KR20200090554A - Method and device to measure analyte using test strip - Google Patents

Abstract

The present invention relates to a device and a method for measuring biomaterials using a test strip. The test strip according to an embodiment includes: a reference layer including a reference electrode connected to the ground; a measurement layer including a measurement electrode for detecting an amount of change in capacitance based on the reference electrode; and a suction layer including a spacer separating the reference layer and the measurement layer. According to an embodiment, the device for measuring biomaterials can determine an amount of a body fluid sample injected into the test strip based on a change in capacitance using the above-described test strip.

Description

METHOD AND DEVICE TO MEASURE ANALYTE USING TEST STRIP}

Hereinafter, a test strip and a biomaterial measuring apparatus and method using the same are provided.

The biosensor is classified into an enzyme sensor, a microbial sensor, an immune sensor, an organella sensor, or a tissue membrane sensor according to the type of biomaterial, and is largely classified into an optical biosensor and an electrochemical biosensor according to a method of quantitatively analyzing a target substance in a biological sample. Classified by sensor

Among the biosensors, the electrochemical biosensor can measure the electrical signal obtained from the reaction and measure the concentration of the target substance. The electrochemical biosensor can amplify the signal even with a very small amount of sample, can be miniaturized, can stably acquire the measurement signal, and can be easily compatible with information and communication devices. The electrochemical biosensor may have a structure in which an enzyme and an adjustment reagent are fixed in a cell composed of a reference electrode and a working electrode. When a sample is introduced into the biosensor, oxygen or electron transport mediators are reduced when the target substance in the sample is oxidized by catalysis of an enzyme. At this time, the reduced oxygen or electron transport medium is forcibly oxidized by the voltage of the electrode and causes electrons to change. The electrochemical biosensor can indirectly measure the amount of the target substance by quantifying this change in electrons.

An example of an electrochemical biosensor is a blood glucose strip. The blood sugar strip has a panel structure capable of absorbing the collected blood. The blood sugar strip may represent a product for measuring the concentration of blood sugar after being inserted into a blood sugar measuring device. Due to the recent high calorie and high fat eating habits and lack of exercise, the obese population increases, and the number of diabetic patients increases rapidly every year as the elderly age increases due to the development of medicine. The demand for blood sugar strips is increasing. In such a blood glucose strip, a technique is required to induce the user to inject an appropriate amount of blood into the test strip in order to measure blood glucose from the blood.

The biomaterial measurement system according to an embodiment may detect whether a sample of a bodily fluid is injected into a test strip.

The biomaterial measurement system according to an embodiment may estimate the amount of the body fluid sample collected.

The biomaterial measurement system according to an embodiment may determine whether the amount of the body fluid sample collected is sufficient to measure blood sugar.

The biomaterial measurement system according to an embodiment may prevent noise caused by external factors.

A test strip according to an embodiment includes a reference layer including a reference electrode connected to ground; A measurement layer including a measurement electrode for detecting a change in capacitance based on the reference electrode; And a spacer separating the reference layer and the measurement layer.

The test strip may further include an insulating layer to prevent contact of the bodily fluid sample through the inhalation layer with the measurement layer and contact with the reference layer of the bodily fluid sample.

The test strip may further include an outer insulating layer to prevent external contact to the electrodes.

The test strip is disposed on top of the measurement layer, a shielding layer for shielding electromagnetic wave signals from the outside; And a shielding insulating layer separating the shielding layer from the measurement layer.

The measurement layer is disposed adjacent to an injection port into which a body fluid sample is injected in the test strip, and includes an injection detection electrode for detecting whether the body fluid sample is injected, and the reference layer corresponds to the injection detection electrode. A reference electrode may be included.

The measurement layer may include a measurement electrode configured to change a capacitance with respect to a reference electrode based on the amount of the body fluid sample injected into the test strip.

The measurement layer may include an error detection electrode configured to change the capacitance of the reference electrode based on environmental changes.

The spacer may be made of an insulating material.

The spacer may be configured to suck a sample of bodily fluid introduced through an inlet and deliver it to a space formed between the measurement layer and the reference layer.

The method for measuring a biological material according to an embodiment may include detecting a capacitance of electrodes included in the test strip in response to a test strip inserted into the insertion hole; And measuring the amount of a bodily fluid sample introduced into the test strip based on the detected capacitance.

The biomaterial measurement method may further include initiating measurement of a target biomaterial included in the bodily fluid sample in response to the amount of the bodily fluid sample exceeding a measurement threshold.

The biomaterial measurement method may further include holding the measurement of the target biomaterial in response to a case in which the amount of the body fluid sample is equal to or less than the measurement threshold.

The detecting of the capacitance may include detecting a capacitance between a reference electrode and a measuring electrode among electrodes included in the test strip.

The step of measuring the amount of the bodily fluid sample may include determining whether the bodily fluid sample is injected into the test strip in response to a change in capacitance between the injection detection electrode and the reference electrode among the electrodes included in the test strip. It may include.

The step of measuring the amount of the bodily fluid sample may include, in response to a change in capacitance between a reference electrode and a measurement electrode among electrodes included in the test strip, to the test strip according to the amount of change in capacitance between the reference electrode and the measurement electrode. And estimating the amount of the bodily fluid sample injected.

The step of measuring the amount of the bodily fluid sample may include estimating the amount of the bodily fluid sample injected into the test strip from a ratio between the amount of change in the injection capacitance for the injection detection electrode and the amount of change in the measured capacitance for the measurement electrode. have.

The detecting of the capacitance may include detecting the capacitance of each of the electrodes included in the test strip every predetermined period.

The detecting of the capacitance includes detecting a capacitance with respect to the error detecting electrode, and measuring the amount of the bodily fluid sample includes when the capacitance detected with respect to the error detecting electrode exceeds an error threshold value. In response, it may include determining that an error has occurred in the test strip.

An apparatus for measuring biomaterial according to an embodiment may include a signal receiver configured to receive electrical signals for electrodes included in the test strip in response to a test strip inserted into the insertion hole; And a control unit that detects a capacitance for the electrodes based on the electrical signal and measures the amount of a bodily fluid sample input to the test strip based on the detected capacitance.

The biomaterial measurement system according to an embodiment may automatically determine whether a sample of bodily fluid is injected into a test strip.

The biomaterial measurement system according to an embodiment may accurately estimate the amount of a sample of bodily fluid collected through a change in capacitance of a test strip.

The biomaterial measurement system according to an embodiment may accurately determine whether the amount of the body fluid sample collected is sufficient to measure the amount of the target biomaterial based on the change in capacitance.

The biomaterial measurement system according to an embodiment may accurately determine the amount of the bodily fluid sample injected by preventing noise caused by external factors through the insulating layer.

The biomaterial measurement system according to an embodiment may prevent an error in blood glucose measurement due to a lack of a body fluid sample.

1 is a view for explaining a biological material measurement system according to an embodiment.
2 is a diagram illustrating a test strip according to an embodiment.
3 and 4 are views illustrating a structure in which a shielding layer is implemented on a test strip according to an embodiment.
5 is a view showing a detailed structure of a test strip according to an embodiment.
6 is a diagram illustrating capacitance for electrodes in a test strip according to an embodiment.
7 is a diagram illustrating a structure in which an additional insulating layer is implemented on a test strip according to an embodiment.
8 is a diagram illustrating a method for measuring a biological material according to an embodiment.

Hereinafter, embodiments will be described in detail with reference to the accompanying drawings. However, various changes may be made to the embodiments, and the scope of the patent application right is not limited or limited by these embodiments. It should be understood that all modifications, equivalents, or substitutes for the embodiments are included in the scope of rights.

The terms used in the examples are used for illustrative purposes only and should not be construed as limiting. Singular expressions include plural expressions unless the context clearly indicates otherwise. In this specification, the terms "include" or "have" are intended to indicate the presence of features, numbers, steps, actions, components, parts or combinations thereof described in the specification, one or more other features. It should be understood that the existence or addition possibilities of fields or numbers, steps, operations, components, parts or combinations thereof are not excluded in advance.

Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by a person skilled in the art to which the embodiment belongs. Terms, such as those defined in a commonly used dictionary, should be interpreted as having meanings consistent with meanings in the context of related technologies, and should not be interpreted as ideal or excessively formal meanings unless explicitly defined in the present application. Does not.

In addition, in the description with reference to the accompanying drawings, the same reference numerals are assigned to the same components regardless of reference numerals, and redundant descriptions thereof will be omitted. In describing the embodiments, when it is determined that detailed descriptions of related known technologies may unnecessarily obscure the subject matter of the embodiments, the detailed descriptions will be omitted.

1 is a view for explaining a biological material measurement system according to an embodiment.

The biomaterial measurement system 100 includes a biomaterial measurement device 110 and a biomaterial measurement module 120.

The biomaterial measurement device 110 is a device that can be coupled to the biomaterial measurement module 120, and may include a socket 111 that can be coupled to the plug 121 of the biomaterial measurement module 120. The biomaterial measurement device 110 may be implemented as a smart device, for example, a smart phone, and may include a display unit for displaying biomaterial measurement results and a power supply unit for supplying power. For example, the socket 111 of the biomaterial measurement device 110 may be a microphone socket.

The biomaterial measurement apparatus 110 may receive measurement data indicating the amount of the biomaterial measured by the biomaterial measurement module 120 from the biomaterial measurement module 120. The measurement data may indicate information indicating the amount of the biological material or the level of the biological material, and may include a series of data signals. The biomaterial measurement apparatus 110 may store an application program for biomaterial measurement capable of processing and managing measurement data indicating the amount of the biomaterial.

When the plug 121 of the biomaterial measurement module 120 is used in combination with the socket 111 of the biomaterial measurement device 110, the biomaterial measurement module 120 inputs the biomaterial measurement device 110 ( Input, Output, and power can all be used. In addition, the data communication method between the biomaterial measurement device 110 and the biomaterial measurement module 120 may be a frequency shift keying (FSK) method, but is not limited thereto. Depending on the purpose and means of use, the data communication scheme may be designed differently.

For example, it may be configured as a phone jack socket 111 that can be coupled to the phone jack plug 121 of the biomaterial measurement module 120 or a port that can be coupled to the pin plug 121. However, the type and shape of the socket 111 of the biomaterial measurement device 110 are not limited. The coupling structure using the above-described pin may be configured as a structure in which the biomaterial measurement device 110 includes a plug 121 and the biomaterial measurement module 120 includes a socket 111.

The biomaterial measurement module 120 measures the amount of the biomaterial contained in the body fluid sample (eg, blood or interstitial fluid) absorbed by the test strip, and is measured in response to the connection with the biomaterial measurement device 110. A data signal indicating the amount of the biomaterial may be transmitted to the biomaterial measurement device 110. The biomaterial measurement module 120 may be used in combination through a socket 111 of the biomaterial measurement device 110. For example, when the plug 121 of the biomaterial measurement module 120 is coupled to the socket 111 of the biomaterial measurement device 110, between the biomaterial measurement module 120 and the biomaterial measurement device 110 Connection can be established. The biomaterial measurement module 120 responds to a case in which a connection with the biomaterial measurement device 110 is detected, in the body fluid sample absorbed by the test strip using the power supplied from the power supply of the biomaterial measurement device 110. The amount of biological material can be measured and calculated. The biomaterial measurement module 120 may transmit measurement data including information indicating the amount of the biomaterial to the biomaterial measurement device 110.

The biomaterial measurement module 120 may include a main body, a strip insertion hole 122, and a plug 121.

The body of the biomaterial measurement module 120 includes a biomaterial measurement unit for measuring the amount of biomaterial contained in the blood absorbed in the test strip, and a central processing unit for calculating and transmitting a result of measuring the amount of biomaterial Can. Since the body of the biomaterial measurement module 120 does not need to include a power supply unit and a display unit, it can be reduced in size and weight.

The strip insertion port 122 is formed on a part of the main body, and may have a structure capable of inserting the above-described test strip. The strip insertion hole 122 may be embodied as a structure capable of inserting a test strip therein, and the structure and design are not limited to the described examples.

The plug 121 may be formed on one surface of the main body to have a structure that can be coupled to the socket 111 of the biomaterial measuring device 110. As described above, the plug 121 may be a phone jack plug or a pin plug, but is not limited thereto.

The test strip can represent a strip made of a material and configuration capable of inhaling or absorbing a bodily fluid sample (eg, blood).

For reference, when the biomaterial measurement device 110 is implemented as a smart phone, the biomaterial measurement device may execute an application for biomaterial measurement. After the biomaterial measurement application is executed, the biomaterial measurement device 110 may determine whether the plug of the biomaterial measurement module 120 is coupled to the socket. When a connection is established between the biomaterial measurement module 120 and the biomaterial measurement device 110, the biomaterial measurement module 120 may receive power from a power source of the biomaterial measurement device 110 and measure the biomaterial The module 120 can execute internal tests. When there is no abnormality in the internal test, the biomaterial measurement device 110 may display a screen requesting the insertion of the strip through the display unit. In response to the case where the test strip is inserted into the strip insertion port 122 of the biomaterial measurement module 120 by the user, the biomaterial measurement device 110 displays a strip alteration presence check screen and checks whether the test strip is altered can do. When it is determined that the test strip is normal, the biomaterial measurement device 110 may display a blood input screen through the display unit.

In response to the user's blood being injected into the test strip, the biomaterial measurement module 120 may transmit measurement data indicating the amount of the biomaterial to the biomaterial measurement device 110. The biomaterial measurement device 110 may display a notification screen during biomaterial measurement, and calculate a biomaterial measurement result in blood from measurement data transmitted from the biomaterial measurement module 120. The biomaterial measurement device 110 may display a biomaterial measurement result, and further store a biomaterial measurement result.

When the test strip 190 is inserted into the biomaterial measurement module 120, the biomaterial measurement device 110 receives the biomaterial data sensed from the test strip 190 by the biomaterial measurement module 120 to the user Can provide.

The test strip 190 can represent a strip that converts biomaterials into arbitrary signals. In the present specification, the biomaterial may refer to a material associated with a living body. Biological material can also be referred to as an analyte. For example, the biological material may be blood sugar, but is not limited thereto. For example, the test strip 190 may be a type of transducer that converts an electrical signal corresponding to the amount of the biomaterial in response to a reaction with the biomaterial. The test strip 190 can be, for example, a blood sugar strip. The blood sugar strip may include test strips chemically prepared to be inhaled or inhaled with blood, and may include enzymes that react with blood sugar in the blood and cause an electrochemical reaction. The enzyme may be applied to any electrode, and the electrode coated with the enzyme may be referred to as a bioelectrode. In this specification, the case where the test strip 190 is a blood sugar strip is mainly described as an example, but it is not limited as described.

According to an embodiment, an electrode portion may be formed on one surface of the test strip 190. For example, the electrode portion of the test strip 190 may be inserted into the strip insertion port of the biomaterial measuring device 110 in the insertion direction. The strip insert may include one or more pins that make electrical contact with the electrode portion of the test strip 190.

The biomaterial measuring apparatus 110 may receive an electrical signal corresponding to measurement data indicating the amount of the biomaterial from the electrode part of the test strip 190, and further, an electrical signal corresponding to the amount of a bodily fluid sample I can receive it. The electrical signal corresponding to the measurement data may include an electrical signal caused by a reaction between an enzyme applied to a biological electrode and a target biological material. The electrical signal corresponding to the amount of a bodily fluid sample may include an electrical signal corresponding to a capacitance value between electrodes.

Hereinafter, an operation of estimating the amount of a bodily fluid sample required for the biomaterial measurement apparatus 110 to measure the biomaterial will be described. The biomaterial measuring apparatus 110 may accurately estimate the amount of the biomaterial by verifying that an appropriate amount of a bodily fluid sample is collected and then measuring the amount of the biomaterial.

For reference, in FIG. 1, the biomaterial measurement apparatus 110 and the biomaterial measurement module 120 in the biomaterial measurement system 100 are illustrated as separate units, but are not limited thereto. The biomaterial measurement device 110 and the biomaterial measurement module 120 may be implemented as an integrated device.

According to an embodiment, the biomaterial measurement device 110 may include a signal receiving unit and a control unit.

The signal receiving unit may receive an electrical signal for electrodes included in the test strip in response to a test strip being inserted into the insertion hole.

The control unit may detect the capacitance of the electrodes based on the electrical signal, and measure the amount of the bodily fluid sample input to the test strip based on the detected capacitance.

The operation of the biomaterial measurement device 110 will be described in detail in FIG. 8 below.

2 is a diagram illustrating a test strip according to an embodiment.

1 and 2, the test strip 200 according to an embodiment may include a plurality of layers. On one side of the test strip 200, an inlet 259 into which a body fluid sample can be introduced may be formed, and on the other side of the test strip 200, an electrode unit 280 for transmitting an electrical signal to the biomaterial measuring device 110 is provided. Can be formed. The injection hole 259 and the electrode portion 280 may be formed to be exposed to the outside. However, the position and shape of the injection hole 259 and the position and shape of the electrode portion 280 are not limited to those illustrated in FIG. 2 and may vary according to design. For example, the inlet 259 can be placed anywhere on the side of the test strip 200.

The test strip 200 illustrated in FIG. 2 may include a measurement layer 210, an intake layer 230, and a reference layer 220. In addition, the test strip 200 may further include a top insulating layer 250, and the above-described inlet 259 may be formed on one side of the top insulating layer 250. The top insulating layer 250 may be shorter than the rest of the layers. The uppermost layer may be formed to expose the electrode portion 280 on the other side of the test strip 200.

The measurement layer 210 may include one or more measurement electrodes. The measurement electrode may indicate an electrode for detecting a change in capacitance based on the reference electrode. For example, the biomaterial measuring apparatus may measure the capacitance between any measuring electrode and a corresponding reference electrode. The measurement electrode may be formed in the region corresponding to the sensing portion 202 in the measurement layer 210. The measuring electrode may be formed long along the length axis of the test strip 200.

The reference layer 220 may include one or more reference electrodes. The reference electrode can be connected to ground. The reference electrode may be formed in the region corresponding to the sensing portion 202 in the reference layer 220.

The suction layer 230 may include a spacer separating the reference layer 220 and the measurement layer 210. The spacer supports the reference layer 220 and the measurement layer 210 to maintain a predetermined distance between the reference layer 220 and the measurement layer 210. The spacer may be made of an electrically insulating material to prevent noise caused by body fluid samples and biological materials contained in the body fluid samples.

In addition, the spacer may be configured to suck a sample of bodily fluid injected through the inlet and deliver it to a space formed between the measurement layer 210 and the reference layer 220. For example, the spacer may form a passage (hereinafter, a suction passage) through which a body fluid sample can be sucked in the space between the measurement layer 210 and the reference layer 220. The suction passage may be formed along the length direction of the test strip 200 inside the test strip 200, but is not limited thereto. The interior of the intake passage is an empty space, which can be filled with a sample of bodily fluid being injected. For example, in FIG. 2, the spacer may form a suction passage in cross-section corresponding to the sensing portion 202. The suction passage formed by the spacer may be connected to the injection hole 259. The bodily fluid sample introduced into the inlet 259 may be sucked into the suction passage, for example, by capillary action. For reference, one side of the suction passage is drilled to be connected to the inlet 259, but the other side of the suction passage may be blocked by a spacer so that a sample of bodily fluid does not leak to the other portion of the test strip 200. However, the shape of the suction passage is not limited to the sensing portion 202 illustrated in FIG. 2, and may vary according to design.

In this specification, the suction passage is mainly described as being composed of one passage, but is not limited thereto. For example, the intake passage can include two passages. At this time, the first passage of the two passages may be covered by the measurement electrode, and the remaining second passage may be covered by the bioelectrode coated with the enzyme. In this case, the body fluid sample injected into the test strip 200 may fill the first passage and the second passage simultaneously. Therefore, the biomaterial measuring apparatus can measure the amount of the bodily fluid sample input to the test strip 200 and the amount of the target biomaterial contained in the bodily fluid sample at one time.

When the user inputs a body fluid sample through the inlet, the body fluid sample may be sucked into the suction passage formed in the suction layer 230 as described above. As the body fluid sample is sucked, a space between the measurement electrode and the reference electrode formed in the region corresponding to the sensing portion 202 may be filled by the body fluid sample. When the intake passage is filled with the body fluid sample, the dielectric constant in the space between the measurement electrode and the reference electrode varies, and thus the capacitance between the measurement electrode and the reference electrode also changes. The amount of change in capacitance may be proportional to the area or volume of the body fluid sample filled in the suction passage. For example, as the area where the body fluid sample is filled in the sensing portion 202 increases, the amount of change in capacitance also increases, so that the biomaterial measurement apparatus can determine the amount of the body fluid sample injected based on the amount of change in capacitance.

Additionally, a bioelectrode coated with an enzyme for measuring a target biomaterial may be disposed on the suction layer 230. For example, the bio-electrode may be disposed in the suction passage or may be disposed on some surface of the spacer. Therefore, when a body fluid sample is sucked into the suction passage, the biomaterial measuring apparatus estimates the amount of the body fluid sample from the capacitance change amount of the measurement electrode, and at the same time also estimates the amount of the target biomaterial from an electrical signal generated from the reaction between the enzyme and the target biomaterial. Can. For another example, when the suction passage is composed of a plurality of passages, the bioelectrode may be disposed in some passages. For reference, the measurement electrode may be separated so as not to contact the body fluid sample, and the bioelectrode may be disposed such that the surface coated with the enzyme can directly contact the body fluid sample.

The layers for the portion 201 for measuring the amount of bodily fluid sample in the test strip 200 are described below.

3 and 4 are views illustrating a structure in which a shielding layer is implemented on a test strip according to an embodiment.

The biomaterial measuring apparatus applies a predetermined electrical signal (eg, a signal of a predetermined voltage) to the measurement layer 310 and measures a change in electrical signal (eg, current, charge amount, etc.) according to the application of the voltage. The target capacitance C _L between the measurement layer 310 and the reference layer 320 may be measured. The biomaterial measurement apparatus may apply a predetermined electrical signal to the measurement layer 310 through the buffer 390. Since the target capacitance C _L changes when the body fluid sample is sucked through the suction layer 330 as described above in FIG. 2, the biomaterial measuring apparatus may determine the amount of the body fluid sample injected from the change amount of the target capacitance C _L. The buffer 390 is an exemplary configuration, and is not limited thereto. The electrical signal applied to the measurement electrode may be transmitted through an electrode part connected to the biomaterial measurement device.

However, when the measurement layer 310 is exposed to the outside, noise due to external factors may occur. For example, in FIG. 3, when the human body 309 comes into contact with or close to the measurement layer 310, a human body capacitance C _H may be formed between the measurement electrode of the measurement layer 310 and the human body 309. When the human body capacitance C _H is formed as described above, since the value changes dynamically according to an external factor, it is difficult for the biomaterial measuring apparatus to measure the value of the target capacitance C _L. Therefore, in order to prevent noise caused by such external factors, it is necessary to shield the contact of external objects and the electromagnetic effects of the external objects.

The test strip may further include a shielding layer 440, as shown in FIG. 4. The shielding layer 440 may be disposed on the measurement layer 310 and may indicate a layer for shielding electromagnetic wave signals from the outside. For example, the shielding layer 440 may include shielding electrodes for canceling external electromagnetic wave signals. In addition, the test strip may further include a shielding insulating layer separating the shielding layer 440 from the measurement layer 310. The shielding insulating layer is described in FIG. 7 below.

The shielding layer 440 may block factors that may affect the measurement of capacitance, such as the human body and surrounding environment. The shielding layer 440 can be connected to ground or a reference to the measurement circuit. As illustrated in FIG. 4, a shielding capacitance C _S may be formed between the shielding layer 440 and the measurement layer 310. For reference, the measurement circuit may indicate a circuit in which the electrode part of the test strip is connected when the test strip is inserted into the biomaterial measurement device or the biomaterial measurement module.

5 is a view showing a detailed structure of a test strip according to an embodiment.

The test strip may further include a shielding insulating layer 541 and outer insulating layers 551 and 552 in addition to the measurement layer 310, the reference layer 320, the suction layer 330, and the shielding layer 440. Can. For example, FIG. 5 shows a portion 501 of the test strip.

The shielding insulating layer 541, as described above in FIG. 4, prevents electrical contact between the shielding layer 440 and the measurement layer 310 and spaces the shielding layer 440 and the measurement layer 310 apart. Can be used.

The outer insulating layers 551 and 552 may represent a layer for preventing electrodes from contacting the outside. The outer insulating layers 551 and 552 may be made of an insulating material. The outer insulating layers 551 and 552 prevent the electrical contact of the measurement electrode and the reference electrode by an external object such as a human body, thereby accurately measuring the target capacitance between the measurement electrode and the reference electrode.

In FIG. 5, as the outer insulating layer, the upper insulating layer 551 and the lower insulating layer 552 are illustrated. The upper insulating layer 551 is the top of the test strip, and may be disposed on the top of the shielding layer 440. The lower insulating layer 552 is the bottom of the test strip and may be disposed under the reference layer 320. However, the present invention is not limited thereto, and the upper insulating layer 551 and the lower insulating layer 552 may be implemented as one body, or an insulating structure surrounding the remaining layers.

FIG. 6 below shows a cross section AA of the sensing portion 502 of the test strip.

6 is a diagram illustrating capacitance for electrodes in a test strip according to an embodiment.

In a test strip according to an embodiment, the measurement layer 310 may include one or more electrodes. For example, the measurement layer 310 may include an injection detection electrode 611, a measurement electrode 612, and an error detection electrode 613.

The injection detection electrode 611 may represent an electrode for detecting whether a body fluid sample is injected. The injection detection electrode 611 may be disposed adjacent to an injection port into which a bodily fluid sample is input in the test strip. In this case, the reference layer 320 may include a reference electrode corresponding to the injection detection electrode 611. For example, the injection detection electrode 611 and the reference electrode may be disposed above and below, respectively, based on a predetermined space of the suction passage. Therefore, the injection detection electrode 611 and the reference electrode can cover a certain space of the suction passage adjacent to the injection hole.

The measurement electrode 612 may represent an electrode configured to change the capacitance with respect to the reference electrode based on the amount of a sample of bodily fluid injected into the test strip. The measuring electrode 612 may be formed long along the length axis of the test strip. Also, the reference layer 320 may include a reference electrode corresponding to the measurement electrode 612. The measurement electrode 612 and the corresponding reference electrode may be disposed above and below each of the suction passages based on the measurement space. The measurement electrode 612 and a corresponding reference electrode may cover the measurement space.

The error detection electrode 613 may represent an electrode configured to change the capacitance with respect to the reference electrode based on environmental changes. The error detection electrode 613 may be spatially separated from other measurement electrodes 612 and injection detection electrodes 611. For example, the space covered by the error detection electrode 613 may be separated from the space covered by the measurement electrode 612 and the space covered by the injection detection electrode 611. The error detection electrode 613 may be disposed spaced apart from the suction passage by the spacer, and the spacer may prevent a bodily fluid sample from flowing into the space covered by the error detection electrode 613. The error detection electrode 613 is an electrode for determining the influence of the surrounding environment, and may be disposed to exclude the influence of temperature, humidity, and test strip shape differences. The capacitance C _RE between the error detection electrode 613 and the reference electrode should be kept constant, and when the capacitance C _RE changes beyond a threshold error, the biomaterial measurement apparatus may determine that an error has occurred.

In FIG. 6, for example, as described above, a body fluid sample may be introduced from one side of the sensing portion to the other side of the test strip. For example, in FIG. 6, a sample of bodily fluid may be sucked through an inlet disposed on the left side, and gradually injected into the right side.

The body fluid sample may gradually fill the space between the injection detection electrode 611 and the corresponding reference electrode among the electrodes of the measurement layer 310 and the reference layer 320 after filling a portion around the injection hole. When a body fluid sample is filled between the injection detection electrode 611 and the corresponding reference electrode, the capacitance C _RL between the injection detection electrode 611 and the corresponding reference electrode may be significantly increased than when only air is present. Capacitance C _RL increases gradually as the body fluid sample is introduced into the suction passage, and may maintain a constant value when the amount of the body fluid sample exceeds a certain level. For example, when the injected body fluid sample fills all the space covered by the injection detection electrode 611 and the corresponding reference electrode, the capacitance C _RL may exhibit a constant value. The constant value at this time can be expressed as capacitance C _RL,max .

According to an embodiment of the present invention, the biomaterial measurement apparatus may have a capacitance C _RL between the injection detection electrode 611 and a reference electrode corresponding thereto, or a predetermined value (eg, constant) over time, or a previously measured capacitance. When C _RL,max is indicated, it can be determined that injection of a bodily fluid sample has started.

Subsequently, when the body fluid sample is gradually suctioned into the suction passage of the suction layer 330, the body fluid sample fills the measurement space covered by the measurement electrode 612, beyond the space covered by the injection detection electrode 611. I can go out. In FIG. 6, the body fluid sample may be filled from the left side of the measurement space. The capacitance C _L between the measurement electrode 612 and the reference electrode may be gradually increased in proportion to the degree (eg, area) of the body fluid sample filling the measurement space in the suction passage. Therefore, based on the cross-sectional area of the suction passage and the shape of the electrode, the biomaterial measuring apparatus can estimate the amount of the body fluid sample. The operation of estimating the amount of a bodily fluid sample according to an increase in capacitance C _L is described in FIG. 7 below.

The biomaterial measurement apparatus according to an embodiment may measure capacitance between electrodes corresponding to each other in the measurement layer 310 and the reference layer 320 using a microcontroller and an LCR meter. For reference, capacitance can be influenced by factors such as the type of body fluid sample and the shape of the test strip (eg, the thickness of the strip, the width of the tube through which the body fluid sample flows, etc.). In addition, the biomaterial measurement apparatus may minimize errors in capacitance measurement by using capacitances C _SRL , C _SL , and C _SRE due to capacitive coupling formed between the shielding layer and the measurement layer 310.

7 is a diagram illustrating a structure in which an additional insulating layer is implemented on a test strip according to an embodiment.

The test strip according to an embodiment may further include inner insulating layers 761 and 762. The inner insulating layers 761 and 762 may be insulating layers to prevent contact of the bodily fluid sample with the measurement layer and the reference layer of the bodily fluid sample through the suction layer. The first inner insulating layer 761 may be disposed below the measurement layer 310 and above the suction layer 330. The second inner insulating layer 762 may be disposed above the reference layer 320 and below the suction layer 330. For reference, two internal insulating layers 761 and 762 are illustrated in FIG. 7, but are not limited thereto. Only one of the first inner insulating layer 761 or the second inner insulating layer 762 may be disposed on the test strip.

As described above, the biomaterial measurement apparatus may determine the amount of a bodily fluid sample injected into the suction passage based on a change in capacitance of each electrode. For example, the biomaterial measuring apparatus can measure and store the initial capacitance of each electrode before a body fluid sample is put into the test strip, and then use it.

According to an embodiment, the biomaterial measuring apparatus may determine whether a body fluid sample is injected into the test strip in response to a change in capacitance between the injection detection electrode and the reference electrode among the electrodes included in the test strip. The capacitance C _RL for the injection detection electrode may be an initial value C _RL0 until the body fluid sample reaches the first point 791. Thereafter, when the body fluid sample fills all the space covered by the injection detection electrode, the capacitance C _RL can be kept constant. For example, after the body fluid sample reaches the second point 792 in the inhalation passage, the capacitance C _RL may represent C _RL,max .

In addition, the biomaterial measuring apparatus estimates the amount of the bodily fluid sample injected into the test strip according to the amount of change in capacitance between the reference electrode and the measurement electrode in response to a change in capacitance between the reference electrode and the measurement electrode among the electrodes included in the test strip. Can. For example, the biomaterial measuring apparatus may determine the extent of the reaction by estimating an area filled with a body fluid sample from the total area inside the intake passage.

For example, the biomaterial measuring apparatus may quantitatively estimate the amount of a bodily fluid sample injected based on a fill ratio (FR). The filling ratio can be expressed by Equation 1 below.

[Equation 1]

은 측정 전극에 대한 커패시턴스 변화량을 나타낼 수 있고,

은 주입 검출 전극에 대한 커패시턴스 변화량을 나타낼 수 있다. C_L 는 현재 투입된 체액 샘플의 양에 대응하는 측정 전극의 커패시턴스, C_L0는 측정 전극에 의해 커버되는 영역에 체액 샘플이 채워지기 전의 초기 커패시턴스, C_RL,max는 주입 검출 전극의 최대 커패시턴스, C_RL0는 체액 샘플이 투입되기 전의 주입 검출 전극의 초기 커패시턴스를 나타낼 수 있다. 상술한 바와 같이, 주입 검출 전극에 의해 커버되는 영역이 모두 채워진 후에는 주입 검출 전극의 커패시턴스가 일정한 값을 나타내므로,

는 상수일 수 있다. 생체 물질 측정 장치는 주입 검출 전극에 대한 주입 커패시턴스 변화량 및 측정 전극에 대한 측정 커패시턴스 변화량 간의 비율에 기초하여 체액 샘플의 양을 추정할 수 있다. 예를 들어, 주입 검출 전극 및 측정 전극이 동종 재질로 구성되고, 동일한 너비를 가지며, 주입 검출 전극의 길이가 미리 주어지는 경우, 생체 물질 측정 장치는 상술한 채움 비율로부터 측정 전극에 의해 커버되는 영역이 채워진 길이를 추정할 수 있다.In the above equation (1),

Can represent the amount of change in capacitance for the measurement electrode,

May represent the amount of change in capacitance with respect to the injection detection electrode. C _L is the capacitance of the measurement electrode corresponding to the amount of the currently injected body fluid sample, C _L0 is the initial capacitance before the body fluid sample is filled in the area covered by the measurement electrode, C _RL,max is the maximum capacitance of the injection detection electrode, C _RL0 may represent the initial capacitance of the injection detection electrode before the body fluid sample is added. As described above, after all of the areas covered by the injection detection electrode are filled, the capacitance of the injection detection electrode shows a constant value,

Can be a constant. The biomaterial measuring apparatus may estimate the amount of a bodily fluid sample based on a ratio between the amount of change in injection capacitance for the injection detection electrode and the amount of change in measurement capacitance for the measurement electrode. For example, when the injection detection electrode and the measurement electrode are made of the same material, have the same width, and the length of the injection detection electrode is given in advance, the biomaterial measuring device has an area covered by the measurement electrode from the above-described filling ratio. The filled length can be estimated.

For example, since the body fluid sample is not filled in the area covered by the measurement electrode at the third point 793 in FIG. 7, the capacitance C _L of the measurement electrode may represent an initial value C _L0 .

When the body fluid sample is filled from the intake passage to an arbitrary fourth point 794, the biomaterial measurement device may calculate the filling ratio according to Equation 1 above. The biomaterial measuring apparatus can relatively accurately estimate the amount of the bodily fluid sample injected based on the filling ratio and the reference volume covered by the injection detection region. Since the reference volume represents the volume of the area covered by the injection detection area in the intake passage, for example, the product of the fill ratio and the reference volume can represent the amount of bodily fluid sample injected.

When the body fluid sample is filled up to the fifth point 795, the capacitance C _L of the measurement electrode may represent the maximum value C _L,max . Once the bodily fluid sample is filled to the fifth point 795, further input may be restricted.

In addition, the filling ratio is not limited to Equation 1 described above. The biomaterial measuring device is not limited to estimating the amount of a bodily fluid sample at a filling rate. Various ratios, criteria, or formulas for estimating the amount of bodily fluid samples may be used depending on the design.

8 is a diagram illustrating a method for measuring a biological material according to an embodiment.

First, in step 810, the biomaterial measuring device may detect the capacitance of the electrodes included in the test strip in response to the case where the test strip is inserted into the insertion hole. For example, the biomaterial measurement apparatus may detect the capacitance between the reference electrode and the measurement electrode among the electrodes included in the test strip. The biomaterial measuring apparatus can also detect the capacitances of the injection detection electrode and the error detection electrode, respectively. The biomaterial measuring apparatus may detect the capacitance of each of the electrodes included in the test strip at a predetermined period. The cycle may vary depending on the design.

Then, in step 820, the biomaterial measuring apparatus may measure the amount of the bodily fluid sample input to the test strip based on the detected capacitance.

For example, the biomaterial measuring apparatus may determine whether a bodily fluid sample is injected into the test strip in response to a change in capacitance between the injection detection electrode and the reference electrode among the electrodes included in the test strip. The biomaterial measuring apparatus may determine that the injection of the bodily fluid sample has started, in response to a case where the amount of change in the capacitance of the injection detection electrode exceeds the injection threshold. The injection threshold amount may correspond to a difference between the capacitance before the region covered by the injection detection electrode is filled with a body fluid sample and the capacitance after being filled.

The biomaterial measuring apparatus may estimate the amount of a bodily fluid sample injected into the test strip according to the amount of change in capacitance between the reference electrode and the measurement electrode in response to a change in capacitance between the reference electrode and the measurement electrode among the electrodes included in the test strip. have. As described above with reference to FIG. 7, the biomaterial measuring apparatus may estimate the amount of a bodily fluid sample injected into the test strip from a ratio between the amount of change in injection capacitance for the injection detection electrode and the amount of change in measurement capacitance for the measurement electrode.

Additionally, the biomaterial measurement device may determine that an error has occurred in the test strip in response to a case where the detected capacitance for the error detection electrode exceeds an error threshold. When an error occurs, the biomaterial measuring device may provide a notification to end or hold the measurement of the biomaterial, or to request a user to replace the test strip.

Subsequently, the biomaterial measurement apparatus may start measuring the target biomaterial included in the bodily fluid sample in response to the amount of the bodily fluid sample exceeding the measurement threshold. The biomaterial measurement apparatus may hold the measurement of the target biomaterial in response to a case in which the amount of the body fluid sample is equal to or less than the measurement threshold. The measurement threshold may vary depending on the design. The biomaterial measuring apparatus may measure the amount of a bodily fluid sample from a filling ratio according to Equation 1 described above or a capacitance ratio calculated based on other methods. Accordingly, the biomaterial measurement apparatus can start measurement after a sufficient amount of a bodily fluid sample (for example, blood) required for measurement of a biomaterial (eg, blood sugar) is secured.

The method according to the embodiment may be implemented in the form of program instructions that can be executed through various computer means and recorded on a computer-readable medium. The computer-readable medium may include program instructions, data files, data structures, or the like alone or in combination. The program instructions recorded on the medium may be specially designed and configured for the embodiment or may be known and usable by those skilled in computer software. Examples of computer-readable recording media include magnetic media such as hard disks, floppy disks, and magnetic tapes, optical media such as CD-ROMs, DVDs, and magnetic media such as floptical disks. -Hardware devices specially configured to store and execute program instructions such as magneto-optical media, and ROM, RAM, flash memory, and the like. Examples of program instructions include high-level language code that can be executed by a computer using an interpreter, etc., as well as machine language codes produced by a compiler. The hardware device described above may be configured to operate as one or more software modules to perform the operations of the embodiments, and vice versa.

The software may include a computer program, code, instruction, or a combination of one or more of these, and configure the processing device to operate as desired, or process independently or collectively You can command the device. Software and/or data may be interpreted by a processing device or to provide instructions or data to a processing device, of any type of machine, component, physical device, virtual equipment, computer storage medium or device. , Or may be permanently or temporarily embodied in the transmitted signal wave. The software may be distributed on networked computer systems, and stored or executed in a distributed manner. Software and data may be stored in one or more computer-readable recording media.

As described above, although the embodiments have been described by the limited drawings, those skilled in the art can apply various technical modifications and variations based on the above. For example, the described techniques are performed in a different order than the described method, and/or the components of the described system, structure, device, circuit, etc. are combined or combined in a different form from the described method, or other components Alternatively, even if replaced or substituted by equivalents, appropriate results can be achieved.

Therefore, other implementations, other embodiments, and equivalents to the claims are also within the scope of the following claims.

310: measurement layer
320: reference layer
330: suction layer
440: shielding layer
501: part of the test strip
502: sensing part
541: shielding insulating layer
551: upper insulating layer
552: lower insulating layer

Claims (19)

A reference layer including a reference electrode connected to ground;
A measurement layer including a measurement electrode for detecting a change in capacitance based on the reference electrode; And
A suction layer including a spacer separating the reference layer and the measurement layer
Test strip containing. According to claim 1,
An insulating layer to prevent contact of the bodily fluid sample through the inhalation layer with the measurement layer and contact with the reference layer of the bodily fluid sample
Test strip further comprising. According to claim 1,
At least one outer insulating layer to prevent external contact to the electrodes
Test strip further comprising. According to claim 1,
A shielding layer disposed on the measurement layer and shielding an external noise signal; And
A shielding insulating layer disposed between the measuring layer and the shielding layer
Test strip further comprising. According to claim 1,
The measurement layer,
The injection detection electrode for detecting whether or not the bodily fluid sample is injected is disposed adjacent to the inlet to which a bodily fluid sample is injected in the test strip.
Including,
The reference layer,
Reference electrode corresponding to the injection detection electrode
Test strip containing a. According to claim 1,
The measurement layer,
A measurement electrode configured to change the capacitance with respect to the reference electrode based on the amount of a bodily fluid sample being put into the test strip
Test strip containing a. According to claim 1,
The measurement layer,
Error detection electrode configured to change the capacitance to the reference electrode based on environmental changes
Test strip containing a. According to claim 1,
The spacer,
Configured to inhale a sample of bodily fluid injected through an inlet and deliver it to a space formed between the measurement layer and the reference layer,
Test strip. In response to a test strip inserted into the insertion hole, detecting capacitance for electrodes included in the test strip; And
Measuring an amount of a bodily fluid sample introduced into the test strip based on the detected capacitance
Method for measuring a biological material comprising a. The method of claim 9,
In response to the amount of the bodily fluid sample exceeding a measurement threshold, initiating a measurement of the target biological material contained in the bodily fluid sample
The method of measuring a biological material further comprising. The method of claim 9,
In response to the amount of the bodily fluid sample being equal to or less than a measurement threshold, holding a measurement for the target biological material
The method of measuring a biological material further comprising. The method of claim 9,
The step of detecting the capacitance,
Detecting a capacitance between a reference electrode and a measurement electrode among the electrodes included in the test strip
Method for measuring a biological material comprising a. The method of claim 9,
Measuring the amount of the body fluid sample,
Determining whether a sample of the bodily fluid is injected into the test strip in response to a change in capacitance between the injection detection electrode and the reference electrode among the electrodes included in the test strip
Method for measuring a biological material comprising a. The method of claim 9,
Measuring the amount of the body fluid sample,
Estimating the amount of the bodily fluid sample injected into the test strip according to a change in capacitance between the reference electrode and the measurement electrode in response to a change in capacitance between the reference electrode and the measurement electrode among the electrodes included in the test strip
Method for measuring a biological material comprising a. The method of claim 9,
Measuring the amount of the body fluid sample,
Estimating the amount of the bodily fluid sample injected into the test strip from the ratio between the amount of change in injection capacitance for the injection detection electrode and the amount of change in measurement capacitance for the measurement electrode
Method for measuring a biological material comprising a. The method of claim 9,
The step of detecting the capacitance,
Detecting a capacitance for each of the electrodes included in the test strip at a predetermined period
Method for measuring a biological material comprising a. The method of claim 9,
The step of detecting the capacitance,
Detecting the capacitance for the error detection electrode
Including,
Measuring the amount of the body fluid sample,
Determining that an error has occurred in the test strip in response to a case where the detected capacitance for the error detection electrode exceeds an error threshold value
Method for measuring a biological material comprising a. A computer-readable recording medium storing one or more computer programs comprising instructions for performing the method of claim 9. A signal receiver configured to receive electrical signals for electrodes included in the test strip in response to a test strip inserted into the insertion hole; And
A control unit that detects a capacitance for the electrodes based on the electrical signal and measures the amount of a bodily fluid sample input to the test strip based on the detected capacitance
Biological material measurement device comprising a.

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