JP2007014382A - Biosensor integrated with puncturing instrument - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a biosensor integrated with a puncturing instrument which is assembled easily by forming the biosensor of an extremely simple structure while retaining a strength to sufficiently withstand an impact caused by puncturing by a user and enables reliable measurement with a small amount of a sample fluid by making the entire biosensor minute. <P>SOLUTION: The biosensor integrated with a puncturing instrument uses a hollow needle, which has at least two electrodes formed in a stripe pattern in the longitudinal direction, has a part other than the electrodes preferably formed of an electrical insulating member, and has a hole part, as a puncture needle. Since the biosensor has the needle and the electrodes which are formed integrally to collect a sample body fluid, it has an extremely simple structure which facilitates the assembly. The biosensor enables the reliable collection of a small amount of the sample body fluid without wasting by having a blood collecting means by a method either of a capillary phenomenon method or a vacuum blood collecting method. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a puncture device integrated biosensor. More specifically, a puncture device having a configuration in which a puncture device for piercing the skin to obtain a body fluid (blood, etc.) and a biosensor for collecting and analyzing the body fluid taken out on the surface of the skin are integrated. The present invention relates to a body type biosensor.

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 needs to puncture again and replace the biosensor, and the measurement must be performed again.
JP-A-9-266898 Japanese Patent Publication No. 8-20412

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

Further, in the puncture device integrated biosensor disclosed in Patent Document 4, the puncture needle is left to the external drive, and the puncture needle moves in parallel along the longitudinal direction of the elongated piece-like biosensor. It has a structure. However, in this type, since the puncture needle moves in the blood collection conveyance path and the reagent layer of the biosensor, there is a risk that the surface of the puncture needle is contaminated with the reagent before the puncture needle pierces the skin of the subject.
Republished 2002-056769

  In addition, there are many problems such as inadequate consideration for infectious diseases and the like after disposal, and the biosensor unit with integrated puncture device cannot withstand the impact of driving during puncture. ing.

  The object of the present invention is to form an extremely simple structure while maintaining sufficient strength to withstand impacts caused by puncture performed by the user himself / herself. It is an object to provide a biosensor with a puncture device that can reliably measure even a small amount of sample liquid.

  The object of the present invention is to provide a hollow needle having a hole, in which at least two electrodes are formed in a stripe shape in the major axis direction, and preferably a portion other than the electrodes is formed of an electrically insulating member. This is achieved by the biosensor integrated with the puncture device used as the above.

  The biosensor integrated with a puncture device according to the present invention has a very simple structure because a needle and an electrode are integrally formed for collecting a sample body fluid, so that assembly is easy, and capillary action Alternatively, by providing a blood collection means by any one of the vacuum blood collection methods, a sample body fluid can be reliably collected in a small amount without waste.

  In addition, when a hollow needle is manufactured, a tube having continuously formed striped electrodes can be obtained by using an extrusion method that enables the formation of electrodes at the same time. It has an excellent effect that a biosensor integrated with a puncture device can be produced at low cost.

  Since such a biosensor can be used as a cartridge, it can be easily carried by simple packaging and has an effect of being hygienic after use.

As a biosensor puncture device integrated with a puncture device, it is sufficient that a needle-like structure and an electrode capable of performing puncture are integrated with the tip portion serving as a blood collection port, and specifically, it is used as an injection needle. A hollow needle having at least two electrodes formed in a stripe shape in the major axis direction is used.

As the electrode material, a conductive polymer such as graphite (25 kScm ^-1 ), polyacetylene, polypyrrole, polythiophene, poly p-phenylene, polyphenylene vinylene, iodine polyacetylene, etc., preferably polyacetylene (170 kScm ^-1 ) prepared by Naarmann method is used. The parts other than the electrodes of the hollow needle used are electrically insulating members, for example, non-conductive plastics, inorganic materials such as ceramics, biodegradable materials, etc., preferably polyamide, tetrafluoroethylene, polycarbonate, polyethylene, polyethylene Examples include terephthalate, polystyrene, acrylic, rigid polyvinyl chloride, ABS, polylactic acid, and polyetheretherketone.

  Such a hollow needle is formed by an extrusion method. Specifically, a tube obtained by continuously extruding a conductive polymer and an electrically insulating material melted by heating and shearing heat generated by a screw from a mold designed so that they are adjacent to each other is formed. A hollow needle in which the electrodes are integrated can be produced by forming a desired shape, for example, by cutting one side into a ring and the other with a diagonal cut.

  The electrode 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, a reference electrode, or an electrode method with more poles, but at least inside the hollow needle Two electrodes, the working electrode and the counter electrode, are formed, and the portion opposite to the tip of the hollow needle forms a terminal for sending an electrical signal from the biosensor to the measuring device.

  A reagent layer can be formed on the electrode according to the substance to be measured. The reagent is preferably immobilized on the electrode surface, and the reagent layer is formed on the electrode or the like by a screen printing method or a dispenser method, and is immobilized by an adsorption method involving drying or a covalent bond method.

  Here, when the puncture device-integrated biosensor is configured for blood glucose measurement, for example, a reagent containing glucose oxidase as an oxidase and potassium ferricyanide as a mediator is employed.

  When the reagent is dissolved by the blood, the enzyme reaction is started. As a result, potassium ferricyanide coexisting in the reagent 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 measurement apparatus main body, which will be described later, calculates and determines a glucose concentration (blood glucose level) from the anode current measured at this time, and displays it on a display unit arranged on the surface of the main body.

  The blood is transferred to the biosensor electrode by capillary action. At this time, the electrode may not be sufficiently covered with blood, such as when the hematocrit value is high. The electrode part covered with resist. The resist is formed by a technique such as a screen printing method. Thereby, even when the hematocrit value is high, the electrode can be filled at a minimum, so that the sample liquid can be transferred without being influenced by the state.

  On the other hand, when the hematocrit value is low and blood transfer is performed smoothly, it is necessary to stop capillary action in order to prevent excessive blood collection. This also makes it possible to define the electrode area without using a resist. Examples of this means include a method of providing a through hole in the hollow needle, and a method of narrowing or expanding a portion opposite to the tip of the hollow needle.

  In order to store and use the biosensor integrated with the puncture device in a sanitary manner, at least a part of the puncture device may be provided with a photocatalytic function. As an example of the method, a thin film of titanium oxide or titanium dioxide may be formed on the surface of the puncture device by vapor deposition or sputtering.

  The puncture device integrated biosensor of the present invention may use a vacuum blood sampling method in order to realize rapid movement of blood sampling to the electrode reaction part. In that case, in the case of the vacuum blood collection method, a commercially available vacuum blood collection tube may be used, and it may be assembled into the puncture device-integrated biosensor, or may be assembled at the time of use as an external attachment type. Alternatively, if the inside of the biosensor can be kept confidential, the inside can be kept in a vacuum by providing a diaphragm at the puncture blood collection port. The diaphragm also serves as an introduction guide during blood collection.

  In addition, the puncture device integrated biosensor of the present invention is made into a cartridge type to which a measuring device can be attached, so that operability during use can be improved. As a form of the cartridge, a tubular body, for example, an elastic body such as rubber is fitted on the outer periphery of the biosensor. Furthermore, if this is a disposable type, it is possible to realize the same ease of use as that of a disposable blood glucose sensor currently on the market. In addition, in the case of such a puncture device integrated biosensor, it is preferable in production and use that the packaging form is simple. In consideration of prevention of infectious diseases after use, it is desirable that a simple packaging form that can be repackaged when discarded is taken.

  The cartridge described above can be used for blood collection not only by the user himself but also by puncture using an external puncture drive. In such a form, it is desirable to provide a puncture drive in the measuring device that reads the electrical signal from the cartridge.

Packaging Form As a packaging form of the puncture device integrated biosensor, first, packaging of individual puncture device integrated biosensors, particularly one that protects the puncture blood collection part at the tip of the puncture device integrated biosensor. In particular, the biosensor integrated with a puncture device according to the present invention has a very small structure in order to reduce the amount of collected blood, and therefore cannot be operated by picking it with a finger and attaching it to a measuring device. Therefore, in the case of such a form, the biosensor integrated with the puncture device is a cartridge that can be easily attached to and detached from the measuring device, packaged one by one, or a plurality are contained in one cartridge, You may make it a form which a user does not touch a puncture device integrated biosensor directly at the time of a setting. Thereby, the puncture blood collection part can be protected hygienically and safely until use. Furthermore, by having such a form, repackaging after use is possible, and it is possible to prevent infectious diseases that are a concern after disposal, and as another method of use, body fluid after puncture collection is stored. It is also possible.

  As a first packaging form for packaging one by one, a container or a connected body of a plurality of packages in which a plurality of puncture device integrated biosensor cartridges that are simply packaged can be carried together. In the latter case, after using one, the puncture device-integrated biosensor may be stored in its original state, repackaged, and then separated and discarded. The biosensor cartridge integrated with the puncture device of the present invention is sufficiently small to include the bulk of the simple packaging, so even if a plurality of puncture device integrated biosensor cartridges are stored together in a container, the overall size of the packaging container is small. . Specifically, it is desirable that the pocket size is easy to carry.

  As the second packaging form, a packaging container itself is capable of individually packaging and storing a puncture device integrated biosensor cartridge. In this case, for example, the biosensor cartridge integrated with the puncture device is separately stored in a well-shaped tray, and individually wrapped with a packaging film or the like in order to maintain airtightness.

Measuring device for measuring device puncture device integrated biosensor is easy to carry and has operability and durability for repeated and reliable measurement using cartridge type puncture device integrated biosensor. Those are preferred.

  Specifically, a form in which a cartridge-type puncture device integrated biosensor is slid sideways or inserted in a vertical direction into an introduction portion at the lower part of the measurement apparatus is preferable. At this time, the terminal of the biosensor is connected to the connector of the measuring device so that measurement is possible. After that, when the user decides the puncture portion and starts puncturing, puncturing, blood sampling and measurement are automatically performed, and finally the measurement result is derived.

  An example of structural features will be described in more detail. This measuring device includes a cartridge introduction part, a connector, an electrochemical measurement circuit, a memory part, an operation panel, a measurement part for measuring electrical values in the electrodes of the biosensor, and a display part for displaying the measurement values in the measurement part. In addition, the apparatus can be equipped with radio waves such as Bluetooth (registered trademark) as wireless means.

  In addition, an illumination function can be provided in consideration of use by a dark place or a low vision person. In this case, it is preferable that the user can improve the operability when attaching and puncturing the puncture device-integrated biosensor cartridge. By irradiating the light, the user can easily introduce the cartridge into the measuring apparatus, and the puncture part is illuminated by illumination from the introduction part even after the cartridge is attached. Therefore, it is preferable that a material such as a spacer or a diaphragm for fixing the electrode plate member of the biosensor cartridge integrated with a puncture device having an illumination function is a transparent material.

  In addition to the automatic illumination function of the display unit and puncture unit in the dark place, the measurement device includes a voice guide function and a voice recognition function corresponding to visual impairment due to diabetes, a measurement data management function using a built-in radio clock, measurement data A communication function for a medical institution, a charging function, and the like can be provided.

  The measuring method in the measuring unit of the measuring device is not particularly limited, and potential step chronoamperometry, coulometry, cyclic voltammetry, or the like can be used.

  As described above, the puncture device integrated biosensor, the puncture device integrated biosensor cartridge, and the package thereof according to the present invention do not limit the user, that is, can support universal projects.

  Next, although this invention is demonstrated using an Example, this invention is not limited to a present Example at all.

  FIG. 1 shows an example of a biosensor integrated with a puncture device, which is a hollow needle having a hole portion like an injection needle and in which two electrodes are formed in a stripe shape in the long axis direction. 1a is a block diagram, FIG. 1b is a cross-sectional view taken along the center line in FIG. 1a, FIG. 1c is a front view, and FIG. 1d is a rear view. As shown in FIG. 1a, the hollow needle 1 having a sharp tip is formed with striped electrodes 6 and 6 in the major axis direction, and the portions opposite to the tip are terminals 6 'and 6'. Yes. By puncturing the subject into the puncture unit 7, blood is collected from the puncture blood collection port 8, and then the electrode reaction layer 5 is filled with blood collection by capillary action. Since the puncture device integrated biosensor has the simplest structure, it is most easily manufactured.

  FIG. 2 shows an example of use of the puncture device integrated biosensor shown in FIG. Fig. 2a shows a state before use, Fig. 2b shows a state where the tip of the biosensor 13 integrated with the puncture device is punctured into the skin 14 of the subject, Fig. 2c shows that the subject 14 bleeds after puncture, and the puncture device FIG. 2d shows a state where the blood collection 26 is in contact with the puncture blood collection port of the body-shaped biosensor 13, and FIG. It shows how it is.

  FIG. 3 shows an example of a manufacturing method of the puncture device-integrated biosensor 13 shown in FIG. FIG. 3 a shows the striped tube 4 formed by the extrusion-type striped tube manufacturing apparatus 40. The tube 4 is formed in stripes of two electrically insulating materials and two electrically conductive materials alternately. In this figure, the tip of the tube 4 coming out of the extrusion-type striped tube manufacturing apparatus 40 is connected to a switching valve 45 made of a T-shaped tube, and at that time, by a rotary cutter 41 in front of the extrusion-type striped tube manufacturing apparatus 40 It is cut into a predetermined length (FIG. 3b). At that time, the cutter base 42 is provided with a cutter groove 43 and a groove 44 for fixing the tube, thereby enabling accurate cutting. FIG. 3 b shows a state in which the reagent solution 46 fed from the switching valve 45 is passed through the inner wall of the striped tube 4 after being formed. FIG. 3 c shows a method for forming a reagent layer by the subsequent drying air 47. FIG. 3d shows a state in which the striped tube 4 formed in this way is cut perpendicularly or obliquely with respect to the long axis direction at a constant interval, and the puncture device integrated biosensor 13 is cut out.

  FIG. 4 is an example in which a stopper 2 that is a tubular body is provided on the outer periphery of the biosensor in the needle-integrated biosensor having the shape shown in FIG. 1 so as to be perpendicular to the major axis direction of the biosensor. 1a is a block diagram, FIG. 1b is a cross-sectional view taken along the center line in FIG. 1a, FIG. 1c is a front view, and FIG. 1d is a rear view. Thereby, excessive puncture to the skin due to a failure of the puncture device can be prevented. Also with such a configuration, the needle-integrated biosensor can be used as a cartridge type.

  FIG. 5 shows an example in which an air outlet is provided in the biosensor integrated with the puncture device shown in FIG. 5a is a structural view, FIG. 5b is a cross-sectional view taken along the center line in FIG. 5a, FIG. 5c is a front view, and FIG. 5d is a rear view. As shown in FIG. 5a, stripe-shaped electrodes 6 and 6 are formed on the hollow needle 1 having an acute angle, and terminals 6 'and 6' are formed at portions opposite to the tip. In FIG. 5a, an air discharge port 10 (capillary phenomenon stop) is provided near the terminal side electrode 6 'in order to prevent unnecessarily taking in the blood sample obtained by puncturing. As a result, the air discharge port 10 also plays a role of defining the electrode area.

  FIG. 6 shows an example in which the hollow needle-like puncture device integrated biosensor shown in FIG. 1 is improved for vacuum blood collection. 6a is a configuration diagram, FIG. 6b is a longitudinal cross-sectional view of the center line in FIG. 6a, FIG. 6c is a cross-sectional view along A-A ', and FIG. 6d is a rear view. In FIG. 6, unlike the biosensor integrated with the puncture device shown in FIG. 5, the air discharge port 10 is not provided, and the puncture blood collection unit 8 has the diaphragm 11 and the terminal 6 ′ side in order to maintain the internal vacuum level. Is provided with a partition wall 28.

  FIG. 7 shows an example of use of the vacuum blood collection type puncture device integrated biosensor shown in FIG. FIG. 7a shows a state before use, FIG. 7b shows a state in which the tip of the hollow needle-like puncture device-integrated biosensor 13 is punctured into the skin 14 of the subject, and the diaphragm 11 is broken, and FIG. The specimen 14 bleeds and the blood collection 26 is in contact with the puncture blood collection port of the puncture device integrated biosensor 13, and FIG. 7D shows the electrode from the puncture blood collection port of the puncture device integrated biosensor 13. It shows a state in which it is in a state of measurement after being quickly transferred to the reaction section.

  FIG. 8 shows a connection example of the needle-integrated biosensor and the measuring device according to the present invention. In FIG. 8a, the terminal side is cut out, and the needle integrated biosensor 13 serving as the air discharge port 10 and the capillary action stop is shown in FIG. 8d. In FIG. 8d, the needle integrated biosensor forms two connectors 29 and 29. A state of being connected to a measuring device 18 having 30 is shown. In this embodiment, the contact with the measuring device 18 does not need to come into contact with the sample solution by the air discharge port 10 and the capillary action stop provided in the needle integrated biosensor 13, so that the connector 29 can be prevented from being contaminated.

  FIG. 9 is a view showing another example of connection between the needle-integrated biosensor and the measuring device according to the present invention, and shows a connector 29 having a shape different from that of the connector 29 shown in FIG. The connector 29 shown in FIG. 9a has the shape of the sensor holder 30 as a whole, and the needle-integrated biosensor 13 can be fixed more securely than the connector 29 shown in FIG. Yes. As shown in FIG. 9b, the sensor holder 30 includes a sensor holder upper lid 31 and a sensor holder base 32, and a gap for sandwiching the terminal 6 ′ portion of the needle-integrated biosensor 13 between the sensor holder 30 and the sensor holder base 32, A terminal stop 12 for preventing the terminal-side electrode 6 ′ of the needle-integrated biosensor 13 from entering the holder 30 more than necessary is provided inside the sensor holder upper lid 31. Terminal 6 ′ portions are provided at two locations on the sensor holder base 32 for electrical connection to the terminal 6 ′ of the needle integrated biosensor 13 inserted in the gap 29. FIG. 9c shows a front view of the connector 29, and FIG. 9d shows the connector 29 in the AA 'cross section. A terminal stop 12 for removing the needle-integrated biosensor 13 connected to the connector 29 is provided on the inner wall surface of the sensor holder upper lid 31 so as not to contact the sensor holder base 32.

  FIG. 10 is a diagram showing an example of use of a needle-integrated biosensor connector. 10a shows a state in which the needle-integrated biosensor 13 is connected to the connector, FIG. 10b shows a state in which the needle-integrated biosensor 13 is connected, and FIG. 10c shows a state in which the needle-integrated biosensor 13 is removed after use. . As shown in FIG. 10c, when the connection between the terminal and the connector of the needle-integrated biosensor 13 is released, the sensor holder base 32 moves in the direction opposite to the direction of the sensor. The terminal is pulled away from the connector.

  FIG. 11 shows a case where the needle-integrated biosensor shown in FIG. 10 is connected to a measuring device and used. The measuring device 33 includes a trigger unit 34 with a sensor detachment / puncture drive, an operation panel 36, a display unit 37, a button 38, a hook 49, a puncture start button 39, and a needle-integrated biosensor introduction unit 35. It is attached to the sensor holder 30 of the needle-integrated biosensor introduction part 35 under the measuring device 33. This sensor holder 30 is shown in FIG. The shape of the measuring device 33 is easy to carry and has excellent operability.

  FIG. 12 shows an example of use of the measuring apparatus of FIG. In FIG. 12a, the sensor 13 is attached in a state where the trigger part 34 with sensor detachment / puncture drive is in the middle stage. 12B, the trigger for puncture driving is set by pulling up the trigger part 34 with cartridge detachment / puncture drive to the upper stage, and the sensor 13 shown in FIG. FIG. 12c shows a state in which the sensor 13 protrudes from the measuring device 33 by a predetermined length by pressing the puncture start button 39 after the puncture site is determined. At this time, the trigger part 34 with sensor attachment / detachment / puncture drive returns to the original middle position. FIG. 12d shows a state in which the puncture and blood collection are finished, the sensor is stored in the measuring device 33, and the electrochemical measurement is performed. FIG. 12e shows how the sensor 13 is removed by the mechanism of the sensor holder 30 shown in FIG. 10 by lowering the trigger part 34 with sensor detachment / puncture drive to the lower stage after the electrochemical measurement is completed.

  FIG. 13 is a diagram illustrating another example of use of the connector for a needle-integrated biosensor. 13a is a state before the needle-integrated biosensor 13 is connected to the connector 29, FIG. 13b is a cross-sectional view taken along the center line in FIG. 13a, FIG. 13c is a state when these are connected, and FIG. The centerline cross-sectional view at 13c is shown respectively. As shown in FIGS. 13 a and 13 b, the sensor introduction guide 3 is provided at the tip of the connector 29, that is, the connection portion with the sensor 13. The sensor introduction guide 3 has a rounded shape so that the tiny sensor 13 can be easily connected to the connector 29. Further, the terminal 29 is provided in the connector 29 so that the sensor 13 cannot enter more than a certain depth. With this type of connector 29, there is no risk of contact with the connector 29 even if the sample liquid is seen in the sensor 13. Further, by making the thickness of the terminal stop portion 12 thinner than the wall thickness of the sensor 13, it is possible to prevent the sample liquid from spreading into the connector 29. In the case of this connector 29, the sensor 13 can be removed after use by spreading the connector 29 including two terminals 6 'and 6'.

  FIG. 14 shows a case where the needle-integrated biosensor 13 is connected to the measuring apparatus having the connector 29 shown in FIG.

  FIG. 15 shows an example of use of the measuring apparatus of FIG. In FIG. 15a, the trigger part 34 with sensor detachment / puncture drive is in the middle state, and as shown in FIG. 15b, the trigger 29 with sensor detachment / puncture drive is lowered to the lower stage, so that the connector 29 is attached from below the measuring device 33. appear. In this state, the sensor 13 is attached (FIG. 15c). In FIG. 15 d, the trigger for puncture driving is set by pulling up the trigger portion 34 with cartridge detachment / puncture drive to the upper stage, and the sensor 13 shown in FIG. 14 enters the measuring device 33. In this state, the user determines the puncture site. FIG. 15e shows a state in which the sensor 13 protrudes from the measuring device 33 by a predetermined length when the puncture start button 39 is pressed. At this time, the trigger part 34 with sensor attachment / detachment / puncture drive returns to the original middle position. FIG. 15f shows a state in which the puncturing / blood collection is completed and the sensor is stored in the measuring device 33 and the electrochemical measurement is performed. FIG. 15g shows a state in which the distance between the terminals of the connector 29 is increased and the sensor 13 is removed by lowering the trigger part 34 with sensor attachment / detachment / puncture drive after the electrochemical measurement is completed.

  FIG. 16 shows an example in which the needle-integrated biosensor with stopper 2 shown in FIG. 13 is used in a mortar-like container (packaging body) 52. As shown in this figure, it is shown that the needle integrated biosensor 13 can be used in a cartridge type by providing the stopper 2 on the outer periphery. FIG. 16 a shows the state from the side of the sensor 13, and FIG. 16 b shows the state from the top of the sensor 13. As shown in FIGS. 16 a-i, the stopper 2 provided on the outer periphery causes the tip of the needle-integrated biosensor 13 packaged in the container 52 not to contact the bottom of the container 52, which may cause damage. There is no. The needle-integrated biosensor 13 is fixed at a predetermined position in the container 52 by the stopper 2. Further, an adhesive film 54 is provided on the upper portion of the container 52, and simple packaging is possible. 16b-i, unlike the case shown in FIG. 16a-i, there is a space around the stopper 2. FIG. This is a space for the connector 29 of the measuring device to be described later to open the needle-integrated biosensor 13 after use. FIG. 16ii shows a state before the adhesive film 54 is peeled off and the sensor introduction part 35 of the measuring device is fitted into the needle-integrated biosensor 13. FIG. 16iii shows a state in which the sensor 13 placed in the deep part of the package 52 is set by the mechanism of the sensor holder 30 shown in FIGS. 13 to 15, and the connector 29 is connected to the biosensor 13 integrated with a needle. Each terminal is connected. Here, the wrapping body 52 has a mortar shape in order to facilitate the attachment of the sensor 13 to the measuring device 33 which is extremely small and difficult to operate by directly touching the hand. The tip of the measuring device 33 is securely attached to the sensor 13. Moreover, it is necessary to prevent a short circuit that may occur in the connection of each terminal with the measuring device and the needle-integrated biosensor 13. Therefore, a mark is attached to the packaging container 52 so that the orientation of the measuring device inserted by the user is not mistaken, or the needle-integrated type is used only in a direction in which the shape of the sensor container 35 of the packaging container 52 and the measuring device is determined. A structure in which the biosensor 13 can be fitted, for example, a part of the packaging container 52 and the sensor introduction part 35 of the measuring device may have a key-keyhole relationship. FIG. 16iii shows a state in which the sensor introduction part 35 of the measuring device is inserted into the packaging container 52, and the needle-integrated biosensor 13 is pushed vertically and fitted. Here, when the connector 29 is fitted into the terminal portion of the needle-integrated biosensor 13, the needle-integrated biosensor 13 is taken into the sensor introduction portion 35 of the measuring device and used for measurement as shown in FIG. 16iv. FIG. 16v shows how the needle-integrated biosensor 13 is removed after use. Thereafter, the adhesive film 54 is reapplied as shown in FIG. Thus, by repackaging the needle-integrated biosensor 13 after use, it is possible to prevent infectious diseases in disposal after use.

  FIG. 17 shows a state in which a plurality of packaging bodies 52 shown in FIG. 16 are connected in a stick shape (FIG. 17a). A perforation 53 is provided at the boundary between the individual packaging bodies 52, and can be used (FIG. 17b) or separated (FIG. 17c) as needed.

  FIG. 18 is a view showing an operation mechanism in the measuring apparatus in the case of the sensor assembly cartridge 48 to which the eight needle-integrated biosensors 13 with stoppers shown in FIG. 13 are attached, and FIG. From the top, FIG. 18b is shown from the side. FIG. 18 a i shows a state in which the sensor assembly cartridge 48 and the presser 56 sandwich the sensor holder 30 therebetween. At this time, the sensor holder 30 is actually disposed at the upper part between both the sensor assembly cartridge 48 and the presser 56 (FIG. 18b i). In FIG. 18ii, the sensor assembly cartridge 48 and the presser 56 are moved directly below the sensor holder 30, and one of the sensors 13 fitted in the sensor assembly cartridge 48 is pressed by the presser 56. Show. FIG. 18iii shows a state in which the sensor holder 30 descends from the top toward the terminal of the sensor 13 being pressed by the presser 56 and is connected. Thereafter, the sensor holder 30 to which the sensor 13 is connected rises to the original position, and at the same time, both the sensor assembly cartridge 48 and the presser 56 return to the original position (FIG. 18iv). In this state, a series of operations of puncture, blood collection, and measurement are performed. Thereafter, the used sensor 13 is removed from the sensor holder 30 as shown in FIG. In parallel with this operation, the sensor assembly cartridge 48 is rotated by 45 °, and the next sensor 13 is set in front of the presser 56. With such an 8-series sensor assembly cartridge 48, it is easy to attach the sensor to the measuring device 33, and unlike the embodiment shown in FIG. 14, the labor of replacing the sensor 13 each time can be saved.

  FIG. 19 shows an example of use of the measuring device 33 provided with the mechanism of the sensor assembly cartridge 48 shown in FIG. FIG. 19 a shows how the sensor assembly cartridge 48 is stored in the openable sensor assembly cartridge housing 62. Here, the sensor assembly cartridge 48 is also stored in the sensor assembly cartridge housing 62. In addition, when the openable sensor assembly cartridge housing 62 is set in the measuring device 33, the openable sensor assembly cartridge housing 62 opens inside the measuring device, and the measuring device can take out the sensor 13 attached to the sensor assembly cartridge 48. FIGS. 19a iii and iv show examples of attaching the sensor assembly cartridge 48 to the measuring device 33 when the cartridge introduction part 50 is viewed from the side and the front. In FIG. 19a iii, the configuration of the measuring device 33 is shown. The measuring device 33 includes a trigger unit 34 with a sensor detachment / puncture drive, an operation panel 36, a display unit 37, a button 38, a hook 49, a puncture start button 39, and a needle-integrated biosensor cartridge introduction unit 50, and a sensor assembly. The cartridge 48 is attached to the sensor assembly cartridge introducing portion 50 under the measuring device 33. A groove (sensor assembly cartridge insertion groove) 64 for facilitating the insertion of the sensor assembly cartridge 48 is dug in the upper part of the sensor assembly cartridge introducing portion 50. A dial 51 is provided at the lower portion of the introduction portion 50, and an insertion groove 64 for the sensor assembly cartridge 48 is dug in the dial 51 so that the sensor assembly cartridge 48 can be held by the upper and lower grooves. It has become. Furthermore, since the lower portion is a dial 51, the rotation mechanism shown in FIG. 18v works on the dial 51, so that the inserted sensor assembly cartridge 48 does not come off.

  FIG. 19b shows the measuring device 33 with the sensor assembly cartridge 48 attached. FIG. 19c shows a state in which the trigger part 34 with sensor detachment / puncture drive is lowered to the lower stage, and the mechanism shown in FIGS. 18ii to iii works inside the measuring apparatus, and the sensor 13 is set in the sensor holder 30. Yes. FIG. 19d shows a state in which the trigger part 34 with sensor attachment / detachment / puncture drive is raised in two stages, and the mechanism shown in FIG. 18iv works inside the measurement apparatus, and the sensor holder 30 with the sensor 13 set is used for the measurement apparatus 33 for puncture. It has moved to the top of FIG. 19e shows a state in which the sensor 13 protrudes from the measuring device 33 by a predetermined length when the puncture start button 39 is pressed. At this time, the trigger part 34 with sensor detachment / puncture drive stops at the middle position. FIG. 19f shows a state in which the puncturing / blood collection is completed, the sensor is stored in the measuring device 33, and the electrochemical measurement is performed. FIG. 19g shows how the sensor 13 is removed by the mechanism of the sensor holder 30 shown in FIG. 12 by lowering the trigger part 34 with sensor detachment / puncture drive to the lower stage after the electrochemical measurement is completed. The mechanism inside the measuring device 33 at this time is as shown in FIG. If it is the shape of this measuring apparatus 33, it can also carry and it is excellent also in the point of operativity.

It is a figure which shows an example of the puncture device integrated biosensor which concerns on this invention. It is a figure which shows the usage example of the biosensor with a puncture device which concerns on this invention. It is a figure which shows one manufacture example of the puncture device integrated biosensor which concerns on this invention. It is a figure which shows an example of the biosensor cartridge with a puncture device with stopper according to the present invention. It is a figure which shows the other example of the puncture device integrated biosensor which concerns on this invention. It is a figure which shows an example of the vacuum blood collection type puncture device integrated biosensor which concerns on this invention. It is a figure which shows one usage example of the vacuum blood collection type puncture device integrated biosensor which concerns on this invention. It is a figure which shows one example of a connection to the measuring apparatus of the needle | hook integrated biosensor which concerns on this invention. It is a figure which shows an example of the connector for needle integrated biosensors which concerns on this invention. It is a figure which shows the example of one connection to the connector of the needle | hook integrated biosensor which concerns on this invention. It is a figure which shows one example of a connection to the measuring apparatus of the needle-integrated biosensor cartridge according to the present invention. It is a figure which shows one use example of the measuring apparatus equipped with the needle-integrated biosensor cartridge according to the present invention. It is a figure which shows the other example of a connection to the connector of the needle | hook integrated biosensor which concerns on this invention. It is a figure which shows the other example of a connection to the measuring apparatus of the needle | hook integrated biosensor which concerns on this invention. It is a figure which shows one use example of the measuring apparatus equipped with the needle-integrated biosensor cartridge according to the present invention. It is a figure which shows one structural example and one usage example of the packaging body for needle | hook-integrated biosensor cartridges with a stopper which concerns on this invention. It is a figure which shows the example of 1 aspect of the packaging body for needle | hook integrated biosensor cartridges based on this invention. It is a figure which shows one connection example to the measuring apparatus of the needle | hook integrated biosensor assembly cartridge which concerns on this invention. It is a figure which shows one structural example and one usage example which mounted | wore with the needle-integrated biosensor assembly cartridge according to the present invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Hollow needle 2 Stopper 3 Sensor introduction guide 4 Striped tube 5 Electrode reaction layer 6 Electrode 6 'Terminal side electrode 7 Puncture part 8 Puncture blood collection port 9 Electrical insulator 10 Air discharge port 11 Diaphragm 12 Terminal stop part 13 Puncture device integrated type Biosensor 14 Subject 18 Measuring device 26 Blood collection 28 Septum 29 Connector 30 Sensor holder 31 Sensor holder upper lid 32 Sensor holder base 33 Measuring device 34 with puncture drive 35 Sensor introduction unit 36 Operation panel 37 Display unit 38 Operation button 39 Puncture start button 40 Extrusion-type striped tube manufacturing device 41 Rotating cutter 42 Cutter base 43 Cutter groove 44 Tube fixing groove 45 Switching valve 46 Reagent liquid 47 Dry air 48 Sensor assembly cartridge 49 Hook 50 Cartridge introduction 51 dial 52 package 53 perforation 54 adhesive film 55 re package 56 retainer 62 retractable sensor assembly cartridge housing 64 cartridge inserting groove

Claims (23)

  A puncture device-integrated biosensor in which a hollow needle having a hole, in which at least two electrodes are formed in a stripe shape in the long axis direction, is used as a puncture needle.   The biosensor according to claim 1, wherein the electrode material is a conductive polymer.   The biosensor with integrated puncture device according to claim 1, wherein a portion other than the electrode of the hollow needle is formed of an electrically insulating member.   The biosensor according to claim 1, 2 or 3, wherein the hollow needle is formed by an extrusion molding method.   The puncture device integrated biosensor according to claim 1, wherein a portion opposite to the tip of the hollow needle forms a terminal for sending an electric signal to the measuring device.   The puncture device integrated biosensor according to claim 1, wherein an electrode area is defined by a resist.   The biosensor with integrated puncture device according to claim 1, wherein a reagent layer is formed on the electrode.   The puncture device-integrated biosensor according to claim 1, wherein a hollow needle provided with a photocatalytic function is used.   The biosensor with integrated puncture device according to claim 1, further comprising a body fluid collection stop portion due to a capillary phenomenon.   The puncture device integrated biosensor according to claim 1, wherein blood collection is performed by a vacuum blood collection method.   The biosensor with integrated puncture device according to claim 10, wherein a diaphragm is provided at a puncture blood collection port having a columnar structure.   The biosensor according to any one of claims 1 to 11, which is of a cartridge type.   A biosensor cartridge in which a tubular body is fitted on the outer periphery of the biosensor integrated with a puncture device according to any one of claims 1 to 12.   14. The puncture device integrated biosensor cartridge according to claim 13, which is a disposable type.   The puncture device integrated biosensor cartridge according to claim 13, which is in a packaged state.   The biosensor cartridge according to claim 15, wherein the biosensor cartridge is packaged in a repackable state.   A sensor assembly cartridge containing a plurality of puncture device-integrated biosensor cartridges according to any one of claims 12 to 14.   A puncture device-integrated biosensor cartridge package containing a plurality of puncture device-integrated biosensor cartridges according to any one of claims 12 to 16.   17. The biosensor cartridge integrated with a puncture device according to any one of claims 12 to 16, a biosensor cartridge introduction portion integrated with a puncture device into which the cartridge is inserted and set, and a connector that captures an electrical signal at an electrode of the cartridge Unit, a measurement unit that measures electrical values via a connector unit, an operation panel unit for measurement, a display unit that displays measurement values in the measurement unit, a memory unit that stores measurement values, a drive unit for a puncture needle, A measurement device for a biosensor integrated with a puncture device, comprising a drive trigger portion and a puncture start button for starting puncture with a puncture needle.   The puncture device-integrated biosensor measurement device according to claim 19, further comprising a sensor assembly cartridge introducing portion for mounting a sensor housing storing the sensor assembly cartridge.   21. The measurement device for a biosensor with an integrated puncture device according to claim 19 or 20, wherein a potential step chronoamperometry method, a coulometry method, or a cyclic voltammetry method is applied as a measurement method in the measurement unit.   The measuring device for a biosensor integrated with a puncture device according to any one of claims 19 to 21, wherein the insertion port of the biosensor cartridge with an integrated puncture device can be illuminated. The puncture according to any one of claims 19 to 22, comprising at least one of a voice guide function and a voice recognition function, a measurement data management function using a built-in radio clock, a communication function of measurement data to a medical institution, and a charging function. Instrument-integrated biosensor measurement device.

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