JP5005200B2 - Puncture device and puncture needle tip - Google Patents

Description

  The present invention relates to a puncture device that punctures the skin in order to measure components such as glucose in blood and a puncture needle tip attached to the puncture device.

  Diabetic patients are encouraged to perform routine self-management by measuring their own blood glucose fluctuations. The blood glucose level is measured by providing a measuring section such as a test paper impregnated with a reagent that is colored according to the amount of glucose in the blood, supplying blood to the test paper to cause coloration, and determining the degree of coloration. A blood component measuring apparatus that obtains and displays a blood glucose level by optical measurement has been put into practical use. A blood component measuring apparatus using an electrochemical sensor has also been put into practical use.

  When a patient collects his / her blood, a puncture needle tip equipped with a puncture needle or a puncture needle capable of moving back and forth in the housing is used on the puncture device, and a repulsive force is applied to the puncture needle by an elastic body. The puncture needle punctures the skin (for example, finger, palm, arm, etc.) by projecting instantaneously, and after the puncture, a small amount of blood is discharged and used for measurement. In addition, a retraction mechanism is provided for retreating the puncture needle in order to relieve the puncture feeling and promote appropriate outflow after puncturing (see, for example, Patent Document 1).

  These advancing and retracting mechanisms use an elastic body such as a coil spring arranged in series opposite to each other. At the time of advancing, the puncture needle is projected by the elastic force of the driving coil spring compressed in advance, and the puncture is performed. Sometimes the puncture needle is retracted by the elastic force of the return coil spring that is momentarily compressed.

  Note that the puncture needle used in the conventional puncture device has only the action of puncturing the skin and allowing the blood necessary for measurement to flow out appropriately and is unnecessary after puncturing the skin. It is set to be fully retracted from.

  On the other hand, if a blood component measurement chip in which the measurement part such as the test paper is integrally provided on the puncture needle chip is used, the chip is mounted on the blood component measurement device to perform optical measurement, The measurement process can be performed automatically and continuously. As a result, the operation becomes simple and accurate and reliable measurement is possible. In the case where a measurement unit is provided on the puncture needle tip, it has been proposed to use the capillary phenomenon of the puncture needle in order to introduce blood collected by puncture to the measurement unit. (For example, refer to Patent Document 2).

JP 2000-245717 A JP 2000-116629 A

  By the way, in the conventional puncture device and puncture needle tip, only the elastic bodies such as the drive coil spring and the return coil spring are used for the advancement mechanism and the retraction mechanism of the puncture needle. The elastic body retracts to a position where the elastic force balances, and the expansion and contraction of the elastic body stops due to natural damping and friction caused by some sliding surfaces.

  In such a conventional retraction operation, since the puncture needle does not stop until the expansion and contraction operations of the drive coil spring and the return coil spring are attenuated, the damped vibration is transmitted to the patient's hand, giving a sense of incongruity or instability. There is.

  Further, the method described in Patent Document 2 is painful because there is no suitable mechanism for moving the puncture needle, and blood is sucked out on the same principle as the syringe while the puncture needle is punctured into the skin. If a conventional puncture needle moving mechanism is added to Patent Document 2, it is difficult for the puncture needle to retreat excessively and contact the blood clot.

  The present invention has been made in consideration of such a problem. A puncture device and a puncture needle tip that can suppress a damped vibration when the puncture needle retracts and can give a stable operation feeling to an operator. The purpose is to provide.

  Another object of the present invention is to use a puncture needle effectively to introduce blood collected by puncture to a measurement unit after retreating and perform a puncture device and a puncture needle with a simple configuration The purpose is to provide a chip.

  The puncture device according to the present invention is a puncture device used together with a puncture needle, and includes a first urging unit that advances the puncture needle from a predetermined reference position toward a puncture site on the skin, and the first urging unit. A second urging means for retracting the puncture needle that has punctured the skin; a contact portion that contacts the skin around the puncture site; and the puncture needle is defined when the puncture needle is retracted. And a stopper for stopping at the puncture operation end position. In this way, by restricting the puncture needle from being retracted by the stopper, the damping vibration when the puncture needle is retracted is suppressed, and a stable operation feeling can be given to the operator.

  In this case, the puncture operation end position is further stabilized when it is set on the distal end side with respect to the position where the first urging means and the second urging means are balanced.

  When the puncture operation end position is set at a position where the tip of the puncture needle comes into contact with the blood clot that has flowed out of the skin, the blood clot moves along the puncture needle due to the action of surface tension, and flows out. Even if the amount of blood clot obtained is smaller, the measurement part or its guide part can be reliably introduced.

  When the shortest distance from the skin in contact with the tip of the puncture needle at the puncture operation end position is set to 0.1 mm or more and 3 mm or less, the puncture needle easily comes into contact with the blood clot.

  The puncture needle tip is provided with a detachable puncture needle tip, and the puncture needle is held in the housing of the puncture needle tip so as to be able to advance and retreat, and a plunger that contacts the first urging means and the second urging means. You may make it engage and hold | maintain.

  Further, the stopper includes a bulging portion provided on the outer surface of the housing, an elastic piece provided on the plunger, riding on the bulging portion when moving forward, and being pushed up, and when the plunger retracts, the elastic member It can comprise by the engaging part engaged with a part of piece.

  In addition, the puncture needle has a measurement part for measuring the collected blood component and a blood introduction part that extends from the inner wall surface of the housing toward the lumen and introduces blood into the measurement part. The blood that has moved along is easy to contact the blood introduction part.

  In addition, it has a measurement part for measuring the collected blood component, the puncture needle is a hollow needle, and the measurement part is in the vicinity of the opening on the rear end side of the puncture needle or in the hollow part of the puncture needle It may be provided. Thereby, blood can be introduced to the measurement part through the hollow part of the puncture needle.

  On the other hand, the puncture needle tip according to the present invention includes a puncture needle that is movable forward and backward in the housing, and is a puncture needle tip that is attached to the puncture device, and a contact portion that contacts the skin around the puncture site by the puncture needle; A stopper that allows the advancing operation when the puncture needle advances toward the skin by the operation of the puncture device, restricts the retreat operation when retreating, and stops at a predetermined puncture operation end position. Features. In this way, by restricting the puncture needle from being retracted by the stopper, the damping vibration when the puncture needle is retracted is suppressed, and a stable operation feeling can be given to the operator.

  In this case, the stopper may include an elastic body provided in the housing, and a hook provided at the tip of the elastic body and protruding to the inner peripheral side from the inner peripheral surface of the housing. The stopper has a spiral groove provided on the inner peripheral surface of the housing, and a ridge groove provided at a tip of the spiral groove, and a protrusion provided on a hub for holding the puncture needle is provided. You may make it engage with the said spiral groove and the said groove | channel. Further, the stopper may be an elastic ring having an asymmetric cross section, and may be inserted into a support member that holds the puncture needle.

  According to the puncture device and the puncture needle tip according to the present invention, by controlling the retraction of the puncture needle by the stopper, the damping vibration when the puncture needle retracts is suppressed, and a stable operation feeling for the operator. Can be given.

  Further, when the puncture operation end position by the stopper is set at a position where the tip of the puncture needle comes into contact with the blood clot that has flowed out of the skin, the blood clot is moved along the puncture needle by the action of surface tension or capillary action. Even if the blood clot that moves and is obtained by outflow is smaller, it can be surely introduced to the measuring section or its guide section. Thus, the puncture needle can be effectively used to introduce blood to the measurement unit, and a mechanism for introducing blood can be simply configured.

  Embodiments of a puncture device and a puncture needle tip according to the present invention will be described below with reference to FIGS. 1 to 14C. Blood component measuring device 10 as a puncture device and blood component measurement chip 12a as a puncture needle tip according to the present embodiment are components such as glucose in blood or the amount of the component (hereinafter, the amount of glucose in blood is a blood sugar level). Measured and displayed). The blood component measuring chip 12a is mounted on the blood component measuring apparatus 10 and used as a part thereof. The blood component measurement device 10 includes a puncture device that performs puncture prior to measurement of blood components. In the following description, for the sake of convenience, the left side in the drawing is the front, the right side is the rear, and the vertical direction is described in accordance with the drawing. In actual use, the vertical direction is not limited to this.

  As shown in FIGS. 1 and 2, the blood component measurement chip 12 a includes a cylindrical housing 14, a puncture needle unit (puncture needle) 18 that can advance and retreat in the axial direction within the housing 14, and an outer surface of the housing 14. And a test paper holder 20 provided on the test paper.

  An annular abutting portion 22 that abuts against the skin around the puncture site P (see FIG. 4) on the measurer's skin at the time of measurement is provided at the end of the housing 14. The abutting portion 22 has an elliptical view (see FIG. 3) and is formed with a tapered portion 22a that gradually decreases in diameter toward the center. The abutting portion 22 is easy to abut on the palm, the side surface of the finger, etc. The vicinity of the puncture site can be appropriately raised to appropriately promote blood outflow after puncture. A small bulging portion 23 having a gentle slope toward the front and rear is provided on the rear upper surface of the housing 14.

  A first blood introduction guide (blood introduction portion) 24a and a second blood introduction guide (blood introduction portion) 24b extend from the vicinity of the opening 26a of the blood flow passage 26 in the inner wall surface 14a of the housing 14 toward the lumen. Exist. As shown in FIG. 3, the shortest distances R1 and R2 between the puncture needle 34 and the distal ends of the first blood introduction guide 24a and the second blood introduction guide 24b are sufficiently small and set to 1 mm or less. By setting the distances R1 and R2 to 1 mm or less, blood that is captured by the distal end portion 34c of the puncture needle 34 and moves along the puncture needle 34 comes into contact with the first blood introduction guide 24a and the second blood introduction guide 24b. Cheap. Further, in consideration of interference due to product variations, the distances R1 and R2 may be set to 0.1 mm or more. The first blood introduction guide 24a is formed integrally with the housing 14 and has a substantially flat plate shape. The distal end surface on the lumen side and the surface on the rear side are hydrophilized.

  The second blood introduction guide 24b is a part of the test paper holder 20, is substantially cylindrical, is inserted into the opening 26a, and extends toward the lumen. It is desirable that the surface of the second blood introduction guide 24b is subjected to a hydrophilic treatment. The first blood introduction guide 24a and the second blood introduction guide 24b are disposed adjacent to each other. Hereinafter, the first blood introduction guide 24a and the second blood introduction guide 24b are collectively referred to as a blood introduction guide 24.

  The test paper holder 20 is a small piece of a square plate, and is fitted into the fitting portion 14b on the outer side surface of the housing 14 and fused (for example, ultrasonic fusion). By fusing the test paper holder 20, a narrow blood flow passage 26 is formed on the mating surface. These blood flow passages 26 are set to have a sufficiently small diameter so as to suck up blood by capillary action.

  A test paper (measuring unit) 28 impregnated with a predetermined reagent is fixed on the upper surface of the test paper holder 20. Examples of the material of the test paper 28 include polyethersulfone. Examples of the reagent include color formers such as glucose oxidase (GOD), peroxidase (POD), 4-aminoantipyrine, and N-ethyl-N- (2-hydroxy-3-sulfopropyl) -m-toluidine. The reagent may contain a predetermined buffer. Moreover, an electrochemical sensor can also be used as a measurement part.

  As shown in FIG. 1, the puncture needle unit 18 includes a puncture needle 34 at the distal end, a hub 36 that holds the puncture needle 34, and a flange (expanded diameter portion) 38 that has an enlarged diameter and protrudes from a middle portion of the hub 36. And have.

  The puncture needle 34 has a hydrophilic portion 34a at the distal end region that has been subjected to hydrophilic treatment, and a hydrophobic portion 34b at the rear end side. In practice, the hydrophilic portion 34a and the hydrophobic portion 34b are difficult to distinguish visually, but on the drawings (FIG. 1, FIG. 4, etc.), the hydrophobic portion 34b is provided with a cross hatch, and the hydrophilic portion 34a. Is shown without hatching.

  Hydrophilic treatment includes surface plasma treatment, surfactant coating, or hydrophilic polymer coating (polyvinyl pyrrolidone, polyethylene glycol, polyvinyl alcohol, polysaccharide, hydrophilic polyurethane, polyhydroxy acrylate, dextran, xanthan, hydroxypropyl cellulose, methyl cellulose, A coupling agent with the surface of the puncture needle 34 can be used as required, such as hydrophilic silicone). Preferably, hydrophilic silicone is applied. The hydrophilic treatment needs to be safe for the human body including these.

  The outer diameter of the hub 36 is substantially the same as the inner diameter of the small diameter portion 16 a of the housing 14, and the outer diameter of the flange 38 is substantially the same as the inner diameter of the large diameter portion 16 b of the housing 14. The inner wall surface of the large-diameter portion 16b is provided with an annular bulging portion 40 that slightly protrudes in the lumen direction, and is engaged with a shallow annular undercut 42 provided on the outer peripheral surface of the flange 38 to be lightly fixed. And has a sealing effect. In addition, a sealing action is exerted by a stopper not shown in the front. The puncture needle 34 is sterilized in advance by γ rays, electron beams or the like, and this sterilized state is maintained until use. The rear end 38a of the hub 36 is engaged with a plunger 106 described later.

  Next, the blood component measuring apparatus 10 will be described with reference to FIGS. 1 and 2. The blood component measuring device 10 is a small and lightweight device suitable for carrying, and is provided with a mounting hole 100 in which a blood component measuring chip 12a is mounted at the tip. The blood component measuring apparatus 10 is configured based on a case main body 101, and includes a front upper control unit 104 and a mechanism unit 102 that occupies other parts.

  The mechanism 102 includes an axially movable plunger 106, a driving coil spring (first urging means) 108 coaxially disposed at the middle stage of the plunger 106, and a return coaxial disposed at the rear end. A coil spring (second urging means) 110, a recharge lever 114 that pulls the plunger 106 backward, and a puncture button 116 that is a part of the case main body 101 are provided.

  The plunger 106 includes a gripping bar 118 extending forward, a first elastic piece 120 extending forward from below the middle step, and a second elastic piece extending forward from above the middle step ( A stopper) 122, an intermediate flange 124 that can be engaged with and supported by one end of the drive coil spring 108, and a retreat lever 114 that is retracted, and an end support of the return coil spring 110. A rear end flange 126 and a protruding piece 128 that acts as a retaining member when protruding.

  Two gripping members 130 capable of elastically gripping the rear end 38a of the hub 36 of the blood component measurement chip 12a are provided at the tip of the gripping bar 118. A first ring portion 132 and a second ring portion 134 that protrude toward the lumen side are provided coaxially with the plunger 106 at the slightly rear portion of the case body 101 in order toward the rear.

  The front surface of the first ring portion 132 is in contact with and supported by the end of the drive coil spring 108, and in the initial state shown in FIG. 1, the drive coil spring 108 is kept in a slightly compressed state together with the intermediate flange 124. . When the plunger 106 protrudes, the rear surface of the first ring portion 132 abuts on the protruding piece 128 to limit further advancement. For example, the first ring portion 132 may be provided with a mechanism for adjusting the thickness by adjusting the dial so that the protruding amount of the puncture needle 34 at the time of puncture can be adjusted.

  The rear surface of the second ring portion 134 is set to have a diameter that can contact and support one end of the return coil spring 110. In the initial state, the distance between the second ring portion 134 and the rear end flange 126 is longer than the natural length of the return coil spring 110, and the return coil spring 110 is in an uncompressed state.

  The first elastic piece 120 is elastically biased downward with the middle step portion of the plunger 106 as a base portion, and the tip end portion is in contact with the protruding portion 136 of the case main body 101. The first elastic piece 120 includes a knob 138 formed downward from a substantially central portion and a small protruding piece 140 formed downward from the tip portion. The small protruding piece 140 has a shape in which the front surface is a substantially vertical surface and gradually decreases toward the rear.

  The protrusion 136 is formed upward from the lower surface of the case main body 101, the rear surface is a substantially vertical surface, and has a shape that gradually decreases toward the front. In the initial state, the small projecting piece 140 is in contact with the front inclined surface of the projecting portion 136. An axially long hole 142 is provided behind the protrusion 136 in the case main body 101, and the knob 138 can move along the hole 142.

  A puncture button 116 extending toward the front is provided from the lower surface or slightly rear part of the case body 101, and a pusher 146 is provided on the upper surface of the substantially central portion of the puncture button 116. The pusher 146 is provided at a position facing the knob 138 when the plunger 106 is set at the puncture preparation position (see FIG. 6).

  The recharge lever 114 extends from the lever main body 150, a first stop lever (engaging portion) 152 extending from the lower portion of the lever main body 150 toward the front, and from the side surface of the lever main body 150 toward the rear. It has the 2nd stop lever 153 (refer FIG. 2), and the engaging pin 154 provided in the front surface of the lever main body 150. FIG. An engagement pin 156 is fixed to the ceiling surface of the case body 101 slightly in front of the engagement pin 154.

  A tension coil spring 158 is placed between the engagement pin 154 and the engagement pin 156, and the hooks at both ends engage with the engagement pin 154 and the engagement pin 156. Pulling forward. The tension coil spring 158 is a strong spring and has a spring constant set considerably larger than that of the return coil spring 110. A long hole 160 is provided in the upper surface of the case main body 101 in the axial direction, and a part of the lever main body 150 is exposed to the outside through the hole 160 and is movable along the hole 160.

  The first stop lever 152 is elastically biased downward with the lever body 150 as a base. The front end 152a of the first stop lever 152 is formed to be slightly thicker through a small stepped portion inclined obliquely forward, and the front end is a substantially vertical surface. The first stop lever 152 does not necessarily need to be an elastic material depending on the shape of the second elastic piece 122 and the small bulging portion 23.

  As shown in FIG. 2, the second stop lever 153 is elastically biased outward with the lever body 150 as a base. Further, a triangular protrusion 153a is provided on the outer surface near the tip of the second stop lever 153, and in the initial state, is engaged with a groove 155a provided on the side surface of the case body 101. Slightly behind the groove 155a, a groove 155b is provided in which the triangular protrusion 153a engages when the recharge lever 114 is retracted.

  Returning to FIG. 1, the second elastic piece 122 is elastically biased upward with the middle portion of the plunger 106 as a base. The second elastic piece 122 has a small protruding piece 157 formed upward from the tip end portion 122a. The lower surface of the distal end portion 122a is a gently inclined surface that becomes thinner toward the front. The small protruding piece 157 has a shape in which the rear surface is a substantially vertical surface and gradually decreases toward the front. In the initial state, the small protruding piece 157 is in contact with the lower surface of the tip portion 152a.

  As will be described later, when the puncture needle 34 is retracted after puncturing, the small protruding piece 157 engages with the distal end surface of the distal end portion 152a and acts as a stopper. That is, the puncture operation end position of the plunger 106 is defined by the positional relationship between the small projecting piece 157 and the distal end portion 152a. In the conventional puncture device, the puncture needle has only the effect of performing puncture and appropriately draining blood necessary for measurement, and since it is unnecessary after puncture, it is sufficiently retracted from the contact portion. Although the blood component measuring apparatus 10 according to the present embodiment is set so as to be moved, the puncture operation end position is regulated by the small protruding piece 157 and the distal end portion 152a so as not to return excessively. I have to.

  The puncture operation end position is set so that the tip 34c of the puncture needle 34 comes into contact with the blood clot 164 flowing out of the skin 162, and the elastic force of the drive coil spring 108 and the return coil spring 110 is set. Is on the tip side with respect to the position where is balanced. By setting the shortest distance L (see FIG. 4) between the distal end of the puncture needle 34 at the puncture operation end position and the distal end 22b of the contact portion 22 to a value of 0.1 mm or more and 3 mm or less, the distal end portion 34c becomes a blood clot. It is easy to contact 164 and is preferable. In consideration of the shape of the tapered portion 22a, the bulging of the skin, and the like, it is more preferable to set the tip 34c away from the surface of the skin 162 and in contact with the blood clot 164. The blood clot 164 is blood that has not solidified and is synonymous with a blood drop.

  Furthermore, the positional relationship between the puncture needle 34 and the blood introduction guide 24 in a side view (see FIG. 4) is such that the distal end of the puncture needle 34 is in the axial direction and more distal than the blood introduction guide 24. It is desirable to set within the range W of the hydrophilic portion 34a of the puncture needle 34 at the directional position.

  Next, returning to FIGS. 1 and 2, the control unit 104 includes an optical measurement unit 178, a control board 170 that performs electrical overall control, a liquid crystal monitor 172 that displays the measured blood components, and a power switch 174. And a battery 176 that supplies power in conjunction with the operation of the power switch 174. The control unit 104 includes a switch unit 180, a predetermined external output unit (not shown), a data storage unit, and the like.

  The optical measurement unit 178 is provided at a position facing the test paper 28 in the mounted blood component measurement chip 12a. The optical measuring unit 178 is controlled under the action of the control board 170, and includes a light emitting element (such as a light emitting diode) 182, a light receiving element (such as a photodiode) 184, and an amplifying unit 186. The light emitted from the light emitting element 182 with the blood component measuring chip 12a mounted in the mounting hole 100 is reflected by the test paper 28, and the reflected light is received by the light receiving element 184 and subjected to photoelectric conversion. An analog signal corresponding to the amount of received light is output from the light receiving element 184, and after being appropriately amplified by the amplifying unit 186, is supplied to the control board 170.

  The control board 170 is connected to the optical measurement unit 178 via a signal line, and causes the light emitting element 182 to emit light at an appropriate timing (for example, intermittent pulse emission), and an analog signal supplied from the light receiving element 184. Can be obtained by converting the signal into a digital signal by an A / D converter. In the control board 170, based on the acquired digital signal, a predetermined calculation process is performed based on the amount of received light and the rate of change thereof, and a correction calculation is performed as necessary to determine the amount of glucose (blood glucose level) in the blood. Ask. The obtained blood glucose level is displayed on the liquid crystal monitor 172 to inform the measurer.

  Next, the operation of the blood component measuring apparatus 10 configured as described above will be described.

  First, the blood component measurement chip 12a is inserted into the mounting hole 100 and pushed into it, so that the plunger 106 moves integrally while compressing the driving coil spring 108, and at the same time, two rear end portions 38a of the hub 36 are provided. The nipping material 130 is caught and gripped. As shown in FIG. 6, when the plunger 106 moves until the driving coil spring 108 is sufficiently compressed, the first elastic piece 120 is elastically deformed so that the small protruding piece 140 gets over the protruding portion 136. Thereby, the front surface of the small projecting piece 140 and the rear surface of the projecting portion 136 come into contact with each other, and the plunger 106 is fixed at the puncture preparation position.

  When the plunger 106 is disposed at the puncture preparation position and the blood component measurement chip 12a is attached, the knob 138 is disposed at a position facing the pusher 146, and the test paper 28 of the blood component measurement chip 12a faces the optical measurement unit 178. It is arranged at the position to Further, the small projecting piece 157 of the second elastic piece 122 is disposed behind the front end portion 152 a of the first stop lever 152.

  Next, the power switch 174 is turned on. As a result, the light emitting element 182 starts pulsed light emission under the action of the control unit 104. Next, the contact part 22 of the blood component measurement chip 12 a is pressed against the skin (for example, finger, palm, arm, etc.) 162 of the measurer, and the knob 138 is pushed down via the puncture button 116. As a result, the engagement state between the small projecting piece 140 and the projecting portion 136 is released, and the plunger 106 is elastically biased by the driving coil spring 108 and driven forward, and pushes the puncture needle unit 18 through the gripping bar 118. .

  As shown in FIG. 7, the small protruding piece 157 of the second elastic piece 122 passes through the portion while contacting the tip portion 152 a of the first stop lever 152, and the second elastic piece 122 is an inclined surface below the tip. Rides on the small bulging portion 23 of the housing 14 of the blood component measuring chip 12a and is pushed upward.

  The distal end portion 34 c of the puncture needle 34 provided in the puncture needle unit 18 is pushed out to the vicinity of the tapered portion 22 a in the contact portion 22 and punctures the skin 162. At this time, since the plunger 106 moves vigorously, the return coil spring 110 is momentarily compressed moderately. Accordingly, the plunger 106 is immediately pushed back backward by the elastic force of the return coil spring 110 returning to its original length, and the plunger 106 and the puncture needle unit 18 are retracted.

  As shown in FIG. 8, since the second elastic piece 122 is pushed up by the small bulging portion 23, when the plunger 106 is retracted, the rear surface of the small protruding piece 157 is the end of the distal end portion 152 a of the first stop lever 152. Contact the front. At this time, the second stop lever 153 of the recharge lever 114 has the triangular protrusion 153a at the tip engaged with the groove 155a, and the recharge lever 114 moves backward even if the small protruding piece 157 contacts the first stop lever 152. The plunger 106 and the puncture needle unit 18 are reliably stopped at a predetermined puncture operation end position. Even if the triangular protrusion 153a is detached from the groove 155a due to the momentum at the time of collision, the tension coil spring 158 is stronger than the return coil spring 110, so that it is hardly stretched and the recharge lever 114 is securely connected. Then, the plunger 106 and the puncture needle unit 18 are fixed at the puncture operation end position.

  As described above, in the blood component measuring apparatus 10, the puncture needle unit 18 is controlled by restricting the retraction of the puncture needle unit 18 by the stoppers such as the small protruding piece 157, the first stop lever 152, and the second stop lever 153. Damping vibrations of the drive coil spring 108 and the return coil spring 110 when retreating are suppressed, and the operator feels uncomfortable or unstable due to the transmission of vibrations, thereby providing a stable operation feeling. In addition, according to such a mechanism, virtually no vibration is generated.

  On the other hand, as shown in FIG. 4, blood clot 164 flows out from puncture site P punctured by puncture needle 34. The blood clot 164 gradually increases with time and comes into contact with the tip 34c of the puncture needle 34. At this time, since the distance L is set to 0.1 mm or more and 3 mm or less, the puncture needle 34 comes into contact with the blood clot 164 and is easily captured. Moreover, since the distal end region of the puncture needle 34 is a hydrophilic portion 34a, blood is likely to move along the surface of the puncture needle 34, and the blood is restricted from moving at the hydrophobic portion 34b. Thus, it becomes difficult to reach the rear end side unnecessarily, and a sufficient amount of blood accumulates in the hydrophilic portion 34a. When the puncture needle 34 is made of a metal material such as SUS, the same effect can be obtained due to the inherent hydrophilicity of the metal surface even if the tip region of the puncture needle 34 is not particularly hydrophilic. Furthermore, the puncture needle 34 has an action of capturing the blood clot 164 even if it is made of a material that is not particularly high in hydrophilicity, and at least the one that has not been subjected to hydrophobic treatment is preferably used.

  In addition, as a form in which the blood clot 164 is introduced to the blood introduction guide 24, there can basically be three forms. That is, first, when the blood clot 164 grows in size while being captured by the puncture needle 34 and comes into contact with the blood introduction guide 24, and secondly, the blood clot 164 is captured by the tip of the puncture needle 34. There may be a case where it is introduced after flowing along the surface, and thirdly, an intermediate case between the two forms. According to puncture needle 34, blood clot 164 can be easily introduced to blood introduction guide 24 in any of these cases.

  Furthermore, the distal end portion 34c of the puncture needle 34 is set to the distal end side with respect to the blood introduction guide 24 in the axial direction, and the blood introduction guide 24 is set within the range W of the hydrophilic portion 34a of the puncture needle 34 at the axial position. Therefore, blood moves from the puncture needle 34 to the blood introduction guide 24. In particular, the distances R1 and R2 are sufficiently small and set to a value of 0.1 mm or more and 1 mm or less, and blood that has moved along the puncture needle 34 is easily brought into contact with the blood introduction guide 24 and easily introduced. As described above, the puncture needle 34 has an effect of introducing the obtained blood up to the blood introduction guide 24 as well as an effect of performing puncture and causing blood necessary for measurement to flow out.

  If the puncture needle 34 is not near the skin 162, the blood clot 164 'flows downward as shown by the one-dot chain line portion in FIG. On the other hand, according to the present embodiment, the blood clot 164 flowing out from the skin 162 becomes larger while being captured by the puncture needle 34, or moves along the surface of the puncture needle 34. Flowing in an unrelated direction on the skin 162 is suppressed, and the blood introduction guide 24 is easily introduced.

  In addition, as shown in FIG. 5, a small annular protrusion 35 may be provided in the middle of the puncture needle, specifically, at the boundary between the hydrophilic portion 34a and the hydrophobic portion 34b. Blood is blocked by the annular protrusion 35, and further movement to the rear end side is further suppressed. Thereby, a more sufficient amount of blood accumulates in the hydrophilic portion 34a.

  Thereafter, the blood adheres to the tip of the blood introduction guide 24 and spreads between the rear surface of the first blood introduction guide 24a and the second blood introduction guide 24b by the effect of capillary action or surface tension. Eventually, a part thereof is guided to the blood flow passage 26 along the outer surface of the second blood introduction guide 24b.

  Next, blood is sucked up in the blood flow passage 26 by capillary action and introduced to the test paper 28. The blood is impregnated into the test paper 28, and reacts with the reagent to give a color according to the amount of glucose (blood glucose level) in the blood.

  During this time, the optical measurement unit 178 continues to measure the pulsed light projection and the amount of received light, and the control board 170 automatically recognizes that the blood has been impregnated by the change in the amount of received light based on the discoloration of the test paper 28, The blood glucose level of blood is obtained by a predetermined calculation process, displayed on the liquid crystal monitor 172, and stored in the data storage unit, and the measurement is terminated. In addition, past data recorded in the data storage unit can be redisplayed or erased based on the operation of the switch unit 180, and these data and the like can be exchanged with an external computer by the external output unit. It may be. After the measurement is completed, the power switch 174 is turned off to stop the operation of the control unit 104. The used blood component measurement chip 12a is discarded as a medical waste by a predetermined method.

  In addition, the recharge lever 114 can be used when it is necessary to reenter the puncture preparation state, including when the puncture button 116 is accidentally pressed in the puncture preparation state. That is, by pulling the recharge lever 114 backward (see the two-dot chain line portion in FIG. 6), the triangular protrusion 153a is detached from the groove 155a, and the plunger 106 moves integrally backward while compressing the driving coil spring 108. To do. When the plunger 106 moves to a position where the driving coil spring 108 is sufficiently compressed, the small projecting piece 140 and the projecting portion 136 come into contact with each other, and the plunger 106 is fixed at the puncture preparation position. At this time, the triangular protrusion 153a (see FIG. 2) is engaged with the groove 155b, and the operator can confirm that the driving coil spring 108 has been appropriately charged with a light click feeling. When the rear hand is released, since the tension coil spring 158 is a relatively strong spring, the triangular protrusion 153a is detached from the groove 155b, and the recharge lever 114 returns to the original position.

  The puncture needle 34 is preferably a solid needle, but even a hollow needle may be used as long as the rear end is closed.

  Next, blood component measurement chips 12b to 12e according to first to fourth modifications of the blood component measurement chip used in blood component measurement apparatus 10 (or an apparatus equivalent thereto) according to the present embodiment will be described. For the description of these blood component measurement chips 12b to 12e, the same parts as those of the blood component measurement chip 12a are denoted by the same reference numerals, and detailed description thereof is omitted.

  As shown in FIG. 9, the blood component measurement chip 12 b according to the first modification includes a puncture needle unit 18, a housing 200, and a test strip holder 202. The housing 200 corresponds to the housing 14 and holds the puncture needle unit 18. The test paper holder 202 corresponds to the test paper holder 20 and is fitted to the fitting portion 200a at the top end portion of the upper surface of the housing 200. The test paper 28 is provided on the upper surface.

  The fitting part 200a has an inclination that rises by 45 ° toward the tip side, and the test paper holder 202 and the test paper 28 are also inclined by 45 ° in accordance with this inclination. A tube 204 having a blood flow path 204 a is provided at the center of the lower surface of the test strip holder 202. This tube 204 corresponds to the blood introduction guide 24. The inclination of the test paper holder 202 and the tube 204 is not limited to 45 °, and can be set to an appropriate inclination angle according to design conditions.

  The blood flow passage 204a opens at the tip of the tube 204, and the other communicates with the test paper 28. The blood flow passage 204a is set to have such a small diameter that blood can be introduced by capillary action. The tube 204 is inserted into a hole 200b provided in the center portion of the fitting portion 200a, and extends with an inclination of 45 ° obliquely downward according to the inclination of the fitting portion 200a. When the puncture needle unit 18 is at the puncture operation end position, the distance between the distal end portion of the tube 204 and the hydrophilic portion 34a of the puncture needle 34 is set to 0.1 mm or more and 1 mm or less.

  In the optical measuring unit 206 corresponding to the blood component measuring chip 12b, the directions of the light emitting element 182 and the light receiving element 184 are set in accordance with the surface of the test paper 28, like the optical measuring unit 178.

  According to such a blood component measurement chip 12b, after puncturing with the puncture needle 34, as shown in FIG. 9, the puncture needle unit 18 stops at the same puncture operation end position as described above, and the puncture needle The tip 34c of the needle 34 is disposed in the vicinity of the puncture site P. Therefore, the blood clot 164 that has flowed out by puncturing gradually increases with time and contacts the tip of the puncture needle 34. Thereafter, the blood is held by the hydrophilic portion 34a of the puncture needle 34, and is further brought into contact with the tip of the tube 204 and introduced to the test paper 28 through the blood flow passage 204a by the action of surface tension and capillary action.

  Next, as shown in FIG. 10, the blood component measurement chip 12 c according to the second modification has a puncture needle unit 220 and a housing 222. The housing 222 corresponds to the housing 14 and holds the puncture needle unit 220. The housing 222 is different from the housing 14 in that it does not include the test paper holder 20 in the blood component measurement chip 12a, the fitting portion 14b to which the test paper holder 20 is mounted, the blood flow passage 26 and the blood introduction guide 24. A small bulging portion 23 is provided on the rear upper surface of the housing 222.

  The puncture needle unit 220 includes a puncture needle 224 at the front end, a hub 226 that holds the puncture needle 224, a gripped portion 230 at the rear end, and a pair of electric wires 232.

  The puncture needle 224 is a hollow needle, and the portion supported by the hub 226 has a slightly larger diameter. The distal end side of the large diameter portion is set to a small diameter so that blood can be introduced by capillary action, and the large diameter portion is also set sufficiently narrow. The rear end of the hollow portion 224 a of the puncture needle 224 communicates with the rear via a vent hole 236 and a center hole 238 provided in the gripped portion 230. The inner surface of the hollow portion 224a is subjected to a hydrophilic treatment from the distal end portion 224b to the electrode 242, while the outer surface of the puncture needle 224 is not subjected to the hydrophilic treatment and is hydrophobic.

  The electric wire 232 is provided across the hollow portion 224a of the puncture needle 224 from the upper and lower end surfaces of the gripped portion 230 through the outer surface of the gripped portion 230, through the wall, and through the vent hole 236. Yes. An electrode (measuring unit) 242 is provided at the tip of each electric wire 232 and is slightly separated. The electrode 242 is disposed almost at the tip of the large diameter portion of the puncture needle 224. Depending on design conditions, the electrode 242 may be provided in the vicinity of the opening on the rear end side of the puncture needle 224.

  It is preferable that an insulating film is provided on a portion of the electric wire 232 other than the portion disposed on the gripped portion 230 and the electrode 242.

  On the other hand, a pair of terminals 246 that are in contact with the electric wires 232 are provided on the lumen side of the holding member 244 (corresponding to the holding member 130) that holds the gripped portion 230 in the blood component measuring apparatus 10. The terminal 246 is connected to the control board 170, and a reaction reagent is applied around both electrodes 242. With this reaction reagent, blood components are converted by an enzyme reaction, and the current value can be measured by transferring electrons through a predetermined mediator.

  According to such a blood component measurement chip 12c, after puncturing, the puncture needle unit 220 stops at the puncture operation end position at the same position as described above, and the distal end portion 224b of the puncture needle 224 is blood in the vicinity of the puncture location P. It will be a position in contact with the mass 164. The blood clot 164 in contact with the distal end portion 224b moves along the hollow portion 224a by capillary action, and eventually immerses the pair of electrodes 242. Since the rear end of the hollow portion 224a communicates with the rear via the vent hole 236, capillary action tends to occur and blood can be easily introduced to the electrode 242. Further, since the hollow portion 224a is hydrophilic and the outer surface of the puncture needle 224 is not subjected to hydrophilic treatment, blood flows intensively into the highly hydrophilic hollow portion 224a and blood is easily introduced. . On the other hand, the control board 170 can measure the current value based on the enzyme reaction between the electrodes 242 via the terminal 246 and the electric wire 232, obtain the blood sugar level from these measured values, and display it on the liquid crystal monitor 172.

  Next, as shown in FIG. 11, the blood component measurement chip 12 d according to the third modification has a puncture needle unit 250 and a housing 222. The housing 222 corresponds to the housing 14 and holds the puncture needle unit 250.

  The puncture needle unit 250 is provided in the distal end of the puncture needle 252, a hub 254 that holds the puncture needle 252, a flange 256 that expands and projects from a midway portion, a gripped portion 258 at the rear end, and a flange 256. Test paper (measuring unit) 260. The test paper 260 is made of the same material as that of the test paper 28 and impregnated with the same reagent, and is cut into an area that can be mounted in the flange 256.

  The puncture needle 252 is a hollow needle, and has a small diameter so that blood can be introduced by capillary action. The inner surface of the hollow part 252a is subjected to hydrophilic treatment, and the outer surface of the puncture needle 252 is not subjected to hydrophilic treatment. The gripped portion 258 has a cylindrical shape having a hollow portion 264, and the front end side is fitted in the hole of the flange 256, and the front end surface is covered with one surface of the test paper 260. The other surface of the test paper 260 is in contact with the rear end surface of the puncture needle 252.

  On the other hand, a bar 268 extending in parallel with the sandwiching material 130 is provided from the center of the tip of the gripping bar 266 (corresponding to the gripping bar 118) in the blood component measuring apparatus 10, and is inserted into the hollow portion 264. ing. A light emitting element 182 and a light receiving element 184 are provided at the tip of the bar 268 and are arranged in the vicinity of the test paper 260. The light emitting element 182 and the light receiving element 184 are the same as those in the optical measuring unit 178, and emit and receive light under the action of the control board 170.

  According to such a blood component measurement chip 12d, after puncture, the puncture needle unit 250 stops at the puncture operation end position at the same position as described above, and the distal end portion 252b of the puncture needle 252 is blood in the vicinity of the puncture location P. It will be a position in contact with the mass 164. The blood clot 164 in contact with the distal end portion 252b moves along the hollow portion 252a by capillary action, and is eventually impregnated in the test paper 260. In the puncture needle 252, the inner surface of the hollow portion 252 a is hydrophilic, and the outer surface is not subjected to hydrophilic treatment. Therefore, like the puncture needle 224, capillary action is likely to occur, and blood is used for the test paper 260. Easy to introduce up to. On the other hand, the control board 170 obtains the blood glucose level based on the amount of light received from the light receiving element 184 and the rate of change thereof, and displays it on the liquid crystal monitor 172, as described above.

  Next, as shown in FIG. 12A, a blood component measurement chip 12e according to a fourth modification includes a cylindrical housing 300, a puncture needle unit 18 that can advance and retreat in the axial direction within the housing 300, and the housing 300. And a test paper holder 20 provided on the outer side surface. The housing 300 corresponds to the housing 14 described above, and is different in that it has two elastic stoppers 302 and there is no small bulging portion 23. Similarly to the blood component measurement chip 12a, the blood component measurement chip 12e (and blood component measurement chips 12f and 12g) includes a contact portion 22, a test paper 28, a blood flow path 26, and a blood introduction guide 24.

  The elastic stoppers 302 are respectively provided in the long holes 300a on the upper surface and the lower surface of the housing 300. The axial end portions are connected to the end surfaces of the long holes 300a, and the elastic stoppers 302 are elastic toward the outer diameter direction with reference to the connecting portions. It can be deformed. At the free end of the elastic stopper 302, a hook 306 is provided that partially protrudes toward the lumen of the housing 300. The hook 306 has a substantially vertical surface on the front end side in the axial direction (left side in FIG. 12A) and a gently inclined surface on the rear end side toward the rear. The end of the inclined surface of the hook 306 is at a position deeper in the outer diameter direction than the inner peripheral surface of the housing 300. In FIG. 12A, the elastic stopper 302 is connected to the housing 300 at the front in the axial direction, but may be connected to the housing 300 at the rear in the axial direction as long as the directions of the vertical surface and the inclined surface of the hook 306 are not changed.

  According to such a blood component measurement chip 12e, as shown in FIG. 12B, when the puncture needle unit 18 advances, the outer peripheral surface of the flange 38 of the hub 36 slides with respect to the inclined surface of the hook 306. , And the elastic stopper 302 passes through the portion while being elastically pushed out toward the outer diameter direction. Since the elastic stopper 302 is soft, even if it comes into contact with the puncture needle unit 18, it is hardly braked and allows an advancing operation, and the puncture needle 34 can project violently and perform puncture.

  As shown in FIG. 12C, when performing puncturing, the flange 38 passes through the hook 306, and the elastic stopper 302 returns to its original position. Thereafter, as shown in FIG. 12D, when the puncture needle unit 18 is retracted, the rear end surface of the flange 38 is a substantially vertical surface, and thus comes into contact with the vertical surface of the hook 306. In this case, only the axial force acts on the elastic stopper 302, and the elastic stopper 302 does not receive the force toward the outer diameter direction, so that it does not elastically deform. Therefore, the puncture needle unit 18 stops at that position, that is, the same position as the puncture operation end position, and the puncture needle 34 is disposed in the vicinity of the puncture site.

  In the conventional tip, the puncture needle has only the effect of performing puncture and appropriately flowing out for measurement, and it is unnecessary after puncture so that it can be sufficiently retracted from the contact portion. The blood component measurement chip 12e (and the blood component measurement chips 12f and 12g) regulates the end position of the puncture operation so that it does not return excessively. Therefore, the blood clot 164 comes into contact with the tip 34c of the puncture needle 34 and is easily introduced from the surface of the puncture needle 34 to the test paper 28 through the blood introduction guide 24 and the blood flow passage 26 by surface tension. In addition, since the blood component measuring apparatus 10 has the elastic stopper 302, the second elastic piece 122, the small protruding piece 157, the first stop lever 152, the second stop lever 153, and the like are not required. It is also possible to apply to a conventional blood component measuring apparatus without the above.

  Next, as shown in FIG. 13A, a blood component measurement chip 12f according to a fifth modification includes a cylindrical housing 308, a puncture needle unit 310 that can advance and retreat in the axial direction within the housing 308, and a housing 308. And a test paper holder 20 provided on the outer side surface. The housing 308 corresponds to the housing 14 described above, and is different in that the spiral groove 312 and the introduction groove 314 are provided on the inner peripheral surface and the small bulging portion 23 is not provided. The puncture needle unit 310 is different from the puncture needle unit 18 in that the projection 316 that engages with the spiral groove 312 is provided on the side surface of the flange 38.

  The spiral groove 312 has a spiral shape that rotates approximately 90 ° in accordance with the advance distance of the puncture needle unit 310, and is set to have a margin that is greater than the puncture depth adjusted in the blood component measuring apparatus 10. At the tip of the spiral groove 312, a ridge groove portion (stopper) 318 having a slightly wider width is provided in the spiral turning direction (upward in FIG. 13A). The end portion in the turning direction of the groove portion 318 and the front end portion of the spiral groove 312 are connected in a straight line in the axial direction, and the groove portion 318 has a substantially triangular shape.

  The introduction groove 314 is provided linearly from the rear end of the housing 308 and communicates with the rear end of the spiral groove 312. The puncture needle unit 310 is inserted from the rear of the housing 308 while engaging the projection 316 with the introduction groove 314, and the position is fixed when the projection 316 reaches the connecting portion between the introduction groove 314 and the spiral groove 312 ( (See FIG. 13B). The groove width of the connecting portion between the introduction groove 314 and the spiral groove 312 may be set to be slightly narrow, and may be lightly brought into contact with the side surface of the protrusion 316 to exert a sealing action.

  According to such a blood component measurement chip 12f, as shown in FIG. 13C, the protrusion 316 moves along the spiral groove 312 when the puncture needle unit 310 advances and punctures. Moves forward while turning in the direction of the arrow in FIG. 13C.

  As shown in FIG. 13D, when the puncture needle unit 310 is retracted, a certain amount of rotational force remains in the puncture needle unit 310, so that the protrusion 316 extends along the linear portion on the side surface in the turning direction of the ridge groove portion 318. Retreating while sliding, it comes into contact with the rear end face of the groove portion 318 and stops. This stop position is the same position as the puncture operation end position, and the puncture needle 34 is disposed in the vicinity of the puncture site. When this blood component measuring chip 12f is used, the gripping bar 118 in the blood component measuring device 10 that grips the flange 38 may be configured to be rotatable.

  Next, as shown in FIG. 14A, a blood component measurement chip 12g according to a sixth modification includes a housing 320, the puncture needle unit 18, the test paper holder 20, and a rubber ring (stopper, elastic ring) 322. And have. The housing 320 corresponds to the housing 14 described above, and is different in that there is no small bulging portion 23.

  The rubber ring 322 is inserted to a position in contact with the flange 38 on the circumference of the hub 36 of the puncture needle unit 18. The rubber ring 322 is asymmetric in cross section (up and down in FIG. 14A). Specifically, on the rear end surface of the rubber ring 322, the outer periphery is concentric with the hub 36 and is in light contact with the inner peripheral surface of the housing 320, while the inner periphery is eccentric and has a triangular cross section below. 324a has occurred. The peripheral end portion at the front end of the flange 38 is in contact with the rear end surface of the rubber ring 322. On the front end face of the rubber ring 322, the inner periphery is in contact with the hub 36, while the outer periphery is eccentric, and a gap 324b having a triangular cross section is formed above.

  According to such a blood component measurement chip 12g, as shown in FIG. 14B, when the puncture needle unit 18 advances and punctures, the rear end surface of the rubber ring 322 receives force equally from the front end of the flange 38, and the puncture Advances integrally with the needle unit 18.

  As shown in FIG. 14C, when the puncture needle unit 18 is retracted, the rubber ring 322 attempts to retract together with the puncture needle unit 18 due to the frictional force of the contact portion with the hub 36, but the cross section is asymmetrical. Since the contact area with the hub 36 is different, a frictional force difference is generated, the balance is lost, and the rubber ring 322 is elastically twisted. As a result, as the puncture needle unit 18 moves backward, a part of the rubber ring 322 strongly presses the surface of the hub 36, and the puncture needle unit 18 eventually stops. This stop position is the same position as the puncture operation end position, and the puncture needle 34 is disposed in the vicinity of the puncture site. At this time, the rubber ring 322 suppresses vibration and impact at the time of stopping by appropriate elasticity and surface frictional force, and a suitable braking performance can be obtained. In order for the stop position of the puncture needle unit 18 to be a predetermined puncture operation end position, the shape and material of the rubber ring 322 may be set based on calculations or experiments. In FIG. 10 to FIG. 14C, the blood component measuring device 10 to be attached is not shown for easy understanding.

  As described above, according to the blood component measurement device 10 and the blood component measurement chips 12a to 12g according to the present embodiment, the retraction of the puncture needle units 18, 220, 250, 310 is regulated by the stopper. Damping vibration during movement is suppressed, and it is possible to eliminate a sense of incongruity and instability of the operator due to transmission of vibration, and to give a stable operation feeling. Moreover, according to these mechanisms, virtually no vibration is generated.

  Furthermore, when the tip of the puncture needles 34, 224, 252 is set at a position where the tip of the puncture needle 34, 224, 252 contacts the blood clot 164 flowing out from the skin 162, the blood clot 164 is captured by each tip, and surface tension or capillary action is caused. Even if a small amount of blood clot 164 obtained by outflow grows or moves along the puncture needles 34, 224, 252 due to the action, it can be introduced to the measurement part or its guide part. Accordingly, the puncture needles 34, 224, and 252 can be effectively used to introduce blood to the measurement unit or its guide unit, and a mechanism for introducing blood can be simply configured. In addition, blood is more reliably introduced to the measurement unit.

  Further, since blood is introduced from the puncture needle 34, the blood introduction guides 24a and 24b do not need to have a complicated shape surrounding the puncture site P, and can be, for example, a simple cylindrical shape. And easy to manufacture.

  Furthermore, since the puncture needle is removed from the skin after the puncture is performed, the pain does not continue. Furthermore, since a small amount of blood clot 164 is sufficient, the puncture depth can be set shallow, and pain is reduced. In practice, the pain is felt only for the moment of puncture, which should be called a puncture sensation.

  In each of the above embodiments, the blood component measuring device 10 and blood component measuring chips 12a to 12g that also serve as a puncture device have been described. However, the present invention is applicable to a puncture-only device or chip that does not have a blood component measurement function. Of course.

  Of course, the puncture device and the puncture needle tip according to the present invention are not limited to the above-described embodiments, and various configurations can be adopted without departing from the gist of the present invention.

It is a cross-sectional side view which shows the blood component measuring device and blood component measuring chip which concern on this Embodiment. It is a partial cross section top view of the blood component measuring device which concerns on this Embodiment. It is a front view of the blood component measuring device equipped with the blood component measuring chip. It is a partial expanded sectional side view of the blood component measuring device in the state where the puncture needle unit stopped at the puncture operation end position. It is an expanded sectional side view of the front-end | tip part of the blood component measuring chip which has an annular protrusion part in the middle part of a puncture needle, and a blood component measuring device. It is a cross-sectional side view of the blood component measuring apparatus in a state where the puncture needle unit is at the puncture preparation position. It is a cross-sectional side view of the blood component measurement apparatus in a state where the puncture needle protrudes. It is a cross-sectional side view of the blood component measurement device in a state where the puncture needle unit is stopped at the puncture operation end position. It is a cross-sectional side view of the front-end | tip part of the blood component measurement chip | tip and blood component measuring apparatus which concern on a 1st modification. It is a section side view of the blood component measuring chip concerning the 2nd modification. It is a section side view of the blood component measurement chip concerning the 3rd modification. FIG. 12A is a cross-sectional side view of the blood component measurement chip according to the fourth modification example in a state where the puncture needle unit is in the initial position, and FIG. 12B is a fourth modification example in which the puncture needle unit is advanced. 12C is a cross-sectional side view of a blood component measurement chip according to an example, FIG. 12C is a cross-sectional side view of a blood component measurement chip according to a fourth modification example in which the puncture needle unit is punctured, and FIG. 12D is a puncture needle unit FIG. 10 is a cross-sectional side view of a blood component measurement chip according to a fourth modified example in a state where is at the puncture operation end position. FIG. 13A is an exploded side view of the blood component measurement chip according to the fifth modification example in a state where the puncture needle unit is in the initial position, and FIG. 13B is a fifth modification example in which the puncture needle unit is in the initial position. 13C is a cross-sectional side view of a blood component measurement chip according to an example, FIG. 13C is a cross-sectional side view of a blood component measurement chip according to a fifth modification example in which the puncture needle unit is punctured, and FIG. 13D is a puncture needle unit FIG. 9 is a cross-sectional side view of a blood component measurement chip according to a fifth modified example in a state where is at the puncture operation end position. FIG. 14A is a cross-sectional side view of the blood component measurement chip according to the sixth modification example in a state where the puncture needle unit is in the initial position, and FIG. 14B relates to a sixth modification example in which the puncture needle unit is in the puncture state. FIG. 14C is a cross-sectional side view of the blood component measurement chip according to the sixth modification in a state where the puncture needle unit is at the puncture operation end position.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 ... Blood component measuring device 12a-12g ... Blood component measuring chip 14,200,222,300,308,320 ... Housing 18,310 ... Puncture needle unit 20,202 ... Test paper holder 22 ... Abutting part 24,24a, 24b ... Blood introduction guide 26, 204a ... Blood flow path 28, 260 ... Test paper 34, 224, 252 ... Puncture needle 34a ... Hydrophilic portion 34c, 224b, 252b ... Tip portion 106 ... Plunger 108 ... Driving coil spring (No. 1) 1 biasing means)
110 ... Return coil spring (second urging means)
122 ... Second elastic piece (stopper) 152, 153 ... Stop lever
158 ... Tension coil spring 162 ... Skin
164 ... Blood clot 302 ... Elastic stopper
306 ... Hook 312 ... Spiral groove
314 ... Introducing groove 318 ... Groove groove
322 ... Rubber ring

Claims (11)

A puncture device for use with a puncture needle,
A puncture needle chip that includes the puncture needle that is removably held in a housing and is detachable from the puncture device;
The case body,
A first urging means provided on the case main body, and advances the puncture needle from a predetermined reference position toward a puncture site on the skin;
Second urging means provided on the case main body and retreating the puncture needle that has punctured the skin by the first urging means;
An abutting portion disposed at a distal end portion of the case body, and abutting against the skin around the puncture site;
A stopper for stopping the puncture needle at a predetermined puncture operation end position when the puncture needle is retracted;
The puncture needle is engaged and held by a plunger that contacts the first urging means and the second urging means,
The stopper is provided on the outer surface of the housing, an elastic piece provided on the plunger, which rides on the bulge when moving forward, and is provided on the case body. during movement, the lancing device according to claim Rukoto of having a an engaging portion for engaging a portion of the elastic piece. The puncture device according to claim 1, wherein
The puncture device is characterized in that the puncture operation end position is set on the distal end side with respect to a position where the first urging means and the second urging means are balanced. The puncture device according to claim 1 or 2 ,
The puncture operation end position is set to a position where the tip of the puncture needle flows out from the puncture site on the skin and contacts a blood clot formed on the puncture site. The puncture device according to claim 3 ,
When the puncture needle stops at the puncture operation end position, the shortest distance between the tip of the puncture needle and the skin is 0.1 mm or more and 3 mm or less. The puncture device according to any one of claims 1 to 4 ,
A measuring unit for measuring the components of the collected blood;
A blood introduction part that extends from the inner wall surface of the housing toward the lumen and introduces blood into the measurement part;
A puncture device comprising: The puncture device according to any one of claims 1 to 4 ,
It has a measuring part that measures the components of the collected blood,
The puncture device is characterized in that the puncture needle is a hollow needle, and the measurement unit is provided in the vicinity of the opening on the rear end side of the puncture needle or in the hollow portion of the puncture needle. In a puncture needle chip equipped with a puncture needle that can move forward and backward in the housing and attached to the puncture device,
A contact part that contacts the skin around the puncture site by the puncture needle;
A stopper that allows the advancing operation when the puncture needle advances toward the skin by operation of the puncture device and restricts the retreat operation when retreating, and stops at a predetermined puncture operation end position;
The puncture needle tip, wherein the stopper includes an elastic body provided in the housing and a hook provided at a distal end of the elastic body and protruding to an inner peripheral side from an inner peripheral surface of the housing. In a puncture needle chip equipped with a puncture needle that can move forward and backward in the housing and attached to the puncture device,
A contact part that contacts the skin around the puncture site by the puncture needle;
A stopper that allows the advancing operation when the puncture needle advances toward the skin by operation of the puncture device and restricts the retreat operation when retreating, and stops at a predetermined puncture operation end position;
The stopper has a spiral groove provided on the inner peripheral surface of the housing, and a ridge groove provided at the tip of the spiral groove,
A puncture needle tip, wherein a protrusion provided on a hub for holding the puncture needle engages with the spiral groove and the ridge groove. In a puncture needle chip equipped with a puncture needle that can move forward and backward in the housing and attached to the puncture device,
A contact part that contacts the skin around the puncture site by the puncture needle;
A stopper that allows the advancing operation when the puncture needle advances toward the skin by operation of the puncture device and restricts the retreat operation when retreating, and stops at a predetermined puncture operation end position;
The puncture needle tip, wherein the stopper is an elastic ring having an asymmetrical cross section, and is inserted into a support member that holds the puncture needle. In the puncture needle tip according to any one of claims 7 to 9 ,
The puncture operation end position is set to a position where the tip of the puncture needle flows out of the puncture site on the skin and contacts a blood clot formed on the puncture site. The puncture needle tip according to claim 10 ,
When the puncture needle is stopped at the puncture operation end position, the shortest distance between the tip of the puncture needle and the skin is 0.1 mm or more and 3 mm or less.

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