JP4576628B2 - 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 the 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 long time to train and it takes a considerable amount of time before a reliable measurement can be performed by the patient. Actually, measurements at sites other than the fingertip and forearm (abdominal wall, earlobe, etc.) are difficult even for a skilled person. 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 supplying less invasive specimens 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.
JP-A-9-266898 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 measurement is performed 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

Moreover, in the needle-integrated biosensor disclosed in Patent Document 4, the puncture needle is entrusted to external driving, and the puncture needle moves in parallel along the longitudinal direction of the elongated piece-like biosensor. Have taken. However, in this type, since the puncture needle is exposed from the biosensor, a cover for protecting the tip of the puncture needle is necessary, and the puncture needle moves through the blood collection conveyance path and the reagent layer of the biosensor, so that the puncture needle is covered. There is a risk that the surface of the puncture needle is contaminated with the reagent before the skin of the specimen is pierced.
Republished 2002-056769

  An object of the present invention is to provide a biosensor in which a biosensor provided with at least two electrodes and a puncture needle for collecting body fluid by piercing the skin of a subject are integrated. An object of the present invention is to provide a needle-integrated biosensor that allows a puncture needle to be kept hygienic without requiring a protective cover or the like.

An object of the present invention is to provide a biosensor composed of at least two electrically insulating substrates, a spacer and an electrode placed in a space sandwiched between them, and pierce the skin of the subject into the biosensor to obtain a body fluid. In a biosensor configured integrally with a puncture needle for collection, this is achieved by a needle-integrated biosensor in which a puncture needle and an electrode reaction part into which a measurement sample is introduced are separated by a brush-like partition wall. The

The needle-integrated biosensor according to the present invention has an excellent effect of keeping the puncture needle hygienic until it is used because the tip of the puncture needle is separated from the electrode reaction portion by the brush-like partition wall. With this configuration, since the puncture needle passes through the electrode reaction part only at the time of puncture, the puncture needle is stored in the reagent layer atmosphere when a reagent layer is provided in the electrode reaction part. Therefore, contamination with reagents during storage can be effectively prevented.

Also, by the partition wall portion and the brush-like shape, after penetration of the puncture needle, again because the partition wall portion through-hole of the formed partition wall is closed, preventing the flow of sample liquid into the other electrode reaction portion be able to. As a result, measurement can be performed without collecting more body fluid than necessary, so that the number of measurement samples can be reduced. Furthermore, since the needle-integrated biosensor having such a configuration does not require a member such as a protective cover for the puncture needle, it is excellent in operability and can achieve reduction in manufacturing cost.

  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.

  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. From the viewpoint of reducing the sample volume, the electrodes are disposed relative to the two substrates. A facing structure in which an electrode formed on the surface of two substrates is sandwiched with a spacer made of a resist layer or an adhesive layer is preferable. Thereby, the electrochemical reaction proceeds efficiently, and the volume of the reaction layer can be effectively reduced by reducing the distance between the electrodes and the electrode area. As a result, the number of samples can be reduced.

  A reagent layer can be formed mainly on the electrode reaction part 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 to the periphery of the blood collection port, the electrode, or the surface of the electrode reaction part (reagent layer). By applying a surfactant or lipid, the sample can be moved smoothly.

  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.

  Further, in the biosensor, the electrode may be defined by a resist layer, and this resist layer can be easily formed by screen printing or the like. The resist in this case is not particularly limited as long as it does not react or dissolve with the substrate, as in the case of the adhesive, and examples thereof include ultraviolet curable vinyl / acrylic resins, urethane acrylate resins, and polyester acrylate resins. Can be mentioned. The purpose of using the resist is mainly to clarify the electrode pattern and to clarify the above-mentioned definition of the electrode area, and to insulate the sample transport path where no reagent layer is present. Therefore, the resist layer may or may not form the same pattern as the adhesive layer. In the latter case, the resist layer is preferably formed on the electrode substrate for insulation. Furthermore, by providing this resist layer thicker than the electrode in the sample transport path in which the puncture needle of the needle-integrated biosensor of the present invention is accommodated, contact between the puncture needle and the electrode can be suppressed. Such a resist layer can also be formed by a screen printing method. For example, the resist layer formed with a thickness of about 5 to 500 μm, preferably about 10 to 100 μm, using any of the above-mentioned materials also acts as a spacer. To do.

  The two substrates are bonded via an adhesive such as an acrylic resin adhesive to constitute a biosensor. Such an adhesive layer can also be formed by a screen printing method, and is formed with a thickness of about 5 to 500 μm, preferably about 10 to 100 μm, and such an adhesive layer acts as a spacer as well as a resist layer. In addition, the said reagent can also be contained in an adhesive bond layer. The adhesive layer may be either the same pattern as the resist layer or a different pattern.

  In addition, a biosensor as a folded molded body can be manufactured by folding the substrate having the above-described configuration in which the puncture needle is disposed along the connecting portion. 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 has a length of about 0.5 to 0.9 mm on the insulating substrate, for example, a gear-shaped thin disk whose convex part is a blade, a broken line shape In addition, a connecting portion having a length of about 1 to 4 mm is hinge-molded by punching an 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 further, an electrode or the like is formed and then folded along the connecting portion. After that, a large number of biosensors can be manufactured at once by punching into the sensor shape. 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.

For the puncture needle for collecting body fluid from the skin of the subject, it penetrates the brush-like partition wall part, and if it is equipped with a suction mechanism, penetrates the soft material provided in the sample blood collection port, Since it is necessary to puncture the subject, it is desirable to have a strength that can withstand this, and to be sharp, and in order to suppress pain during puncture, a thin puncture needle is preferable. Specifically, a 21-33 gauge thing by Terumo company 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.

  In the biosensor, a puncture needle for puncturing the subject's skin and collecting body fluid is arranged. The puncture needle can be arranged in any orientation such as parallel or orthogonal to the electrode at the time of puncturing, but is preferably arranged in a state orthogonal to the electrode at the time of puncturing. When the puncture needle is arranged in a state perpendicular to the electrode, the shape of the needle-integrated biosensor becomes asymmetrical with the puncture needle as the center line by arranging the measurement terminal at a position off the trajectory of the puncture needle. Therefore, for the user, the insertion into the measuring device can be performed without any mistake, and the measuring device also has a mechanism for specifying the position of the measurement terminal of the needle-integrated biosensor of the present invention. be able to.

The partition wall is arranged inside the biosensor so that the tip of the puncture needle is separated from the electrode reaction part (reagent layer). As the shape of the partition wall , a brush shape is used . Examples of the material used for the partition wall include polymer materials such as nylon and polybutylene terephthalate , and preferably a material that can be sterilized is used. As the sterilization method, ethanol sterilization, dry heat sterilization, autoclave, ultraviolet rays, gamma rays, and the like are used. For example, agar sterilized by autoclave is applied to the partition wall after cooling and before gelation. Furthermore, an antibacterial action can be imparted to the partition wall. Metals such as copper and silver are known as antibacterial materials, and these metal parts are adhered to the surface of the partition wall material by vacuum deposition or sputtering to obtain a partition wall having antibacterial activity. Can do. In the process until the puncture needle receives the puncture drive and the puncture needle punctures the skin of the subject, the partition wall portion needs not to adhere to the surface of the puncture needle and its fragments should not be mixed into the blood collection. It is fixed on at least a part of the biosensor, for example, on the substrate using an acrylic adhesive.

The brush-like partition portion, for example, as toothbrushes, are unified length of each bristle, at equal intervals hair root to densely is used that is fixed by an adhesive. By this adhesion, the root of the hair, which is the opposite portion of the hair tip, becomes an adhesive layer, which can be affixed as a partition that separates the reagent layer and the tip of the puncture needle. In this case, there are several methods for arranging the brushes. For example, if the length of the brush is almost the same as the distance between the substrates inside the biosensor, it is only necessary to provide an adhesive layer on only one of the substrates or on the hair tip and attach the brush adhesive layer to both substrates. When the length of the brush is about half the distance between the substrates inside the biosensor, the brush is placed so that the brush tip faces the other by attaching the adhesive layer of the brush to both substrates The The brush with both ends fixed has a feature that the bristles are easy to return to the original state, and the brush arranged so that the tip of the brush faces each other is because the tip of the puncture needle contacts only the tip of the brush There is a feature that the puncture needle tip can be punctured without being pierced by the hair trunk, with the state of the tip of the puncture needle before the puncture needle reaches the skin of the subject being sharper. In any case, the hair may be arranged in only one row or in a plurality of rows.

  With this configuration, the puncture needle and the electrode reaction part (reagent layer) are separated until just before puncturing, and the tip of the puncture needle passes between the hair and the electrode reaction part (reagent layer) at the time of puncture, and the skin of the subject. Thus, the puncture needle can be kept hygienic until use, and the puncture needle is stored in the reagent layer atmosphere even when a reagent layer is provided in the electrode reaction part. Therefore, contamination with reagents during storage can be prevented. Similarly, the puncture needle is not contaminated by a surfactant, lipid, or the like applied to the periphery of the blood collection port, the electrode or the reagent layer (electrode reaction part) surface. Furthermore, after the puncture, the needle returns to its original position, and the brush is also in its original state, separating the electrode reaction part (reagent layer) and the needle, so blood collection is introduced from the puncture blood collection port. After that, although it reaches the electrode reaction part (reagent layer), it does not enter before the brush, so that it is possible to prevent the sample liquid from flowing into other than the electrode reaction part. As a result, measurement can be performed without collecting more body fluid than necessary, so that the number of measurement samples can be reduced.

  The biosensor having the above-described configuration is made of a soft material such as silicone rubber, soft polyurethane, polyvinyl chloride, or polystyrene foam at the time of manufacture under conditions of negative pressure, preferably vacuum conditions, than the outside air. On the puncture drive side, the inside of the sensor can be constructed by using a stretchable material such as natural rubber between the two substrates constituting the biosensor and the puncture needle support. Is sealed in a negative pressure state, and a suction means can be used in addition to capillary action for the movement of blood collection after puncture. At this time, immediately after the puncture, the puncture needle is further pulled in the direction opposite to the puncture direction, so that the stretchable material is stretched and the negative pressure inside can be further increased to suck the blood sample. By adopting such a configuration, blood can be collected smoothly. Here, when the puncture needle and the electrode are arranged in a state where they are perpendicular to each other at the time of puncture, the terminal can be removed from the trajectory of the puncture needle, so that the inside of the biosensor including the puncture needle is maintained at a negative pressure. A structure for maintaining airtightness can be easily obtained. In addition, the soft material covering the puncture blood collection port has an effect of maintaining negative pressure and improving the adhesion between the skin of the subject and the puncture blood collection port.

  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. In this case, for example, with respect to puncture driving, it is desirable to have a mechanism in which the needle penetrates the soft material of the biosensor and breaks through the skin of the subject, and a mechanism that quickly returns to the original position immediately after puncturing.

  Furthermore, when the needle-integrated biosensor of the present invention includes a suction mechanism, the puncture drive system in the measurement device may be further improved in order to increase the suction force during blood collection. That is, by using a mechanism that returns the puncture needle to its original position immediately after puncture, the stretchable material is stretched by further pulling the puncture needle in the opposite direction to the puncture direction, and the internal negative pressure is further increased. Also good.

  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. Insert the needle-integrated biosensor into the introduction part at the bottom so that the puncture needle support is facing upward, and the terminal of the biosensor is connected to the connector of the measuring device, so that measurement is possible. The preparation for the 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 puncture start button switch. 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 an 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 assembly example of the needle-integrated biosensor of the present invention. FIGS. 1a) to c) are examples of manufacturing a needle-integrated biosensor, i) is a constituent material required for manufacturing the needle-integrated biosensor, and ii) and iii) indicate the molded body. FIG. 1a) shows a resist layer 6 in which conductors 7, 7 are formed on one surface of a substrate 1, 1 of a biosensor. The resist layer 6 serves not only as a spacer 2 but also to define the electrode area and to prevent contact between the electrode surface and the puncture needle during puncture. Accordingly, the through hole 4 is provided in the resist layer 6. Here, the board | substrate 1 can be safely used by rounding a corner | angular. FIG. 1b) shows how the adhesive layer 5 is formed on the resist layer. Here, since the adhesive layer 5 is also provided between the plate members of the substrates 1 and 1, it plays the role of the spacer 2 like the resist layer. FIG. 1 b) ii) shows an electrode whose area is defined by the resist layer 6 and the adhesive layer 5 and its electrode reaction part 13. FIG. 1c) i) shows the configuration of the puncture needle section 14. The puncture needle section 14 is composed of a puncture needle 20, a support body 19 that supports the puncture needle 20, and an external drive connection section 17, and the external drive connection section 17 is shown. Is connected to a measuring device equipped with a puncture drive so that the puncture drive from the measurement device can be obtained. Further, in FIG. 1c), the puncture needle portion 14 is arranged so as to be orthogonal to the electrode at the time of puncture. FIG. 1c) i) shows the members constituting the partition wall 36, which can isolate the electrode reaction layer (reagent layer) and the puncture needle 14 as shown in FIG. 1c) ii). Placed in. FIG. 1 c) iii) shows a needle-integrated biosensor 3 which is a folded molded body formed via a connection portion 21. FIG.

  FIG. 2 shows a cross-sectional view of the needle-integrated biosensor 3 shown in FIG. FIG. 2b) shows a cross-sectional view taken along the line A-A 'shown in FIG. 2a). As shown in this figure, the puncture needle 14 is arranged on the pattern surface provided on the biosensor substrate 1, and the reagent layer 13 and the puncture needle 20 are isolated by the arrangement of the partition wall 36. Further, the puncture needle portion 14 has a structure in which contact with the electrode surface during puncture can be avoided by forming a resist layer. Therefore, even if the reagent layer is formed on the surface of the electrode, contact between the reagent layer and the puncture needle portion 14 can be prevented, so that contamination of the puncture needle 20 with the reagent can be prevented. FIG. 2c) shows a cross-sectional view along B-B 'shown in FIG. 2a). As shown in these figures, the needle-integrated biosensor 3 of the present invention is perpendicular to the long axis direction of the electrodes 10 and 10 formed inside one substrate 1 when the puncture needle 14 is punctured. Thus, the terminal 11 can be removed from the trajectory of the puncture needle 14. Further, since the terminal 11 is disposed at a position off the trajectory of the puncture needle 14, the shape of the needle-integrated biosensor 3 is asymmetrical with the puncture needle as the center line, which is a mark for the user. The insertion into the measuring device can be performed without mistake, and the measuring device can also be provided with a mechanism for specifying the position of the terminal 11 of the needle-integrated biosensor 3 of the present invention. Further, by reducing the width of the electrode and the distance between the electrodes, the width of the substrate at that portion is also reduced, so that the amount of the sample solution can be reduced.

  FIG. 3 shows an enlarged view (a) of the partition wall periphery of the cross-sectional view shown in FIG. 2 (b) and an operation mechanism (b to e) of the brush-like partition wall. As shown in FIG. 3 a), the reagent layer 13 and the puncture needle 20 are isolated by the arrangement of the partition wall 36. 3b to 3e are enlarged views of the partition wall. As shown in b), the partition wall 36 is composed of a brush 38 and a brush adhesive layer 37, and the brushes 38 are respectively disposed on the resist layers on the surface of the two substrates and are arranged facing each other. 3c) shows that the puncture needle 20 starts to pass through the border of the facing brush 38, FIG. 3d) shows a state in which the puncture needle 20 penetrates the facing brush 38, and FIG. 3e) shows that the puncture needle 20 penetrates the skin. Each of them shows a return to a fixed position inside the brush 38 after puncturing. Here, in FIG. 3e), the blood collection 24 fills the reagent layer 13 after puncturing the skin, but does not reach the space where the puncture needle 20 is located. The entry of the blood collection 24 is impeded by the surface tension of blood acting between the brushes. On the other hand, since the brush 36 allows air to pass therethrough, the brush 36 performs air exhaust to prompt the blood collection 24 to flow into the reagent layer 13.

FIG. 4 shows an example of use of the needle-integrated biosensor 3 shown in FIG. In FIG. 4, each step is shown by a) to d), i) and ii) show the state of the needle-integrated biosensor 3 at that time in i), and ii) shows the A-A shown in FIG. 2a). 'Shown in cross section. FIG. 4a) shows a state before use of the needle-integrated biosensor 3 connected to a measuring apparatus with a puncture drive. At this time, the skin as the subject is in close contact with the puncture blood collection port 12 of the needle-integrated biosensor 3. FIG. 4b) shows the state of the puncture, and although not shown, the puncture needle 20 protrudes from the sensor and also pierces the skin. FIG. 4c) shows a state where the puncture needle portion 14 has returned to its original position after puncturing. FIG. 4d) shows a state in which the blood collection 24 from the punctured skin is subsequently sucked by capillary action.

  FIG. 5 shows another configuration example of the needle-integrated biosensor of the present invention. FIGS. 5a) to 5d) are examples of manufacturing a needle-integrated biosensor, i) is a constituent material required for manufacturing the needle-integrated biosensor, and ii) and iii) indicate the molded body. The difference from the needle-integrated biosensor shown in FIG. 1 is that a blood collection suction mechanism is provided. The blood collection / suction mechanism uses the elastic material 16 for sealing the space between the soft material 15 near the puncture blood collection port 12 and the substrate 1 and the puncture needle support 17 to allow the sample conveyance path / puncture drive unit 8 to be exposed to the outside air. It consists of blocking. Further, the soft material is useful for bringing the skin of the subject into close contact with the puncture blood collection port 12, and the joint 21 of the substrate necessary for the folding structure is provided with the stretchable material 16 as shown in FIG. 5d) ii). It also serves as a hook 22 for fixing to the substrate 1.

  FIG. 6 shows a cross-sectional view of the needle-integrated biosensor 3 shown in FIG. FIG. 6b) shows a cross-sectional view taken along the line A-A 'shown in FIG. 6a). 2 differs from the needle-integrated biosensor shown in FIG. 2 in that it has a blood collection suction mechanism. A soft material 15 is installed in the puncture blood collection port 12, and the puncture needle portion 14 is formed on the substrate by an elastic material 16. 1 and 1 and the bonding part 23 are fixed.

FIG. 7 shows a usage example of the needle-integrated biosensor 3 shown in FIG. In FIG. 7, each step is shown by a) to d), i) and ii) show the state of the needle-integrated biosensor 3 at that time in i), and in ii) A-A shown in FIG. 6a). 'Shown in cross section. FIG. 7a) shows a state before use of the needle-integrated biosensor 3 connected to a measuring device with a puncture drive. At this time, the skin as the subject is in close contact with the soft material 15 provided in the puncture blood collection port 12 of the needle-integrated biosensor 3. FIG. 7 b) shows a state of puncture, and shows a state where the puncture needle 20 penetrates the soft material 15. Although not shown, the puncture needle 20 also pierces the skin. Further, it can be seen that the elastic material 16 is contracted. FIG. 7c) shows a state where the puncture needle portion 14 has returned to its original position after puncturing. Here, the soft material 15 penetrated by the puncture needle 20 is shown. In this state, the negative pressure in the biosensor is applied to the punctured skin. FIG. 7d) shows a state in which the bleeding 24 from the punctured skin is subsequently sucked by the internal negative pressure.

It is a figure which shows one assembly example of the needle-integrated biosensor according to the present invention. It is a figure which shows one structural example of the needle-integrated biosensor according to the present invention. It is a figure which shows one operation | movement mechanism of the brush-shaped partition part in the needle | hook integrated biosensor which concerns on this invention. It is a figure which shows the usage example of the needle | hook integrated biosensor which concerns on this invention. It is a figure which shows the other assembly example of the suction type needle | hook integrated biosensor which concerns on this invention. It is a figure which shows the other structural example of the aspiration type | mold integrated biosensor which concerns on this invention. It is a figure which shows the other usage example of the suction type | mold needle integrated biosensor which concerns on this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Substrate 2 Spacer 3 Needle-integrated biosensor 4 Through hole 5 Adhesive layer 6 Resist layer 7 Conductor 8 Sample transport path / puncture needle path 10 Electrode 11 Terminal 12 Puncture blood sampling port 13 Electrode reaction part (reagent layer)
14 Puncture Needle 15 Soft Material 17 External Drive Connection 18 Folding Molded Body 19 Puncture Needle Support 20 Puncture Needle 21 Connection 22 Hook 23 Adhesion 24 Blood Collection 36 Partition 37 Brush Adhesive Layer 38 Brush

Claims (8)

A biosensor comprising at least two electrically insulating substrates, a spacer and an electrode placed in a space between them, and a puncture needle for piercing the skin of the subject into the biosensor to collect a body fluid; In the biosensor configured as a unit,
A needle-integrated biosensor characterized in that a puncture needle and an electrode reaction part into which a measurement sample is introduced are separated by a brush-like partition wall part.   The needle-integrated biosensor according to claim 1, further comprising a reagent layer provided in the electrode reaction part. The needle-integrated biosensor according to claim 1, wherein the material used for the brush-like partition wall is a polymer material. The needle-integrated biosensor according to claim 3, wherein the polymer material is nylon or polybutylene terephthalate. The needle-integrated biosensor according to claim 1, wherein a brush-like partition wall to which sterilization treatment or antibacterial action is applied is used. The needle-integrated biosensor according to claim 1, wherein the spacer is composed of a resist layer and / or an adhesive layer. The needle-integrated biosensor according to claim 6, wherein the resist layer is formed thicker than the electrode. Further, the puncture blood collection port at the tip of the puncture needle is sealed with a puncturable soft material, and the rear portion of the puncture needle is formed of a stretchable material and a puncture needle support for fixing the puncture needle to the substrate. 2, wherein the biosensor is kept at a negative pressure, and the puncture needle penetrates both the soft material and the skin at the same time to collect blood and measure a detected component. Needle integrated biosensor.

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