WO2014038358A1

WO2014038358A1 - Test piece for biological-component measurement, measurement-device main body, and biological-component measurement device including these

Info

Publication number: WO2014038358A1
Application number: PCT/JP2013/071817
Authority: WO
Inventors: 賢一郎財津; 中嶋　聡; 時田　宗雄
Original assignee: オムロンヘルスケア株式会社
Priority date: 2012-09-06
Filing date: 2013-08-12
Publication date: 2014-03-13
Also published as: CN104603608B; JP6149363B2; CN104603608A; JP2014052260A

Abstract

A test piece (10) is provided with: a substrate (11); a working electrode (12) and a counter electrode (13) which are respectively provided with electrode terminals (12f, 13f); and a sensor (15) which is formed extending over the space between the working electrode (12) and the counter electrode (13), and with which a body fluid of a subject causes an electrochemical reaction. A measurement-device main body (50A) is provided with: a receptacle (61) into which a portion of the test piece (10) including at least the electrode terminals is to be inserted; detection contact points (62, 63) which are provided to the receptacle (61), and which each come into contact with the respective electrode terminals of the working electrode (12) and the counter electrode (13); a measurement unit which receives outputs of the sensor (15), and measures the concentration of a specific component in the body fluid; and a working member (71) which irreversible deforms, breaks, or changes the colour of the insertion portion of the test piece (10) inserted into the receptacle (61).

Description

Test piece for measuring biological components, measuring device main body, and biological component measuring device including them

The present invention relates to a measuring apparatus main body, and more particularly to a measuring apparatus main body to which a test piece to which a bodily fluid is attached is attached in order to measure the concentration of a specific component in the bodily fluid of a subject.

The present invention also relates to a test piece for measuring biological components, and more particularly to a test piece to which a body fluid is attached in order to measure the concentration of a specific component in the body fluid of a subject.

The present invention also relates to a biological component measuring apparatus that includes such a test piece and a measuring apparatus main body to which the test piece is mounted, and measures the concentration of a specific component in a body fluid of a subject.

Conventionally, as this kind of biological component measuring device, as disclosed in, for example, Patent Document 1 (Japanese Patent Laid-Open No. 2006-038841), when a used test piece is mounted on the measuring device main body, the test is performed. Based on the electrical characteristics of the piece, the measuring device main body detects and recognizes whether or not the test piece has been used, and outputs an error message to the user (including the subject; the same shall apply hereinafter). Are known.

Further, as disclosed in, for example, Patent Document 2 (Japanese Patent Laid-Open No. 2009-063324), in order to indicate whether or not the sensor has been used, a sensor part of the test piece (a part to which blood or the like is attached and reacts) ) Is transparent so that blood or the like between the sensor portion and the cover can be visually recognized.

JP 2006-038841 A JP 2009-063324 A

However, the method of Patent Document 1 (Japanese Patent Laid-Open No. 2006-038841) has a problem that it takes time and effort because the test piece must be attached to the measuring apparatus body to recognize whether or not the test piece has been used. .

Further, in the method of Patent Document 2 (Japanese Patent Application Laid-Open No. 2009-063324), since the amount of blood used in recent years has decreased, whether or not blood has adhered to the sensor unit, that is, has been used. There is a problem that it is difficult for the user to understand whether or not there is, especially for a user with weak eyesight.

Accordingly, an object of the present invention is to provide a measuring apparatus body that can easily and easily show for a user whether or not a test piece for measuring a biological component has been used, without taking the trouble of remounting or the like. It is to provide.

The subject of the present invention is a test piece to which a body fluid is attached in order to measure the concentration of a specific component in the body fluid of a subject, and whether or not it has been used is time-consuming to remount. An object of the present invention is to provide a test piece that can be shown easily and easily for the user.

Moreover, the subject of this invention is equipped with such a test piece and the measuring apparatus main body to which the test piece is mounted | worn, and takes the effort of re-mounting etc. whether the test piece is used or not. An object of the present invention is to provide a living body component measuring apparatus that can be shown easily and easily for the user.

In order to solve the above problems, the measuring device body of the present invention is a measuring device body to which a test piece to which a body fluid is attached is attached in order to measure the concentration of a specific component in the body fluid of a subject,
The test piece is
A substrate,
A working electrode and a counter electrode extending apart from each other on the substrate, each of the working electrode and the counter electrode having an electrode terminal;
On the substrate, provided between the working electrode and the counter electrode, a sensor unit that causes an electrochemical reaction by a body fluid of a subject to cause a change in electrical characteristics,
The measuring device body is
A receiving portion into which at least a portion including the electrode terminal of the test piece is to be inserted;
A contact for detection to be brought into contact with the electrode terminal of the working electrode and the counter electrode,
A measurement unit that receives the output of the sensor unit via the electrode terminal and the detection contact, and measures the concentration of the specific component in the body fluid;
An operating portion for irreversibly deforming, destroying, or discoloring an insertion portion inserted into the receiving portion of the test piece is provided.

In the present specification, the specific component in the body fluid of the subject refers to, for example, blood sugar (glucose), cholesterol, lactic acid and the like.

In addition, the “contact” for detection of the measuring apparatus main body is in contact with the electrode terminal of the working electrode or the counter electrode regardless of the name of “contact”, “terminal”, “electrode”, “electrode terminal”, etc. Widely refers to a conductive member.

“The change in electrical characteristics” of the sensor section includes generating an electromotive current and changing the electrical resistance from infinity to a finite value.

Further, “irreversibly deformed, destroyed or discolored” means that the test piece is deformed, destroyed or inserted into the insertion portion inserted into the receiving portion even after the test piece is removed from the measuring apparatus body. This means that the discoloration remains.

In the measurement apparatus main body of the present invention, the concentration of the specific component in the body fluid of the subject is measured as follows, for example, by mounting the test piece.

First, with the body fluid of the subject not attached to the test piece (the sensor part), the test piece is inserted and attached to the receiving part of the measuring apparatus main body. Thereby, each electrode terminal of the said working electrode on the said board | substrate and the said counter electrode contacts the contact for a detection corresponding to a measuring apparatus main body. When the body fluid is not attached, the electric resistance of the sensor unit is usually substantially infinite.

Next, the body fluid of the subject is attached to the test piece and comes into contact with the sensor part (this is referred to as “body fluid adhesion state”). As a result, the sensor section causes an electrochemical reaction with the body fluid to cause a change in electrical characteristics. For example, an electromotive current is generated. After the change of the electrical characteristics of the sensor unit, the measurement unit of the measurement apparatus main body detects the electrical characteristics of the sensor unit in a body fluid adhesion state, and the concentration of a specific component in the body fluid based on the electrical characteristics of the sensor unit Is calculated. Thereby, concentration measurement can be performed.

Here, the action part of the measuring device main body irreversibly deforms, destroys or discolors the insertion part inserted into the receiving part of the test piece. Therefore, when the concentration measurement is completed and the user removes the test piece from the measurement apparatus main body, deformation, destruction or discoloration remains in the insertion portion of the test piece inserted into the receiving portion. Therefore, whether or not the test piece has been used can be shown easily and easily for the user without taking the trouble of remounting or the like.

In the measuring device main body of one embodiment,
The test piece spans between a spacer that forms opposite sidewalls on the substrate and the opposite sidewalls of the spacer so as to regulate the amount of body fluid that contacts the sensor unit on the substrate. And a flat cover that covers the sensor unit,
The working portion peels and deforms the insertion portion inserted into the receiving portion of the cover from the spacer as the portion including the electrode terminal of the test piece is inserted into the receiving portion. It has a wedge-shaped member.

In the measuring apparatus main body according to this embodiment, as the test piece is inserted into the receiving part, the wedge-shaped member of the action part inserts the insertion part inserted into the receiving part of the cover into the spacer. Peel and deform. Therefore, when the concentration measurement is completed and the user removes the test piece from the measurement apparatus main body, the insertion portion of the cover inserted into the receiving portion is peeled off from the spacer and deformed. Therefore, it can be shown more simply and easily for the user whether or not the test piece has been used.

Also, even if the user tries to reattach the used test piece to the measuring apparatus body by mistake, the peeled part of the cover is not inserted into the receiving part of the measuring apparatus body, or at least difficult to insert. Therefore, the user can notice that the test piece has been used.

In the test piece, the amount of body fluid that comes into contact with the sensor unit on the substrate is defined by the spacer and the cover. Therefore, accurate concentration measurement can be performed.

In the measuring device main body of one embodiment,
The cover of the test piece has an end surface in the insertion direction inserted into the receiving portion inclined in a reverse taper with respect to the substrate,
The wedge-shaped member of the action portion is in contact with the end face of the cover inserted into the receiving portion, and the insertion portion of the cover is peeled off from the spacer.

In the measuring apparatus main body according to this embodiment, when the test piece is inserted into the receiving part, the wedge-shaped member of the action part is an end surface in the inserting direction inserted into the receiving part of the cover, that is, the substrate. It abuts against the end surface inclined in a reverse taper. When the wedge-shaped member abuts on the end surface of the cover, the end surface of the cover receives a force in a direction away from the spacer by the wedge-shaped member. Therefore, the wedge-shaped member of the action portion can reliably peel the insertion portion of the cover from the spacer.

In the measurement apparatus main body of one embodiment,
In the spacer of the test piece, the end surface in the insertion direction inserted into the receiving portion is inclined forwardly with respect to the substrate,
The wedge-shaped member of the action part is in contact with the vicinity of the interface between the cover of the test piece and the spacer in the thickness direction of the test piece.

In the measuring apparatus main body according to this embodiment, when the test piece is inserted into the receiving portion, the wedge-shaped member of the action portion is configured so that the cover of the test piece and the spacer are in the thickness direction of the test piece. It abuts near the interface between the two. Here, in the cover of the test piece, an end surface in the insertion direction inserted into the receiving portion is inclined in a reverse taper with respect to the substrate. Therefore, when the end surface of the cover comes into contact with the wedge-shaped member of the working portion due to position variation, the insertion portion of the test piece has an interface between the cover and the spacer in the thickness direction. A force is applied in a direction approaching the member. On the other hand, as for the said spacer of the said test piece, the end surface of the insertion direction inserted in the said receiving part inclines in the forward taper with respect to the said board | substrate. Therefore, when the end face of the spacer comes into contact with the wedge-shaped member of the working portion due to position variation, the insertion portion of the test piece has an interface between the cover and the spacer in the thickness direction. A force is applied in a direction approaching the member. In any case, the insertion portion of the test piece is guided in the direction in which the interface between the spacer and the cover sheet approaches the wedge-shaped member in the thickness direction. As a result, the wedge-shaped member of the action portion can easily enter the interface between the cover and the spacer. Therefore, the insertion portion of the cover can be more reliably peeled from the spacer.

In the measuring device main body of one embodiment,
The cover of the test piece has a substantially semi-conical shape on the end surface in the insertion direction to be inserted into the receiving portion, the inner diameter gradually decreases toward the side opposite to the insertion direction, and is open to the spacer. Has a hole with a form,
The wedge-shaped member of the action part has a substantially semi-conical projection directed to the inlet of the receiving part corresponding to the hole of the cover.

In the measuring apparatus main body according to this embodiment, as the test piece is inserted into the receiving portion, the protrusion of the wedge-shaped member of the action portion enters the hole of the cover of the test piece, The insertion part of the cover helps peel off from the spacer. Therefore, the wedge-shaped member of the action portion can more reliably peel the insertion portion of the cover from the spacer.

The measuring apparatus main body according to an embodiment has a guide path that guides a portion of the cover peeled off by the wedge-shaped member in a direction inclined with respect to the insertion direction of the test piece.

In the measuring apparatus main body according to this embodiment, when the test piece is inserted into and attached to the receiving portion of the measuring apparatus main body, a portion of the cover of the test piece that is peeled off by the wedge-shaped member is the guide path. And is guided in a direction inclined with respect to the insertion direction of the test piece. Therefore, the insertion portion of the cover can be more reliably peeled from the spacer.

In the measuring device main body of one embodiment,
A resistance portion having electrical resistance representing attribute information including sensitivity of the test piece is provided on an inner surface or an outer surface of a portion of the cover of the test piece to be peeled off by the wedge-shaped member. Has a calibration terminal,
The guide path is provided with a calibration contact to be brought into contact with the pair of calibration terminals of the resistance unit,
A first attribute information recognition unit that acquires the electrical resistance of the resistance unit of the test piece via the pair of calibration terminals and the calibration contact and recognizes the attribute information,
The measurement unit calculates a concentration of a specific component in the body fluid based on the attribute information in addition to the electrical characteristics of the sensor unit.

In this specification, “attribute information” of the test piece refers to, for example, the sensitivity of the sensor part of the test piece (for example, the correspondence between the concentration of the specific component in the body fluid and the electromotive current generated by the sensor part). Information to be displayed, information for selecting a calibration curve suitable for the component to be measured, and the like can be included.

In the measuring apparatus main body according to this embodiment, when the test piece is inserted and attached to the receiving portion of the measuring apparatus main body, the test piece is peeled off by the wedge-shaped member out of the cover of the test piece, and the receiving portion is guided. A resistance portion having an electrical resistance representing the attribute information (including sensitivity) of the test piece is present on the inner or outer surface of the portion guided along the road. In this state, the pair of calibration terminals of the resistor section come into contact with corresponding calibration contacts provided in the guide path of the measurement apparatus main body. A first attribute information recognition unit recognizes the attribute information by acquiring the electrical resistance of the resistance unit of the test piece via the pair of calibration terminals and the calibration contact. The measurement unit calculates the concentration of the specific component in the body fluid based on the attribute information in addition to the electrical characteristics of the sensor unit. Thereby, the concentration measurement can be accurately performed.

In the measuring device main body of one embodiment,
A mark representing attribute information including sensitivity of the test piece is provided on an inner surface or an outer surface of a portion of the cover of the test piece to be peeled off by the wedge-shaped member,
An optical reading unit for optically reading the mark is provided facing the guide path,
A second attribute information recognition unit for recognizing the attribute information based on the output of the optical reading unit;
The measurement unit calculates a concentration of a specific component in the body fluid based on the attribute information in addition to the electrical characteristics of the sensor unit.

In the measuring apparatus main body according to this embodiment, when the test piece is inserted and attached to the receiving portion of the measuring apparatus main body, the test piece is peeled off by the wedge-shaped member out of the cover of the test piece, and the receiving portion is guided. A mark representing the attribute information (including sensitivity) of the test piece is present on the inner or outer surface of the portion guided along the road. In this state, the optical reading unit optically reads the mark, and the second attribute information recognition unit recognizes the attribute information based on the output of the optical reading unit. The measurement unit calculates the concentration of the specific component in the body fluid based on the attribute information in addition to the electrical characteristics of the sensor unit. Thereby, the concentration measurement can be accurately performed.

In the measuring device main body of one embodiment,
The end of the guide path is open toward the outside of the measuring device body,
The tip of the insertion portion inserted into the receiving portion of the cover of the test piece projects through the guide path to the outside of the measuring apparatus main body.

In the measurement apparatus main body of this embodiment, the end of the guide path is opened toward the outside of the measurement apparatus main body. And the front-end | tip of the insertion part inserted in the said receiving part among the said covers of the said test piece protrudes outside this measuring apparatus main body through the said guide path. Therefore, the user pushes back the tip of the cover of the test piece, which protrudes outside the measurement apparatus main body through the guide path, with respect to the measurement apparatus main body using a finger. It can be easily removed from the measuring device body. This means that, for example, when a nurse as a user removes a used test piece from the main body of the measuring apparatus, the nurse does not need to pull the sensor part to which the subject's bodily fluid adheres or its vicinity with a finger, or At least reduce the pulling force. Therefore, it becomes easy to prevent a situation in which the nurse contacts the body fluid of the subject and is infected.

In the measuring device main body of one embodiment,
The test piece spans between a spacer that forms opposite sidewalls on the substrate and the opposite sidewalls of the spacer so as to regulate the amount of body fluid that contacts the sensor unit on the substrate. And a flat cover that covers the sensor unit,
The spacer and / or cover of the test piece covers the electrode terminal;
The wedge-shaped member of the action portion is in contact with the end surface of the spacer and / or cover to be inserted into the receiving portion, and separates the insertion portion of the spacer and / or cover from the substrate. .

In the measuring apparatus main body according to this embodiment, when the test piece is inserted into the receiving portion, the wedge-shaped member of the action portion contacts the end surface of the spacer and / or cover inserted into the receiving portion. In contact therewith, the insertion portion of the spacer and / or the cover is peeled off from the substrate (including the electrode terminal). Therefore, when the concentration measurement is completed and the user removes the test piece from the measurement apparatus main body, the insertion portion inserted into the receiving portion of the spacer and / or cover is peeled off from the substrate and deformed. Become. Therefore, it can be shown more simply and easily for the user whether or not the test piece has been used.

Further, even if the user tries to reattach the used test piece to the measuring apparatus body by mistake, the peeled part of the spacer and / or cover is not inserted into the receiving part of the measuring apparatus body, or at least inserted. hard. Therefore, the user can notice that the test piece has been used.

In the measuring device main body of one embodiment,
The action portion breaks by forming a cut in the insertion portion of the test piece inserted into the receiving portion as the portion including the electrode terminal of the test piece is inserted into the receiving portion. It has a notch member.

In the measuring apparatus main body according to this embodiment, as the portion including the electrode terminal of the test piece is inserted into the receiving portion, the cutting member of the action portion is the receiving portion of the test piece. A cut is formed in the insertion part inserted into the and destroyed. Therefore, when the concentration measurement is completed and the user removes the test piece from the measurement apparatus main body, a cut is formed in the insertion portion of the test piece that is inserted into the receiving portion, resulting in a broken state. Therefore, it can be shown more simply and easily for the user whether or not the test piece has been used.

In the measuring apparatus main body of one embodiment, the action part has a dent forming member that forms a dent and deforms or destroys the insertion part inserted into the receiving part of the test piece.

In this specification, “dent” refers to an element that is recessed regardless of the name of the recess, hole, or recess.

In the measuring apparatus main body according to this embodiment, as the test piece is inserted into the receiving portion, the depression forming member of the action portion is inserted into the insertion portion inserted into the receiving portion of the test piece. A depression is formed to deform or destroy. Therefore, when the concentration measurement is completed and the user removes the test piece from the measurement apparatus main body, a recess is formed in the insertion portion inserted into the receiving portion of the test piece, resulting in a deformed or destroyed state. . Therefore, it can be shown more simply and easily for the user whether or not the test piece has been used.

In one embodiment of the measuring apparatus main body, the slide further allows the recess forming member to move toward the insertion portion of the test piece when the test piece is inserted into the receiving portion to a certain position. And a switch mechanism.

In the measuring apparatus main body of this embodiment, the slide switch mechanism is configured such that when the test piece is inserted into the receiving portion to a certain position, the recess forming member moves toward the insertion portion of the test piece. Is acceptable. Therefore, the said hollow can be formed in the location away from the edge part of the test piece among the insertion parts of the said test piece. In that case, it can be shown to a user in an easy-to-understand manner whether or not the test piece has been used.

In the measuring apparatus main body of one embodiment, the action part has an ink adhering member that attaches ink to the insertion part inserted into the receiving part of the test piece and changes the color.

In the measuring apparatus main body of this embodiment, as the test piece is inserted into the receiving part, the ink adhering member of the working part is inserted into the insertion part inserted into the receiving part of the test piece. Ink is applied and discolored. Therefore, when the density measurement is completed and the user removes the test piece from the measurement apparatus main body, the ink is attached to the insertion portion of the test piece inserted into the receiving portion and is discolored. Therefore, it can be shown more simply and easily for the user whether or not the test piece has been used.

In the measuring apparatus main body according to one embodiment, the ink adhering member is composed of a roller-shaped ink penetrating mark having a rotation axis intersecting with the insertion direction of the test piece, and is inserted into the receiving portion of the test piece. Ink is attached by contact while rotating following the inserted portion.

In this specification, the “ink penetrating seal” is a sponge-like porous member (porous rubber, etc.), and the ink is soaked into the porous member without the use of vermilion or a stamp stand. It means a mark that enables ink adhesion.

In the measuring apparatus main body of this embodiment, the ink adhering member is composed of a roller-shaped ink penetrating mark having a rotation axis that intersects the insertion direction of the test piece, and is inserted into the receiving portion of the test piece. The ink is adhered by contacting and rotating following the inserted portion. Therefore, a driving source for moving the ink adhering member, vermilion or a stamp stand is not required for ink adhering. Therefore, it can be shown more simply whether or not the test piece has been used.

A test piece according to the present invention is a test piece for measuring a biological component that is attached to a receiving portion of a measurement apparatus main body and to which the body fluid is attached in order to measure the concentration of a specific component in the body fluid of a subject. ,
A substrate,
A working electrode and a counter electrode extending apart from each other are provided on the substrate, and each of the working electrode and the counter electrode has an electrode terminal to be in contact with a contact for detection provided in the receiving portion,
A sensor unit that is formed between the working electrode and the counter electrode on the substrate and causes an electrochemical reaction by a body fluid of a subject to cause a change in electrical characteristics;
In order to regulate the amount of body fluid in contact with the sensor unit on the substrate, the sensor unit is formed on the substrate so as to straddle between the side walls facing each other and the side walls facing each other. With a flat cover to cover,
The end surface of the cover inserted in the receiving portion is inclined in a reverse taper with respect to the substrate, and when inserted into the receiving portion, the end surface of the cover contacts the inside of the receiving portion. In contact therewith, the insertion portion of the cover peels off from the spacer and is irreversibly deformed.

In this specification, to contact the “inside” of the receiving portion includes the case of contacting the member provided inside the receiving portion.

When the test piece of the present invention is inserted into the receiving portion of the measuring apparatus main body, the end surface in the insertion direction inserted into the receiving portion of the cover, that is, the end surface inclined in a reverse taper with respect to the substrate, It contacts the inside of the receiving part. Thereby, the end surface of the cover receives a force in a direction away from the spacer, and the insertion portion of the cover is peeled off from the spacer and deformed irreversibly. Therefore, when the concentration measurement is completed and the user removes the test piece from the measurement apparatus body, the insertion portion of the test piece inserted into the receiving portion remains deformed. Therefore, whether or not the test piece has been used can be shown easily and easily for the user without taking the trouble of remounting or the like.

In the test piece of one embodiment, the end face of the insertion direction inserted into the receiving portion of the spacer is further inclined in a forward taper with respect to the substrate.

When the test piece of this embodiment is inserted into the receiving portion of the measuring apparatus main body, for example, a wedge-shaped member provided inside the receiving portion is near the interface between the cover of the test piece and the spacer. Abut. Here, in the cover of the test piece, an end surface in the insertion direction inserted into the receiving portion is inclined in a reverse taper with respect to the substrate. Therefore, when the end surface of the cover comes into contact with the wedge-shaped member due to position variation, the insertion portion of the test piece is oriented in the thickness direction so that the interface between the cover and the spacer approaches the wedge-shaped member. To receive power. On the other hand, as for the said spacer of the said test piece, the end surface of the insertion direction inserted in the said receiving part inclines in the forward taper with respect to the said board | substrate. Therefore, when the end surface of the spacer comes into contact with the wedge-shaped member due to position variation, the insertion portion of the test piece is oriented in the thickness direction so that the interface between the cover and the spacer approaches the wedge-shaped member. To receive power. In any case, the insertion portion of the test piece is guided in the direction in which the interface between the spacer and the cover sheet approaches the wedge-shaped member in the thickness direction. As a result, the wedge-shaped member of the action portion can easily enter the interface between the cover and the spacer. Therefore, the insertion portion of the cover can be more reliably peeled from the spacer.

In another aspect, the test piece of the present invention is mounted on a receiving part of a measuring device main body for measuring the concentration of a specific component in a body fluid of a subject, and for measuring a biological component to which the body fluid is attached. A test piece,
A substrate,
A working electrode and a counter electrode extending apart from each other are provided on the substrate, and each of the working electrode and the counter electrode has an electrode terminal to be in contact with a contact for detection provided in the receiving portion,
A sensor unit that is formed between the working electrode and the counter electrode on the substrate and causes an electrochemical reaction by a body fluid of a subject to cause a change in electrical characteristics;
In order to regulate the amount of body fluid in contact with the sensor unit on the substrate, the sensor unit is formed on the substrate so as to straddle between the side walls facing each other and the side walls facing each other. With a flat cover to cover,
When the spacer and / or cover covers the electrode terminal, and the end surface in the insertion direction inserted into the receiving part of the spacer and / or cover covering the electrode terminal is inserted into the receiving part In contact with the inside of the receiving portion, the insertion portion of the spacer and / or cover is peeled off from the substrate and deformed irreversibly.

When the test piece of the present invention is inserted into the receiving portion of the measuring apparatus main body, the end surface in the inserting direction inserted into the receiving portion of the spacer and / or cover covering the electrode terminal is Abuts inside. Thereby, the said end surface of the said spacer and / or the said cover receives the force of the direction away from the said board | substrate (an electrode terminal is included). Thereby, the insertion part of the spacer and / or the cover is peeled off from the substrate and deformed irreversibly. Therefore, when the concentration measurement is completed and the user removes the test piece from the measurement apparatus body, the insertion portion of the test piece inserted into the receiving portion remains deformed. Therefore, whether or not the test piece has been used can be shown easily and easily for the user without taking the trouble of remounting or the like.

The biological component measurement apparatus of the present invention includes a test piece to which a body fluid is attached in order to measure the concentration of a specific component in the body fluid of the subject, and a measurement device body to which the test piece is attached, A biological component measuring apparatus for measuring the concentration of a specific component of
The test piece is
A substrate,
A working electrode and a counter electrode extending apart from each other on the substrate, each of the working electrode and the counter electrode having an electrode terminal;
On the substrate, provided between the working electrode and the counter electrode, a sensor unit that causes an electrochemical reaction by a body fluid of a subject to cause a change in electrical characteristics,
The measuring device body is
A receiving portion into which at least a portion including the electrode terminal of the test piece is to be inserted;
A contact for detection to be brought into contact with the electrode terminal of the working electrode and the counter electrode,
A measurement unit that receives the output of the sensor unit via the electrode terminal and the detection contact, and measures the concentration of the specific component in the body fluid;
A biological component measuring apparatus comprising an action part for irreversibly deforming, destroying, or discoloring an insertion part inserted into the receiving part of the test piece.

In the biological component measuring apparatus of the present invention, the concentration of the specific component in the body fluid of the subject is measured as follows, for example, by attaching the test piece to the measuring apparatus main body.

As is clear from the above, according to the measuring apparatus main body of the present invention, it is easy for the user to know whether or not the test piece for measuring the biological component has been used, without taking the trouble of remounting or the like. It can be shown easily.

Further, according to the test piece of the present invention, it is a test piece to which a body fluid is attached in order to measure the concentration of a specific component in the body fluid of a subject, and whether or not it has been used is determined by the trouble such as remounting. It can be shown easily and easily understood by the user without applying.

Further, according to the biological component measuring apparatus of the present invention, it is provided with such a test piece and a measuring apparatus main body to which the test piece is attached, whether or not the test piece has been used, reattachment, etc. It can be shown easily and in an easy-to-understand manner for the user without the hassle of.

It is a perspective view which shows the biological component measuring device of one Embodiment of this invention provided with the general test piece for a biological component measurement, and the measuring apparatus main body with which the test piece is mounted | worn. It is a figure which shows the said test piece in a decomposition | disassembly state. FIG. 3A is a plan view showing the test piece, and FIG. 3B is a view showing an equivalent circuit of the test piece. It is a figure which shows the functional block structure of the said biological component measuring apparatus. It is a figure which shows the circuit which measures the density | concentration of the specific component in the bodily fluid by the said biological component measuring apparatus. 6A is a plan view showing a specific configuration example of a measurement apparatus main body having a general test piece and a receiving portion into which the test piece is inserted, and FIG. 6B is shown in FIG. 6A. It is sectional drawing equivalent to seeing things from the side. 7A is a cross-sectional view showing a state before the test piece shown in FIG. 6 is inserted into the receiving part, and FIG. 7B is a cross-sectional view showing a state where the test piece is inserted into the receiving part. FIG. 7C is a cross-sectional view showing a state where the test piece is removed from the receiving portion. FIG. 8A is a plan view showing a test piece of one embodiment, and FIG. 8B is a side view showing the test piece as viewed from the side. 9A is a cross-sectional view showing a state before the test piece shown in FIG. 8 is inserted into the receiving part, and FIG. 9B is a cross-sectional view showing a state in which the test piece is being inserted into the receiving part. FIG. 9C is a cross-sectional view showing a state in which the test piece is inserted into the receiving portion. FIG. 10A is a side view showing a test piece of another embodiment, FIG. 10B is a side view showing a test piece of still another embodiment, and FIG. 10C is a test of still another embodiment. It is a side view which shows a piece. FIG. 11A is a side view showing a test piece of still another embodiment, FIG. 11B is a view of what is shown in FIG. 11A viewed from the right end surface side, and FIG. FIG. 11D is a cross-sectional view corresponding to the measurement device body viewed from the side, and a plan view showing a specific configuration example of the measurement device body suitable for the piece. FIG. 12A is a plan view showing a test piece of still another embodiment, FIG. 12B is a side view showing the test piece viewed from the side, and FIG. 12C is the test piece. It is sectional drawing which shows the place which looked at the suitable measuring apparatus main body from the side. FIG. 13A is a plan view showing a test piece of still another embodiment, FIG. 13B is a side view showing the test piece viewed from the side, and FIG. 13C is the test piece. It is sectional drawing which shows the place which looked at the suitable measuring apparatus main body from the side. FIG. 14A is a plan view showing a test piece of still another embodiment, FIG. 14B is a side view showing the test piece viewed from the side, and FIG. 14C is the test piece. It is sectional drawing which shows the place which looked at the suitable measuring apparatus main body from the side. FIG. FIG. 15A is a plan view showing a general test piece and a measuring apparatus body of a modified example having a receiving portion into which the test piece is inserted, and FIG. 15B is the one shown in FIG. It is sectional drawing equivalent to seeing from the side. 16A is a cross-sectional view showing a state before the test piece shown in FIG. 15 is inserted into the receiving part, and FIG. 16B is a cross-sectional view showing a state where the test piece is inserted into the receiving part. FIG. 16C is a cross-sectional view showing a state in which the test piece is removed from the receiving portion. FIG. 17A is a plan view showing a general test piece and a measuring device main body of another modified example having a receiving portion into which the test piece is inserted, and FIG. 17B is shown in FIG. It is sectional drawing equivalent to seeing things from the side. 18A is a plan view showing a state in which the test piece shown in FIG. 17 is inserted into the receiving portion, and FIG. 18B corresponds to the side shown in FIG. 18A viewed from the side. It is sectional drawing. FIG. 19A is a plan view showing a state where the test piece shown in FIG. 18 is removed from the receiving portion, and FIG. 19B is a cross-sectional view corresponding to the side view of the test piece. FIG. 20A is a plan view showing a general test piece and a measuring device main body of still another modified example having a receiving portion into which the test piece is inserted, and FIG. 20B is a plan view of FIG. It is sectional drawing equivalent to seeing what was shown from the side. FIG. 21A is a cross-sectional view showing a state before the test piece shown in FIG. 20 is inserted into the receiving part, and FIG. 21B is a cross-sectional view showing a state where the test piece is being inserted into the receiving part. FIG. FIG. 22A is a cross-sectional view showing a state where the test piece is being inserted into the receiving portion following FIG. 21B, and FIG. 22B is a state where the test piece is inserted into the receiving portion. It is sectional drawing shown. FIG. 23 (A) is a cross-sectional view showing a state in which the test piece is being removed from the receiving portion following FIG. 22 (B), and FIG. 23 (B) is the test piece being received following FIG. 23 (A). It is sectional drawing which shows the state in the middle of removing from a part. FIG. 24A is a cross-sectional view showing a state in which the test piece is being removed from the receiving portion following FIG. 23B, and FIG. 24B is a view showing the test piece being received following FIG. It is sectional drawing which shows the state in the middle of removing from a part. FIG. 25A is a plan view showing a state in which the test piece shown in FIG. 24 is removed from the receiving portion, and FIG. 25B is a cross-sectional view corresponding to the side view of the test piece. FIG. 26 (A) is a plan view showing a general test piece and a measuring device main body of still another modified example having a receiving portion into which the test piece is inserted, and FIG. 26 (B) is shown in FIG. 26 (A). It is sectional drawing equivalent to seeing what was shown from the side. FIG. 27A is a plan view showing a state in which the test piece shown in FIG. 26 is inserted into the receiving portion, and FIG. 27B corresponds to the side shown in FIG. 27A. It is sectional drawing. FIG. 28A is a plan view showing a state in which the test piece shown in FIG. 27 is removed from the receiving portion, and FIG. 28B is a cross-sectional view corresponding to the side view of the test piece.

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

FIG. 1 shows a living body component measuring apparatus (the whole is denoted by reference numeral 1) according to an embodiment of the present invention as viewed obliquely. The biological component measuring apparatus 1 is roughly divided into a test piece 10 to which a body fluid is attached in order to measure the concentration of a specific component in a body fluid of a subject, and a measuring apparatus main body (hereinafter simply referred to as a test piece 10). "Main body") 50. Examples of the specific component in the body fluid include blood glucose (glucose), cholesterol, and lactic acid.

(General specimen configuration)
A general test piece 10 includes a substrate 11, a spacer 16, and a cover sheet 18, as can be clearly understood from FIG. 2 (showing an exploded state). In FIG. 2, XYZ orthogonal coordinates are also shown.

The substrate 11 is made of an insulating plastic material in this example, and has a rectangular shape extending in one direction (X direction in FIG. 2).

The working electrode 12 and the counter electrode 13 are provided on the upper surface 11a (the surface on the + Z side in FIG. 2) of the substrate 11 so as to be separated from each other and elongated in a strip shape along the X direction. These working electrode 12 and counter electrode 13 are formed by screen printing a conductive carbon paste or the like. The working electrode 12 and the counter electrode 13 are bent in the + Y direction and the −Y direction perpendicular to the X direction, respectively, in the region on the one end 11e side (−X side) of the substrate 11 with respect to the X direction. The overall shape is L-shaped. The working electrode 12 and the

end portions

12f and 13f of the counter electrode 13 are set as electrode terminals in the region (on the + X side) of the other end portion 11f opposite to the one end portion 11e of the substrate 11 in the X direction. These

electrode terminals

12f and 13f are expected to come into contact with

detection contacts

62 and 63, which will be described later, provided on the main body 50 when the test piece 10 is mounted on the main body 50, respectively.

The ends (L-shaped short sides) 12e and 13e of the working electrode 12 and the counter electrode 13 are separated from each other in the X direction. In this example, a sensor unit 15 made of a circular reagent layer is provided between the working electrode 12 and the

end portions

12e and 13e of the counter electrode 13.

The sensor unit 15 is formed as a solid material in which an oxidoreductase is dispersed in a mediator (electron transfer substance). As the electron transfer substance, an iron complex such as potassium ferricyanide or a Ru complex having NH ₃ as a ligand is used. The oxidoreductase is selected according to the type of specific component to be measured. For example, when measuring blood sugar (glucose), glucose dehydrogenase, glucose oxidase, etc. are used as oxidoreductases. When measuring cholesterol, cholesterol dehydrogenase, cholesterol oxidase and the like are used as oxidoreductases. When measuring lactic acid, lactate dehydrogenase, lactate oxidase and the like are used as oxidoreductases.

In this example, it is assumed that the sensor unit 15 is configured by dispersing glucose dehydrogenase or glucose oxidase in an iron complex or Ru complex in order to measure blood glucose (glucose).

As shown in FIG. 2, a substantially flat spacer 16 and a cover sheet 18 as a flat cover are further provided on the substrate 11 in this order.

The spacer 16 and the cover sheet 18 are each made of an insulating plastic material, and generally have a rectangular shape that is elongated in the X direction. The dimension in the Y direction of the spacer 16 and the cover sheet 18 matches the dimension in the Y direction of the substrate 11. The X direction dimension of the spacer 16 and the cover sheet 18 is set shorter than the X direction dimension of the substrate 11. Specifically, the spacer 16 and the

end portions

16e and 18e of the cover sheet 18 are located at the same position as the end portion 11e of the substrate 11 in the region on the one end portion 11e side (−X side) of the substrate 11 in the X direction. In the X direction, the spacer 16 and the

end portions

16f and 18f of the cover sheet 18 are the end portions of the substrate 11 in the region of the other end portion 11f side (+ X side) opposite to the one end portion 11e of the substrate 11. It is in a position retracted from 11f. Thereby, the

end portions

12f and 13f of the working electrode 12 and the counter electrode 13 are exposed as electrode terminals. Therefore, these

electrode terminals

12 f and 13 f can come into contact with detection contacts 62 and 63 (described later) of the main body 50 when the test piece 10 is mounted on the main body 50.

The end portion 16 e on the −X side of the spacer 16 is recessed in a substantially U shape so as to constitute a flow path 17 from the end portion 11 e of the substrate 11 to the sensor unit 15. Thereby, the spacer 16 has the

side walls

16a and 16b which oppose each other, and the side wall 16c which connects them.

The region near the end portion 18e on the −X side of the cover sheet 18 covers the sensor portion 15 across the

side walls

16a and 16b of the spacer 16 facing each other.

Thereby, the body fluid adhered to the end portion 11e on the −X side of the substrate 11 reaches the sensor portion 15 through the flow path 17 by, for example, a capillary phenomenon. Then, a body fluid layer is formed on the sensor unit 15 in a state having a certain layer thickness corresponding to the height of the spacer 16. Therefore, the amount of body fluid to be measured by contacting the sensor unit 15 on the substrate 11 is determined, and accurate concentration measurement can be performed.

In the cover sheet 18, an air vent through hole may be provided in the vicinity of the side wall 16 c facing the flow path 17 and not directly facing the sensor unit 15. As a result, when the body fluid attached to the end portion 11e on the −X side of the substrate 11 enters the flow path 17 by capillary action, air existing in the flow path 17 escapes through the through hole. Therefore, the body fluid can easily enter the flow path 17.

In the completed state, the test piece 10 is configured as shown in the plan view of FIG. 3A and is expressed as the equivalent circuit of FIG.

In a state where the body fluid (blood) of the subject is not attached to the sensor unit 15 of the test piece 10 (this is referred to as a “body fluid non-attached state”), the electrical resistance of the sensor unit 15 is substantially infinite. . On the other hand, in a state where the blood of the subject is attached to the test piece 10 and is in contact with the sensor unit 15 (this is referred to as a “body fluid adhesion state”), as shown in FIG. An electromotive force is generated as a source. The correspondence relationship between the blood glucose level and the electromotive current of the sensor unit 15 is, for example, the level shown in Table 1 below.
(Table 1)

Table 1 shows that, for example, if the blood glucose level is 90 mg / dL, the sensor unit 15 generates a current of 0.1 nA. If the blood glucose level is 180 mg / dL, the sensor unit 15 generates a current of 1.3 nA. If the blood glucose level is 600 mg / dL, the sensor unit 15 generates a current of 7.0 nA.

However, in the current mass production technology, the correspondence relationship between the blood glucose level and the electromotive current of the sensor unit 15 (in this example, this is expressed as a calibration curve) varies, for example, for each production lot of the test piece. In order to accurately calculate the blood glucose level from the electromotive current, it is desirable to use a calibration curve corresponding to the sensitivity of the sensor unit 15.

(Basic configuration and operation of the main unit)
As shown in FIG. 1, the main body 50 includes a substantially rectangular parallelepiped casing 50 M that a user (typically, a subject) can hold with one hand. A display unit 55 serving as a notification unit and an operation unit 56 for a user to operate are provided on the front surface (upper surface in FIG. 1) of the casing 50M.

As shown by an arrow A, a receiving portion 61 into which the end portion 11f of the test piece 10 (substrate 11) is to be inserted is provided on the end surface of the casing 50M. When the end portion 11 f of the test piece 10 is inserted into the receiving portion 61, the working electrode 12 of the test piece 10 and the

electrode terminals

12 f and 13 f of the counter electrode 13 are in contact with the

detection contacts

62 and 63 provided on the receiving portion 61, respectively. And conduct.

In the casing 50M of the main body 50, as shown in the block diagram of FIG. 4, an output detection unit 51 and a calculation unit 52 are mounted as measurement units.

The output detection unit 51 detects the output of the test piece 10 via the

detection contacts

62 and 63 of the receiving unit 61.

The calculation unit 52 includes a CPU (Central Processing Unit) 53 as a control unit and a memory 54.

The memory 54 stores data of a program for controlling the biological component measuring apparatus 1, data of a calibration curve representing a correspondence relationship between the blood glucose level and the electromotive current of the sensor unit 15, data of measurement results, and the like. To do. In this example, the calibration curve data is 16 so that the sensitivity of the test piece 10 (sensor unit 15) varies (that is, the variation in the correspondence between the blood glucose level and the electromotive current of the sensor unit 15). The type is stored. The memory 54 is also used as a work memory when the program is executed.

A CPU (Central Processing Unit) 53 controls the biological component measuring apparatus 1 according to a program stored in the memory 54.

In this example, the display unit 55 is composed of a liquid crystal display or an EL (electroluminescence) display. This display part 55 is controlled by the calculating part 52, and displays the measurement result regarding the density | concentration (in this example, blood glucose level) of the specific component in a bodily fluid, and other information.

The operation unit 56 includes three push button switches 57, 58, 59 as shown in FIG. The central push button switch 58 is used to turn on and off the operation of the biological component measuring apparatus 1. The push button switches 57 and 59 on both sides are used to display the previous measurement result recorded in the memory 54 on the display unit 55 by lowering or raising it.

As shown in FIG. 5, the output detection unit 51, specifically referred to the power source potential V _CC and connected operational amplifier between the low potential V _EE than its source potential Vcc (hereinafter the "operational amplifier" .) 52, a feedback resistor (resistance value is R2) 53 connected between the inverting input terminal (−) of the operational amplifier 52 and the output terminal (terminal for outputting the output voltage Vout), and a test piece 10 working electrodes 12 and a power source (not shown) for applying a predetermined voltage Vin. The output current from the counter electrode 13 of the test piece 10 is input to the inverting input terminal (−) of the operational amplifier 52 as the output of the test piece 10. The non-inverting input terminal (+) of the operational amplifier 52 is grounded. With this configuration, the output detection unit 51 outputs an output voltage Vout corresponding to the output (output current) of the test piece 10.

Here, assuming that the electrical resistance of the test piece 10 is R1, the output voltage of the operational amplifier 52 is generally:
Vout = − (R2 / R1) × Vin (1)
Represented as:

Even when the test piece 100 is attached to the main body 50, the electric resistance R1 of the sensor unit 15 is substantially infinite when the body fluid is not attached, so that a current flows through the test piece 100 (and therefore the feedback resistor 53). There is no flow. Therefore, the output voltage Vout of the output detection unit 51 is substantially zero.

In the body fluid adhering state, an electromotive current (this is assumed to be i) is generated in the sensor unit 15, so that the working electrode 12, the sensor unit 15, the counter electrode 13, and the feedback resistor on the substrate of the test piece 100 are applied by applying the voltage Vin. A current i flows through 53. In this body fluid adhesion state, the CPU 53 can detect the output voltage Vout of the output detection unit 51 according to the current i.

(Specific configuration example of the main unit)
FIGS. 6A and 6B respectively show specific configuration examples of a general test piece 10 and a main body (indicated by reference numeral 50A) having a receiving portion 61 into which the test piece 10 is inserted. The place seen from above and from the side is schematically shown.

In this main body 50A, the receiving portion 61 is a rectangular parallelepiped space roughly defined by a rectangular upper wall 61a, lower wall 61b, side wall 61c, side wall 61d, and back wall 61f. The dimensions of the opening (width and height) of the receiving portion 61 are substantially the same as the width and thickness of the test piece 10 (the Y-direction dimension and the Z-direction dimension of the substrate 11 in FIG. 2). In practice, the size of the opening of the receiving portion 61 is set slightly larger than the width and thickness of the test piece 10 in order to provide a margin for insertion. In this example, the depth dimension of the receiving portion 61 is set to approximately 1/3 to approximately 1/2 of the dimension in the longitudinal direction of the test piece 10 (dimension in the X direction of the substrate 11 in FIG. 2). As a result, when the receiving portion 61 is inserted until the end portion 11f of the test piece 10 comes into contact with the inner wall 61f, a part of the test piece 10 in the longitudinal direction, in this example, approximately 1/3 to approximately 1/2. The part of is to be accommodated.

Detection contacts

62 and 63 are provided on the upper wall 61 a of the receiving portion 61. When the end portion 11f of the test piece 10 is inserted into the receiving portion 61, the working electrode 12 of the test piece 10 and the

electrode terminals

12f and 13f of the counter electrode 13 come into contact with the

detection contacts

62 and 63, respectively. These

detection contacts

62 and 63 are made of a substantially U-shaped metal plate having elasticity, and the bent portion (vertex of the U-shape) of the metal plate is in contact with the

electrode terminals

12 f and 13 f of the test piece 10. Is directed downwards.

Further, inside the receiving portion 61, a wedge-shaped member 71 as an action portion is provided along the upper wall 61a. The wedge-shaped member 71 is a substantially rectangular plate-shaped member (the portion where the

detection contacts

62 and 63 are present is cut out), and the tip (in this example) facing the inlet side of the receiving portion 61. Side) 71e has an acute angle cross section. The acute angle of the tip 71e is formed by a horizontal lower surface and an inclined surface extending to the upper right (in FIG. 6B). The width of the wedge-shaped member 71 is substantially the same as the width of the test piece 10. The thickness of the wedge-shaped member 71 substantially matches the thickness of the cover sheet 18 of the test piece 10. The wedge-shaped member 71 is provided to peel off the insertion portion inserted into the receiving portion 61 of the cover sheet 18 of the test piece 10 from the spacer 16 by the tip 71e.

Further, above the receiving portion 61, a guide path 80 is provided extending obliquely from right above the tip 71e of the wedge-shaped member 71 to the upper right (in FIG. 6B). In FIG. 6A, for the sake of easy understanding, illustration of a portion (including the guide path 80) corresponding to the upper side of the wedge-shaped member 71 is omitted. The inlet 80 e of the guide path 80 is inside the receiving portion 61 and directly above the tip 71 e of the wedge-shaped member 71. In this example, the end 80f of the guide path 80 is stopped inside the main body 50A. The guide path 80 is provided to guide the portion of the cover sheet 18 that has been peeled off by the wedge-shaped member 71 in a direction inclined with respect to the insertion direction of the test piece 10.

FIG. 7 (A) shows a state before the test piece 10 is inserted into the receiving portion 61 of the main body 50A. When the body fluid of the subject is not attached to the test piece 10 (the sensor part 15), the test piece 10 is inserted into the receiving part 61 and attached to the main body 50A as shown in FIG. 7B. Is done. Accordingly, the

electrode terminals

12f and 13f of the working electrode 12 and the counter electrode 13 on the substrate 11 come into contact with the corresponding

detection contacts

62 and 63 of the main body 50A. In the body fluid non-adhered state, the electrical resistance of the sensor unit 15 is substantially infinite, so the output voltage Vout of the output detection unit 51 is substantially zero. Next, the body fluid of the subject is attached to the test piece 10 and comes into contact with the sensor unit 15 (this is referred to as “body fluid attached state”). Thereby, the sensor part 15 raise | generates an electromotive reaction as a change of an electrical property, raise | generating an electrochemical reaction with a bodily fluid. After the change in the electrical characteristics of the sensor unit 15, the output detection unit 51 and the calculation unit 52 of the main body 50 A detect the electrical characteristics of the sensor unit 15 in the body fluid adhesion state, and based on the electrical characteristics of the sensor unit 15, Calculate the concentration of a specific component. Thereby, concentration measurement can be performed.

Here, as the test piece 10 is inserted into the receiving portion 61, the tip 71 e of the wedge-shaped member 71 is at the root of the end surface 18 f of the cover sheet 18 of the test piece 10 (portion close to the upper surface 16 a of the spacer 16). The insertion portion 18 i inserted into the receiving portion 61 of the cover sheet 18 is peeled off from the upper surface 16 a of the spacer 16 and deformed. A portion 18 i of the cover sheet 18 separated by the wedge-shaped member 71 is guided to the guide path 80. Therefore, the insertion portion 18 i of the cover sheet 18 can be more reliably peeled from the upper surface 16 a of the spacer 16.

Thereafter, as shown in FIG. 7C, the test piece 10 is removed from the receiving portion 61. In this removal process, the insertion portion 18i of the cover sheet 18 is bent and once approaches (or contacts) the upper surface 16a of the spacer 16, but after the removal, the insertion portion 18i inserted into the receiving portion 61 of the cover sheet 18 is inserted. It will peel from the spacer 16 and will be in the state which deform | transformed irreversibly. Therefore, it can be easily and easily shown to the user whether or not the test piece 10 has been used.

Also, even if the user tries to reattach the used test piece 10 to the main body 50A by mistake, the peeled portion 18i of the cover sheet 18 is not inserted into the receiving portion 61 of the main body 50A, or at least difficult to insert. Therefore, the user can notice that the test piece 10 has been used.

(Several examples of test piece configuration)
FIG. 8A and FIG. 8B respectively show a test piece (indicated by reference numeral 10A) of an embodiment suitable for being mounted on the main body 50A as viewed from above and from the side. This is shown schematically.

In this test piece 10A, the end face (indicated by reference numeral 18f ') in the insertion direction inserted into the receiving portion 61 of the cover sheet 18 from the general test piece 10 has an upper right side from right above the end face 16f of the spacer 16. The difference is that the substrate 11 is inclined in a reverse taper direction (in FIG. 8B). Other configurations of the test piece 10A are the same as those of the general test piece 10.

FIG. 9A shows a state before the test piece 10A is inserted into the receiving portion 61 of the main body 50A. The test piece 10A is inserted into the receiving part 61 in a state in which the body fluid of the subject is not attached to the test piece 10A (the sensor part 15). Here, as shown in FIG. 9B, as the test piece 10A is inserted into the receiving portion 61, the tip 71e of the wedge-shaped member 71 is moved to the end face 18f 'of the cover sheet 18 of the test piece 10A, that is, It abuts on the base of the end surface 18 f ′ inclined in a reverse taper with respect to the substrate 11 (portion close to the upper surface 16 a of the spacer 16). When the wedge-shaped member 71 comes into contact with the end surface 18 f ′ of the cover sheet 18, the end surface 18 f ′ of the cover sheet 18 receives a force F in a direction away from the upper surface 16 a of the spacer 16 by the tip 71 e of the wedge-shaped member 71. Therefore, the wedge-shaped member 71 can reliably peel the insertion portion 18 i of the cover sheet 18 from the spacer 16. The part 18i peeled off by the wedge-shaped member 71 in the cover sheet 18 is guided to the guide path 80 as in the previous example.

Therefore, when the concentration measurement is completed and the user removes the test piece 10A from the main body 50A, the insertion portion 18i inserted into the receiving portion 61 of the cover sheet 18 peels off from the spacer 16 and becomes irreversible as in the previous example. Will be deformed. Therefore, whether or not the test piece 10A has been used can be easily and easily shown to the user.

Also, even if the user tries to reattach the used test piece 10A to the main body 50A by mistake, the peeled portion 18i of the cover sheet 18 is not inserted into the receiving portion 61 of the main body 50A, or at least difficult to insert. Therefore, the user can notice that the test piece 10A has been used.

As shown in FIG. 9C, the concentration measurement is performed until the end 11f of the test piece 10A is in contact with the back wall 61f, and the test piece 10A is attached to the main body 50A. Done in the same way as the example.

FIG. 10A schematically shows a test piece (indicated by reference numeral 10B) of another embodiment suitable for being mounted on the main body 50A as viewed from the side.

The test piece 10B has an end face 18f 'in the insertion direction inserted into the receiving portion 61 of the cover sheet 18 with respect to the test piece 10A described above from the position on the left side of the end face 16f of the spacer 16 (see FIG. B) is different from the substrate 11 in that the substrate 11 is inclined in a reverse taper. The other configuration of the test piece 10B is the same as the configuration of the above-described test piece 10A.

In this test piece 10B, as the test piece 10B is inserted into the receiving portion 61, the tip 71e of the wedge-shaped member 71 passes directly above the end face 16f of the spacer 16 and covers the upper face 16a of the spacer 16. It reaches the root of the end surface 18f ′ in the insertion direction of the sheet 18 (portion close to the upper surface 16a of the spacer 16). Therefore, the tip 71e of the wedge-shaped member 71 can easily enter the interface between the spacer 16 and the cover sheet 18. Therefore, the wedge-shaped member 71 can more reliably peel the insertion portion 18 i of the cover sheet 18 from the upper surface 16 a of the spacer 16.

FIG. 10B schematically shows a side view of a test piece (indicated by reference numeral 10C) of still another embodiment suitable for being mounted on the main body 50A.

In the test piece 10C, the end face (indicated by 16f ′) inserted in the receiving portion 61 of the spacer 16 is inclined forwardly with respect to the substrate 11 with respect to the test piece 10B. Is different. The other configuration of the test piece 10C is the same as that of the above-described test piece 10B.

The height of the opening of the receiving portion 61 is actually set slightly larger than the thickness of the test piece 10C in order to provide a margin for insertion. For this reason, when the test piece 10C is inserted into the receiving portion 61, the tip 71e of the wedge-shaped member 71 is applied near the interface between the cover sheet 18 and the spacer 16 of the test piece 10C with a positional variation in the thickness direction. Touch. Here, as shown by a two-dot chain line 71u in FIG. 10B, when the end surface 18f 'of the cover sheet 18 abuts against the tip of the wedge-shaped member 71 due to position variation, the end surface 18f' of the cover sheet 18 faces upward. The force F1 is received. On the other hand, as indicated by a one-dot chain line 71v, when the end surface 16f 'of the spacer 16 abuts on the tip of the wedge-shaped member 71 of the action portion due to position variation, the end surface 16f' of the spacer 16 receives a downward force F2. In any case, the insertion portion of the test piece 10 C is guided in the direction in which the interface between the spacer 16 and the cover sheet 18 approaches the tip 71 e of the wedge-shaped member 71 in the thickness direction. Therefore, the tip 71e of the wedge-shaped member 71 can easily enter the interface between the spacer 16 and the cover sheet 18. Therefore, the wedge-shaped member 71 can more reliably peel the insertion portion 18 i of the cover sheet 18 from the upper surface 16 a of the spacer 16.

FIG. 10C schematically shows a test piece (indicated by reference numeral 10D) of still another embodiment suitable for being mounted on the above-described main body 50A as viewed from the side.

In this test piece 10D, the planar dimensions of the spacer 16 and the cover sheet 18 are substantially the same as the planar dimensions of the substrate 11 with respect to the general test piece 10, and the spacer 16 and the cover sheet 18 are connected to the

electrode terminals

12f and 13f. The point that covers is different. Note that end faces in the insertion direction of the spacer 16 and the cover sheet 18 are denoted by reference numerals 16f ″ and 18f ″, respectively. Other configurations of the test piece 10D are the same as those of the general test piece 10.

In the main body 50A, the thickness of the wedge-shaped member 71 is substantially equal to the total thickness of the spacer 16 and the cover sheet 18 of the test piece 10D.

In this test piece 10D, as the test piece 10D is inserted into the receiving part 61, the tip 71e of the wedge-shaped member 71 comes into contact with the root of 16f ″ of the spacer 16 (the part close to the upper surface 11a of the substrate 11). As a result, the insertion portion inserted into the receiving portion 61 of the spacer 16 and the cover sheet 18 is peeled off and deformed from the upper surface 11a of the substrate 11. The spacer 16 and the cover sheet 18 were peeled off by the wedge-shaped member 71. The portion is guided to the guide path 80.

Therefore, when the concentration measurement is completed and the user removes the test piece 10D from the main body 50A, the insertion portion inserted into the receiving portion 61 of the spacer 16 and the cover sheet 18 is peeled off from the substrate 11 and irreversibly deformed. become. Therefore, whether or not the test piece 10D has been used can be shown simply and easily for the user.

Note that only one of the spacer 16 and the cover sheet 18 may cover the

electrode terminals

12f and 13f. In this case, the wedge-shaped member 71 peels off one of the spacer 16 and the cover sheet 18 that covers the

electrode terminals

12 f and 13 f from the upper surface 11 a of the substrate 11 and deforms irreversibly. Therefore, similarly, whether or not the test piece has been used can be easily and easily shown to the user.

FIG. 11 (A) schematically shows a test piece of another embodiment (indicated by reference numeral 10E) viewed from the side. FIG. 11B schematically shows the state shown in FIG. 11A viewed from the right end surface side.

The test piece 10E is provided with a hole 18h having a substantially semi-conical shape on an end surface 18f in the insertion direction to be inserted into the receiving portion 61 of the cover sheet 18 with respect to a general test piece 10. Are different. The hole 18 h has a shape in which the inner diameter gradually becomes smaller toward the side opposite to the insertion direction and is open to the spacer 16. Other configurations of the test piece 10E are the same as those of the general test piece 10.

FIG. 11C and FIG. 11D each schematically show a specific configuration example of a main body (indicated by reference numeral 50B) suitable for the test piece 10E as viewed from above and from the side. ing.

In the main body 50B, the wedge-shaped member 71 provided in the receiving portion 61 is formed on a flat and substantially vertical front surface 71g corresponding to the hole 18h of the cover sheet 18 and directed to the entrance of the receiving portion 61. It has a conical protrusion 71h. The other configuration of the main body 50B is the same as the configuration of the main body 50A.

In the main body 50B, as the test piece 10E is inserted into the receiving portion 61, the protrusion 71h of the wedge-shaped member 71 and the hole 18h of the cover sheet 18 of the test piece 10 are inserted, and the insertion portion 18i of the cover sheet 18 is a spacer. It helps to peel off the upper surface 16a of the sixteen. Therefore, the wedge-shaped member 71 can more reliably peel the insertion portion 18 i of the cover sheet 18 from the spacer 16.

In the main body 50B, the front surface 71g of the wedge-shaped member 71 is flat and vertical. However, the present invention is not limited to this. The front surface 71g of the wedge-shaped member 71 may be slightly inclined from the lower left to the upper right.

12 (A) and 12 (B) schematically show a test piece (indicated by reference numeral 10F) of still another embodiment as viewed from above and from the side.

The test piece 10F is provided with a resistance portion 40A having an electrical resistance representing attribute information (including sensitivity) of the test piece 10F on an upper surface 18a as an outer surface of the cover sheet 18 with respect to a general test piece 10. Is different. In this example, the resistance portion 40A is electrically connected to the resistance layer 41 that extends in the longitudinal direction (insertion direction) of the test piece 10F and overlaps both ends of the resistance layer 41, and the working electrode 12 and the counter electrode. 13 and a pair of

calibration terminals

42 and 43 extending along the line 13. The electric resistance of the resistance layer 41 is variably set in 16 steps so as to represent the attribute information of the test piece 10F. The other configuration of the test piece 10F is the same as the configuration of the general test piece 10.

FIG. 12C schematically shows a specific configuration example of the main body (indicated by reference numeral 50C) suitable for the test piece 10F as viewed from the side.

In the main body 50C, above the guide path 80, a pair of

calibration contacts

82A and 83A to be brought into contact with the pair of

calibration terminals

42 and 43 of the resistor 40A, and a support for supporting these

calibration contacts

82A and 83A. 81A. Similar to the

detection contacts

62 and 63, these

calibration contacts

82A and 83A are made of a substantially U-shaped metal plate having elasticity, and the bent portion of the metal plate (vertex of the U shape) is used for calibration. It protrudes to the guide path 80 so as to come into contact with the

terminals

42 and 43.

Note that the depth of the receiving portion 61 is set to be somewhat longer than that of the basic main body 50A ((Accordingly, the

electrode terminals

62 and 63 are disposed behind the wedge-shaped member 71. The same applies to FIGS. 13 and 14 of FIG.

As shown in FIG. 12C, in the state in which the test piece 10F is inserted into the receiving portion 61, as described above, the

electrode terminals

12f and 13f of the working electrode 12 and the counter electrode 13 on the substrate 11, respectively. Contacts the

corresponding detection contacts

62 and 63 of the main body 50C. Therefore, the output detection unit 51 and the calculation unit 52 of the main body 50 C can detect the electrical characteristics of the sensor unit 15. At the same time, the resistance portion 40 A is present on the upper surface 18 a of the portion guided along the guide path 80 of the cover sheet 18. In this state, the calculation unit 52 works as a first attribute information recognition unit to change the electrical resistance of the resistance unit 40A (resistance layer 41) of the test piece 10F to the pair of

calibration terminals

42 and 43 and the calibration contacts 82A, Acquired via 83A. Thereby, the attribute information of the test piece 10F is recognized. And the calculating part 52 calculates the density | concentration of the specific component in a bodily fluid by selecting the calibration curve memorize | stored in the memory 54 based on the attribute information in addition to the electrical property of the sensor part 15. FIG. Thereby, the concentration measurement can be accurately performed.

When the concentration measurement is completed and the user removes the test piece 10F from the main body 50C, the insertion portion 18i inserted into the receiving portion 61 of the cover sheet 18 peels off from the spacer 16 and becomes irreversible, as in the previous example. It will be in a deformed state. Therefore, it can be easily and easily shown to the user whether or not the test piece 10F has been used.

Also, even if the user tries to reattach the used test piece 10F to the main body 50C by mistake, the peeled portion 18i of the cover sheet 18 is not inserted into the receiving portion 61 of the main body 50C, or at least difficult to insert. Therefore, the user can notice that the test piece 10F has been used.

FIGS. 13 (A) and 13 (B) schematically show a test piece (indicated by reference numeral 10G) of still another embodiment as viewed from above and from the side.

The test piece 10G is provided with a resistance portion 40B having an electrical resistance representing attribute information (including sensitivity) of the test piece 10G on the lower surface 18b as the inner surface of the cover sheet 18 with respect to the general test piece 10. Is different. In this example, the resistance portion 40B is electrically connected to the resistance layer 41 that is elongated in the longitudinal direction (insertion direction) of the test piece 10G and overlaps both ends of the resistance layer 41, and the working electrode 12 and the counter electrode. 13 and a pair of

calibration terminals

42 and 43 extending along the line 13. The electric resistance of the resistance layer 41 is variably set in 16 steps so as to represent the attribute information of the test piece 10G. The other configuration of the test piece 10G is the same as the configuration of the general test piece 10. In other words, this test piece 10G is provided with a resistance portion 40B having the same configuration on the lower surface 18b of the cover sheet 18 in place of the resistance portion 40A provided on the upper surface 18a of the cover sheet 18 in the test piece 10F described above. It can be said that.

FIG. 13C schematically shows a specific configuration example of the main body (indicated by reference numeral 50D) suitable for the test piece 10G as viewed from the side.

In the main body 50D, below the guide path 80, a pair of calibration contacts 82B and 83B to be brought into contact with the pair of

calibration terminals

42 and 43 of the resistor 40B, and a support for supporting these calibration contacts 82B and 83B. Part 81B. Similar to the

detection contacts

62 and 63, these calibration contacts 82B and 83B are made of a substantially U-shaped metal plate having elasticity, and the bent portion (vertex of the U shape) of the metal plate is used for calibration. It protrudes to the guide path 80 so as to come into contact with the

terminals

42 and 43.

As shown in FIG. 13C, when the test piece 10G is inserted into the receiving portion 61, as described above, the

electrode terminals

12f and 13f of the working electrode 12 and the counter electrode 13 on the substrate 11, respectively. Comes into contact with the corresponding

detection contacts

62 and 63 of the main body 50D. Therefore, the output detection unit 51 and the calculation unit 52 of the main body 50 D can detect the electrical characteristics of the sensor unit 15. At the same time, the resistance portion 40 B is present on the lower surface 18 b of the portion guided along the guide path 80 of the cover sheet 18. In this state, the calculation unit 52 works as a first attribute information recognition unit to change the electrical resistance of the resistance unit 40B (resistance layer 41) of the test piece 10G to the pair of

calibration terminals

42 and 43 and the calibration contact 82B, Acquired via 83B. Thereby, the attribute information of the test piece 10G is recognized. And the calculating part 52 calculates the density | concentration of the specific component in a bodily fluid by selecting the calibration curve memorize | stored in the memory 54 based on the attribute information in addition to the electrical property of the sensor part 15. FIG. Thereby, the concentration measurement can be accurately performed.

When the concentration measurement is completed and the user removes the test piece 10G from the main body 50D, the insertion portion 18i inserted into the receiving portion 61 of the cover sheet 18 peels off from the spacer 16 and becomes irreversible, as in the previous example. It will be in a deformed state. Therefore, whether or not the test piece 10G has been used can be easily and easily shown to the user.

In addition, even if the user tries to reattach the used test piece 10G to the main body 50D by mistake, the peeled portion 18i of the cover sheet 18 is not inserted into the receiving portion 61 of the main body 50D or at least difficult to insert. Therefore, the user can notice that the test piece 10G has been used.

FIG. 14 (A) and FIG. 14 (B) schematically show a test piece (indicated by reference numeral 10H) of still another embodiment as viewed from above and from the side.

The test piece 10H is different from the general test piece 10 in that a mark 40C representing attribute information (including sensitivity) of the test piece 10H is provided on an upper surface 18a as an outer surface of the cover sheet 18. Is different. In this example, the mark 40 C includes a barcode 44 arranged along the longitudinal direction (insertion direction) of the test piece 10 H. The barcode 44f is variably set in 16 stages so as to represent the attribute information of the test piece 10H. Other configurations of the test piece 10H are the same as those of the general test piece 10.

FIG. 14C schematically shows a specific configuration example of the main body (indicated by reference numeral 50E) suitable for the test piece 10H viewed from the side.

In the main body 50E, an image sensor 85 for optically reading the barcode 44 of the mark 40C is provided as an optical reading unit facing the guide path 80 and above it. The image sensor 85 includes a light emitting unit 87 that irradiates light L toward the barcode 44 and a light receiving unit 88 that receives reflected light from the barcode 44 and outputs an electrical signal corresponding to the reflected light. . The light emitting unit 87 and the light receiving unit 88 are supported by the support unit 86 along the guide path 80.

As shown in FIG. 14C, in the state in which the test piece 10H is inserted into the receiving portion 61, the

electrode terminals

12f and 13f of the working electrode 12 and the counter electrode 13 on the substrate 11 as described above. Contacts the

corresponding detection contacts

62, 63 of the main body 50E. Therefore, the output detection unit 51 and the calculation unit 52 of the main body 50E can detect the electrical characteristics of the sensor unit 15. At the same time, the mark 40 C is present on the upper surface 18 a of the portion guided along the guide path 80 of the cover sheet 18. In this state, the calculation unit 52 functions as a second attribute information recognition unit, and recognizes the attribute information of the test piece 10H based on the output of the image sensor 85 (electric signal corresponding to the reflected light). And the calculating part 52 calculates the density | concentration of the specific component in a bodily fluid by selecting the calibration curve memorize | stored in the memory 54 based on the attribute information in addition to the electrical property of the sensor part 15. FIG. Thereby, the concentration measurement can be accurately performed.

When the concentration measurement is completed and the user removes the test piece 10H from the main body 50E, the insertion portion 18i inserted into the receiving portion 61 of the cover sheet 18 peels off from the spacer 16 and becomes irreversible, as in the previous example. It will be in a deformed state. Therefore, whether or not the test piece 10H has been used can be easily and easily shown to the user.

Further, even if the user tries to reattach the used test piece 10H to the main body 50E by mistake, the peeled portion 18i of the cover sheet 18 is not inserted into the receiving portion 61 of the main body 50E, or at least difficult to insert. Therefore, the user can notice that the test piece 10H has been used.

The mark 40C is a barcode 44 in this example, but is not limited thereto. The mark 40C only needs to be able to represent the attribute information of the test piece, and may be, for example, a number or a symbol.

(Several variations of the main body)
FIGS. 15A and 15B respectively show a main body (indicated by reference numeral 50F) of a modified example having a general test piece 10 and a receiving portion 61 into which the test piece 10 is inserted. It shows a view from the side.

In the main body 50F, as compared with the basic main body 50A, the end of a guide path (indicated by reference numeral 81) provided above the receiving portion 61 is open toward the outside of the main body 50F. Is different. Specifically, the entrance 81e of the guide path 81 is inside the receiving portion 61 and just above the tip 71e of the wedge-shaped member 71, as in the main body 50A. In this example, the outlet 81 f of the guide path 81 is above the substantially central portion of the wedge-shaped member 71. For easy understanding, the positions of the inlet 81e and the outlet 81f of the guide path 81 are indicated by broken lines in FIG.

Further, the depth of the receiving portion 61 is set to be somewhat longer than that of the basic main body 50A (accordingly, the

electrode terminals

62 and 63 are disposed behind the wedge-shaped member 71).

The other configuration of the main body 50F is the same as that of the basic main body 50A.

FIG. 16 (A) shows a state before the test piece 10 is inserted into the receiving portion 61 of the main body 50F. The test piece 10 is inserted into the receiving portion 61 in a state in which the body fluid of the subject is not attached to the test piece 10 (the sensor unit 15 thereof). As the test piece 10 is inserted into the receiving portion 61, the tip 71e of the wedge-shaped member 71 is moved to the root of the end surface 18f of the cover sheet 18 of the test piece 10 (on the upper surface 16a of the spacer 16). The insertion portion 18 i of the cover sheet 18 is peeled off from the spacer 16. A portion 18 i of the cover sheet 18 separated by the wedge-shaped member 71 is guided to the guide path 81. As shown in FIG. 16 (B), when the end portion 11f of the test piece 10 is inserted until it abuts against the inner wall 61f of the receiving portion 61, the electrode terminals 12f of the working electrode 12 and the counter electrode 13 on the substrate 11 respectively. , 13f come into contact with the corresponding

detection contacts

62, 63 of the main body 50F. Further, the tip 18 f of the insertion portion 18 i inserted into the receiving portion 61 of the cover sheet 18 of the test piece 10 protrudes outside the main body 50 F through the guide path 81.

In this state, the body fluid of the subject is attached to the test piece 10 and contacts the sensor unit 15. Then, the concentration measurement is performed in the same manner as in the previous example.

When the concentration measurement is completed and the user removes the test piece 10 from the main body 50F, the user passes through the guide path 81 in the cover sheet 18 of the test piece 10 as shown by an arrow B in FIG. The tip 18f protruding to the outside is pushed back against the main body 50F using a finger. Thereby, the test piece 10 can be easily removed from the main body 50F. This means that, for example, when a nurse as a user removes the used test piece 10 from the main body 50F, the nurse does not need to pull the sensor part 15 to which the subject's body fluid has adhered or the vicinity thereof with a finger, Or at least reduce the pulling force. Therefore, it becomes easy to prevent a situation in which the nurse contacts the body fluid of the subject and is infected.

As shown in FIG. 16C, after the test piece 10 is removed from the main body 50F, the insertion portion 18i inserted into the receiving portion 61 of the cover sheet 18 is peeled off from the spacer 16 as in the previous example. And irreversibly deformed. Therefore, it can be easily and easily shown to the user whether or not the test piece 10 has been used.

Also, even if the user tries to reattach the used test piece 10 to the main body 50F by mistake, the peeled portion 18i of the cover sheet 18 is not inserted into the receiving portion 61 of the main body 50F, or at least difficult to insert. Therefore, the user can notice that the test piece 10 has been used.

17 (A) and 17 (B) respectively show a main body of a modified example (denoted by reference numeral 50G) having a general test piece 10 and a receiving portion 61 into which the test piece 10 is inserted. The view from the side is shown schematically.

This main body 50G is different from the basic main body 50A in that a cutting member 72 as an action portion is provided inside the receiving portion 61 in place of the wedge-shaped member 71. The cutting member 72 forms a cut in the insertion portion of the test piece 10 inserted into the receiving portion 61 as the portion including the

electrode terminals

12f and 13f of the test piece 10 is inserted into the receiving portion 61. A plate-like member for performing the above operation, substantially at the center in the width direction of the receiving portion 61 as shown in FIG. 17A, and with the upper wall 61a of the receiving portion 61 as shown in FIG. It is attached between the lower wall 61b. The cutting member 72 has a blade 72e that is inclined obliquely from the lower left to the upper right in FIG.

Further, in the main body 50G, the guide path 80 is omitted as compared with the basic main body 50A. The other configuration of the main body 50G is the same as that of the basic main body 50A.

As shown in FIG. 18A (viewed from above) and FIG. 18B (viewed from the side), the part including the

electrode terminals

12f and 13f of the test piece 10 was inserted into the receiving portion 61. Accordingly, the cutting member 72 cuts into the insertion portion of the test piece 10 inserted into the receiving portion 61, in this example, the substrate insertion portion 11i, the spacer insertion portion 16i, and the cover sheet insertion portion 18i. Form and destroy. When the end portion 11f of the test piece 10 is inserted until it abuts against the inner wall 61f of the receiving portion 61, the

respective electrode terminals

12f and 13f of the working electrode 12 and the counter electrode 13 on the substrate 11 are detected corresponding to the main body 50G. The

contact contacts

62 and 63 are contacted.

When the concentration measurement is completed and the user removes the test piece 10 from the main body 50G, as shown in FIG. 19A (viewed from above) and FIG. 19B (viewed from side), the test is performed. The cut portion 73 is formed in the insertion portion of the piece 10 inserted into the receiving portion 61 and is in a broken state. Therefore, whether or not the test piece 10 has been used can be shown more simply and easily for the user.

20 (A) and 20 (B) show still another modified main body (indicated by reference numeral 50H) having a general test piece 10 and a receiving portion 61 into which the test piece 10 is inserted. The place seen from above and from the side is schematically shown.

This main body 50H is different from the basic main body 50A in that a recess forming member 91 as an action portion and a slide switch mechanism 93 are provided inside the receiving portion 61 in place of the wedge-shaped member 71. Yes.

The depression forming member 91 is a conical member provided in this example, in order to form a depression in the insertion portion of the test piece 10 inserted into the receiving portion 61. The recess forming member 91 is attached to an end portion 98e of a later-described action arm 98 with the tip thereof downward, that is, toward the receiving portion 61.

The slide switch mechanism 93 includes an outer cylinder portion 94 provided so as to be slidable with respect to the receiving portion 61, and a hook portion 95 provided continuously to the back side (right side in FIG. 20B) of the outer cylinder portion 94. , A swing shaft 97 supported by the main body 50H, an action arm 98 and an engagement arm 99 integrally attached to the swing shaft 97, and

coil springs

92 and 96 are included.

The outer cylinder portion 94 has an upper plate portion 94 a, a lower plate portion 94 b, and side plate portions 94 c and 9 cd and is a substantially rectangular tube-shaped member that surrounds the receiving portion 61, and can slide relative to the receiving portion 61. Is provided. A projection 94f that protrudes into the receiving portion 61 is provided through an opening 61w provided in the lower wall 61b of the receiving portion 61 at the inner end of the lower plate portion 94b of the outer cylindrical portion 94. When the test piece 10 is inserted into the receiving portion 61, the end portion 11f of the test piece 10 comes into contact with the protrusion 94f and pushes the outer cylinder portion 94. Thereby, the outer cylinder part 94 slides to the back side relatively with respect to the receiving part 61.

The hook portion 95 includes a horizontal portion 95a that extends horizontally from the back side of the outer cylinder portion 94, a vertical portion 95b that extends upward from an end on the back side of the horizontal portion 95a, and the vertical portion 95b. And a return portion 95c extending from the upper end to the inlet side (left side in FIG. 20B).

The engagement arm 99 includes a vertical portion 99a extending downward from the swing shaft 97 and an engagement portion 99b extending from the lower end of the vertical portion 99a to the back side (right side in FIG. 20B). It is out. In a state where the test piece 10 is not inserted into the receiving portion 61, the engaging portion 99 b is in contact with and overlaps with the lower portion 95 c of the hook portion 95.

The oscillating shaft 97 is provided at a position on the back side of the receiving portion 61 and extends in a direction intersecting the insertion direction of the test piece 10. The swing shaft 97 is supported by

side walls

50c and 50d provided in the main body 50H so as to be swingable around its center.

The action arm 98 includes a horizontal portion 98a that extends substantially horizontally through the swing shaft 97, an inclined portion 98b that extends obliquely from the left end (in FIG. 20B) of the horizontal portion 98a, and a horizontal portion. A vertical portion 98c extending upward from the right end of 98a (in FIG. 20B).

As described above, the recess forming member 91 is attached to the lower surface of the end portion 98e (left end in FIG. 20B) 98e of the inclined portion 98b with the front end facing downward.

The upper end 98f of the vertical portion 98c protrudes outside the main body 50H through an opening 82 provided in the main body 50H.

The coil spring 92 is provided to urge the recess forming member 91 toward the insertion portion of the test piece 10. The coil spring 92 is provided so as to extend in a substantially vertical direction between the end 98e of the action arm 98 and the upper wall 50a provided on the main body 50H (opposing the lower wall 50b). . In a state where the test piece 10 is not inserted into the receiving portion 61, the coil spring 92 is compressed and biases the end portion 98 e of the working arm 98 downward. However, in a state where the test piece 10 is not inserted into the receiving portion 61, the engaging portion 99 b of the engaging arm 99 is locked by the return portion 95 c of the hook portion 95. Does not rotate with the swing shaft 97.

The coil spring 96 is provided so as to extend in a substantially horizontal direction between the vertical portion 95b of the hook portion 95 and the back wall 50f provided in the main body 50H. In a state where the test piece 10 is not inserted into the receiving portion 61, the coil spring 96 is generally in an uncompressed state.

In the main body 50H, the guide path 80 is omitted as compared with the basic main body 50A. Other configurations of the main body 50H are the same as the basic configuration of the main body 50A.

FIG. 21 (A) shows a state before the test piece 10 is inserted into the receiving portion 61 of the main body 50H. As shown in FIG. 21B, the test piece 10 is inserted into the receiving portion 61 in a state where the body fluid of the subject is not attached to the test piece 10 (the sensor unit 15 thereof). As the test piece 10 is inserted into the receiving portion 61, the end portion 11 f in the insertion direction of the test piece 10 contacts the protrusion 94 f and pushes the outer cylinder portion 94. Thereby, the outer cylinder part 94 slides in the back side relative to the receiving part 61 against the urging force of the coil spring 96 together with the hook part 95.

As shown in FIG. 22 (A), when the test piece 10 is inserted in a certain position in the receiving portion 61, in this example, until the end portion 11f of the test piece 10 comes into contact with the rear wall 61f of the receiving portion 61, the hook 10 The return portion 95 c of the portion 95 is separated from the engagement portion 99 b of the engagement arm 99. As a result, as shown in FIG. 22B, the engaging arm 99 and the action arm 98 rotate counterclockwise (in FIG. 22B) together with the swing shaft 97 by the biasing force of the coil spring 92. Permissible. Thereby, the recess forming member 91 is deformed or broken by forming the recess 90 in the insertion portion of the test piece 10 inserted into the receiving portion 61, in this example, the upper surface 18a of the cover sheet 18. In this configuration example, since the recess forming member 91 is biased by the coil spring 92 as the biasing member, a relatively deep recess 90 can be formed on the upper surface 18a of the cover sheet 18.

When the test piece 10 is inserted until the end portion 11f of the test piece 10 comes into contact with the inner wall 61f of the receiving portion 61, the

electrode terminals

12f and 13f of the working electrode 12 and the counter electrode 13 on the substrate 11 are detected correspondingly to the main body 50H. The

contact contacts

62 and 63 are contacted. In this state, the body fluid of the subject is attached to the test piece 10 and comes into contact with the sensor unit 15. Then, the concentration measurement is performed in the same manner as in the previous example.

When the concentration measurement is completed and the user removes the test piece 10 from the main body 50H, as shown by an arrow C in FIG. The upper end 98f of the part 98c is pushed so as to be pushed into the main body 50H. Then, as shown in FIG. 23B, the engagement arm 99 and the action arm 98 rotate clockwise together with the swing shaft 97 (in FIG. 23B), and the engagement portion 99b of the engagement arm 99 is rotated. Moves below the return portion 95c of the hook portion 95. In this state, as shown in FIGS. 24A and 24B, the test piece 10 is pulled out from the receiving portion 61. Then, the outer cylindrical portion 94 slides toward the inlet side relative to the receiving portion 61 by the urging force of the coil spring 96 together with the hook portion 95. Thereby, it returns to the state before insertion as shown in FIG.

In the test piece 10 thus removed from the main body 50H, as shown in FIG. 25A (viewed from above) and FIG. 25B (viewed from the side), Of these, an inverted conical depression 90 is formed in the insertion portion inserted into the receiving portion 61, in this example, the upper surface 18a of the cover sheet 18, and is irreversibly deformed or destroyed. Moreover, in this configuration example, the location where the recess 90 is formed is a location away from the end portion 11 f of the test piece 10 by adjusting the position where the recess formation member 91 descends according to the length of the action arm 98 ( In this example, the upper surface 18a) of the cover sheet 18 can be set. Therefore, it can be shown to the user in an easy-to-understand manner whether or not the test piece 10 has been used.

26 (A) and 26 (B) respectively show a modified main body (indicated by reference numeral 50I) having a general test piece 10 and a receiving portion 61 into which the test piece 10 is inserted. The view from the side is shown schematically.

This main body 50I is different from the basic main body 50A in that an ink adhering member 76 as an action portion is provided inside the receiving portion 61 in place of the wedge-shaped member 71. The ink adhering member 76 is composed of a roller-shaped ink penetrating mark having a rotating shaft 75. The rotation shaft 75 is disposed along the upper wall 61 a in the vicinity of the entrance of the receiving portion 61, and extends in a direction intersecting the insertion direction of the test piece 10. The rotating shaft 75 is supported by the main body 50I so as to be rotatable around its own center. In this example, the radius of the ink adhering member 76 is set to a dimension that does not exceed the thickness of the cover sheet 18. The axial dimension of the ink adhering member 76 is set to be smaller than the dimension of the gap between the working electrode 12 and the counter electrode 13. In this example, the ink penetrating mark as the ink adhering member 76 is a member that enables ink adhering without vermilion or a stamp stand by infiltrating vermilion ink inside the porous rubber.

In the main body 50I, the guide path 80 is omitted as compared with the basic main body 50A. Other configurations of the main body 50I are the same as the basic configuration of the main body 50A.

As shown in FIG. 27A (viewed from above) and FIG. 27B (viewed from the side), the portion including the

electrode terminals

12f and 13f of the test piece 10 is inserted into the receiving portion 61. Accordingly, the ink adhering member 76 adheres to the insertion portion of the test piece 10 inserted into the receiving portion 61, in this example, the upper surface 18 a of the cover sheet 18 while being driven to rotate and adheres the ink 77. Change color. When the test piece 10 is inserted until the end portion 11f of the test piece 10 contacts the inner wall 61f of the receiving portion 61, the

respective electrode terminals

12f and 13f of the working electrode 12 and the counter electrode 13 on the substrate 11 are detected correspondingly to the main body 50I. The

contact contacts

62 and 63 are contacted.

When the concentration measurement is completed and the user removes the test piece 10 from the main body 50I, as shown in FIG. 28 (A) (viewed from above) and FIG. 28 (B) (viewed from the side), the test is performed. The ink 77 is attached to the insertion portion of the piece 10 inserted into the receiving portion 61, in this example, the upper surface 18 a of the cover sheet 18, and is irreversibly discolored. Therefore, whether or not the test piece 10 has been used can be shown more simply and easily for the user. In addition, in this configuration example, the location where the ink 77 is adhered is a location away from the end portion 11f of the test piece 10 by adjusting the position and size of the ink adhesion member 76 (in this example, the location of the cover sheet 18). The upper surface 18a) can be set. Therefore, it can be shown to the user in an easy-to-understand manner whether or not the test piece 10 has been used.

The above embodiments are merely examples, and various modifications can be made without departing from the scope of the present invention. Various characteristics of the above-described test piece and various characteristics of the main body may be combined.

In the above example, the description has been given mainly focusing on the test piece for measuring blood glucose (glucose) in the blood as a specific component in the body fluid, but the present invention is not limited to this. By appropriately selecting the reagent layer of the sensor unit 15 from known materials, the concentration of cholesterol and lactic acid in blood can also be measured.

In the above example, the biological component measuring apparatus 1 is configured as a stand-alone apparatus, but is not limited thereto. The main body may have a communication unit. This communication unit transmits information representing a measurement result (such as blood glucose level in blood) by the CPU 53 to an external device via a network, or receives information from an external device via a network for control. I pass it to the department. Thereby, for example, it becomes possible for the subject to receive doctor's advice or the like via the network. Communication via this network may be either wireless or wired.

DESCRIPTION OF SYMBOLS 1 Biological

component measuring device

10, 10A, 10B, 10C, 10D, 10E Test piece 11 Board | substrate 12 Working electrode 13

Counter electrode

12f, 13f Electrode terminal 15

Reaction part

40A, 40B Resistance

part 40C Mark

50, 50A, 50B, 50C, ..., 50I Main body 61 Receiving

portion

62, 63 Contact for detection 71 Wedge member 72 Cutting member 76

Ink adhering member

80, 81 Guide path 91 Depression forming member 93 Slide switch mechanism

Claims

In order to measure the concentration of a specific component in a body fluid of a subject, a measuring apparatus body to which a test piece to which the body fluid is attached is attached,
The test piece is
A substrate,
A working electrode and a counter electrode extending apart from each other on the substrate, each of the working electrode and the counter electrode having an electrode terminal;
On the substrate, provided between the working electrode and the counter electrode, a sensor unit that causes an electrochemical reaction by a body fluid of a subject to cause a change in electrical characteristics,
The measuring device body is
A receiving portion into which at least a portion including the electrode terminal of the test piece is to be inserted;
A contact for detection to be brought into contact with the electrode terminal of the working electrode and the counter electrode,
A measurement unit that receives the output of the sensor unit via the electrode terminal and the detection contact, and measures the concentration of the specific component in the body fluid;
A measuring apparatus main body comprising an action part for irreversibly deforming, destroying, or discoloring an insertion part inserted into the receiving part of the test piece.
In the measuring apparatus main body according to claim 1,
The test piece spans between a spacer that forms opposite sidewalls on the substrate and the opposite sidewalls of the spacer so as to regulate the amount of body fluid that contacts the sensor unit on the substrate. And a flat cover that covers the sensor unit,
The working portion peels and deforms the insertion portion inserted into the receiving portion of the cover from the spacer as the portion including the electrode terminal of the test piece is inserted into the receiving portion. A measuring apparatus main body having a wedge-shaped member.
In the measuring apparatus main body according to claim 2,
The cover of the test piece has an end surface in the insertion direction inserted into the receiving portion inclined in a reverse taper with respect to the substrate,
The measuring apparatus main body characterized in that the wedge-shaped member of the action part abuts on the end face of the cover inserted into the receiving part, and the insertion part of the cover is peeled off from the spacer.
The measuring apparatus main body according to claim 3, further comprising:
In the spacer of the test piece, the end surface in the insertion direction inserted into the receiving portion is inclined forwardly with respect to the substrate,
The measuring apparatus main body, wherein the wedge-shaped member of the action part abuts in the vicinity of an interface between the cover of the test piece and the spacer in the thickness direction of the test piece.
In the measuring apparatus main body according to claim 2,
The cover of the test piece has a substantially semi-conical shape on the end surface in the insertion direction to be inserted into the receiving portion, the inner diameter gradually decreases toward the side opposite to the insertion direction, and is open to the spacer. Has a hole with a form,
The measuring apparatus main body, wherein the wedge-shaped member of the action part has a substantially semi-conical protrusion directed to the inlet of the receiving part corresponding to the hole of the cover.
In the measuring apparatus main body according to claim 2,
A measuring apparatus main body comprising a guide path for guiding a portion of the cover peeled off by the wedge-shaped member in a direction inclined with respect to the insertion direction of the test piece.
In the measuring device main body according to claim 6,
A resistance portion having electrical resistance representing attribute information including sensitivity of the test piece is provided on an inner surface or an outer surface of a portion of the cover of the test piece to be peeled off by the wedge-shaped member. Has a calibration terminal,
The guide path is provided with a calibration contact to be brought into contact with the pair of calibration terminals of the resistance unit,
A first attribute information recognition unit that acquires the electrical resistance of the resistance unit of the test piece via the pair of calibration terminals and the calibration contact and recognizes the attribute information,
The measurement device main body, wherein the measurement unit calculates a concentration of a specific component in the body fluid based on the attribute information in addition to the electrical characteristics of the sensor unit.
In the measuring device main body according to claim 6,
A mark representing attribute information including sensitivity of the test piece is provided on an inner surface or an outer surface of a portion of the cover of the test piece to be peeled off by the wedge-shaped member,
An optical reading unit for optically reading the mark is provided facing the guide path,
A second attribute information recognition unit for recognizing the attribute information based on the output of the optical reading unit;
The measurement device main body, wherein the measurement unit calculates a concentration of a specific component in the body fluid based on the attribute information in addition to the electrical characteristics of the sensor unit.
In the measuring device main body according to any one of claims 6 to 8,
The end of the guide path is open toward the outside of the measuring device body,
A measuring apparatus main body, wherein a tip of an insertion portion inserted into the receiving portion of the cover of the test piece protrudes outside the measuring apparatus main body through the guide path.
In the measuring apparatus main body according to claim 2,
The test piece spans between a spacer that forms opposite sidewalls on the substrate and the opposite sidewalls of the spacer so as to regulate the amount of body fluid that contacts the sensor unit on the substrate. And a flat cover that covers the sensor unit,
The spacer and / or cover of the test piece covers the electrode terminal;
The wedge-shaped member of the action portion is in contact with the end surface of the spacer and / or cover to be inserted into the receiving portion, and separates the insertion portion of the spacer and / or cover from the substrate. Measuring device body.
In the measuring apparatus main body according to claim 1,
The action portion breaks by forming a cut in the insertion portion of the test piece inserted into the receiving portion as the portion including the electrode terminal of the test piece is inserted into the receiving portion. A measuring apparatus main body having a cutting member.
In the measuring apparatus main body according to claim 1,
The measuring device main body, wherein the action portion has a dent forming member that forms a dent in an insertion portion inserted into the receiving portion of the test piece and deforms or destroys the dent.
The measuring apparatus main body according to claim 12, further comprising:
And a slide switch mechanism that allows the recess forming member to move toward the insertion portion of the test piece when the test piece is inserted into the receiving portion to a certain position. The device body.
In the measuring apparatus main body according to claim 1,
The measuring device main body, wherein the action part has an ink attaching member that attaches ink to the insertion part inserted into the receiving part of the test piece and changes the color.
In the measuring device main body according to claim 14,
The ink adhering member is composed of a roller-shaped ink penetrating mark having a rotation axis intersecting with the insertion direction of the test piece, and is in contact with rotation while being driven by an insertion portion inserted into the receiving portion of the test piece. Then, the measuring device main body is characterized by adhering ink.
In order to measure the concentration of a specific component in a body fluid of a subject, a test piece for measuring a biological component that is attached to a receiving portion of a measurement apparatus body and to which the body fluid is attached,
A substrate,
A working electrode and a counter electrode extending apart from each other are provided on the substrate, and each of the working electrode and the counter electrode has an electrode terminal to be in contact with a contact for detection provided in the receiving portion,
A sensor unit that is formed between the working electrode and the counter electrode on the substrate and causes an electrochemical reaction by a body fluid of a subject to cause a change in electrical characteristics;
In order to regulate the amount of body fluid in contact with the sensor unit on the substrate, the sensor unit is formed on the substrate so as to straddle between the side walls facing each other and the side walls facing each other. With a flat cover to cover,
The end surface of the cover inserted in the receiving portion is inclined in a reverse taper with respect to the substrate, and when inserted into the receiving portion, the end surface of the cover contacts the inside of the receiving portion. The test piece is characterized in that the inserted portion of the cover peels off from the spacer and deforms irreversibly.
The test piece according to claim 16, wherein
The test piece, wherein an end surface of the spacer inserted in the receiving portion in the insertion direction is inclined forwardly with respect to the substrate.
In order to measure the concentration of a specific component in a body fluid of a subject, a test piece for measuring a biological component that is attached to a receiving portion of a measurement apparatus body and to which the body fluid is attached,
A substrate,
A working electrode and a counter electrode extending apart from each other are provided on the substrate, and each of the working electrode and the counter electrode has an electrode terminal to be in contact with a contact for detection provided in the receiving portion,
A sensor unit that is formed between the working electrode and the counter electrode on the substrate and causes an electrochemical reaction by a body fluid of a subject to cause a change in electrical characteristics;
In order to regulate the amount of body fluid in contact with the sensor unit on the substrate, the sensor unit is formed on the substrate so as to straddle between the side walls facing each other and the side walls facing each other. With a flat cover to cover,
When the spacer and / or cover covers the electrode terminal, and the end surface in the insertion direction inserted into the receiving part of the spacer and / or cover covering the electrode terminal is inserted into the receiving part A test piece, wherein the inserted portion of the spacer and / or cover is peeled off from the substrate and irreversibly deforms in contact with the inside of the receiving portion.
A living body that includes a test piece to which a body fluid is attached in order to measure the concentration of a specific component in a body fluid of a subject, and a measuring device body to which the test piece is attached, and that measures the concentration of the specific component in the body fluid of the subject A component measuring device comprising:
The test piece is
A substrate,
A working electrode and a counter electrode extending apart from each other on the substrate, each of the working electrode and the counter electrode having an electrode terminal;
On the substrate, provided between the working electrode and the counter electrode, a sensor unit that causes an electrochemical reaction by a body fluid of a subject to cause a change in electrical characteristics,
The measuring device body is
A receiving portion into which at least a portion including the electrode terminal of the test piece is to be inserted;
A contact for detection to be brought into contact with the electrode terminal of the working electrode and the counter electrode,
A measurement unit that receives the output of the sensor unit via the electrode terminal and the detection contact, and measures the concentration of the specific component in the body fluid;
A biological component measuring apparatus comprising an action part for irreversibly deforming, destroying, or discoloring an insertion part inserted into the receiving part of the test piece.