KR20220116633A - Biosensor strip, manufacturing method thereof, and blood collection measuring device - Google Patents

Abstract

The present invention relates to a biosensor strip and a blood sampling measuring device using the same and, more specifically, to a biosensor strip and a blood sampling measuring device using the same, wherein the structure of the biosensor strip is modified to integrate a blood measuring device and the biosensor strip so that a user can measure a specific component in the blood at once without the need to alternately use a blood sampling device and the measuring device. According to one embodiment of the present invention, the biosensor strip for detecting the physical quantity of the specific component contained in the blood comprises: a sensing unit including a hollow support wall in which the blood is accommodated and an electrode formed on the support wall and measuring the physical quantity of the specific component contained in the blood; and a blood sampling unit coupled to one end of the sensing unit and sampling blood from the user.

Description

Biosensor strip, manufacturing method thereof, and blood collection measuring device using same

The present invention relates to a strip for a biosensor and a blood collection measuring device using the same, and more particularly, by modifying the structure of the biosensor strip to integrate the blood measuring device and the biosensor strip so that the user can alternately use the blood sampler and the measuring device. It relates to a strip for a biosensor capable of measuring a specific component in blood at once without the need and to a blood collection measuring device using the same.

A biosensor refers to a system that converts a recognizable useful signal such as a color, fluorescence, or electrical signal by using a biological element obtained from a measurement target. The biosensor is a futuristic fusion technology that requires technology across sciences such as electronics, chemistry, biology, materials engineering, and enzyme engineering.

Recent research and development trends focus on developing a biosensor using a minimum amount of sample, and in particular, a lot of research on the technical aspects of biosensor manufacturing for achieving this purpose is being conducted.

As a related technology, Korean Utility Model No. 20-0448186 discloses a technology related to a multi-channel strip for a biosensor that includes a plurality of reaction units in one strip and enables analysis of a plurality of in vivo substances at once. is starting

Conventional techniques for detecting a specific component contained in blood using the above-described biosensor include a process of collecting blood by pricking a finger, introducing the collected blood into the biosensor, and analyzing the specific component contained in the blood.

That is, conventional blood collection measuring devices using strips for biosensors require a separate blood collection process for measurement and analysis, and thus have a disadvantage in that it is cumbersome for a user to use it alone.

(Utility Model Document 001) KR 20-0448186 Y1

In order to solve the above-mentioned problems, the present invention provides a strip for a biosensor capable of increasing user convenience by integrating a strip of a blood collection device and a measuring device, and enabling rapid detection even when a small amount of blood is used, and a blood collection measuring device using the same aim to do

As an embodiment of the present invention, a strip for a biosensor for detecting a physical amount of a specific component contained in blood is provided.

A strip for a biosensor for detecting a physical amount of a specific component included in blood according to an embodiment of the present invention includes a hollow support wall in which blood is accommodated, and a specific component included in the blood by being formed on the support wall. It may include a sensing unit including an electrode for measuring a physical amount of , and a blood collection unit coupled to one end of the sensing unit and collecting blood from a user.

In the strip for a biosensor for detecting a physical quantity of a specific component included in blood according to an embodiment of the present invention, the sensing unit includes a substrate, a plurality of electrodes formed on the substrate, and a plurality of electrodes for measuring the physical quantity of the specific component It is provided on some of the electrodes of the electrode and may further include a selective permeable membrane that selectively transmits a specific component contained in the blood.

In the strip for a biosensor for detecting a physical amount of a specific component contained in blood according to an embodiment of the present invention, the sensing unit may further include a blood separation membrane provided on the electrode or the selective permeable membrane to separate the blood. can

In the strip for a biosensor for detecting a physical quantity of a specific component included in blood according to an embodiment of the present invention, the electrode measures the physical quantity of the specific component in blood through which the specific component is not permeated by the selective permeable membrane It may further include a reference electrode, and a measuring electrode for measuring the physical amount of the specific component in the blood through which the specific component is permeated by the selective permeable membrane.

In the strip for a biosensor for detecting a physical amount of a specific component contained in blood according to an embodiment of the present invention, the blood collection unit is provided at the end of the blood collection unit, and the blood collection needle for exposing the user's body to the outside of the body and the blood It may further include an inlet hole for guiding the inflow into the sensing unit.

The strip for a biosensor for detecting a physical amount of a specific component included in blood according to an embodiment of the present invention may further include a support part inserted into the sensing part and coupled to one end of the blood collection part.

As an embodiment of the present invention, there is provided a blood collection measuring device using the above-described biosensor strip.

A blood collection measuring apparatus according to an embodiment of the present invention includes the above-described biosensor strip; a connection unit inserted into the biosensor strip and configured to receive a signal including information on the physical quantity of the specific component measured by the sensing unit; It may include a pressing part for moving the connection part up and down, and a housing provided with the connection part and the pressing part.

The blood collection measuring apparatus according to an embodiment of the present invention may further include a control unit for receiving the signal from the connection unit to calculate the physical quantity of the specific component, and a display unit for displaying the physical quantity of the specific component calculated by the control unit. can

As an embodiment of the present invention, there is provided a method of manufacturing a strip for a biosensor for detecting a physical amount of a specific component contained in blood.

A method for manufacturing a strip for a biosensor for detecting a physical quantity of a specific component contained in blood according to an embodiment of the present invention includes a substrate preparation step of preparing a substrate, and measuring the physical quantity of a specific component contained in blood on the substrate an electrode forming step of forming a plurality of electrodes to It may include a film forming step of forming a separation film, and a substrate processing step of processing the substrate to have a columnar shape by rolling it.

According to the present invention, there is an advantage in that the amount of blood required for measurement and the measurement time can be reduced by simultaneously performing blood collection and measurement without a separate blood collection process.

The effects obtainable in the present disclosure are not limited to the above-mentioned effects, and other effects not mentioned may be clearly understood by those of ordinary skill in the art to which the present disclosure belongs from the description below. will be.

1 is a perspective view of a strip for a biosensor according to an embodiment of the present invention.
2 is an exploded view and a cross-sectional view of a sensing unit of a strip for a biosensor according to an embodiment of the present invention.
3 is an exemplary view of a blood collection unit of a strip for a biosensor according to an embodiment of the present invention.
4 is an exemplary view of a blood collection unit of a strip for a biosensor according to an embodiment of the present invention.
5 is an exemplary view of a blood collection unit of a strip for a biosensor according to an embodiment of the present invention.
6 is an exemplary view of a support part of a strip for a biosensor according to an embodiment of the present invention.
7 is a plan view of a blood collection device using a strip for a biosensor according to an embodiment of the present invention.
8 is an overall configuration diagram of a blood collection device using a strip for a biosensor according to an embodiment of the present invention.
9 is a flowchart of a method of manufacturing a strip for a biosensor according to an embodiment of the present invention.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings so that those of ordinary skill in the art can easily carry out the present invention. However, the present invention may be embodied in various different forms and is not limited to the embodiments described herein. And in order to clearly explain the present invention in the drawings, parts irrelevant to the description are omitted, and similar reference numerals are attached to similar parts throughout the specification.

Terms used in this specification will be briefly described, and the present invention will be described in detail.

The terms used in the present invention have been selected as currently widely used general terms as possible while considering the functions in the present invention, which may vary depending on the intention or precedent of a person skilled in the art, the emergence of new technology, and the like. In addition, in a specific case, there is a term arbitrarily selected by the applicant, and in this case, the meaning will be described in detail in the description of the corresponding invention. Therefore, the term used in the present invention should be defined based on the meaning of the term and the overall content of the present invention, rather than the name of a simple term.

In the entire specification, when a part "includes" a certain component, it means that other components may be further included, rather than excluding other components, unless otherwise stated. In addition, terms such as "~ unit" and "module" described in the specification mean a unit that processes at least one function or operation, which may be implemented as hardware or software, or a combination of hardware and software. In addition, throughout the specification, when a part is "connected" with another part, this includes not only the case of "directly connected" but also the case of "connecting with another element in the middle".

Hereinafter, the present invention will be described in detail with reference to the accompanying drawings.

1 is a perspective view of a strip 1000 for a biosensor according to an embodiment of the present invention.

Referring to FIG. 1 , a biosensor strip 1000 for detecting a physical amount of a specific component included in blood according to an embodiment of the present invention may include a sensing unit 1100 and a blood collection unit 1200 . .

The sensing unit 1100 may include a hollow support wall in which blood is accommodated, and an electrode 1120 formed on the support wall to measure a physical quantity of a specific component contained in blood.

The cross-section of the support wall may have various shapes, such as a circle, a triangle, and a square. However, it is not limited to the above-described example, and any shape that forms a space in which blood can be accommodated may be applied.

The electrode 1120 may be configured as an ion-selective electrode or a potential-measuring electrode according to the type of a specific component included in the blood.

The ion-selective electrode may include an ion-selective permeable membrane, and may be made of a natural polymer-derived material such as cellulose acetate or a synthetic polymer, and the potentiometric electrode may include a conductive material such as gold, silver, platinum, or carbon. can be formed with

The blood collection unit 1200 is coupled to one end of the sensing unit 1100, and collects blood from a user. That is, the blood collection unit 1200 applies a physical force to the user's skin to discharge the user's blood outside the body. It is preferable to be made of a material that can withstand it. For example, a synthetic material such as plastic or a metal material such as iron may be applied.

FIG. 2A is an exploded view of the sensing unit 1100 of the strip 1000 for a biosensor according to an embodiment of the present invention, and FIG. 2B is a view for a biosensor according to an embodiment of the present invention. A cross-sectional view of strip 1000 .

Referring to FIG. 2A , the sensing unit 1100 of the biosensor strip 1000 according to an embodiment of the present invention may include a substrate 1110 , an electrode 1120 , and a selective transmission film 1130 . can

The substrate 1110 serves as a base of the biosensor, and includes polystyrene (PS), polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyester (PE), polycarbonate (PC), Polyimide (PI), polyurethane (PU), polyvinylidene fluoride (PVDF), polyamide (PA), polyethersulfone (PES), polytetrafluoroethylene (PTFE) or polymethylmethacrylate (PMMA) ) may be formed including at least any one or more of a synthetic polymer or metal containing.

The electrode 1120 is formed on the substrate 1110 and measures a physical quantity of a specific component included in blood. The physical quantity may include a concentration according to an embodiment. For example, the concentration of blood glucose included in blood may be measured.

The selective permeable membrane 1130 is provided on some of the electrodes 1120 among the plurality of electrodes 1120 and selectively transmits a specific component included in blood or reacts only with a specific component.

According to an embodiment, the electrode 1120 is specified by the reference electrode 1121 and the selective permeable membrane 1130 for measuring the physical quantity of a specific component in blood to which the specific component is not permeated by the selective permeable membrane 1130 . It may further include a measuring electrode 1122 for measuring a physical quantity of a specific component in the blood through which the component has passed.

In addition, according to an embodiment, the electrode 1120 may further include an auxiliary electrode (not shown in the drawing) in addition to the measurement electrode 1122 and the reference electrode 1121 .

For example, the selective transmission layer 1130 may be formed only on the measurement electrode 1122 and the auxiliary electrode.

Accordingly, the measurement electrode 1122 is in contact with a solution through which a specific component is selectively transmitted by the selective transmission layer 1130 , and the reference electrode 1121 is a solution through which the specific component is not transmitted through the selective transmission layer 1130 . contact with

Accordingly, a physical quantity of a specific component is calculated by detecting an electrical signal change such as a potential difference generated according to a difference in the physical quantity of a specific component between the reference electrode 1121 and the measuring electrode 1122 .

Referring to FIG. 2( b ), the sensing unit 1100 of the biosensor strip 1000 according to an embodiment of the present invention is provided on the plurality of electrodes 1120 or the selective permeable membrane 1130 , and A blood separation membrane 1140 to separate may be further included.

When there is a substance with a large size in the blood, a specific component contained in the blood may not be easily permeated by the selective permeation membrane 1130, so the blood separation membrane 1140 filters out the large size substance present in the blood. The efficiency of selective permeation of a specific component by the selective permeation membrane 1130 is increased.

In this case, the material transmitted by the selective permeable membrane 1130 may be a specific component included in the blood, and the material separated by the blood separation membrane 1140 may be a large-sized material such as white blood cells or red blood cells in the blood.

3 to 5 are exemplary views of the blood collection unit 1200 of the biosensor strip 1000 according to an embodiment of the present invention.

3 to 5 , in the strip 1000 for a biosensor for detecting a physical amount of a specific component included in blood according to an embodiment of the present invention, the blood collection unit 1200 includes a needle 1210 and an inlet hole. (1220).

The blood collection needle 1210 is a configuration for exposing the user's body to the outside of the body, and is formed at the end of the blood collection unit 1200 and may be formed to have a pointed shape or formed by attaching a needle.

The inlet hole 1220 guides blood to flow into the sensing unit 1100 . That is, the blood exposed to the outside by the blood collection needle 1210 flows into the blood collection unit 1200 through the inlet hole 1220 formed in the blood collection unit 1200, and the inside of the blood collection unit 1200 is a sensing unit ( Since it is connected to the inside of the 1100 , blood flows into the sensing unit 1100 through the inflow hole 1220 .

According to an embodiment, the blood collection unit 1200 may further include a transfer path 1230 so that the blood exposed outside the user's body flows into the sensing unit 1100 through the inlet hole 1220 .

6 is an exemplary view of the support part 1300 of the strip 1000 for a biosensor according to an embodiment of the present invention.

Referring to FIG. 6 , the strip 1000 for a biosensor for detecting a physical amount of a specific component included in blood according to an embodiment of the present invention may further include a support unit 1300 .

The support unit 1300 is configured to have a sensing unit 1100 inserted therein, and is coupled to one end of the blood collection unit 1200 . The support unit 1300 serves to protect the sensing unit 1100 so that the sensing unit 1100 is not damaged by a physical force generated in the sensing unit 1100 when the blood collection unit 1200 applies a force to the user's skin. carry out

7 is a plan view of a blood collection apparatus and a measuring apparatus using the biosensor strip 1000 according to an embodiment of the present invention, and FIG. 8 is a blood collection using the biosensor strip 1000 according to an embodiment of the present invention. It is the overall configuration diagram of the device and the measuring device.

7 and 8 , the blood collection device and the measuring device according to an embodiment of the present invention include the biosensor strip 1000 , the connection part 2000 , the pressing part 3000 , and the housing 4000 . may include

The connection part 2000 is a configuration that is inserted into the biosensor strip 1000 and connects the biosensor strip 1000 and the pressing part 3000 . The connection unit 2000 receives a signal including information on a physical quantity of a specific component measured by the sensing unit 1100 , and transmits the received signal to the control unit.

The pressing part 3000 moves the connection part 2000 in the vertical direction, and the connection part 2000 moves in the vertical direction by the pressing part 3000 . That is, when the user presses the pressing unit 3000 , the connecting unit 2000 moves in the vertical direction. At this time, when the connecting part 2000 is inserted into the biosensor strip 1000 , the blood in the user's body is exposed to the outside by the blood collection part 1200 formed at the end of the biosensor strip 1000 .

The housing 4000 may include a connection part 2000 and a pressing part 3000 .

According to an embodiment, the housing 4000 may have a shape in which the cross-sectional area decreases from the end to the center. Accordingly, even when the user presses the pressing part 3000 to move the connection part 2000 in the vertical direction, the movement of the housing 4000 is minimized, thereby increasing stability. However, the shape of the housing 4000 is not limited thereto, and may be appropriately deformed according to the user's convenience.

According to an embodiment, the blood collection measuring apparatus may further include a control unit and a display unit 5000 .

The control unit may be implemented as a circuit board 1110 accommodated in the housing 4000 , and the display unit 5000 may be provided outside the housing 4000 .

The control unit (not shown in the drawing) may receive a signal from the connection unit 2000 and calculate a physical quantity of a specific component. Regarding the process of calculating the physical quantity of a specific component, the description is omitted since the same technique as the conventional technique can be applied.

The display unit 5000 may provide information on the specific component to the user by displaying the physical quantity of the specific component calculated by the control unit. The information on the specific component provided through the display unit 5000 may relate to the concentration, amount, and rate of change of the specific component.

According to an embodiment, the housing 4000 may be provided with a button 6000 for transmitting a user's command to the control unit. The user may operate the control unit through the button 6000, and the button 6000 may transmit a command input from the user to the control unit through wired/wireless communication.

9 is a flowchart of a method of manufacturing a strip 1000 for a biosensor according to an embodiment of the present invention.

Referring to FIG. 9 , the method for manufacturing a strip 1000 for a biosensor for detecting a physical amount of a specific component included in blood according to an embodiment of the present invention includes a substrate preparation step (S100) and an electrode forming step (S200). , a film forming step (S300) and a substrate processing step (S400) may be included.

In the substrate preparation step (S100), the substrate 1110 is prepared. The substrate 1110 may be made of a material such as glass, silicon, or polymer, and an appropriate substrate 1110 may be selected according to the type of a specific component.

In the electrode forming step (S200), a plurality of electrodes 1120 for measuring the physical amount of a specific component included in blood are formed on the substrate 1110 . For example, it may be formed by printing on the substrate 1110 using ink composed of carbon or platinum-treated carbon, and may be formed by vacuum deposition using gold.

In the film forming step (S300), a selective permeation membrane 1130 or blood that selectively transmits a specific component included in blood or reacts only with the specific component on some of the electrodes 1120 of the plurality of electrodes 1120 A blood separation membrane 1140 to separate is formed.

According to an embodiment, in the film forming step ( S300 ), the type of the selective transmission film 1130 formed according to the type of the electrode 1120 or the type of a specific component to be measured may be selected differently.

For example, a selectively permeable membrane 1130 that selectively transmits blood glucose or reacts only with blood glucose is formed only on the measuring electrode 1122, and a reference electrode 1121 and a selective permeable membrane 1130 are formed on the measuring electrode A blood separation membrane 1140 for separating plasma from blood may be formed on the 1122 .

In this case, the material transmitted by the selective permeable membrane 1130 may be a specific component included in the blood, and the material separated by the blood separation membrane 1140 may be a large-sized material such as white blood cells or red blood cells in the blood.

In the substrate processing step (S400), the substrate 1110 is rolled and processed to have a columnar shape. That is, the substrate 1110 according to the present invention has a shape in which the substrate 1110 itself can receive blood through the substrate processing step (S400).

According to an embodiment, the substrate processing step (S400) may be performed between the substrate preparation step (S100) and the electrode forming step (S200).

The above description of the present invention is for illustration, and those of ordinary skill in the art to which the present invention pertains can understand that it can be easily modified into other specific forms without changing the technical spirit or essential features of the present invention. will be. Therefore, it should be understood that the embodiments described above are illustrative in all respects and not restrictive. For example, each component described as a single type may be implemented in a distributed manner, and likewise components described as distributed may be implemented in a combined form.

The scope of the present invention is indicated by the following claims rather than the above detailed description, and all changes or modifications derived from the meaning and scope of the claims and their equivalent concepts should be interpreted as being included in the scope of the present invention. do.

1000: strip for biosensor
1100: sensing unit
1110: substrate
1120: electrode
1121: reference electrode
1122: measuring electrode
1130: selective permeable membrane
1140: blood separation membrane
1200: blood collection unit
1210: blood collection needle
1220: inlet hole
1230: transfer path
1300: support
2000: connection
3000: press
4000: housing
5000: display
6000: button

Claims (9)

In the biosensor strip for detecting the physical amount of a specific component contained in blood,
a sensing unit including a hollow support wall in which blood is accommodated, and an electrode formed on the support wall to measure a physical amount of a specific component contained in the blood; and
A strip for a biosensor coupled to one end of the sensing unit and comprising a blood collection unit for collecting blood from a user.
The method of claim 1,
The sensing unit,
Board;
a plurality of electrodes formed on the substrate and measuring a physical quantity of the specific component; and
A strip for a biosensor that is provided on some of the plurality of electrodes and further comprises a selective permeable membrane that selectively transmits a specific component included in the blood or reacts only with the specific component.
3. The method of claim 2,
The sensing unit,
A strip for a biosensor that is provided on the electrode or the selective permeable membrane and further comprises a blood separation membrane for separating the blood.
3. The method of claim 2,
The electrode is
a reference electrode for measuring a physical quantity of the specific component in blood through which the specific component is not permeated by the selective permeable membrane; and
The strip for a biosensor further comprising a measuring electrode for measuring a physical amount of the specific component in the blood through which the specific component has passed through the selective permeable membrane.
The method of claim 1,
The blood collection unit
a blood collection needle provided at the end of the blood collection unit and exposing the user's body to the outside of the body; and
The strip for a biosensor further comprising an inlet hole for guiding the blood to flow into the sensing unit.
The method of claim 1,
The sensing part is inserted therein, and the biosensor strip further comprises a support part coupled to one end of the blood collection part.
The strip for the biosensor of any one of claims 1 to 5;
a connection unit inserted into the biosensor strip and configured to receive a signal including information on the physical quantity of the specific component measured by the sensing unit;
a pressing part for moving the connecting part in a vertical direction; and
A blood collection measuring device using a strip for a biosensor including a housing provided with the connection part and the pressing part.
8. The method of claim 7,
a control unit for receiving the signal from the connection unit and calculating a physical quantity of the specific component; and
The blood collection measuring device further comprising a display unit for displaying the physical quantity of the specific component calculated by the control unit.
In the manufacturing method of the strip for a biosensor,
A substrate preparation step of preparing a substrate;
an electrode forming step of forming a plurality of electrodes on the substrate for measuring a physical quantity of a specific component contained in blood;
a film forming step of selectively permeating a specific component contained in the blood or forming a selective permeable membrane that reacts only with the specific component or a blood separation membrane that separates the blood on some of the plurality of electrodes; and
A method of manufacturing a strip for a biosensor comprising a substrate processing step of rolling up the substrate and processing the substrate to have a columnar shape.

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