CN115856048A - Method for manufacturing microneedle biosensor including passivation layer - Google Patents
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- CN115856048A CN115856048A CN202210656270.2A CN202210656270A CN115856048A CN 115856048 A CN115856048 A CN 115856048A CN 202210656270 A CN202210656270 A CN 202210656270A CN 115856048 A CN115856048 A CN 115856048A
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- 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
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- A—HUMAN NECESSITIES
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Abstract
The invention provides a method for manufacturing a microneedle biosensor comprising a passivation layer, which comprises the following steps: a) Forming grooves corresponding to the shapes of the micro needles of the working electrode, the counter electrode and the reference electrode on the solid resin block to form a mold; b) Respectively imprinting the working electrode, the counter electrode and the reference electrode on the mold by using acrylic or PLA; c) Forming a shadow mask corresponding to the patterns of the working electrode, the counter electrode and the reference electrode, and sputtering an Au or Au + Ti/Cr bonding layer to form a metal electrode layer; and d) forming a passivation layer on the metal electrode layer.
Description
Technical Field
The present invention relates to a method of manufacturing a microneedle biosensor including a passivation layer.
Background
In order to diagnose and manage diabetes so that it does not develop into complications, systemic blood glucose measurements and treatment should be performed simultaneously. Generally, disease management of diabetes is performed by setting an insulin injection amount according to a blood glucose level of a patient and administering insulin at predetermined time intervals. However, since the blood glucose level of each patient and the blood glucose change depending on the administration of insulin are different for each patient, there is a problem that it is difficult to accurately and efficiently determine the dose of insulin, the timing of administration, and the interval.
To solve these problems, a Continuous Glucose Monitoring (CGM) system may be used. Continuous glucose monitors were first developed by Medtronic, minneapolis, MN, USA and approved by the FDA in the united states 6 months 1999, and are useful in the treatment of diabetic patients with large blood glucose excursions and frequent hypoglycemia. The continuous blood sugar monitor consists of three parts, namely a blood sugar sensor, a wireless transmitter and a receiver. The sensor was inserted into subcutaneous fat and the sugar was measured in the interstitial fluid. The latest versions of continuous glucose monitors display glucose readings in real time so that appropriate action can be taken immediately.
Existing continuous blood glucose monitoring devices include: a sensor inserted into a body to measure blood glucose in blood; a needle that guides the sensor for insertion into the body; and further an applicator attachment structure for applying the sensor module to the body. The sensor is disposed in a central bore of the syringe needle and is inserted into the subcutaneous fat by subcutaneous penetration of the syringe needle. The sensor is disposed in the central bore of the syringe needle. Since the size of a syringe needle used in the detection of blood glucose reaches 21 Gauge (Gauge) and a sensing strip must be disposed in the central hole of the syringe needle, the syringe needle used as a sensor needle of a continuous blood glucose measuring device is generally 600nm to 800nm in diameter. When the diameter of the sensor needle is 600nm to 800nm, there is a problem that pain is given to a user and unpleasant in continuous use.
Disclosure of Invention
Technical problem to be solved
The present invention has been made to solve the above-described problems of the prior art, and an object of the present invention is to provide a method for manufacturing a microneedle biosensor, which can reduce pain of a user when the microneedle biosensor is worn with minimal invasion.
Means for solving the problems
In order to achieve the above object, the present invention provides a method for manufacturing a microneedle biosensor including a passivation layer, characterized in that,
the microneedle biosensor includes:
a working electrode, a counter electrode and a reference electrode,
the working electrode includes: the first substrate is a circular film; a plurality of microneedles vertically protruding on the first substrate; and a first wiring extending from one end of the circumference of the first substrate;
the counter electrode includes: the second substrate is concentric with the first substrate, the second substrate and the first substrate are spaced at a set distance from each other at the circumference of the first substrate, and the second substrate is a 3/4-circumference strip-shaped film; a plurality of microneedles vertically protruding on the second substrate; and a second wiring extending from one end of the second substrate to be arranged horizontally with the first wiring;
the reference electrode includes: the third substrate is concentric with the first substrate, the third substrate is spaced from the other end of the second substrate by a set distance, the third substrate is spaced from the circumference of the first substrate by a set distance, and the third substrate is a strip-shaped film with 1/4 of the circumference; a plurality of microneedles vertically protruding on the third substrate; and a third wiring extending from one end of the third substrate;
the manufacturing method comprises the following steps:
a) Forming grooves corresponding to the shapes of the micro needles of the working electrode, the counter electrode and the reference electrode on the solid resin block to form a mold;
b) Respectively imprinting the working electrode, the counter electrode and the reference electrode on the mold by using acrylic or PLA;
c) Forming a shadow mask corresponding to the patterns of the working electrode, the counter electrode and the reference electrode and sputtering an Au or Au + Ti/Cr adhesive layer to form a metal electrode layer; and
d) Forming a passivation layer on the metal electrode layer,
the step of forming the passivation layer comprises the following processes:
a plastic adhesive tape and a PET (polyethylene terephthalate) layer, each having an adhesive layer formed on one surface of the metal electrode layer, wherein holes are formed at the positions of the microneedles of the working electrode 110, the counter electrode 120, and the reference electrode 130 in a size smaller than the thickest diameter of the microneedles;
inserting the microneedles into the holes so that the adhesive surface of the plastic adhesive tape formed with the holes is in contact with a substrate, and then inserting the microneedles into the holes of the PET layer;
the top of the PET layer was pressed with an elastomer and the pressing was continued in this state on a heated hot plate.
Provided is a method for manufacturing a microneedle biosensor including a passivation layer, wherein bottom surfaces of the first, second, and third substrates are attached to an adhesive sheet.
There is provided a method of manufacturing a microneedle biosensor including a passivation layer, wherein the first wire extends vertically at one end of the circumference of the first substrate, the second wire extends from one end of the second substrate to be arranged horizontally with the first wire, and the third wire extends from one end of the third substrate to be arranged horizontally with the first wire.
Provided is a method for manufacturing a microneedle biosensor including a passivation layer, wherein the hot plate is at 80-200 ℃ and the elastomer is pressurized for 3-60 seconds.
ADVANTAGEOUS EFFECTS OF INVENTION
According to the embodiments of the present invention configured as described above, it is possible to provide a method of manufacturing a microneedle biosensor including a passivation layer, which can reduce pain of a user while performing accurate sensing and is most suitable for a skin surface shape when worn.
Drawings
Fig. 1 is a diagram illustrating a microneedle sensor according to an embodiment of the present invention.
Fig. 2 is a flow chart illustrating a microneedle sensor manufacturing process.
Fig. 3 is a flowchart illustrating a hot stamping process in the PLA microneedle sensor manufacturing process.
Fig. 4 is a flowchart illustrating a UV imprinting process in the acryl micro-needle sensor manufacturing process.
Fig. 5 is a diagram for explaining step S12 in fig. 2.
Fig. 6 to 9 are diagrams for explaining step S13 of fig. 2.
Fig. 10 is a diagram showing a state where step S13 of fig. 2 ends.
Detailed Description
The present invention will be described in detail below with reference to the accompanying drawings. Here, the same reference numerals are used for the same structures, and a repetitive description, a known function which may unnecessarily obscure the gist of the present invention, and a detailed description of the structure are omitted. The embodiments of the present invention are provided to more fully explain the present invention to those skilled in the art. Therefore, the shapes and sizes of elements in the drawings may be exaggerated for clarity of illustration.
The microneedle biosensor according to the embodiment of the present invention is a minimally invasive microneedle sensor. The present invention relates to a biosensor for monitoring bio-signals by contacting body fluids through the invasion of microneedles into the skin. The biosensor according to an embodiment of the present invention is to measure the blood glucose concentration in interstitial fluid (ISF) of an invaded host, although it is referred to as being installed on the skin surface in order to continuously measure the blood glucose concentration for a set time, but is not limited thereto.
Fig. 1 is a diagram illustrating a microneedle sensor according to an embodiment of the present invention. As shown, the micro-needle sensor includes a Working Electrode (WE) 110, a Counter Electrode (CE) 120, a Reference Electrode (RE) 130, and an adhesive sheet 200. The working electrode 110 includes: a first substrate 111, the first substrate 111 being circular; a plurality of microneedles 112, the plurality of microneedles 112 protruding vertically on the first substrate 111; and a first wiring 113, the first wiring 113 extending vertically from one end of the first substrate 111. The counter electrode 120 includes: a second substrate 121, the second substrate 121 being concentric with the first substrate 111 and having a strip shape with a 3/4 circumference spaced from the circumference of the first substrate 111 by a set distance; a plurality of microneedles 122, the plurality of microneedles 122 protruding vertically on the second substrate 121; and a second wiring 123 extending from one end of the second substrate 121 to be horizontally arranged with the first wiring 113. The reference electrode 130 includes: a third substrate 131, the third substrate 131 being concentric with the first substrate 111 and spaced a set distance from the other end of the second substrate 121, and having a strip shape with a circumference spaced a set distance of 1/4 of the circumference of the first substrate 111; a plurality of microneedles 132, the plurality of microneedles 132 protruding vertically on the third substrate 131; and a third wiring 133, the third wiring 133 vertically extending from one end of the third substrate 131 to be horizontally arranged with the first wiring 113.
Fig. 2 is a flowchart illustrating a manufacturing process of the microneedle sensor. As shown in the figure, the method for manufacturing the microneedle biosensor includes a microneedle manufacturing process S10 and a post-treatment process S20, the microneedle manufacturing process S10 is composed of a mold and imprinting process S11, a metallization process S12, and a passivation process S13, and the post-treatment process S20 is composed of a coating silver/silver chloride (Ag/AgCl), platinum black (Pt-black), perfluorosulfonic acid (Nafion), and a wiring and packaging process.
Fig. 3 is a flowchart illustrating a hot embossing process S11 for manufacturing a PLA microneedle layer in the microneedle sensor manufacturing process of fig. 2.
As shown in the figure, the method comprises the following steps: a mold manufacturing step S111 of forming a groove of a shape corresponding to the needle on a Polytetrafluoroethylene (PTFE) block with a laser; a mold release agent application step S112a of applying a mold release agent on the mold; a release agent drying step S113a; a step S114a of forming a PLA layer on the mold in which the groove is formed and pressurizing with ceramic; a step S115a of baking in a vacuum oven at 200 ℃; and a step S116a of closing the vacuum and then pressurizing the vacuum by a press. Forming PLA (Poly Lactic Acid) micro-needle which is environment-friendly, nontoxic, biodegradable and biocompatible material. The PLA needle has a high modulus of elasticity and a buckling stiffness.
Fig. 4 is a flowchart illustrating a UV imprinting process S11 of manufacturing an acryl microneedle layer in the microneedle sensor manufacturing process of fig. 2. The method comprises the following steps: a mold manufacturing step S111 of forming a groove of a shape corresponding to the needle on a Polytetrafluoroethylene (PTFE) block with a laser; a step S112b of disposing an acryl UV resin on the mold in a vacuum state; a step S113b of closing the vacuum and pressurizing by a press; a UV curing step S114b; and a mold release step S115b. The acryl micro needle has an advantage that the manufacturing process is as short as 5 to 10 minutes, and the acryl micro needle has an advantage of excellent adhesion to Au.
Fig. 5 is a diagram for explaining a metallization process in the microneedle sensor manufacturing process of fig. 2. The metallization process is characterized in that a shadow mask (shadow mask) corresponding to the pattern of the working electrode 110, the counter electrode 120, and the reference electrode 130 of fig. 1 is formed on the polymer microneedle layer manufactured by the imprinting process of fig. 3 or 4, and a metal electrode layer is formed by sputtering an Au or Au + Ti/Cr adhesive layer.
Fig. 6 to 9 are diagrams for explaining a passivation layer manufacturing process in the microneedle sensor manufacturing process of fig. 2. A Passivation layer (Passivation layer) refers to an insulating layer formed on an underlayer on the metal electrode layer, which is used to define an area exposed for sensing. It is possible to prevent noise that may be generated in the substrate area due to the contact of the sensing material.
Fig. 6 is a view for explaining a process after a metal electrode layer is formed, and after a passivation layer is formed on the metal electrode layer, a sensing layer is formed on the exposed electrode.
The passivation layer forming process consists of the following processes:
as shown in fig. 7, holes are formed at the positions of the microneedles of the working electrode 110, the counter electrode 120, and the reference electrode 130 in a size smaller than the thickest diameter of the microneedles, on a plastic adhesive tape and a PET (polyethylene terephthalate) layer, respectively, in which an adhesive layer is formed on one surface of the metal electrode layer;
as shown in fig. 8, the microneedles are inserted into the holes so that the adhesive surface of the plastic adhesive tape formed with the holes is in contact with the substrate, and then the microneedles are inserted into the holes of the PET layer;
as shown in FIG. 9, the upper portion of the PET layer was pressed with an elastomer and the pressing was continued on a heated hot plate for 3 to 60 seconds in this state.
The holes are preferably formed using a laser patterning process.
The hot plate is preferably 80 to 200 ℃.
After that, the post-treatment process S20 is performed.
Fig. 10 is an SEM photograph showing the microneedle biosensor after completing the passivation layer forming process as described above. As shown in the figure, since insulation (insulation) is completed except for the sensing region, noise can be prevented from being generated at the time of sensing.
Claims (4)
1. A method of manufacturing a microneedle biosensor comprising a passivation layer,
the microneedle biosensor includes:
a working electrode, a counter electrode and a reference electrode,
the working electrode includes: the first substrate is a circular thin film; a plurality of microneedles vertically protruding on the first substrate; and a first wiring extending from one end of the circumference of the first substrate;
the counter electrode includes: the second substrate is concentric with the first substrate, the second substrate and the first substrate are spaced at a set distance from each other at the circumference of the first substrate, and the second substrate is a 3/4-circumference strip-shaped film; a plurality of microneedles vertically protruding on the second substrate; and a second wiring extending from one end of the second substrate to be arranged horizontally with the first wiring;
the reference electrode includes: the third substrate is concentric with the first substrate, the third substrate is spaced from the other end of the second substrate by a set distance, the third substrate is spaced from the circumference of the first substrate by a set distance, and the third substrate is a strip-shaped film with 1/4 of the circumference; a plurality of microneedles vertically protruding on the third substrate; and a third wiring extending from one end of the third substrate;
the manufacturing method comprises the following steps:
a) Forming grooves corresponding to the shapes of the micro needles of the working electrode, the counter electrode and the reference electrode on the solid resin block to form a mold;
b) Respectively imprinting the working electrode, the counter electrode and the reference electrode on the mold by using acrylic or PLA;
c) Forming a shadow mask corresponding to the patterns of the working electrode, the counter electrode and the reference electrode, and sputtering an Au or Au + Ti/Cr bonding layer to form a metal electrode layer; and
d) Forming a passivation layer on the metal electrode layer,
the step of forming the passivation layer comprises the following processes:
forming holes in the positions of the microneedles of the working electrode (110), the counter electrode (120) and the reference electrode (130) in a size smaller than the thickest diameter of the microneedles, on a plastic adhesive tape and a PET layer, respectively, on which an adhesive layer is formed on one surface of the metal electrode layer;
inserting the microneedles into the holes so that the adhesive surface of the plastic adhesive tape formed with the holes is in contact with a substrate, and then inserting the microneedles into the holes of the PET layer;
the top of the PET layer was pressed with an elastomer and in this state, the pressing was continued on a heated hot plate.
2. The method of manufacturing a microneedle biosensor comprising a passivation layer according to claim 1,
the bottom surfaces of the first substrate, the second substrate and the third substrate are attached to the adhesive sheet.
3. The method of manufacturing a microneedle biosensor comprising a passivation layer according to claim 1,
the first wiring extends vertically at one end of the circumference of the first substrate,
the second wiring extends from one end of the second substrate to be arranged horizontally with the first wiring,
the third wiring extends from one end of the third substrate to be arranged horizontally with the first wiring.
4. The method of manufacturing a microneedle biosensor comprising a passivation layer according to claim 1,
the hot plate is at 80-200 deg.C, and the elastomer is pressurized for 3-60 seconds.
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| Application Number | Priority Date | Filing Date | Title |
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| KR10-2021-0125522 | 2021-09-23 | ||
| KR1020210125522A KR102505313B1 (en) | 2021-09-23 | 2021-09-23 | Manufacturing method for micro needle bio sensor with passive layer |
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| CN115856048A true CN115856048A (en) | 2023-03-28 |
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| KR20080076434A (en) * | 2007-02-16 | 2008-08-20 | 박정철 | Biological information measuring apparatus and manufacturing method thereof |
| KR100868566B1 (en) * | 2007-03-29 | 2008-11-13 | 케이엠에이치 주식회사 | Device for measuring glucose concentration and a method of measuring the concentration of glucose using the same |
| KR101484161B1 (en) * | 2012-06-27 | 2015-01-22 | 연세대학교 산학협력단 | Polymer-based nano or micro needle through coating and fabricating method thereof |
| KR102469144B1 (en) * | 2015-04-17 | 2022-11-21 | 삼성전자주식회사 | Biometric information measuring sensor, Biometric information measuring system and Measuring method biometric information using the same |
| KR20170038351A (en) | 2015-09-30 | 2017-04-07 | 최규동 | Continous Glucose Measuremrnt System with Flexsible Probe |
| WO2017116503A1 (en) | 2015-12-28 | 2017-07-06 | Medtronic Minimed, Inc. | Methods for continuous glucose monitoring |
| KR101887073B1 (en) * | 2016-04-11 | 2018-08-09 | 국방과학연구소 | Wearable biodevice and manufacturing method thereof |
| KR101773583B1 (en) | 2016-06-03 | 2017-09-01 | 주식회사 아이센스 | Applicator for Continuous Glucose Monitoring System |
| KR102044061B1 (en) | 2016-12-21 | 2019-11-12 | 주식회사 유엑스엔 | Continuous glucose monitoring apparatus, continuous glucose monitoring system comprising said apparatus and method using said system |
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