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WO2019188907A1 - Lancette pour collecter du sang et kit de test sanguin - Google Patents

Lancette pour collecter du sang et kit de test sanguin Download PDF

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Publication number
WO2019188907A1
WO2019188907A1 PCT/JP2019/012373 JP2019012373W WO2019188907A1 WO 2019188907 A1 WO2019188907 A1 WO 2019188907A1 JP 2019012373 W JP2019012373 W JP 2019012373W WO 2019188907 A1 WO2019188907 A1 WO 2019188907A1
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WO
WIPO (PCT)
Prior art keywords
needle
blood
lancet
tip
opening
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2019/012373
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English (en)
Japanese (ja)
Inventor
中津川　晴康
野口　修由
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fujifilm Corp
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Fujifilm Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fujifilm Corp filed Critical Fujifilm Corp
Priority to JP2020510035A priority Critical patent/JPWO2019188907A1/ja
Publication of WO2019188907A1 publication Critical patent/WO2019188907A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood

Definitions

  • the present invention relates to a blood collection lancet and a blood test kit, and more particularly, to a blood collection lancet and a blood test kit that are used for a subject to be self-collected.
  • a general qualified blood sample is collected by a doctor or other qualified person using a syringe to collect blood from the vein, and the subject is self-collected by inserting a blood collection needle into his / her finger or the like.
  • Blood sampling Blood collected by blood collection is transported to a medical institution or inspection in a state where the blood is sealed in a collection container, where an inspection is performed.
  • a test is performed after blood is separated into blood cells and plasma by a centrifuge at a medical institution or inspection institution.
  • Patent Document 1 includes a blood collection needle having a plurality of fine needles and a vacuum blood collection tube having a space that is depressurized from atmospheric pressure, and blood is passed through the needle hole into the vacuum blood collection tube.
  • a blood collection device for collecting blood is described.
  • Patent Document 2 describes a blood collection device that includes a container for storing blood and a hollow needle, and collects blood by promoting capillary action of the hollow needle by reducing the internal pressure of the container to atmospheric pressure or less. Yes.
  • JP 2008-99992 A Japanese Patent Laid-Open No. 2008-22898
  • Patent Document 1 or 2 the skin is punctured using a plurality of microneedles, and blood is collected from the microneedle into the container.
  • a large number of microneedles are required, and the inside of the blood collection container is made lower than atmospheric pressure, which makes the structure complicated and costly.
  • Adopted for simple test kits for example, disposable It was difficult to do.
  • the blood was not diluted and blood cells were isolate
  • the present invention has been made in view of such circumstances, and a blood collection lancet and blood that can bleed blood sufficient for blood collection and can easily collect a necessary amount of blood regardless of the method of use by the user.
  • the purpose is to provide a test kit.
  • a lancet for blood collection includes a lancet body provided with an opening, a needle provided inside the lancet body, and a first that imparts longitudinal movement to the needle.
  • the first elastic member is disposed on the opposite side of the opening across the needle, and the first elastic member causes the needle tip of the needle to protrude from the opening.
  • the second elastic member is provided between the opening and the needle. The second elastic member accommodates the needle tip of the needle in the lancet body and has two or more needle tips.
  • the present invention since there are two or more needle tips provided inside the lancet body, two or more positions can be injured and bleeding can be performed with a single puncturing operation. . Therefore, it is possible to bleed enough blood for blood collection, and it is possible to collect an amount of blood necessary for the examination.
  • the needle tip punctured into the skin can be immediately removed, so pain can be reduced. Can be tempered.
  • two or more needle tips are constituted by two or more needles provided in the lancet body.
  • the two or more needle tips are configured such that the needle is divided into two or more forks toward the tip.
  • one or more needle gauges of two or more needle tips are different from the needle gauges of other needle tips.
  • a needle having a thin outer diameter of the needle is used on the finger tip side where nerves are concentrated, A needle with a thick outer diameter can be used on the base side of the finger.
  • pain can be relieved by changing the outer diameter of the needle corresponding to the portion where pain is easily felt.
  • the length from the opening of one or more needle tips to the tip of the needle tip is different from the opening of another needle tip. It is preferably different from the length to the tip.
  • the position of the tip of one or more needle tips protruding from the opening is made different from the position of the tip of the other needle tip, thereby projecting from the opening toward the finger tip where the nerves are concentrated.
  • a needle with a small amount can be used, and a needle with a large amount of protrusion from the opening on the base side of the finger can be used.
  • pain can be relieved by changing the amount of protrusion of the needle tip, that is, the depth of puncture into the skin, corresponding to a portion where pain is easily felt.
  • a lancet body provided with an opening, a needle provided inside the lancet body, a first elastic member and a second elastic member for imparting longitudinal movement to the needle
  • the first elastic member is disposed on the opposite side of the opening across the needle, the first elastic member causes the needle tip of the needle to protrude from the opening, and the second elastic member includes the opening Provided between the needles, the needle tip of the needle is accommodated in the lancet body by the first elastic member, and the lancet body has a fitting portion that can be fitted to another lancet body, and two or more lancet bodies Are mated.
  • the present invention by fitting two or more lancet bodies into a blood collection lancet, it is possible to scratch and bleed at two or more positions with a single puncturing operation. Therefore, it is possible to bleed enough blood for blood collection, and it is possible to collect an amount of blood necessary for the examination.
  • the needle tip punctured into the skin can be immediately removed, so pain can be reduced. Can be tempered.
  • needle needle gauges of one or more needles out of needles provided on two or more lancet bodies are needle gauges of needle tips of needles provided on other lancet bodies. Preferably they are different.
  • a needle having a thin outer diameter of the needle is used on the finger tip side where nerves are concentrated, A needle with a thick outer diameter can be used on the base side of the finger.
  • pain can be relieved by changing the outer diameter of the needle corresponding to the portion where pain is easily felt.
  • the position of the tip of one or more needles protruding from the opening is the position of the tip of a needle provided on another lancet body. Preferably they are different.
  • the position of the tip of one or more needle tips protruding from the opening is made different from the position of the tip of the other needle tip, thereby projecting from the opening toward the finger tip where the nerves are concentrated.
  • a needle with a small amount can be used, and a needle with a large amount of protrusion from the opening on the base side of the finger can be used.
  • pain can be relieved by changing the amount of protrusion of the needle tip, that is, the depth of puncture into the skin, corresponding to a portion where pain is easily felt.
  • the needle is preferably replaceable.
  • a single lancet body can be used for a plurality of aspects such as one or two needles.
  • the needles provided on the lancet bodies can be used as different modes.
  • the needle tip preferably has a gauge number of 23 G or less.
  • the present invention it is possible to bleed from two or more places by having two or more needle tips. Therefore, even if there is little bleeding from one place, sufficient blood can be collected as a whole, so that the gauge number of the needle tip can be reduced to 23 G or less, and puncture pain can be alleviated.
  • the opening side of the lancet body is preferably formed of a material having good adhesion to the skin.
  • the opening side of the lancet body with a material having good adhesion to the skin, when the needle tip is punctured into the skin, the blood collection lancet is displaced, Or it can prevent that the puncture depth changes.
  • a blood test kit contains the blood collection lancet described above, a blood collection device for collecting a blood sample, a diluent for diluting the collected blood sample, and a dilution of the blood sample For analyzing the concentration of a target component in a blood sample using a standard component that is constantly present in the blood or a standard component that is not present in the blood contained in the diluent. This is a blood test kit.
  • the lancet for blood collection described above it is possible to bleed blood sufficient for blood collection, and it is possible to reliably collect a necessary amount of blood with a blood collection device. Therefore, by using it as a test kit, the person to be tested can perform blood sample collection, dilution, and the like by himself.
  • the blood collection device preferably includes a fiber rod for absorbing blood, and the distance between the needle tips of two or more needles is shorter than the diameter of the fiber rod.
  • the distance of each needle tip of the blood collection lancet needle is made shorter than the diameter of the fiber rod that absorbs the blood of the blood sampling device, so that the fiber rod is pressed against the Sampling can be performed reliably.
  • One aspect of the present invention preferably includes a separation device for separating and collecting plasma components from a diluted blood sample.
  • the blood collection lancet and blood test kit of the present invention it is possible to puncture two or more needle tips into the skin or the like with a single puncture of the needle tip, and to bleed from two or more locations. Therefore, it is possible to bleed a sufficient amount of blood for blood collection, and it is possible to collect a necessary amount of blood for examination.
  • FIG. 1 It is sectional drawing of the lancet for blood collection of 1st Embodiment. It is an exploded view of the lancet for blood collection of 1st Embodiment. It is an enlarged view of the needle part shown in FIG. It is a figure which shows other embodiment of a needle part. It is a figure which shows other embodiment of a needle part. It is a figure which shows other embodiment of a needle part. The operation of the blood collection lancet will be described. It is a perspective view of the lancet for blood collection of 2nd Embodiment. It is an exploded view of the blood collection lancet of 2nd Embodiment. It is a figure explaining the state which fits a lancet main body.
  • a numerical range expressed using “to” means a range including numerical values described before and after “to” as a lower limit value and an upper limit value.
  • a standard component that is constantly present in blood may be referred to as an external standard substance or an external standard.
  • a standard component that does not exist in blood may be referred to as an internal standard substance or an internal standard.
  • FIG. 1 is a cross-sectional view of a blood collection lancet according to the first embodiment
  • FIG. 2 is an exploded view.
  • the blood collection lancet 10 includes a distal end main body portion 14 and a proximal end main body portion 16 constituting the lancet body 12.
  • An opening 18 is provided on the distal end side of the distal end main body portion 14.
  • a needle 24 and a first elastic member the first member disposed on the opposite side of the opening 18 across the needle 24).
  • a first elastic member 20, a needle portion 26 having a needle 24, a fastener 27, a second elastic member 28, and a holder 30 are provided from the proximal end main body 16 side. Further, a cap 32 is provided on the opening 18 side of the distal end main body portion 14.
  • the first elastic member 20 is a member that is disposed on the proximal end main body 16 side in the lancet body 12 and imparts a longitudinal movement of the blood collection lancet 10 to the needle 24.
  • the needle 24 can be protruded from the opening 18 by the action of the first elastic member 20.
  • a spring can be used as the first elastic member 20.
  • the needle part 26 includes a needle 24, a holding part 25 that holds the needle 24, and an engaging part 23 that engages with the fastener 27 and suppresses the firing of the needle part 26.
  • the two needles 24 are supported by the holding portion 25, thereby having two needle tips 24a and 24b. The configuration of the needle portion 26 and the needle 24 will be described later.
  • the fastener 27 is a member that controls the movement of the needle portion 26 toward the distal end of the blood collection lancet 10.
  • the claw portion 27 a of the fastener 27 is engaged with the engaging portion 23 of the needle portion 26, thereby controlling the movement of the needle portion 26. Further, when the claw portion 27 a is opened outward, the engaging portion 23 is released, and the needle 24 protrudes from the opening 18 by the first elastic member 20.
  • the second elastic member 28 is a member that is disposed between the opening 18 in the lancet body 12 and the needle 24 and imparts a longitudinal movement to the needle 24.
  • the needle 24 protruding from the opening 18 can be accommodated in the lancet body 12 by the action of the second elastic member 28.
  • the needle 24 passes through the gap of the second elastic member 28 or the second elastic member 28 and protrudes from the opening 18.
  • a spring capable of penetrating the needle 24 can be used.
  • the second elastic member 28 can be disposed around the needle 24.
  • the holder 30 is provided inside the lancet main body 12 on the distal end main body 14 side, and is disposed around the second elastic member 28 and the needle portion 26. By moving the holder 30 to the proximal end side of the lancet body 12, the claw portion 27 a of the fastener 27 can be opened to the outside, and the needle portion 26 is moved to the distal end side of the lancet body 12.
  • the cap 32 is provided on the opening 18 side of the lancet body 12 and prevents the needle 24 from protruding from the lancet body 12 before use. Further, the cleanliness of the needle 24 inside the lancet body 12 can be maintained.
  • the needle 24 has two or more needle tips.
  • a configuration having two or more needle tips will be described with reference to FIGS.
  • FIG. 3 is a diagram showing the needle portion 26 shown in FIG. In FIG. 3, two needle points 24 a and 24 b are provided by providing two needles 24 in the holding portion 25.
  • FIG. 4 is a diagram showing another embodiment of the needle portion.
  • the needle portion 56 shown in FIG. 4 has two needle tips 54a and 54b formed by dividing one needle 54 into two forks toward the tip. By forming two needle tips 24a, 24b, 54a, 54b, when puncturing the needle tip into the skin, it is possible to bleed from two locations with a single puncture.
  • FIG. 5 and 6 are diagrams showing still another embodiment of the needle portion.
  • FIG. 5 is a modification of the needle portion 26 shown in FIG. 3, and the needle portion 56 is provided with two needles 64 and 64 in the holding portion 25 and has needle tips 64 a and 64 b. The longitudinal positions of the tips of the needle tips 64a and 64b are different.
  • FIG. 6 is a modified example of the needle portion 56 shown in FIG. 4, and the needle portion 76 is provided with one needle 74 in the holding portion 25, the tip is divided into two crotches, and the needle tips 74a and 74b. Have The longitudinal positions of the tips of the needle tips 74a and 74b are different.
  • the position of the tip of one needle tip protruding from the opening 18 can be made different from the position of the tip of the other needle tip.
  • the needle gauge at the needle tip is preferably 23 gauge (G) or less. Moreover, it is preferable to determine the needle gauge number of the needle tip so that the needle gauge number of one or more needle tips and the needle gauge number of the other needle tips are different. Table 1 shows the relationship between the needle gauge number and the outer diameter of the needle.
  • a needle with a needle gauge of 21G is used as a lancet needle used for bleeding from the skin or a hollow needle for blood collection.
  • the 21G needle may be painful at the time of puncture.
  • the pain at the time of puncture can be relieved by making the needle gauge number 23 G or less.
  • since bleeding can be performed from two or more places even if the needle gauge is increased, that is, even if the outer diameter of the needle is decreased, a sufficient amount of bleeding necessary for the inspection is ensured. Can do. Further, by reducing the outer diameter of the needle, healing of the wound can be accelerated.
  • the “thinness of 23G or less” means that the outer diameter of the needle is thinner than the needle gauge number of 23G, that is, the needle gauge numbers of 23G, 24G, 25G and 30G in Table 1.
  • the needle gauge numbers of one or more needle tips may be different from those of other needle tips.
  • the needle gauge on the fingertip side that is susceptible to pain is set to a large needle (needle with a small outer diameter)
  • the needle on the base side of the finger is a needle with a small needle gauge (needle with a large outer diameter) )
  • the pain of the needle can be relieved at the time of puncture.
  • the lancet body 12 is pushed in the direction of the arrow in the figure.
  • the holder 30 is pushed into the lancet body 12, and the holder pushes the fastener 27 toward the proximal end side of the lancet body 12, so that the needle part 26 is also based. It is pushed to the end side.
  • the first elastic member 20 is also pushed to the proximal end side, and the first elastic member 20 is in a contracted state.
  • the holder 30 when the holder 30 is pushed toward the proximal end and the needle part 26 stops moving, the holder 30 is further pushed, whereby the claw part 27a of the fastener 27 moves in the direction of the arrow in the figure, and the claw part 27a. Then, the engaging portion 23 of the needle portion 26 is released.
  • the first elastic member 20 is extended by the repulsive force of the contracted first elastic member 20, and at this time, the needle 24 protrudes from the opening 18 and the finger 40 Punctured.
  • the second elastic member 28 is pushed by the needle portion 26 and contracts.
  • the needle portion 26 moves to the proximal end side of the lancet body 12 due to the repulsive force of the contracted second elastic member 28, and the needle 24 is accommodated inside the lancet body 12. . Since the needle 24 protruding from the opening 18 of the lancet body 12 is immediately accommodated in the lancet body 12 by the second elastic member 28, safety can be ensured. Note that the fastener 27 is in an open state when the needle 24 is projected. Therefore, even if the needle part 26 is pushed back into the lancet body 12, the first elastic member 20 is contracted because the fastener 27 and the engaging part 23 of the needle part 26 are not engaged. It becomes.
  • the opening 18 side of the distal end main body portion 14 is a portion in contact with the finger, it is preferably formed of a material having good adhesion to the finger (skin).
  • a material having good adhesion to the finger for example, rubber is preferably used as the material having good adhesion to the finger so as to follow the unevenness of the fingertip.
  • the puncture depth may change when the needle 24 protrudes.
  • FIG. 8 is a perspective view of the distal end main body 114 of the blood collection lancet according to the second embodiment.
  • FIG. 9 is an exploded view.
  • FIG. 10 is a figure explaining the state which fits a lancet main body.
  • the blood collection lancet 110 according to the second embodiment includes a lancet body 112 including a distal end body 114 and a proximal end body 116, and a cap 132.
  • a convex fitting portion 113a is provided on one side surface (first surface 142) of the tip main body 114, and a concave fitting portion is provided on the other side surface (second surface 143).
  • 113b is a convex fitting portion 113a.
  • the convex fitting part 113a formed in the 1st surface 142 of one lancet main body 112, and the concave fitting part formed in the 2nd surface 143 of another lancet main body By fitting 113b, it can be used as a blood collection lancet 110 in which the two lancet bodies 112, 112 are fitted.
  • the number of lancet bodies to be fitted is not limited to two and can be three or more. It is possible to bleed from two or more places by fitting two or more lancet bodies together.
  • one needle 124 and a needle tip 124a can be provided in one lancet body 112.
  • a blood collection lancet having two or more needle tips can be obtained.
  • bleeding can be performed from a plurality of locations with a single puncture.
  • the fitting portions 113a and 113b are arranged so that the positions of the openings 18 of the tip body portions 114 of the lancet bodies 112 are the same in the height direction (perpendicular to the skin). It is preferable to fit. With this configuration, when the needle 124 is punctured into the skin, the holders 30 provided on the two lancet bodies 112 can be simultaneously pushed into the lancet body 112 with the same force. Therefore, the needles 124 provided on each lancet body 112 can be reliably projected.
  • the lancet bodies 112 can be prevented from being displaced in the height direction so that any of the needles 124 is not punctured.
  • the needle 124 provided on the lancet body 112 preferably has a needle gauge of the needle point 124a of the needle 124 of one or more lancet bodies 112 different from the needle point 124a of the needle 124 of the other lancet body 112.
  • the lancet body 112 having the needle tip 124a having a large needle gauge is set to the fingertip side where pain is easily felt, and the needle tip 124a having a small needle gauge is set to the base side of the finger. By doing so, the pain can be eased.
  • the length of the needle 124 of one or more lancet bodies 112 is the needle 124 of another lancet body 112.
  • the length may be different from the length of.
  • FIG. 11 to 13 are diagrams for explaining a method of puncturing a finger of a blood collection lancet 110 in which two lancet bodies 112 are fitted.
  • the position of the needle 124 is described so that the portion punctured by the needle 124 can be easily understood.
  • the lancet body 112 is arranged so that the needles 124 are arranged along the base side from the fingertip 40. By arranging in this way, the bleeding position from the finger 40 can be bleeding from the central portion of the belly portion of the finger 40, which makes it difficult to spill blood from the finger, which is preferable.
  • the lancet body 112 may be arranged such that the needles 124 are arranged along the width direction of the finger 40.
  • FIG. 13 shows that the lancet body 112c of the two lancet bodies to be combined has a thin outer diameter, a needle 124c with a high needle gauge is used, or the length of the needle 124c is shortened to puncture the finger 40.
  • the lancet body 112d is a lancet body whose outer diameter is larger than that of the needle 124c of the lancet body 112c and whose needle gauge is low, or the needle 124d is longer and the puncture depth to the finger 40 is deeper. 112d.
  • the needle 24 can be protruded from the lancet body 112 and accommodated by the same method as in the first embodiment, and thus the description thereof is omitted.
  • the needle 24 of the blood collection lancet is preferably exchangeable.
  • a single lancet body 12 can use a plurality of modes such as one or two needles 24.
  • the needles 124 provided in the respective lancet main bodies 112 can have different modes.
  • the blood test kit contains a blood collection device for collecting a blood sample, a diluent for diluting the collected blood sample, and a dilution of the blood sample.
  • the concentration of the target component in the blood sample by using a standard component that is constantly present in the blood or a standard component that is contained in the diluent and not present in the blood. This is a blood test kit for analysis.
  • a separation device for separating and collecting plasma components from the diluted blood sample.
  • FIG. 14 is a cross-sectional view showing an example of the configuration of a storage device for storing a diluted blood sample.
  • the storage device 400 includes a cylindrical blood collection container 410 made of a transparent material.
  • a screw portion 412 is formed on the outer surface, and a locking portion 414 is projected on the inner surface.
  • a conical bottom portion 416 that protrudes to the lower end side is formed at the lower end portion of the blood collection container 410.
  • a cylindrical leg portion 418 is formed around the bottom portion 416. “Upper” and “lower” mean “upper” and “lower” in a state where the legs 418 are installed on the placement surface.
  • the leg portion 418 has the same outer diameter as a sample cup (not shown) used at the time of blood analysis test, and preferably, a slit groove 420 is formed in a vertical direction at a position opposite to the lower end thereof. . Furthermore, as shown in FIG. 14, the blood collection container 410 preferably contains a required amount, for example, a diluted solution 422 of 500 mm 3 .
  • the upper end opening of the blood collection container 410 is preferably sealed with a cap 424 via a packing 426 before the storage device 400 is used.
  • the blood test kit of the present invention is preferably a blood test kit for analyzing the concentration of a target component in a blood sample using a standard component that is constantly present in blood. is there.
  • “using” the standard component is for analyzing the concentration of the target component based on the standard value for the standard component (or the constant value if a standard component that is constantly present in blood is used). Is intended to determine the dilution ratio. Therefore, when analyzing the concentration of a target component in a blood sample using a standard component that is constantly present in blood, dilution is performed based on the constant value (standard value) of the standard component that is constantly present in blood. It is also determining the magnification and analyzing the concentration of the target component.
  • Standard components that are constantly present in blood include sodium ions, chloride ions, potassium ions, magnesium ions, calcium ions, total protein, and albumin.
  • concentration of these standard components contained in the serum and plasma of the blood sample is such that the sodium ion concentration is 134 mmol / L to 146 mmol / L (mean value: 142 mmol / L), and the chloride ion concentration is 97 mmol / L to 107 mmol.
  • potassium ion concentration is 3.2 mmol / L to 4.8 mmol / L (average value: 4.0 mmol / L)
  • magnesium ion concentration is 0.75 mmol / L to 1 0.0 mmol / L (average value: 0.9 mmol / L)
  • calcium ion concentration is 4.2 mmol / L to 5.1 mmol / L (average value: 4.65 mmol / L)
  • total protein concentration is 6.7 g.
  • albumin concentration is 4.1 g / 10 mL from 5.1 g / 100 mL (mean: 4.6 g / 100 mL) is.
  • it is intended to enable measurement of a target component when the amount of blood collected to relieve pain of the subject is very small.
  • the diluent It is necessary to accurately measure the concentration of the “standard component that is constantly present in the blood” present in the blood.
  • the concentration of components originally present in the blood decreases in the diluted solution, and depending on the dilution rate, there is a possibility that a measurement error is included in the concentration measurement. Therefore, in order to detect the above-mentioned standard component with sufficient accuracy when a very small amount of blood component is diluted at a high dilution rate, it is preferable to measure a standard component present at a high concentration in a very small amount of blood.
  • the average value of sodium ion represents a standard value (median value of the reference range), and the value is 142 mmol / L, which accounts for 90 mol% or more of the total cations in plasma.
  • One of the preferred aspects of the embodiment is a blood test kit for analyzing the concentration of a target component in a blood sample using a standard component that is not present in blood.
  • a blood test kit may be used for using a standard component that does not exist in the blood together with a standard component that exists constantly in the blood, and uses a standard component that exists constantly in the blood.
  • a standard component that does not exist in blood may be used alone.
  • standard components that are not present in the blood can be used by adding them to a diluting solution described later so as to have a predetermined concentration.
  • a substance that is not contained at all in the blood sample or is contained in a trace amount even if it is contained can be used.
  • Standard components that are not present in blood include substances that do not interfere with the measurement of target components in blood samples, substances that do not degrade due to the action of biological enzymes in blood samples, substances that are stable in dilution, and blood cell membranes. It is preferable to use a substance that does not permeate and is not contained in blood cells, a substance that does not adsorb to a buffer storage container, and a substance that can use a detection system that can measure with high accuracy.
  • a standard component that does not exist in blood a substance that is stable even after being stored for a long time in a state of being added to a diluent is preferable.
  • An example of a standard component that is not present in the blood is glycerol triphosphate.
  • These standard components that are not present in blood can be colored by adding a second reagent during concentration measurement after blood dilution, and the concentration in the diluted blood can be determined from the color density.
  • concentration in the diluted blood can be determined from the color density.
  • the measurement of glycerol triphosphate added to a diluted solution is performed by, for example, a known document, “home medical revolution” (clinical examination, Vol. 59, p397, 2015). It is possible to easily measure a large amount of sample with a small amount of sample using a biochemical automatic analyzer utilizing concentration measurement.
  • the blood test kit includes a diluent for diluting the collected blood sample.
  • the dilution liquid is a standard component that is constantly present in blood when the blood test kit is used to analyze the concentration of the target component in the blood sample by using the standard component that is constantly present in the blood. Does not contain. “Not contained” means “not substantially contained”. Here, “substantially does not contain” means that it does not contain a substance having homeostasis used at the time of determining the dilution factor, or even if it is contained, the homeostasis of the diluted solution after diluting the blood sample It means a case where it is contained at a very small concentration that does not affect the measurement of a toxic substance. When sodium ions or chloride ions are used as a standard component that is constantly present in blood, a diluent that does not substantially contain sodium ions or chloride ions is used as the diluent.
  • the dilution solution is pH 6.5 to pH 8.0 in order to prevent decomposition and denaturation of the target component.
  • the buffer solution has a buffering action in the pH range of pH 7.0, preferably pH 7.0 to pH 7.5, more preferably pH 7.3 to pH 7.4. It is preferable that it is a buffer solution containing the buffer component which suppresses.
  • These buffers can be selected from buffers that are substantially free of sodium ions or chloride ions.
  • the buffer solution may contain a chelating agent, a surfactant, an antibacterial agent, a preservative, a coenzyme, a saccharide and the like for the purpose of keeping the analysis target component stable.
  • a chelating agent include ethylenediaminetetraacetic acid (EDTA) salt, citrate, and oxalate.
  • the surfactant include a cationic surfactant, an anionic surfactant, an amphoteric surfactant, and a nonionic surfactant.
  • the preservative include sodium azide and antibiotics.
  • the coenzyme include pyridoxal phosphate, magnesium, zinc and the like.
  • saccharide of the erythrocyte stabilizer examples include mannitol, dextrose, oligosaccharide and the like.
  • by adding antibiotics it is possible to suppress the growth of bacteria partially mixed from the finger surface at the time of hand blood collection, to suppress the degradation of the biological components by bacteria, and to stabilize the biological components.
  • the buffer also contains a standard component that is not present in blood in a blood test kit for analyzing a target component using a standard component that is not present in blood. It is also important not to include an internal standard substance to be described later and not to interfere with the blood analysis measurement system.
  • the osmotic pressure of the buffer solution is equivalent to that of blood (285 mOsm / kg (mOsm / kg is the osmotic pressure of 1 kg of water in the solution and represents the number of millimolar ions)) or more By doing so, hemolysis of blood cells can be prevented.
  • the osmotic pressure can be adjusted to be isotonic with salts, sugars, buffers or the like that do not affect the measurement of the target component and the measurement of the standard component that is constantly present in the blood.
  • the osmotic pressure of the buffer solution can be measured with an osmometer.
  • ALT aminotransferase
  • AST aminotransferase
  • ⁇ -GTP ⁇ glutamyl transpeptidase
  • ALP alkaline phosphatase
  • total bilirubin The concentration in the blood of several or more substances such as total protein and albumin is measured.
  • the amount of diluted blood is required to some extent in consideration of the possibility of remeasurement. Therefore, it is important to secure a certain amount of the diluent for diluting the collected blood.
  • the dilution factor is, for example, a high factor of about 7 times or more.
  • FIG. 15 is a perspective view of blood collection device 200.
  • the blood sampling device 200 includes a case 210 in which an opening 212 is defined on one side, and a fiber rod 202 that is detachably held on the opening 212 side.
  • the case 210 includes a distal end accommodation portion 214 that accommodates the fiber rod 202, a center portion 216, a flange portion 218, and a proximal end accommodation portion 220 from the opening 212 side to the other side.
  • the proximal end accommodating portion 220 has an opening 222, and the push rod 240 is inserted through the opening 222.
  • the case 210 is an integrally formed bump, and the opening 212 and the opening 222 penetrate therethrough.
  • the fiber rod 202 is detachably held in the tip accommodating portion 214.
  • the central portion 216 has a lock lever 300.
  • the push rod 240 has an opening (not shown) that engages with the tip of the lever 318 of the lock lever 300, and by moving the lever operating portion 322 of the lever 318, the relationship between the tip of the lever 318 and the opening is provided.
  • the fiber rod 202 can be removed from the tip accommodating portion 214 by releasing the coupling and moving the push rod 240 in the longitudinal direction.
  • the proximal end accommodating portion 220 has a slide groove 228 along the axial direction of the blood collection device 200, and the protrusion 242 directed toward the push rod 240 is inserted into the slide groove 228, whereby the push rod 240 is axial. Restrict rotation around the direction.
  • the blood sample collected by the blood collection device 200 is a fiber that is held by the case 210 of the blood collection device 200 on the blood sample that the subject himself / herself has injured a fingertip or the like using the blood collection lancet described above.
  • the rod 202 is brought into contact. Since the blood sample is absorbed into the gap of the fiber rod 202, the blood sample can be collected in the fiber rod 202. When it is confirmed that the fiber rod 202 has turned red as a whole, the collection of the blood sample is terminated.
  • the blood collection lancet of the present invention has two or more needle tips, and can bleed from two or more locations in one puncture operation. At this time, the distance between the two or more needle tips is preferably shorter than the outer diameter of the fiber rod 202. By making the distance between each of the two or more needle tips shorter than the outer diameter of the fiber rod 202, the fiber rod 202 can be pressed against the bleeding site, and blood can be collected reliably.
  • the cap 424 is removed from the blood collection container 410 of the storage device 400. From the upper end opening of the blood collection container 410, the fiber rod 202 that has absorbed the blood sample with the blood collection device 200 is put into the diluent 422. The upper end opening of the fiber rod 202 is sealed with a cap 424.
  • the upper part of the blood collection container 410 is held, the blood collection container 410 is swung in a pendulum tens of times, and the blood specimen is released from the fiber rod 202 to the diluent 422.
  • the diluted blood sample is stored in the storage device 400.
  • the blood collection container 410 is completely shaken.
  • the blood sample collected by the blood collection device 200 may elapse for a long time in the storage device 400 in a diluted state until analysis.
  • substances or enzymes present in the blood cells elute into the plasma or serum and affect the test results, or the absorption of the eluted hemoglobin causes the optical properties of the analyte to be analyzed.
  • This may have an impact on the measurement of the amount of analysis target components using optical information such as typical absorption. Therefore, it is preferable to prevent hemolysis. Therefore, it is preferable that the blood test kit includes a separation instrument for separating and collecting a plasma component from a diluted blood sample.
  • a preferred example of the separation device is a separation membrane.
  • the separation membrane can be used, for example, by applying pressure to a diluted blood sample to capture blood cell components with the separation membrane, allowing plasma components to pass through, separating blood cells, and collecting plasma components.
  • an anticoagulant it is preferable to use an anticoagulant.
  • the plasma that has passed through the separation membrane does not flow back to the blood cell side.
  • a backflow prevention means described in JP-A-2003-270239 is used. It can be a component of a kit.
  • FIG. 17 is a diagram illustrating an example of a holding device having a separation device.
  • the holding device 500 is provided at a cylindrical body 510 that can be inserted into the blood collection container 410 of the storage device 400, a cap piston 512 attached to the cylindrical body 510, and a lower end of the cap piston 512.
  • a sealing lid 514 that functions as a sealing device.
  • the cylinder 510 is made of a transparent material and has a cylindrical shape.
  • An enlarged diameter portion 516 is formed at the upper end portion 542 of the cylindrical body 510.
  • the enlarged diameter portion 516 is connected to the main body portion 520 via the thin portion 518.
  • a reduced diameter portion 522 is formed at the lower end of the cylindrical body 510.
  • a locking projection 524 is formed on the inner surface of the reduced diameter portion 522.
  • an outer flange 526 is formed at the lower end of the reduced diameter portion 522.
  • the lower end opening of the outer casing 526 is covered with a filtration membrane 528 that functions as a separation instrument.
  • the filtration membrane 528 is configured to allow passage of plasma in the blood and prevent passage of blood cells.
  • a cover 530 made of silicon rubber is attached to the outer periphery of the reduced diameter portion 522.
  • the cap piston 512 is configured by a substantially cylindrical knob 532 and a mandrel 534 that is concentric with the knob 532 and extends downward.
  • a cylindrical space 536 into which the diameter-enlarged portion 516 of the cylindrical body 510 can be fitted is formed at the inner upper end of the knob portion 532, and the lower portion thereof is screwed and can be screwed into the screw.
  • the lower end portion 538 of the mandrel portion 534 is formed in a pin shape, and a sealing lid 514 is detachably provided on the lower end portion 538.
  • the sealing lid 514 is made of silicon rubber.
  • a lower end portion of the sealing lid 514 has a substantially cylindrical shape formed in an outer casing shape, and a step portion 540 is formed over the outer periphery.
  • the knob portion 532 has a top portion 544, and the inner surface of the top portion 544 and the enlarged diameter portion 516 are in contact with each other.
  • the cap 424 and the packing 426 are removed from the blood collection container 410 from the blood collection container 410 containing the fiber rod 202 and the diluted blood sample.
  • the cylindrical body 510 to which the cap piston 512 is attached is inserted into the blood collection container 410.
  • the knob portion 532 is screwed into the screw portion 412. Initially, the knob 532 and the cylinder 510 are rotated.
  • the locking portion 414 of the blood collection container 410 is locked to a stopper portion (not shown) formed on the outer peripheral surface of the cylindrical body 510, the rotation of the cylindrical body 510 is restrained, and the thin portion 518 is broken by torsion.
  • the cylindrical body 510 is separated into the main body portion 520 and the enlarged diameter portion 516.
  • the knob portion 532 is further rotated, the upper end portion 542 of the main body portion 520 enters the space 536 inside the enlarged diameter portion 516. Since the cylinder 510 is pressed downward by the inner surface of the top portion 544 of the knob portion 532, the cylinder 510 is further lowered.
  • the filtration membrane 528 held by the cylinder 510 moves to the bottom 416 side of the blood collection container 410. At that time, plasma moves through the filtration membrane 528 to the cylindrical body 510 side, and blood cells cannot pass through the filtration membrane 528 and remain on the blood collection container 410 side.
  • the cylinder 510 descends in a state of being in close contact with the inner surface of the blood collection container 410. Therefore, there is no possibility that the diluent 422 in the blood collection container 410 leaks outside through the gap between the blood collection container 410 and the cylinder 510 in the process of inserting the cylinder 510 into the blood collection container 410.
  • the sealing lid 514 When the knob portion 532 is screwed to the screw portion 412 to the lowest position, the sealing lid 514 is fitted to the reduced diameter portion 522. The flow path between the blood collection container 410 and the cylinder 510 is sealed with a sealing lid 514. The sealing lid 514 prevents mixing of plasma and blood cells due to backflow.
  • the blood collection container 410 constitutes a storage device in which a diluent is stored, and also a storage device for storing a diluted blood sample.
  • the cylindrical body 510 constitutes a storage device for storing the collected plasma.
  • the storage device for storing the blood sample corresponds to the combination of the blood collection container 410 and the cylindrical body 510. That is, the number of storage devices for storing the diluted blood sample may be one or a combination of two or more.
  • the blood test kit makes it possible to realize a method capable of analyzing a component to be analyzed with high measurement accuracy even with a blood collection volume of 100 ⁇ L or less.
  • a handling description in which the subject is able to accurately measure even with a small blood collection volume of 100 ⁇ L or less, and to what extent a blood sample should be collected by the fiber rod 202 of the blood collection device 200 A blood test kit containing a certificate is preferred.
  • the blood analysis method is preferably carried out by self-collection in which the subject (patient, subject) himself collects blood that has come off the skin by damaging a fingertip or the like using a blood collection lancet.
  • the biological sample to be analyzed is blood, and blood is a concept including serum or plasma.
  • plasma or serum obtained by collecting a small amount of blood from a subject, diluting with a buffer solution, and then separating blood cells by a filter or centrifugation can be used.
  • the component of the blood sample is preferably a plasma component separated from the blood sample by the separation means.
  • the origin of the blood sample is not limited to humans, and may be mammals, birds, fishes, etc., which are non-human animals (non-human animals). Examples of animals other than humans include horses, cows, pigs, sheep, goats, dogs, cats, mice, bears, pandas, and the like.
  • the source of the biological sample is human.
  • the concentration of the target component is analyzed using standard components that are constantly present in the blood sample.
  • standard components that are constantly present in the blood sample, the above description also applies here.
  • the occupation ratio of plasma components in the blood of the subject is about 55% in terms of volume, but varies depending on changes in the amount of salt intake of the subject. Therefore, in the embodiment, the dilution ratio of plasma is calculated using the standard value of the standard component that is constantly present in plasma, and the concentration of the target component in plasma in the blood sample is calculated using the calculated dilution ratio. analyse.
  • the dilution factor can be obtained by calculating the dilution factor (Y / X) of the plasma component in the blood sample from the known concentration value (concentration Y; 142 mmol / L in the case of sodium ion) of ions, etc. . Using this dilution factor, the measurement value (concentration Z) of the target component in the plasma dilution is measured, and this measurement value is multiplied by the dilution factor, so that the analyte actually contained in the plasma of the blood sample The component concentration [Z ⁇ (Y / X)] can be measured.
  • the concentration of sodium ion or the like can be measured by a known method such as a flame photometric method, a glass electrode method, a titration method, an ion selective electrode method, an enzyme activity method, or a method using ⁇ -galactosidase.
  • a dilution factor independently from the other standard components and confirm that the value matches the dilution factor obtained above.
  • the coincidence means that in two measured values (a, b), the ratio of their difference to their average value, that is,
  • a standard component that is constantly present in plasma other than sodium ions or chloride ions it is preferably selected from total protein or albumin, and more preferably total protein.
  • total protein or albumin There are known methods for measuring total protein, such as the Burette method, the ultraviolet absorption method, the Breadford method, the Raleigh method, the bicinchoninic acid (BCA) method, and the fluorescence method.
  • BCA bicinchoninic acid
  • fluorescence method A method to be used as appropriate can be selected according to the amount and the like.
  • the concentration of the target component is analyzed using standard components that are not present in the blood.
  • a blood test kit containing a diluent containing standard components not present in blood is used.
  • bleeding is performed from two or more places in one puncturing operation by using a blood collection lancet having two or more needle tips or a combination of two or more lancet bodies. Can do. Thereby, it is possible to bleed a sufficient amount of blood for blood collection, and it is possible to collect a sufficient amount of blood for examination.

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Abstract

L'invention concerne : une lancette pour collecter du sang qui est capable de provoquer suffisamment de saignement pour collecter du sang et facilite la collecte d'une quantité requise de sang ; et un kit de test sanguin. La présente invention comprend : un corps de lancette (12) qui a une ouverture (18) ; une aiguille (24) qui est disposée à l'intérieur du corps de lancette (12) ; et un premier élément élastique (20) et un second élément élastique (28) qui confèrent un mouvement longitudinal à l'aiguille (24). Le premier élément élastique (20) est disposé sur un côté opposé de l'aiguille (24) à partir de l'ouverture (18) et amène l'aiguille (24) à faire saillie à partir de l'ouverture (18). Le second élément élastique (28) est disposé entre l'ouverture (18) et l'aiguille (24) et amène une pointe d'aiguille de l'aiguille (24) à être logée à l'intérieur du corps de lancette (12). La présente invention comporte au moins deux pointes d'aiguille (24a, 24b) de l'aiguille (24).
PCT/JP2019/012373 2018-03-29 2019-03-25 Lancette pour collecter du sang et kit de test sanguin Ceased WO2019188907A1 (fr)

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Cited By (1)

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CN115931839A (zh) * 2022-11-18 2023-04-07 天津医科大学总医院 穿刺检测试剂盒、穿刺检测方法、穿刺检测针及应用

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WO2003084401A1 (fr) * 2002-04-04 2003-10-16 Matsushita Electric Industrial Co., Ltd. Dispositif de lancette
JP2007536008A (ja) * 2004-05-07 2007-12-13 ベクトン・ディキンソン・アンド・カンパニー 接触作動式ランセット装置
JP2008507346A (ja) * 2004-07-20 2008-03-13 バイエル・ヘルスケア・エルエルシー 多先端ランセット
JP2008535585A (ja) * 2005-04-07 2008-09-04 ベクトン・ディキンソン・アンド・カンパニー ランセット装置
JP2011521226A (ja) * 2008-05-14 2011-07-21 エフエイビープラウス ビー．ブイ． 血液を分離および分析する装置並びにその方法
JP2017015713A (ja) * 2015-07-06 2017-01-19 富士フイルム株式会社 血液検査キット及び血液分析方法
JP2017015712A (ja) * 2015-07-06 2017-01-19 富士フイルム株式会社 血液検査キット及び血液分析方法

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US20070276425A1 (en) * 2006-05-29 2007-11-29 Stanley Kim Painless Blood Sampling Lancet with Bundled Multiple Thin Needles
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JPS57168644A (en) * 1981-03-23 1982-10-18 Becton Dickinson Co Automatic shrinkable lancet assemblage
JP2002503118A (ja) * 1996-05-17 2002-01-29 マーキュリー ダイアグノスティックス インコーポレイテッド 体液をサンプル採取する装置に使用する使い捨て素子
WO2003084401A1 (fr) * 2002-04-04 2003-10-16 Matsushita Electric Industrial Co., Ltd. Dispositif de lancette
JP2007536008A (ja) * 2004-05-07 2007-12-13 ベクトン・ディキンソン・アンド・カンパニー 接触作動式ランセット装置
JP2008507346A (ja) * 2004-07-20 2008-03-13 バイエル・ヘルスケア・エルエルシー 多先端ランセット
JP2008535585A (ja) * 2005-04-07 2008-09-04 ベクトン・ディキンソン・アンド・カンパニー ランセット装置
JP2011521226A (ja) * 2008-05-14 2011-07-21 エフエイビープラウス ビー．ブイ． 血液を分離および分析する装置並びにその方法
JP2017015713A (ja) * 2015-07-06 2017-01-19 富士フイルム株式会社 血液検査キット及び血液分析方法
JP2017015712A (ja) * 2015-07-06 2017-01-19 富士フイルム株式会社 血液検査キット及び血液分析方法

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115931839A (zh) * 2022-11-18 2023-04-07 天津医科大学总医院 穿刺检测试剂盒、穿刺检测方法、穿刺检测针及应用

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