Test piece for analyzing electrolyte solution, electrolyte solution analyzing device, and electrolyte solution analyzing method

The test piece for electrolyte analysis addresses the challenge of electrode contact verification by using a liquid detection electrode system to ensure reliable ion concentration measurements through impedance detection, enhancing measurement accuracy.

JP7619484B2Active Publication Date: 2025-01-22OMRON HEALTHCARE CO LTD
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Patent Information

Application Number
JP2023565690
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Filing Date
2021-12-06
Publication Date
2025-01-22
Estimated Expiration
2041-12-06

AI Technical Summary

Technical Problem

Existing electrolyte analysis methods face challenges in determining whether the electrolyte is properly in contact with ion-sensitive electrodes, leading to unreliable measurement results due to the small size and visual difficulty in confirming electrode contact.

Method used

The test piece for electrolyte analysis includes an ion-sensitive electrode and a liquid detection electrode system that detects contact with the electrolyte through impedance changes, ensuring reliable measurement by confirming electrolyte coverage before analysis.

Benefits of technology

This approach enhances the reliability of ion concentration measurements by verifying electrolyte contact with the ion-sensitive electrodes, thereby improving the accuracy of measurement results.

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Patent Text Reader

Abstract

The present invention is directed to a test piece (30) for electrolyte analysis for measuring the concentration of ions contained in an electrolyte, the test piece (30) for electrolyte analysis comprising: a substrate (31) extending in one direction (X); ion-sensitive electrodes (41, 42) provided in specific regions (51w1, 51w2) on a one end (31e) side of a main surface (31a) of the substrate (31) with respect to the one direction (X); main extraction electrodes (43, 44) extending from the ion-sensitive electrodes (41, 42) toward an opposite end (31f); a liquid detection electrode (45) provided in a proximal region (51w3) with some space from the main extraction electrodes (43, 44) to detect contact or non-contact with the electrolyte; and an auxiliary extraction electrode (47) provided with some space from the main extraction electrodes (43, 44) and extending from the liquid detection electrode (45) toward the opposite end.
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Description

[Technical field]

[0001] The present invention relates to a test strip for analyzing an electrolyte solution, more particularly to a test strip equipped with an ion-sensitive electrode for measuring the concentration of ions contained in an electrolyte solution, and also to an electrolyte analysis device and an electrolyte analysis method that are provided with such a test strip for analyzing an electrolyte solution and measure the concentration of ions contained in the electrolyte solution. [Background technology]

[0002] Conventionally, as a test piece for electrolyte analysis of this kind, for example, as disclosed in Patent Document 1 (JP Patent No. 6127460), a sensor head having a first ion selective electrode for selecting a first ion species and generating a potential corresponding to the concentration of the first ion species and a second ion selective electrode for selecting a second ion species and generating a potential corresponding to the concentration of the second ion species, on a substrate, is known. With the sensor head mounted on the main body (equipped with a CPU) of an electrolyte analyzer, an electrolyte (a standard solution with a known concentration ratio, or a liquid to be measured such as urine) is "contacted" with the region of the sensor head where the first and second ion selective electrodes are provided, and the potential difference between the first ion selective electrode and the second ion selective electrode is calculated by the CPU as the concentration ratio between the first ion species and the second ion species. In the document, when the liquid is "contacted" with the first and second ion selective electrodes, the liquid may be sprinkled on the first and second ion selective electrodes, or the first and second ion selective electrodes may be immersed in the liquid. If the electrolyte is sprinkled on the first and second ion selective electrodes, the user does not need to prepare a container for the liquid each time the electrodes are used. This is therefore convenient for the user. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 6127460 specification Summary of the Invention [Problem to be solved by the invention]

[0004] By the way, when a user brings the electrolyte into contact with the area of ​​the sensor head where the first and second ion selective electrodes are provided, in order to obtain accurate measurement results, the electrolyte needs to contact the area so that it covers the first and second ion selective electrodes together.

[0005] Here, the sensor head is small and is intended to be disposable. In Patent Document 1, the dimensions of the substrate are set to, for example, 50 mm in the X direction × 20 mm in the Y direction in the surface direction, and the thickness is set to about 200 μm. For this reason, for example, in a usage mode in which a user sprinkles an electrolyte on the area of ​​the sensor head where the first and second ion selective electrodes are provided, there is a problem that it is difficult to visually determine whether the electrolyte is in contact with the first and second ion selective electrodes (hereinafter collectively referred to as "ion-sensitive electrodes"). In this way, when a measurement is performed in a state where it is unclear whether the electrolyte is in contact with the ion-sensitive electrodes, the reliability of the measurement result is questionable.

[0006] Therefore, an object of the present invention is to provide an electrolyte analysis test strip equipped with an ion-sensitive electrode for measuring the concentration of ions contained in an electrolyte solution, which is capable of determining whether the electrolyte solution is in contact with and covers the ion-sensitive electrode.Another object of the present invention is to provide an electrolyte analysis device and an electrolyte analysis method that include such an electrolyte analysis test strip and measure the concentration of ions contained in the electrolyte solution after confirming that the electrolyte solution is in contact with and covers the ion-sensitive electrode. [Means for solving the problem]

[0007] In order to solve the above problems, in a first aspect, the disclosed test strip for analyzing an electrolyte solution comprises: A test strip for analyzing an electrolyte for measuring the concentration of ions contained in an electrolyte, A substrate extending in one direction from one end to the other end; an ion-sensitive electrode for measuring a concentration of the ions, the electrode being provided in a specific region on the main surface of the substrate on the side of the one end in the one direction; a main extraction electrode extending from the ion-sensitive electrode toward the other end; a liquid detection electrode for detecting whether or not the electrode has come into contact with the electrolyte, the liquid detection electrode being provided on the main surface in a proximal region corresponding to a region between the specific region and the other end in the one direction and spaced apart from the main extraction electrode; an auxiliary extraction electrode spaced apart from the main extraction electrode and extending from the liquid detection electrode toward the other end; Equipped with The liquid detection electrode is a proximal partial electrode provided in the proximal region; a distal partial electrode provided in a distal region corresponding to between the specific region and the one end in the one direction on the main surface for detecting whether or not the electrode has come into contact with the electrolyte; The auxiliary extraction electrodes extend from the distal partial electrode and the proximal partial electrode toward the other end, respectively, spaced apart from each other. It is characterized by:

[0008] As used herein, "electrolyte" refers broadly to a liquid that contains at least one ionic species.

[0009] The "principal surface" of a substrate refers to the spatially extending plate surface, and is different from the edge surface.

[0010] The term "one end side" refers to the side closer to the one end out of the one end and the other end in the one direction. Also, the term "the other end side" refers to the side closer to the other end out of the one end and the other end in the one direction.

[0011] To "contact" the electrolyte with the electrolyte analysis test strip (particularly the liquid sensing electrode), a user (typically a subject) may sprinkle the electrolyte onto the electrolyte analysis test strip so as to completely cover the area from the one end to the proximal region, or may immerse the electrolyte analysis test strip from the one end to the proximal region in the electrolyte.

[0012] When the electrolyte analysis test strip disclosed herein is used, the other end side with respect to the one direction is inserted into a connector of the main body of the electrolyte analysis device described below. In this state (referred to as the "attached state"), for measurement, the user contacts the electrolyte so as to cover the entire area from the one end of the electrolyte analysis test strip, including the specific area where the ion-sensitive electrode is provided, to the proximal area where the liquid detection electrode is provided (this is referred to as the "electrolyte contact operation"). Then, the electrolyte comes into contact with the ion-sensitive electrode and the liquid detection electrode so as to cover them together. As a result, the contact of the electrolyte with the liquid detection electrode can be detected by an element (e.g., a liquid detection processing unit described below) included in the main body of the electrolyte analysis device via the auxiliary extraction electrode. For example, the liquid detection electrode and The impedance between the test strip and the ion-sensitive electrode decreases. This decrease in impedance can be detected by an element included in the main body of the electrolyte analysis device, for example, via the main extraction electrode and the auxiliary extraction electrode. When it is detected that the electrolyte has come into contact with the liquid detection electrode (provided in the proximal region), it is determined that the electrolyte has come into contact with and covered the ion-sensitive electrode, under the assumption that the electrolyte contact operation brings the electrolyte into contact with the ion-sensitive electrode so as to cover the entire area from the one end of the electrolyte analysis test strip to the proximal region. Furthermore, in this electrolyte analysis test strip, the liquid detection electrode includes a proximal partial electrode provided in the proximal region, and a distal partial electrode provided in a distal region on the main surface corresponding to between the specific region and the one end in the one direction, for detecting whether or not the liquid detection electrode has come into contact with the electrolyte. Therefore, when a user performs the electrolyte contact operation in the wearing state, the electrolyte comes into contact with the distal partial electrode, the ion-sensitive electrode, and the proximal partial electrode so as to cover them together. This reduces the impedance between the distal partial electrode and the proximal partial electrode. This reduction in impedance can be detected by an element (for example, a liquid detection processing unit described later) included in the main body of the electrolyte analysis device through the auxiliary extraction electrodes that extend from the distal partial electrode and the proximal partial electrode to the other end side, respectively, at a distance from each other. This allows it to be determined that the electrolyte is in contact with the ion-sensitive electrode so as to cover it. Moreover, in this electrolyte analysis test strip, the ion-sensitive electrode is disposed between the distal partial electrode and the proximal partial electrode in the one direction, so that when the impedance between the distal partial electrode and the proximal partial electrode decreases, it can be said that the electrolyte is in contact with and covers the ion-sensitive electrode, and therefore it is possible to determine whether the electrolyte is in contact with and covers the ion-sensitive electrode.

[0013] Furthermore, when it is determined that the electrolyte is in contact with and covers the ion-sensitive electrode, the determination serves as a trigger to detect a change in potential of the ion-sensitive electrode via the main extraction electrode by an element included in the main body of the electrolyte analyzer. Based on this change in potential, the concentration of ions contained in the electrolyte can be measured. In this way, when a measurement is performed after it is confirmed that the electrolyte is in contact with and covers the ion-sensitive electrode, the reliability of the measurement result (ion concentration) can be increased.

[0014] In one embodiment of the test strip for electrolyte analysis, The proximal partial electrode, the ion-sensitive electrode, and the distal partial electrode are aligned in a line along the one direction. It is characterized by:

[0016] In a second aspect, the electrolyte analytical test strip of the present disclosure comprises: A test strip for analyzing an electrolyte for measuring the concentration of ions contained in an electrolyte, A substrate extending in one direction from one end to the other end; an ion-sensitive electrode for measuring a concentration of the ions, the electrode being provided in a specific region on the main surface of the substrate on the side of the one end in the one direction; a main extraction electrode extending from the ion-sensitive electrode toward the other end; a liquid detection electrode for detecting whether or not the electrode has come into contact with the electrolyte, the liquid detection electrode being provided on the main surface in a proximal region corresponding to a region between the specific region and the other end in the one direction and spaced apart from the main extraction electrode; an auxiliary extraction electrode spaced apart from the main extraction electrode and extending from the liquid detection electrode toward the other end; Equipped with The liquid sensing electrode includes a first proximal partial electrode and a second proximal partial electrode spaced apart from each other in the proximal region; The auxiliary extraction electrodes extend from the first and second proximal partial electrodes toward the other end, respectively, spaced apart from each other. It is characterized by:

[0017] In the electrolyte analysis test strip of the disclosure, the liquid detection electrode includes a first proximal partial electrode and a second proximal partial electrode spaced apart from each other in the proximal region. A change in impedance between the first proximal partial electrode and the second proximal partial electrode can be detected by an element (e.g., a liquid detection processing unit described later) included in the main body of the electrolyte analysis device through the auxiliary extraction electrodes extending from the first and second proximal partial electrodes to the other end side at a distance from each other. Therefore, under the premise that the electrolyte is contacted so as to cover the entire area from the one end of the electrolyte analysis test strip to the proximal region according to the electrolyte contact operation, it can be determined whether the electrolyte is in contact with the ion-sensitive electrode so as to cover it according to a change in impedance between the first proximal partial electrode and the second proximal partial electrode.

[0018] In one embodiment of the test strip for electrolyte analysis, The first proximal partial electrode and the second proximal partial electrode are spaced apart from each other in the one direction. It is characterized by:

[0019] In the electrolyte analysis test strip of this embodiment, the first proximal partial electrode and the second proximal partial electrode are spaced apart from each other in the one direction. Therefore, if the ranges contacted from the one end in the one direction for two types of electrolytes (these are called the "first electrolyte" and the "second electrolyte"; for example, the first electrolyte can be a standard solution with a known concentration ratio, and the second electrolyte can be urine as a measurement target) are set to be different in advance, the two types of electrolytes can be distinguished and detected by the first and second proximal partial electrodes. Specifically, the first proximal partial electrode is disposed closer to the one end than the second proximal partial electrode in the one direction. In this case, for example, the range contacted by the first electrolyte in the one direction by the electrolyte contact operation is adjusted in advance to be a range that covers the entire area from the one end to the first proximal partial electrode, and does not reach the second proximal partial electrode. In addition, the range in which the second electrolytic solution is immersed in the one direction by the electrolytic solution contact operation is adjusted in advance to a range that covers the entire area from the one end to the second proximal partial electrode beyond the first proximal partial electrode. Then, when an element (e.g., a liquid detection processing unit to be described later) included in the main body of the electrolytic solution analyzer detects through the auxiliary extraction electrode that an electrolytic solution is in contact with the first proximal partial electrode and that the electrolytic solution is not in contact with the second proximal partial electrode, it is possible to know that the electrolytic solution that is currently in contact with the first proximal partial electrode so as to cover the area from the one end to the first proximal partial electrode is the first electrolytic solution. In addition, when an element (for example, a liquid detection processing unit described later) included in the main body of the electrolyte analyzer detects, via the auxiliary extraction electrode, that a certain electrolyte is in contact with the first proximal partial electrode and that the electrolyte is in contact with the second proximal partial electrode, it is possible to know that the electrolyte currently in contact so as to cover the area from the one end to the second proximal partial electrode is the second electrolyte. This makes it possible to distinguish and detect the two types of electrolyte as described above.

[0020] In one embodiment of the test strip for electrolyte analysis, The electrolyte contains a first ion species and a second ion species that are different from each other, The ion-sensitive electrodes include a first ion-sensitive electrode that is in contact with the electrolytic solution to generate a first potential corresponding to a concentration of the first ion species, and a second ion-sensitive electrode that is in contact with the electrolytic solution to generate a second potential corresponding to a concentration of the second ion species, the first ion-sensitive electrode being spaced apart from the first ion-sensitive electrode in the specific region; and The main extraction electrode includes first and second main extraction electrodes extending from the first and second ion-sensitive electrodes toward the other end, respectively, and spaced apart from each other. It is characterized by:

[0021] In the electrolyte analysis test strip of this embodiment, the ion-sensitive electrodes include a first ion-sensitive electrode that contacts the electrolyte to generate a first potential corresponding to the concentration of the first ion species, and a second ion-sensitive electrode that contacts the electrolyte to generate a second potential corresponding to the concentration of the second ion species, which are provided in the specific region and spaced apart from each other. The first and second potentials are transmitted to the other end via the first and second main extraction electrodes, respectively. The first and second potentials transmitted to the other end can be detected by an element (for example, a calculation unit described later) included in the main body of the electrolyte analysis device. As a result, a concentration ratio between the first ion species and the second ion species contained in the electrolyte can be calculated based on the potential difference between the first and second potentials.

[0022] In one embodiment of the test strip for analyzing an electrolyte solution, a reference electrode provided in the specific region and spaced apart from the first and second ion-sensitive electrodes, the reference electrode being in contact with the electrolyte to generate a reference potential; a reference extraction electrode spaced apart from the first and second main extraction electrodes and extending from the reference electrode toward the other end; The present invention is characterized by comprising:

[0023] In the test strip for analyzing an electrolyte solution according to this embodiment, the reference potential is determined by extracting the reference extraction potential from the reference electrode. veryThe reference potential transmitted to the other end side can be detected by an element (for example, a calculation unit described later) included in the main body of the electrolyte solution analyzer. As a result, the concentration of the first ion species contained in the electrolyte solution can be calculated based on the potential difference between the reference potential and the first potential. Also, the concentration of the second ion species contained in the electrolyte solution can be calculated based on the potential difference between the reference potential and the second potential.

[0024] In a third aspect, the electrolyte analyzer of the present disclosure comprises: An electrolytic solution analyzer for measuring a concentration ratio between a first ion species and a second ion species contained in an electrolytic solution, A test piece for electrolyte analysis; A main body; The test strip for electrolyte analysis is A substrate extending in one direction from one end to the other end; On the main surface of the substrate, a specific region on the one end side in the one direction is provided. Ta An ON-sensitive electrode; a main extraction electrode extending from the ion-sensitive electrode toward the other end; a liquid detection electrode for detecting whether or not the electrode has come into contact with the electrolyte, the liquid detection electrode being provided on the main surface in a proximal region corresponding to a region between the specific region and the other end in the one direction and spaced apart from the main extraction electrode; an auxiliary extraction electrode spaced apart from the main extraction electrode and extending from the liquid detection electrode toward the other end; Equipped with The ion-sensitive electrodes include a first ion-sensitive electrode that is in contact with the electrolytic solution to generate a first potential corresponding to a concentration of the first ion species, and a second ion-sensitive electrode that is in contact with the electrolytic solution to generate a second potential corresponding to a concentration of the second ion species, the first ion-sensitive electrode being spaced apart from the first ion-sensitive electrode in the specific region; and the main extraction electrode includes first and second main extraction electrodes extending from the first and second ion-sensitive electrodes toward the other end, respectively, and spaced apart from each other; The above body is a connector having contact electrodes which come into contact with the first main extraction electrode, the second main extraction electrode and the auxiliary extraction electrode, respectively, when the other end of the test piece for electrolyte analysis is inserted into the connector; a liquid detection processing unit that detects, when the electrolyte comes into contact with the liquid detection electrode in a mounted state in which the other end of the test piece for electrolyte analysis is inserted into the connector, via the auxiliary extraction electrode, that the electrolyte has come into contact with the liquid detection electrode; a calculation unit that calculates a concentration ratio between the first ion species and the second ion species contained in the electrolyte based on a potential difference between the first potential obtained through the first main extraction electrode and the second potential obtained through the second main extraction electrode, when the contact of the electrolyte with the liquid detection electrode is detected as a trigger; and The present invention is characterized by comprising:

[0025] In the electrolyte analysis device disclosed herein, when using the electrolyte analysis device, the user inserts the other end of the electrolyte analysis test strip into the connector of the main body (this is called the "attachment operation"). This attachment operation brings the contact electrodes of the connector into contact with the first main extraction electrode, the second main extraction electrode, and the auxiliary extraction electrode of the electrolyte analysis test strip, respectively. In this state (attachment state), the user contacts the electrolyte for measurement so as to cover the entire area from the one end of the electrolyte analysis test strip, including the specific area where the first and second ion-sensitive electrodes are provided, to the proximal area where the liquid detection electrode is provided (as described above, this is called the "electrolyte contact operation"). Then, the electrolyte comes into contact with the first and second ion-sensitive electrodes and the liquid detection electrode so as to cover them together. This allows the contact of the electrolyte with the liquid detection electrode to be detected by a liquid detection processing unit provided in the main body via the auxiliary extraction electrode (and the corresponding contact electrode of the connector). For example, the impedance between the liquid detection electrode and the first and second ion-sensitive electrodes decreases. This decrease in impedance can be detected by the liquid detection processing unit via the first and second main extraction electrodes and the auxiliary extraction electrode (and the corresponding contact electrodes of the connector). When the contact of the electrolyte with the liquid detection electrode is detected, it is determined that the electrolyte is in contact with the first and second ion-sensitive electrodes so as to cover them together, under the premise that the electrolyte contact operation brings the electrolyte into contact with the electrolyte analysis test strip so as to cover the entire area from the one end to the proximal region. Thus, triggered by detection of contact of the electrolytic solution with the first and second ion-sensitive electrodes, the calculation unit calculates a concentration ratio between the first ion species and the second ion species contained in the electrolytic solution based on a potential difference between the first potential obtained through the first main extraction electrode and the second potential obtained through the second main extraction electrode. In this way, by performing a measurement after confirming that the electrolytic solution is in contact with the first and second ion-sensitive electrodes so as to cover them together, it is possible to increase the reliability of the measurement result (the concentration ratio between the first ion species and the second ion species).

[0026] In one embodiment of the electrolyte analyzer, The body further comprises: a mounting detection unit that detects that the other end of the test strip for electrolyte analysis is inserted into the connector; and a power supply control unit that turns on the power supply of the main body when the wearing state is detected as a trigger; The present invention is characterized by comprising:

[0027] "Turning on the power supply of the main body" means supplying power to each part of the main body (including the liquid detection processing unit and the calculation unit) to make each part operable. Note that when the power supply of the main body is turned off, the mounting detection unit is operable, but no power is supplied to parts of the main body other than the mounting detection unit, and they are in an inoperable state.

[0028] In the electrolyte analysis device of this embodiment, when using the electrolyte analysis device, the user performs an attachment operation of inserting the other end of the electrolyte analysis test strip into the connector of the main body. The attachment detection unit then detects that the other end of the electrolyte analysis test strip has been inserted into the connector and is in an attached state. The detection of the attached state is used as a trigger to cause the power control unit to turn on the power of the main body. Therefore, when using the electrolyte analysis device, the user does not need to perform an operation to turn on the power of the main body in addition to the attachment operation. This can improve user convenience. In addition, there is no need to provide a power switch on the main body.

[0029] In one embodiment of the electrolyte analyzer, the test piece for analyzing an electrolyte solution has a conductive layer provided on the other end side in the one direction and spaced apart from the first and second main extraction electrodes and the auxiliary extraction electrode, the connector has an additional contact electrode that corresponds to and comes into contact with the conductive layer when the other end of the electrolyte analytical test strip is inserted into the connector; The attachment detection unit detects the attached state in response to the additional contact electrode of the connector contacting the conductive layer. It is characterized by:

[0030] In the electrolyte analyzer of this embodiment, the attachment detector detects the attachment state in response to the additional contact electrode of the connector coming into contact with the conductive layer, thereby making it possible to detect the attachment state with a simple configuration.

[0031] In one embodiment of the electrolytic solution analyzer, The body has an outer peripheral wall that houses the elements that the body comprises; The outer peripheral wall exposes a display screen that displays information controlled by the computing unit and a slot for the connector to receive the electrolyte analysis test strip, while covering the remaining area other than the area occupied by the display screen and the slot without any operating element. It is characterized by:

[0032] The "elements included in the main body" refer to the connector, the liquid detection processing unit, the calculation unit, Installation The device includes a detection unit, the power supply control unit, and a display that forms the display screen.

[0033] The term "operation element" refers to an element such as a button switch for inputting instructions by the user.

[0034] In the electrolyte solution analyzer of this embodiment, the main body has an outer peripheral wall that houses the elements of the main body. The outer peripheral wall exposes a display screen that displays information controlled by the calculation unit and a slot for the connector to receive the electrolyte solution analysis test strip, while covering the remaining area other than the area occupied by the display screen and the slot without any operating elements. Since no operating elements are provided on the outer peripheral wall of the main body, the configuration of the main body is simplified.

[0035] In a fourth aspect, the present disclosure provides an electrolyte analysis method, comprising: An electrolyte analysis method for measuring a concentration ratio between the first ion species and the second ion species contained in the electrolyte by using the electrolyte analysis device of the third aspect, the calculation unit of the electrolyte solution analyzer is triggered by detection of contact of the electrolyte solution with the liquid detection electrode, waits for a potential difference between the first and second potentials obtained through the first and second main extraction electrodes to converge, performs calibration based on the potential difference between the first and second potentials that has converged, and then calculates a concentration ratio between the first ion species and the second ion species using parameters obtained by the calibration; The electrolyte analysis method includes: The other end of the test strip for electrolyte analysis is inserted into the connector to be in a mounted state. In the mounted state, an operation is performed in which a standard solution containing the first ion species and the second ion species in a predetermined concentration ratio is brought into contact with the main surface of the electrolyte analysis test piece so as to cover the entire area from the one end to the proximal region, thereby causing the liquid detection processing unit to detect that the electrolyte has come into contact with the liquid detection electrode via the auxiliary extraction electrode, and further causing the calculation unit to perform the calibration based on the potential difference between the first and second potentials obtained for the standard solution, using the detection of the standard solution coming into contact with the liquid detection electrode as a trigger. It is characterized by:

[0036] "Calibration" refers to a process of determining parameters necessary for calculating the concentration ratio between the first ionic species and the second ionic species in the liquid to be measured, based on the potential difference between the first and second potentials obtained in a standard liquid having a known concentration ratio.

[0037] In the disclosed electrolyte analysis method, the user inserts the other end of the electrolyte analysis test strip into the connector to set it in an attached state, and in the attached state, performs an operation of contacting the electrolyte with a standard solution containing the first ion species and the second ion species in a predetermined concentration ratio as the electrolyte so as to cover the main surface of the electrolyte analysis test strip from the one end to the proximal region. This causes the liquid detection processing unit to detect that the electrolyte has contacted the liquid detection electrode via the auxiliary extraction electrode, and further causes the calculation unit to perform the calibration based on the potential difference between the first and second potentials obtained for the standard solution, using the detection of the contact of the standard solution with the liquid detection electrode as a trigger. In this way, when the calibration is performed after confirming that the standard solution is in contact with the first and second ion-sensitive electrodes, the reliability of the calibration can be increased. In addition, when starting the calibration, the user does not need to perform an operation such as turning on a calibration switch in addition to the operation of contacting the standard solution. This improves user convenience and eliminates the need to provide a calibration switch on the main body.

[0038] In one embodiment of the electrolyte analysis method, The electrolyte solution analyzer is a mounting detection unit that detects that the other end of the test strip for electrolyte analysis is inserted into the connector; and a power supply control unit that turns on the power supply of the main body when the wearing state is detected as a trigger; Equipped with The electrolyte analysis method includes: By performing a mounting operation of inserting the other end of the test strip for electrolyte analysis into the connector of the main body, the mounting detection unit detects that the other end of the test strip for electrolyte analysis is inserted into the connector and the detection of the mounted state triggers the power supply control unit to turn on the power supply of the main body. It is characterized by:

[0039] In the electrolyte analysis method of this embodiment, when a user starts using the electrolyte analyzer, the user performs an attachment operation of inserting the other end of the electrolyte analysis test strip into the connector of the main body. This causes the attachment detection unit to detect the attached state, and the detection of the attached state serves as a trigger to cause the power control unit to turn on the power of the main body. In this case, when the user starts using the electrolyte analyzer, the user does not need to perform an operation to turn on the power of the main body separately from the attachment operation. This can improve user convenience. Also, there is no need to provide a power switch on the main body.

[0040] In one embodiment of the electrolyte analysis method, the calculation unit of the electrolyte solution analyzer determines, following the calibration, whether or not a potential difference between the first and second potentials obtained through the first and second main extraction electrodes shows a change exceeding a predetermined threshold value, and waits until the potential difference between the first and second potentials converges again, triggered by the potential difference between the first and second potentials showing a change exceeding the threshold value, and calculates a concentration ratio between the first ion species and the second ion species using parameters determined by the calibration based on the potential difference between the first and second potentials that has converged; The electrolyte analysis method includes: After the calculation unit performs the calibration, By performing an operation of contacting the test strip with a liquid to be measured so as to cover the entire main surface of the test strip from the one end to the proximal region so as to cause a change in the potential difference between the first and second potentials that exceeds the threshold value, the calculation unit is caused to calculate the concentration ratio using the parameters obtained by the calibration based on the potential difference between the first and second potentials obtained for the liquid to be measured. It is characterized by:

[0041] In the electrolyte analysis method of this embodiment, the user causes the calculation unit to perform the calibration, and then, at the start of measurement, performs an operation of contacting the test strip for electrolyte analysis with the liquid to be measured so as to cover the entire main surface of the test strip from the one end to the proximal region so as to cause a change in the potential difference between the first and second potentials that exceeds the threshold. Here, the calculation unit determines whether or not the potential difference between the first and second potentials obtained through the first and second main extraction electrodes shows a change that exceeds a predetermined threshold. When the potential difference between the first and second potentials shows a change that exceeds the threshold, it is determined that the standard solution in contact with the first and second ion-sensitive electrodes has been replaced with the liquid to be measured. At this time, the calculation unit waits until the potential difference between the first and second potentials converges again, triggered by the potential difference between the first and second potentials exceeding the threshold value, and calculates the concentration ratio between the first ion species and the second ion species using the parameters obtained by the calibration based on the converged potential difference between the first and second potentials. In this way, the reliability of the calculated concentration ratio can be improved by calculating the concentration ratio after confirming that the standard solution in contact with the first and second ion-sensitive electrodes has been replaced with the liquid to be measured. In addition, when starting measurement of the liquid to be measured, the user does not need to perform an operation such as turning on a measurement switch in addition to the operation of contacting the liquid to be measured. Therefore, the convenience of the user can be improved. In addition, there is no need to provide a measurement button switch on the main body. In a fifth aspect, the electrolyte analyzer of the present disclosure comprises: An electrolyte analyzer for measuring the concentration of ions contained in an electrolyte, A test piece for electrolyte analysis; A main body; The test strip for electrolyte analysis is A substrate extending in one direction from one end to the other end; an ion-sensitive electrode for measuring a concentration of the ions, the electrode being provided in a specific region on the main surface of the substrate on the side of the one end in the one direction; a main extraction electrode extending from the ion-sensitive electrode toward the other end; a liquid detection electrode for detecting whether or not the electrode has come into contact with the electrolyte, the liquid detection electrode being provided on the main surface in a proximal region corresponding to a region between the specific region and the other end in the one direction and spaced apart from the main extraction electrode; an auxiliary extraction electrode spaced apart from the main extraction electrode and extending from the liquid detection electrode toward the other end; Equipped with The above body is a connector having contact electrodes which come into contact with the main extraction electrode and the auxiliary extraction electrode when the other end of the test strip is inserted into the connector; a liquid detection processing unit that detects, when the electrolyte comes into contact with the liquid detection electrode in a mounted state in which the other end of the test strip for electrolyte analysis is inserted into the connector, via the auxiliary extraction electrode, that the electrolyte has come into contact with the liquid detection electrode; a calculation unit that calculates a concentration of ions contained in the electrolyte based on a potential obtained through the main extraction electrode, using the detection of contact of the electrolyte with the liquid detection electrode as a trigger; The present invention is characterized by comprising: In one embodiment of the electrolytic solution analyzer, The test strip for electrolyte analysis is a reference electrode provided in the specific region and spaced apart from the ion-sensitive electrode, the reference electrode being in contact with the electrolyte to generate a reference potential; a reference extraction electrode spaced apart from the main extraction electrode and extending from the reference electrode toward the other end; The present invention is characterized by comprising: Effect of the Invention

[0042] As is apparent from the above, the disclosed electrolyte analysis test strip can determine whether the electrolyte is in contact with the ion-sensitive electrode. Also, the disclosed electrolyte analysis device and electrolyte analysis method can measure the concentration of ions contained in the electrolyte after confirming that the electrolyte is in contact with the ion-sensitive electrode. [Brief description of the drawings]

[0043] [Figure 1] Fig. 1(A) is a diagram showing a schematic configuration of an electrochemical sensor as an electrolyte analyzer according to a first embodiment of the present invention, and Fig. 1(B) is a diagram showing a schematic oblique view of the main body of the electrolyte analyzer. [Diagram 2] Fig. 2(A) is a diagram showing a planar layout of a test piece for analyzing an electrolyte solution included in the electrochemical sensor, and Fig. 2(B) is a diagram showing a cross section (end face) taken along line IIB-IIB in Fig. 2(A). [Diagram 3] FIG. 2 is a block diagram showing the configuration of the electrochemical sensor. [Figure 4] FIG. 13 is a diagram showing the flow of an electrolyte analysis method in which a subject as a user uses the electrochemical sensor to measure the concentration ratio between sodium ions and potassium ions in urine as an electrolyte. [Diagram 5] 5(A) to 5(D) are diagrams showing a schematic diagram of the procedure (first half) of the above-mentioned electrolyte analysis method. [Figure 6] 6(A) to 6(E) are diagrams showing a schematic diagram of the procedure (latter half) of the above-mentioned electrolytic solution analysis method. [Figure 7] 7(A) to 7(C) are diagrams showing in more detail a part of the procedure of the above-mentioned electrolyte analysis method (corresponding to FIG. 5(D) to FIG. 6(A)). [Figure 8] 1 is a diagram illustrating an example of a change in output observed in the main body in response to a change in the DC resistance value of a liquid detection electrode when the electrolyte comes into contact with the liquid detection electrode of the electrolyte analysis test strip. FIG. [Figure 9] FIG. 2 is a diagram illustrating the change in potential difference between a sodium ion-sensitive electrode and a potassium ion-sensitive electrode of the test strip for analyzing an electrolyte solution. [Figure 10] Fig. 10(A) is a diagram showing a planar layout of a modified test piece for electrolyte analysis, and Figs. 10(B) to 10(C) are diagrams for explaining a measurement procedure using the test piece for electrolyte analysis of Fig. 10(A). [Figure 11]Fig. 11(A) is a diagram showing a planar layout of a test piece for electrolyte analysis according to still another modified example, and Fig. 11(B) is a diagram showing a cross section (end face) taken along line XIB-XIB in Fig. 11(A). [Figure 12] Fig. 12(A) is a diagram showing a planar layout of a test piece for electrolyte analysis according to still another modified example, and Fig. 12(B) is a diagram showing a cross section (end face) taken along line XIIB-XIIB in Fig. 12(A). [Figure 13] Fig. 13(A) is a diagram showing a planar layout of a test piece for electrolyte analysis according to still another modified example, and Fig. 13(B) is a diagram showing a planar layout of a test piece for electrolyte analysis according to still another modified example. [Figure 14] Fig. 14(A) is a diagram showing a planar layout of a test piece for electrolyte analysis according to another embodiment, and Fig. 14(B) is a diagram showing a schematic oblique view of a main body corresponding to the test piece for electrolyte analysis in Fig. 14(A). [Figure 15] 14(A) and 14(B) are diagrams showing a block configuration of an electrochemical sensor serving as an electrolyte analyzer of a second embodiment, the sensor including the test strip for electrolyte analysis of FIG. 14(A) and the main body of FIG. 14(B). [Figure 16] FIG. 14(B) is a diagram showing the flow of an electrolyte analysis method in which a subject as a user uses the electrochemical sensor of FIG. 14(A) to measure the concentration ratio between sodium ions and potassium ions in urine as an electrolyte. [Figure 17] 17(A) to 17(D) are diagrams showing a schematic diagram of the procedure (first half) of the above-mentioned electrolytic solution analysis method. [Figure 18] 18(A) to 18(E) are diagrams typically showing the procedure (latter half) of the above-mentioned electrolytic solution analyzing method. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0044] Hereinafter, an embodiment of the present invention will be described in detail with reference to the drawings.

[0045] (First embodiment) (Schematic configuration of electrochemical sensor) FIG. 1(A) shows a schematic configuration of an electrochemical sensor 90 serving as an electrolyte analyzer according to a first embodiment of the present invention.

[0046] This electrochemical sensor 90 is roughly divided into an embodiment of a test strip for analyzing an electrolyte (hereinafter, simply referred to as a "test strip") 30 and a main body 10 to which the test strip 30 should be attached. For ease of understanding, an XYZ orthogonal coordinate system is also shown as appropriate in some of the drawings described below. This test strip 30 is used to measure the concentration ratio between a first ion species and a second ion species contained in an electrolyte to be measured. In this example, the electrolyte to be measured is urine, the first ion species is sodium ions, and the second ion species is potassium ions.

[0047] (Test piece composition) Fig. 2(A) shows a planar layout of the test piece 30. Fig. 2(B) shows a cross section (end face) taken along line IIB-IIB in Fig. 2(A). As can be seen from these figures, the test piece 30 includes a single substrate 31 extending in an elongated manner from one end 31e to the other end 31f in the X direction as one direction, a sodium ion-sensitive electrode 41 as a first ion-sensitive electrode provided in a circular specific region 51w1 on the one end 31e side in the X direction on a surface 31a as a main surface of the substrate 31, a potassium ion-sensitive electrode 42 as a second ion-sensitive electrode provided in another circular specific region 51w2 closer to the other end 31f than the specific region 51w1, and first and second main extraction electrodes 43 and 44 extending from the sodium ion-sensitive electrode 41 and the potassium ion-sensitive electrode 42 to the other end 31f side, respectively.

[0048] The "side of one end 31e" refers to the side between one end 31e and the other end 31f that is closer to one end 31e in the X direction. The "side of the other end 31f" refers to the side between one end 31e and the other end 31f that is closer to the other end 31f in the X direction.

[0049] The first main extraction electrode 43 has a circular base portion 43a provided in the specific region 51w1, a lead portion 43b extending in an elongated manner from the base portion 43a toward the other end 31f, and an electrode pad portion 43c connected to the lead portion 43b and provided on the other end 31f side and wider than the lead portion 43b. The second main extraction electrode 44 has a circular base portion 44a provided in the specific region 51w2, a lead portion 44b extending in an elongated manner from the base portion 44a toward the other end 31f, and an electrode pad portion 44c connected to the lead portion 44b and provided on the other end 31f side and wider than the lead portion 44b.

[0050] As can be seen from FIG. 2B, the sodium ion sensitive electrode 41 is provided on the base portion 43a of the first main extraction electrode 43 in electrical contact with the base portion 43a. Ta, The second main extraction electrode 44 includes a base portion 44a of the second main extraction electrode 44 and a potassium ion-sensitive membrane 42i serving as a second ion-sensitive membrane provided on and in electrical contact with the base portion 44a. The sodium ion-sensitive electrode 41 and the potassium ion-sensitive electrode 42 come into contact with the electrolyte to be measured (urine in this example) and generate a first potential (referred to as E1) corresponding to the concentration of sodium ions and a second potential (referred to as E2) corresponding to the concentration of potassium ions, respectively.

[0051] Further, as shown in FIG. 2(A), the test piece 30 is provided on the surface 31a of the substrate 31 with a proximal electrode 45 and a distal electrode 46, which are liquid detection electrodes for detecting whether or not the test piece 30 has come into contact with an electrolyte. The proximal electrode 45 is provided in a circular proximal region 51w3 corresponding to the region between the specific region 51w2 and the other end 31f in the X direction, and is spaced apart from the first and second main extraction electrodes 43 and 44. The distal electrode 46 is provided in a circular distal region 51w4 corresponding to the region between the specific region 51w1 and the one end 31e in the X direction. In this example, the shapes of the proximal electrode 45 and the distal electrode 46 are circular, approximately corresponding to the proximal region 51w3 and the distal region 51w4, respectively. Furthermore, a first auxiliary extraction electrode 47 extending from the proximal partial electrode 45 toward the other end 31f and a second auxiliary extraction electrode 48 extending from the distal partial electrode 46 toward the other end 31f are provided on the surface 31a of the substrate 31.

[0052] The first auxiliary extracted electrode 47 has a lead portion 47b extending in an elongated manner from the proximal electrode 45 toward the other end 31f, and an electrode pad portion 47c connected to the lead portion 47b and provided on the other end 31f, the electrode pad portion 47c being wider than the lead portion 47b. The second auxiliary extracted electrode 48 has a lead portion 48b extending from the distal electrode 46 toward the other end 31f, and an electrode pad portion 48c connected to the lead portion 48b and provided on the other end 31f, the electrode pad portion 48c being wider than the lead portion 48b.

[0053] In this example, lead portions 43b, 47b, 44b, and 48b are arranged in this order at a distance from one another from the +Y side to the -Y side on the front surface 31a of the substrate 31. Correspondingly, electrode pad portions 43c, 47c, 44c, and 48c are arranged in this order at a distance from one another along the other end 31f of the substrate 31.

[0054] An insulating film 51 is provided as a protective layer on the surface 31a of the substrate 31. The insulating film 51 covers the substrate 31 from one end 31e in the X direction to approximately the electrode pad portions 43c, 47c, 44c, and 48c. Therefore, the lead portions 43b, 47b, 44b, and 48b are each protected by the insulating film 51. On the other hand, the electrode pad portions 43c, 47c, 44c, and 48c are exposed from the insulating film 51 and are adapted to be electrically connected to a connector of the main body, which will be described later.

[0055] On the surface 31a of the substrate 31, the insulating film 51 has four circular openings (represented by the same reference numerals 51w1, 51w2, 51w3, and 51w4 as the areas they define) penetrating in the thickness direction (Z direction) to define the specific areas 51w1, 51w2, proximal area 51w3, and distal area 51w4, respectively. The effective areas (functioning areas) of the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 are defined by the size of the openings 51w1 and 51w2 (each about 4 mm in diameter in this example). In this example, the size of the openings 51w3 and 51w4 is set to about 5 mm in diameter.

[0056] The substrate 31 is made of an insulating material such as PET (polyethylene terephthalate), glass, silicon, polyimide film, glass epoxy, polycarbonate, or acrylic. Therefore, the front surface 31a (and the back surface 31b) are also insulating. In this example, the size of the substrate 31 is set to about 60 to 100 mm in the X direction (longitudinal direction), about 15 to 30 mm in the Y direction (width direction), and about 200 μm in the Z direction (thickness direction).

[0057] The first main extraction electrode 43, the second main extraction electrode 44, the first auxiliary extraction electrode 47, and the second auxiliary extraction electrode 48 are each made of a conductive material such as Pt, Ag, Au, Ir, C, or IrO2. The first main extraction electrode 43, the second main extraction electrode 44, the first auxiliary extraction electrode 47, and the second auxiliary extraction electrode 48 each have a thickness of about 10 μm.

[0058] The insulating film 51 is made of a photocurable or thermosetting insulating resist, or an insulating seal, sheet, tape, etc. The insulating film 51 has a thickness of about 30 μm to 100 μm.

[0059] In this example, a solution obtained by dissolving Bis(12-corwn-4), polyvinyl chloride (PVC), 2-nitrophenyl octyl ether (NPOE), and potassium tetrakis(4-chlorophenyl)borate (K-TCPB) in tetrahydrofuran (THF) is used as the material liquid for forming the sodium ion sensitive film 41i. In this example, a solution obtained by dissolving Bis(benzo-15-crown-5), PVC, NPOE, and K-TCPB in THF is used as the material liquid for forming the potassium ion sensitive film 42i. These material liquids are dried and hardened during the manufacturing process.

[0060] The manufacturing process of the test piece 30 is, for example, as follows. First, the first main extraction electrode 43, the second main extraction electrode 44, the proximal partial electrode 45 and the first auxiliary extraction electrode 47 connected thereto, and the distal partial electrode 46 and the second auxiliary extraction electrode 48 connected thereto are simultaneously formed on the surface 31a of the substrate 31 by, for example, a screen printing method. Next, an insulating film 51 is formed thereon by, for example, a screen printing method. At this time, the insulating film 51 is formed in a state in which the electrode pad portions 43c, 47c, 44c, and 48c are exposed, and the insulating film 51 has four openings 51w1, 51w2, 51w3, and 51w4 to expose the base portion 43a of the first main extraction electrode 43, the base portion 44a of the second main extraction electrode 44, the proximal partial electrode 45, and the distal partial electrode 46, respectively. Next, a material liquid for forming a sodium ion sensitive film 41i as a first ion sensitive film is applied to the opening 51w1 of the surface 31a of the substrate 31 by, for example, inkjet printing. Then, the applied material liquid is dried and hardened to form the sodium ion sensitive film 41i in the area corresponding to the opening 51w1. The base portion 43a and the sodium ion sensitive film 41i constitute the sodium ion sensitive electrode 41. Next, a material liquid for forming a potassium ion sensitive film 42i is applied to the opening 51w2 of the surface 31a of the substrate 31 by, for example, inkjet printing. Then, the applied material liquid is dried and hardened to form the potassium ion sensitive film 42i in the area corresponding to the opening 51w2. The potassium ion sensitive electrode 42 is constituted by the base portion 44a and the potassium ion sensitive film 42i.

[0061] (Main body configuration) 1(B) is a schematic diagram showing the main body 10 of the electrochemical sensor 90 as seen obliquely. In this example, the main body 10 has an elongated prismatic shape to be held by a user's hand. As a result, the electrochemical sensor 90 is configured as a handheld device that is used by a user holding the main body 10 in his or her hand.

[0062] The main body 10 includes a housing 10s having an outer peripheral wall of a substantially rectangular column shape, a display unit 20 as a display screen provided at substantially the center of a front surface (+Z side surface) 10f of the housing 10s, an operation unit 13 provided on the front surface 10f at a position on the +X side of the display unit 20, and a connector 21 provided on an end surface 10t on the -X side of the housing 10s. In this example, the display unit 20 is made of an LCD (liquid crystal display element) and displays various information such as the results of calculations performed by a control unit 11 (see FIG. 3) described below. In this example, the operation unit 13 includes three push button switches, namely, a power switch 13a for turning on and off the power of the electrochemical sensor 90, a calibration switch 13b for inputting an instruction to start calibration using an electrolyte (standard solution) having a known concentration ratio between sodium ions and potassium ions, and a measurement switch 13c for inputting an instruction to start calculation of the concentration ratio between sodium ions and potassium ions in urine as a measurement target liquid.

[0063] The connector 21 has a slot 22 that opens toward the -X side to detachably receive the test strip 30. Contact electrodes 21a, 21b, 21c, and 21d made of L-shaped leaf springs are provided in the slot 22 at positions corresponding to the electrode pads 43c, 47c, 44c, and 48c of the test strip 30, respectively. As shown in FIG. 1(A), when the user inserts the other end 31f of the test strip 30 into the slot 22 in the direction indicated by the arrow X1, The electrode pads 43c, 47c, 44c, and 48c are in contact with and conduct with the contact electrodes 21a, 21b, 21c, and 21d, respectively. As a result, the first potential E1 generated by the sodium ion sensitive electrode 41 of the test strip 30 and the second potential E2 generated by the potassium ion sensitive electrode 42 are transmitted to the contact electrodes 21a and 21c via the first and second main lead electrodes 43 and 44, respectively, and can be input to the main body 10. In addition, the proximal partial electrode 45 and the distal partial electrode 46, which form the liquid detection electrodes, are in conduction with the contact electrodes 21b and 21d via the first and second auxiliary lead electrodes 47 and 48, respectively. Therefore, the impedance between the proximal partial electrode 45 and the distal partial electrode 46 can be detected from the main body 10 side via the contact electrodes 21b and 21d.

[0064] As shown in FIG. 3, the main body 10 is equipped with and accommodates the control unit 11, the potential difference measuring unit 12, the impedance measuring unit 14, the memory unit 18, the communication unit 19, and the power supply unit 25 in addition to the display unit 20, the operation unit 13, and the connector 21. The control unit 11 is composed of an MCU (Micro Controller Unit) including a CPU (Central Processing Unit) operated by software, and controls the operation of the entire electrochemical sensor 90 as described later. The potential difference measuring unit 12 receives the potential difference ΔE between the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 of the test strip 30 via the contact electrodes 21a and 21c, amplifies it, and inputs it to the control unit 11. The impedance measuring unit 14 measures the impedance between the proximal partial electrode 45 and the distal partial electrode 46 via the contact electrodes 21b and 21d, and inputs it to the control unit 11. The storage unit 18 is made of a semiconductor memory and stores data of a program for controlling the electrochemical sensor 90, setting data for setting various functions of the electrochemical sensor 90, data of measurement values, etc. The storage unit 18 is also used as a work memory when the program is executed. The communication unit 19 transmits information (measurement value data in this example) from the control unit 11 to another device (e.g., a server) via the network 900. The communication unit 19 also receives information from other devices via the network 900 and passes it to the control unit 11. The power supply unit 25 supplies power to the control unit 11, the display unit 20, the potential difference measurement unit 12, the impedance measurement unit 14, the storage unit 18, the communication unit 19, and other parts in the main body 10.

[0065] In particular, the control unit 11 works as a liquid detection processing unit to determine whether or not the electrolyte is in contact with the distal partial electrode 46 to the proximal partial electrode 45 so as to cover them together. As shown in FIG. 8, when the electrolyte is not in contact and the distal partial electrode 46 and the proximal partial electrode 45 are open, the output of the impedance measurement unit 14 is at a level of a voltage Vo (≒3.2V) close to the power supply voltage (in this example, 3.3V) according to the DC resistance value (approximately ∞) between the distal partial electrode 46 and the proximal partial electrode 45. On the other hand, when the electrolyte is in contact with the distal partial electrode 45 to the proximal partial electrode 46 so as to cover them together, the output of the impedance measurement unit 14 is at a level of a voltage Vc (≒0.1V) close to approximately zero according to the DC resistance value between the distal partial electrode 46 and the proximal partial electrode 45 (in this example, the electrolyte is in contact at time tc). Therefore, the control unit 11 can determine whether or not the electrolyte is in contact with the distal partial electrode 46 to the proximal partial electrode 45 so as to cover them together, depending on the output level of the impedance measurement unit 14. If the electrolyte is in contact with the proximal partial electrode 45 to the distal partial electrode 46 so as to cover them together, it can be said that the electrolyte is in contact with the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 arranged between the distal partial electrode 46 and the proximal partial electrode 45 so as to cover them together. Therefore, the control unit 11 can determine whether or not the electrolyte is in contact with the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 so as to cover them together, depending on the output level of the impedance measurement unit 14.

[0066] In addition, the control unit 11 functions as a calculation unit and calculates the concentration ratio (C1 / C2) between the concentration C1 of sodium ions and the concentration C2 of potassium ions contained in the electrolyte to be measured (urine in this example) using the potential difference ΔE between the first potential E1 and the second potential E2 input to the main body 10.

[0067] In this electrochemical sensor 90, the concentration ratio (C1 / C2) between the concentration C1 of sodium ions and the concentration C2 of potassium ions contained in the measurement target liquid is found according to the following principle. Here, the sensitivity S1 and selectivity k1 of the sodium ion sensitive electrode 41 are set to be equal to the sensitivity S2 and selectivity k2 of the potassium ion sensitive electrode 42, respectively. In other words, S1-S2≈0 and k1-k2≈0. In this case, as disclosed in Patent Document 1 (Japanese Patent No. 6127460), the potential difference ΔE between the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 is simplified and expressed as the following equation (Eq.1). ΔE=E1 0 -E2 0 +S1log(C1 / C2) …(Eq.1) Here, E1 0 -E2 0 is a constant that is assumed to be determined in advance. Therefore, if ΔE is measured for an electrolyte (standard solution) having a known concentration ratio between sodium ions and potassium ions to determine sensitivity S1 as a parameter, the concentration ratio Ms (=C1 / C2) between sodium ions and potassium ions in the electrolyte to be measured can be calculated based on equation (Eq.1) by measuring the potential difference ΔE for the electrolyte to be measured.

[0068] (Electrolyte analysis method) Fig. 4 shows the flow of an electrolyte analysis method in which a subject as a user measures the concentration ratio between sodium ions and potassium ions in urine as an electrolyte using an electrochemical sensor 90. Next, the measurement procedure by the user will be described with reference to Figs. 5(A) to 5(D) and 6(A) to 6(E) in addition to Fig. 4.

[0069] First, as shown in Fig. 5(A), the user inserts the other end 31f of the test strip 30 into the slot 22 of the main body 10 as indicated by the arrow X1 to attach it (step S101 in Fig. 4). This is called the "attaching operation." Through this attachment operation, the electrode pad portions 43c, 47c, 44c, and 48c of the test strip 30 come into contact with the contact electrodes 21a, 21b, 21c, and 21d of the connector 21, respectively, and are electrically connected.

[0070] Next, in this state (worn state), as shown by arrow P1 in Fig. 5(B), the user presses power switch 13a to turn it on (step S102 in Fig. 4). Then, as shown in Fig. 5(B), control unit 11 causes display unit 20 to display "ON" as a character string indicating that the power is turned on.

[0071] Next, as shown by an arrow P2 in Fig. 5(C), the user presses the calibration switch 13b to turn it on (step S103 in Fig. 4). Then, as shown in Fig. 5(C), the control unit 11 causes the display unit 20 to display "CAL" as a character string indicating that the calibration process is waiting.

[0072] When the calibration switch 13b is turned on, the control unit 11 operates as a liquid detection processing unit and starts observing the output level of the impedance measurement unit 14 described above (step S104 in FIG. 4). According to the output level of the impedance measurement unit 14, it is determined whether or not the electrolyte (here, the standard solution) is in contact with the test piece 30 so as to cover the entire area from the proximal electrode 45 to the distal electrode 46 (step S105). Here, the standard solution has a known concentration ratio Mr between the concentration of sodium ions and the concentration of potassium ions. If it is not detected that the electrolyte is in contact (NO in step S105), the control unit 11 returns to step S104 and waits until a predetermined time (3 minutes in this example) has elapsed while observing the output level of the impedance measurement unit 14 (NO in step S106). In this example, while observing the output level of the impedance measuring unit 14, as shown in FIG. 5(D), the user contacts the test piece 30 with a standard solution 98 as an electrolyte so as to cover an area A1 (indicated by hatching with dashed lines) from one end 31e to the distal area 51w4, the specific areas 51w1, 51w2, and the proximal area 51w3 in a manner that covers the area (this is called an "electrolyte contact operation"). Then, the control unit 11 works as a liquid detection processing unit and determines that the electrolyte has contacted the distal electrode 46 to the proximal electrode 45 in a manner that covers the area (therefore, the electrolyte has contacted the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 in a manner that covers the area) in accordance with the output level of the impedance measuring unit 14. If it is detected that the electrolyte has contacted the test piece 30 (YES in step S105 of FIG. 4), the detection of the electrolyte contact is used as a trigger to cause the control unit 11 to proceed to step S108 described later and start a calibration process. If a predetermined time (3 minutes in this example) has elapsed without detecting contact with the electrolyte (YES in step S106), the control unit 11 determines that an error has occurred (step S107) and turns off the power supply to the electrochemical sensor 90 (step S119). The electrolyte contact operation itself may be performed before the calibration switch 13b is turned on.

[0073] Here, the electrolyte contact operation of bringing the standard solution 98 into contact with the region A1 of the test piece 30 so as to completely cover it can be performed by sprinkling the standard solution 98 so as to completely cover the region A1 of the test piece 30. It can also be performed as follows. For example, as shown in FIG. 7(A), a sponge 81 pre-impregnated with the standard solution 98 is placed in a predetermined container 80 to prepare it. The user inserts one end 31e of the test piece 30 into the sponge 81 as shown by the arrow X2. This allows the standard solution 98 to come into contact with the region A1 of the test piece 30 so as to completely cover it, as shown in FIG. 7(B).

[0074] In step S105 of FIG. 4, when the standard solution 98 is brought into contact with the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 (YES in step S105), the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 each generate a first potential (E 1r ), and the second potential (E 2r ) is generated.

[0075] In step S108, the control unit 11 functions as a calibration processing unit, and measures the potential difference ΔE (=E 1r -E 2r) is observed. Here, as shown in the period of "calibration in progress" in FIG. 9, the potential difference ΔE converges to a value (Er in this example) corresponding to the concentration ratio between sodium ions and potassium ions contained in the standard solution 98 (for example, the fluctuation is within 2 mV in 5 seconds). In this example, it is assumed that the potential difference ΔE converges to Er at time t1 shown in FIG. 9. When the potential difference ΔE converges to Er (YES in step S109 in FIG. 4), the control unit 11 determines the potential difference ΔE for the standard solution 98 as Er, and uses this potential difference Er and the concentration ratio Mr to calculate the sensitivity S1 based on the above-mentioned formula (Eq. 1) (calibration completed). Then, the user is notified that the calibration is completed. In this example, the control unit 11 causes the display unit 20 to display "OK" as a character string indicating that the calibration is completed, as shown in FIG. 5(D) (step S110 in FIG. 4).

[0076] Next, the control unit 11 causes the display unit 20 to display "MES" as a character string indicating that the urine measurement is waiting, as shown in FIG. 6(A) (step S111 in FIG. 4). Seeing this display, the user performs an operation to replace the electrolyte in contact with the region A1 so as to cover it entirely from the standard solution 98 to urine 99 as the liquid to be measured. Here, the operation to replace the electrolyte in contact with the region A1 from the standard solution 98 to urine 99 can be performed by sprinkling urine 99 so as to cover the region A1 of the test piece 30 entirely. Also, as shown in FIG. 7(C), the electrolyte impregnated in the sponge 81 may be replaced from the standard solution 98 to urine 99 by pouring urine 99 so as to overflow into a container 80 containing the standard solution 98 (this container 80 is typically disposed of after the measurement is completed).

[0077] At this time, the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 come into contact with the urine 99 and generate a first potential E1 corresponding to the concentration of sodium ions and a second potential E2 corresponding to the concentration of potassium ions, respectively.

[0078] Next, in Figure 6(A) there is an arrow P3As shown in FIG. 9, the user presses the measurement switch 13c to instruct the start of measurement of the concentration ratio Ms (=C1 / C2) between sodium ions and potassium ions in the urine 99 (step S112 in FIG. 4). Then, the control unit 11 starts the urine measurement process. That is, the control unit 11 works as a calculation unit and observes the potential difference ΔE (=E1-E2) between the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 of the test strip 30 via the potential difference measurement unit 12 (step S113). Here, as shown in the period of "waiting for urine measurement" in FIG. 9, the potential difference ΔE fluctuates once with replacement of the electrolyte. However, after fluctuating once, the potential difference ΔE gradually converges again to a value (Es in this example) corresponding to the concentration ratio between sodium ions and potassium ions in the urine 99 as shown in the period of "urine measurement in progress" in FIG. 9 (for example, the fluctuation is within 2 mV in 5 seconds). In this example, it is assumed that the potential difference ΔE converges to Es at time t3 shown in Fig. 9. When the potential difference ΔE converges to Es (YES in step S114 in Fig. 4), the control unit 11 determines the potential difference ΔE for urine 99 as Es (step S115 in Fig. 4). At the same time, as shown in Fig. 6(B), the control unit 11 causes the display unit 20 to display "OK" as a character string indicating that the potential difference ΔE has been determined.

[0079] Next, the control unit 11 functions as a calculation unit and calculates the concentration ratio Ms (=C1 / C2) (i.e., the Na / K ratio) for urine 99 based on the previously described formula (Eq.1) using the sensitivity S1 determined in step S110 of FIG. 4 and this potential difference Es (step S116 of FIG. 4).

[0080] Next, the control unit 11 causes the display unit 20 to display the measurement result (Na / K ratio in this example) (step S117 in FIG. 4). For example, assume that the Na / K ratio as the measurement result is 4.0. In this case, as shown in FIG. 6(C), the control unit 11 causes the display unit 20 to display "Na / K=4.0" as a character string representing the measurement result. At the same time, in this example, the control unit 11 operates the communication unit 19 to transmit information representing the measurement value data (i.e., the Na / K ratio) to another device (a server in this example) via the network 900. In this case, as shown in FIG. 6(D), the control unit 11 causes the display unit 20 to display "CONNECT" as a character string representing that the measurement value data is being transmitted.

[0081] Thereafter, the control unit 11 waits for some instruction to be input by the user via the operation unit 13 (step S118 in FIG. 4). If a predetermined time (three minutes in this example) has elapsed without an instruction being input (YES in step S118), the power supply to the electrochemical sensor 90 is turned off (step S119). This causes the display unit 20 to turn off, as shown in FIG. 6(E).

[0082] In this manner, in the flow of the electrolyte analysis method, in step S105 of Fig. 4, it is determined whether or not the electrolyte has come into contact with the test piece 30 so as to cover the entire area from the distal partial electrode 46 to the proximal partial electrode 45, depending on the output level of the impedance measurement unit 14. Therefore, it is possible to confirm that the electrolyte has come into contact with the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 so as to cover them entire. In this manner, by performing a measurement after confirming that the electrolyte has come into contact with the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 so as to cover them entire, it is possible to increase the reliability of the measurement result (in this example, the Na / K ratio).

[0083] (Test piece modification 1) In the above example, the test strip 30 includes the proximal partial electrode 45 provided in the proximal region 51w3 and the distal partial electrode 46 provided in the distal region 51w4 as the liquid detection electrodes. However, this is not limited to this. The distal partial electrode 46 (and the second auxiliary extraction electrode 48) may be omitted, and liquid detection may be performed using, for example, the sodium ion sensitive electrode 41 (and the first main extraction electrode 43) instead of the distal partial electrode 46 (and the second auxiliary extraction electrode 48). That is, depending on whether the impedance between the sodium ion sensitive electrode 41 and the proximal partial electrode 45 has decreased, it is determined whether the electrolyte has contacted the sodium ion sensitive electrode 41 to the proximal partial electrode 45 so as to cover them together. This makes it possible to determine whether the electrolyte has contacted the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 so as to cover them together.

[0084] In this case, the number of liquid detecting electrodes can be reduced, which makes it possible to reduce the dimensions of the test piece 30 (substrate 31) in the X and Y directions.

[0085] (Test piece modification 2) In the above example, the number of proximal partial electrodes 45 constituting the liquid detection electrode in the test strip 30 is one, but this is not limited thereto. For example, as shown in Fig. 10(A), the number of proximal partial electrodes 45 may be two. In the following figures, the same components as those in the above example are given the same reference numerals, and duplicated explanations will be omitted.

[0086] The test piece 30A shown in FIG. 10(A) has a first proximal partial electrode 45-1 and a second proximal partial electrode 45-2 as the proximal partial electrodes 45 on the surface 31a of the substrate 31. The first proximal partial electrode 45-1 is provided in a circular proximal region 51w3-1 corresponding to the area between the potassium ion sensitive electrode 42 and the other end 31f in the X direction, and is spaced apart from the first and second main extraction electrodes 43, 44. The second proximal partial electrode 45-2 is provided in a circular proximal region 51w3-2 corresponding to the area between the proximal region 51w3-1 and the other end 31f, and is spaced apart from the first and second main extraction electrodes 43, 44. In this example, the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 are arranged spaced apart from each other in the X direction.

[0087] Further, auxiliary extraction electrodes 47-1 and 47-2 extend from the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2, respectively, toward the other end 31f, with a space therebetween. The auxiliary extraction electrode 47-1 has a lead portion 47b-1 extending in an elongated manner from the first proximal partial electrode 45-1 toward the other end 31f, and an electrode pad portion 47c-1 connected to the lead portion 47b-1 and provided on the other end 31f side and wider than the lead portion 47b-1. The auxiliary extraction electrode 47-2 has a lead portion 47b-2 extending in an elongated manner from the second proximal partial electrode 45-2 toward the other end 31f, and an electrode pad portion 47c-2 connected to the lead portion 47b-2 and provided on the other end 31f side and wider than the lead portion 47b-2.

[0088] In this example, lead portions 43b, 47b-1, 47b-2, 44b, and 48b are arranged in this order at a distance from one another from the +Y side to the -Y side on the front surface 31a of the substrate 31. Correspondingly, electrode pad portions 43c, 47c-1, 47c-2, 44c, and 48c are arranged in this order at a distance from one another along the other end 31f of the substrate 31.

[0089] When this test piece 30A is used, the connector 21 of the main body 10 has contact electrodes (not shown) that correspond to and contact the electrode pads 47c-1 and 47c-2, respectively, instead of the contact electrode 20b described above. The impedance measuring section 14 of the main body 10 can detect the impedance between the first proximal partial electrode 45-1 and the distal partial electrode 46, and can detect the impedance between the second proximal partial electrode 45-2 and the distal partial electrode 46, via the contact electrode (not shown) of the connector 21.

[0090] In this test strip 30A, the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 are spaced apart from each other in the X direction. Therefore, if the contact ranges from one end 31e in the X direction are set differently in advance for two types of electrolytes (these are called the "first electrolyte" and the "second electrolyte". For example, the first electrolyte can be a standard solution 98 with a known concentration ratio, and the second electrolyte can be urine 99 as a measurement target), the first and second proximal partial electrodes 45-1 and 45-2 can distinguish and detect the two types of electrolytes.

[0091] Specifically, as shown in FIG. 10(B), the range in which the first electrolyte is brought into contact with the electrode in the X direction by the electrolyte contact operation is adjusted in advance to a range B1 that covers the entire area from the one end 31e to the first proximal partial electrode 45-1, and does not reach the second proximal partial electrode 45-2. This can be easily achieved, for example, by setting the dimensions of the sponge 81 shown in FIG. 7(A) to correspond to this range B1. In addition, the range in which the second electrolyte is immersed in the X direction by the electrolyte contact operation is adjusted in advance to a range B2 that covers the entire area from the one end 31e to the second proximal partial electrode 45-2 beyond the first proximal partial electrode 45-1. This can be easily achieved by setting the dimensions of the container 80 (the horizontal dimensions in FIG. 7(C)) to correspond to this range B2.

[0092] Then, when the impedance measuring unit 14 of the main body 10 detects that a certain electrolyte is in contact with the first proximal partial electrode 45-1 and that the electrolyte is not in contact with the second proximal partial electrode 45-2 in a mounted state of the test strip 30A mounted on the main body 10, it is possible to know that the electrolyte currently in contact so as to cover the area from the one end 31e to the first proximal partial electrode 45-1 is the first electrolyte (e.g., standard solution 98). When the impedance measuring unit 14 of the main body 10 detects that a certain electrolyte is in contact with the first proximal partial electrode 45-1 and that the electrolyte is in contact with the second proximal partial electrode 45-2 via the auxiliary extraction electrode, it is possible to know that the electrolyte currently in contact so as to cover the area from the one end 31e to the second proximal partial electrode 45-2 is the second electrolyte (e.g., urine 99). This makes it possible to distinguish and detect two types of electrolytes as described above.

[0093] This makes it possible to perform the calibration process (steps S108 to S110 in FIG. 4) after confirming that the standard solution 98 is in contact with the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 so as to cover them together, and to perform the urine measurement process (steps S113 to S117 in FIG. 4) after confirming that the urine 99 is in contact with the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 so as to cover them together. This makes it possible to further increase the reliability of the measurement result (in this example, the Na / K ratio).

[0094] (Test piece modification 3) In the above example, in the test strip 30, the proximal partial electrode 45 and the distal partial electrode 46 constituting the liquid detection electrodes are both exposed through the openings 51w3 and 51w4 of the insulating film 51, but this is not limited thereto. For example, as in the test strip 30B shown in Figs. 11(A) and 11(B), the distal partial electrode 46 may be covered by the insulating film 51. Here, Fig. 11(A) shows a planar layout of the test strip 30B. Fig. 11(B) shows a cross section (end face) taken along line XIB-XIB in Fig. 11(A).

[0095] When using this test piece 30B, the impedance measuring section 14 of the main body 10 can detect the impedance between the proximal partial electrode 45 and the distal partial electrode 46 by applying, for example, an AC voltage from the main body 10 side via the contact electrodes 21b, 21d of the connector 21.

[0096] In this test piece 30B, the distal partial electrode 46 is covered with the insulating film 51, so that the distal partial electrode 46 can be protected and the distal partial electrode 46 can be prevented from deteriorating. In addition, not only the distal partial electrode 46 but also the proximal partial electrode 45 may be covered with the insulating film 51. This can protect the proximal partial electrode 45 and prevent it from deteriorating.

[0097] (Test piece modification 4) In the above example, the proximal partial electrode 45 and the distal partial electrode 46 constituting the liquid detection electrodes in the test strip 30 are both circular, but this is not limited thereto. For example, the proximal partial electrode 45 may be rectangular, as in the test strip 30C shown in Figs. 12(A) and 12(B). Here, Fig. 12(A) shows the planar layout of the test strip 30C. Fig. 12(B) shows a cross section (end face) taken along line XIIB-XIIB in Fig. 12(A).

[0098] The test piece 30C has a first proximal partial electrode 45-1 and a second proximal partial electrode 45-2 as the proximal partial electrodes 45 on the surface 31a of the substrate 31, similarly to the test piece 30A of FIG. 10(A). The first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 are arranged apart from each other in the X direction. In the test piece 30C, unlike the test piece 30A of FIG. 10(A), both the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 are formed in a rectangular shape. Furthermore, the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 are exposed through one rectangular opening (defining the proximal region) 51w3′ of the insulating film 51.

[0099] Further, auxiliary extraction electrodes 47-1 and 47-2 extend from the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2, respectively, toward the other end 31f, with a space therebetween. The auxiliary extraction electrode 47-1 has a lead portion 47b-1 extending in an elongated manner from the first proximal partial electrode 45-1 toward the other end 31f, and an electrode pad portion 47c-1 connected to the lead portion 47b-1 and provided on the other end 31f side and wider than the lead portion 47b-1. The auxiliary extraction electrode 47-2 has a lead portion 47b-2 extending in an elongated manner from the second proximal partial electrode 45-2 toward the other end 31f, and an electrode pad portion 47c-2 connected to the lead portion 47b-2 and provided on the other end 31f side and wider than the lead portion 47b-2.

[0100] In this example, lead portions 43b, 47b-2, 47b-1, and 44b are arranged in this order at a distance from one another from the +Y side to the -Y side on the front surface 31a of the substrate 31. Correspondingly, electrode pad portions 43c, 47c-2, 47c-1, and 44c are arranged in this order at a distance from one another along the other end 31f of the substrate 31.

[0101] When using this test strip 30C, the connector 21 of the main body 10 has contact electrodes (not shown) that correspond to and contact the electrode pads 43c, 47c-2, 47c-1, and 44c, respectively. The potential difference measuring section 12 (and the control section 11) of the main body 10 measures the potential difference ΔE between the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 through the contact electrodes (not shown) of the connector 21 that correspond to the electrode pads 43c and 44c. The impedance measuring section 14 (and the control section 11) of the main body 10 can detect the impedance between the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 through the contact electrodes (not shown) of the connector 21 that correspond to the electrode pads 47c-1 and 47c-2.

[0102] This test piece 30C is used under the assumption that the electrolyte is brought into contact with the one end 31e to the proximal region 51w3′ by the electrolyte contact operation by the user so as to cover the entire area. Under this assumption, when the impedance between the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 decreases (specifically, when the output level of the impedance measuring unit 14 decreases as shown in FIG. 8), it is determined that the electrolyte is brought into contact with the one end 31e to the proximal region 51w3′ so as to cover the entire area. At this time, it can be said that the electrolyte is in contact with the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 so as to cover them together. Therefore, it can be determined whether the electrolyte is in contact with the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 so as to cover them together, depending on the change in the impedance between the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2.

[0103] In this test piece 30C, the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 are both rectangular and arranged in one rectangular opening 51w3' (defining the proximal region) of the insulating film 51. Moreover, the distal partial electrode 46 is omitted. Therefore, it is possible to reduce the X-direction dimensions and the Y-direction dimensions of the test piece 30C (substrate 31).

[0104] In addition, when determining whether the electrolyte is in contact with the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 so as to cover them, depending on the change in impedance between the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2, the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 may be arranged side by side in the Y direction on the surface 31a of the substrate 31, for example, as in the test piece 30D shown in FIG. 13(A). In this test piece 30D, the circular first proximal partial electrode 45-1 and the circular second proximal partial electrode 45-2 are arranged apart from each other in the Y direction on the surface 31a of the substrate 31. The first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 are exposed through the circular openings 51w3-1 and 51w3-2 of the insulating film 51, respectively (which define the proximal region). In this example, lead portions 47b-1, 44b, 47b-2, and 43b are arranged in this order at a distance from one another on the front surface 31a of the substrate 31 from the +Y side to the -Y side. Correspondingly, electrode pad portions 47c-1, 44c, 47c-2, and 43c are arranged in this order at a distance from one another along the other end 31f of the substrate 31. This test piece 30D has the same effects as those of the test piece 30C.

[0105] (Test piece modification 5) In the above example, the test strip 30 has two electrodes used to detect the concentration of ions in the electrolyte, the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42. However, this is not limited to this. For example, a test strip 30E shown in Fig. 13(B) may have a reference electrode 55 that generates a reference potential for detecting the concentration of ions.

[0106] In this test piece 30E, a circular reference electrode 55 is disposed between the potassium ion sensitive electrode 42 and the proximal electrode 45 on the surface 31a of the substrate 31. A reference extraction electrode 56 extends from the reference electrode 55 toward the other end 31f. The reference extraction electrode 56 has a lead portion 56b extending in an elongated manner from the reference electrode 55 toward the other end 31f, and an electrode pad portion 56c that is wider than the lead portion 56b and is provided on the other end 31f side connected to the lead portion 56b. In this example, on the surface 31a of the substrate 31, the lead portions 43b, 56b, 47b, 44b, and 48b are arranged in this order from the +Y side to the -Y side, with a space between them. Correspondingly, the electrode pad portions 43c, 56c, 47c, 44c, and 48c are arranged in this order with a space between them along the other end 31f of the substrate 31. The reference electrode 55 and the reference extraction electrode 56 may be formed simultaneously with the other electrodes (proximal partial electrode 45, distal partial electrode 46, etc.) by, for example, the screen printing method already described.

[0107] When this test strip 30E is used, the connector 21 of the main body 10 has contact electrodes (not shown) that correspond to and contact the electrode pads 43c, 56c, 47c, 44c, and 48c. The potential difference measuring unit 12 (and the control unit 11) of the main body 10 measures the potential difference ΔE between the potential indicated by the sodium ion sensitive electrode 41 and the reference potential indicated by the reference electrode 55 through the contact electrodes (not shown) of the connector 21 corresponding to the electrode pads 43c and 56c, and measures the potential difference ΔE between the potential indicated by the potassium ion sensitive electrode 42 and the reference potential indicated by the reference electrode 55 through the contact electrodes (not shown) of the connector 21 corresponding to the electrode pads 44c and 56c. This makes it possible to measure the concentration of sodium ions and the concentration of potassium ions in the electrolyte solution separately.

[0108] In the above example, the sodium ion sensitive electrode 41 is composed of two layers, a base portion 43a made of a metal material and a hardened sodium ion sensitive film 41i, and the potassium ion sensitive electrode 42 is composed of a base portion 44a made of a metal material and a hardened potassium ion sensitive film 42i. However, this is not limited to this. The sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 may each be an electrode having an internal liquid.

[0109] Second embodiment Fig. 14(A) shows a planar layout of a test strip 30F of another embodiment. Fig. 14(B) shows a schematic oblique view of a main body 10A corresponding to the test strip 30F of Fig. 14(A). The test strip 30F and the main body 10A constitute an electrochemical sensor 90A as an electrolyte analyzer of a second embodiment shown in Fig. 15.

[0110] (Test piece composition) The test piece 30F, like the test piece 30 in FIG. 2(A), includes a single substrate 31 extending in an elongated manner from one end 31e to the other end 31f in the X direction, a sodium ion-sensitive electrode 41 as a first ion-sensitive electrode provided in a circular specific region 51w1 on the surface 31a of the substrate 31 on the side of the one end 31e in the X direction, a potassium ion-sensitive electrode 42 as a second ion-sensitive electrode provided in another circular specific region 51w2 closer to the other end 31f than the specific region 51w1, and first and second main extraction electrodes 43, 44 extending from the sodium ion-sensitive electrode 41 and the potassium ion-sensitive electrode 42, respectively, toward the other end 31f.

[0111] Similar to the test piece 30D in FIG. 13(A), the test piece 30F has a circular first proximal partial electrode 45-1 and a circular second proximal partial electrode 45-2 as the proximal partial electrodes 45 on the surface 31a of the substrate 31. The first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 are arranged spaced apart from each other in the Y direction. The first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 are exposed through one oval opening 51w3″ (defining the proximal region) of the insulating film 51.

[0112] Further, auxiliary extraction electrodes 47-1 and 47-2 extend from the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2, respectively, toward the other end 31f, with a space therebetween. The auxiliary extraction electrode 47-1 has a lead portion 47b-1 extending in an elongated manner from the first proximal partial electrode 45-1 toward the other end 31f, and an electrode pad portion 47c-1 connected to the lead portion 47b-1 and provided on the other end 31f side and wider than the lead portion 47b-1. The auxiliary extraction electrode 47-2 has a lead portion 47b-2 extending in an elongated manner from the second proximal partial electrode 45-2 toward the other end 31f, and an electrode pad portion 47c-2 connected to the lead portion 47b-2 and provided on the other end 31f side and wider than the lead portion 47b-2.

[0113] In this example, on the front surface 31a of the substrate 31, the lead portions 44b, 47b-1, 47b-2, and 43b are arranged in this order from the +Y side to the -Y side, with a space between them. A conductive wiring 58a having a substantially U-shaped pattern as a conductive layer is provided in a region closer to the other end 31f than the proximal region 51w3″ in the X direction and between the lead portions 47b-1 and 47b-2 in the Y direction. Both ends of the conductive wiring 58a are directed toward the other end 31f. A pair of electrode pad portions 58b, 58c are provided on the other end 31f side, connected to both ends of the conductive wiring 58a. Correspondingly, the electrode pad portions 44c, 47c-1, 58b, 58c, 47c-2, 43c are arranged in this order and spaced apart from each other along the other end 31f of the substrate 31. The conductive wiring 58a and the electrode pad portions 58b, 58c can be formed simultaneously with other electrodes (the first proximal partial electrode 45-1, the second proximal partial electrode 45-2, etc.) by, for example, the above-mentioned screen printing method.

[0114] This test strip 30F is used under the assumption that, similarly to the test strip 30C in FIGS. 12(A) and 12(B), the electrolyte is brought into contact with the test strip 30F so as to cover the entire area from the one end 31e to the proximal region 51w3″ by the electrolyte contact operation by the user. Under this assumption, when the impedance between the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 decreases (specifically, when the output level of the impedance measuring unit 14 decreases as shown in FIG. 8), it is determined that the electrolyte has been brought into contact with the test strip 30F so as to cover the entire area from the one end 31e to the proximal region 51w3″. At this time, it can be said that the electrolyte is in contact with the sodium ion-sensitive electrode 41 and the potassium ion-sensitive electrode 42 so as to cover them entire. Therefore, depending on the change in impedance between the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2, it is possible to determine whether the electrolyte is in contact with and covers the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 together.

[0115] (Main body configuration) As shown in FIG. 14(B), the main body 10A includes a housing 10As having a substantially rectangular prism-shaped outer peripheral wall, a display unit 20 as a display screen provided at substantially the center of the front surface (+Z side surface) 10Af of the housing 10As, and a connector 21A provided on the end surface 10At on the -X side of the housing 10As. The connector 21A has a slot 22A that opens toward the -X side to detachably receive the test piece 30F. The housing 10As exposes the display unit 20 and the slot 22A, but does not have an operating element (operating unit 13 shown in FIG. 1(B)) and covers the remaining area other than the area occupied by the display unit 20 and the slot 22A. Since no operating element is provided on the outer peripheral wall of the main body 10A in this way, the configuration of the main body 10A is simplified.

[0116] In the slot 22A of the connector 21A, contact electrodes 21e, 21f, 21g, 21h, 21i, and 21j made of L-shaped leaf springs are provided at positions corresponding to the electrode pad portions 44c, 47c-1, 58b, 58c, 47c-2, and 43c of the test strip 30F, respectively. When the user inserts the other end 31f of the test strip 30F into the slot 22A, the electrode pad portions 44c, 47c-1, 58b, 58c, 47c-2, and 43c come into contact with the contact electrodes 21e, 21f, 21g, 21h, 21i, and 21j, respectively, and are electrically connected. As a result, the first potential E1 generated by the sodium ion sensitive electrode 41 of the test strip 30F and the second potential E2 generated by the potassium ion sensitive electrode 42 are transmitted to the contact electrodes 21j and 21e via the first and second main lead electrodes 43 and 44, respectively, and can be input to the main body 10A. In addition, the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2, which form the liquid detection electrodes, are electrically connected to the contact electrodes 21f and 21i via the auxiliary lead electrodes 47-1 and 47-2, respectively. Therefore, the impedance between the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 can be detected from the main body 10A side via the contact electrodes 21f and 21i. Furthermore, the electrode pad portions 58b and 58c connected to both ends of the conductive wiring 58a are in contact with the contact electrodes (additional contact electrodes) 21g and 21h, respectively. Therefore, it is possible to detect the attached state in which the other end 31f of the test piece 30F is inserted into the slot 22A of the connector 21A from the main body 10A via the contact electrodes 21g and 21h. This makes it possible to detect the attached state with a simple configuration.

[0117] As shown in FIG. 15, in addition to the display unit 20 and the connector 21A, the main body 10A is equipped with and accommodates the control unit 11, the potential difference measuring unit 12, the impedance measuring unit 14, the memory unit 18, the communication unit 19, the insertion / removal detecting unit 24 that functions as an attachment detecting unit, and the power supply unit 25. Unlike the main body 10 in the first embodiment, the main body 10A is not equipped with the operation unit 13. The control unit 11 is composed of an MCU (Micro Controller Unit) including a CPU (Central Processing Unit) that operates by software, and controls the operation of the entire electrochemical sensor 90A as described later. The potential difference measuring unit 12 receives the potential difference ΔE between the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 of the test strip 30F via the contact electrodes 21j and 21e, amplifies it, and inputs it to the control unit 11. The impedance measuring section 14 measures the impedance between the first proximal partial electrode 45-1 and the second proximal partial electrode 45-2 via the contact electrodes 21f and 21i, and inputs the impedance to the control section 11. The insertion / removal detection section 24 detects whether the other end 31f of the test strip 30F is inserted into the slot 22A of the connector 21A and is in an attached state, depending on whether the contact electrodes 21g and 21h are open or short-circuited by the conductive wiring 58a. The power supply section 25 supplies power to the control section 11, the display section 20, the potential difference measurement section 12, the impedance measuring section 14, the memory section 18, the communication section 19, the insertion / removal detection section 24, and other sections in the main body 10A. The memory section 18 and the communication section 19 function in the same manner as in the first embodiment.

[0118] (Electrolyte analysis method) Fig. 16 shows a flow of an electrolyte analysis method in which a subject as a user measures the concentration ratio between sodium ions and potassium ions in urine as an electrolyte using electrochemical sensor 90A. Next, the measurement procedure by the user will be described with reference to Figs. 17(A) to 17(D) and Figs. 18(A) to 18(E) in addition to Fig. 16.

[0119] Before the user starts to use the device, the main body 10A is in a standby state (step S201 in FIG. 16). In the standby state, the display unit 20 is turned off as shown in FIG. 17(A). In the main body 10A, power (voltage) is supplied from the power supply unit 25 only to the insertion / removal detection unit 24, and power supply to other units other than the insertion / removal detection unit 24 is stopped.

[0120] When using the electrochemical sensor 90A, first, as shown in FIG. 17(A), the user inserts the other end 31f of the test strip 30F into the slot 22A of the main body 10A as indicated by the arrow X1 to mount it (YES in step S202 in FIG. 16). This is called the "mounting operation." This mounting operation brings the electrode pads 44c, 47c-1, 58b, 58c, 47c-2, and 43c of the test strip 30F into contact with the contact electrodes 21e, 21f, 21g, 21h, 21i, and 21j of the connector 21A, respectively, and establishes electrical continuity.

[0121] Then, the insertion / removal detection unit 24 of the main body 10A acts as an attachment detection unit, detecting that the state between the contact electrodes 21g, 21h has changed from an open state to a short-circuited state, and that the other end 31f of the test strip 30F has been inserted into the slot 22A of the connector 21A, resulting in an attachment state. This attachment state is used as a trigger for the control unit 11 to act as a power control unit and turn on the power supply to the main body 10A. That is, power is supplied from the power supply unit 25 to each unit in the main body 10A. In addition, the control unit 11 causes the display unit 20 to display "ON" as a character string indicating that the power supply is turned on, as shown in FIG. 17(B).

[0122] In this case, when starting to use the electrochemical sensor 90A, the user does not need to turn on the power of the main body 10A in addition to the operation of attaching the sensor. This improves user convenience. Also, there is no need to provide a power switch on the main body 10A.

[0123] When power is supplied from the power supply unit 25 to each unit in the main body 10A and each unit in the main body 10A is in an operable state (typically, several seconds after "ON" is displayed), the control unit 11 causes the display unit 20 to display "CAL" as a character string indicating that the calibration process is waiting, as shown in FIG. 17(C) (step S203 in FIG. 16). At the same time, the control unit 11 works as a liquid detection processing unit, starts observing the output level of the impedance measurement unit 14 described above, and judges whether or not an electrolyte (here, a standard solution) is in contact with the test piece 30F so as to cover the entire area from the one end 31e to the proximal region 51w3" according to the output level of the impedance measurement unit 14 (step S204 in FIG. 16). Here, the standard solution has a known concentration ratio Mr between the concentration of sodium ions and the concentration of potassium ions. If it is not detected that the electrolyte is in contact (step S20 If the answer is NO in step S204, the control unit 11 returns to step S203 and waits until a predetermined time (3 minutes in this example) has elapsed while observing the output level of the impedance measurement unit 14 (NO in step S205). In this example, while the output level of the impedance measurement unit 14 is being observed, the user contacts the test piece 30F with standard solution 98 as the electrolyte so as to completely cover an area A2 (indicated by dashed hatching) extending from one end 31e to the proximal region 51w3″ as shown in FIG. 17(D) (this is referred to as an “electrolyte contact operation”). Then, the control unit 11 functions as a liquid detection processing unit and determines, according to the output level of the impedance measuring unit 14, that the electrolyte has come into contact with the test strip 30F so as to cover the entire area from the one end 31e to the proximal region 51w3″ (thus, the electrolyte has come into contact with the sodium ion-sensitive electrode 41 and the potassium ion-sensitive electrode 42 so as to cover them entire). If it detects that the electrolyte has come into contact (YES in step S204 of FIG. 16), the detection of the electrolyte has come into contact triggers the control unit 11 to proceed to step S206, which will be described later, and start a calibration process. Note that if a predetermined time (3 minutes in this example) has passed without detecting that the electrolyte has come into contact (YES in step S205), the control unit 11 determines that the electrolyte contact operation has not been performed, turns off the display unit 20 (step S218), and returns the main body 10A to the standby state (step S201).

[0124] In this case, when starting calibration, the user does not need to perform operations such as turning on a calibration switch in addition to the operation of contacting the standard solution 98. This improves user convenience. Also, there is no need to provide a calibration switch on the main body 10A.

[0125] In step S204 of FIG. 16, when the standard solution 98 is brought into contact with the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 (YES in step S204), the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 each generate a first potential (which is called E 1r ), and the second potential (E 2r ) is generated.

[0126] In step S206, the control unit 11 functions as a calibration processing unit and measures the potential difference ΔE (=E 1r -E 2r ) is observed. Here, as shown in the period of "calibration in progress" in FIG. 9, the potential difference ΔE converges to a value (Er in this example) corresponding to the concentration ratio between sodium ions and potassium ions contained in the standard solution 98 (for example, the fluctuation is within 2 mV in 5 seconds). In this example, it is assumed that the potential difference ΔE converges to Er at time t1 shown in FIG. 9. When the potential difference ΔE converges to Er (YES in step S207 in FIG. 16), the control unit 11 determines the potential difference ΔE for the standard solution 98 as Er, and uses this potential difference Er and the concentration ratio Mr to calculate the sensitivity S1 based on the above-mentioned formula (Eq. 1) (calibration completed). At the same time, the user is notified that the calibration has been completed. In this example, the control unit 11 causes the display unit 20 to display "OK" as a character string indicating that the calibration has been completed, as shown in FIG. 17(D) (step S208 in FIG. 16).

[0127] Next, the control unit 11 causes the display unit 20 to display "MES" as a character string indicating that the urine measurement is waiting, as shown in Fig. 18(A) (step S209 in Fig. 16). Seeing this display, the user performs an operation to replace the electrolyte that is in contact with and covers the entire area A2 from the standard solution 98 to urine 99 as the liquid to be measured.

[0128] At this time, the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 come into contact with the urine 99 and generate a first potential E1 corresponding to the concentration of sodium ions and a second potential E2 corresponding to the concentration of potassium ions, respectively.

[0129] Here, in Figure 9, fixed As shown in the "waiting" period, the potential difference ΔE temporarily changes as the electrolyte is replaced. In this example, the control unit 11 functions as a calculation unit and calculates the potential difference ΔE (=E 1r -E 2r 9 (in this example, Eth=Er±5 mV) (step S210 in FIG. 16). Here, when the potential difference ΔE shows a change exceeding the threshold Eth (YES in step S210), the control unit 11 judges that the electrolyte has been replaced from the standard solution 98 to the urine 99. In this example, it is assumed that it is judged that the potential difference ΔE shows a change exceeding the threshold Eth at time t2 shown in FIG. 9. The change in the potential difference ΔE exceeding the threshold Eth is used as a trigger for the control unit 11 to proceed to step S212 in FIG. 16 described later and start a urine measurement process. Note that if a predetermined time (3 minutes in this example) has elapsed without detecting that the potential difference ΔE has exceeded the threshold Eth (YES in step S211), the control unit 11 judges that an operation to replace the electrolyte has not been performed, turns off the display unit 20 (step S218), and returns the main body 10A to the standby state (step S201).

[0130] In this case, when starting measurement of the liquid to be measured, the user does not need to perform operations such as turning on a measurement switch in addition to the operation of contacting the liquid to be measured. This improves user convenience. Also, there is no need to provide a measurement switch on the main body 10A.

[0131] In step S212 in FIG. 16, the control unit 11 functions as a calculation unit and observes the potential difference ΔE (=E1-E2) between the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 of the test strip 30F via the potential difference measurement unit 12. Here, as shown in the period "urine measurement in progress" in FIG. 9, the potential difference ΔE converges again to a value (Es in this example) corresponding to the concentration ratio between the sodium ion and potassium ion contained in the urine 99 (for example, the fluctuation is within 2 mV in 5 seconds). In this example, it is assumed that the potential difference ΔE converges to Es at time t3 shown in FIG. 9. When the potential difference ΔE converges to Es (YES in step S213 in FIG. 16), the control unit 11 determines the potential difference ΔE for the urine 99 as Es (step S214 in FIG. 16). At the same time, the control unit 11 causes the display unit 20 to display "OK" as a character string indicating that the potential difference ΔE has been determined, as shown in FIG. 18(B).

[0132] Next, the control unit 11 functions as a calculation unit and calculates the concentration ratio Ms (=C1 / C2) (i.e., the Na / K ratio) for urine 99 based on the previously described equation (Eq.1) using the sensitivity S1 determined in step S208 of FIG. 16 and this potential difference Es (step S215 of FIG. 16).

[0133] Next, the control unit 11 causes the display unit 20 to display the measurement result (Na / K ratio in this example) (step S216 in FIG. 16). For example, assume that the Na / K ratio as the measurement result is 4.0. In this case, as shown in FIG. 18(C), the control unit 11 causes the display unit 20 to display "Na / K=4.0" as a character string representing the measurement result. At the same time, in this example, the control unit 11 operates the communication unit 19 to transmit information representing the measurement value data (i.e., the Na / K ratio) to another device (a server in this example) via the network 900. In this case, as shown in FIG. 18(D), the control unit 11 causes the display unit 20 to display "CONNECT" as a character string representing that the measurement value data is being transmitted.

[0134] Thereafter, the control unit 11 waits for a predetermined time (in this example, 3 minutes) to elapse, and when the predetermined time has elapsed (YES in step S217), it turns off the display unit 20 (step S218) and returns the main body 10A to the standby state (step S201).

[0135] As described above, in the flow of this electrolyte analysis method, in step S204 of FIG. 16, it is determined whether or not the standard solution 98 is in contact with the test strip 30F so as to cover the entire area from the one end 31e to the proximal region 51w3'', depending on the output level of the impedance measurement unit 14. Therefore, it is possible to confirm whether the standard solution 98 is in contact with the sodium ion sensitive electrode 41 and the potassium ion sensitive electrode 42 so as to cover them entire. Furthermore, in the flow of this electrolyte analysis method, in step S210 of FIG. 16, the electrolyte is replaced with urine 99 from the standard solution 98. It is therefore possible to confirm that the liquid in contact with the sodium ion-sensitive electrode 41 and the potassium ion-sensitive electrode 42 is urine 99 as the liquid to be measured. By performing the calibration process (steps S206 to S208 in FIG. 16) after confirming that the standard solution 98 is in contact in this manner, and then performing the urine measurement process (steps S212 to S216 in FIG. 16) after confirming that the electrolyte has been replaced from the standard solution 98 to urine 99, it is possible to increase the reliability of the measurement result (in this example, the Na / K ratio).

[0136] In the above embodiment, the concentration ratio between sodium ions and potassium ions as the first and second ion species is measured, but the present invention is not limited thereto. According to the test piece for electrolyte analysis and the electrolyte analysis device including the same of the present invention, it is possible to measure the concentration ratio between various ions, such as calcium ions, chloride ions, lithium ions, nitrate ions, nitrite ions, sulfate ions, sulfite ions, iodide ions, magnesium ions, bromide ions, perchlorate ions, and hydrogen ions, in addition to sodium ions and potassium ions. However, in order to perform calculations based only on the potential difference generated by the first and second ion-sensitive films without a reference electrode, the ionic valences of the first and second ion species must be the same. Furthermore, the concentration of the ions in the electrolyte can be measured independently by providing only one ion-sensitive electrode for measuring the concentration of the ions on the main surface of the substrate of the test piece and a reference electrode for generating a reference potential.

[0137] The above-mentioned embodiments are merely examples, and various modifications are possible without departing from the scope of the present invention. The above-mentioned embodiments can be realized independently, but the embodiments can also be combined with each other. In addition, the various features of the different embodiments can be realized independently, but the features of the different embodiments can also be combined with each other. [Explanation of symbols]

[0138] 10,10A Main Unit 10s, 10As housing 21,21A Connector 22,22A Slot 30,30A,30B,30C,30D,30E,30F Test piece for electrolyte analysis 41 Sodium ion sensitive electrode 41i Sodium ion sensitive membrane 42 Potassium ion sensitive electrode 42i Potassium ion sensitive membrane 45 Proximal Segment Electrode 45-1 First proximal segment electrode 45-2 Second proximal segment electrode 46 Distal Segment Electrode 90,90A Electrochemical Sensor

Claims

1. A test strip for analyzing an electrolyte for measuring the concentration of ions contained in an electrolyte, A substrate extending in one direction from one end to the other end; an ion-sensitive electrode for measuring a concentration of the ions, the electrode being provided in a specific region on the main surface of the substrate on the side of the one end in the one direction; a main extraction electrode extending from the ion-sensitive electrode toward the other end; a liquid detection electrode for detecting whether or not the electrode has come into contact with the electrolyte, the liquid detection electrode being provided on the main surface in a proximal region corresponding to a region between the specific region and the other end in the one direction and spaced apart from the main extraction electrode; an auxiliary extraction electrode spaced apart from the main extraction electrode and extending from the liquid detection electrode toward the other end; Equipped with The liquid detection electrode is a proximal partial electrode provided in the proximal region; a distal partial electrode provided in a distal region corresponding to between the specific region and the one end in the one direction on the main surface for detecting whether or not the electrode has come into contact with the electrolyte; The auxiliary extraction electrodes extend from the distal partial electrode and the proximal partial electrode toward the other end, respectively, spaced apart from each other. A test strip for analyzing an electrolyte solution.

2. 2. The test strip for analyzing an electrolyte solution according to claim 1, The proximal electrode, the ion-sensitive electrode, and the distal electrode are aligned in a row along the one direction. A test strip for analyzing an electrolyte solution.

3. A test strip for analyzing an electrolyte for measuring the concentration of ions contained in an electrolyte, A substrate extending in one direction from one end to the other end; an ion-sensitive electrode for measuring a concentration of the ions, the electrode being provided in a specific region on the main surface of the substrate on the side of the one end in the one direction; a main extraction electrode extending from the ion-sensitive electrode toward the other end; a liquid detection electrode for detecting whether or not the electrode has come into contact with the electrolyte, the liquid detection electrode being provided on the main surface in a proximal region corresponding to a region between the specific region and the other end in the one direction and spaced apart from the main extraction electrode; an auxiliary extraction electrode spaced apart from the main extraction electrode and extending from the liquid detection electrode toward the other end; Equipped with The liquid sensing electrode includes a first proximal partial electrode and a second proximal partial electrode spaced apart from each other in the proximal region, The auxiliary extraction electrodes extend from the first and second proximal partial electrodes toward the other end, respectively, spaced apart from each other. A test strip for analyzing an electrolyte solution.

4. The test strip for analyzing an electrolyte solution according to claim 3, The first proximal partial electrode and the second proximal partial electrode are spaced apart from each other in the one direction. A test strip for analyzing an electrolyte solution.

5. The test strip for analyzing an electrolyte solution according to any one of claims 1 to 4, The electrolyte solution contains a first ion species and a second ion species that are different from each other, The ion-sensitive electrodes include a first ion-sensitive electrode that is in contact with the electrolytic solution to generate a first potential corresponding to a concentration of the first ion species, and a second ion-sensitive electrode that is in contact with the electrolytic solution to generate a second potential corresponding to a concentration of the second ion species, the first ion-sensitive electrode being spaced apart from the first ion-sensitive electrode in the specific region; and The main extraction electrode includes first and second main extraction electrodes extending from the first and second ion-sensitive electrodes toward the other end, respectively, spaced apart from each other. A test strip for analyzing an electrolyte solution.

6. The test strip for analyzing an electrolyte solution according to claim 5, further comprising: a reference electrode provided in the specific region and spaced apart from the first and second ion-sensitive electrodes, the reference electrode being in contact with the electrolyte to generate a reference potential; a reference extraction electrode spaced apart from the first and second main extraction electrodes and extending from the reference electrode toward the other end; A test piece for analyzing an electrolyte solution, comprising:

7. An electrolytic solution analyzer for measuring a concentration ratio between a first ion species and a second ion species contained in an electrolytic solution, comprising: A test piece for electrolyte analysis; A main body; The test strip for electrolyte analysis is A substrate extending in one direction from one end to the other end; an ion-sensitive electrode provided in a specific region on the main surface of the substrate on the one end side in the one direction; a main extraction electrode extending from the ion-sensitive electrode toward the other end; a liquid detection electrode for detecting whether or not the electrode has come into contact with the electrolyte, the liquid detection electrode being provided on the main surface in a proximal region corresponding to a region between the specific region and the other end in the one direction and spaced apart from the main extraction electrode; an auxiliary extraction electrode spaced apart from the main extraction electrode and extending from the liquid detection electrode toward the other end; Equipped with The ion-sensitive electrodes include a first ion-sensitive electrode that is in contact with the electrolytic solution to generate a first potential corresponding to a concentration of the first ion species, and a second ion-sensitive electrode that is in contact with the electrolytic solution to generate a second potential corresponding to a concentration of the second ion species, the first ion-sensitive electrode being spaced apart from the first ion-sensitive electrode in the specific region; and the main extraction electrode includes first and second main extraction electrodes extending from the first and second ion-sensitive electrodes toward the other end, respectively, while being spaced apart from each other; The above body is a connector having contact electrodes which come into contact with the first main extraction electrode, the second main extraction electrode and the auxiliary extraction electrode, respectively, when the other end of the test strip for electrolyte analysis is inserted into the connector; a liquid detection processing unit that detects, when the electrolyte comes into contact with the liquid detection electrode in a mounted state in which the other end of the test piece for electrolyte analysis is inserted into the connector, via the auxiliary extraction electrode, that the electrolyte has come into contact with the liquid detection electrode; a calculation unit that calculates a concentration ratio between the first ion species and the second ion species contained in the electrolytic solution based on a potential difference between the first potential obtained through the first main extraction electrode and the second potential obtained through the second main extraction electrode, when the contact of the electrolytic solution with the liquid detection electrode is detected as a trigger; An electrolyte solution analyzer comprising:

8. The electrolyte solution analyzer according to claim 7, The body further comprises: a mounting detection unit that detects that the other end of the test strip for electrolyte analysis is inserted into the connector; and a power supply control unit that turns on the power supply of the main body when the wearing state is detected as a trigger; An electrolyte solution analyzer comprising:

9. 9. The electrolytic solution analyzer according to claim 8, the test piece for analyzing an electrolyte solution has a conductive layer provided on the other end side in the one direction and spaced apart from the first and second main extraction electrodes and the auxiliary extraction electrode, the connector has an additional contact electrode that corresponds to and comes into contact with the conductive layer when the other end of the electrolyte analytical test strip is inserted into the connector; The attachment detection unit detects the attached state in response to the additional contact electrode of the connector coming into contact with the conductive layer. Electrolyte analysis device characterized by:

10. The electrolyte analyzer according to any one of claims 7 to 9, The body has an outer peripheral wall that houses the elements that the body comprises; The outer peripheral wall exposes a display screen that displays information controlled by the computing unit and a slot for the connector to receive the electrolyte analysis test strip, while covering the remaining area other than the area occupied by the display screen and the slot without any operating element. Electrolyte analysis device characterized by:

11. 8. An electrolytic solution analyzing method for measuring a concentration ratio between the first ion species and the second ion species contained in the electrolytic solution by using the electrolytic solution analyzing apparatus according to claim 7, comprising: the calculation unit of the electrolyte solution analyzer is triggered by detection of contact of the electrolyte solution with the liquid detection electrode, waits for a potential difference between the first and second potentials obtained through the first and second main extraction electrodes to converge, performs calibration based on the potential difference between the first and second potentials that has converged, and then calculates a concentration ratio between the first ion species and the second ion species using parameters obtained by the calibration; The electrolyte analysis method includes: The other end of the test strip for electrolyte analysis is inserted into the connector to be attached to the connector. In the mounted state, an operation is performed in which a standard solution containing the first ion species and the second ion species in a predetermined concentration ratio is brought into contact with the main surface of the electrolyte analysis test strip so as to cover the entire surface from the one end to the proximal region, thereby causing the liquid detection processing unit to detect that the electrolyte has come into contact with the liquid detection electrode via the auxiliary extraction electrode, and further causing the calculation unit to perform the calibration based on the potential difference between the first and second potentials obtained for the standard solution, using the detection of the standard solution coming into contact with the liquid detection electrode as a trigger.

13. A method for analyzing an electrolyte solution comprising the steps of:

12. The method for analyzing an electrolyte solution according to claim 11, The electrolyte solution analyzer is a mounting detection unit that detects that the other end of the test strip for electrolyte analysis is inserted into the connector; and a power supply control unit that turns on the power supply of the main body when the wearing state is detected as a trigger; Equipped with The electrolyte analysis method includes: By performing a mounting operation of inserting the other end of the test strip for electrolyte analysis into the connector of the main body, the mounting detection unit detects that the other end of the test strip for electrolyte analysis is inserted into the connector and the detection of the mounted state triggers the power supply control unit to turn on the power supply of the main body.

13. A method for analyzing an electrolyte solution comprising the steps of:

13. The method for analyzing an electrolyte solution according to claim 11 or 12, the calculation unit of the electrolytic solution analyzer determines, following the calibration, whether or not a potential difference between the first and second potentials obtained through the first and second main extraction electrodes shows a change exceeding a predetermined threshold value, and waits until the potential difference between the first and second potentials converges again, triggered by the potential difference between the first and second potentials showing a change exceeding the threshold value, and calculates a concentration ratio between the first ion species and the second ion species using parameters determined by the calibration based on the potential difference between the first and second potentials that has converged; The electrolyte analysis method includes: After the calculation unit performs the calibration, By performing an operation of contacting the test strip with a liquid to be measured so as to cover the entire main surface of the test strip from the one end to the proximal region so as to cause a change in the potential difference between the first and second potentials that exceeds the threshold value, the calculation unit is caused to calculate the concentration ratio using the parameters obtained by the calibration, based on the potential difference between the first and second potentials obtained for the liquid to be measured.

13. A method for analyzing an electrolyte solution comprising the steps of:

14. An electrolyte analyzer for measuring the concentration of ions contained in an electrolyte, A test piece for electrolyte analysis; A main body; The test strip for electrolyte analysis is A substrate extending in one direction from one end to the other end; an ion-sensitive electrode for measuring a concentration of the ions, the electrode being provided in a specific region on the main surface of the substrate on the side of the one end in the one direction; a main extraction electrode extending from the ion-sensitive electrode toward the other end; a liquid detection electrode for detecting whether or not the electrode has come into contact with the electrolyte, the liquid detection electrode being provided on the main surface in a proximal region corresponding to a region between the specific region and the other end in the one direction and spaced apart from the main extraction electrode; an auxiliary extraction electrode spaced apart from the main extraction electrode and extending from the liquid detection electrode toward the other end; Equipped with The above body is a connector having contact electrodes which come into contact with the main extraction electrode and the auxiliary extraction electrode when the other end of the test strip is inserted into the connector; a liquid detection processing unit that detects, when the electrolyte comes into contact with the liquid detection electrode in a mounted state in which the other end of the test piece for electrolyte analysis is inserted into the connector, via the auxiliary extraction electrode, that the electrolyte has come into contact with the liquid detection electrode; a calculation unit that calculates a concentration of ions contained in the electrolyte based on a potential obtained through the main extraction electrode, using the detection of contact of the electrolyte with the liquid detection electrode as a trigger; An electrolyte solution analyzer comprising:

15. The electrolyte solution analyzer according to claim 14, The test strip for electrolyte analysis is a reference electrode provided in the specific region and spaced apart from the ion-sensitive electrode, the reference electrode being in contact with the electrolyte to generate a reference potential; a reference extraction electrode spaced apart from the main extraction electrode and extending from the reference electrode toward the other end; An electrolyte solution analyzer comprising:

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