JP2008200438A - Needle-integrated sensor - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a needle-integrated sensor with a puncture needle secured to the sensor, capable of introducing blood discharged to the skin surface into a cavity even if the needle puncture position is separate from a cavity entrance. <P>SOLUTION: The needle-integrated sensor comprises: a needle-integrated sensor body integrally comprising a puncture needle, a reaction part to store a liquid sample and a detection part to detect the result of the reaction part; and a channel forming body having an attaching part with a recess to insert the distal end of the needle-integrated sensor body and a channel part which forms a channel from an abutting part of a subject to the reaction part and into which the puncture needle is inserted. The channel forming body is fastened to the needle-integrated sensor body with a fastener. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a biosensor used in a simple body fluid measuring device or the like for collecting a liquid sample such as blood by piercing a subject such as a human and simply analyzing its characteristics. The present invention relates to a needle-integrated sensor in which a puncture needle and a sensor are integrated so that a subject can easily perform measurement.

  Conventionally, as a simple body fluid measuring device that punctures a needle such as a human to collect a body fluid such as blood and easily analyzes its characteristics, for example, a blood glucose level measuring device for a diabetic patient to measure a blood glucose level is used. It has been put into practical use.

  The blood glucose level measurement device that is currently in practical use has a puncture needle for draining blood, a sensor that collects the drained blood and converts it into a current value, etc., and a measuring instrument are separated. Because it is a measurement kit, blood is discharged by inserting a needle into the skin using a puncture device, then a sensor is attached to the measuring instrument, and the discharged blood is collected and measured in the cavity of the sensor. ing.

  In this way, in the measurement kit in which the puncture needle is separated from the measuring instrument and the sensor, the blood must be discharged with the puncturing needle and then transferred to the measuring instrument. It is inconvenient for oneself to drain blood and measure. For this reason, a measurement kit that can attach a sensor and a puncture needle to a measuring instrument is desired.

As a measurement kit in which a sensor and a puncture needle can be detachably attached to a measuring instrument, there is a kit using a lancet integrated sensor proposed in Patent Document 1.
Specifically, as shown in FIG. 8, the lancet-integrated sensor disclosed in Patent Document 1 forms a substrate 50 on which an electrode pattern 51 is printed and a reaction reagent is applied, and a space 53 in which a lancet 52 can be accommodated. The lancet 52 is accommodated in the space 53 of the sensor body in combination with the substrate 54, and the lancet 52 is driven in the longitudinal direction in the space 53 by an external driving means. The needle 52a can be moved in and out from the sensor body tip 53a.

  With such a lancet-integrated sensor attached to the measurement device, the lancet 52 is driven and the needle 52a is pierced into the skin with the tip of the sensor body pressed against the subject. As a result, blood is discharged to the skin surface, and further, the needle 52a is stored in the space 53 in the sensor body, so that blood is collected in the space 53, and the potential difference generated by reacting with the reagent there. Is detected by the electrode.

WO2002-056769

  However, since such a lancet-integrated sensor drives the needle 52a in the space 53 that accommodates the sample, the size of the space 53 is the size necessary for driving the needle 52a, and the amount of blood required for measurement However, it becomes more than the measurement kit in which the sensor and the puncture needle are separated. This makes the needle thicker or pierces the needle deeper, and increases the pain when the subject is collected.

  On the other hand, Patent Document 1 also proposes providing a cavity for storing blood separately from the lancet storage space in the sensor body. In this case, since the cavity size can be set independently of the lancet, it can be considered that the amount of collected blood can be reduced. However, despite the fact that the piercing position by the lancet and the cavity entrance are arranged at different positions, the mechanism for effectively accommodating the blood discharged on the skin surface and the blood adhering to the needle into the cavity is as follows: Nothing is disclosed.

  The present invention has been made in view of the circumstances as described above, and an object of the present invention is to provide a needle integrated sensor in which a puncture needle is fixed to a sensor, and the needle piercing position and the cavity entrance are separated from each other. However, an object of the present invention is to provide a needle integrated sensor that can introduce blood discharged to the skin surface into a cavity.

  In the needle-integrated sensor in which the puncture needle is fixed to the sensor, the puncture needle is fixed in a protruding state in order to perform a puncture necessary for discharging a liquid sample such as blood from the subject to the skin surface. It will be. For this reason, the tip of the puncture needle and the entrance of the sample reaction space must be spaced apart from each other. However, a flow path through which the liquid sample can flow is provided from the tip of the puncture needle to the entrance of the sample reaction space. This can be solved. Therefore, the present inventors attached a flow channel forming body that forms a flow channel through which a liquid sample can flow from the tip of the puncture needle to the entrance of the sample reaction space, and variously examined its mounting structure, Completed.

That is, the needle integrated sensor of the present invention integrally includes a puncture needle that discharges a liquid sample from a subject, a reaction unit that stores the liquid sample, and a detection unit that detects the result of the reaction unit. A needle-integrated sensor main body provided; a mounting portion in which a recess into which a tip of the needle-integrated sensor main body is inserted is formed; and a flow path from a contact portion of the subject to the reaction portion; A needle-integrated sensor comprising a flow path forming body having a flow path portion in which the puncture needle is inserted in the flow path, wherein the flow path forming body is attached to the needle integrated sensor main body. It is fastened and fixed by a fastener.
Such a needle-integrated sensor is mass-produced because there is little variation in the mounting work for inserting the flow path forming body in a loosely fitted state and for attaching and fixing the flow path forming body using a fastener after insertion. This is because it is easy to deal with.

  The material of the flow path forming body is not particularly limited, and may be a rigid body, an elastic body, or a viscoelastic body. At least the flow path portion is an elastic body or a viscous body. It is preferable that it is formed of an elastic body. By configuring the flow path portion with an elastic body or a viscoelastic body, the puncture needle can be made to appear and disappear from the flow path forming body by deformation and restoration of the flow path portion. Drawing is automatically performed.

  The shape of the flow path forming body and the type of the fastener are not particularly limited, depending on the shape of the tip of the sensor main body to be inserted, workability, the mounting positional relationship between the flow path forming body and the needle integrated sensor main body, and the like. Are appropriately selected.

  For example, when the insertion part of the needle-integrated sensor body is substantially columnar, the mounting part is cylindrical so that the insertion part can be inserted, and the concave part is tightened from the entire outer periphery to reduce the diameter. Is preferably used.

  Further, when the shape of the insertion part of the needle-integrated sensor main body is a square shape or an asymmetric shape, or when the position where the flow path forming body is to be attached is determined, a fastening tool for tightening the sensor main body from a predetermined direction is preferable. It is. Examples of the fastening tool for fastening the sensor body from a predetermined direction include a screw and a pin. Since the flow path forming body can be mounted and fixed only by tightening from a predetermined direction, not by tightening the entire recess, the shape of the insertion part and the shape of the recess of the needle-integrated sensor body are tightened by the tightening tool. I just need it. Therefore, the shape of the concave portion and the shape of the insertion portion of the needle-integrated sensor main body to be inserted may not be similar to each other. Even if the insertion portion of the sensor main body has a shape other than a substantially circular shape, the concave portion can be formed into a simple shape such as a substantially circular shape or a rectangular shape so that a gap can be formed between the concave portion and the sensor main body. In addition, by providing the sensor body with screw holes and pin holes corresponding to tightening tools such as screws and pins, the attachment position of the flow path forming body can be uniquely determined. Variations in the mounting position during the mounting work can be prevented. Therefore, it is suitable as an attachment structure when the positional relationship between the reaction part inlet and the flow path is determined.

  The needle-integrated sensor of the present invention includes a flow path forming body capable of guiding a liquid sample discharged by puncturing at the reaction portion entrance disposed apart from the tip of the puncture needle, and the flow path forming body Since it is attached and fixed by fitting and tightening work with a tightening tool, the amount of liquid sample required for measurement can be reduced without complicating the structure and manufacturing process of the needle integrated sensor.

An embodiment of a needle integrated sensor of the present invention will be described with reference to the drawings.
FIG. 1 is a cross-sectional view of the needle integrated sensor of the present embodiment.
The needle-integrated sensor of the present embodiment has a needle-integrated sensor main body 10 in which the puncture needle 2 is fixed so that the tip of the puncture needle protrudes on one surface of a flat plate-like detection unit 1 as shown in FIG. A flow path forming body 20 as shown in FIG. 3 is attached.

  The flat plate detection unit 1 is obtained by bonding two electrically insulating substrates 1a and 1b with an adhesive or the like. 1 and 2, 1c is an adhesive part. At the tip of the detection unit 1, there is a rectangular portion to which no adhesive is applied, and this rectangular non-adhesive portion forms a reaction unit 3 that accommodates a liquid sample such as blood. In addition, there is a thin streaky adhesive non-applied part from the reaction part 3 to the side edge of the insulating substrate 1a. The adhesive non-applied part is connected to the reaction part 3 and the outside of the flat plate detection part 1. An air hole 3b that communicates is formed. In FIG. 2, 3 a is an entrance of the reaction unit 3.

  A pair of detection electrode patterns 4 are printed on the surface of the insulating substrate 1a on which the adhesive is applied, and the pattern is drawn so that each of the pair of electrodes 4 intersects the reaction part 3. It is. A reagent that reacts with a liquid sample such as blood is applied to the reaction unit 3. Therefore, the liquid sample accommodated in the reaction unit 3 reacts with the reagent, and the potential and current changes caused by the chemical change can be detected by the pair of electrodes 4. For example, when blood as a liquid sample is accommodated in the reaction unit 3, the potential change caused by the reaction with the reagent is detected by the electrode 4, and desired characteristics such as blood glucose level can be measured by the measurement unit. Yes.

  The puncture needle 2 is fixed by stacking the needle support 5 on the surface of the substrate 1b on which the adhesive is not applied (sometimes referred to as “the outer surface of the insulating substrate”). As the puncture needle here, a hollow needle used in a general syringe, a solid needle having a sharp tip, a lancet needle, or the like can be used. Further, of the two substrates 1a and 1b of the flat plate detection unit 1, the needle-integrated sensor body 10 is attached to the measuring device on the outer surface of the insulating substrate 1a to which the puncture needle 2 is not attached. The mounting portion 6 is stacked. The needle support substrate 5 and the mounting portion 6 are formed in a substantially cylindrical shape centered on the puncture needle 2 so that the tip portion to which the puncture needle 2 is attached can be inserted into the recess 21 of the flow path forming body 20. Yes.

  The flow path forming body 20 is integrally formed with a cylindrical mounting portion in which a columnar concave portion 21 is provided and a cylindrical flow path portion in which a through hole serving as a flow path 22 is provided. Is. The flow path forming body 20 is composed of an elastic body or a viscoelastic body that can be deformed by a pressing force in the puncture direction and can be restored to its original shape by releasing the pressure. Specifically, natural rubber; synthetic rubber such as synthetic isoprene rubber, styrene rubber, nitrile rubber, chloroprene rubber and acrylic rubber; rubber-like elastic body such as silicone rubber and urethane rubber; heat such as ethylene-vinyl acetate copolymer Plastic elastomers; sponges such as polystyrene foam can be used.

  The inner diameter d of the recess 21 is larger than the outer diameter of the tip of the sensor body 10 inserted into the recess 21, and the tip of the sensor body 10 is fitted in the recess 21 in a loosely fitted state. A through-hole penetrating from the bottom surface 21a of the recess 21 to the subject contact surface 20a of the flow path forming body 20 serves as a flow path 22 extending from the puncture position to the reaction portion entrance 3a. The tip of the puncture needle 2 is inserted.

  The outer periphery of the portion corresponding to the concave portion 21 of the flow path forming body 20 is fastened by a C-shaped ring 25 as a tightening tool, whereby the flow path forming body 20 inserted in a loosely fitted state is connected to the needle-integrated sensor body 10. Fixed to the mounting.

  In the needle-integrated sensor having the above-described configuration, first, the tip of the sensor body 10 is inserted into the recess 21 of the flow path forming body 20, and then the recess 21 is tightened from the outer periphery with a C-ring 25 that is a fastener. Can be manufactured. By tightening the flow path forming body 20 to the sensor main body 10 with the C-ring 25, the flow path forming body 20 that has been loosely fitted can be attached and fixed to the sensor main body 10. Even when the puncture needle 2 is pulled out due to the restoration of the path forming body 20, it is possible to prevent the position of the flow path forming body 20 from being displaced. In addition, the insertion operation of the sensor body 10 in a loosely fitting relationship and the mounting and fixing operation of the flow path forming body 20 by tightening with a tightening tool may be performed when the flow path forming body and the sensor main body are fitted and fixed by an interference fit. Compared to the case where the flow path forming body is fixed to the front end of the sensor main body with an adhesive or the like, it is simple and requires less variation in the mounting operation. In particular, when the flow path forming body is made of a soft viscoelastic material, handling is troublesome, and the work of inserting the sensor main body 10 into the flow path forming body 20 having an interference fit relationship is troublesome. In this respect, in the needle integrated sensor of the present invention, since only the insertion work of the flow path forming body and the tightening of the C-ring 25 that are in a loose fitting relationship are performed, the mounting operation is simple regardless of the material of the flow path forming body. And productivity is good.

  The needle-integrated sensor having the above-described configuration is attached to a measuring instrument 40 including a display unit 41, a measuring unit 42, a puncture spring 43, and a spring operation button 44 as shown in FIG. At the time of mounting, the puncture spring 43 is compressed by inserting the mounting portion 6 of the sensor integrated sensor body 10 into a setting portion (not shown) of the measuring instrument. Then, by pushing the spring operation button 44, the spring 43 is released from the compressed state, and accordingly, the needle-integrated sensor body 10 can be driven in the puncturing direction.

  When the puncture spring is in a compressed state (spring biased state), a spring holding the puncture needle 2 by pressing the subject contact surface 20a of the flow path forming body 20 against the skin of the subject, for example, a finger. When the button is operated in the extending direction, the needle-integrated sensor body 10 is pushed toward the skin. Along with this, a pressure in the puncture direction is generated in the flow path forming body 20 attached to the tip of the needle-integrated sensor main body 10, and the flow path forming body 20 is deformed so as to be compressed in the puncture direction or expanded in the radial direction. . Since the puncture needle 2 attached to the tip of the needle-integrated sensor main body 10 is pushed out toward the skin in the deformed state of the flow path forming body 20, puncture is performed from the subject contact surface 20a of the flow path forming body 20. The needle 2 protrudes and punctures the skin. Next, when the biasing by the spring is released, the puncture needle 2 is extracted from the skin and stored in the flow channel 22 as the restoring force of the flow channel forming body 20 returns to the original shape. Is done. Then, blood as a liquid sample discharged to the skin surface by puncture rises along the needle or along the inner wall surface of the flow path 22 and is introduced into the reaction unit 3 from the reaction unit inlet 3a.

  As described above, in the needle integrated sensor according to the present embodiment, the distal end of the puncture needle 2 and the reaction part inlet 3a are accommodated in the reaction part 3 through the flow path 22 even though they are separated from each other. Can be. In order to effectively raise the liquid sample in the flow path 22, an air passage that communicates the flow path 22 with the outside of the flow path forming body 20 may be provided at an appropriate position of the flow path portion. In this case, the flow path is bent so that the liquid sample flowing in the flow path 22 does not flow out of the flow path, the size of the flow path is adjusted, or the flow path 22 is preferentially raised to react. It is preferable to apply a surfactant to the inner wall surface of the flow path 22 or to apply a surfactant in the vicinity of the reaction portion inlet 3a so as to be introduced into the portion 3.

  Moreover, in the said embodiment, although the diameter of the flow path 22 was the size containing the puncture needle 2 and the reaction part entrance 3a, this invention needle | hook integrated sensor is not limited to this. The diameter of the flow path portion may be a diameter that allows the puncture 2 to move relatively. In this case, as shown in FIG. 5, a groove 23 extending to the outside of the flow path forming body 20 ′ is provided on the bottom surface of the recess 21 ′ so that the flow path 22 ′ and the reaction portion inlet 3a communicate with each other. May be. The groove 23 can also serve as an air passage that communicates the flow path 22 ′ with the outside of the flow path forming body 20 ′. In such a case, when the liquid sample that has flowed up through the flow path 22 ′ reaches the tip of the sensor body 10 that is the ceiling surface of the flow path 22, the liquid sample flows toward the groove 23 that is an air flow path in the flow path 22 ′. Then, it is introduced into the reaction part 3 from the reaction part inlet 3a. In this case, the size of the groove 23 is set so that the liquid sample is preferentially accommodated into the reaction part 3 from the reaction part inlet 3a rather than flowing out of the flow path forming body 20 ′ through the groove 23. Is adjusted accordingly.

  Further, in the above-described embodiments, the C-shaped ring is used as the fastener, but the fastener used in the needle integrated sensor of the present invention is not limited to this. Any one can be used as long as the outer periphery of the flow path forming body can be tightened to reduce the diameter of the recess. For example, an O-ring having elasticity can be used, or as shown in FIG. 6 is a combination type fastener 27 divided into two parts, and a fastener 28 in which a semicircular part formed by dividing an O-ring into two parts is connected by a connecting tool 29 such as a hinge as shown in FIG. May be. In the tightening tool 27, an engaging convex portion 27a is provided on one semicircular portion, and an engaging concave portion 27b that engages with the engaging convex portion 27a is provided on the other semicircular portion. The outer periphery of the flow path forming body can be tightened by fitting the portion 27a into the engaging recess 27b. Further, in the tightening tool 28, the flow path forming body can be tightened by attaching the semicircular portion to the outer periphery of the flow path forming body and fitting the engaging convex portion 28a into the engaging concave portion 28b. Furthermore, it is not limited to the ring that tightens the outer periphery of the flow path forming body, but may be a cylindrical tightening tool that covers both the flow path forming body and the sensor body.

  Furthermore, the tightening tool used in the present invention is not limited to a ring-shaped member having a cross-section, and may be tightened by winding a string-like wound body or wire around the outer periphery. In addition, the heat-shrinkable tube or tape may be shrunk by heat after the outer periphery of the mounting portion is wound with a heat-shrinkable resin tube or tape. Further, the tightening tool used in the present invention is not limited to the one that tightens the outer periphery of the mounting portion to reduce the diameter of the recess. The flow path forming body may be attached and fixed to the front end of the sensor body by tightening the concave portion from a specific direction using a tightening tool.

FIG. 7 shows an embodiment of a sensor integrated with a needle in which the flow path forming body 30 is attached and fixed to the sensor body 10 using an adjusting screw 34 as a tightening tool that is tightened from a specific direction.
The flow path forming body 30 used in the needle-integrated sensor shown in FIG. 7 includes an attachment part 30a formed of a hard material such as plastic or metal, and a flow path part 30b made of a viscoelastic material fixed thereto. It consists of and. The concave portion 31 provided in the attachment portion 30a is loosely fitted with a size slightly larger than the portion where the tip of the sensor body 10 is inserted. By tightening the insertion portion of the sensor body 10 with the adjusting screw 34 as a tightening tool, the flow path forming body 30 is attached and fixed to the sensor body 10.

  In the embodiment shown in FIG. 7, the adjustment screw is used as the fastener, but the fastener that is tightened from a specific direction may be a pin or a key in addition to the screw. Tightening and fixing from a specific direction with screws, pins, etc. is suitable when the sensor body 10 has a surface pressed by the screws, pins, etc., and the tip portion of the sensor body 10 has a square shape, polygonal shape, etc. Appropriate tightening of shapes other than circular is possible. Further, the mounting position of the sensor main body 10 and the flow path forming body 30 is set to a fixed position by the male screw, which is a tightening tool, the female screw corresponding to the pin, and the pin hole being recessed in the needle support 5 and the mounting portion 6. Can be fixed. This is useful when the attachment direction of the flow path forming body 30 is determined. For example, when it is desired to use the flow path 33 provided in the flow path portion 30b and the air in the flow path 32 flowing outside the flow path forming body 30 through the flow path 33, that is, along the puncture needle 2. When it is expected that the rising liquid sample or the rising liquid sample along the inner wall surface of the flow path 32 corresponding to the opposite side of the position of the reaction unit 3 with respect to the needle 2 is expected to be introduced into the reaction unit 3. It is necessary to attach the flow path forming body 30 so that the path 33 is located on the reaction part 3 side with respect to the needle 2. In such a case, positioning can be performed by a relationship between a male screw and a female screw, or a pin and a pin hole.

  In each of the above embodiments, the attachment position of the puncture needle is disposed in the vicinity of the reaction portion entrance, but the puncture needle may be attached in the reaction portion. In this case, the electrode is disposed so as not to contact the puncture needle, and the reagent is applied so as to communicate with the electrode and the reaction part. Moreover, in the said embodiment, although the electrode was provided in the insulating board | substrate with which the needle | hook is not attached, the needle | hook integrated sensor of this invention does not limit the positional relationship of a needle | hook attachment position and an electrode board | substrate. Electrodes may be provided on the substrate on the needle mounting side, and it is not necessary that the positive electrode and the negative electrode are provided on the same substrate. One substrate may be provided with a positive electrode and the other substrate may be provided with a negative electrode. In addition, the detection unit has a configuration in which two substrates are bonded together. For example, as disclosed in International Publication No. 2005-010519, a pair of electrodes is arranged on one substrate, and the electrodes are on the inside. You may comprise by bending in this way. The shape of the sensor body may be appropriately designed according to the shape of the detection part, and the shape of the needle support and the mounting part may be appropriately designed. What is necessary is just to select a kind suitably.

It is sectional drawing which shows the structure of the needle | hook integrated sensor of one Embodiment of this invention. It is the top view (a) and sectional drawing (b) which show the structure of the sensor used for the needle | hook integrated sensor of embodiment of FIG. It is a perspective view of the flow-path formation body used for the needle | hook integrated sensor of embodiment of FIG. It is the schematic which shows the structure of one Example of the measuring apparatus equipped with the needle | hook integrated sensor of embodiment of FIG. It is sectional drawing which shows the structure of the needle | hook integrated sensor of other embodiment of this invention. It is sectional drawing which shows the other Example of the fastener used by this invention. It is sectional drawing which shows the structure of the needle | hook integrated sensor of other embodiment of this invention. It is a figure which shows the structure of the conventional lancet integrated sensor.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Detection part 2 Puncture needle 3 Reaction part 3a Reaction part entrance 10 Needle integrated sensor main body 20, 20 ', 30 Flow path formation body 21, 21', 31 Recess 22, 22 ', 32 Flow path 25 C ring 27, 28 Fasteners 34 Adjusting screws

Claims (4)

A needle-integrated sensor main body integrally provided with a puncture needle for discharging a liquid sample from a subject, a reaction unit in which the liquid sample is accommodated, and a detection unit for detecting a result of the reaction unit; A mounting portion in which a concave portion into which the tip of the integrated sensor body is inserted is formed; a flow path from the contact portion of the subject to the reaction section; and the puncture needle is placed in the flow path A needle integrated sensor comprising a flow path forming body having a flow path portion inserted therein,
The needle-integrated sensor, wherein the flow path forming body is fastened and fixed to the needle-integrated sensor main body by a fastening tool. The needle integrated sensor according to claim 1, wherein the flow path forming body has at least the flow path portion formed of an elastic body or a viscoelastic body. The mounting portion is substantially cylindrical,
The needle integrated sensor according to claim 1 or 2, wherein the tightening tool reduces the inner diameter of the recess. The needle-integrated sensor body is loosely inserted in the recess,
The needle integrated sensor according to claim 1 or 2, wherein the tightening tool tightens the needle integrated sensor body from a predetermined direction.

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