CN115541670A - Preparation method of dynamic glucometer sensor and implantable sensor - Google Patents

Preparation method of dynamic glucometer sensor and implantable sensor Download PDF

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Publication number
CN115541670A
CN115541670A CN202211232469.9A CN202211232469A CN115541670A CN 115541670 A CN115541670 A CN 115541670A CN 202211232469 A CN202211232469 A CN 202211232469A CN 115541670 A CN115541670 A CN 115541670A
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electrode
electrodes
sensor
substrate layer
needle
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于东方
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Shenzhen Youwei Health Technology Co ltd
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Shenzhen Youwei Health Technology Co ltd
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • 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
    • A61B5/1468—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 using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473—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 using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood

Abstract

The invention provides a preparation method of a dynamic glucometer sensor and an implanted sensor, comprising the following steps: (a) Forming N first electrodes, N second electrodes and N third electrodes on the surface of a base material layer, wherein N is an integer greater than or equal to 2, and the base material layer is made of a flexible insulating material; (b) Cutting the substrate layer to form a plurality of sensor units, wherein each sensor unit comprises a needle implanting part and an interface part; (c) A first drug coating is formed on the surface of the first electrode of the needle implanted portion of each sensor unit, and a second drug coating is formed on the surface of the third electrode of the needle implanted portion of each sensor unit. According to the invention, the working electrode and the reference electrode for signal acquisition are respectively formed on the two side surfaces of the flexible substrate layer, so that the width of the implanted needle part can be greatly reduced, the foreign body sensation after implantation is reduced, and the comfort level of long-time wearing is improved.

Description

Preparation method of dynamic glucometer sensor and implantable sensor
Technical Field
The invention relates to the field of blood glucose detection, in particular to a preparation method of a dynamic blood glucose meter sensor and an implantable sensor.
Background
Diabetes is a common metabolic endocrine disease, is caused by the lack of insulin or other receptor abnormalities in a human body, is mainly characterized by hyperglycemia, is a worldwide epidemic disease, and has a remarkably rising trend in recent years. The chronic hyperglycemia results in chronic damage and dysfunction of various tissues, particularly eyes, kidneys, heart, blood vessels and nerves.
Glucose detection is important for diabetics, and by glucose detection, it can be determined when to inject insulin to lower the glucose level in the body, or to supplement glucose to bring the glucose to normal levels. The currently adopted diagnosis method (one fasting blood glucose value and glucose tolerance experiment) has obvious defects, the misdiagnosis rate and the missed diagnosis rate are very high, only one time point of blood glucose can be measured each time, the blood glucose needs to be monitored for many times every day, and the blood glucose fluctuation condition can not be comprehensively known.
The dynamic glucometer can give a continuous blood glucose map, discover hidden hyperglycemia and hypoglycemia, provide all-round human blood glucose parameter information, provide accurate and comprehensive data for the diagnosis of diabetes, and further improve the diagnosis level. The method is helpful for doctors to know the influence of factors such as diet, exercise, medicine, mood fluctuation and the like of the diabetics on the blood sugar level and find out the reason of the blood sugar fluctuation, thereby scientifically formulating or adjusting corresponding medication, diet, exercise and monitoring schemes. Currently, ambulatory glucose meters are widely used in the glucose testing of diabetics.
In many conventional dynamic blood glucose meters, a sensor implanted under the skin converts the blood glucose level in the interstitial fluid into an electrical signal, and the electrical signal is stored, recorded, output, and the like. In the existing dynamic blood sugar sensor, a metal needle is usually adopted, however, the hardness of the metal needle is usually higher, and the metal needle needs to be kept under the skin for a long time, so that a patient often has foreign body sensation and is uncomfortable to wear.
Disclosure of Invention
The invention aims to solve the technical problem that the sensor of the dynamic blood glucose meter is uncomfortable to wear due to the adoption of a metal needle, and provides a preparation method of the sensor of the dynamic blood glucose meter and an implanted sensor.
The technical scheme for solving the technical problems is to provide a preparation method of a dynamic blood glucose meter sensor, which comprises the following steps:
(a) Forming N first electrodes, N second electrodes and N third electrodes on the surface of the base material layer, wherein N is an integer greater than or equal to 2; the substrate layer is made of a flexible insulating material, the first electrode is made of a first metal coating layer attached to the front surface of the substrate layer, the second electrode is made of a second metal coating layer attached to the front surface of the substrate layer, the third electrode is made of a second metal coating layer attached to the back surface of the substrate layer, and each third electrode is electrically connected with one second electrode;
(b) Cutting the substrate layer to form a plurality of sensor units, wherein each sensor unit comprises a needle implanting part and a connector part, the first electrode extends from the needle implanting part to the connector part on the front surface of the sensor unit, the second electrode is positioned on the front surface of the connector part, and the third electrode extends from the needle implanting part to the connector part on the back surface of the sensor unit and is electrically connected with the second electrode on the front surface of the connector part;
(c) And forming a first drug coating on the surface of the first electrode of the needle implantation part of each sensor unit, wherein the first drug coating and the first electrode jointly form a working electrode of the sensor unit, and forming a second drug coating on the surface of the third electrode of the needle implantation part of each sensor unit, and the second drug coating, the third electrode and the second electrode jointly form a reference electrode of the sensor.
As a further improvement of the present invention, the method further comprises:
at least one detection electrode is formed on the surface of the base material layer, each detection electrode is formed by a second metal coating which is attached to the back surface of the base material layer and is in a strip shape, a plurality of third electrodes are arranged on one side of the detection electrode side by side, and the plurality of third electrodes are respectively electrically connected with the detection electrode.
As a further improvement of the present invention, when the substrate layer is cut to form a plurality of sensor units, the substrate layer to which the detection electrodes are attached is cut to form connection portions, and the sensor units in which the plurality of third electrodes are electrically connected to the detection electrodes are connected through the connection portions; the method further comprises the following steps:
conducting conductivity detection on a plurality of sensor units respectively connected to the connection parts through the detection electrodes;
said step (c) is performed after the conductivity property test is passed; and after step (c) further comprising: the plurality of sensor units are separated from the connection portion and form a single body of the plurality of sensors.
As a further improvement of the present invention, the substrate layer includes a plurality of sets of through holes, when N first electrodes, N second electrodes, and N third electrodes are formed on the surface of the substrate layer, each of the first electrodes and one of the second electrodes correspond to one of the third electrodes in a projection area of the substrate layer, each of the sets of through holes is covered by one of the second electrodes and one of the third electrodes, and the second electrodes and the third electrodes are electrically connected through a second metal filled in the through holes.
As a further improvement of the present invention, the first metal coating layer is made of gold, and the first metal coating layer is attached to the surface of the substrate layer by an electroplating process;
the second metal coating layer is made of silver, and the second metal coating layer is attached to the surface of the base material layer through an electroplating process or a printing process.
As a further refinement of the present invention, the first drug coating comprises an enzyme-containing sensing material; the second drug coating layer contains a substance that prevents rejection in a human body.
As a further improvement of the present invention, when the substrate layer is cut to form a plurality of sensor units, the substrate layer is cut by a die cutting device to form at least one sensor group, and each sensor group includes a connecting portion and a plurality of sensor units connected to the connecting portion.
As a further improvement of the present invention, each of the third electrodes includes a needle-like portion corresponding to the needle implanted portion of the sensor unit and a sheet-like portion corresponding to the interface portion of the sensor unit;
the third electrodes and the detection electrodes on the surface of the base material layer are formed simultaneously, every two detection electrodes are arranged on the back surface of the base material layer in parallel, two third electrode groups are arranged between the two detection electrodes, and each third electrode group comprises a plurality of third electrodes which are arranged side by side; in the two third electrode groups, each third electrode group is adjacent to one detection electrode, and the sheet parts of all the third electrodes in the same third electrode group are positioned on a straight line parallel to the detection electrodes and are respectively connected with the detection electrodes; the needle-shaped parts of the third electrodes in the two third electrode groups are positioned between the two rows of sheet-shaped parts and are arranged in a staggered mode.
As a further improvement of the invention, the width of the needle implanting part is 0.2-0.4mm, and the width of the interface part is 5.0-8.0 mm; the first electrode and the third electrode are respectively in a 7 shape, the second electrode is in a rectangular shape, and the area of the second electrode is not less than 1.8 multiplied by 2.0mm.
The invention also provides an implanted sensor which is prepared by the preparation method of the dynamic glucometer sensor.
The invention has the following beneficial effects: the working electrode and the reference electrode used for signal acquisition are respectively formed on the surfaces of the two sides of the flexible base material layer, so that the width of the implanted needle part can be greatly reduced, the foreign body sensation after implantation is reduced, and the comfort level of wearing for a long time is improved.
Drawings
FIG. 1 is a schematic flow chart of a method for manufacturing a dynamic blood glucose meter sensor according to an embodiment of the present invention;
fig. 2 is a schematic structural diagram of the back surface of the base material layer in the method for manufacturing a dynamic blood glucose meter sensor according to an embodiment of the present invention;
fig. 3 is a schematic structural diagram of the front surface of the substrate layer in the method for manufacturing a dynamic blood glucose meter sensor according to an embodiment of the present invention;
FIG. 4 is a schematic view of an exploded structure of a sensor cell prepared by a method for manufacturing a dynamic blood glucose meter sensor according to an embodiment of the present invention;
fig. 5 is another schematic structural diagram of a sensor cell prepared by the method for preparing a dynamic blood glucose meter sensor according to an embodiment of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
Fig. 1 is a schematic flow chart of a method for manufacturing a dynamic blood glucose meter sensor according to an embodiment of the present invention, which can be used for manufacturing a sensor implanted under the skin of a human body and continuously monitoring blood glucose data of the human body. Specifically, the method for manufacturing the dynamic blood glucose meter sensor in the embodiment includes the following steps:
step S11: as shown in fig. 2 to 3, N first electrodes 22, N second electrodes 23, and N third electrodes 24 are formed on the surface of the substrate layer 21, where N is an integer greater than or equal to 2.
In the present embodiment, the base material layer 21 may be made of a flexible insulating material such as PET (Polyethylene terephthalate). The first electrodes 22 are formed of a first metal clad attached to the front surface of the substrate layer 21, the second electrodes 23 are formed of a second metal clad attached to the front surface of the substrate layer 21, the third electrodes 24 are formed of a second metal clad attached to the back surface of the substrate layer 21, and each of the third electrodes 24 is electrically connected to one of the second electrodes 23. I.e. the second electrode 23 and the third electrode 24 are composed of the same metal coating and the first electrode 22 is composed of a different metal coating.
In order to ensure the structural strength of the sensor and reduce the foreign body sensation after being implanted into the skin, the thickness of the substrate layer 21 may be set to 0.15 to 0.25mm.
Step S12: the substrate layer 21 is cut to form a plurality of sensor units, as shown in fig. 5, each sensor unit includes a needle implanting portion 281 and an interface portion 282, and on the front side of the sensor unit, the first electrode 22 extends from the needle implanting portion 281 to the interface portion 282, the second electrode 23 is located on the front side of the interface portion 282, and on the back side of the sensor unit, the third electrode 24 extends from the needle implanting portion 281 to the interface portion 282 and is electrically connected to the second electrode 23.
The width L1 of the needle implanting part 281 is 0.2-0.4mm to reduce the discomfort after the needle implanting part 281 is implanted into the human body, and the width L2 of the interface part 282 is 5.0-8.0 mm to ensure the stability of the connection with the printed circuit board. Meanwhile, in order to make the sensor unit contact the tissue fluid after being implanted into the skin, the length (height) L3 of the needle-implanted portion 281 of the sensor unit is 4.5 to 6mm, and the length (height) L4 of the interface portion 282 may be 2.0 to 3.0mm.
In particular, this step can cut the substrate layer 21 by a mechanical cutting device, which is not only faster than other methods (such as laser cutting, etc.), but also does not generate harmful substances to the substrate layer 21 due to the high temperature.
Step S13: a first drug coating 26 is formed on the surface of the first electrode 22 of the needle implanted portion 281 of each sensor unit, and the first drug coating 26 and the first electrode 22 jointly constitute a working electrode of the sensor unit, and a second drug coating 27 is formed on the surface of the third electrode 24 of the needle implanted portion 281 of each sensor unit, and the second drug coating 27, the third electrode 24 and the second electrode 23 jointly constitute a reference electrode of the sensor. Specifically, the first and second drug coatings 26 and 27 may be attached to the outer surfaces of the first and third electrodes 22 and 24, respectively, by mask printing or the like, and the first and second drug coatings 26 and 27 are attached only to the portions of the first and third electrodes 22 and 24 corresponding to the needle implanting portions 281.
In one embodiment of the present invention, the first drug coating 26 includes an enzyme-containing sensing material, for example, the first drug coating 26 may include glucose oxidase or dehydrogenase, etc.; while the second drug coating 27 contains a substance that prevents the human body from developing an rejection reaction, for example, the second drug coating 27 may include a substance that inhibits purine or pyrimidine synthesis, or the like.
Thus, when the needle-implanted portion 281 is implanted into the human body through a tool such as a hard needle, glucose in the human tissue fluid is converted into gluconolactone under the action of the first drug coating 26 (e.g., glucose oxidase or dehydrogenase), the enzyme is converted from an oxidized state to a reduced state, electrons are transferred in the process, the electrons are collected by the enzyme through a loop formed by the first electrode 22, the third electrode 24 and the second electrode 23, a voltage difference is collected by a collecting circuit such as a dynamic blood glucose meter, and the magnitude of the voltage difference has a certain linear corresponding relation with the concentration of the glucose, so that the concentration of the glucose in the human blood can be monitored. The second drug coating 27 on the outer surface of the third electrode 24 does not undergo an oxidation-reduction reaction with the tissue fluid of the human body, and releases a substance for preventing rejection reaction of the human body to the tissue fluid of the human body when contacting the tissue fluid of the human body. Thus, by detecting the voltage difference between the first electrode 22 and the second electrode 23 (i.e., the third electrode 24), the corresponding blood glucose value can be obtained.
According to the sensor prepared by the preparation method of the dynamic glucometer sensor, the working electrodes and the reference electrodes for signal acquisition are respectively formed on the surfaces of the two sides of the flexible substrate layer 21, and compared with a mode that the working electrodes and the reference electrodes are arranged on the same surface of the substrate layer, the width L1 of the needle implanting part 281 can be greatly reduced, so that foreign body sensation after implantation is reduced, and the comfort level of wearing for a long time is improved. Meanwhile, the first electrode 22 and the second electrode 23 for externally connecting a printed circuit board (PC) are positioned on the same surface of the substrate layer 21, which facilitates the connection of the sensor and the printed circuit board. And because there is no adhesive layer, and the second medicine coating 27 is added, the rejection reaction caused by long-time wearing can be prevented.
In one embodiment of the present invention, the first metal cladding layer is composed of gold (Au), and accordingly, the first metal cladding layer is attached to the surface of the base material layer 21 through a plating process, and the thickness of the first metal cladding layer is less than 0.05mm. Compared with other materials, the first metal coating adopts gold electroplated on the surface of the base material layer 21, so that the conductive performance is better, the adhesive capacity is strong, and compared with materials such as carbon, the first metal coating cannot fall off and influence the conductive performance even if being bent for many times, the physical and chemical properties of the gold are extremely stable, and cannot be oxidized even if long-time redox reaction occurs on the surface of the gold, and the generation of oxides which can be dissolved in human tissue fluid and cause harm to a human body can be avoided.
The second metal coating is composed of silver (Ag), and the thickness of the second metal coating is less than 0.05mm. The second metal overlay may be attached to the surface of the substrate layer 21 by a plating or printing process. The second metal coating layer is made of silver, so that the second metal coating layer has extremely high conductivity, and the second metal coating layer is not oxidized because the second drug coating layer 27 does not undergo redox reaction.
In one embodiment of the present invention, the first drug coating 26 may include an enzyme-containing sensing material layer (e.g., composed of glucose oxidase or dehydrogenase, etc.) and a diffusion-controlling layer, with the diffusion-controlling layer being located outside of the enzyme-containing sensing material layer, i.e., the enzyme-containing sensing material layer is located between the diffusion-controlling layer and the first electrode 22. The diffusion control layer can effectively reduce the amount of glucose diffused to the enzyme-containing sensing material layer according to a certain proportion, so that the sufficient amount of substances in the enzyme-containing sensing material layer is ensured, and the concentration of the glucose becomes a main (basically unique) factor for limiting the voltage of the electrode, so that the voltage can correctly reflect the concentration of the glucose, the linear range of the implantable sensor can be increased to a great extent, and the effective service life of the sensor is prolonged.
In one embodiment of the present invention, in addition to steps S11-S13, the method may further include: at least one detection electrode 25 is formed on the surface of the substrate layer 21, each detection electrode 25 is formed by a strip-shaped second metal coating layer attached to the back surface of the substrate layer 21, the plurality of third electrodes 24 are arranged side by side on one side of the detection electrode 25, and the plurality of third electrodes 24 are respectively electrically connected with the detection electrode 25. In practical applications, the detection electrode 25 may be formed simultaneously with the third electrode 24 in the same process.
Accordingly, in step S12, when the substrate layer 21 is cut to form a plurality of sensor units, the substrate layer 21 to which the detection electrodes 25 are attached is cut to form the connection portions 211, and the plurality of sensor units (the third electrodes 24 of the plurality of sensor units are electrically connected to the detection electrodes 25 of the connection portions 211, respectively) are connected by the connection portions 211. That is, when the substrate layer 21 is cut to form a plurality of sensor units in step S12, the substrate layer 21 is cut by a die cutting device to form at least one sensor group, and each sensor group includes a connection portion 211 and a plurality of sensor units connected to the connection portion 211.
Further, the method further includes, after step S12 and before step S13: the plurality of sensor units respectively connected to the connection portions 211 are subjected to conductivity detection by the detection electrodes 25. For example, the detecting electrode 25 and the plurality of second electrodes 23 may be sequentially connected to a circuit, and a conduction test may be performed, and if the voltage difference between the detecting electrode 25 and the second electrodes 23 is smaller than a predetermined value (e.g., 0V), it is determined that the conduction test passes.
Step S13 is only performed after the conductivity detection is passed; and step S13 is followed by: the plurality of sensor units are separated from the connection portion 211 and form a plurality of sensor units.
Referring to fig. 4, in an embodiment of the present invention, the substrate layer 21 includes a plurality of sets of through holes, in step S11, when N first electrodes, N second electrodes, and N third electrodes are formed on the surface of the substrate layer, a projection area of each of the first electrodes 22 and the second electrodes 23 on the substrate layer 21 corresponds to a projection area of each of the third electrodes 24 on the substrate layer 21, each set of through holes 213 is covered by one of the second electrodes 23 and one of the third electrodes 24, and the second electrodes 23 and the third electrodes 24 are electrically connected through the second metal filled in the through holes 213. In this way, the process and the structure of the sensor can be simplified.
In one embodiment of the present invention, as shown in fig. 2, each third electrode 24 includes a needle portion 241 corresponding to the implanting portion 281 of the sensor unit and a sheet portion 242 corresponding to the interface portion 282 of the sensor unit, and in particular, the sheet portion 242 may be rectangular, for example, the needle portion 241 and the sheet portion 242 are connected to form a 7-shape, that is, one side edge of the needle portion 241 is flush with the edge of the corresponding side of the sheet portion 242, in order to save material.
Accordingly, each first electrode 22 also includes a needle portion 221 corresponding to the needle-implanted portion 281 of the sensor unit and a sheet portion 222 corresponding to the interface portion 282 of the sensor unit, i.e., the first electrode 22 and the third electrode 24 are respectively 7-shaped, and the second electrode 23 is rectangular. The implanting part 281 and the interface part 282 of the sensor unit cut and formed in step S12 are also connected in a 7-shape.
Through the structure, the wound of the needle implanting part 281 when being implanted into the human body can be ensured to be small, meanwhile, the needle implanting part 281 is enabled to provide enough surface area for the first drug coating 26 and the second drug coating 27 to be attached, and the first drug coating 26 is enabled to react with glucose in human tissue fluid, so that enough voltage difference is formed between the working electrode and the reference electrode. Moreover, the 7-shaped structure is also beneficial to the production and the manufacture of the sensor, for example, the edge position only needs to be cut in sequence. Of course, in practical applications, the needle implanting portion 281 and the interface portion 282 may be connected in a T-shape or the like.
In order to ensure the stability and reliability of the conductive connection between the sensor and the printed circuit board, the sizes of the sheet portion 222 of the first electrode 22 and the second electrode 23 are not less than 1.8 × 2.0mm, i.e. the surface areas of the first electrode 22 and the second electrode 23 on the front surface of the interface portion 282 are not less than 1.8 × 2.0mm.
In step S12, the third electrodes 24 and the detection electrodes 25 on the surface of the substrate layer 21 are formed simultaneously, every two detection electrodes 25 are arranged in parallel on the back surface of the substrate layer 21, and two third electrode groups are arranged between the two detection electrodes 25, and each third electrode group includes a plurality of third electrodes 24 arranged side by side. In the two third electrode groups, each third electrode group is adjacent to one detection electrode 25, and the tab portions 242 of all the third electrodes 24 in the same third electrode group are located on a straight line parallel to the detection electrodes 25 and are connected to the detection electrodes 25, respectively. The needle portions 241 of the third electrodes 24 in the two third electrode groups are located between the two rows of the sheet portions 242 and are staggered.
Referring to fig. 4 to 5, the present invention further provides an implantable sensor, which is prepared by the above-mentioned method for preparing a dynamic blood glucose meter sensor. Specifically, the implantable sensor includes a substrate layer 21, a first electrode 22, a second electrode 23, a third electrode 24, a first drug coating 26 and a second drug coating 27, wherein the first electrode 22 is attached to the front surface of the substrate layer 21 and extends from the needle implantation portion 281 to the front surface of the interface portion 282, the second electrode 23 is attached to the front surface of the interface portion 282 and is insulated from the first electrode 22, the third electrode 24 is attached to the back surface of the substrate layer 21 and extends from the back surface of the needle implantation portion 281 to the back surface of the interface portion 282, and the third electrode 24 is electrically connected to the second electrode 23. The first drug coating 26 is attached to the outer surface of the first electrode 22 of the needle portion 281, and the second drug coating 27 is attached to the outer surface of the third electrode 24 of the interface portion 282.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims (10)

1. A preparation method of a dynamic blood glucose meter sensor is characterized by comprising the following steps:
(a) Forming N first electrodes, N second electrodes and N third electrodes on the surface of the base material layer, wherein N is an integer greater than or equal to 2; the substrate layer is made of a flexible insulating material, the first electrode is made of a first metal coating layer attached to the front surface of the substrate layer, the second electrode is made of a second metal coating layer attached to the front surface of the substrate layer, the third electrode is made of a second metal coating layer attached to the back surface of the substrate layer, and each third electrode is electrically connected with one second electrode;
(b) Cutting the substrate layer to form a plurality of sensor units, wherein each sensor unit comprises a needle implanting part and a connector part, the first electrode extends from the needle implanting part to the connector part on the front side of the sensor unit, the second electrode is positioned on the front side of the connector part, and the third electrode extends from the needle implanting part to the connector part on the back side of the sensor unit and is electrically connected with the second electrode on the front side of the connector part;
(c) And forming a first drug coating on the surface of the first electrode of the needle implantation part of each sensor unit, wherein the first drug coating and the first electrode jointly form a working electrode of the sensor unit, and forming a second drug coating on the surface of the third electrode of the needle implantation part of each sensor unit, and the second drug coating, the third electrode and the second electrode jointly form a reference electrode of the sensor.
2. The method of manufacturing a dynamic blood glucose meter sensor of claim 1, further comprising:
at least one detection electrode is formed on the surface of the base material layer, each detection electrode is formed by a second metal coating which is attached to the back surface of the base material layer and is in a strip shape, a plurality of third electrodes are arranged on one side of the detection electrode side by side, and the plurality of third electrodes are respectively electrically connected with the detection electrode.
3. The method of manufacturing a dynamic blood glucose meter sensor according to claim 2, wherein when the substrate layer is cut to form a plurality of sensor units, the substrate layer to which the detection electrodes are attached is cut to form connection portions, and the sensor units to which the plurality of third electrodes are electrically connected to the detection electrodes are connected by the connection portions; the method further comprises the following steps:
conducting conductivity detection on a plurality of sensor units respectively connected to the connection parts through the detection electrodes;
said step (c) is performed after the conductivity property test is passed; and said step (c) is further followed by: the plurality of sensor units are separated from the connection portion and form a single body of the plurality of sensors.
4. The method of claim 1, wherein the substrate layer includes a plurality of sets of through holes, when N first electrodes, N second electrodes, and N third electrodes are formed on the surface of the substrate layer, each of the first electrodes and the second electrodes corresponds to one of the third electrodes in the projection area of the substrate layer, each set of through holes is covered by one of the second electrodes and one of the third electrodes, and the second electrodes and the third electrodes are electrically connected through the second metal filled in the through holes.
5. The manufacturing method of dynamic blood glucose meter sensor according to claim 1, wherein the first metal coating layer is made of gold, and the first metal coating layer is attached to the surface of the substrate layer by an electroplating process;
the second metal coating layer is made of silver, and the second metal coating layer is attached to the surface of the base material layer through an electroplating process or a printing process.
6. The method of making a dynamic blood glucose meter sensor of claim 5, wherein the first drug coating comprises an enzyme-containing sensing material; the second drug coating layer contains a substance that prevents rejection in a human body.
7. The manufacturing method of dynamic blood glucose meter sensor according to claim 3, wherein when the substrate layer is cut to form a plurality of sensor units, the substrate layer is cut by a die cutting device to form at least one sensor group, each sensor group comprises a connecting portion and a plurality of sensor units connected to the connecting portion.
8. The manufacturing method of dynamic blood glucose meter sensor according to claim 3, wherein each of the third electrodes includes a needle-like portion corresponding to the needle implanting portion of the sensor unit and a sheet-like portion corresponding to the interface portion of the sensor unit;
the third electrodes and the detection electrodes on the surface of the base material layer are formed simultaneously, every two detection electrodes are arranged on the back surface of the base material layer in parallel, two third electrode groups are arranged between the two detection electrodes, and each third electrode group comprises a plurality of third electrodes arranged side by side; in the two third electrode groups, each third electrode group is adjacent to one detection electrode, and the sheet parts of all the third electrodes in the same third electrode group are positioned on a straight line parallel to the detection electrodes and are respectively connected with the detection electrodes; the needle-shaped parts of the third electrodes in the two third electrode groups are positioned between the two rows of sheet-shaped parts and are arranged in a staggered mode.
9. The method for manufacturing a dynamic blood glucose meter sensor according to claim 1, wherein the width of the needle implanting part is 0.2-0.4mm, and the width of the interface part is 5.0-8.0 mm; the first electrode and the third electrode are respectively in a 7 shape, the second electrode is in a rectangular shape, and the area of the second electrode is not less than 1.8 multiplied by 2.0mm.
10. An implantable sensor prepared by the method of preparing a dynamic blood glucose meter sensor according to any one of claims 1-9.
CN202211232469.9A 2022-10-09 2022-10-09 Preparation method of dynamic glucometer sensor and implantable sensor Pending CN115541670A (en)

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CN202211232469.9A CN115541670A (en) 2022-10-09 2022-10-09 Preparation method of dynamic glucometer sensor and implantable sensor

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