WO2018034032A1 - 血液採取器及び血液収容器を含む血液採取器具 - Google Patents
血液採取器及び血液収容器を含む血液採取器具 Download PDFInfo
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- WO2018034032A1 WO2018034032A1 PCT/JP2017/018763 JP2017018763W WO2018034032A1 WO 2018034032 A1 WO2018034032 A1 WO 2018034032A1 JP 2017018763 W JP2017018763 W JP 2017018763W WO 2018034032 A1 WO2018034032 A1 WO 2018034032A1
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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
- A61B5/150007—Details
- A61B5/150343—Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/02—Burettes; Pipettes
- B01L3/0275—Interchangeable or disposable dispensing tips
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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
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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
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150267—Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
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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
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150274—Manufacture or production processes or steps for blood sampling devices
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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
- A61B5/150007—Details
- A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/02—Burettes; Pipettes
- B01L3/021—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/56—Labware specially adapted for transferring fluids
- B01L3/565—Seals
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
- B04B—CENTRIFUGES
- B04B5/00—Other centrifuges
- B04B5/02—Centrifuges consisting of a plurality of separate bowls rotating round an axis situated between the bowls
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/02—Devices for withdrawing samples
- G01N1/10—Devices for withdrawing samples in the liquid or fluent state
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/02—Devices for withdrawing samples
- G01N1/10—Devices for withdrawing samples in the liquid or fluent state
- G01N1/12—Dippers; Dredgers
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/02—Devices for withdrawing samples
- G01N1/10—Devices for withdrawing samples in the liquid or fluent state
- G01N1/14—Suction devices, e.g. pumps; Ejector devices
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/16—Surface properties and coatings
- B01L2300/161—Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2400/00—Moving or stopping fluids
- B01L2400/04—Moving fluids with specific forces or mechanical means
- B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
- B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2400/00—Moving or stopping fluids
- B01L2400/06—Valves, specific forms thereof
- B01L2400/0688—Valves, specific forms thereof surface tension valves, capillary stop, capillary break
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2400/00—Moving or stopping fluids
- B01L2400/08—Regulating or influencing the flow resistance
- B01L2400/084—Passive control of flow resistance
- B01L2400/088—Passive control of flow resistance by specific surface properties
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/02—Devices for withdrawing samples
- G01N1/10—Devices for withdrawing samples in the liquid or fluent state
- G01N1/14—Suction devices, e.g. pumps; Ejector devices
- G01N2001/1472—Devices not actuated by pressure difference
- G01N2001/149—Capillaries; Sponges
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- 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
Definitions
- the present invention relates to a blood collection device including a blood collection device and a blood container for collecting a small amount of blood.
- modulation and disease in a living body appear as changes in components such as body fluids such as blood, urine, and saliva as biological reactions.
- body fluids such as blood, urine, and saliva
- changes in physical condition and detection of diseases are performed.
- blood tests for measuring blood components are widely performed as an effective means for examining medical conditions and as a means for health management.
- the collected blood is transferred to a blood container and then subjected to analysis according to a predetermined purpose.
- a blood collection kit comprising a blood collection device and a blood collection bottle has been proposed (Patent Document 1).
- the blood collection device is composed of a cylindrical liquid-absorbing liquid containing a blood coagulation-preventing liquid disposed at the tip and a pressing body that separates the liquid-absorbing liquid by pushing the rear surface of the liquid-absorbing liquid, Contains chemicals. Then, when the blood collecting device is pushed into the blood collecting bottle and the pressing body of the blood collecting device is pushed, blood is eluted from the tip of the blood collecting device into the drug solution.
- the collected blood is mixed in the drug solution, not only the plasma of the collected blood can be separated, but also the amount of a specific component in the blood cannot be measured accurately.
- Patent Document 2 a micro blood sampling device using a disposable pipette in which a syringe cylinder and a flexible cap communicate with each other has been proposed (Patent Document 2).
- Patent Document 2 a micro blood sampling device using a disposable pipette in which a syringe cylinder and a flexible cap communicate with each other.
- body fluid collection comprising a suction part for sucking body fluid, a main body part having an air passage for passing a gas for discharging the body fluid sucked by the suction part, and a blocking part provided between the main body part and the suction part
- a body fluid collecting device including a container and a body fluid container capable of storing body fluid collected by the body fluid collector (Patent Document 3).
- the bodily fluid sucked into the sucking part of the bodily fluid collector is transferred from the sucking part to the bodily fluid container due to the pressure generated by the pressure generating part connected to the main body part.
- a blood test using the collected blood is performed using an automatic analyzer, but it is necessary to transfer the blood collected using the blood sampler to the blood container.
- pressure is used to discharge the aspirated body fluid, and there is a possibility that problems such as hemolysis may occur due to the force applied at the time of discharge, and if convenience is pursued It is preferable to transfer blood to the blood container in the container itself to be used.
- JP 2006-288680 A JP 2005-017281 A WO2015 / 034009
- an object of the present invention is to provide a blood sampling instrument that is excellent in convenience in which a small amount of sample can be collected in a state suitable for subsequent examination even when a small amount of sample is collected.
- the blood sampling device includes a pipette chip-shaped blood sampling device having an opening in the upper and lower portions with an internal space for sucking and holding blood by capillary action, and blood collected by the blood sampling device Is a blood collection device including a blood container in which the inner wall and the bottom of the container can be treated with hydrophilicity, and a sealing lid for sealing the blood container. Then, when the lower opening of the blood sampler that sucks and holds the blood in the internal space is brought into contact with the inner wall or bottom of the blood container, the blood easily moves from the blood sampler to the blood container.
- blood can be easily transferred from a blood sampling device to a blood container without using a special discharge mechanism, and no extra force or pressure is applied when blood is discharged.
- the collected blood can be stored in the blood container without causing the above problem.
- Such blood is suitable for subsequent blood analysis.
- FIG. 1st aspect of the blood collection instrument shows the structure of the 1st aspect of the blood collection instrument concerning this invention. It is explanatory drawing of one aspect which collects blood using the blood sampling device of the blood sampling device concerning this invention. It is a figure explaining movement of the blood from a blood sampling device to a blood container in the blood sampling device of the 1st mode of the present invention. In the blood collection instrument of the 1st aspect of this invention, it is the figure explaining another mode of the movement of the blood from a blood collection device to a blood container. It is a figure which shows the structure of the 2nd aspect of the blood collection instrument concerning this invention.
- the first aspect of the blood sampling device is: A pipette tip-shaped blood sampler having openings at the top and bottom with an internal space for sucking and holding blood, and the internal space of the blood sampler communicates with the lower opening and the upper opening
- at least a part of the inner space has a tapered shape from the lower opening toward the upper opening, and is configured to suck blood into the inner space by capillary action when the lower opening is in contact with blood.
- a blood container capable of containing blood collected by the blood sampler, wherein the blood container has a space into which the blood sampler can be inserted, and has an inner wall which is hydrophilically treated; Having a bottom, A sealing lid for sealing the blood container;
- a blood collection device comprising: When the lower opening of the blood sampler that sucks and holds blood in the internal space is brought into contact with the inner wall or bottom of the blood container, the blood is configured to move from the blood sampler to the blood container. Blood sampling device.
- FIG. 1 shows a first embodiment of the present invention.
- the blood sampling device of the present invention is composed of a blood sampling device 100, a blood container 200, and a sealing lid 300 for sealing the blood container.
- the drawing shows a scale 12 for confirming the amount of blood, but the scale may or may not be attached.
- the scale may or may not be attached.
- blood is collected by puncturing the fingertips or ear lobes and then contacting the lower blood opening of the blood sampler with the blood that has come out to cause capillary action or fluid flow. Blood is drawn into the blood sampling device by the negative pressure due to the flow, and blood can be collected.
- blood collection there is no limit to the amount of blood collected, and the blood volume can be varied according to the purpose thereafter.
- Using the blood sampler of the present invention it is possible to collect a small amount of blood (for example, any amount from 10 ⁇ L to 200 ⁇ L).
- FIG. 3 is a diagram showing a state in which a blood sampling device holding blood is placed inside the blood container in order to transfer the sucked blood to the blood container. As shown in the right figure, when the lower opening of the blood sampler comes into contact with the bottom of the blood container that has been subjected to hydrophilic treatment, the blood easily moves to the blood container.
- the lower opening of the blood sampler that sucks and holds blood may be brought into contact with the side wall of the blood container that has been subjected to hydrophilic treatment. Even in such a case, blood is easily transferred from the blood sampler to the blood container by gravity and hydrophilic action. Moreover, as shown in the enlarged view in FIG. 4, the tip end of the blood sampling device can be processed obliquely.
- the blood sampling device After collecting blood using the blood sampling device, the blood is collected by bringing the lower opening of the blood sampling device into contact with the inner wall or bottom of the blood container. Almost move from to the blood container. Before the lower opening of the blood sampler comes into contact with the inner wall or bottom of the blood container, the blood sucked by capillary action is held in the blood sampler. When contacted, the blood is drawn by gravity and hydrophilic action and moves to the blood container.
- the blood suction force (X) based on the capillary phenomenon of the blood blood sampling device The blood discharge force (Y) based on the gravity of the blood and the hydrophilic treatment of the blood container has a relationship of X ⁇ Y, whereby the blood moves from the blood collector to the blood container.
- the inner wall of the blood holding part of the blood sampler is hydrophilically treated to facilitate blood collection, the movement of blood to the blood container is not sufficient by gravity alone. Hydrophilic treatment of the inner wall and bottom of the vessel is essential. In the step of transferring blood to the blood container using the instrument of the present invention, there is no need for force such as air pressure for discharging the blood in the blood sampling device, and there is no fear of problems such as hemolysis.
- a second aspect of the blood sampling device according to the present invention is the blood sampling device according to the first aspect, wherein a protrusion is formed at the bottom of the blood container.
- FIG. 5 shows a process of transferring blood from a blood sampler to a blood container using the blood sampler of the second aspect of the present invention. Since the bottom including the protrusion is hydrophilically treated, when blood near the lower opening of the blood sampling device comes into contact with the protrusion, the blood is discharged and easily transferred to the blood container.
- the blood container can be sealed with the sealing lid after the blood is transferred to the blood container.
- blood can be transported and stored.
- centrifuge in a state where the blood is housed in the blood container, and the blood can be separated into a supernatant (serum or plasma) and a precipitate (blood cell).
- the hydrophilic treatment of the inner wall and bottom of the blood container can be performed using a known method, and is not limited to this.
- the hydrophilic treatment can be achieved by etching, fluorine treatment, or forming irregularities or fine scratches on the surface. it can.
- hydrophilicity can be imparted by forming a porous surface on the inner wall surface by chemical treatment such as chemical vapor deposition, or by introducing a hydrophilic functional group on the inner wall surface via a catalyst.
- a treatment for imparting hydrophilicity to the surface of a material made of a polymer compound, for example, polypropylene or polycarbonate, is known, and these methods can be used.
- the portion for holding the collected blood (hereinafter referred to as “blood holding portion” in the present specification) in the blood sampling device 100 of the present invention is a portion of the sample suction portion of the pipette tip whose inner diameter is continuously increased. A shape similar to the shape is formed.
- the volume of the blood holding part is preferably 200 ⁇ L or less, more preferably 150 ⁇ L or less, and even more preferably 100 ⁇ L or less.
- the inner diameter of the lower end opening of the blood sampling device 100 and the inner diameter of the body part that is the blood holding part can be arbitrarily determined as long as the effect of capillary action can be obtained.
- the inner diameter of the lower end opening of blood sampler 100 is not limited to this, but for example, 0.1 mm or more and less than 2.0 mm, preferably 0.3 mm or more and less than 1.5 mm, more preferably 0.5 mm or more and 1.0 mm. Or less, more preferably 0.7 mm or more and less than 0.9 mm. Thereby, blood can be easily collected from the lower opening by capillary action.
- the blood sampling device is preferably made of a polymer compound material such as polyvinyl chloride, polyethylene, polypropylene, acrylonitrile butadiene styrene (ABS), polycarbonate, polyethylene terephthalate, etc. from the viewpoint of processability and operability.
- a polymer compound material such as polyvinyl chloride, polyethylene, polypropylene, acrylonitrile butadiene styrene (ABS), polycarbonate, polyethylene terephthalate, etc.
- the materials exemplified above are not compatible with water. Therefore, since the tip of a micropipette intended to be discharged after aspirating the solution has a separate power for aspirating and discharging, the hydrophobicity of the surface of the tip material causes high water drainage when discharging the aspirated solution. Can be granted.
- this property is not preferable when blood is aspirated utilizing capillary action, in the blood sampling device of the instrument of the present invention, it is preferable that the inner wall of the blood holding part is treated with a hydrophilic treatment. If the inner wall is not hydrophilically treated, there is a problem that blood is difficult to flow smoothly when blood is collected. In the blood sampler of the present invention, the target amount of blood can be collected easily by combining the effect of capillary action and the hydrophilic treatment of the inner wall.
- the hydrophilic treatment of the inner wall and bottom of the blood container can be performed using a known method, and is not limited to this.
- the hydrophilic treatment can be achieved by etching, fluorine treatment, or forming irregularities or fine scratches on the surface. it can.
- hydrophilicity can be imparted by forming a porous surface on the inner wall surface by chemical treatment such as chemical vapor deposition, or by introducing a hydrophilic functional group on the inner wall surface via a catalyst.
- a treatment for imparting hydrophilicity to the surface of a material made of a polymer compound, for example, polypropylene or polycarbonate, is known, and these methods can be used.
- the blood container 200 is not limited in its shape and the material is not limited as long as the blood sampling device 100 can be inserted and its lower opening can be brought into contact with the wall surface or bottom of the container. Considering sample collection, gripping property, transportation, etc. by the operator, a hard material with high transparency is preferable.
- the shape and the material of the sealing lid 300 of the blood container 200 are not limited as long as the container can be sealed, but preferably one that can prevent elution during centrifugation and drying of the internal sample.
- the amount of blood collected by the blood sampler can be changed according to the intended examination and measurement, and the length and diameter of the sample collection part can be adjusted accordingly.
- the amount of sample to be collected can be adjusted in the range of 10 ⁇ L to 300 ⁇ L, preferably 10 ⁇ L to 200 ⁇ L, more preferably 50 ⁇ L to 100 ⁇ L.
- the blood sampler by providing the blood sampler with the guide line 12 indicating that a specific amount has been collected, it is possible to accurately collect a specific amount of blood.
- the blood sampling device of the present invention When the blood sampling device of the present invention is used, good blood suitable for blood analysis can be prepared even with a small amount of peripheral blood collected from a fingertip or earlobe. By diluting such blood, it can be analyzed by a conventional protocol used for analyzing brachial venous blood collected with a conventional blood collection tube or the like or an existing analyzer. That is, blood analysis similar to the conventional one can be performed using a small amount of peripheral blood collected from a fingertip or earlobe.
- the blood collected using the blood collection device of the present invention is a cancer marker in addition to a general biochemical item and / or immune item test commonly used in blood tests, so-called blood biochemical tests. It can also be used for special examination items such as allergies.
- Processing example 1 Hydrophilic treatment of the inner wall and bottom of the sampling device by etching A blood container molded with ABS is immersed in a solution containing chromium hexafide for 12 minutes to dissolve butadiene on the ABS surface. Fine pores were formed by creating etching holes.
- Processing Example 2 Hydrophilic treatment of inner wall and bottom of blood container with mixed gas of fluorine gas and oxygen gas
- hydrophilic treatment by fluorine gas treatment is disclosed in JP 2010-150460 A Based on the above, entrusted to Takamatsu Teito Co., Ltd. (Takamatsu City, Kagawa Prefecture). Surface modification treatment was performed using a mixed gas.
- hydrophilicity such as a carboxyl group or a hydroxyl group can be expressed by utilizing the high reactivity of fluorine gas and oxygen.
- Processing Example 3 Hydrophilic treatment of inner wall and bottom of blood container by application of surfactant The following was performed using the blood sampling device of the present invention shown in FIG. In a blood container molded with polycarbonate and having protrusions, the inner wall and bottom are immersed in a 0.2% (w / w) polyoxyethylene sorbitan monolaurate aqueous solution for 30 seconds, washed with pure water, and dried well Thus, hydrophilic treatment by applying a surfactant was performed. As soon as the tip of the blood sampler sucking 50 ⁇ l of the colored solution touched the protrusion of the blood container, the solution was transferred to the blood container. On the other hand, even if the same operation was performed on the blood container not subjected to the hydrophilic treatment, the solution did not migrate.
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Abstract
Description
特に、血液成分を測定する血液検査は、病状などを調べるために有効な手段として、また健康管理のための手段として広く行われている。
しかしながら、上記のような従来の採取装置では、吸引した体液を排出するために圧力を用いており、放出時にかかる力により溶血等の問題が生じる恐れがあり、且つ利便性を追求するのであれば、使用する容器自体で血液収容器へ血液を移すことが好ましい。
なお、文中で特に断らない限り、本明細書で用いるすべての技術用語及び科学用語は、本発明が属する技術分野の当業者に一般に理解されるのと同じ意味をもつ。また、本明細書に記載されたものと同等又は同様の任意の材料及び方法は、本発明の実施において同様に使用することができる。
また、本明細書に記載された発明に関連して本明細書中で引用されるすべての刊行物及び特許は、例えば、本発明で使用できる方法や材料その他を示すものとして、本明細書の一部を構成するものである。
(第一の態様)
本発明に係る血液採取器具の第一の態様は、
血液を吸引して保持する内部空間を備えた上部および下部に開口部を有するピペットチップ形状の血液採取器と、ここで、血液採取器の内部空間は、下部開口部および上部開口部が連絡し、少なくとも前記内部空間の一部は下部開口部から上部開口部に向かってテーパー形状を有し、そして、下部開口部を血液に接すると毛細管現象により血液を内部空間に吸引するように構成されている、
前記血液採取器により採取された血液を収容可能な血液収容器と、ここで、血液収容器は、前記血液採取器が挿入可能な空間を内部に有し、かつ、親水性処理された内壁及び底部を有する、
前記血液収容器を密閉するための密閉蓋と、
を備える血液採取器具であって、
血液を内部空間に吸引し保持した前記血液採取器の下部開口部を、前記血液収容器の内壁又は底部に接触させると、血液が血液採取器から血液収容器へと移動するように構成されている血液採取器具である。
血液の採取は、例えば、指先や耳たぶから末梢血を採取する場合は、指先や耳たぶに穿刺をした後、出てきた血液に血液採取器の下部開口部を接触させることにより毛細管現象や流体の流れによる陰圧によって血液採取器内へ血液が誘導され、血液の採取が可能である。
本発明の器具を用いた血液収容器へ血液を移す工程においては、血液採取器内の血液を吐出させるための空気圧等の力は不要で、溶血等の問題が生じる心配がない。
本発明に係る血液採取器具の第二の態様は、第一の態様の血液採取器具において、血液収容器の底部に突起が形成されているものである。本発明の第二の態様の血液採取器具を用いて、血液を、血液採取器から血液収容器へと移す工程を図5に示す。突起部を含む底部は親水性処理がなされているので、血液採取器の下部開口部付近の血液が突起部と接触すると、血液が吐出し血液収容器へと容易に移される。
また、血液採取器に、特定の量が採取されたことを示すガイド線12を備えることにより、特定の量の血液の採取を正確に行うことができる。
例えば、本発明の血液採取分器具を用いて採取した血液は、血液検査で通常用いられている、一般の生化学項目および/または免疫項目の検査、いわゆる、血液生化学検査に加え、癌マーカーやアレルギーのような特殊検査項目にも用いることができる。
加工例1:エッチングによる試料採取器具の内壁及び底部の親水性処理
ABSで成型された血液収容器を、六化クロムを含有する溶液に12分間浸漬し、ABS表面のブタジエンを溶解させ、表面のエッチングホールを作製することにより微細な多孔質を形成させた。
ポリカーボネイトで成型された血液収容器において、フッ素ガス処理による親水性処理を、特開2010-150460号公報を基礎とし高松帝酸株式会社(香川県高松市)に委託し、フッ素ガス分圧1.33Pa、酸素ガス分圧93100Pa、処理温度25℃、処理時間600秒の条件のフッ素ガスと酸素ガスの混合ガスを用いて表面改質処理を行った。
なお本フッ素処理においては、フッ素ガスと酸素の高反応性を利用して、カルボキシル基や水酸基等の親水性を発現させることができる。
図5に示される本発明の血液採取器具を用いて以下を行った。
ポリカーボネイトで成型され且つ突起部を有する血液収容器において、0.2%(w/w)ポリオキシエチレンソルビタンモノラウラート水溶液にて内壁及び底部を30秒間浸漬したのち、純水で洗浄、よく乾燥させることにより、界面活性剤塗布による親水性処理を行った。
着色溶液50μlを吸引している血液採取器先端を、血液収納器の突起部に触れると直ちに血液収納器に溶液が移行した。一方、上記親水処理を行っていない血液収納器に対して同様の操作を行っても、溶液が移行することはなかった。
11.下部開口部
12.ガイド線
21.突起部
100.血液採取器
200.血液収容器
300.密閉蓋
Claims (5)
- 血液を吸引して保持する内部空間を備えた上部および下部に開口部を有するピペットチップ形状の血液採取器と、ここで、血液採取器の内部空間は、下部開口部および上部開口部が連絡し、親水性処理された内壁を有する血液保持部を構成する前記内部空間の下部は下部開口部先端から上部開口部に向かってテーパー形状を有し、そして、下部開口部を血液に接すると毛細管現象により血液を内部空間に吸引するように構成されている、
前記血液採取器により採取された血液を収容可能な血液収容器と、ここで、血液収容器は、前記血液採取器が挿入可能な空間を内部に有し、かつ、親水性処理された内壁及び底部を有する、
前記血液収容器を密閉するための密閉蓋と、
を備える血液採取器具であって、
前記血液収容器の底部に、突起部が設けられ、前記血液保持部の保持された血液を前記突起部に接触させて前記血液収容器内に吐出する血液採取器具。 - 血液を吸引して保持する内部空間を備えた上部および下部に開口部を有するピペットチップ形状の血液採取器と、ここで、血液採取器の内部空間は、下部開口部および上部開口部が連絡し、親水性処理された内壁を有する血液保持部を構成する前記内部空間の下部は下部開口部先端から上部開口部に向かってテーパー形状を有し、そして、下部開口部を血液に接すると毛細管現象により血液を内部空間に吸引するように構成されている、
前記血液採取器により採取された血液を収容可能な血液収容器と、ここで、血液収容器は、前記血液採取器が挿入可能な空間を内部に有し、かつ、親水性処理された内壁及び底部を有する、
前記血液収容器を密閉するための密閉蓋と、
を備える血液採取器具であって、
血液が前記血液保持部に保持された状態で前記血液採取器の下部開口部を、前記血液収容器の内壁又は底部に接触させた場合、前記血液採血器の毛細管現象に基づく血液の吸引力(X)と、血液の重力と血液収容器の親水性処理に基づく血液吐出力(Y)が以下の関係:X<Y、となるように構成されている血液採取器具であり、
前記血液収容器の底部に、突起部が設けられ、前記血液保持部の保持された血液を前記突起部に接触させて前記血液収容器内に吐出する血液採取器具。 - 前記血液採取器または前記血液収容器の親水性処理が、エッチング、フッ素加工によりなされている請求項1又は2に記載の血液採取器具。
- 前記血液収容器の親水性処理が、血液収容器の内壁及び底面の表面に凹凸又は小さな傷を形成することによりなされている請求項1又は2に記載の血液採取器具。
- 前記下部開口部が、内径が、0.5mm以上1.0mm未満の開口部である請求項1~4のいずれかひとつに記載の血液採取器具。
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EP17841260.7A EP3428609A4 (en) | 2016-08-17 | 2017-05-19 | BLOOD DETECTOR AND BLOOD DETECTION TOOL WITH BLOOD CONTAINER |
KR1020187027968A KR102123499B1 (ko) | 2016-08-17 | 2017-05-19 | 혈액 채취기 및 혈액 수용기를 포함하는 혈액 채취 기구 |
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SG11201809404WA (en) | 2018-11-29 |
US20190159710A1 (en) | 2019-05-30 |
EP3428609A4 (en) | 2019-05-08 |
JP2018027190A (ja) | 2018-02-22 |
KR20180123057A (ko) | 2018-11-14 |
CN108780028A (zh) | 2018-11-09 |
CN108780028B (zh) | 2020-11-03 |
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EP3428609A1 (en) | 2019-01-16 |
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