WO2002046747A1 - Unite d'inspection de fluide corporel facilitee - Google Patents

Unite d'inspection de fluide corporel facilitee Download PDF

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Publication number
WO2002046747A1
WO2002046747A1 PCT/JP2001/010701 JP0110701W WO0246747A1 WO 2002046747 A1 WO2002046747 A1 WO 2002046747A1 JP 0110701 W JP0110701 W JP 0110701W WO 0246747 A1 WO0246747 A1 WO 0246747A1
Authority
WO
WIPO (PCT)
Prior art keywords
body fluid
reagent
data
blood
porous sheet
Prior art date
Application number
PCT/JP2001/010701
Other languages
English (en)
Japanese (ja)
Inventor
Keiichiro Okabe
Kayo Sugimoto
Yoshiaki Kanda
Original Assignee
Kabushiki Kaisya Advance
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
Priority claimed from JP2000372095A external-priority patent/JP2002174634A/ja
Priority claimed from JP2001053097A external-priority patent/JP2002257829A/ja
Application filed by Kabushiki Kaisya Advance filed Critical Kabushiki Kaisya Advance
Priority to AU2002221075A priority Critical patent/AU2002221075A1/en
Publication of WO2002046747A1 publication Critical patent/WO2002046747A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/1451—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
    • A61B5/14514—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
    • 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
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • 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
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • 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
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • 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
    • A61B5/150847—Communication to or from blood sampling device
    • A61B5/150854—Communication to or from blood sampling device long distance, e.g. between patient's home and doctor's office
    • 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
    • A61B5/150969—Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
    • 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
    • A61B5/150977—Arrays of piercing elements for simultaneous piercing
    • A61B5/150984—Microneedles or microblades
    • 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

Definitions

  • the present invention relates to a simple body fluid testing unit. (Prior art)
  • Dry chemistry has been proposed as a technology that can contribute to such systems, and devices that can easily measure blood glucose levels have been proposed.
  • Japanese Patent Application Laid-Open No. 10-2046417 proposes an apparatus for measuring blood glucose level based on dry chemistry.
  • This device comprises a light-permeable, water-impermeable support, a reagent that reacts with components in the blood and exhibits a color development having an absorbance at 200 to 900 nm, or 200 to 900 nm.
  • a plurality of reagent parts comprising a reagent that emits light of nm and a transparent hydrophilic carrier holding the reagent are provided in a plane, and a blood dropping part is connected to the reagent part, and the blood dropping part and the reagent part are connected to form a blood cell. It has a configuration in which a connecting portion having a separating function is provided.
  • the blood dropped on the blood dropping section reaches the reagent section via the connection section, and reacts with the reagent to develop color. Is this color outside the support By observing them, the concentration of the component specified by the reagent in the blood can be known.
  • a plurality of specific components in blood can be measured relatively easily at once, but the configuration of the device is complicated and has a drawback that it is not suitable for mass production. . Furthermore, it takes a relatively long time for the blood dropped on the dropping part to reach each reagent and to proceed with the color reaction to such an extent that optical measurement becomes possible. Therefore, it takes a considerable amount of measurement time to perform highly accurate measurements.
  • an object of the present invention is to provide a simple body fluid inspection unit which has a simple structure, is suitable for mass production, and can easily and speedily measure a plurality of body fluids with high accuracy. It was done
  • a first simplified body fluid inspection unit of the present invention includes a plurality of reagent members, a support member having a plurality of openings for accommodating the respective reagent members, and a housing member housed in the opening.
  • a porous sheet member disposed on the support member so as to cover at least a part of each reagent member; and an opening exposing a part of the porous sheet member, the porous sheet member having And a force par member configured to force the force from the side opposite to the surface in contact with the support member.
  • the support member may be provided with a plurality of ventilation holes for connecting the reagent members to the outside.
  • the porous sheet member CAPA one and case may ⁇ thereof by a transparent member surface opposite to the contact surfaces and the portion of the face the reagent member of the transparent cover of the support member A ventilation hole may be provided in a part.
  • the ventilation holes provided in the support member may be omitted.
  • the test kit is constituted only by laminating the porous sheet and the cover member on the support member holding a plurality of reagent members. Because the manufacturing process is simplified and suitable for mass production.
  • a second simple body fluid inspection unit includes a porous sheet member having at least a part thereof exposed so that a bodily fluid can be dropped, and a side opposite to the one surface of the porous sheet member.
  • a test chip having a plurality of reagent members arranged so that a part thereof is in contact with the porous sheet member, and a rotating unit for rotating the test chip. This rotating means may rotate the exposed portion of the porous sheet member around the center. Further, the test chip may be provided with a vent for connecting the reagent member to the outside.
  • the body fluid dropped on the porous sheet quickly penetrates into the reagent member by the centrifugal force of the rotation by rotating the detection chip by the rotating means. I do.
  • porous sheet material in the simple body fluid inspection unit of the present invention described above.
  • nylon, PET, non-woven fabric, porous sheet, etc. can be mentioned, but when blood is used in a state where blood cells are not separated by dropping, Hemasep (registered trademark) having blood cell separation ability is used.
  • V-film manufactured by Nippon Pall
  • a porous sheet made of nylon or the like coated with a blood cell adsorbent or the like may be used.
  • the area of the porous sheet is, for example, 12.5 mm 2 to 3 14 mm 2, and the thickness is, for example, 0.5 mn!
  • the reagent member according to the present invention may be, for example, a filter paper, a nonwoven fabric, or a known hydrophilic carrier, for example, a natural material such as gelatin, albumin, collagen, agar, agarose, or dextran.
  • polyacrylamide Riruami de synthetic polymer compounds such as polyacrylic acrylic acid are exemplified, an area of for example 5 mm 2 ⁇ 1 3 8 mm 2, the thickness, for example, 0. 2 m ⁇ ! 00.6 mm, preferably 5 mm 2 ⁇ area that allows a short time to reach the reagent to be colored and allows sufficient color development: L 0 mm 2 , thickness 0.2 mm to 0.4 mm Exemplified.
  • the area of the contact portion between the porous sheet member and the reagent member is, for example, 5 mm 2 to 1 38 mm 2, preferably 5 mm 2 to 10 mm 2 .
  • Specific components to be tested in the present invention include, for example, glucose, urea, nitrogen, creatine, uric acid, total cholesterol, high density lipoprotein (HDL), cholesterol, triglyceride, Chemical substances such as total pyrilvin, calcium, inorganic phosphorus, total protein, albumin, ammonia, hemoglobin, and Y-glutamyl transpeptidase (0 / —GPT), glutamate oxazamine citrate transaminase (GOT ), Glutamate pyruvate tolane Examples include enzymes such as suaminase (GPT), creatine phosphokinase, lactate dehydrogenase (LDH), alkaline phosphatase (ALP), amylase and leucine aminopeptidase.
  • GPT Glutamate pyruvate tolane
  • enzymes such as suaminase (GPT), creatine phosphokinase, lactate dehydrogenase (LDH), alkaline phosphat
  • the rotating means in the present invention utilizes centrifugal force generated by the rotation to promote various filtration separation of bodily fluids and to quickly reach bodily fluids to the reagent member.
  • An electric rotating means such as a motor, a mechanical rotating means such as a mainspring drive, or other means capable of rotating manually may be used.
  • test chip When the test chip is rotated by the rotating means, it is preferable to rotate around the part where the body fluid is dropped, but when a centrifugal force is expected in a part of the plurality, the whole is rotated. No need to put on top 0
  • the rotation time varies, and is not particularly limited.For example, various rotations such as a floppy disk drive, a CD drive, a DVD drive, and an MO drive attached to a computer used for personal use. However, the speed of the drive for reading and writing data is preferable.
  • test chip By forming the test chip in a disk shape and storing it in a floppy disk-shaped housing, or by processing the test chip itself into a floppy disk-shaped housing, this housing is replaced with a floppy disk. Can be mounted inside the drive. As a result, the test chip can be automatically rotated using the floppy disk drive, and the bodily fluid can be quickly penetrated into the reagent member by centrifugal force.
  • the body fluid test information which is shown as a coloring phenomenon on the reagent member, can be automatically inserted into the personal computer only by inserting this housing into the floppy disk drive. And can execute various information processing on the read information.
  • the porous material, the structure of the reagent section, the reagent components, the supporting material, and the like in the present invention are preferably those disclosed in Japanese Patent Application Laid-Open No. H10-204714. Available.
  • Examples of the body fluid in the present invention include blood, urine, semen, and sweat.
  • FIG. 1A is a top view of a simplified body fluid inspection unit according to one embodiment of the present invention.
  • FIG. 1B is a cross-sectional view taken along line AA of FIG. 1A.
  • FIG. 1C is a rear view of the unit shown in FIGS. 1A and 1B with the rear force par removed.
  • FIG. 2 is a perspective view showing a configuration of a simple body fluid inspection unit according to another embodiment of the present invention.
  • FIG. 3 is a graph showing an experimental result obtained by the simple liquid detection unit shown in FIG.
  • FIG. 4A is a side view of one embodiment of the blood collector according to the present invention.
  • 4B is a side view showing one use state of the blood collector shown in FIG. 4A.
  • FIG. 4C is a side view showing another use state of the blood collector shown in FIG. 4A.
  • FIG. 4D is a partially enlarged view of the blood collection device shown in FIG. 4A.
  • FIG. 5A is a side view of another embodiment of the blood collector according to the present invention.
  • FIG. 5B is a bottom view of the blood applicator shown in FIG. 5A.
  • FIG. 5C is a side view showing one use state of the blood collector shown in FIG. 5A.
  • FIG. 5D is a side view showing another use state of the blood collector shown in FIG. 5A.
  • FIG. 5E is a partially enlarged view of the blood collection device shown in FIGS. 5A to 5D.
  • FIG. 6 is a side view of another embodiment of the blood collector according to the present invention.
  • FIG. 7A is a cross-sectional view of still another embodiment of the blood collector according to the present invention.
  • FIG. 7B is a diagram showing a use state of the blood collector according to FIG. 7A.
  • FIG. 7C is a partially enlarged view of the blood collection device shown in FIGS. 7A and 7B.
  • FIG. 8 is a side view of still another embodiment of the blood collector according to the present invention.
  • FIG. 9A is a cross-sectional view of one embodiment of the body fluid sampling device according to the present invention.
  • FIG. 9B is a bottom view of the bodily fluid collection device shown in FIG. 9A.
  • FIG. 10 is a cross-sectional view of another embodiment of the body fluid sampling device according to the present invention.
  • FIG. 11 is a cross-sectional view of still another embodiment of the body fluid sampling device according to the present invention.
  • FIG. 12 is a partially cutaway perspective view of a body fluid detecting device according to the present invention, which is still another embodiment.
  • FIG. 13 is a perspective view of still another embodiment of the body fluid sampling device according to the present invention.
  • FIG. 14A is a perspective view showing the configuration of still another embodiment of the bodily fluid collection device according to the present invention.
  • FIG. 14B illustrates the operation of the main part of the bodily fluid collection device shown in Fig. 14A.
  • FIG. 14B illustrates the operation of the main part of the bodily fluid collection device shown in Fig. 14A.
  • FIG. 15 is a block diagram showing a configuration of one embodiment of the body fluid testing system according to the present invention.
  • FIG. 16 is a block diagram showing the configuration of another embodiment of the body fluid inspection system according to the present invention.
  • FIG. 17 is a schematic view showing the configuration of a further embodiment of the body fluid inspection system according to the present invention.
  • FIG. 1 shows a simplified body fluid test kit according to one embodiment of the present invention. Since this unit is formed in a chip shape, it is hereinafter referred to as a detection chip.
  • FIG. 1A is a top view of the test chip
  • FIG. 1B is a cross-sectional view taken along line AA ′ of FIG. 1A.
  • FIG. 1C is a bottom view of the test chip when the reagent cover 7 is removed.
  • reference numeral 1 denotes a sheet-like force par member having an opening for forming a drip portion 2 for bodily fluid in a central portion, and is formed of PVC, PET, or the like.
  • Reference numeral 3 denotes a porous sheet member, in which a single or a plurality of the above-described porous sheets are laminated.
  • the porous sheet member 3 preferably has, for example, a blood cell separating ability, and Hemasep (registered trademark) V membrane (manufactured by Nippon Pall Corporation) is suitably used.
  • a support member 6 having a plurality of openings 5 is provided on the back surface of the porous sheet member 3.
  • the opening 5 has a circular shape, and reagent members 5a to 5f formed by attaching, coating or impregnating various reagents on the porous base material are arranged therein. These reagents may be different reagents corresponding to the measurement items.
  • the number of openings 5 is As shown, about 6 to 15 are shown, but are appropriately selected depending on the body fluids and components to be measured.
  • the support member 6 is provided with ventilation holes 8 a to 8 f for each opening 5.
  • the ventilation holes 8a to 8 # are provided for more smoothly penetrating and diffusing body fluids, and a plurality of ventilation holes may be provided for each opening.
  • the support member 6 holds the reagent members 5a to 5f uniformly from the side, and is formed of, for example, rubber, synthetic resin, or the like.
  • Reference numeral 7 denotes a reagent part cover member for protecting the reagent surface, and is made of PET, polyester, or the like. It is preferable that the reagent member 7 has a light transmitting property when optically measuring the reagent member.
  • the reagent member 7 is unnecessary when, for example, the reagent members 5a to 5f are sufficiently held in the opening 5 and do not drop.
  • an air opening 8 g may be formed on the contact surface between the reagent part 7 and the reagent members 5a to 5f. In this case, the vents 8a to 8f can be omitted.
  • the size of the entire test chip depends on the number of reagents, but when six reagents are formed as in this example, the diameter of the porous sheet is about 1 Omm and the thickness is about 2 mm However, it is not limited to this.
  • the shape is a disk shape, but may be a square, a rectangle, or any other shape that clarifies positional information of a plurality of reagent parts, and the shape and material thereof are appropriately selected. Further, such an inspection chip may be housed in a case of a floppy disk, or may be entirely processed into a floppy disk.
  • the body fluid is blood. Quantify one drop of blood from fingertips with a lancet needle, etc. Take a blood collection capillary and dilute 10 to 10 times the blood 80 to 3001 with 9 volumes of physiological saline into the dropping part 2.
  • the amount of blood It is not limited to this numerical range because it is appropriately adjusted depending on the size of the data.
  • the dropped diluted blood moves concentrically and in a downward direction while separating and diffusing blood cells, and reaches each reagent holding member. Thereafter, the reagents dissolve and react, penetrate evenly into each reagent holding member, and the color reaction corresponding to each reagent develops color in proportion to the serum content.
  • the time from the dropping to the reaction is as fast as 1 minute to several minutes, and thereafter it is stable for several minutes to 5 to 10 minutes, and it is possible to obtain biometric information more quickly. Further, as shown in the present embodiment, the present apparatus has a possibility of simplifying the manufacturing since it has a simple laminated configuration with a small number of parts.
  • FIG. 2 shows the configuration of a second embodiment of the simplified body fluid inspection unit according to the present invention.
  • Reference numeral 20 denotes an inspection chip having the configuration shown in FIG. 1, for example.
  • Reference numeral 21 denotes a drop portion of a body fluid
  • 22 denotes a reagent member, which correspond to the drop portion 2 shown in FIG. 1 and the reagent members 5a, 5b, respectively.
  • the reagent holding member 22 may be formed in a disk shape having a little depth (for example, the thickness of the reagent members 5a, 5b ... shown in FIG. 1B), but at least for optical measurement.
  • Surface area e.g., the surface area of 5a to 5f shown in Fig.
  • a reagent member having an elongated shape for example, a curved shape along the circumference may be formed.
  • the coloring reaction is further promoted.
  • the configuration of the inspection chip is not particularly limited to the above configuration. Deformation is possible. Alternatively, devices described in Japanese Patent Application Laid-Open Nos. Hei 10-204 617, Hei 10-204 6 18, Japanese Patent Laid-Open No. Hei 10-264 19, etc. Can also be used.
  • Reference numeral 30 denotes a rotating means for storing and rotating the test chip 20, and has a concave portion 33 having a shape for mounting the test chip, in which the test chip 20 is stored and fixed. At the same time, a removable configuration is adopted.
  • the concave portion 33 is formed at a position on the rotating plate 34 such that the center thereof corresponds to the center of the dropping portion 21 of the test chip 20.
  • the rotating plate 34 has a disk shape in the figure, but may be appropriately selected depending on the intended use, such as a square shape. Further, the inspection chip 20 and the rotating plate 34 may be of an integral type.
  • 35 is a motor.
  • the motor generates rotational motion by supplying electric power such as direct current or alternating current, and may use a motor capable of digitally controlling the number of rotations, stopping, and the like.
  • the bodily fluid L is dropped on the dropping portion 21 of the inspection chip 20, and the inspection chip 20 is mounted on the concave portion 33 of the rotating plate 34.
  • the motor 35 is driven to rotate the rotating plate 34 and the inspection chip 20.
  • the bodily fluid moves from the dropping part 21 to the reagent holding member 22.
  • the rotation of the motor 35 is stopped before and after the reagent and the body fluid react to form a color, the test chip 20 is removed from the concave portion 33, and the colored reagent member is photographed with a camera, a scanner or the like and analyzed.
  • a camera, optical sensor, etc. can be attached to the bottom of the concave part 3 3 facing the reagent member 22 so that it is possible to easily photograph the colored part without removing the test chip. It is.
  • a body fluid test unit as shown in Fig. 1 was prepared.
  • Six reagent members were arranged concentrically so that a part thereof overlapped the material.
  • Each reagent member has a structure in which the same reagent is applied to two pieces of filter paper # 50 (manufactured by Adpantech) having a diameter of 3 mm and a thickness of 0.15 mm, freeze-dried, and laminated and contacted.
  • a reagent for each component to be measured for glucose (GLU), glucose B_Test Co., Ltd.
  • a contact member which is in contact with a portion capable of holding a living body, a damaged member which is disposed on the contact member and damages the portion capable of holding the living body, and which is capable of holding the damaged member and the living body.
  • a simple and practically painless blood collection device has been realized by a combination of moving means for relatively moving a part and causing contact damage.
  • the portion of the living body that can be pinched includes an earlobe, a fingertip, a state where the skin is picked up, and the like.
  • the contact member according to the present invention indicates a case where the contact member simply touches or a member that sandwiches the contact member.
  • the contact member may be any member that can be fixed to the damaged part and form a damaged environment. .
  • the damage means for damaging a living body disposed on the contact member in the present invention may be, for example, a needle or a blade, but may be any other sharp material such as a sharp glass piece or a ceramic piece.
  • the arrangement on the contact member is, for example, such a state that the damage means is arranged through a space in the living body skin or is not damaged but is arranged, and the damage means is damaged. At this time, it is appropriately selected according to the moving amount, the size of the damage means, and the like.
  • the pinching member according to the present invention has, for example, a structure like a clothespin when the pinching is maintained for a certain time in the earlobe, and a structure like a stapler when the damage work is instantaneously completed. Is shown, but it is not limited to this.
  • the part that can be pinched in the living body is a state in which the living tissue is small in the pinched state, and even if stimulus is given, very little pain is required, and the part can be pinched. Stimulation can sufficiently alleviate the pain experienced by the organism.
  • the thickness is not particularly limited as long as it can be pinched, but a thin portion is preferable.
  • the moving means for relatively moving the damaged member and the pinched portion of the living body to cause contact damage may include, for example, a means provided for colliding the damaged means with a living body, or fixing the damaged means.
  • the living body is lifted by suction and brought into contact with the damaging means to cause damage, the suctioning means, the living body sandwiching portion on the opposite side to the damaging means side to contact and damage the living body and the damaging means, and Movement includes those that show vertical contact with the living body, as well as those in which the damage means moves on the surface of the living body at an angle.
  • the present invention includes a contact member and a damaging means.
  • the contact member the contact member is fixed to one surface of a portion capable of sandwiching a living body by pressing with a hand or the like, sticking, suctioning, or fixing the contact member with a fixture.
  • a structure that can hold a living body such as clothespins or hot foxes, to fix a damaged part and form a favorable damage environment. It is preferable in that it can do things.
  • the damaging means is constituted by a blade, a needle or the like having a sharp portion as described above, which may be plural or singular, and the damaging means is arranged in the touching member, and This is exemplified by an operation in which it moves up or down quickly or slowly and comes into contact with a living body to cause damage.
  • the contact member is fixed in such a manner that it comes into contact with the living body or is held at a certain distance, and the surface of the living body is lifted by suction to damage the contacting means with the damage means.
  • An example is a configuration in which the surface opposite to the living body surface on which the damage means is attached is pushed up to make contact with the damage means.
  • Japanese Utility Model Laid-Open No. 5-63506 is preferably used as a structure for fixing such a damaging means and sucking the periphery thereof.
  • reference numeral 111 denotes a housing, which has a hollow cylindrical shape, and is formed of a lightweight material such as plastic.
  • the upper part of this case is equipped with an adjusting part 1 16 that adjusts the movement of the puncture part 112 toward the skin, and the lower part of the case 111 is used to extend the skin surface. Extension part 1 1 4 is attached.
  • a puncturing portion 112 is connected to the hollow portion via an elastic member 113 such as rubber, panel, or the like. Puncture section 1 1 2 A concave portion 115 for forming a locking relationship with the adjusting portion 116 is formed on a side surface portion.
  • the adjusting portion 116 has a shaft portion 162 formed on the adjusting support portion 161, and a panel portion 163 is mounted on the shaft portion 162.
  • the adjustment support section 16 1 is rotatable about the shaft section 16 2, and the elastic force of the panel section 16 3 is the tip of the adjustment support section 16 1, and the puncture section 1
  • the locking portion 165 which has a locking relationship with the concave portion 1 15 of the module 12, is formed so that a force is applied in the direction of pressing the locking portion 165 toward the puncturing portion 112.
  • Reference numeral 164 denotes an operation unit for performing an external operation, which is turned in the direction of the arrow by applying a little force to this portion.
  • the extension portion 114 is formed of a non-deformable member, and has one end connected to the hollow edge portion of the housing 111 and moves around the center.
  • the extension portion 114 may be at least a rectangular plate-like body, and it is preferable that the other end is provided with a sheet of rubber or the like that increases the coefficient of friction with the skin.
  • a holding member 117 for holding a living body may be provided so as to face the housing 111.
  • the holding device 1 17 has substantially the same area as the housing 1 1 1, and more preferably has a structure that can hold a living body or a structure that allows a certain amount of holding force to be applied. Things.
  • the extension section 114 operates to open toward the living body, and comes into contact with the living skin surface H as shown in FIG. 4B in a state where the living skin surface between the extension sections 114 is extended.
  • the elastic member 113 is in an extended state, and the recessed part 115 of the puncture part 112 and the locking part 165 of the adjusting part 116 are in the locked state as shown in FIG. 1D.
  • the state shown in FIG. 4B may be fixed by hand, fixed by an adhesive applied to the surface of the extension 114, fixed by a fixing band or other fixing device. It may be fixed and fixed, but if the blood collection operation is completed in a short time, holding it in hand may be sufficient.
  • the operation unit 164 of the adjustment unit 116 shown in FIG. 4D is rotated in the direction of the arrow.
  • the locking state between the locking portion 16 5 and the concave portion 1 15 is released, and the elasticity of the elastic member 113 in the extended state allows the puncturing portion 112 to It moves vigorously in the direction of the skin and collides with the skin's body-holding area H (Fig. 4C).
  • the elastic members 1 13 come off the skin and return to the original state as shown in FIG. 4A.
  • the area where the puncture collided is damaged and blood appears.
  • the puncture degree When adjusting the puncture degree, it is adjusted according to the distance moved to the information of the puncture part. The longer the puncture, the greater the degree of collision, the more damage to the skin and the larger the blood collection volume, but the more pain The travel distance is appropriately selected.
  • the holding portion is used to hold the living body holding portion using a holding tool 117.
  • the pinching force stimulates the living body, and the irritation of the stimulus and the damage at the time of injury are offset, so that the pain can be further relieved.
  • Substantial painlessness includes the extent to which blood sampling can be performed at least continuously even if there is a slight tingling stimulus, except for more subjectively felt pain.
  • the blood collecting device of the embodiment shown in FIG. 5 has a shape of a clothespin, and the upper holding portion 201 and the lower holding portion 202 rotate around the shaft portion 204. .
  • the panel section 203 is attached to the shaft section 204, and a pinching force is generated in the direction of the puncture section. It is configured to be conducted.
  • Reference numerals 205 and 206 denote gripping portions. By gripping both of them and applying a force in both directions, a force is applied to both the gripping portions to open the connection between the living body gripping site and the blood collection device. .
  • Reference numeral 207 denotes a puncture portion, which is formed of one or more sharp members.
  • the void 208 is a columnar void.
  • the void 208 forms a gap between the living body and the puncture part 207, and if at least the puncture part 207 does not puncture the living body but is in a contacting position, puncturing is performed. There may be no gap between the part and the living body.
  • Reference numeral 209 denotes a pressing portion, which moves up and down.
  • the panel 210 is disposed in the middle, and the panel 210 is fixed to the end by the convex portion 211 integrally formed with the lower holding portion 202 and moves upward. It has the elasticity to exert the force to return downward.
  • Reference numeral 212 denotes an end of the pressing portion 209, and the surface thereof has a substantially spherical shape. At least this surface is pressed by the pressing member 209 by the collision of the sliding member 213. Any shape can be used as long as it can be pushed up without any holes.
  • Numeral 213 denotes a sliding member, and a hollow groove portion 214 is formed in the middle in the axial direction, and convex portions 215 are arranged on both sides of the hollow groove portion 214 in the middle.
  • FIG. 5B is a view of the sliding member viewed from the bottom surface direction.
  • reference numeral 216 denotes a panel portion which is connected to the sliding member 213 to exhibit elasticity during sliding.
  • 2 17 to 220 indicate release buttons, and an enlarged view thereof is shown in FIG. 5E.
  • Reference numeral 217 denotes a pressing portion, which is a portion pressed by the user.
  • Reference numeral 218 denotes an unlocking portion, which is a portion for releasing the engagement with the convex portion 215.
  • Reference numeral 219 denotes a locking portion, which is a portion having a shape larger than that of the locking release portion 218.
  • Reference numeral 220 denotes a panel portion, and in the figure, the panel portion has a panel shape. More elasticity that returns the moved release button to its original position.
  • a force is applied to the gripping portions 205 and 206 so as to increase the distance between the puncturing portion 206 and the pressing portion 209, sandwiching the living body holding portion H, and releasing the holding portion.
  • the formation of the living body holding portion H indicates the state of the ear lobe or the like when it can be already held, and indicates the state of the abdomen, arm, or the like when the skin is pulled up or pinched by the holding portion. It is formed by
  • a pinching force acts between the puncture part 2007 and the pressing part 209 due to the force of the panel part 203, and the puncture part 207 is fixed to that part.
  • the sliding member 2 13 is slid in the direction of the grip portion 206 in advance. Due to this sliding, the convex portion 2 15, the locking portion 2 15 and the locking portion 2 19 of the release button are engaged, and the panel 2 16 is in a compressed state.
  • the pressing portion 209 has a state in which the end portion 212 protrudes from the lower holding portion 202 (FIG. 5A).
  • the pressing portion 2 17 of the release button is pressed in the upward direction of the grip.
  • the engaging portion 2 15 and the engaging portion 2 19 in the engaged state are moved in the direction of the upper holding portion 201 so that the engaging portion 2 19 is engaged with the position of the convex portion 2 15. Since the engagement state is released by moving from the stop portion 2 19 to the engagement release portion 2 19, the compressed panel 2 16 is released, so that the sliding member 2 13 vigorously It collides with the end portion 2 12, and pushes up the pressing portion 209 toward the upper holding portion.
  • the movement of the pressing portion 209 generates a pressing force on the living body, and the living body punctures the puncturing portion 207 as shown in FIG. 5C.
  • the driving member 2 13 further slides due to the opening force of the panel 2 16, and the end 2 12 of the pressing portion 2 09 reaches the hollow groove 2 14.
  • the pressing part 209 is momentarily returned to its original position, and the puncturing part 207 is separated from the skin as shown in Fig. 5D, and the damaged area of the skin is released, and blood is released. Appears.
  • the pressing and puncturing of the pressing portion is performed by the sliding force of the sliding member.
  • this pressing force may be replaced with air pressure.
  • reference numeral 221 denotes an air pressure output unit, which has a configuration in which air pressure from an externally provided air pressure storage unit 223 is connected by a conduit via an on-off valve 222.
  • the pneumatic storage section 223 is composed of a pump and a simple compressed air cylinder.
  • the on-off valve 222 is opened, the compressed air is transmitted to the pneumatic output section 221 to press the sandwiched living body part. By this pressing, the living body comes into contact with the puncture section 207 (punctured portion in FIG. 6).
  • the on-off valve 222 is closed and the air pressure of the air pressure output part 222 is released to the outside, the pressing force on the living body holding part is released, and blood comes out from the damaged part of the skin and blood is collected.
  • reference numeral 401 denotes an upper pressing body, which is connected to the lower pressing body 403 and the intermediate body 402 around the shaft section 404, and each of which rotates around the shaft section 404. It is possible to move.
  • the upper pressing body 401 has a U-shape that is open downward
  • the intermediate body 402 has a U-shape that is open upward.
  • Each has a flat plate shape, and each has a rectangular shape when viewed from above.
  • Reference numerals 405 and 406 denote panels.
  • the panel 405 connects the upper pressing body 401 and the intermediate body 402 to give elasticity when pressed.
  • Pa Ne 406 connects the lower pressing body 403 and the intermediate body 402 to give elasticity when pressed.
  • Reference numeral 407 denotes a sliding member, to which the upper pressing body 401 is connected by a support rod 408.
  • the sliding member 407 slides left and right in the longitudinal direction when the support rod 408 opens and closes between the upper pressing body 410 and the intermediate body 402 on the intermediate body 402. .
  • Figure 7C shows an enlarged view of the area around the damage support.
  • Reference numeral 409 denotes a damage support portion, which is formed in a cylindrical shape, and whose upper side surface 410 is arranged so as to slightly protrude from the intermediate body 402, and a sliding member 407 is provided on the upper side surface 41.
  • the damage support portion 409 rotates in the C1 direction about the axis 4111.
  • a sharp edge-shaped damage portion 412 is attached, and the damage portion 4122 rotates in conjunction with the rotation of the damage support portion 409.
  • a panel 4 13 is arranged on the shaft 4 1 1. The panel 4 13 is mounted such that when the damaged support 4 11 rotates, it is compressed and a repulsive force is formed such that it rotates in the opposite direction (C 2).
  • the living body holding portion H is sandwiched between the intermediate body 402 and the lower holding body 403, and the upper pressing body 401 and the lower holding body 403 are gripped to apply a pressing force in both directions.
  • the upper holding body 401, the intermediate body 402, and the lower holding body 400 move in the overlapping direction, and the panels 405 and 406 arranged between them are compressed, and the support rods 40 8 moves the sliding member 40.7 toward the damaged support.
  • the sliding member 407 rotates the damaged support portion 409 (C 1), and the panel 413 is compressed and the damaged portion 412 rotates to damage the skin (FIG. 7B). .
  • Damaged support 4 0 9 is a panel 4 1 It rotates in the opposite direction (C 2) with the repulsive force of 3 and returns to the state shown in Fig. 7A. Blood is extracted from the area of skin damage caused by the injury, and blood is collected. With such a configuration, it is possible to easily collect blood in a work such as when using a stapler, and it is possible to reduce and eliminate pain due to pressing of the living body holding portion and shortening of the damage process.
  • the present invention can also show a configuration in which a member adapted to a once damaged portion is always placed on the damaged portion, and if necessary, the body fluid is collected by suctioning the sample.
  • reference numeral 501 denotes a holding body, which connects two holding side surfaces while having elasticity via a connecting portion 505, for example, by continuously holding the earlobe H. Is done.
  • Reference numeral 502 denotes a hollow body, and the lid 503 is arranged in the hollow so as to be movable up and down. The vertical movement of the lid portion 503 may be performed manually or automatically by using an elastic member such as a motor or a panel. The lid 503 is inserted into the damaged portion once and used so as to maintain the inserted state continuously. Therefore, its surface or its material is formed of a biocompatible material. I have.
  • This may be formed, for example, from a titanium material, or from a calcium phosphate compound such as hide mouth xiapatite or tricalcium phosphate.
  • the lid portion 503 may be formed in a blade shape or a needle shape and having a damaging ability for a living body.
  • Reference numeral 504 denotes a blood sampling unit, from which blood is taken out to the outside via a porous material impregnated with blood and a capillary tube.
  • the lid portion 503 also serves as a damaged portion, the ear lobe or the like is sandwiched between the holding members 501, and the lid portion 503 is pressed against the living body to be damaged.
  • Lift the lid 503 (503 U).
  • the blood that has emerged from the damaged part is moved upward in the lifted lid 503
  • the expression is promoted by the suction force.
  • a capillary for blood collection and an impregnating material are introduced and collected.
  • the lid 503 is lowered. When blood is collected again, it is performed by raising the sandal part, and blood can be continuously collected from the same site while being attached to the earlobe.
  • a biocompatible member is used for the lid, but a member that does not adhere to the living body, for example, titanium is preferable.
  • the simple and substantially painless expression and collection of blood can be performed by proposing a combination configuration in which blood is collected at a site where a living body can be clamped. It has the effect that it can be performed.
  • the present embodiment relates to an apparatus for collecting a bodily fluid exudate.
  • it is common to collect blood and test its blood components, but blood collection is performed by piercing the needle to some extent deeply, and it is painful. Due to the associated damage, blood is not easily collected unless necessary.
  • This method discloses a configuration in which the body fluid is collected by aspirating the surface of a living skin, but requires several tens of treatments with an adhesive tape or the like in order to remove the stratum corneum, which is a plya layer. And it takes effort is there.
  • This device realizes obtaining exudate bodily fluid by a simple operation with a combination structure consisting of a damage member that damages a shallow part of the surface of the living skin, and a suction unit that suctions the damaged part after the damage member is damaged. did.
  • this device vibrates or rotates abrasives such as paper files, short needles, short blades, etc., and abuts the skin, causing slight damage to the stratum corneum and part of the epidermis, Extraction of the exuded bodily fluid was easily achieved by aspirating the site.
  • Damaged members in this device are, for example, for abrasives, particle size
  • suction unit in the present apparatus examples include a mechanical suction unit such as a suction electromagnetic pump and a physical suction unit such as a molecular sieve.
  • the extent of suction is exemplified by the range shown in the above-mentioned known paper. However, in this device, the damage to the stratum corneum is more efficient, and the damage may be less than that. In some cases, the above-mentioned known papers may be used.
  • This device first creates an environment in which exudate bodily fluids can be extracted by moderate damage to the stratum corneum, and then promotes exudation by suction.
  • Moderate damage to the stratum corneum can be obtained by vibrating or rotating each of the fine abrasives, needles, blades, or a combination thereof, and bringing them into contact with the skin surface in that state.
  • the degree of contact damage is originally about a few tens of microns in the stratum corneum, so contact damage should be performed at such a depth.However, from the viewpoint of promoting bodily fluid leaching, further modification is required. In addition, contact damage may be performed at a depth of about several tens of microns.
  • the thickness of the stratum corneum differs in each part of the human body, and the amount of bodily fluid exudation also differs in various parts of the living body.
  • the contact damage time may be as short as several seconds, but it is also appropriately selected depending on the body part, the amount of the detected body fluid, and the like.
  • FIG. 9A and 9B show an embodiment of the present apparatus, which will be described in detail.
  • FIG. 9A is a side view showing a cross section of a side surface of the present apparatus
  • FIG. 9B is a view showing a surface of a carrier to which an abrasive is attached, that is, a bottom surface.
  • the disk-shaped carrier 611 is provided with the abrasive selected from the above, or the damaging means 614 made of fine needles and blades having a height of about several millimeters, and further suctioning.
  • a plurality of suction ports 613B and suction grooves 613A are provided.
  • the surface area of the carrier 611 is selectively used depending on several mm 2 or more, an adaptation site, a sampling amount, and the like.
  • the suction port 6 1 3 B is provided with a conduction path 6 13 for suction inside the carrier 6 1 1, and all the conduits 6 1 2 are connected at the suction connection end 6 1 5, and the suction opening and closing valve 6 1 7 It is connected to the suction device 6 18 via.
  • Reference numeral 619 denotes a force-par member, which has a concave shape with respect to the skin and has a structure that seals the space containing the carrier 611 when coming into contact with the skin.
  • the suction groove 6 13 A is used to form a suction path for sucking bodily fluid at the periphery of the carrier without forming a conduction path 6 13 inside the carrier, and a suction port 6 13 It has a role to connect with B and increase the suction efficiency of the carrier surface.
  • suction port 6 13 B and the suction groove 6 13 A may be provided.In order to suction the surface of the carrier, it is preferable that the suction area is large. Selected. Furthermore, with suction port 6 1 3 B The suction groove 6 13 A may be used effectively when the exuded bodily fluid is retained by utilizing its capillary action. That is, the bodily fluid that has been expressed by suction is held in contact with each suction port and suction groove, and then immersed in a buffer solution in this state. This is because the detection may be completed.
  • the driving means 6 16 is a driving means.
  • the driving means 6 16 has a configuration for generating a driving force such as vibration and rotation of the carrier 6 11.
  • a driving force such as vibration and rotation of the carrier 6 11.
  • the driving means 6 16 may be other than such an electric means, and may use, for example, a compression instantaneous force of a panel such as a mainspring, a panel panel, and a coil spring.
  • the drive means may be moved manually.
  • the frequency may be higher than that of ultrasonic waves, in which case less damaging and damaging actions can be obtained.
  • Reference numeral 620 denotes a connecting portion for transmitting the driving force generated by the driving means 6 16 to the carrier 6 11.
  • the drive means 6 16 is driven by bringing the carrier's abrasive 614 attached surface into contact with the living skin H.
  • the driving means 6 16 vibrates or rotates with respect to the skin, for example, in the range of vibration directions A to C.
  • the vibration in the direction A is a longitudinal vibration to the living body.
  • a needle may be appropriate as a damaging means, but other than that, even abrasives can sufficiently damage the living body.
  • the vibration in the direction B vibrates in parallel to the living body.In this case, the blade may be appropriate as a damaging means. B may be preferred in some cases.
  • C indicates the direction of rotation, and the number of rotations and the direction of rotation are arbitrary, The higher the number of rotations, the more preferable it is that the amount of stimulation to the living body can be suppressed.
  • the damage means one coated with an abrasive is preferably used. This vibration or rotation is transmitted to the carrier 6 11 and damages the skin H. Thereafter, the suction device 618 is activated, and the skin is sucked from the suction port 613B or the suction groove 613A. The suction time is determined by the amount of bodily fluid exuded, the amount to be collected, and the detection site.
  • the suction time is, for example, several seconds to several tens of minutes, but is not particularly limited.
  • the body fluid exposed at the damaged part may be collected by suctioning with another suction tool or by holding it in the suction port 613B or suction groove 613A.
  • the skin When the skin is damaged, the skin may be sucked in advance or may be sucked in the course of the damage, and the body fluid can be obtained more quickly by sucking in advance during the course of the damage. .
  • the present device can damage the skin more quickly and effectively by stretching the surface of the living skin when polishing or aspirating the skin.
  • reference numeral 621 denotes an extension portion, on which a member having a high friction coefficient such as an adhesive or rubber is disposed on a contact surface with a living body.
  • Reference numeral 622 denotes a connecting portion for connecting the force par member 6 19 to the extension portion 6 21.
  • the connecting portion 62 2 is configured to operate so as to open outward of the carrier 6 11 1 and lock in that state. That is, when attaching the carrier to the living body, the extension part 62 1 is attached to the living body, and in this state, the carrier is pushed toward the living body, whereby the connecting part 62 2 moves outward, With the outward movement, the skin is also stretched, and when the connecting portion 62 is locked in that state, the skin is also stretched.
  • FIG. 11 Another embodiment of the present apparatus is shown in FIG. 11 and described.
  • 631 is a porous carrier, which is made of ceramics, metal, wood, or the like, the surface of which is composed of a large number of holes, and has an overall fine uneven shape.
  • the size of the porous aperture should be large when aspirating through the porous carrier 631, and smaller when maintaining the exposed body fluid. It may be preferable to do so. Further, an abrasive may be attached to the surface.
  • Reference numeral 632 denotes a suction port, and here, a configuration in which suction is performed via the carrier 631 is shown.
  • Reference numeral 633 denotes a cover member, which is formed by a concave member opened toward the skin and has a structure for forming a closed structure for efficiently sucking the periphery including the carrier.
  • Reference numeral 634 denotes a driving unit, which has the same configuration as the driving unit 6 16 shown in FIG.
  • Reference numeral 635 denotes a connecting portion, which has a configuration for transmitting the driving force of the driving means 634 to the carrier 631.
  • Reference numeral 636 denotes an on-off valve for starting and stopping the suction operation.
  • 6 3 7 is a suction means. It has the configuration as described above.
  • Reference numeral 638 denotes a conduit for connecting the suction means 637, the on-off valve 636, and the suction port 632.
  • the carrier 631 is attached to the surface of the living skin. If it is a hand-held type, it is attached by hand with a hand, and it is also attached with a fixed band.In some cases, it is adhered together with the adhesive material applied to the contact surface between the force member 633 and the living body Configurations are also possible. In this state, the driving means 634 is driven. The carrier 631 vibrates or rotates based on the driving force of the driving means 634, and damages the stratum corneum on the skin surface.
  • the suction means 637 is driven, the on-off valve 636 is opened, and the skin is sucked through the carrier 632.
  • the leached bodily fluid is filled with voids in the porous material.
  • the carrier 632 is immersed in a buffer for dilution if necessary, so that the bodily fluid is released from the carrier 632.
  • FIG. 12 shows another embodiment.
  • Reference numeral 641 denotes a carrier, which is provided with a concave portion in the center, and is preferably made of a deformable member such as rubber, and has a damaged portion around which an abrasive, a needle, a blade or the like is attached. 2 are formed, and a plurality of suction grooves 643 are provided in a part thereof. The suction groove 643 extends around the carrier 641, and a passage 644 is formed.
  • Numeral 645 is a driving means for exerting a driving force for vibrating and rotating the carrier 641.
  • Reference numeral 646 denotes a force par member which is open toward the living body, and has a configuration for being in contact with the living body to seal the space containing the carrier and to effectively apply a suction force.
  • Reference numeral 647 denotes a suction port for connecting to an external suction means (not shown).
  • the external suction means those shown in FIGS. 9 and 10 are referred to.
  • the carrier 641 is brought into contact with the surface of the living skin.
  • the force-par member 6 4 6 is also brought into contact with the surface of the living skin to form a closed space.
  • the concave portion 641 'of the carrier has a function of sucking a living body with the deformation of the carrier itself at the time of contact. With this suction force, concentration of body fluid can be promoted.
  • the driving means 645 is driven, the carrier 641 is driven, and the living skin is damaged by the damaged portion 642.
  • the suction means is operated, and the portion immediately below the damaged portion 642 is sucked through the suction groove 6443. By this suction, the exposed body fluid is held in the suction groove 643. In that state, stop suction.
  • the body fluid held in the suction groove 6 To be collected. In this case, it is preferable because the configuration of the suction groove 644 to the carrier can be simplified.
  • FIG. 1 Another embodiment is shown in FIG. 1
  • reference numeral 651 denotes a carrier, which has a triangular pyramid configuration.
  • a suction port 653 is provided at the center of the tip of the carrier 651, and a damaged portion 652 is formed around the suction port 653.
  • the suction port 653 is connected to the suction path 654, and is connected to an opening / closing valve and suction means (not shown).
  • Reference numeral 655 denotes a driving means, which is exemplified by a driving means for electrically or mechanically or manually driving the driving force as described above, but may also have a suction means in some cases.
  • Reference numeral 656 denotes a grip portion, which is provided mainly for being used by hand.
  • Driving means 65 5 is driven.
  • the driving means 6555 operates, for example, to rotate the carrier 654 in parallel with the living body.
  • the suction means is driven to suck the living body from the suction port 653.
  • the suction port may hold the bodily fluid in some cases.
  • the present embodiment has a configuration in which the area to be damaged can be reduced, and the body fluid can be collected more easily.
  • FIG. 14A is a perspective view
  • FIG. 14B is a side view
  • reference numeral 661 denotes a force par member having a shape having an opening 666 on a contact surface with a living body, and showing an electric razor-like configuration.
  • the shape of the opening 666 is exemplified by one or more rectangular shapes and circular shapes.
  • Reference numeral 662 denotes a carrier, which operates so as to rotate in the vertical direction with respect to the living body around the shaft 665.
  • Carrier 6 6 2 Partially spiral
  • the blade body 6 64 having a simple configuration is mounted. This blade body 664 is composed of one or more. '
  • Reference numeral 666 denotes a motor, which transmits the rotation to the carrier 662 via a transmission member 667.
  • the motor 666 is merely an example, and when continuous rotation is not required, a configuration using an instantaneous force of a mainspring, a spring coil, a plate panel, or the like, or a manual drive may be used.
  • Reference numeral 666 denotes an on-off valve, which is connected to the suction means 669 to suck a living body from the opening 666 at the time of opening.
  • a suction unit 669 and a driving unit 663 such as a motor may be integrally provided, and the whole may be configured as an electric razor.
  • the opening 666 of the force-par member 661 is brought into contact with the skin surface H of the living body.
  • the motor 663 is driven to rotate the carrier 662.
  • Blade 664 damages the skin surface slightly projecting from opening 666.
  • the amount of force applied during this abutment controls the degree of damage.
  • the suction means is driven, the on-off valve 668 is opened, the skin is sucked through the opening 666, and the body fluid is exposed.
  • the exposed body fluid is collected with a suction device such as a spot.
  • the present embodiment is mainly of a hand-held type, but can be used in such a manner as to use an electric razor, so that simple use is possible.
  • the body fluid sampling device does not need to cause deep damage to the living body such as blood sampling, and can be used repeatedly and can collect sufficient body fluid to obtain biological information. It has effects such as:
  • an information forming means for forming in-vivo information a means for embedding and transmitting body fluid component information digitized by the information forming means on a transmission medium, and a diagnostic process for restoring the transmitted body fluid component information
  • the present invention proposes a body fluid testing system including means for returning the diagnostic information to the transmission source.
  • information that can diagnose a health condition or various diseases from the body fluid component by, for example, collecting a body fluid.
  • by transmitting the detected information to a doctor or a medical institution capable of diagnosing, accurate and accurate in-vivo information can be easily obtained.
  • the in-vivo information mainly refers to the collected bodily fluids, their bodily fluid components, and non-invasive but not collected It shows the body fluid components obtained from the attack, but also shows information obtained from the living body such as electrocardiogram, heart rate, body temperature, etc., and a combination of these, and is collected or detected as appropriate as necessary Things.
  • the body fluid include blood, sweat, urine, semen and the like, but any fluid excreted from a living body may be used without having a liquid property directly.
  • Informatization for example, means that components in body fluids are separated and extracted and converted into data.
  • the means for separation and extraction is a special method that removes unnecessary substances from collected body fluids. Filter paper may be used, and such a filtration step may not be necessary depending on the state of the measuring device.
  • Tongue-out refers to a state in which visual, audible, and tactile information on the target component can be obtained.
  • a reagent impregnated with a reagent that develops or changes color in response to individual components of bodily fluids A case is shown in which paper is impregnated with a bodily fluid or a separated liquid that has been subjected to a specific separation from a bodily fluid, and the reaction shows a pattern that can be optically inspected such as color.
  • the reaction appears as a pattern, a state in which a sound with a specific wavelength is repeatedly output, and a state in which the surface is undulated depending on the component amount.
  • a specific light source may be irradiated to the body fluid sample, and the reflected return light may be in the form of a photoelectrically converted analog signal.
  • diagnosis cannot be performed on the spot, but such conversion processing may be included in the extraction as long as the data is appropriate for transmission to the organization that processes the diagnosis.
  • the data is, for example, data that can be carried on a transmission medium, and may be represented by numerical data or encoded data. This indicates, for example, an electronic, optical, ultrasonic, sonic, magnetic, or electromagnetic signal that can be digitally or analogly modulated, but can be transmitted to at least a diagnostic processing institution. Anything is fine.
  • the transmission medium for ⁇ embedding and transmitting on the transmission medium '' in the ⁇ means for embedding and transmitting the body fluid component information digitized by the information conversion means on the transmission medium '' includes, for example, radio waves, infrared rays, ultrasonic waves, Embedding means, for example, amplitude, frequency, or digital modulation, such as sound waves and electricity, and should be at least reproducible on the transmission medium.
  • "means for restoring the transmitted body fluid component information for diagnosis and returning the diagnostic information to the transmission source, restoring the transmitted body fluid component information for diagnostic processing” indicates mainly a doctor, hospital, or institution that can make a diagnosis, and if it is a healthy person, a public service organization or a private service organization may further function as the receiver.
  • Reconstruction refers to, for example, a signal obtained by demodulating a modulated signal. If the transmitted data is in the state of an electric signal including spectrum information, it is analyzed and converted into desired data. May be shown.
  • Diagnosis processing is processing to derive judgment information within a range that can be known, such as judgment of the presence or absence of disease, judgment of the amount of drug solution to be administered, judgment of the presence or absence of drug solution administration, etc. This includes diagnosis by numerical data processing, diagnosis by numerical processing of data, or processing of further transmitting to a specialized organization to receive comments on the transmitted information and summing up the information.
  • the term "reply" in this system indicates that at least the diagnostic data or diagnostic-related data is transmitted to the sender, and the same communication medium as that used for transmission is used. If so, it may indicate that the information will be sent to the user via another medium that is available even at the destination, and the content of the reply will be returned to the sender again as information that is likely to be related to internal information
  • the transmission of the message may be a request from a user. If you can go to a hospital, such as a hospital, your doctor or ad pie The action that the user visits and explains directly to the user may be included in the “reply”.
  • FIG. 15 is a diagram showing an embodiment of the main body liquid inspection system.
  • reference numeral 710 denotes a body fluid adjusting unit, which is a simple body fluid test unit shown in FIGS. 1 and 2 or, for example, Japanese Patent Application Laid-Open Nos. — Blood is diluted and developed as needed, as described in JP-A-2004-204, JP-A-10-204, 199, and blood cells are filtered between them.
  • a configuration is shown in which color is supplied by supplying to a plurality of reagent layers.
  • the reagent layer is where individual optical information is displayed, depending on the components and amounts reached. This is merely an example, and may be, for example, magnetic information or other information, whether invasive or non-invasive, rather than optical. It is sufficient that the type and amount of the components can be read from the surface of at least the reading section 71 1 at the subsequent stage.
  • Reference numeral 711 denotes a reading unit, which only needs to be able to read the information obtained by the above-mentioned body fluid adjusting unit 7110.
  • a CCD camera, a photographic film, an image scanner, etc. and if measuring absorbance, irradiate a coherent light such as a laser or infrared light to capture the screen or the reflected or transmitted light.
  • An example of obtaining a spectrum distribution and converting it to an electric signal is exemplified.
  • the state to be converted is determined at least by the processing form of the subsequent processing unit 712.
  • the processing unit 712 is a combi- ter
  • the reading unit 711 has a function of converting into a digital electric signal such as an AD converter.
  • Reference numeral 712 denotes a processing unit, which is constituted by a computer or the like.
  • the data obtained by the reading unit 711 is processed simply or in detail, and The value is calculated and converted into data suitable for transmission to the subsequent central processing unit 7 16.
  • Appropriate data is, for example, information to which data such as the patient's name, age, and symptoms are added.
  • Reference numeral 713 denotes a display / storage unit, which includes a monitor display, a hard disk, and the like, and displays data processed by the processing unit 712, and temporarily or permanently records the data. .
  • Reference numerals 714 and 718 denote transmission / reception units, each of which includes a modem, a TA, a mobile phone, a laser, a light emitting diode, an ultrasonic transducer, and the like, is appropriately configured by a transmission medium, and has a modulation and demodulation function. are doing.
  • Reference numeral 715 denotes a transmission medium, which indicates a wired form or a wireless form such as a telephone line, an optical fiber, an electric wave, an ultrasonic wave, an infrared ray, etc., and is appropriately selected in that situation.
  • Reference numeral 716 denotes a central processing unit, which processes the data transmitted from the processing unit 7 12 into data that can be diagnosed, and can diagnose data that cannot be diagnosed by the central processing unit 7 16 This is a part for composing data to be transmitted to the processing unit, and is converted into data that can be stored in the storage unit 171 divided according to each processing unit.
  • Reference numeral 177 denotes a storage unit, which separates data sent from each processing unit and records the data temporarily or permanently.
  • the configuration from the reading section 7 11 1 to the transmission / reception section 7 14 is referred to as a user terminal 700, and the configuration after the transmission / reception section 7 18 as a diagnostic terminal 7 01 .
  • Blood L obtained from a fingertip or the like is dropped into body fluid adjusting section 710 in a diluted state as necessary. After the blood cells are separated, the reagent is allowed to react and the color is developed.
  • the reading unit 711 captures the type of color development and shading using an image scanner, CCD camera, etc.
  • the signal is converted into a digital signal, converted to a digital signal, and output to the processing unit 712 as basic data.
  • the processing unit 712 compares the basic data with template data comprising a relationship between the color, shading and component amount provided in advance, and displays the simplified diagnostic data on the monitor of the display recording unit 713.
  • the date, time, weather, interrogative health status, and other preliminary information are stored together on the recording medium.
  • the processing section 712 outputs the basic data to the transmission / reception section 714, and outputs the modulated data.
  • the processing section 712 may not perform a simple diagnosis.
  • the data to be sent takes a long time or when it is necessary to send and receive data faster, it is possible to pick up only the main part of the data and send it, or perform so-called data compression. It is more preferable to send it in a compact form.
  • the selection of the main part is mainly made by arbitrarily or automatically selecting a place where the reaction is sufficiently performed.
  • known methods such as JPEG, LZW, and LHA are suitably used.
  • the diagnostic terminal 701 receives the transmitted data, demodulates the data, and inputs the demodulated data to the central processing unit 716.
  • the central processing unit 716 possesses various template data in advance, analyzes the basic data by various methods based on the template data, diagnoses the data, and displays the data on a monitor. Diagnostic data is created automatically, or doctors and advisors create diagnostic data based on data displayed on a monitor. It is recorded in the recording unit 717 together with the transmitted data, the accompanying data and the diagnostic data.
  • the data recorded in this recording section 7 17 is used as reference data for the next diagnosis. Used to diagnose patient trends and conditions. Further, the data created by the diagnosis is transmitted to the user terminal 700 that is the transmission source.
  • the data is transmitted from the diagnostic terminal 8 11 to other specialized diagnostic terminals 8 12 to 8 15 as shown in Fig. 16, Therefore, they may obtain specialized information.
  • the reading unit 711 in FIG. 15 indicates a small CCD camera and image scanner, and the processing unit 712
  • the storage display unit 713 and the transmission / reception unit 714 constitute a mobile phone. This is shown, for example, by the combination of the reading section 9 14 and the mobile phone 9 17 in FIG. Note that mobile phones naturally include PHS, iridium and the like. Further, the reading unit 711 is more preferable because a CCD camera or the like mounted on a mobile phone has unity and portability.
  • the color developing state of the body fluid component to be measured is read by the reading unit 7111 by the body fluid adjusting unit 7110. Displays the surface image of the reagent part of the body fluid adjustment unit that was read and, when sending data as it is, the ability to send it as is, or when there is a large amount of data, visually select the part that needs to be sent Or automatically select a predetermined site in the image, or automatically select a site effective for diagnosis in the image, and perform compression and compression as necessary.
  • the transmitted data is transmitted.
  • the coloration state is compared with the built-in coloration state and template data indicating a numerical relationship, and the numerical value corresponding to the matching coloration state is displayed.
  • Template If the template data cannot be stored, an external storage device that stores the template data may be further connected, or the template table may be sequentially read, and the match / mismatch may be compared by the processing unit 7 12 in the mobile phone. .
  • the means of using the template data is merely an example, and a diagnosis algorithm in another device may be applied.
  • the data processed as described above is transmitted from the processing unit 7 12 to the transmission / reception unit 7 14. It is transmitted to the diagnostic terminal 701 via the radio wave medium 715 via the radio communication medium 715.
  • the diagnostic terminal 700 performs the above-described diagnostic processing on the transmitted data, and returns the result to the user terminal 700. At this time, if the user terminal 700 cannot receive it, for example, using an Internet mail server, it is temporarily stored there, or the voice mail function is carried in the same state as voice. It may be recorded temporarily inside the phone.
  • the format of the returned data may be audio only, image only, or both.
  • a mobile phone As a user terminal in this way, it can be suitably used by elderly people, people with physical disabilities, and people who do not know computers. It should be noted that this may be an ordinary wired phone instead of a mobile phone, and in particular, since the phone diagnostic data combined with the fax is displayed on paper, the data is sent to the user in an easy-to-understand manner, which is preferable. It is. Alternatively, for a telephone with an LCD, the user can easily understand it by displaying it on the LCD.
  • the diagnostic data may be output by digital synthesized voice, and in this case, the transmission data capacity can be reduced.
  • a mail server is preferably used from an economical point of view. That is, the user terminal uses his or her basic data Into a file and send it to the e-mail address corresponding to the diagnostic terminal. The diagnostic terminal opens this e-mail and diagnoses it, then attaches the diagnostic data to the e-mail and sends it to the user terminal. The user terminal arbitrarily opens this e-mail and obtains the diagnosis result.
  • the e-mail is restricted by the information unique to the user terminal and the diagnostic terminal, and it is preferable that only the both can be opened.
  • a publicly known encryption means for that purpose may be incorporated. If an interview is required, a TV function, a telephone function, a chat function, and other direct communication means used on the Internet will be used.
  • the Internet it is preferable to use the Internet as a transmission medium and to connect directly to a diagnostic terminal via a telephone line. That is, they are used alternately, and general-purpose information that may be leaked or seen by others is connected via the Internet, and private information is connected using a dedicated line. By doing so, complicated operations such as encryption can be avoided.
  • the user or the patient may perform the processing until the body fluid is provided, and the other processing may be performed by remote control of a diagnostic institution.
  • the computer must be in a state where the remote computer can be operated by remote access between the same protocols such as TCP 7 IP, Net BEUI, SPX / IPX, etc. Processing, acquisition, analysis, etc. may be performed by an arbitrary operation of an external diagnostic processing organization.
  • the burden on the user side is reduced, and the diagnostic processing institution can obtain only necessary and accurate data in order to make an accurate diagnosis. It is possible to have a role like a doctor.
  • diagnostic processing institutions use the Internet on a per-user basis.
  • homepage-type data that can be used, and by accessing the homepage-type data, users can arbitrarily read existing data, expert comments, and advice.
  • Such homepage-type personal data can be used on the Internet if the data is protected.
  • dial-up is done to the provider and the basic data is transferred in various formats.
  • the Internet line is cut off and dial-up to the telephone number of the diagnostic terminal to send the personal data. After transmission is complete, block dial-up.
  • the format of the personal data to be transmitted is, for example, one data in a state where a delimiter is attached by a code such as personal information and basic data information, and a specific folder (directory) is specified. Formats such as a basic data file and a personal information data file with names (for example, basic data should be a file prefixed with b and a personal information data folder prefixed with P).
  • this system uses a mobile phone or digital satellite Stable users in emergency situations by further combining Levi broadcasting
  • the connection between the terminal and the diagnostic terminal can be secured.
  • a mobile phone using a communication satellite for example, an iridium type mobile phone, connects to a specific Internet provider.
  • a Web connection such as the Internet is more stable than a telephone line.
  • the diagnostic terminal may diagnose the basic data and transmit the resulting file or message to the other party using a public satellite digital television line. It is preferable that the data unique to the user terminal is transmitted in a file format, but it may be sufficient to display it directly in an emergency in case of emergency.
  • reliable data transmission / reception may be achieved by simultaneously transmitting data to usable media.
  • FIG. 17 is a diagram showing another embodiment of the present system.
  • Reference numeral 911 denotes a blood separation / development unit, in which a blood dropping unit 913 is formed in the center, and a plurality of reagent units 912 for forming color by contact with various blood components are formed around the blood dropping unit 913.
  • a blood dropping unit 913 is formed in the center, and a plurality of reagent units 912 for forming color by contact with various blood components are formed around the blood dropping unit 913.
  • Reference numeral 914 denotes a reading section, which is a section for reading the displayed coloring information and converting it into electrical information in the blood cell separation and development section 911.
  • the terminal 915 is a terminal on the patient and user side.
  • the terminal 915 indicates a general-purpose personal computer, a digital television, or the like in the figure, but is not limited thereto, and may be a general-purpose mobile terminal such as a PDA, a notebook computer, a mobile phone, or the like. It may be a dedicated terminal having only a specific function.
  • 916A and 916B are imaging devices that allow doctors, advisors, and other specialists, patients, and users to send and receive data and perform medical interviews, etc., via computer monitors, televisions, etc. Although the imaging equipment is not particularly necessary, it can be an effective element at the time of diagnosis by having the imaging equipment.
  • Reference numeral 917 denotes a wireless output means, which is the same as the terminal 915 described above, and also for outputting data by radio waves.
  • Reference numeral 918 denotes a connection mediation unit, which is a connection provider such as a provider, and is mainly used to connect the terminal 915 to the network 923.
  • the connection mediation unit 918 mainly connects a wired line or a wireless line to the network.
  • Reference numeral 919 denotes a connection intermediary unit, which is a connection provider such as a provider, which mainly has a function of connecting a mobile phone or the like to the network 923.
  • Reference numeral 920 denotes a center, which is an institution and site for receiving data from other terminals such as the terminal 915, diagnosing based on the received data, creating diagnostic data, storing and returning the diagnostic data.
  • the center 920 may be connected to another center having more specialized knowledge, and may also serve as any or all of the connection mediating sections 918, 919, 923 .
  • the center is operated with the authority of the user.
  • the right in this case is at least the right to manipulate your information, and according to this right
  • the third party such as a data center, cannot obtain data without the consent of the user, or cannot decrypt the data by encrypting it, and the following centers are formed even when the center goes bankrupt or disappears. Secure the safekeeping of information until
  • Reference numeral 22 denotes a network, which indicates a general-purpose two-way communication network such as the Internet, a local network such as a LAN, and the like, which can perform bidirectional information communication regardless of wired or wireless. You should.
  • connection mediation unit 923 denotes a connection mediation unit, which is mainly for connecting the center 920 with the network 9222.
  • the connection mediation unit 923 represents a unit that connects a wired line or a wireless line to a network. Next, the operation will be described.
  • the body fluid is dropped into the dropping section 913 of the blood decomposition developing section 911.
  • the dropped bodily fluid reaches the reagent section 912 while separating unnecessary components and reacts with the reagent to develop color.
  • the color is introduced into the reading section 914, where a change caused by the reagent section 912 is detected and converted into data.
  • Examples of the data include data before analysis such as blood glucose level and the like, which can be understood by immediate numerical visual observation, spectrum data, infrared absorption spectrum data, CCD image data, and the like.
  • the data is taken into, for example, the terminal 915 and automatically diagnosed based on a pre-recorded diagnostic criterion, stored in a storage medium, displayed on a monitor, and in the case of the Internet,
  • the data is converted into data that can be read by users, such as bitmaps and text status, as so-called attachment files for transmission mails, transmission files, etc.
  • it is transmitted via a dedicated line or telephone line 93C, a connection intermediary unit 918, a network 9222, a connection intermediary unit 923, via a dedicated line or telephone line.
  • the transmission from the terminal 915 to the center 920 is routed by mail, etc. using the floppy disk 93A, a wired telephone circuit such as a television telephone, or a wireless telephone such as a mobile telephone.
  • a direct communication route using a line, a general-purpose telephone line or a dedicated line 9.3 B without using the connection mediation section 918, or a cell phone 917 that may be transmitted using the center 920 Based on this data, a diagnosis is made, or if the transmitted data is diagnostic data, a more specialized diagnosis is performed together with other information, and the diagnosis result data is transmitted to the terminal 915.
  • the above-mentioned route is appropriately used to store and reply in some cases.
  • the center 920 communicates directly with the terminal 915 via the mobile phone 917, the wired phone 933B, and other telephone functions using voice or the photographing device 916 to conduct an interview. Obtain more detailed data and perform a re-diagnosis, or explain precautions directly.
  • this system uses the terminal 915 having such a tabletop property, and transmits the data obtained by the reading section 914 to the center 920 using the mobile phone 917. In some cases. In this case, the burden on the patient may be reduced because the desktop terminal is not used.
  • the body fluid component data and the like transmitted to the mobile phone 917 are temporarily stored therein as a file, and then transmitted to the center 920 (93E). If it is larger, the input component data may be transmitted to the center 920 sequentially.
  • the data transmitted by the mobile phone 917 is transmitted to the connection mediation unit 911 and transmitted to the center 920 via the general-purpose network 922.
  • An example is the Internet using mobile phones such as the so-called I-mode (trademark).
  • the communication intermediary unit 921 Via the communication intermediary unit 921, it is preferably used in places where there is no wired communication means, no relay means for mobile phones, or in an unusable state, etc., and is suitably used for elderly people in depopulated areas.
  • the center 920 provides the home page type user data for mobile phone display as described above, and the user can use his / her own terminal anywhere on the mobile terminal through a specific route.
  • the preferred mode is to browse data, add-ups, etc., and send requests.
  • the terminal 915 is also used, for example, as a component of wired or wireless digital television broadcasting. Data is transmitted using wired or wireless media, but reception is captured via satellite or wire (93G), and by switching channels to handle television. It will be possible to obtain data and receive a diagnosis. Alternatively, the terminal 915 may transmit data to the center 920 in the morning, and the transmitted data from the center 920 may be obtained by a mobile phone 917 or the like. The diagnostic data may be obtained. Also, in this system, when data is transmitted using a route that may leak personal data such as a general-purpose network, data related to individuals and measurement data are divided, and personal data is dialed up.
  • personal data such as a general-purpose network
  • the measurement data is transmitted over a general-purpose network such as the Internet using a transmission / reception method based on direct connection.
  • a general-purpose network such as the Internet using a transmission / reception method based on direct connection.
  • these In transmission they may adopt a method in which common data is divided in a state where they are added, and the data is transmitted along each route, and when the data arrives at the center, the data is combined based on the common data.
  • this system has effects such that health information based on in-vivo information can be known at home and an accurate diagnosis can be received.

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  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Optics & Photonics (AREA)
  • Dermatology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Cette invention a trait à une unité d'inspection de fluide corporel facilitée, qui comprend plusieurs parties réactives, un élément de support comportant plusieurs parties d'ouverture destinées à contenir les parties réactives, une feuille poreuse disposée sur l'élément de support de façon à couvrir au moins partiellement les parties réactives contenues dans les ouvertures, et un élément de revêtement comportant une ouverture destinée à exposer une partie de la feuille poreuse et à recouvrir la feuille poreuse depuis le côté opposé à la surface en contact avec l'élément de support.
PCT/JP2001/010701 2000-12-06 2001-12-06 Unite d'inspection de fluide corporel facilitee WO2002046747A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002221075A AU2002221075A1 (en) 2000-12-06 2001-12-06 Facilitated body fluid inspection unit

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP2000372095A JP2002174634A (ja) 2000-12-06 2000-12-06 簡易体液検査ユニット
JP2000-372095 2000-12-06
JP2001053097A JP2002257829A (ja) 2001-02-27 2001-02-27 簡易体液検査ユニット
JP2001-053097 2001-02-27

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WO2004060143A2 (fr) * 2002-12-30 2004-07-22 Roche Diagnostics Gmbh Systeme de suspension d'acquisition du sang
EP1586268A2 (fr) * 2004-04-16 2005-10-19 Lifescan, Inc. Lancette
EP1767150A3 (fr) * 2005-09-26 2009-08-05 Lifescan Scotland Ltd Dispositif pour la promotion de l'expression de fluides corporels
JP2019211439A (ja) * 2018-06-08 2019-12-12 株式会社島津製作所 流体デバイスの製造方法および流体デバイス

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WO2004060143A2 (fr) * 2002-12-30 2004-07-22 Roche Diagnostics Gmbh Systeme de suspension d'acquisition du sang
WO2004060143A3 (fr) * 2002-12-30 2004-09-10 Roche Diagnostics Gmbh Systeme de suspension d'acquisition du sang
US7351212B2 (en) 2002-12-30 2008-04-01 Roche Diagnostics Operations, Inc. Blood acquisition suspension system
US7927291B2 (en) 2002-12-30 2011-04-19 Roche Diagnostics Operations, Inc. Blood acquisition suspension system
US8684951B2 (en) 2002-12-30 2014-04-01 Roche Diagnostics Operations, Inc. Blood acquisition suspension system
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EP1767150A3 (fr) * 2005-09-26 2009-08-05 Lifescan Scotland Ltd Dispositif pour la promotion de l'expression de fluides corporels
JP2019211439A (ja) * 2018-06-08 2019-12-12 株式会社島津製作所 流体デバイスの製造方法および流体デバイス
JP7206645B2 (ja) 2018-06-08 2023-01-18 株式会社島津製作所 流体デバイスの製造方法および流体デバイス

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