diabetic. In order to overcome the above-mentioned drawbacks, it is necessary to provide a method for continuously monitoring blood sugar of a patient, so that the patient can conveniently know the blood sugar status of the patient in real time, and take measures in time to effectively control the state of an illness and prevent complications, thereby achieving a high quality of life.
In view of the above-mentioned needs, the technical staff developed a continuous blood glucose monitoring system that can be implanted into subcutaneous tissue for continuous monitoring of subcutaneous blood glucose, the system applied a body surface attachment unit to the surface of the skin of a host by an implanter, sensor electrodes attached to the body surface attachment unit were then penetrated into the subcutaneous tissue, the sensor electrodes generated an oxidation reaction between interstitial fluid of a patient and glucose in the body, an electrical signal was formed upon the reaction, the electrical signal was converted into a blood glucose reading by an electronic component, the blood glucose reading was transmitted to a wireless receiver every 1-5 minutes, corresponding blood glucose data and a map were displayed on the wireless receiver for the patient and the doctor to refer.
The existing continuous blood glucose monitoring system attaches the sensor electrode to the body surface attachment unit in a pre-connection manner and pre-connects the sensor electrode with the electronic component on the body surface attachment unit, and the body surface attachment unit adopting the structure is easy to damage the electronic component when the sensor electrode is subjected to radiation sterilization. In addition, at present, electronic components are generally arranged on a PCB, and such an arrangement causes the existing body surface attachment unit to have a large volume, which affects the wearing comfort.
Disclosure of Invention
An object of the present invention is to provide a body surface attachment unit and an assembling method thereof, which can prevent the electronic parts from being damaged when the sensor electrodes are subjected to radiation sterilization, and which is more compact in size.
In order to achieve the purpose of the invention, the technical scheme adopted by the invention is as follows: a body surface attachment unit includes a housing, and a sensor electrode and a needle assembly attached to the housing, the needle assembly configured to guide an internal body portion of the sensor electrode into a subcutaneous region of a host, and an electronic component mounted in the housing after the sensor electrode and the needle assembly are sterilized by radiation, the sensor electrode being electrically connected to the electronic component.
In the above technical solution, the housing includes an upper case and a lower case, the external portion of the sensor electrode is attached to the upper surface of the lower case, and the internal portion of the sensor electrode protrudes from the lower surface of the lower case.
In the above technical solution, the outer portion of the sensor electrode is adhered to the upper surface of the lower case through the first conductive portion.
In the above technical solution, 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 is electrically connected to the reference electrode, and the other first conductive member is electrically connected to the working electrode.
In the above technical solution, the first conductive member includes a conductive cloth pasted on the upper surface of the lower case and a conductive foam pasted on the conductive cloth, and the external portion 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, a second portion and a sensor electronic component, the first portion, the second portion and the sensor electronic component are stacked and disposed on an upper surface of the first portion, and the first portion is stacked on an external portion of the sensor electrode and electrically connected to the external portion of the sensor electrode.
In the above technical solution, an electrode signal input terminal is formed on a lower surface of the first portion, and the first portion is electrically connected to an external portion of the sensor electrode through the electrode signal input terminal.
In the above solution, the sensor electronics includes a battery, a processor, conductive traces, and a wireless communication circuit, the battery being disposed on the 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, the second conductive portion includes one second conductive member disposed on the upper surface of the first portion and another second conductive member disposed on the lower surface of the second portion, wherein the one second conductive member is electrically connected to one of a positive electrode and a negative electrode of the battery, the another second conductive member is electrically connected to the other of the positive electrode and the negative electrode of the battery, and the second conductive portion constitutes 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 the upper surface of the first portion and another third conductive member disposed on the 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, including attaching a sensor electrode and a needle assembly to a housing of the body surface attachment unit before radiation sterilizing the sensor electrode and the needle assembly, and mounting electronic components into the housing of the body surface attachment unit after radiation sterilizing 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:
the invention can effectively avoid the harm to the electronic components caused by radiation sterilization by installing the electronic components in the shell of the body surface attachment unit after the sensor electrodes and the needle assembly are subjected to radiation sterilization; the electronic component is divided into a first part and a second part which are mounted in a laminating way, and the sensor electronic component is clamped between the first part and the second part, so that the space utilization rate is effectively improved, and the volume of the body surface attaching unit is smaller; and the electronic components are superposed on the external part of the sensor electrode, so that the mounting operation is simplified while effective electric connection is ensured, and the assembly efficiency is improved.
Drawings
FIG. 1 is a schematic diagram of a continuous blood glucose monitoring system according to an embodiment of the present invention.
Fig. 2 is a schematic structural diagram of a continuous blood glucose monitoring system according to an embodiment of the present invention.
Fig. 3 is a 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 a needle assembly of an embodiment of the present invention.
Fig. 5 is a schematic view of the body surface attaching unit mounting the electronic parts 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. puncturing 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. a conductive bubble; 270. a second conductive portion; 280. a third conductive portion; 300. a receiver; 400. an implanter unit; 500. and (4) a cap.
Detailed Description
The following description and examples detail certain exemplary embodiments of the disclosed invention. Those skilled in the art will recognize that there are numerous variations and modifications of the present invention encompassed by its scope. Accordingly, the description of a certain exemplary embodiment should not be taken as limiting the scope of the invention.
Continuous blood Glucose Monitoring (CGM) system
Referring to FIG. 1, a schematic of a continuous blood glucose monitoring system attached to a host 100 is shown. A continuous blood glucose monitoring system comprising a body surface attachment unit 200 with sensor electrodes 210 is shown attached to the skin surface of a host 100 by an adhesive layer. The body surface attachment unit 200 houses electronic components 250 electrically connected to the sensor electrodes 210 for transmitting information on the glucose concentration monitored by the sensor electrodes 210 to the receiver 300, which receiver 300 may typically be a smart phone, a smart watch, a dedicated device, and the like. During use, the sensor electrodes 210 are positioned partially beneath the skin of the host 100, in contact with subcutaneous interstitial fluid.
FIG. 2 is a schematic view of a continuous blood glucose monitoring system, comprising an implanter unit 400, a body surface attachment unit 200 and a cap 500, wherein the body surface attachment unit 200 is pre-assembled in the cap 500 and then mounted on the implanter unit 400 together with the cap 500, and when in use, the cap 500 is removed from the implanter 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 implanter unit 400 is then fitted to the skin surface of the host 100, and the body surface attachment unit 200 inside the implanter unit 400 is applied to the skin surface of the host 100 by operating the implanter unit 400 while the sensor electrodes 210 are partially implanted under the skin of 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 grade nonwoven tape.
For example, the release layer 220 is release paper or release film, and the surface is coated with a release agent.
The body surface attachment unit 200 will be described in detail below
Referring to fig. 3, which is a schematic 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 internal portion of the sensor electrode 210 into the subcutaneous space 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 radiation sterilized, and the sensor electrode 210 is electrically connected to the electronic component 250.
The shell 230 includes upper casing 231 and lower casing 232, and upper casing 231 can be fixed through buckle connection with lower casing 232, for the leakproofness of promotion shell 230, can dispose rubber seal at the junction of upper casing 231 and lower casing 232, can also coat sealed glue at the junction of upper casing 231 and lower casing 232 on this basis to further promote the leakproofness of shell 230, prevent that steam from entering into inside the shell 230.
The sensor electrode 210 includes an in-vivo portion, which means a portion introduced under the skin of the host 100 and in contact with subcutaneous tissue fluid, and an in-vitro portion, which means a portion exposed outside the skin of the host 100 and attached in the housing 230.
The assembly of the body surface attachment unit 200 of the present invention comprises two stages: a pre-sterilization stage and a post-sterilization stage.
Referring to fig. 4, the pre-sterilization stage includes mounting the sensor electrode 210 and the needle assembly 240 on the lower housing 232, wherein the external portion of the sensor electrode 210 is adhered to the upper surface of the lower housing 232 by the first conductive portion 260, and the internal portion of the sensor electrode 210 protrudes from the lower surface of the lower housing 232.
In one embodiment, the first conductive portion 260 includes two first conductive members, and the sensor electrode 210 includes a reference electrode 211 and a working electrode 212, wherein 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 working electrode 212.
For example, the first conductive member includes a double-sided adhesive-backed conductive cloth 261 adhered on the upper surface of the lower case 232 and a conductive foam 262 adhered on the conductive cloth 261, and the external portion of the sensor electrode 210 is positioned between the conductive cloth 261 and the conductive foam 262, so that the external portion of the sensor electrode 210 is wrapped by the conductive cloth 261 and the conductive foam 262, forming a good electrical connection.
The needle assembly 240 includes a puncture needle 241 and a hub 242, the hub 242 is disposed at a blunt portion of the puncture needle 241, a groove 243 extending to a sharp portion of the puncture needle 241 is formed on a sidewall of the puncture needle 241, and an in-vivo portion of the sensor electrode 210 is embedded into the puncture needle 241 through the groove 243, thereby being introduced subcutaneously into the host 100 following the movement of the puncture needle 241.
After the sensor electrode 210 and the needle assembly 240 are mounted on the lower case 232, the lower case 232 with the sensor electrode 210 and the needle assembly 240 is subjected to radiation sterilization, at which time the electronic component 250 is not damaged by the radiation sterilization because the electronic component 250 is not mounted.
For the post-sterilization stage, referring to fig. 3 and 5, the electronics 250 include 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, processor, and wireless communication circuitry are located on the first portion 251, with portions of the conductive traces located on the first portion 251 and portions of the conductive traces located on the second portion 252.
When the electronic component 250 is mounted, the first part 251 is 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, 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 in a stacked manner on the second portion 252. 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 to the electronic component 250 through a second conductive portion 270, wherein the second conductive portion 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 also disposed between the first portion 251 and the second portion 252, the third conductive portion 280 including one third conductive member disposed on the upper surface of the first portion 251 and another third conductive member disposed on the 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 made between the first portion 251 and the second portion 252, thereby forming a complete blood glucose signal transmission circuit 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 the second part 252 can be made almost parallel to the first part 251 when laminated onto the first part 251 by the two third conductive members of the third conductive part 280 abutting against each other.
The second conductive component and the third conductive component are both made of conductive foam.
In other embodiments, for example, conductive rubber, conductive metal spring, conductive metal probe, etc. may be used instead of the conductive foam of the present invention.
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.
After the second part 252 is installed, the upper shell 231 is installed on the lower shell 232, and at this time, the upper shell 231 and the lower shell 232 perform a pressing function on the first part 251 and the second part 252, since the electrical connection of the present invention uses an elastic conductive material, such as conductive foam, which is compressible, the conductive foam can be compressed by the pressing function of the upper shell 231 and the lower shell 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, in such full, clear, concise and exact terms, provides the best mode contemplated of carrying out the present invention, and the manner and process of making and using it, to enable any person skilled in the art to which it pertains, to make and use the same. The invention is, however, susceptible to modifications and alternative constructions from that described above which are fully equivalent. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed. Rather, the invention is to cover 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) are to be given their ordinary and customary meaning to those skilled in the art, and are not to be taken as limiting to a specific or special meaning unless expressly defined herein. It should be noted that the use of particular terminology when describing certain features or aspects of the disclosure should not be taken to imply that the terminology is being redefined herein to be restricted to including any specific characteristics or aspects of the disclosure with which that terminology is associated. The terms and phrases used in this application, and variations thereof, particularly in the appended claims, should be construed to be open ended and not limiting unless otherwise expressly stated. As an example of the foregoing, the term "including" shall mean "including but not limited to" or the like.
Furthermore, although 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 of ordinary skill in the art that certain changes and modifications may be practiced. Therefore, the description and examples should not be construed 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 (14)
1. A body surface attachment unit comprising a housing, and a sensor electrode and a needle assembly attached to the housing, the needle assembly configured to introduce an intracorporeal portion of the sensor electrode subcutaneously into a host, characterized in that: also included are electronic components mounted in the housing after the sensor electrodes and the needle assembly are radiation sterilized, the sensor electrodes being electrically connected to the electronic components.
2. The body surface attachment unit of claim 1, wherein: the housing includes an upper case and a lower case, the external portion of the sensor electrode is attached to an upper surface of the lower case, and the internal portion of the sensor electrode protrudes out of a lower surface of the lower case.
3. The body surface attachment unit of claim 2, wherein: the outer part of the sensor electrode is pasted on the upper surface of the lower shell through the first conducting part.
4. The body surface attachment unit of claim 3, wherein: the first conductive part comprises two first conductive components, the sensor electrode comprises a reference electrode and a working electrode, one of the first conductive components is electrically connected with the reference electrode, and the other first conductive component is electrically connected with the working electrode.
5. The body surface attachment unit of claim 4, wherein: the first conductive component comprises conductive cloth pasted on the upper surface of the lower shell and conductive foam pasted on the conductive cloth, and the external part of the sensor electrode is positioned between the conductive cloth and the conductive foam.
6. The body surface attachment unit of claim 1, wherein: the electronic component includes a first portion, a second portion, and sensor electronics disposed at least partially on an upper surface of the first portion in a stacked configuration, the first portion overlying and electrically connected to an extracorporeal portion of the sensor electrode.
7. The body surface attachment unit of 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 with the external part of the sensor electrode through the electrode signal input terminal.
8. The body surface attachment unit of claim 6, wherein: the sensor electronics include a battery, a processor, conductive traces, and wireless communication circuitry, the battery being disposed on the upper surface of the first portion.
9. The body surface attachment unit of claim 8, wherein: the battery is electrically connected with the first part and the second part respectively through a second conductive part, the second conductive part comprises 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 the second conductive component is electrically connected with one of the positive pole and the negative pole of the battery, the second conductive component is electrically connected with the other of the positive pole and the negative pole of the battery, and the second conductive part forms a power input terminal of the electronic component.
10. The body surface attachment unit of claim 6, wherein: a third conductive portion is also disposed between the first portion and the second portion, the third conductive portion including 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.
11. The body surface attachment unit of claim 6, wherein: the first and second portions of the electronic component are flexible circuit boards.
12. A method of assembling a body surface attachment unit, characterized by: including attaching the sensor electrodes and the needle assembly to a housing of the body surface attachment unit before radiation sterilizing the sensor electrodes and the needle assembly, and mounting electronic components into the housing of the body surface attachment unit after radiation sterilizing the sensor electrodes and the needle assembly.
13. The method of assembling a body surface attachment unit of claim 12, wherein: and superposing the electronic component on the external part of the sensor electrode and electrically connecting the electronic component with the external part of the sensor electrode.
14. The method of assembling a body surface attachment unit of claim 12, wherein: 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.
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CN202111529186.6A CN114391839A (en) | 2021-12-14 | 2021-12-14 | Body surface attachment unit and method of assembling the same |
PCT/CN2022/082920 WO2023108944A1 (en) | 2021-12-14 | 2022-03-25 | Body surface attachment unit and assembly method therefor |
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CN202111529186.6A CN114391839A (en) | 2021-12-14 | 2021-12-14 | Body surface attachment unit and method of assembling the same |
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- 2021-12-14 CN CN202111529186.6A patent/CN114391839A/en active Pending
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- 2022-03-25 WO PCT/CN2022/082920 patent/WO2023108944A1/en unknown
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