JP2007082954A - Component measurement tip - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a component measurement tip which can surely puncture a surface of a living body, and can surely collect a body fluid even if the amount of the body fluid outflowing from a puncture site of the surface of the living body is small. <P>SOLUTION: A component measurement tip 1 is equipped with: a puncture needle 14 which has a needle body 141 with a keen needle tip 144 and has a hub 142 fixed on the periphery of the needle body 141; a casing 13 which houses the puncture needle 14 being movable and has a tip opening through which the needle tip 144 can pass; a test paper 18 which is installed on the casing 13 and detects a certain component in the body fluid outflowing from a puncture site of a sampling site 900 which is punctured by the needle tip 144; and a fluid-sampling site 2 which has a fluid-introducing channel which introduces the body fluid outflowing from the puncture site of the sampling site 900 to the test paper 18. In the fluid-sampling site 2, an inlet 22 of the fluid-introducing channel can be positioned on either a first position located on a pathway through which the needle tip 144 passes or a second position to which the needle tip 144 is retreated from the pathway. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a component measuring chip.

  In recent years, with the increase in the number of diabetic patients, self blood glucose measurement in which patients themselves monitor fluctuations in daily blood glucose levels has been recommended.

  This blood glucose level is measured by supplying blood to a test paper that develops color according to the amount of glucose in the blood, developing the color, and measuring the color level optically (color measurement). It is carried out using a blood glucose measuring device for quantifying.

  In order to perform the above-described measurement with this blood glucose measurement device, the blood glucose measurement device includes a puncture needle that punctures the patient's skin to collect blood from the patient, a casing that movably houses the puncture needle, blood It is necessary to mount a chip (component measurement chip) provided with a test paper that is colored according to the amount of glucose in the medium.

  As a chip having such a configuration, a chip in which a blood introduction guide is provided on an inner peripheral portion of a casing is known (see, for example, Patent Document 1). The blood introduction guide has a function of contacting blood that has flowed out of the patient's skin by the puncture of the puncture needle and introducing this blood into the test paper.

  This blood introduction guide is formed to protrude from the inner peripheral part of the casing toward the central axis thereof, but without disturbing the movement of the puncture needle (needle tip), that is, without interfering with the moving puncture needle, The puncture needle is formed apart from the passage path of the puncture needle so that the surface of the living body can be punctured. Therefore, when the amount of blood that has flowed out from the puncture site on the surface of the living body is small, there is a risk that the blood will not reach the blood introduction guide, that is, it may be difficult for the blood introduction guide to collect blood. there were.

JP 2002-58662 A

  An object of the present invention is to provide a component measuring chip that can reliably puncture the surface of a living body and can reliably collect the body fluid even when a small amount of body fluid has flowed out from the puncture site on the surface of the living body. Is to provide.

Such an object is achieved by the present inventions (1) to (11) below.
(1) a puncture needle having a needle body having a sharp needle tip at the tip and a hub fixed to the outer periphery of the needle body;
A casing having a tip opening through which the puncture needle is movably stored and the needle tip can pass through;
A detection unit that is provided in the casing and detects a predetermined component in the body fluid that has flowed out from the puncture site on the living body surface that is punctured by the needle tip;
A bodily fluid collection part having a bodily fluid introduction channel for introducing bodily fluid flowing out from the puncture site on the surface of the living body into the detection unit;
The bodily fluid collection unit includes a first body fluid introductory channel, at least an inlet of the bodily fluid introduction channel is provided in the vicinity of the puncture site, and is located in a passage route through which the needle tip passes when puncturing the living body surface. A component measuring chip that is displaceable to a position and a second position retracted from the passage route.

  (2) The component measuring chip according to (1) above, wherein the surface of the living body is punctured with the needle tip when the body fluid collecting unit is located at the second position.

  (3) The bodily fluid introduction channel is a minute channel that can absorb bodily fluid by capillary force, the bodily fluid collection unit has flexibility, and on the outlet side of the bodily fluid introduction channel, The component measuring chip according to (1) or (2), which is supported by a casing.

  (4) The bodily fluid collection unit located at the first position is displaced to the second position when the vicinity of the inflow port is pressed by the needle tip of the puncture needle moved in the distal direction (1) The component measuring chip according to any one of (1) to (3).

  (5) The component measuring chip according to (4), wherein a concave portion that abuts the needle tip and guides the needle body is formed near the inflow port.

  (6) The component measuring chip according to (4) or (5), wherein the vicinity of the inflow port is made of a material having wear resistance.

(7) The bodily fluid collecting part is provided with a protruding part protruding from the bodily fluid collecting part,
The bodily fluid collecting part located at the first position is displaced to the second position when the projecting part is pressed by a portion other than the needle tip of the puncture needle moved in the distal direction. The component measuring chip according to any one of (3).

  (8) The needle body has an outer shape changing portion whose outer diameter is changed, and the outer diameter changing portion contacts and is pressed against the projecting portion, whereby body fluid sampling located at the first position is collected. The component measuring chip according to (7), wherein the portion is displaced to the second position.

  (9) The component measurement chip according to any one of (1) to (8), wherein the detection unit includes a test paper that carries a reagent that reacts with a predetermined component in a body fluid and develops a color.

  (10) The detection unit includes at least two electrodes, a reagent application unit applied with a reagent that reacts with a predetermined component in a body fluid to generate a current between the electrodes, the pair of electrodes, and the reagent application unit The component measuring chip according to any one of (1) to (8), further including a support portion that supports the component.

(11) The support portion is provided to be rotatable with respect to the casing.
The body fluid sampling part is provided in the support part, and is displaced between the first position and the second position when the support part is rotated. Chip.

  According to the present invention, at least the inflow port of the bodily fluid introduction channel of the bodily fluid collection unit can be displaced between the first position located in the passing path through which the needle tip passes and the second position retracted from the passing path. Therefore, the surface of the living body can be punctured reliably, and the body fluid can be reliably collected even if a small amount of body fluid has flowed out from the puncture site on the surface of the living body.

  Moreover, when the bodily fluid collection part is comprised by the member which has flexibility, the inflow port of a bodily fluid introduction flow path can be easily displaced to the 1st position and the 2nd position.

  Hereinafter, the component measuring chip of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

<First Embodiment>
FIG. 1 is a longitudinal sectional view showing a first embodiment of a component measuring chip according to the present invention, and FIGS. 2 to 4 are used by mounting the component measuring chip shown in FIG. 1 on a component measuring apparatus. FIG. 5 is an enlarged longitudinal sectional view in the vicinity of the body fluid collecting part of the component measuring chip shown in FIG. 1, and FIG. 6 is a view of the body fluid collecting part in FIG. is there. In the following, for convenience of explanation, the upper side in FIGS. 1 to 6 will be described as “base end” or “upper”, and the lower side will be described as “tip” or “lower”.

  The component measuring chip (hereinafter simply referred to as “chip”) 1 of the present invention shown in FIG. 1 (similarly in FIGS. 2 to 4) 1 accommodates the puncture needle 14 and the puncture needle 14 slidably (movable). As an inner cylinder 15, an outer cylinder 16 installed on the outer peripheral part of the inner cylinder 15, a test paper fixing part 17 installed on the outer peripheral part of the outer cylinder 16, and a detection part fixed to the test paper fixing part 17 The test paper 18 and the body fluid collecting unit 2 for introducing blood into the test paper 18. Among these, the inner cylinder 15 and the outer cylinder 16 constitute a casing 13. The chip 1 having such a configuration is used by being loaded (mounted) on the component measuring apparatus 10 (see FIGS. 2 to 4). Hereinafter, a state in which the chip 1 is loaded in the component measuring apparatus 10 is referred to as a “chip loaded state”.

  The component measuring apparatus 10 loaded with a chip collects a body fluid (hereinafter, blood will be described as a representative in this embodiment), and a predetermined component in the blood (hereinafter, glucose is representative in this embodiment). It is a device that measures the amount.

  The component measuring apparatus 10 includes a measuring unit 7 that measures the amount of glucose in the blood absorbed and spread on the test paper 18 in a state where the chip is loaded, and a puncture means (movement) that moves the puncture needle 14 of the chip 1 in the state where the chip is loaded. Means) 4.

  As shown in FIGS. 2 to 4, the measuring unit 7 optically measures the amount of glucose in the blood developed on the test paper 18 included in the chip 1, and the installation position thereof is in a chip loading state. In the vicinity of the side where the test paper 18 is located.

  The measuring unit 7 includes a light emitting element (light emitting diode) and a light receiving element (photodiode) (not shown).

  When the light emitting element is turned on with the chip loaded, the light emitted from the light emitting element is applied to the test paper 18, and the reflected light is received by the light receiving element and subjected to photoelectric conversion. An analog signal corresponding to the amount of received light is output from the light receiving element, amplified as desired, converted to a digital signal by an A / D converter, and input to a control means (not shown).

  The control means performs predetermined calculation processing based on the input signal, and performs correction calculation as necessary to obtain the amount of glucose (blood glucose level) in the blood.

  The puncture means 4 includes a plunger 41 connected to the hub 142 of the puncture needle 14 in a state where the tip is loaded, and a spring (not shown) that biases the plunger 41 in the distal direction.

  By the operation of the puncturing means 4, the puncture needle 14 can be moved between a puncture position (see FIG. 3) and a retracted position (see FIGS. 2 and 4). The puncture position is a position at which the needle tip 144 of the puncture needle 14 punctures the blood collection site 900 while the blood collection site 900 on the surface of the living body is in contact with the contact portion 163 of the chip 1. The retracted position is a position where the needle tip 144 of the needle body 141 is retracted from the puncture position, that is, a position where the puncture needle 14 is stored in the chip 1.

  Examples of the blood collection site 900 (biological surface) used for blood collection in the component measuring apparatus 10 include the palm, the back of the hand, the side of the hand, the finger (fingertip), the arm, the abdomen, the thigh, and the earlobe. In the following embodiments, a form in which a finger (fingertip) is punctured will be described as a representative.

Next, the configuration of each part of the chip 1 will be described.
The puncture needle 14 is composed of a needle body 141 and a hub 142 fixed to the outer periphery of the needle body 141, and is housed in a lumen 152 of the inner cylinder 15 (casing 13).

  The needle body 141 is constituted by a hollow member or a solid member made of a metal material such as stainless steel, aluminum, aluminum alloy, titanium, titanium alloy, and the like, and a sharp needle tip (blade tip) 144 is formed at the tip thereof. ing. With this needle tip 144, the surface (skin) of the fingertip is punctured.

  The hub 142 is formed of a substantially columnar member, and has a diameter-enlarged portion 143 in a part thereof, and the outer peripheral portion of the enlarged-diameter portion 143 slides on the inner peripheral surface 154 of the inner cylinder 15.

  The base end portion of the hub 142 is fitted (connected) to the plunger 41 (puncture means 4) in a state where the tip is loaded.

  The hub 142 is preferably made of a resin material. Examples of the resin material include ABS resin, AS resin, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene chloride resin, polyphenylene oxide, thermoplastic polyurethane, polymethylene methacrylate, polyoxyethylene, fluororesin, polycarbonate, and polyamide. And thermoplastic resins used in injection molding such as acetal resin, acrylic resin, and polyethylene terephthalate, and thermosetting resins such as phenol resin, epoxy resin, silicone resin, and unsaturated polyester.

  The inner cylinder 15 is formed of a bottomed cylindrical member having a wall portion 153 as a bottom portion, and a lumen portion 152 is formed therein.

  A hole 151 having a circular cross-sectional shape is formed at a substantially central portion of the wall portion 153. When puncturing the fingertip (blood collection site 900), the needle tip 144 of the needle body 141 passes through the hole 151 and the tip opening (hole) 162 of the outer cylinder 16. Further, the hole diameter (diameter) of the hole 151 is set smaller than the outer diameter of the tip of the hub 142. Therefore, when the puncture needle 14 moves toward the distal end of the lumen 152 and the distal end of the hub 142 and the proximal end surface of the wall 153 come into contact with each other, the puncture needle 14 is prevented from further moving toward the distal end. Is done.

  A ring-shaped convex portion 155 that protrudes inward is formed on the proximal end side of the inner peripheral surface 154, and the diameter of the convex portion 155 is increased before the tip 1 is attached to the component measuring device 10. The outer peripheral portion of the portion 143 is locked and fixed (see FIG. 1). In this state, the needle tip 144 of the needle body 141 is set so as not to protrude from the hole 151. The fixing force between the convex portion 155 and the enlarged diameter portion 143 is such that when the tip 1 is attached to the component measuring apparatus 10, the puncture needle 14 can be attached (coupled) to the plunger 41 without hindrance. When the mounting of the chip 1 is completed, the fixing between the convex portion 155 and the hub 142 is released, and a puncture preparation state (FIG. 2) is obtained.

  The fixing method of the hub 142 and the inner cylinder 15 is not limited to this, and for example, a locking means is provided on the outer peripheral portion of the inner peripheral surface 154 and / or the enlarged diameter portion 143, or the inner peripheral surface 154 The frictional force with the outer peripheral part of the enlarged diameter part 143 may be utilized (used), or the inner peripheral surface 154 and the enlarged diameter part 143 may be weakly bonded or weakly bonded.

  Further, the constituent material of the inner cylinder 15 is not particularly limited, but for example, the materials mentioned in the description of the hub 142 can be used.

  An outer cylinder 16 is fixed to the outer peripheral portion of the inner cylinder 15. The outer cylinder 16 is composed of a substantially cylindrical member, and has a lumen 161 therein.

  A contact portion 163 protruding in a ring shape is formed at the tip of the outer cylinder 16. Inside the abutting portion 163, a distal end opening 162 is formed through which the lumen portion 161 of the outer cylinder 16 (the lumen portion of the casing 13) is opened.

  As will be described later, in this embodiment, when the blood collection site 900 is pressed against the contact portion 163 when the blood collection site 900 is punctured, the tip opening 162 is blocked by the blood collection site 900 ( 2 to 4).

  The outer cylinder 16 is formed with a ring-shaped flange 164 that protrudes outward (outward) in the vicinity of the contact portion 163. The flange 164 has a base end face in contact with the tip of the component measuring device 10 in a state where the chip is loaded, and the tip 1 is positioned with respect to the component measuring device 10 (positioned in the vertical direction in FIGS. 2 to 4). .

  A test paper fixing unit 17 is provided on the outer periphery of the outer cylinder 16, and a test paper 18 is fixed to the test paper fixing unit 17.

  Further, a blood passage (specimen passage) 172 communicating with the body fluid introduction channel (lumen portion) 21 of the body fluid collecting unit 2 is formed in the test paper fixing unit 17 (see FIG. 5). The blood passage 172 is a flow path for guiding blood obtained by puncture from the body fluid collecting unit 2 to the test paper 18. The blood outlet 173 from which the blood in the blood passage 172 flows out is located near the center of the test paper 18.

  As shown in FIG. 5, the test paper fixing portion 17 is provided with a recess 174 having a groove shape concentrically provided with the central axis of the blood passage 172.

  In such a test paper fixing portion 17, a part of the test paper 18 is fixed in the blood passage 172 and the concave portion 174, respectively.

  In addition, although it does not specifically limit as a constituent material of the outer cylinder 16 and the test paper fixing | fixed part 17, For example, the material which was mentioned by description of the hub 142 can be used.

  The test paper 18 is provided on the outer cylinder 16 (casing 13) via the test paper fixing part 17. The test paper 18 is composed of a plate-like member. The shape of the test paper 18 in plan view is not particularly limited. For example, the test paper 18 is appropriately selected as necessary, such as a circle, an ellipse, a square such as a square, a rectangle, and a rhombus, a triangle, a hexagon, an octagon, and the like. Can be used.

  This test paper 18 is obtained by carrying a reagent on a carrier (member) that can absorb and spread blood (specimen) flowing out from a blood collection site 900 punctured by a needle tip 144. Thereby, the amount of glucose can be reliably detected.

  Examples of the carrier include sheet-like porous bodies such as nonwoven fabrics, woven fabrics, and stretched sheets. This porous body preferably has hydrophilicity.

  The reagent supported on the carrier is colored by reacting with glucose. Specific examples thereof include glucose oxidase (GOD), peroxidase (POD), and 4-aminoantipyrine, N-ethyl-N, for example. -(2-Hydroxy-3-sulfopropyl) -m-toluidine-like color former (coloring reagent), and other blood such as ascorbate oxidase, alcohol oxidase, cholesterol oxidase, etc., depending on the measurement component Examples thereof include those that react with the components, and color formers (coloring reagents) similar to those described above. Further, a buffering agent such as a phosphate buffer may be included. Needless to say, the types and components of the reagents are not limited to these.

  As shown in FIGS. 1 to 5, the bodily fluid collection part 2 is provided in the test paper fixing part 17 (outer cylinder 16) so as to be inclined with respect to the longitudinal direction of the outer cylinder 16 toward the lumen part 161. Yes.

  As shown in FIG. 6, the body fluid sampling unit 2 has a micro flow path that is flexible, has an outer shape that is substantially a quadrangular prism, and can be absorbed by capillary force. In the body fluid collection part 2 (capillary tube), the hollow part functions as a body fluid introduction channel 21 for introducing the blood flowing out from the blood collection site 900 into the test paper 18. The body fluid introduction channel 21 has a quadrangular cross-sectional shape.

  An inlet 22 through which blood flows into the body fluid introduction channel 21 and an outlet 23 through which blood flows out of the body fluid introduction channel 21 are formed at both ends of the body fluid collection unit 2 (body fluid introduction channel 21). Has been. The inflow port 22 is located on the front end side of the outflow port 23, that is, on the front end opening 162 side of the outer cylinder 16, and is on the central axis of the front end opening 162 so as to easily contact the blood flowing out from the blood collection site 900. In addition, it is provided at a position slightly closer to the proximal end from the distal end opening 162.

  The body fluid introduction channel 21 has an end face on the outflow port 23 side supported by the test paper fixing part 17, that is, the outflow port 23 is connected to the blood passage 172, and the body fluid introduction is performed via the outflow port 23. The flow path 21 and the blood passage 172 communicate with each other.

  As shown in FIG. 1 and FIG. 2, in the body fluid sampling unit 2, the inflow port 22 is located in the passage route 145 through which the needle tip 144 passes (hereinafter, this position is referred to as “first position”).

  As shown in FIGS. 2 and 3, when the puncture needle 14 moves in the distal direction by the operation of the puncture means 4, the bodily fluid collection part 2 in which the inflow port 22 is located at the first position is the edge 25 of the inflow port 22. (Near) is pressed toward the inner peripheral surface 165 of the outer cylinder 16 by the needle tip 144 of the puncture needle 14. Thereby, the inflow port 22 is displaced to a position (hereinafter, this position is referred to as a “second position”) where the inflow port 22 is retracted from the passage route 145 (first position). When the inflow port 22 (the body fluid collection part 2) is located at the second position, the blood collection site 900 is punctured by the needle tip 144 (see FIG. 3).

  As shown in FIG. 4, when the puncture needle 14 moves in the proximal direction by the operation of the puncture means 4, the pressure on the edge 25 of the inflow port 22 by the needle tip 144 is released. Thereby, the inflow port 22 displaced to the second position returns again to the first position.

  As described above, in the chip 1, the inflow port 22 of the body fluid sampling unit 2 can be easily displaced between the first position and the second position in accordance with the movement of the puncture needle 14.

  As a result, at the second position, the inlet 22 of the body fluid collection unit 2 is retracted from the passage route 145, so that the vicinity of the inlet 22 does not prevent the puncture needle 14 from puncturing the blood collection site 900, and the puncture needle 14 Can puncture the blood collection site 900 reliably.

  In addition, after the puncture needle 14 punctures the blood collection site 900 and moves in the proximal direction, the blood rises at least in a hemispherical shape from the puncture site of the blood collection site 900 to the passage path 145 (see FIG. 4). At this time, since the inflow port 22 has returned from the second position to the first position, even if a small amount of blood that has risen (outflowed), through the inflow port 22 that is located at the first position, The blood is reliably collected in the body fluid introduction channel 21 and reaches the test paper 18 by capillary action.

  Moreover, it is preferable that the vicinity of the body fluid introduction flow channel 21 and the inlet 22 of the body fluid collection part 2 has hydrophilicity, that is, has been subjected to a hydrophilic treatment. Thereby, blood is reliably introduced into the body fluid introduction channel 21 from the inlet 22 at the first position.

  Examples of the hydrophilization treatment include physical activation treatment such as ozone treatment, plasma treatment, glow discharge, corona discharge, and ultraviolet irradiation, and application of surfactant, water-soluble silicon, hydroxypropylcellulose, polyethylene glycol, polypropylene glycol, etc. (Coating) can be performed.

  As shown in FIGS. 1 and 5, the end surface on the inlet 22 side of the body fluid collection unit 2 is inclined with respect to the longitudinal direction (center axis) of the body fluid collection unit 2. As a result, at the first position, the inflow port 22 faces the distal end direction, and thus faces the blood collection site 900 when the blood collection site 900 contacts the contact portion 163. With such an inflow port 22, blood can be collected more reliably from the blood collection site 900 after puncture.

  Further, as described above, the vicinity of the inflow port 22 is pressed (contacted) by the needle tip 144. For this reason, it is preferable that the vicinity of the inflow port 22 has a strength (for example, wear resistance) that is not damaged by the needle tip 144. The material used in the vicinity of the inflow port 22 is not particularly limited, and examples thereof include polytetrafluoroethylene, ultrahigh molecular weight polyethylene, acetal resin, ionomer resin, fluorine-coated and DLC-coated materials. Thereby, it is possible to prevent the vicinity of the inlet 22 from being damaged (cut) by the needle tip 144.

  In addition, the constituent material of the body fluid collecting unit 2 is not particularly limited, but, for example, a soft resin material is suitable, and specific examples thereof include, for example, fluorine-based resins such as PTFE, ETFE, and PFA, polyethylene, polypropylene, and the like. Olefin-based resins or a mixture thereof, polyurethane, polyester, polyamide, polyether nylon resin, a mixture of the olefin-based resin and an ethylene-vinyl acetate copolymer, and the like.

Second Embodiment
FIG. 7 is a view showing a body fluid collecting part of the component measuring chip of the present invention (second embodiment), (a) is a front view of the body fluid collecting part, and (b) is a rear view of the body fluid collecting part. (C) is a longitudinal cross-sectional view of a bodily fluid collection part.

Hereinafter, the second embodiment of the component measuring chip of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and description of similar matters will be omitted.
This embodiment is the same as the first embodiment except that the shape of the body fluid collection unit is different.

  As shown in FIG. 7, a concave portion (defect portion) 24 in which a part of the edge portion 25 is missing is formed at the edge portion 25 of the inflow port 22 of the body fluid sampling portion 2 </ b> A. The concave portion 24 has a circular cross-sectional shape, and further has an inclined portion 26 on the proximal end side surface of the body fluid sampling portion 2A, and functions as a guide for guiding the needle tip 144.

  When the puncture needle 14 is changed from the state of FIG. 2 to the state of FIG. 3, that is, when puncturing, the needle tip 144 abuts the inclined portion 26 and is guided by the recess shape. Thereby, the positional relationship between the inflow port 22 of the body fluid sampling part 2A and the moving puncture needle 14 in a direction perpendicular to the central axis direction of the puncture needle 14 (lateral direction in FIG. 7) is defined. Therefore, the puncture needle 14 moves stably in the distal direction, and the blood collection site 900 can be punctured more reliably.

<Third Embodiment>
8 to 10 are longitudinal sectional views showing a state in which the component measuring chip of the present invention (third embodiment) is mounted on the component measuring device. In the following description, for convenience of explanation, the upper side in FIGS. 8 to 10 will be described as “base” or “upper”, and the lower side will be described as “tip” or “lower”.

Hereinafter, the third embodiment of the component measurement chip of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
This embodiment is the same as the first embodiment except that the configuration of the body fluid collection unit is different.

  As shown in FIGS. 8 to 10, the body fluid sampling part 2 </ b> B protrudes upward from the outer peripheral part in the middle of the body fluid sampling part 2 </ b> B, that is, is inclined with respect to the central axis direction of the body fluid sampling part 2 </ b> B. A protruding portion 3 that protrudes is provided.

  The protruding portion 3 includes a columnar portion 31 having a substantially cylindrical shape whose lower end is fixed to or integrally formed with the outer peripheral portion of the body fluid sampling portion 2B, and a head portion 32 provided at the upper end of the columnar portion 31. Has been. The head 32 has a rugby ball shape whose center is curved and deformed in a concave shape, and its axis is located in a direction orthogonal to the central axis of the body fluid sampling part 2B.

  In addition, although it does not specifically limit as a constituent material of the protrusion part 3, For example, various metal materials, various plastics, etc. can be used individually or in combination.

  Further, the puncture needle 14B has a pressing portion 146 that presses the head 32 of the protruding portion 3. The pressing portion 146 is a portion whose diameter is larger than the outer diameter of the needle body 141. The pressing portion 146 is formed integrally with the hub 142 on the outer peripheral portion of the needle body 141 between the hub 142 and the needle tip 144.

  In the state shown in FIG. 8, the inflow port 22 of the body fluid sampling part 2 </ b> B is located at the first position in substantially the same manner as in the first embodiment. From this state, when the puncture needle 14B advances in the distal direction by the operation of the puncture means 4, the head 32 of the protrusion 3 moves the needle tip 144 of the puncture needle 14B before the inflow port 22 contacts the needle tip 144. The body fluid sampling part 2B is pressed through the protruding part 3 by contacting the part to be removed, that is, the pressing part 146 (see FIG. 9). Thereby, when the inflow port 22 begins to retract toward the second position and the needle tip 144 punctures the blood collection site 900, the inflow port 22 is positioned at the second position (see FIG. 10).

  With such a configuration, while the puncture needle 14B is displaced from the retracted position (refer to FIG. 8) to the puncture position (refer to FIG. 10), the inflow port 22 does not contact the needle tip 144 at any one time. The second position is displaced from the first position.

  Thus, in the process in which the puncture needle 14B is displaced from the retracted position to the puncture position, the needle tip 144 abuts on a part constituting the tip 1B (for example, the edge 25 of the inlet 22 of the bodily fluid collecting part 2B). Is prevented. As a result, for example, the needle tip 144 can be prevented from being rounded or bent, so that when the skin is punctured, puncture pain due to blunting of the needle base can be reduced.

  In addition, since the protruding portion 3 is provided from the middle of the body fluid collecting portion 2B, the moving distance until the inflow port 22 at the first position is located at the second position becomes long. For this reason, the inlet 22 at the second position is located at a position relatively separated from the passage route 145. Thereby, it is possible to reliably prevent the vicinity of the inflow port 22 from blocking the puncture of the blood collection site 900 by the puncture needle 14, and thus the puncture needle 14 can puncture the blood collection site 900 more reliably.

<Fourth embodiment>
FIG. 11 is a longitudinal sectional view showing a fourth embodiment of the component measuring chip of the present invention, and FIG. 12 is a perspective view of the vicinity of the body fluid collecting portion shown in FIG. In the following, for convenience of explanation, the upper side in FIGS. 11 to 12 will be described as “base end” or “upper”, and the lower side will be described as “tip” or “lower”.

Hereinafter, the fourth embodiment of the component measuring chip of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
This embodiment is the same as the third embodiment except that the configuration of the detection unit is different.

  As shown in FIGS. 11 to 12, the chip 1 </ b> C has a sensor unit 5 as a detection unit that detects the amount of glucose in the blood.

  As shown in FIG. 12, the sensor unit 5 includes a pair of electrodes 51, a reagent application unit 52 to which a reagent is applied, and a support unit 53 that supports the pair of electrodes 51 and the reagent application unit 52. .

  The support part 53 is configured by a plate-like body. One end portion of the support portion 53 is provided so as to be rotatable with respect to the outer cylinder 16 (casing 13) (see FIG. 11). Further, it is biased in one direction (base end direction) by a torsion spring or the like.

  The two electrodes 51 are separated from each other and are provided in the support portion 53 by coating or printing. Each electrode 51 is electrically connected to the terminal 54 exposed (protruded) from the outer peripheral portion of the outer cylinder 16. In the chip loading state, each terminal 54 of the chip 1C (sensor unit 5) is electrically connected to the component measuring apparatus 10.

  The reagent application unit 52 is provided so as to be in contact with and include the two electrodes 51. The reagent application unit 52 (reagent) reacts with glucose in the blood that flows out from the outflow port 23 of the body fluid collection unit 2 </ b> C in a chip-loaded state, thereby generating an electric current between the two electrodes 51. The amount of glucose in the blood can be detected according to this current.

  Although it does not specifically limit as a reagent contained in the reagent application part 52, For example, glucose oxidase which is an oxidoreductase, and electron acceptors, such as potassium ferricyanide and a ferrocene derivative, can be used in combination as appropriate. The two electrodes 51 function as a working electrode and a counter electrode, but may be a three-pole system having a reference electrode as a third electrode.

  As shown in FIG. 12, a body fluid collection part 2 </ b> C is provided at the other end of the support part 53. The body fluid collecting part 2C has an outer diameter shape of a block shape or a plate shape. The body fluid collection part 2C includes a body fluid introduction channel 21 that penetrates the body fluid collection unit 2C, an inlet 22 in which one end of the body fluid introduction channel 21 is opened downward, and the other end of the body fluid introduction channel 21. And an outflow port 23 opened upward. Further, the outlet 23 is opened near the reagent application part 52 of the sensor part 5. Thereby, the blood which flowed out from the outflow port 23 of 2 C of body fluid collection parts can reach | attain the reagent application part 52 rapidly.

  Further, the puncture needle 14C (needle body 141) has an enlarged diameter portion (outer shape changing portion) 147 in which the outer diameter of the needle body 141 is changed, that is, the diameter is larger than that of the needle tip 144.

  In the state shown in FIG. 11, the inflow port 22 of the body fluid sampling part 2C is located at the first position in substantially the same manner as in the first embodiment. When the puncture needle 14C advances in the distal direction by the operation of the puncture means 4 from this state, the needle tip 144 of the puncture needle 14C is placed on the head 32 of the protrusion 3 before the needle tip 144 contacts the inflow port 22. The part to be removed, that is, the enlarged diameter portion 147 comes into contact, and the bodily fluid collection portion 2C (support portion 53) is pressed and rotated through the protruding portion 3. As a result, when the inflow port 22 begins to retract toward the second position and the needle tip 144 punctures the blood collection site 900, the inflow port 22 is positioned at the second position (the two-dot chain line in FIG. 11). Part shown by).

  While the puncture needle 14C is displaced from the retracted position to the puncture position, the inlet 22 is displaced from the first position to the second position without contacting the needle tip 144 at any one time.

  Thus, in the process in which the puncture needle 14C is displaced from the retracted position to the puncture position, the needle tip 144 abuts on a part constituting the tip 1C (for example, the edge 25 of the inlet 22 of the body fluid sampling part 2C). Is prevented. Accordingly, for example, the needle tip 144 can be prevented from being rounded or bent, and pain due to blunting of the needle tip 144 can be reduced.

  Further, in the chip 1C, each electrode 51 and the reagent application unit 52 are disposed in the vicinity of the blood collection site 900 that is in contact with the contact portion 163, that is, in the vicinity of the distal end opening 162 of the outer cylinder 16. The length of 21 can be set relatively short. As a result, the amount of blood collected can be reduced, and the blood can be reached quickly and reliably to the sensor unit 5, that is, the blood can be collected quickly and reliably.

  As described above, the component measuring chip of the present invention has been described with respect to the illustrated embodiment. However, the present invention is not limited to this, and each component constituting the component measuring chip is an arbitrary element that can exhibit the same function. It can be replaced with the configuration of Moreover, arbitrary components may be added.

  Moreover, the component measuring chip of the present invention may be a combination of any two or more configurations (features) of the above embodiments.

  For example, in the chip of the third embodiment, the puncture needle may be the puncture needle of the fourth embodiment.

  In the chip of the fourth embodiment, the puncture needle may be the puncture needle of the third embodiment.

  In the chip of the fourth embodiment, the puncture needle may be the puncture needle of the first embodiment, and the protruding portion protruding from the body fluid sampling portion may be omitted.

In addition, the body fluid collection unit of the second embodiment may be applied to the chips of other embodiments.
Moreover, in the bodily fluid collection part of the first embodiment, the inlet is displaced from the first position to the second position by being cantilevered and bent by the bodily fluid collection part. In combination with this configuration, a configuration in which the support point of the body fluid sampling unit can be rotated may be employed.

It is a longitudinal cross-sectional view which shows 1st Embodiment of the chip | tip for a component measurement of this invention. It is a longitudinal cross-sectional view which shows the state which mounted | wore the component measuring device with the component measuring chip | tip shown in FIG. It is a longitudinal cross-sectional view which shows the state which mounted | wore the component measuring apparatus with the component measuring chip | tip shown in FIG. 1, and punctured the biological body surface. FIG. 2 is a longitudinal sectional view showing a state in which a body fluid flowing out is collected after the component measuring chip shown in FIG. 1 is attached to the component measuring device and punctured on the surface of a living body. FIG. 2 is an enlarged longitudinal sectional view in the vicinity of a body fluid collecting part of the component measuring chip shown in FIG. 1. It is the figure which looked at the bodily fluid collection part in FIG. 5 from the arrow A side. It is a figure which shows the bodily fluid collection | recovery part of the chip | tip for a component measurement (2nd Embodiment) of this invention. It is a longitudinal cross-sectional view which shows the state which mounted | wore the component measuring apparatus with the chip | tip for component measurement (3rd Embodiment) of this invention. It is a longitudinal cross-sectional view which shows the state which act | operated the puncture needle, after mounting | wearing the component measuring device with the component measuring chip | tip (3rd Embodiment) of this invention. It is a longitudinal cross-sectional view which shows the state which punctured the biological body surface after mounting | wearing the component measuring apparatus with the component measuring chip | tip (3rd Embodiment) of this invention. It is a longitudinal cross-sectional view which shows 4th Embodiment of the chip | tip for a component measurement of this invention. FIG. 12 is a perspective view of the vicinity of the body fluid collection unit shown in FIG. 11.

Explanation of symbols

1, 1B, 1C Component measurement chip (chip)
2, 2A, 2B, 2C Body fluid collection part 21 Body fluid introduction flow path 22 Inlet 23 Outlet 24 Recessed part (defect part)
25 Edge portion 26 Inclined portion 3 Protruding portion 31 Columnar portion 32 Head portion 4 Puncturing means (moving means)
41 Plunger 5 Sensor part 51 Electrode 52 Reagent application part 53 Support part 54 Terminal 7 Measurement part 10 Component measurement device 13 Casing 14, 14B, 14C Puncture needle 141 Needle body 142 Hub 143 Diameter expansion part 144 Needle tip 145 Passing path 146 Press part 147 Diameter expansion part (outer shape change part)
DESCRIPTION OF SYMBOLS 15 Inner cylinder 151 Hole 152 Inner part 153 Wall part 154 Inner peripheral surface 155 Convex part 16 Outer cylinder 161 Inner part 162 End opening 163 Contact part 164 Flange 165 Inner peripheral surface 17 Test paper fixing | fixed part 172 Blood passage (sample passage) )
173 Blood outlet 174 Concavity 18 Test paper 900 Blood sampling site

Claims (11)

A puncture needle having a needle body having a sharp needle tip at the tip and a hub fixed to the outer periphery of the needle body;
A casing having a tip opening through which the puncture needle is movably stored and the needle tip can pass through;
A detection unit that is provided in the casing and detects a predetermined component in the body fluid that has flowed out from the puncture site on the living body surface that is punctured by the needle tip;
A bodily fluid collection part having a bodily fluid introduction channel for introducing bodily fluid flowing out from the puncture site on the surface of the living body into the detection unit;
The bodily fluid collection unit includes a first body fluid introductory channel, at least an inlet of the bodily fluid introduction channel is provided in the vicinity of the puncture site, and is located in a passage route through which the needle tip passes when puncturing the living body surface. A component measuring chip that is displaceable to a position and a second position retracted from the passage route.   The component measurement chip according to claim 1, wherein when the body fluid collecting unit is located at the second position, puncture of the living body surface with the needle tip is performed.   The body fluid introduction channel is a minute channel that can absorb body fluid by capillary force, and the body fluid collection unit has flexibility and is supported by the casing on the outlet side of the body fluid introduction channel The component measuring chip according to claim 1 or 2.   4. The body fluid collecting part located at the first position is displaced to a second position when the vicinity of the inflow port is pressed by the needle tip of the puncture needle moved in the distal direction. The component measuring chip according to any one of the above.   5. The component measuring chip according to claim 4, wherein a concave portion is formed in the vicinity of the inflow port so as to contact the needle tip and guide the needle body.   6. The component measuring chip according to claim 4, wherein the vicinity of the inflow port is made of a material having wear resistance. The bodily fluid collecting part is provided with a protruding part protruding from the bodily fluid collecting part,
The bodily fluid collecting part located at the first position is displaced to the second position when the projecting part is pressed by a portion excluding the needle tip of the puncture needle moved in the distal direction. The component measuring chip according to any one of the above.   The needle body has an outer shape changing portion whose outer diameter is changed, and the outer diameter changing portion is pressed against the projecting portion, whereby the bodily fluid collecting portion located at the first position is The component measuring chip according to claim 7, which is displaced to the second position.   The component measuring chip according to claim 1, wherein the detection unit includes a test paper carrying a reagent that reacts with a predetermined component in a body fluid and develops a color.   The detection unit supports at least two electrodes, a reagent application unit applied with a reagent that reacts with a predetermined component in a body fluid to generate a current between the electrodes, and the pair of electrodes and the reagent application unit The component measuring chip according to claim 1, further comprising a support portion. The support portion is provided to be rotatable with respect to the casing,
The component measurement chip according to claim 10, wherein the body fluid sampling unit is provided in the support unit, and is displaced between the first position and the second position by rotating the support unit. .

Images