JP4822511B2 - Needle integrated biosensor - Google Patents

Description

  The present invention relates to a needle-integrated biosensor. More particularly, the present invention relates to a needle-integrated biosensor having a configuration in which a puncture needle for piercing the skin to obtain blood and a biosensor for collecting and analyzing body fluid taken on the surface of the skin are integrated.

Conventionally, a diabetic patient himself collects blood and measures a blood glucose level which is a glucose level in blood. In this case, the patient uses a blood collection device called a lancet that attaches and detaches a blood collection needle. is doing. In such a measurement method, the patient must carry a set of measuring instruments consisting of several points such as a blood glucose analyzer, a lancet, a blood collection needle and an analytical element, and combine them when necessary to perform the measurement. However, it takes a lot of training and it takes a considerable amount of time before the patient can make reliable measurements. Actually, measurements at parts other than the fingertips and forearms (abdominal wall, earlobe, etc.) are difficult even for an expert. In recent years, biosensors that can be measured with a sample volume of 1 μl or less have been developed due to the need for less invasive specimen supply with less pain. The work of supplying accurately becomes very difficult. As a result, the measurement fails, and the patient who is the subject has the inconvenience of having to puncture again and replacing the biosensor and restart the measurement.
Japanese Patent No. 3,621,502 Japanese Patent Publication No. 8-20412

Thus, several needle-integrated biosensors have been devised. First, in the needle-integrated biosensor disclosed in Patent Document 3, the puncture needle and the biosensor are placed in different positions in a pen-type (two-color ballpoint pen-like) measuring device equipped with a puncture needle drive unit. The blood glucose is measured by setting the tip of the pen-like measuring device to the skin of the subject and puncturing it, exposing the biosensor to the tip, and collecting blood. However, in this method, the troublesomeness of setting the needle and the biosensor in the measuring device has not been solved.
JP 2000-217804 A

In order to solve such inconvenience, in Patent Document 4, a puncture needle for collecting body fluid by piercing the skin of a subject and a sensor body for analyzing the collected body fluid are configured integrally. A needle-integrated sensor has been proposed in which a puncture needle is driven by an external driving means to pierce the skin. However, in the sensor described in the above document, the end opposite to the needle tip protrudes from the sensor main body, and the puncture needle is driven by engaging with an external driving means. When setting the biosensor to the measuring device, there is a possibility that the end opposite to the needle tip is accidentally pushed. In addition, in order to define the movement range of the puncture needle, it is necessary to form a recess that accommodates the protrusion integrated with the puncture needle inside the sensor, which causes a problem that the manufacturing process of the biosensor becomes complicated.
Republished 2002-056769

  An object of the present invention is that a puncture needle for collecting body fluid by piercing the skin of a subject and a sensor body for analyzing the collected body fluid are integrally configured, and the puncture needle is externally provided. A biosensor integrated with a needle that is driven by a driving means and pierces the skin. The puncture needle can be moved without malfunction by driving from the outside, and the configuration of the biosensor is simple and can be easily manufactured. To provide what can be done.

  It is an object of the present invention to integrate an electrode, a spacer, and a puncture needle for collecting blood by piercing the subject's skin with an external driving means between at least two electrically insulating substrates. In the biosensor, a puncture needle support is attached to the rear part of the puncture needle, and the puncture needle support passes through an electrically insulating substrate for transmitting external driving to the puncture needle support. The biosensor has a puncture needle support moving groove for projecting the tip of the needle from the inside of the sensor to the outside of the sensor, and an external drive connection to at least one substrate. This is achieved by a needle-integrated biosensor having a through hole required for movement of a part.

  The needle-integrated biosensor according to the present invention measures the biosensor because the puncture needle is moved by the external drive acting on the end of the external drive connection portion protruding on the electrically insulating substrate of the biosensor. The puncture needle can be prevented from malfunctioning when it is set in the device, and the puncture needle support moving groove in which the support attached to the puncture needle moves is formed together with the puncture needle drive track by the spacer. About the direction and range, the external drive connection unit end integrated with the puncture needle support is projected out of the biosensor from the through hole provided in the electrically insulating substrate, and is defined by this movable range, The structure is simple and the biosensor can be easily manufactured.

  The puncture needle is used for collecting body fluid from the skin of the subject, and it is necessary to puncture the subject. Therefore, the puncture needle has a strength that can withstand this, and is preferably sharp. In order to suppress pain, a thin puncture needle is preferable. As long as the puncture needle satisfies the above conditions, any of known materials such as metal and resin can be used. Specifically, for example, a 21-33 gauge needle manufactured by Terumo Corporation is used. . The puncture needle may be a hollow needle or a rod-like needle as long as it can penetrate the subject's skin. Furthermore, since the puncture needle needs to be hygienicly stored in the biosensor until it is used, a photocatalytic function effective for antibacterial and antiviral effects may be imparted to the needle tip surface. In that case, a film of titanium oxide or titanium dioxide is desirable.

  Such a puncture needle is provided with a puncture needle support at its rear part. The shape of the puncture needle support is not particularly limited as long as the puncture needle can be stably held in the biosensor, but a flat plate is preferably used from the viewpoint of miniaturization of the biosensor. .

  The puncture needle support is integrated with an external drive connection portion that plays a role of transmitting external drive to the puncture needle support. The external drive connection portion need only have a shape that penetrates the electrically insulating substrate from the puncture needle support disposed in the biosensor and protrudes to the outside of the biosensor, for example, a cylindrical shape, a prismatic shape, a flat plate shape, etc. Preferably, a prismatic shape, a flat plate shape, more preferably a flat plate shape is used. When a flat plate is used as the puncture needle support, the external drive connection portion is perpendicular to the external drive connection portion, for example, in the case of a cylindrical or prismatic external drive connection portion, the long axis direction is the puncture needle. In a state perpendicular to one side or both sides of the needle support, and in the case of a flat external drive connection portion, the plane is along the long axis direction of the puncture needle with respect to one side or both sides of the puncture needle support. It is integrated with the puncture needle support in a vertical state.

  A puncture needle (hereinafter referred to as a puncture needle portion) equipped with a puncture needle support integrated with an external drive connection portion is disposed between at least two electrically insulating substrates together with electrodes and spacers. At this time, when a flat plate is used as the puncture needle support, the puncture needle support is set in a horizontal state with the electrically insulating substrate.

  As the substrate, it is sufficient if it is electrically insulating, for example, plastic, biodegradable material, paper or the like is used, and preferably polyethylene terephthalate is used. Further, an oxygen permeable material can be used, and in this case, since the reagent can be prevented from being reduced, there is an effect of suppressing variation in the measured value depending on the state of reduction.

  At least one of the electrically insulating substrates is provided with a through hole necessary for the movement of the external drive connecting portion. This through-hole plays an important role of defining the moving direction and range of the puncture needle, but its formation can be easily performed, for example, by punching out the substrate, which facilitates the manufacture of the biosensor. Can be.

  On the substrate, electrodes, spacers and the like are formed prior to the placement of the puncture needle portion.

  The electrode is formed on the substrate by a screen printing method, a vapor deposition method, a sputtering method, a foil pasting method, a plating method, etc., and the materials include carbon, silver, silver / silver chloride, platinum, gold, nickel, copper, Examples include palladium, titanium, iridium, lead, tin oxide, and platinum black. Here, as the carbon, carbon nanotubes, carbon microcoils, carbon nanohorns, fullerenes, dendrimers, or derivatives thereof can be used.

  The electrode may be a two-pole method formed with a working electrode and a counter electrode or a three-pole method formed with a working electrode and a counter electrode, 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, it is possible to measure the moving speed of the blood sample introduced into the transport path, thereby measuring the hematocrit value. Moreover, you may be comprised by 2 or more sets of electrode systems. These electrodes are formed on a single substrate or separately on two substrates.

  A reagent layer (electrode reaction part) can be formed on the substrate on which the electrode is formed. The reagent layer is formed by a screen printing method or a dispenser method, and the reagent layer can be immobilized on the electrode surface or the substrate surface by an adsorption method involving drying or a covalent bonding method. Examples of the reagent disposed in the electrode reaction part of the biosensor include those containing glucose oxidase as an oxidase and potassium ferricyanide as a mediator when configured for blood glucose measurement. When the reagent is dissolved by the blood, the enzyme reaction is started. As a result, 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, ie the glucose concentration in the blood. The reduced electron carrier accumulated for a certain time is oxidized by an electrochemical reaction. An electronic circuit in the main body of the measuring apparatus, which will be described later, calculates and determines the glucose concentration (blood glucose level) from the anode current measured at this time, and displays it on the display unit arranged on the main body surface.

  In addition, a surfactant and lipid can be applied around the blood collection port and on the surface of the electrode or reagent layer (electrode reaction part). By applying a surfactant or lipid, the sample can be moved smoothly.

  Here, when the puncture needle moves through the sample transport path, there is a possibility that the puncture needle contained in the sample transport path is contaminated by the application of the reagent layer, surfactant or lipid into the sample transport path. In order to prevent such contamination, it is preferable not to apply these reagents around the tip of the puncture needle, or to have a configuration in which the puncture needle moves in a site different from the sample transport path.

  In the biosensor in which the reagent layer is provided on the electrode filled with the above blood collection, the blood collection and the reagent react when the blood collected from the blood collection port contacts the reagent layer on the electrode. This reaction is monitored as an electrical change at the electrode.

  In addition to the electrodes, spacers are formed on the insulating substrate. The spacer is composed of at least one of an adhesive, a resist, and an insulating substrate, and plays a role of forming a groove for moving the puncture needle support in the biosensor. The groove in which the puncture needle support moves is not particularly limited as long as it forms a space in the biosensor in which the puncture needle support can move, and the range in which the puncture needle support moves is the minimum. In addition to a limited pattern, a pattern having a width wider than this may be used.

  Since the adhesive is used for bonding the substrates together, it is not particularly limited as long as it does not react or dissolve with the substrates and can bond the substrates. For example, an acrylic resin adhesive, etc. Is used. The adhesive layer can be formed by a screen printing method, and is formed with a thickness of about 5 to 500 mm, preferably about 10 to 100 mm. The adhesive layer also functions as a spacer as described above. In addition, the said reagent can also be contained in an adhesive bond layer.

  The resist is used to define the electrode area and is not particularly limited as long as it does not react or dissolve with the substrate in the same manner as the adhesive layer. For example, an ultraviolet curable vinyl / acrylic resin is used. , Urethane acrylate resins, polyester acrylate resins, and the like. The resist layer is also formed by screen printing or the like with a thickness of about 5 to 500 mm, preferably about 10 to 100 mm. The resist layer also functions as a spacer as described above. The purpose of using the resist is to clarify the electrode pattern mainly as described above, and to insulate the sample transport path where the reagent layer is not present, in addition to defining the electrode area. Therefore, the resist layer may or may not have the same pattern as the adhesive layer. In the latter case, the resist layer is preferably formed on the electrode substrate for insulation.

  The electrically insulating substrate used as the spacer may be connected to the insulating substrate on which the electrode is formed by a connecting portion, and if the connecting portion is provided between the substrates, it is folded along this. Thus, the spacer can be easily formed without going through a process such as alignment. As the connecting portion, one having a length of 0.5 to 3.0 mm, preferably 1.0 to 2.0 mm, is preferably provided at least two places between two substrates. If such a connection part is about 0.5 to 0.9 mm in length on the electrically insulating substrate, for example, a gear-shaped thin disk whose convex part is a blade is used as a broken line A connecting portion having a length of about 1 to 3 mm is hinge-molded by punching out an electrically insulating substrate with a mold. Here, when the connecting portion has a length of about 1 to 3 mm, there is no need to prevent the warping by fixing the folded portion by thermocompression bonding or using a fixing tool.

  A spacer constituted by at least one of an adhesive, a resist, and an insulating substrate forms a trajectory driven by the puncture needle and a sample transport path that guides blood onto the electrode together with a groove in which the puncture needle support moves. The simultaneous formation of these by the spacer has the effect of facilitating the production of the biosensor.

The trajectory driven by the puncture needle and the sample transport path for guiding blood onto the electrode can be provided at either the same location or different locations, but preferably the puncture port for puncturing the skin of the subject and blood After being provided as a puncture blood collection port so that the blood collection introduction port for collection is at the same location, these are configured to be branched from the puncture blood collection port. Examples of such embodiments include the following embodiments.
(1) A puncture needle drive track other than the puncture port is provided on the sample transport path other than the blood collection inlet via a separator made of an electrically insulating substrate. At this time, the sample transport path and the puncture needle drive trajectory can be made upside down.
(2) The sample transport path other than the blood collection inlet is provided on an electrically insulating substrate different from the position where the puncture needle drive track other than the puncture opening is provided.

  An air discharge hole is provided at the puncture port end of the puncture needle drive track formed in this way. In the case of (1), the air discharge hole is on the electrically insulating substrate positioned relative to the separator that forms the puncture needle drive track, and in the case of (2), the puncture needle drive track Are formed on at least one of the insulating substrates. This air discharge hole can stop the flow of blood sample into the puncture needle drive orbit, so that it is possible to prevent the waste of the blood sample and to quantify the blood components by the prescribed blood sample volume. There is an effect.

  A puncture needle portion is disposed on an electrically insulating substrate on which electrodes, spacers and the like are formed. Specifically, the puncture needle support is moved in the puncture needle support moving groove formed by the spacer in the biosensor, the external drive connection portion is in the through hole provided in the insulating substrate, and the puncture needle drive track is in the air. The puncture needle portion is arranged in a state where the puncture needle is set in a state where it does not overlap with the discharge hole.

  A biosensor as a foldable molded body is produced by folding a substrate having the above-described configuration in which a puncture needle portion is disposed when a connection portion is provided between two substrates. You can also As the connecting portion, the length of the connecting portion is not less than the thickness of the spacer, that is, 0.5 to 4 mm, preferably 1.0 to 3.0 mm, and preferably at least two places are provided between two substrates. If such a connection part is about 0.5 to 0.9 mm in length on the electrically insulating substrate, for example, a gear-shaped thin disk whose convex part is a blade is used as a broken line A connecting portion having a length of about 1 to 4 mm is hinge-molded by punching out an electrically insulating substrate with a mold. Here, when the connecting portion has a length of about 1 to 4 mm, there is no need to prevent the warping by fixing the folded portion by thermocompression bonding or using a fixture. In the case of a biosensor that is such a folded molded body, a connecting portion as a folding line is provided so as to be horizontal in the long axis direction of a long substrate, and after punching through holes, electrodes and the like are further formed. A large number of biosensors can be manufactured at one time by punching into a sensor shape after folding along the connection part. The needle-integrated biosensor manufactured by such a manufacturing method has very good reproducibility and has features that cannot be achieved by a conventional lamination method.

  In the needle-integrated biosensor of the present invention, it is desirable that a series of operations of puncture, blood collection, and measurement be performed by a measurement device having a puncture drive. As the measuring device, one having a driving means for driving the puncture needle to move the tip of the puncture needle into and out of the biosensor by engaging with the end of the external drive connecting portion protruding from the needle integrated biosensor.

  As a measuring device for a needle-integrated biosensor, a measuring device that uses operability and durability to ensure repeatable and reliable measurement using a needle-integrated biosensor and is easy to carry is used. For example, by inserting a biosensor with a needle into the introduction part at the lower part so that the puncture needle faces downward, the terminal of the biosensor is connected to the connector of the measuring device, and measurement is possible. The preparation for measurement is completed by pulling the trigger to give the puncture drive to the inside of the needle integrated biosensor, and then the puncture, blood collection, and measurement are automatically activated by pressing the switch of the puncture start button, A system that finally leads to measurement results is used.

  An example of the structural features of the measuring device will be described in more detail. In this measurement apparatus, the puncture needle drive unit and the measurement apparatus unit are integrated, and the puncture needle drive unit includes a trigger unit, a puncture start button unit, and a drive unit using an elastic body such as a spring. On the other hand, for the measuring device section, the sensor introduction section, the connector, the electrochemical measurement circuit, the memory section, the operation panel, the measurement section that measures the electrical values at the electrodes of the biosensor, and the display that displays the measurement values at the measurement section Further, a radio wave, for example, Bluetooth (registered trademark) can be mounted as a wireless means. With such a slide structure, since the puncture drive is received while the needle-integrated biosensor is securely held, the strength of the entire measuring apparatus can be increased. The measurement device can further include a mechanism that can recognize the left-right asymmetric structure with the puncture needle of the needle-integrated biosensor as the center line by the protruding portion of the measurement terminal.

  The puncture drive of the measuring device is preferably a mechanism that returns quickly after tapping the upper part of the needle-integrated biosensor in the vertical direction, and preferably has a mechanism that can adjust the depth at which the skin of the subject is punctured.

  The measuring device must have voice guidance and voice recognition functions for visual impairment caused by diabetes, measurement data management functions using the built-in radio clock, communication functions for medical data such as measurement data, and charging functions. Can do.

  A measurement method in the measurement unit of the measurement apparatus is not particularly limited, and potential step chronoamperometry, coulometry, cyclic voltammetry, or the like can be used.

  As described above, the needle-integrated biosensor of the present invention does not limit the user, that is, can handle a universal project.

  The needle-integrated biosensor according to the embodiment of the present invention will be described in detail with reference to the drawings. However, the present invention is not limited to the following examples unless it exceeds the gist.

  FIG. 1 shows an example of a needle-integrated biosensor according to the present invention. In a), an electrically insulating substrate 1 and an adhesive layer 6 are shown. In the electrically insulating substrate 1, the base portion 2 provided with the conductors 5 constituting electrodes and terminals, the cover portion 3, and the spacer portion 4 are connected by a perforation 8 forming a connection portion. The base portion 2 and the cover portion 3 are provided with through holes 17 required for movement of an external drive connection portion integrated with a puncture needle support described later, and the adhesive layer 6 and the spacer portion 4 are A pattern for forming the puncture needle support moving groove 21 and the puncture needle drive track 18 is formed when the biosensor is constructed, and the thickness thereof is also used as a spacer. In this figure, the pattern for forming the puncture needle support moving groove 21 is the same as the range in which the puncture needle support moves. However, the movement range of the puncture needle support is not limited to external drive connection. As a pattern for forming the puncture needle support moving groove 21, a range in which the puncture needle support moves is ensured to a minimum. Any pattern may be sufficient, for example, a width wider than this. Therefore, when the puncture needle support moving groove 21 is formed, as in the sensor shown in the above-mentioned Patent Document 4, the size of the puncture needle support moving groove 21 is large when the recess that accommodates the protrusion integrated with the puncture needle is formed inside the sensor. It is not necessary to set the length precisely, and the biosensor can be manufactured more easily.

  b) shows a state before the adhesive layer 6 is formed on the electrically insulating substrate 1 and the spacer portion 4 is folded over the base portion 2. A round air outlet 7 is provided in the puncture needle drive track 18 on the electrically insulating substrate 1. Furthermore, the pattern for the base portion 2 of the adhesive layer 6 provided on the electrically insulating substrate 1 is different from the pattern for the cover portion 3, and the sample transport path 9 (electrode reaction portion 10) is determined by the base portion 2 pattern. ) Is formed. The pattern of the adhesive layer 4 forms the puncture needle support moving groove 21 and the puncture needle drive track 18 together with the insulating substrate that forms the spacer portion 4. In the biosensor exemplified here, the puncture needle drive track 18 and the sample transport path 9 are branched at the puncture blood collection port 16 so that the puncture needle cannot contact the electrode. In addition, a mechanism that can prevent blood from flowing into the sensor by the air discharge hole 7 provided at the end of the puncture blood sampling port 16 of the puncture needle drive track 18 is employed. In such a configuration, it is possible to prevent blood from flowing into the puncture needle and eliminate unnecessary use of the sample body fluid, so that it is possible to quantify blood components with a specified blood volume. Play.

  c) A side view of the puncture needle 13 is shown in i). The puncture needle portion 13 includes a puncture needle 11 and a puncture needle support 12 that supports the puncture needle 11, and the puncture needle support 12 is further integrated with an external drive connection portion 19 that transmits external driving to the puncture needle 11. c) ii) shows a view of the puncture needle 13 seen from the front. A puncture needle 11 is disposed at the center, and an external drive connection portion 19 and a puncture needle support 12 are shown at the rear thereof. In these figures, a flat puncture needle support 12 is used, and a flat needle external drive connection portion 19 is formed perpendicularly to the puncture needle portion 13 along the longitudinal direction of the puncture needle. It is shown. c) iii) is a puncture needle support moving groove of the biosensor during assembly so that the puncture needle support 12 is horizontal with respect to the electrically insulating substrate 1 for the puncture needle 13 shown in c) i). 21 shows a state before fitting.

  d) The puncture needle portion 13 is formed in the biosensor puncture needle support moving groove 21, the puncture needle support 12 is formed in the through hole 17, and the external drive connection portion 19 is formed in the puncture needle drive track 18. A state in which the puncture needle 11 is arranged without overlapping is shown. Here, the puncture needle support 12 is set to a thickness that enables horizontal movement within the puncture needle support moving groove 21 of the biosensor, that is, thinner than the thickness of the puncture needle support moving groove 21. d) shows a state before the puncture needle portion 13 is stored inside the biosensor by folding the cover portion 3 toward the base portion 2. Here, the external drive connection portion 19 of the puncture needle portion 13 can move only within the range of the through hole 17 provided in the base portion 2 and the cover portion 3, and the tip of the puncture needle 11 is the base portion before and after the puncture. It is shown that it can be accommodated inside the sensor with respect to the air discharge hole 7 on the No. 2 side. For this reason, blood collection after the puncture cannot enter deeper than the air discharge hole 7, so that the contact between the puncture needle 11 and the blood collection does not occur.

  e) shows a plan view (e) i)) and a bottom view (e) ii)) of the needle-integrated biosensor 14 assembled by the above steps. As shown in this figure, the movement range of the puncture needle portion 13 is defined by the external drive connection portion 19 of the puncture needle portion 13 and the through hole 17 of the biosensor. f) i) shows a front view of the needle-integrated biosensor 14. As shown here, the external drive connection portion 19 of the puncture needle portion 13 protrudes from the biosensor body. This convex part is a part which receives external driving by engaging with a puncture driving part built in the measuring apparatus. f) ii) shows a left side view of the needle-integrated biosensor 14. f) iii) shows a right side view of the needle-integrated biosensor 14.

  g) is a diagram related to the same biosensor as e) i), but h) the cross-sectional parts of each figure of the needle-integrated biosensor 14 shown in i) to iv) are indicated by i to iv, respectively. h) In i) and iii), a biosensor formed by folding the electrically insulating substrate 1 connected by the connecting portion using the adhesive layer 6 so as to become the base portion 2, the spacer portion 4, and the cover portion 3. Is shown. In h) ii), the puncture needle 11 and the puncture needle drive track 18 are not in contact with each other, and the position of the puncture needle is seen from the puncture opening rather than the air discharge hole 7 before and after the puncture. It is shown that it is in the back. h) iv) shows a state in which the puncture needle 11 is arranged in the puncture needle drive track 18. The puncture needle 11 is not in direct contact with the puncture needle drive track 18, and this state is the same in a series of puncture operations.

  FIG. 2 shows an example of use of the needle-integrated biosensor 14. a) before puncture, b) during puncture, and c) after puncture. Further, i) shows a plan view of the needle-integrated biosensor 14, and ii) shows a bottom view of the needle-integrated biosensor 14. As can be seen from these figures, the puncture needle portion 13 protrudes from the puncture blood collection port 16 at the time of puncture, but the movement of the puncture needle portion 13 is externally fitted in the through hole 17 provided in the electrically insulating substrate 1. It is defined by the drive connection 19. Since the through-hole 17 that defines the movement range of the puncture needle 11 can be easily formed by punching out a substrate, for example, the needle-integrated biosensor according to the present invention is simple in configuration and easy to manufacture. The effect that it is.

It is a figure which shows an example of the needle-integrated biosensor according to the present invention. It is a figure which shows the usage example of the needle | hook integrated biosensor which concerns on this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Electrically insulating board | substrate 2 Base part 3 Cover part 4 Spacer part 5 Conductor 6 Adhesive layer 7 Air discharge hole 8 Perforation (connection part)
9 Sample transport path 10 Electrode (reagent layer)
DESCRIPTION OF SYMBOLS 11 Puncture needle 12 Puncture needle support body 13 Puncture needle part 14 Needle integrated biosensor 15 Terminal 16 Puncture blood sampling port 17 Through hole 18 Puncture needle drive track 19 External drive connection part 21 Puncture needle support body movement groove

Claims (9)

In a biosensor in which a puncture needle for collecting blood by piercing the skin of a subject with an electrode, a spacer, and external driving means is integrated between at least two electrically insulating substrates,
A puncture needle support is attached to the back of the puncture needle,
The puncture needle support is integrated with an external drive connection portion that penetrates the electrically insulating substrate and projects to the outside of the biosensor for transmitting external driving to the puncture needle support,
The biosensor has a puncture needle support moving groove for projecting the needle tip portion from the inside of the sensor to the outside of the sensor, and has a through hole required for movement of the external drive connection portion on at least one substrate A biosensor with an integrated needle.   The needle-integrated biosensor according to claim 1, wherein a movable range of the external drive connection portion is determined by a through hole provided in the substrate, and thereby a moving direction and a moving range of the puncture needle are defined.   The biosensor according to claim 1, wherein the puncture needle support has a flat plate shape and is set horizontally with the electrically insulating substrate.   The needle-integrated biosensor according to claim 3, wherein the external drive connection portion is flat and the plane is formed perpendicular to the puncture needle support along the direction of the straight axis of the puncture needle.   The needle-integrated biosensor according to claim 3, wherein the external drive connection portion has a columnar shape or a prismatic shape, and a long axis direction thereof is formed perpendicular to the plane of the puncture needle support.   The needle-integrated biosensor according to claim 1, wherein the puncture needle support moving groove is formed of at least one of an adhesive, a resist, and an electrically insulating substrate.   The needle-integrated biosensor according to claim 6, wherein an electrically insulating substrate for forming a puncture needle support moving groove is connected to an insulating substrate on which an electrode is formed by a connecting portion.   The needle-integrated biosensor according to claim 1, wherein an air discharge hole is provided in an electrically insulating substrate which is a trajectory driven by the puncture needle and does not overlap with the puncture needle stored in the biosensor. A measurement capable of measuring a current value output by applying a voltage to an electrode of a biosensor into which a measurement sample liquid is introduced, wherein the needle-integrated biosensor according to any one of claims 1 to 8 is detachable. A device,
A needle integrated type comprising driving means for driving the puncture needle to move the tip of the puncture needle into and out of the biosensor by engaging with the end of the external drive connecting portion protruding from the needle integrated biosensor Measuring device for biosensor.

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