JP2010119865A - Method of manufacturing biosensor integrated with puncture device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a biosensor integrated with a puncture device facilitating the manufacture by forming the biosensor in an extremely simple structure while retaining sufficient strength capable of withstanding an impact by puncture performed by a user himself/herself, and capable of reliably measuring a small amount of sample solution by minimizing the biosensor as a whole. <P>SOLUTION: The biosensor integrated with the puncture device uses a puncture needle formed with at least two electrodes on the inner wall of the hollow needle with a hole section. The biosensor is manufactured by forming a thin film of electric insulation on the surface of a metal flat plate that serves as the inner wall of the hollow needle, and disposing at least two conductive materials on the surface so as to be parallel to the longitudinal axis direction of the hollow needle, and afterward by forming a hollow tubular structure from the metal flat plate with the electrodes located inside thereof, and cutting it into a needle shape. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

The present invention relates to a method for producing a biosensor integrated with a puncture device. 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 method for manufacturing 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 to attach and detach the blood collection needle, collect blood by inserting a blood collection needle into his / her fingertip or arm, etc., and transfer the collected blood to a blood glucose analyzer to measure the blood glucose level. 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 sites 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, measurement failure occurs, and the patient who is the subject has the inconvenience of having to pierce again and replace the biosensor and perform measurement again (see Patent Documents 1 and 2).

  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.

  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.

  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.

JP-A-9-266898 Japanese Patent Publication No. 8-20412 JP 2000-217804 A Republished 2002-056769

  The object of the present invention is that it is easy to manufacture and is miniaturized as a whole by forming it with a very simple structure while maintaining sufficient strength to withstand impact 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.

An object of the present invention is to provide an electrically insulating thin film on the surface of a metal flat plate that serves as the inner wall of a hollow needle, and further provide at least two conductive materials on the surface so as to be parallel to the long axis direction of the hollow needle. After placement, a puncture needle in which at least two electrodes are formed on the inner wall of a hollow needle having a hole by forming a hollow cylindrical structure with the metal plate as an electrode inside and cutting out into a needle shape is used. This is achieved by manufacturing a biosensor with integrated puncture device .

The biosensor integrated with a puncture device produced by the manufacturing method according to the present invention has a very simple configuration because it is formed integrally with a needle and an electrode for collecting a sample body fluid, and therefore easy to produce. In addition, by providing a blood collection means by any one of capillary action or vacuum blood collection method, it has a feature that a sample body fluid can be reliably collected in a small amount without waste. 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.

It is a figure which shows one manufacture example of a puncture device integrated biosensor. It is a figure which shows an example of a puncture device integrated biosensor. It is a figure which shows one usage example of a biopsy sensor integrated with a puncture device. It is a figure which shows an example of a vacuum blood collection type puncture device integrated biosensor. It is a figure which shows one example of use of a vacuum blood collection type puncture device integrated biosensor. It is a figure which shows one example of a connection to the measuring apparatus of a needle integrated biosensor. It is a figure which shows one structural example of the connector for needle | hook integrated biosensors. It is a figure which shows one connection example to the connector for needle-integrated biosensors. It is a figure which shows an example of the puncture device integrated biosensor cartridge with a stopper. It is a figure which shows one example of connection to the measuring apparatus of the needle | hook-integrated biosensor cartridge with a stopper. It is a figure which shows one example of use of the measuring apparatus with which the needle | hook integrated biosensor cartridge with a stopper was mounted | worn. 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. It is a figure which shows the example of 1 aspect of the packaging body for needle | hook integrated biosensor cartridges. It is a figure which shows one example of a connection to the measuring apparatus of a needle | hook integrated biosensor assembly cartridge. 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.

The biosensor puncture device integrated with the puncture device only needs to have a needle-like structure capable of performing puncture at the tip portion serving as a blood collection port, and specifically, a hollow needle used as an injection needle Is used. As such a hollow needle, one made of a conductive material is used . As the conductive material , stainless steel, brass, steel, titanium, titanium alloy, copper, or the like is used.

The inner surface of the hollow needle, Ru is formed at least two or more electrodes Tei. Between the hollow needle and the electrode made of a conductive material, electrically insulating thin film is provided. By forming the electrically insulating thin film , the target substance can be measured without being affected by the hollow needle material made of a conductive material.

As an electrode forming method on the inner surface of the hollow needle, an ordinary hollow needle manufacturing method in which a metal flat plate is formed into a cylindrical shape is applied, that is, an electrically insulating thin film is formed on the surface of the metal flat plate serving as the inner wall of the hollow needle. And a method of forming the hollow needle by arranging at least two conductive materials on the surface thereof so as to be parallel to the long axis direction of the hollow needle when molded.

The hollow needle (puncture device integrated biosensor) formed by the above manufacturing method needs strength and sharpness that can pierce the skin of the subject, but to increase the strength, the size of the hollow needle is increased. This is not preferable because it causes pain and increased blood sampling, resulting in physical and mental distress to the user. Therefore, the size of the hollow needle needs to be as thin and thick as possible while maintaining the strength to withstand puncture, and the outer diameter of the needle is 21 to 33 gauge, similar to a commercially available injection needle. It is preferable. Further, the shape of the tip is not an acute angle as seen in a normal puncture needle, but is preferably an obtuse angle that allows blood to be collected efficiently even when the contact angle is small, specifically the angle of the tip. Of 30 to 70 degrees is used. Furthermore, in order to relieve the pain of puncture, it is preferable that the puncture portion has a sharp shape.

  As the electrode material, in addition to the above conductive polymer, carbon, silver, silver / silver chloride, platinum, gold, nickel, copper, palladium, titanium, iridium, lead, tin oxide, platinum black, etc., preferably copper Used. Here, as the carbon, carbon nanotubes, carbon microcoils, carbon nanohorns, fullerenes, dendrimers, or derivatives thereof can be used. Such an electrode is preferably a thin film, and the electrode is formed by a screen printing method, a vapor deposition method, a sputtering method, a foil attaching method, a plating method, or the like. Such an electrode is formed such that a portion opposite to the tip of the hollow needle can form a terminal for sending an electric signal from the biosensor to the measuring device.

  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 Thus, two working and counter electrodes are formed.

  A reagent layer can be formed on the electrode according to the substance to be measured. The reagent is preferably immobilized uniformly inside the hollow needle, and the reagent layer is formed through dry air after feeding the reagent solution into the hollow needle, and can be immobilized by an adsorption method or a covalent bonding method with drying. Done.

  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 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.

  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 an immersion 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 the means include a method of providing a through hole in the hollow needle, a method of cutting, 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 may use a vacuum blood sampling method in order to realize rapid movement of blood sampling to the electrode reaction part. In that case, the inside of the biosensor can be kept confidential, and the inside of the biosensor 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.

Moreover, the operability at the time of use can be improved by making the biosensor integrated with the puncture device into a cartridge type to which the measuring device can be attached. 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.

From the above, the puncture device integrated biosensor and the puncture device integrated biosensor cartridge obtained by the manufacturing method according to the present invention , and the package thereof can be used for universal planning without limiting the user. It has become a thing.

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

FIG. 1 is a view showing an example of manufacturing a biosensor integrated with a puncture device according to the present invention. FIG. 1 ai is formed by sputtering on an electrical insulating layer formed on the surface of a metal flat plate 57 in parallel with the long axis direction when two electrodes 6 are formed into hollow needles at regular intervals. A front view is shown. FIG. 1 a ii shows a side view of FIG. 1 a i. FIG. 1 a iii shows a hollow cylindrical structure 58 in which the metal flat plate 57 is formed with the electrode 6 inside. 1 a iv shows a hollow needle 1 formed by cutting the cylindrical structure 58 of FIG. 1 a iii by cutting one end perpendicular to the long axis direction and the other end obliquely with respect to the long axis direction. Indicates. FIG. 1 b shows a completed drawing of the hollow needle 1 formed as described above.

FIG. 2 shows an example of a biopsy sensor integrated with a puncture device in which an electrode is formed on the inner wall of a hollow needle having a hole like an injection needle produced by the production method according to the present invention . Figure 2 a is a configuration diagram, Fig. 2 b is the center line cross-sectional view in FIG. 2 a, FIG. 2 c is a front view, FIG. 2 d shows a rear view. As shown in FIG. 2 a, electrodes 6 and 6 ′ are formed as thin films on the front and back sides of the inner wall of the hollow needle 1 having an acute angle. In this figure, the electrode is directly formed on the inner wall of the hollow needle. However, when the hollow needle is conductive, an electrode pattern is formed after an electrically insulating thin film is formed on the inner wall. In FIG. 2 a, an air outlet 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. Therefore, the air outlet 10 also plays a role of defining the electrode area. 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.

Figure 3 shows an example of use of the puncture device integrated-type biosensor shown in FIG. Figure 3 a is a state before use, Fig. 3 b is a state where the tip end of the puncture device integrated-type biosensor 13 on the skin 14 of the subject is punctured, FIG. 3 c is after puncturing, the subject 14 is bleeding, state puncturing blood inlet to blood sampling 26 of the puncture device integrated-type biosensor 13 is in contact, FIG. 3 d is punctured blood outlet from the collection 26 of the puncture device integrated-type biosensor 13 is transported by capillary action to the electrode reaction part of the measurement It shows a state entering.

FIG. 4 shows an example in which the hollow needle-like puncture device integrated biosensor shown in FIG. 2 is improved for vacuum blood collection. Figure 4 a is a configuration diagram, FIG. 4 b is a center longitudinal sectional view taken along a line in FIG. 4 a, FIG. 4 c is cross section B-B ', and FIG. 4 d shows a rear view. In FIG. 4 , unlike the puncture device integrated biosensor shown in FIG. 2 , the air discharge port 10 is not provided, and the puncture blood collection unit 8 has a diaphragm 11 and a terminal 6 side in order to maintain the degree of vacuum inside. Is provided with a partition wall 28.

Figure 5 shows an example of the use of the vacuum blood collection lancing device integrated-type biosensor shown in FIG. Figure 5 a is a pre-use state, FIG. 5 b the distal end portion of the hollow needle-like puncture device integrated-type biosensor 13 on the skin 14 of the subject punctures, state diaphragm 11 is broken, Fig. 5 c puncture after the subject 14 bleeding puncture device integrated state blood 26 to puncture blood collecting port of the biosensor 13 are in contact, FIG. 5 d is a vacuum blood collection 26 is an internal from the puncture blood port of the puncture device integrated-type biosensor 13 It shows a state in which it is in a state of measurement after being promptly transferred to the electrode reaction part in the atmosphere.

FIG. 6 is a diagram illustrating an example of connection between a needle-integrated biosensor and a measurement device. In FIG. 6 a, the needle-integrated biosensor 13 with the terminal side cut out and provided with an air discharge port 10 serving as a capillary action stop is provided in a measuring device 18 having a sensor holder 30 in which two connectors 29 and 29 are arranged. It shows how they are connected. In such a form, the capillary phenomenon is stopped by the air discharge port 10 provided in the needle integrated biosensor 13, so that the contact point with the measuring device 18 does not need to come into contact with the sample solution, and the connector 29 is contaminated. Can be prevented.

Figure 7 is a diagram showing another example of connection of the needle-integrated biosensors of the present invention and the measurement device, which is a connector 29 of a different shape from the connector 29 shown in FIG. Entire connector 29 shown in FIG. 7 a has taken the shape of the sensor holder 30, compared to the case of the connector 29 shown in FIG. 6, the fixation of the needle-integrated biosensor 13 becomes more reliably performed structure ing. Then, the sensor holder 30 and the clearance for 7 consists sensor holder top cover 31 and the sensor holder base 32, as shown in b, between the two sandwiching terminals 6 'portion of the needle-integrated biosensors 13, A terminal stop 12 for preventing the terminal side electrode 6 ′ of the needle-integrated biosensor 13 from entering the sensor 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. 7 c shows a front view of the connector 29, and FIG. 7 d 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. 8 is a diagram showing an example of use of the needle-integrated biosensor connector. Figure 8 a shows a state in which the needle-integrated biosensor 13 is connected to the connector, FIG. 8 b shows a state when connected, FIG. 8 c is a state when removing the needle-integrated biosensor 13 after use Show. As shown in FIG. 8 c, when releasing the connection between the terminals and the connector of the needle-integrated biosensor 13, that sensor holder base 32 moves in opposite direction with a sensor, needle-integrated biosensor 13 The terminal is pulled away from the connector.

Figure 9 is the needle-integrated biosensor having the shape shown in FIG. 6, so as to be perpendicular to the long axis direction of the biosensor, an example in which the stopper 2 is tubular body biosensor periphery. 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. 10 shows a case where the needle-integrated biosensor with a stopper shown in FIG. 9 is connected to a measuring apparatus and used. The measuring device 33 includes a trigger unit 34 with 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. The sensor 13 is attached to the sensor holder 30 of the needle-integrated biosensor introduction unit 35 under the measuring device 33. The sensor holder 30 are those shown in FIG. The shape of the measuring device 33 is easy to carry and has excellent operability.

Shown in FIG. 11 is an example of using the measuring apparatus of FIG. 10. In FIG. 11 a, the sensor 13 with the stopper 2 is attached in a state where the trigger portion 34 with sensor detachment / puncture drive is in the middle stage. In FIG. 11 b, 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. 9 enters the measuring device 33. After Figure 11 c is that defines the puncture site, the sensor 13 by pressing the puncturing start button 39 indicates a state of protruding from the predetermined length measuring device 33. At this time, the trigger part 34 with sensor attachment / detachment / puncture drive returns to the original middle position. Figure 11 d shows a state where the puncture-blood is stored sensors completed into the interior of the measuring device 33, an electrochemical measurement is made. FIG. 11 e shows a state where the sensor 13 is removed by the mechanism of the sensor holder 30 shown in FIG. 8 by lowering the trigger part 34 with sensor detachment / puncture drive to the lower stage after the electrochemical measurement is completed. .

FIG. 12 shows an example in which the stopper-integrated needle-integrated biosensor shown in FIG. 9 is packaged and used in a container. 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. In FIG. 12 a, the sensor 13 is contained in a mortar-like container (packaging body) 52 and is simply packaged by an adhesive film 54. The packaged sensor 13 is provided with a stopper 2, thereby preventing the tip of the sensor 13 from coming into contact with the inner wall of the container. FIG. 12 b shows a state before the adhesive film 54 of the package 52 is peeled off and the sensor introduction part 35 portion of the measuring device is attached to the sensor holder 30 at the tip. Figure 12 c shows a state where the sensor 13 is placed deep in the package 52 by a mechanism of the sensor holder 30 shown in FIG. 8 is set. Here, the wrapping body 52 has a mortar shape in order to facilitate the attachment of the sensor 13 to the measuring device 33 that is extremely small and difficult to operate by direct hand contact. The tip of the measuring device 33 is securely attached to the sensor 13. In addition, since 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, is a mark that prevents the user from inserting the measuring device into the packaging container 52 in the wrong direction? Or, a structure in which the needle-integrated biosensor 13 can be fitted only in a direction in which the shape of the packaging container 52 and the sensor introduction part 35 of the measuring device is determined, for example, a part of the packaging container 52 and the sensor introduction part 35 of the measuring device. It is good also as a structure which becomes the relationship between a key and a keyhole. FIG. 12 d shows a state in which the sensor 13 is attached to the measuring device 33 and detached from the package 52. FIG. 12 e shows how the sensor 13 is returned to the packaging container after use. This operation is performed by the same operation as Figure 11 e. FIG. 12 f shows the sensor 13 being repackaged 55 with the adhesive film 54 after use. By repackaging, it is possible to prevent infectious diseases caused by the body fluid adhering to the sensor 13 in advance.

Figure 13 shows a state in which the package 52 shown in FIG. 12 connected to a plurality stick (Figure 13 a). The boundary of an individual packaging body 52 perforation 53 is provided, it is used (FIG. 13 b) or disconnect the individual packaging body as needed (Fig. 13 c).

Figure 14 is a diagram showing the operation mechanism in the measuring apparatus in the case of the sensor assembly cartridge 48 the stopper with a needle-integrated biosensor 13 shown in FIG 9 is attached eight, their 14 a , from the top, FIG. 14 b is shown from the side. FIG. 14 a i shows a state where 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. 14 b i). In FIG. 14 ii, 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. Is shown. FIG. 14 iii shows a state in which the sensor holder 30 is lowered and connected to the terminal of the sensor 13 pressed by the pressing tool 56 from directly above. 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. 14 iv). In this state, a series of operations of puncture, blood collection, and measurement are performed. Thereafter, the sensor 13 after use, as shown in Figure 14 v is removed from the sensor holder 30. 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. 10 , the labor of replacing the sensor 13 each time can be saved.

Shown in FIG. 15 shows an example of using the measuring device 33 having a mechanism of the sensor assembly cartridge 48 shown in FIG. 14. FIG. 15 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 housing 62 is set in the measuring device 33, the openable sensor housing 62 opens in the measuring device, and the measuring device can take out the sensor 13 attached to the sensor assembly cartridge 48. FIGS. 15 a iii and iv show an example 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. FIG. 15 a iii shows the configuration of the measuring device 33. 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. Further, the lower is because has a dial 51, the rotation mechanism shown in FIG. 14 v that work in the dial 51, the inserted sensor assembly cartridge 48 is structured to not come off.

Figure 15 b shows a measuring device 33 in the state of attaching the sensor assembly cartridge 48. FIG. 15 c 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. ing. Figure 15 d is in a state where the sensor desorption-piercing drive with the trigger portion 34 is raised two steps, acts a mechanism shown in FIG. 14 iv is inside the measuring apparatus, the measurement for sensor holder 30 equipped with a sensor 13 of the puncture It has moved to the upper part of the device 33. FIG. 15 e 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. At this time, the trigger part 34 with sensor detachment / puncture drive stops at the middle position. FIG. 15 f shows a state in which the puncture and blood collection are completed and the sensor is stored in the measuring device 33 and the electrochemical measurement is performed. Figure 15 g after electrochemical measurement is finished, by lowering the sensor desorption-piercing drive with trigger portion 34 to the lower stage shows a state in which the sensor 13 is removed by a mechanism of the sensor holder 30 shown in FIG. Measuring device 33 inside the mechanism at this time is as shown in FIG. 14 v. If it is the shape of this measuring apparatus 33, it can also carry and it is excellent also in the point of operativity.

DESCRIPTION OF SYMBOLS 1 Hollow needle 2 Stopper 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 instrument integrated biosensor 14 Subject 18 Measuring device 26 Blood Collection 28 Septum 29 Connector 30 Sensor Holder 31 Sensor Holder Upper Cover 32 Sensor Holder Base 33 Measuring Device with Puncture Drive 34 Sensor Desorption / Puncture Drive with Trigger 35 Sensor Introduction Unit 36 Operation Panel 37 Display Unit 38 Operation Button 39 Puncture Start Button 48 Sensor assembly cartridge 49 Hook 50 Sensor assembly cartridge introduction part 51 Dial 52 Packaging body 53 Perforation 54 Adhesive film 55 Repackaging body 56 Presser 57 Metal flat plate 58 Hollow cylinder 62 Opening and closing type sensor assembly cartridge housing 64 Sensor Coalescing cartridge insertion groove

Claims (2)

An electrically insulating thin film is provided on the surface of a metal flat plate serving as the inner wall of the hollow needle, and at least two conductive materials are arranged on the surface so as to be parallel to the long axis direction of the hollow needle, and then the metal flat plate A puncture device using a puncture needle in which at least two electrodes are formed on the inner wall of a hollow needle having a hole, characterized in that a hollow cylindrical structure is formed with the electrode on the inside and cut into a needle shape Manufacturing method of integrated biosensor. A puncture device-integrated biosensor manufactured by the method for manufacturing a puncture device-integrated biosensor according to claim 1.

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