JP2009112416A - Puncture device, puncture device with biosensor and biosensor measuring apparatus - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a puncture device, a puncture device with a biosensor and a biosensor measuring apparatus which can easily performing a measurement processing with a simple structure. <P>SOLUTION: The puncture device 1 comprises: a holder part 3 having a mounting chamber 37 where a biosensor chip 11 is mounted; a sucker part 5 provided on one surface of the holder part 3 to be stuck to a subject; a puncture part 7 provided on the other surface of the holder part 3, for moving a puncture implement N inside a volume variable cavity 41 communicated with the mounting chamber 37 in a direction vertical to the surface of the biosensor chip 11, making it pass through the mounting chamber 37 and projecting it from the sucker part 5; and a backflow preventing valve 9 provided in the holder part 3, for blocking external air inflow by the negative pressure of the mounting chamber 37 and making internal air outflow by the positive pressure of the mounting chamber 37 possible. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a puncture device, a puncture device with a biosensor, and a biosensor measurement device.

Conventionally, a biosensor in which a biosensor chip and a lancet are integrated has been disclosed (see, for example, Patent Document 1).
FIG. 7A is a perspective view of the biosensor described in Patent Document 1, and FIG. 7B is an exploded perspective view of the biosensor.

  As shown in FIG. 7, the lancet-integrated sensor 100 includes a chip body 101, a lancet 103, and a protective cover 105. The chip body 101 has a cover 101a and a substrate 101b that can be opened and closed, and an internal space 102 is formed on the inner surface of the cover 101a. The internal space 102 has a shape that can accommodate the lancet 103 in a movable manner.

  The needle 104 provided at the tip of the lancet 103 can be moved in and out from an opening 102 a formed at the front end of the internal space 102 of the chip body 101 as the lancet 103 moves.

  The shape of the internal space 101a is curved so that the width of the inner space 101a is slightly narrower than that of the lancet 103 at the end where the protrusion 103a is located, and the lancet 103 is locked to the chip body 101 by the mutual pressing force and frictional force. It is like that.

The protective cover 105 has a tube part 105 a into which the needle 104 is inserted, and the tube part 105 a can be accommodated inside the chip body 101 as the needle 104 moves.
Therefore, in a state before use, the protective cover 105 is put on the needle 104 to protect the needle 104 and prevent the user from being accidentally injured. Note that the substrate 101b is provided with a pair of electrode terminals 106 so that it can be electrically connected to a measuring apparatus (not shown).

  In use, the protective cover 105 is removed and the lancet 103 is pushed to cause the needle 104 to protrude from the chip body 101. After puncturing the subject in this state, the needle 104 is housed inside the chip body 101, and the opening 102a provided at the front end of the chip body 101 is brought close to the puncture port to collect the outflowed blood.

WO02-056769

  However, the lancet-integrated sensor 100 described in Patent Document 1 is integrated by incorporating the lancet 103 inside the chip body 101, but strictly speaking, the chip body 101 and the lancet 103 have a separate structure. The lancet 103 can move with respect to the chip body 101. For this reason, the structure is complicated, the manufacturing is troublesome, and there is an inconvenience that the size of the sensor 100 is increased and the manufacturing cost is increased.

Further, in the conventional lancet-integrated sensor 100, the lancet 103 is pushed and the subject is punctured by the protruding needle 104, and then the needle 104 is housed inside the chip body 101, and the opening 102a at the front end of the chip is inserted into the puncture port. Therefore, it is necessary to collect the spilled blood, and puncture, needle storage and collection must be performed separately. For this reason, when measuring several times a day, there existed a problem which a work became complicated and lacked convenience.
Furthermore, in blood sampling measurement using a conventional sensor integrated with a lancet, it is desirable to provide a decompression-type blood collection assisting mechanism in order to improve the measurement success probability. However, if an airtight chamber or a decompression pump is provided, the structure becomes complicated. The manufacturing is troublesome and the manufacturing cost is increased due to the increase in size. Therefore, a biosensor-equipped puncture device having a simple structure and capable of collecting a sample with a simple operation has been demanded.
Accordingly, the present invention has been made in view of the above circumstances, and it is an object of the present invention to provide a puncture device, a puncture device with a biosensor, and a biosensor measurement device that can perform measurement with a simple structure.

The object of the present invention is to provide a holder portion having a mounting chamber in which a biosensor chip is mounted;
A suction cup provided on one surface of the holder part and in close contact with the subject;
The sucker unit is provided on the other surface of the holder unit and moves a puncture device in a variable volume cavity communicating with the mounting chamber in a direction perpendicular to the surface of the biosensor chip, penetrating through the mounting chamber. A puncture part to protrude from,
A backflow prevention valve that is provided in the holder portion and prevents an outside air inflow due to a negative pressure in the mounting chamber, while allowing an internal air outflow due to a positive pressure in the mounting chamber;
This is achieved by a puncture device characterized by comprising:

  According to the puncture device having the above-described configuration, the puncture device in the variable volume cavity is moved in the direction opposite to the moving direction by the puncture portion in a state where the suction cup portion is pressed against the subject, and is arranged at the puncture preparation position. Then, a negative pressure is generated by the volume in the volume variable cavity increased by the movement, and the negative pressure acts on the suction cup part through the mounting chamber, and the suction cup part comes into close contact with the subject.

The puncture device moved to the puncture preparation position is moved by the puncture portion in a direction perpendicular to the surface of the biosensor chip, penetrates the mounting chamber, protrudes from the suction cup portion, and puncture is performed.
At this time, the air in the variable volume cavity and the mounting chamber that have become positive pressure flows out from the backflow prevention valve. When the volume variable cavity contracted by flowing out the internal air tries to return to the original volume by the restoring force, the backflow prevention valve is closed, and the volume variable cavity becomes negative pressure. This negative pressure acts on the puncture port of the subject through the mounting chamber and the suction cup, and the sample that has flowed out is sucked into the mounting chamber. Therefore, only by moving the puncture device of the puncture device to the puncture preparation position and operating the puncture section, it is possible to perform puncture and sample suction.

  In the puncture device having the above-described configuration, it is preferable that the puncture portion is constituted by an elastic wall that forms the variable volume cavity.

  According to the puncture device having such a configuration, the variable volume cavity including the puncture device can be formed while ensuring airtightness, and the variable volume cavity can be expanded and contracted to prevent generation of puncture driving force during expansion and contraction. Generation of the sample suction negative pressure at the time of restoration can be realized with a simple structure only by the elastic force of the elastic wall without using other members. Moreover, the suction force of blood collection can also be changed by changing the stretchability of the elastic wall.

  In the puncture device having the above-described configuration, it is desirable that the holder portion, the suction cup portion, and the puncture portion are integrally formed of a soft material.

  According to the puncture device having such a configuration, since the holder portion, the suction cup portion, and the puncture portion are integrally formed of a single material, the production can be facilitated and the production cost can be reduced, and the puncture portion and the holder The inside of the part and the suction cup part can be formed with one continuous airtight structure. In addition, the adhesion of the suction cup portion to the subject can be enhanced, and negative pressure can be reliably applied to the puncture opening.

Further, the object of the present invention is a biosensor-equipped puncture device having any one of the puncture devices described above and a biosensor chip attached to the holder portion,
The biosensor chip is
Two electrically insulating substrates facing each other with a spacer layer interposed therebetween;
Two detection electrodes provided on the surface on the spacer layer side of at least one of the substrates;
A hollow reaction part formed in the opposing part of the two detection electrodes between the two substrates;
A sampling port through which the puncture device penetrates in communication with the hollow reaction part;
A reagent provided in the vicinity of the detection electrode in the hollow reaction part;
This is achieved by a biosensor-equipped puncture device.

According to the biosensor-equipped puncture device having the above-described configuration, when puncture is performed by the puncture device, the negative pressure in the variable volume cavity acts on the puncture port, and the outflowed sample is sucked into the mounting chamber. The sample enters the sample collection port of the attached biosensor chip by capillary action.
When the sample entering the sample collection port comes into contact with the reagent, the reagent is dissolved by the sample, and the enzyme reaction is started. As a result of starting the enzyme reaction, the electron carrier is accumulated, and the electron carrier accumulated for a certain period of time is oxidized by an electrochemical reaction. Therefore, only by moving the puncture device of the puncture device to the puncture preparation position and operating the puncture section, it is possible to perform puncture, sample aspiration, and electrochemical reaction of the aspirated sample.

In addition, the object of the present invention is a biosensor measurement device having the biosensor-attached puncture device and a measurement device connected to the biosensor chip,
The measuring instrument is
A control unit for measuring an electrical value of the biosensor chip mounted on the holder unit;
A switch for measurement connected to the control unit;
A display unit connected to the control unit and displaying the measured value;
A memory unit connected to the control unit for storing measurement values;
It is achieved by a biosensor measuring device characterized by comprising:

  According to the biosensor measurement device having the above configuration, when the puncture is performed by the puncture instrument and the sample that has flowed out is sucked into the mounting chamber by the negative pressure in the variable volume cavity, the biosensor mounted in the mounting chamber Chip reagents are dissolved by the sample. Enzymatic reaction is started by this dissolution, and the electron carrier accumulated for a certain time is oxidized by electrochemical reaction. The control unit calculates and determines the substrate concentration based on the current value from the detection electrode measured at this time, and displays it on the display unit. Therefore, by simply moving the puncture device of the puncture device to the puncture preparation position and operating the puncture section, the puncture, sample aspiration, electrochemical reaction of the aspirated sample, calculation / determination of the detection value based on the reaction, and display are performed. It becomes possible.

  According to the puncture device, the puncture device with biosensor and the biosensor measurement device according to the present invention, the puncture, sample suction, etc. can be performed only by moving the puncture device of the puncture device to the puncture preparation position and operating the puncture unit. It becomes possible, and puncture and measurement can be easily performed with a simple structure.

Hereinafter, a puncture device, a puncture device with a biosensor, and a biosensor measurement device according to an embodiment of the present invention will be described in detail with reference to the accompanying drawings.
The embodiment disclosed this time should be considered as illustrative in all points and not restrictive. The scope of the present invention is defined by the terms of the claims, rather than the meanings described below, and is intended to include any modifications within the scope and meaning equivalent to the terms of the claims.

FIG. 1 is an external view showing a puncture device and a biosensor chip according to an embodiment of the present invention.
As shown in FIG. 1, the puncture device 1 according to the present embodiment includes main components roughly divided into a holder portion 3, a suction cup portion 5, a puncture portion 7, and a backflow prevention valve 9.
The puncture device 1 can attach the biosensor chip 11 formed in a plate shape to the holder portion 3. The puncture device 1 is punctured by moving a puncture device N (see FIG. 4), which will be described later, in a direction perpendicular to the surface of the attached biosensor chip 11.

  As will be described later, the puncture device 1 is equipped with a biosensor chip 11 to constitute a biosensor-equipped puncture device 13 (see FIG. 4). Furthermore, this biosensor-equipped puncture device 13 can constitute a biosensor measurement device 17 by connecting a measuring device 15 (see FIG. 5) to the biosensor chip 11.

First, the biosensor chip 11 will be described.
FIG. 2 is a configuration diagram in which a plan view of the biosensor chip mounted on the puncture device shown in FIG. 1 is (A), a cross section taken along the line AA is represented by (B), and a cross section taken along the line BB is represented by (C). FIG. 3 is an exploded plan view of the biosensor chip shown in FIG.

2 and 3, the biosensor chip 11 has two substrates 19a and 19b facing each other and a spacer layer 21 sandwiched between the two substrates 19a and 19b. Yes.
Two detection electrodes 23a and 23b are provided on the surface on the spacer layer 21 side of at least one of the two substrates 19a and 19b, and the tip portions (upper ends in FIG. 2) face each other. It is bent in an L shape in the direction to maintain a predetermined interval.

At the rear end portion 11a of the biosensor chip 11, the substrate 19a extends beyond the substrate 19b and the spacer layer 21, and the detection electrodes 23a and 23b are exposed on the substrate 19a.
The detection electrodes 23a and 23b may be a two-pole method formed with a working electrode and a counter electrode, a three-pole method formed with a working electrode and a counter electrode, or a reference electrode, or an electrode method with more poles. Here, when the tripolar method is adopted, in addition to the electrochemical measurement of the measurement target substance, when measuring blood as a sample, it is possible to measure the moving speed of the introduced blood sample, thereby measuring the hematocrit value. . Moreover, you may be comprised by 2 or more sets of electrode systems.

Further, a hollow reaction portion 25 is formed by the two substrates 19 a and 19 b and the spacer layer 21 from the tip of the biosensor chip 11 to a portion where the two detection electrodes 23 a and 23 b face each other.
The spacer layer 21 is formed by laminating an adhesive layer 27 and a resist layer 29. The spacer layer 21 and the adhesive layer 27 can be formed by a screen printing method. As the adhesive layer 27, for example, an acrylic resin adhesive is used, and it is formed with a thickness of about 5 to 500 μm, preferably about 10 to 100 μm. The adhesive layer 27 also functions as a spacer. Further, a reagent may be contained in the adhesive layer 27.

On the distal end side of the substrate 19a, a sample collection port 31 communicating with the hollow reaction portion 25 and penetrating a puncture device N (see FIG. 4) described later is formed. The substrate 19b is provided with a through hole 33 that communicates with the hollow reaction portion 25 and is coaxial with the sample collection port 31 and allows the puncture instrument N to pass therethrough.
In the adhesive layer 27 and the resist layer 29, elongated holes 27a and 29a for forming the hollow reaction portion 25 are formed. The opening hole 35 of the substrate 19b communicates with the hollow reaction part 25.

In the hollow reaction part 25, the detection electrodes 23a and 23b are exposed, and, for example, an enzyme and a mediator are fixed immediately above or in the vicinity of the detection electrodes 23a and 23b in the hollow reaction part 25 (for example, components in the sample (for example, A reagent (not shown) that generates an electric current by reacting with glucose in blood) is provided. Accordingly, the hollow reaction part 25 is a part where a sample such as blood collected from the sample collection port 29 undergoes a biochemical reaction with the reagent.
A surfactant or lipid can also be applied to the periphery of the sample collection port 31 and the hollow reaction part 25. By applying a surfactant or lipid, the sample can be moved smoothly.

  Examples of the reagent include enzymes such as glucose oxidase (GOD), glycolose dehydrogenase (GDH), cholesterol oxidase, and urigase, and electron acceptors such as potassium ferricyanide, ferrocene, and benzoquinone. When blood is used as a sample, the volume of the hollow reaction part 25 is preferably 1 μL (microliter) or less, particularly preferably 300 nL (nanoliter) or less, considering the blood collection burden of the subject. By using such a small hollow reaction part 25, a sufficient blood volume of the specimen can be collected even if the diameter of the puncture device N is small. The puncture device N preferably has a diameter of 1000 μm or less.

  As the material of the substrates 19a and 19b and the spacer layer 21, an insulating material film is selected. As the insulating material, ceramics, glass, paper, biodegradable material (for example, polylactic acid microorganism-producing polyester), poly Examples thereof include thermoplastic resins such as vinyl chloride, polypropylene, polystyrene, polycarbonate, acrylic resin, polybutylene terephthalate and polyethylene terephthalate (PET), thermosetting resins such as epoxy resins, and plastic materials such as UV curable resins. A plastic material such as polyethylene terephthalate is preferable because of its mechanical strength, flexibility, and ease of chip fabrication and processing. Representative PET resins include Melinex and Tetron (trade names, manufactured by Teijin DuPont Films, Inc.), Lumirror (trade names, manufactured by Toray Industries, Inc.), and the like.

FIG. 4 is a longitudinal sectional view of a biosensor-equipped puncture device in which a biosensor chip is mounted on the puncture device.
As described above, the puncture device 1 constitutes the puncture device with biosensor 13 by mounting the biosensor chip 11. Hereinafter, the puncture device 1 will be described as one component of the biosensor puncture device 13.

As shown in FIG. 4, the puncture device 1 is provided with a holder portion 3, and the holder portion 3 has a mounting chamber 37 in which the biosensor chip 11 is mounted.
A circular suction cup 5 is provided on one surface of the holder 3 (the lower surface in FIG. 4), and the concave curved surface 5 a of the suction cup 5 is in close contact with the subject M. A puncture hole 39 is opened at the center of the suction cup 5, and the puncture hole 39 communicates with the mounting chamber 37 and coincides with the sample collection port 31 of the biosensor chip 11 mounted in the mounting chamber 37.

The other surface (upper surface in FIG. 4) of the holder unit 3 is provided with an inverted conical puncture unit 7, and the puncture unit 7 has a variable volume cavity 41 inside. The variable volume cavity 41 communicates with the mounting chamber 37 via the communication port 41a. Inside the variable volume cavity 41, a puncture device N is suspended in the axial direction toward the communication port 41a.
Examples of the puncture device N include a hollow injection needle, a lancet needle, a cannula, and the like. In the present embodiment, a lancet needle is illustrated as an example of puncture device N. Further, since the puncture device N needs to be stored hygienically in the variable volume cavity 41 until it is used, the photocatalytic function effective for antibacterial and antiviral effects can be imparted to the needle surface. good. In that case, a film of titanium oxide or titanium dioxide is desirable.

  The puncture device N is moved in the vertical direction with respect to the biosensor chip 11 as the variable volume cavity 41 is deformed downward, penetrates the biosensor chip 11 in the mounting chamber 37, and the puncture hole of the suction cup portion 5 It protrudes from 39. That is, the puncture device N projects through the through hole 33, the hollow reaction part 25, the sample collection port 31, and the puncture hole 39. On the upper surface of the variable volume cavity 41, a gripping portion 43 that is pulled up by a finger or a driving means (not shown) protrudes.

  The puncture unit 7 of this embodiment is constituted by an elastic wall 45 that forms a variable volume cavity 41. Since the puncture portion 7 is constituted by the elastic wall 45, the variable volume cavity 41 including the puncture device N can be formed while ensuring airtightness, and the variable volume cavity 41 can be expanded and contracted, so that the puncture driving force when extended The generation of the sample and the generation of the sample suction negative pressure at the time of restoration from the contraction can be realized with a simple structure only by the elastic force of the elastic wall 45 without using other members. Further, by changing the stretchability of the elastic wall 45, the suction force of blood collection can also be changed.

Moreover, in the puncture device 1 of this embodiment, the holder part 3, the suction cup part 5, and the puncture part 7 are integrally molded with a soft material. Therefore, the manufacturing can be facilitated and the manufacturing cost can be reduced, and the inside of the puncture portion 7, the mounting chamber 37 and the suction cup portion 5 constituting the variable volume cavity 41 can be formed with one continuous airtight structure.
In addition, the adhesion of the suction cup part 5 to the subject M can be improved, and a negative pressure can be reliably applied to the puncture opening. The soft material is preferably a gel-like elastic material, a foamable material, etc., for example, a rubber composed of a polymer alone or a copolymerized polymer such as silicone, urethane, acrylic, ethylene, styrene, butadiene, acrylonitrile, propylene, chloroprene, or the like. Examples thereof include polyolefins such as sponge, polyethylene, and polypropylene, polyesters such as polyethylene terephthalate and polybutylene terephthalate, and fluorine resins such as polytetrafluoroethylene and PFA which is a copolymer of perfluoroalkoxyethylene and polyfluoroethylene.

  The holder portion 3 is provided with a backflow prevention valve 9. The backflow prevention valve 9 prevents inflow of outside air due to negative pressure in the mounting chamber 37, while allowing internal air outflow due to positive pressure in the mounting chamber 37. That is, it closes when the volume of the variable volume cavity 41 increases, and opens when the volume of the variable volume cavity 41 decreases.

  As a result, when the suction part 5 is pressed against the subject M and the grasping part 43 of the puncture part 7 is pulled up to increase the volume of the variable volume cavity 41, the backflow prevention valve 9 is closed and negative pressure is generated. To do. Note that the insertion opening of the biosensor chip 11 in the mounting chamber 37 hermetically seals the gap between the insertion opening and the biosensor chip 11 by a gasket (not shown) when the biosensor chip 11 is mounted. Thereby, the airtightness of the variable volume cavity 41 is ensured.

Next, the operation of the biosensor-equipped puncture device 13 will be described.
FIG. 5 is an operation explanatory view showing from puncture preparation to sample collection of the biosensor-equipped puncture device in (A) to (C).
The small biosensor-equipped puncture device 13 is, for example, a handy type that the user can hold with one hand, and can be used by the user himself. To use the biosensor-equipped puncture device 13, first, one biosensor chip 11 is prepared, and this biosensor chip 11 is inserted into the mounting chamber 37 of the holder unit 3.

Next, as shown in FIG. 5A, the suction cup portion 5 is pressed against the subject M, and the puncture portion 7 is moved, that is, the grasping portion 43 is pulled up.
When the puncture unit 7 is moved, the puncture device N in the variable volume cavity 41 is moved in the direction opposite to the direction of movement by the puncture unit 7 (upward in the figure), and reaches the puncture preparation position shown in FIG. When arranged, a negative pressure is generated by the volume in the volume variable cavity 41 increased by this movement, the negative pressure acts on the suction cup part 5 through the mounting chamber 37, and the suction cup part 5 is in close contact with the subject M.
Therefore, when the suction cup portion 5 is in close contact with the subject M, positional deviation is prevented, and the planned puncture position is punctured accurately. Moreover, the suction of the suction cup part 5 makes the skin of the puncture planned portion swelled and enables good puncture with little pain.

  When the holding of the grip portion 43 is released, the variable volume cavity 41 contracts as shown in FIG. 5B, and the puncture device N penetrates the mounting chamber 37 and protrudes from the suction cup portion 5, so that the puncture is performed. Done. At this time, the air in the variable volume cavity 41 and the mounting chamber 37 having positive pressure flows out from the backflow prevention valve 9 to the outside.

  When the volume-variable cavity 41 contracted by flowing out the internal air attempts to return to the original volume by the restoring force of the elastic wall, the backflow prevention valve 9 is closed as shown in FIG. Negative pressure. This negative pressure acts on the puncture port through the mounting chamber 37 and the suction cup 5, and the sample B that has flowed out is sucked into the sample collection port 31 of the biosensor chip 11 mounted in the mounting chamber 37.

  Further, in the biosensor-equipped puncture device 13 to which the biosensor chip 11 is attached, puncture is performed by the puncture unit 7, the negative pressure in the volume variable cavity 41 acts on the puncture port, and the sample B that has flowed out enters the attachment chamber 37. When sucked, the sample B enters the sample collection port 31 of the biosensor chip 11 mounted in the mounting chamber 37 by capillary action.

When the sample B entering the sample collection port 31 comes into contact with the reagent, the reagent is dissolved by the sample B, and an enzyme reaction is started. As a result of starting the enzyme reaction, potassium ferricyanide coexisting in the reaction layer is reduced, and potassium ferrocyanide, which is a reduced electron carrier, is accumulated. The amount is proportional to the substrate concentration, for example the glucose concentration in the blood. The reduced electron carrier accumulated for a certain time is oxidized by an electrochemical reaction.
Therefore, the biosensor-equipped puncture device 13 can perform puncture, sample aspiration, and electrochemical reaction of the aspirated sample simply by moving the puncture device N of the puncture device 1 to the puncture preparation position and operating the puncture unit 7. It becomes.

  According to the puncture device 1 of the present embodiment described above, the holder unit 3 having the mounting chamber 37 in which the puncture device N is moved in the direction perpendicular to the surface of the biosensor chip 11 and the biosensor chip 11 is mounted; The sucker part 5 provided on one surface of the holder part 3 and the puncture device N in the variable volume cavity 41 provided on the other surface of the holder part 3 and communicating with the mounting chamber 37 protrude from the sucker part 5. A simple structure is provided with the puncture unit 7 to be made and the backflow prevention valve 9 which is provided in the holder unit 3 and prevents the outside air inflow due to the negative pressure in the mounting chamber 37 while allowing the internal air outflow due to the positive pressure. Can be punctured easily.

  Moreover, according to the biosensor-provided puncture device 13 composed of the puncture device 1 and the biosensor chip 11, the two electrically insulating substrates 19a and 19b that are opposed to each other with the biosensor chip 11 sandwiching the spacer layer 21 therebetween. And two detection electrodes 23a and 23b provided on the surface of the spacer layer side of one substrate 19a, and the two detection electrodes 23a and 23b between the two electrically insulating substrates 19a and 19b. Since it is provided with the formed hollow reaction part 25, the sample collection port 31 that communicates with the hollow reaction part 25 and penetrates the puncture instrument N, and the reagent provided in the vicinity of the detection electrode of the hollow reaction part 25, In addition to puncture, the reaction between the effluent sample and the reagent can be easily performed with a simple structure.

Next, a biosensor measuring device 17 composed of the biosensor-equipped puncture device 13 and the measuring device 15 will be described.
FIG. 6 is a schematic configuration diagram of a biosensor measuring apparatus in which a measuring instrument is provided in the biosensor-equipped puncture device.
The biosensor-equipped puncture device 13 can be configured as a biosensor measurement device 17 by connecting a measuring device 15 to the biosensor chip 11 mounted on the holder unit 3, for example. The measuring device 15 is connected to the control unit 47 for measuring the electrical value of the biosensor chip 11 attached to the holder unit 3, the switch 49 for measurement connected to the control unit 47, and the control unit 47. Then, a display unit 51 that displays the measurement value, a memory unit 53 that is connected to the control unit 47 and stores the measurement value, and a power source 55 are provided, and these are electrically connected to each other.

The measuring instrument 15 is provided with a terminal insertion portion (not shown) that inserts and fixes the rear end portion 11a of the biosensor chip 11 and conducts the detection electrodes 23a and 23b to the control unit 47. . The reaction information between the sample B and the reagent detected by the detection electrodes 23a and 23b of the biosensor chip 11 is transmitted to the control unit 47 through the terminal insertion unit.
In the measuring instrument 15, the operation of the switch 49 causes the control unit 47 to read into the memory unit 53, and the history of accumulated measurement results is sequentially displayed from the past or sequentially close to the present to the display unit 51. It is displayed.

  A measurement method in the control unit 47 of the measuring instrument 15 is not particularly limited, but a potential step chronoamperometry method, a coulometry method, a cyclic voltammetry method, or the like can be used.

Next, blood glucose level measurement will be described as an example.
The biosensor chip 11 is provided in the hollow reaction part 25 using GOD or GDH enzyme and potassium ferricyanide as reagents. The measuring device 15 can also be equipped with various correction mechanisms. Important corrections in blood glucose measurement include temperature correction and hematocrit values. Temperature correction is often important especially when shortening the measurement time because the activity of the enzyme used for blood glucose measurement is easily affected by temperature. The hematocrit value is also a factor that affects blood glucose measurement. The measurement of the hematocrit value can be estimated from the moving speed of blood collection in the biosensor chip (blood glucose level sensor chip) 11, for example. As the means, for example, using three electrodes, the time when the blood collection has passed through the first two and the time when the third blood collection has been obtained are obtained, and the moving speed of the blood collection is calculated from the time difference and the distance between the electrodes. You can also.
In addition, it is necessary to suppress fluctuations in measured values due to differences in lots of biosensor chips 11. In that case, you may provide the function which can calibrate automatically for every lot.

  In the biosensor measurement device (blood glucose level sensor measurement device) 17 of the present embodiment, when the puncture is performed by the puncture unit 7 and the sample B that has flowed out is sucked into the mounting chamber 37 by the action of negative pressure, the mounting chamber 37. The reagent of the biosensor chip 11 attached to is dissolved by the sample B. An enzyme reaction is started by this dissolution, and the reduced electron carrier accumulated for a certain time is oxidized by an electrochemical reaction.

The control unit 47 calculates and determines the blood glucose level based on the current values from the detection electrodes 23a and 23b measured at this time, and displays the blood glucose level on the display unit 51.
Therefore, only by moving the puncture device N of the puncture device 1 to the puncture preparation position and operating the puncture unit 7, puncture, sample aspiration, electrochemical reaction of the aspirated sample, calculation and determination of glucose concentration (blood glucose level) , Display is possible.

  Thus, according to the biosensor measurement device 17 of the present embodiment, the biosensor puncture device 13 and the measurement device 15 are included, and the measurement device 15 measures the electrical value of the biosensor chip 11. 47, a switch 49 for measurement, a display unit 51 for displaying the measurement value, and a memory unit 53 for storing the measurement value, so that the puncture and the reaction between the sample B and the reagent can be performed with a simple structure. The calculation / determination and display of the detection value based on this can be easily performed. Particularly in diabetic patients, the blood glucose level needs to be measured several times a day, so that the effect is great.

It is an external view which shows the puncture device and biosensor chip which concern on one Embodiment of this invention. It is the block diagram which represented the planar view of the biosensor chip with which the puncture device shown in FIG. 1 was mounted | worn with (A), the AA cross section to (B), and the BB cross section to (C). FIG. 3 is an exploded plan view of the biosensor chip shown in FIG. 2. It is a longitudinal cross-sectional view of a biosensor-equipped puncture device in which a biosensor chip is attached to the puncture device. It is operation | movement explanatory drawing which represented from the puncture preparation of a biosensor puncture device to sample collection to (A)-(C). It is a schematic block diagram of the biosensor measuring apparatus which provided the measuring device in the puncture device with a biosensor. (A) is a perspective view which shows the conventional biosensor chip. (B) is an exploded perspective view showing a conventional biosensor chip.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Puncture device 3 ... Holder part 5 ... Suction cup part 7 ... Puncture part 9 ... Backflow prevention valve 11 ... Biosensor chip 13 ... Puncture device with a biosensor 15 ... Measuring device 17 ... Biosensor measuring device 19a, 19b ... Electrical insulation Substrate 21 ... spacer layer 23a, 23b ... detection electrode 25 ... hollow reaction part 31 ... sample sampling port 37 ... mounting chamber 41 ... volume variable cavity 45 ... elastic wall 47 ... control part 49 ... switch 51 ... display part 53 ... memory Part M ... Subject N ... Puncture device

Claims (5)

A holder having a mounting chamber in which a biosensor chip is mounted;
A suction cup provided on one surface of the holder part and in close contact with the subject;
The sucker unit is provided on the other surface of the holder unit and moves a puncture device in a variable volume cavity communicating with the mounting chamber in a direction perpendicular to the surface of the biosensor chip, penetrating through the mounting chamber. A puncture part to protrude from,
A backflow prevention valve that is provided in the holder portion and prevents an outside air inflow due to a negative pressure in the mounting chamber, while allowing an internal air outflow due to a positive pressure in the mounting chamber;
A puncture device comprising:   The puncture device according to claim 1, wherein the puncture portion is configured by an elastic wall that forms the variable volume cavity.   The puncture device according to claim 1 or 2, wherein the holder portion, the suction cup portion, and the puncture portion are integrally formed of a soft material. A puncture device with a biosensor comprising the puncture device according to any one of claims 1 to 3 and a biosensor chip mounted on the holder part,
The biosensor chip is
Two electrically insulating substrates facing each other with a spacer layer interposed therebetween;
Two detection electrodes provided on the surface on the spacer layer side of at least one of the substrates;
A hollow reaction part formed in the opposing part of the two detection electrodes between the two substrates;
A sampling port through which the puncture device penetrates in communication with the hollow reaction part;
A reagent provided in the vicinity of the detection electrode in the hollow reaction part;
A biosensor-equipped puncture device comprising: A biosensor measurement device comprising the biosensor-equipped puncture device according to claim 4 and a measurement device connected to the biosensor chip,
The measuring instrument is
A control unit for measuring an electrical value of the biosensor chip mounted on the holder unit;
A switch for measurement connected to the control unit;
A display unit connected to the control unit and displaying the measured value;
A memory unit connected to the control unit for storing measurement values;
A biosensor measurement apparatus comprising:

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