WO2011125562A1 - Seringue pré-remplie et procédé d'assemblage de la seringue pré-remplie - Google Patents

Seringue pré-remplie et procédé d'assemblage de la seringue pré-remplie Download PDF

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Publication number
WO2011125562A1
WO2011125562A1 PCT/JP2011/057468 JP2011057468W WO2011125562A1 WO 2011125562 A1 WO2011125562 A1 WO 2011125562A1 JP 2011057468 W JP2011057468 W JP 2011057468W WO 2011125562 A1 WO2011125562 A1 WO 2011125562A1
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WIPO (PCT)
Prior art keywords
chemical solution
needle
gas
prefilled syringe
needle tube
Prior art date
Application number
PCT/JP2011/057468
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English (en)
Japanese (ja)
Inventor
立川　浩一
小川　淳一
智紀 岡山
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テルモ株式会社
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Publication of WO2011125562A1 publication Critical patent/WO2011125562A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2422—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A61M5/2429—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by telescoping of ampoules or carpules with the syringe body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A61M2005/247—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase with fixed or steady piercing means, e.g. piercing under movement of ampoule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104—Caps for syringes without needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3123—Details having air entrapping or venting means, e.g. purging channels in pistons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/425—Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion

Definitions

  • the present invention relates to a prefilled syringe in which a chemical solution is stored in advance in a syringe and a method for assembling the prefilled syringe.
  • Patent Document 1 prefilled syringes that have been pre-filled with a chemical solution in a syringe have been widely used.
  • Patent Document 1 it is not necessary to suck the drug solution from the vial into the syringe at the time of drug solution administration, and the time required for administration can be shortened and the waste of the drug solution can be reduced.
  • Patent Document 2 discloses a technique for filling the chemical solution storage filled with the chemical solution with nitrogen, which is an inert gas, and preventing the chemical solution from coming into contact with gas components in the atmosphere. Is described.
  • nitrogen is used as an inert gas that replaces the gas in the chemical solution storage section.
  • Nitrogen is the most abundant gas in the atmosphere, and the concentration in the atmosphere reaches approximately 78% on the ground. Therefore, even if the gas in the chemical solution storage is replaced with nitrogen, it is almost the same as the gas component in the atmosphere, so it is difficult to confirm whether the gas in the chemical solution storage is replaced with nitrogen. Have a problem.
  • an object of the present invention is to provide a prefilled syringe and a prefilled syringe assembly method capable of easily confirming that the gas is reliably replaced when the gas in the chemical solution storage unit is replaced. There is to do.
  • the prefilled syringe of the present invention is a small-diameter prefilled syringe, in which a chemical solution is stored and a chemical solution storage portion in which the internal gas is a rare gas, And a sealing member that seals the chemical solution and the rare gas stored in the chemical solution storage unit.
  • the rare gas is preferably helium gas.
  • the assembly method of the prefilled syringe of this invention includes the process shown to the following (1) to (3).
  • (1) A step of filling the chemical solution storage unit with the chemical solution.
  • (2) The process of replacing the gas in the chemical
  • (3) A step of attaching a sealing member to a chemical solution storage unit filled with a chemical solution and replacing air with a rare gas, and sealing the chemical solution and the rare gas in the chemical solution storage unit.
  • a rare gas is used as a gas to be substituted for the gas in the chemical solution storage section. Since the amount of the rare gas present in the atmosphere is extremely small, it can be easily confirmed whether or not the gas in the chemical solution storage is reliably replaced after the replacement operation. Furthermore, since the rare gas is a gas having low reactivity, it does not react with the chemical solution filled in the chemical solution storage unit. As a result, the medicinal solution can be stored in the medicinal solution storage unit without impairing the medicinal effect of the medicinal solution.
  • FIG. 1 is a sectional view showing a prefilled syringe of this example
  • FIG. 2 is a sectional view showing a state after puncturing.
  • the prefilled syringe 1 of this example stores a drug solution M to be administered to a living body in advance, and administers this drug solution M to the upper skin portion of the living body.
  • the upper skin layer refers to the epidermis and dermis of the skin.
  • the prefilled syringe 1 includes an outer cylinder 2, a hollow needle tube 3 having a needle hole, a needle hub 4 that holds the needle tube 3, a chemical solution container 5 having a chemical solution storage unit 6, and a cap 7. And a sealing member 23.
  • the medicinal solution M stored in the prefilled syringe 1 in advance includes various vaccines for preventing various infectious diseases such as influenza, but is not limited to vaccines.
  • vaccines for example, glucose injection solutions such as glucose, electrolyte correction injection solutions such as sodium chloride and potassium lactate, vitamin agents, antibiotic injection solutions, contrast agents, steroid agents, proteolytic enzyme inhibitors, fat Emulsions, anticancer agents, anesthetics, stimulants, narcotics, heparin calcium, antibody drugs and the like can be mentioned.
  • the outer cylinder 2 is formed in the cylindrical shape which has the cylinder hole 2a in the approximate center.
  • the outer cylinder 2 is open at both ends in the axial direction.
  • the needle hub 4 is arrange
  • the inner diameter of the outer cylinder 2 is set to 9 mm or less, and preferably set to 6.5 mm or less.
  • the material of the outer cylinder 2 a material excellent in gas permeability filled in the chemical solution storage unit 6, for example, polyethylene, polypropylene, polystyrene, acrylic resin, polyester, and cyclic polyolefin can be used. Polypropylene and cyclic polyolefin are preferable. In addition, it is preferable that the material of the outer cylinder 2 is substantially transparent in order to ensure internal visibility.
  • the needle tube 3 having a size of 22 to 33 gauge (outer diameter 0.2 to 0.7 mm) based on the ISO medical needle tube standard (ISO9626: 1991 / Amd.1: 2001 (E)) can be used.
  • ISO medical needle tube standard ISO9626: 1991 / Amd.1: 2001 (E)
  • those having a gauge of 26 to 33 gauge can be used, preferably those having a gauge of 30 to 33 gauge.
  • the first needle tip 9 has a blade surface 9a.
  • the length of the blade surface 9a in the direction in which the needle tube 3 extends (hereinafter referred to as “bevel length B”) may be 1.4 mm (adult) or less, which is the thinnest thickness of the upper skin layer described later, Further, it may be about 0.5 mm or more which is a bevel length when a short bevel is formed on a 33 gauge needle tube. That is, the bevel length B is preferably set in the range of 0.5 to 1.4 mm.
  • the bevel length B is even better if the thinnest thickness of the upper skin layer is 0.9 mm (child) or less. That is, the bevel length B is more preferably set in the range of 0.5 to 0.9 mm.
  • the “short bevel” refers to a blade surface that is generally used for an injection needle and forms an angle of 18 to 25 ° with respect to the longitudinal direction of the needle.
  • the second needle tip 10 has a blade surface 10a.
  • the length of the blade surface 10a in the direction in which the needle tube 3 extends can be arbitrarily set, but can be set to the same length as the blade surface 9a of the first needle tip 9.
  • the needle tube 3 is held at its intermediate portion by a needle hub 4.
  • the needle tube 3 may be a straight needle or a tapered needle at least partially having a tapered structure.
  • the outer diameter on the second needle tip 10 side may be made larger than the outer diameter on the first needle tip 9 side, and the intermediate portion thereof may have a tapered structure. In this case, the shapes of the first needle tip 9 and the second needle tip 10 are different.
  • a thin sheet-like cover member may be placed on the second needle tip 10 side of the needle tube 3 exposed from the needle hub 4 in the needle tube 3. Accordingly, the second needle tip 10 of the needle tube 3 can be maintained in a sterile state until puncturing the drug solution storage unit 6.
  • the needle hub 4 includes a substantially disc-shaped hub body 11, an adjustment portion 12, a stabilization portion 13, a guide portion 14 that is a pressing guide portion, and a sealing member contact portion 15.
  • the needle hub 4 is disposed so as to close the opening on one end side of the outer cylinder 2 while holding the needle tube 3.
  • the second needle tip 10 of the needle tube penetrating the needle hub 4 is disposed in the internal space 20 formed by the tube hole 2 a of the outer tube 2 and the needle hub 4.
  • the adjustment part 12 and the stabilization part 13 are provided in the one end side of the hub main body 11, and the sealing member contact part 15 is provided in the other end side.
  • the material of the needle hub 4 is not particularly limited. For example, the same material as that of the outer cylinder 2 described above can be used. Further, the needle hub 4 may be formed integrally with the outer cylinder 2.
  • the hub body 11 is provided with a first vent hole 18 penetrating from one end side to the other end side.
  • a filter may be provided in the first vent hole 18 in order to enhance the maintenance of the sterilized state of the internal space 20 surrounded by the cylindrical hole 2a of the outer cylinder 2 and the needle hub 4.
  • the present invention is not limited to this, and a plurality of the first ventilation holes 18 may be formed in the hub body 11. Good.
  • the adjustment unit 12 is provided at the center of one end surface 11 a of the hub body 11, and is configured as a protrusion that protrudes in the axial direction of the hub body 11.
  • the axis of the adjustment unit 12 is coincident with the axis of the hub body 11.
  • the needle tube 3 passes through the adjusting portion 12.
  • the end surface of the adjustment part 12 is a needle projecting surface 12a from which the first needle tip 9 side of the needle tube 3 projects.
  • the needle protruding surface 12 a is formed as a plane orthogonal to the axial direction of the needle tube 3. This needle protruding surface 12a defines the depth at which the needle tube 3 is punctured in contact with the surface of the skin when the needle tube 3 is punctured into the upper skin portion. That is, the depth at which the needle tube 3 is punctured into the upper skin layer is determined by the length of the needle tube 3 protruding from the needle protruding surface 12a (hereinafter referred to as “projection length L”).
  • the thickness of the upper skin portion corresponds to the depth from the skin surface to the dermis layer, and is generally in the range of 0.5 to 3.0 mm. Therefore, the protruding length L of the needle tube 3 can be set in the range of 0.5 to 3.0 mm.
  • the vaccine is generally administered to the upper arm, but when it is considered to be applied to the upper skin part, it is considered that the shoulder peripheral part where the skin is thick, especially the deltoid part is suitable. Therefore, the thickness of the upper layer of the deltoid muscle was measured for 19 children and 31 adults. This measurement was performed by imaging the upper layer of the skin with high ultrasonic reflectivity using an ultrasonic measurement device (NP60R-UBM, high-resolution echo for small animals, Nepagene). In addition, since the measured value was logarithmic normal distribution, the range of MEAN ⁇ 2SD was obtained by geometric mean.
  • the thickness of the upper skin layer of the deltoid muscle of the child was 0.9 to 1.6 mm.
  • the thickness of the upper skin layer of the deltoid muscle of adults was 1.4 to 2.6 mm at the distal part, 1.4 to 2.5 mm at the central part, and 1.5 to 2.5 mm at the proximal part. It was. From the above, it was confirmed that the thickness of the upper skin layer in the deltoid muscle was 0.9 mm or more in the case of children and 1.4 mm or more in the case of adults. Therefore, in the injection at the upper layer portion of the deltoid skin, the protruding length L of the needle tube 3 is preferably set in the range of 0.9 to 1.4 mm.
  • the blade surface 9a of the first needle tip 9 can be reliably positioned on the upper skin layer.
  • the needle hole (chemical solution discharge port) that opens in the blade surface 9a can be located in the upper skin layer portion at any position in the blade surface 9a.
  • the chemical solution discharge port is located in the upper skin portion, if the first needle tip 9 is deeply stabbed into the upper skin portion, the gap between the side surface of the end of the first needle tip 9 and the incised skin Since the drug solution M flows under the skin, it is important that the blade surface 9a is surely in the upper skin portion.
  • the needle projecting surface 12a is formed such that the distance S from the peripheral edge to the peripheral surface of the needle tube 3 is 1.4 mm or less, preferably in the range of 0.3 to 1.4 mm.
  • the distance S from the peripheral edge of the needle protruding surface 12a to the peripheral surface of the needle tube 3 is set in consideration of the pressure applied to the blisters formed by administering the drug solution to the upper skin layer. That is, the needle projecting surface 12a is set to a size that is sufficiently smaller than the blisters formed on the upper layer portion of the skin and does not hinder the formation of blisters. As a result, it can be prevented that the needle protruding surface 12a presses the skin around the needle tube 3 and the administered drug solution leaks.
  • the stabilizing portion 13 is provided on the one end surface 11 a of the hub body 11.
  • the stabilizing portion 13 is formed in a cylindrical shape that is continuous with the peripheral edge portion of the one end face 11a.
  • a first needle tip 9 and an adjustment unit 12 in the needle tube 3 are disposed in the cylindrical hole of the stabilization unit 13. That is, the stable portion 13 is formed in a cylindrical shape that covers the periphery of the adjusting portion 12 through which the needle tube 3 passes.
  • the needle protruding surface 12a contacts the surface of the skin and also contacts the end surface 13a of the stabilizing portion 13.
  • the prefilled syringe 1 is stabilized by the end surface 13a of the stabilizing portion 13 coming into contact with the skin, and the needle tube 3 can be maintained in a posture substantially perpendicular to the skin.
  • the end surface 13a of the stabilizing portion 13 may be positioned on the same plane as the needle protruding surface 12a, or may be positioned closer to the first needle tip 9 side of the needle tube 3 than the needle protruding surface 12a. 3 can be maintained in a posture substantially perpendicular to the skin.
  • the axial distance r between the end surface 13a of the stable portion 13 and the needle protruding surface 12a is preferably set to 1.3 mm or less.
  • the inner diameter d of the stable portion 13 is set to be equal to or larger than the diameter of the blister formed on the skin.
  • the distance T from the inner wall surface of the stabilizing portion 13 to the peripheral edge of the needle protruding surface 12a is set to be in the range of 4 mm to 15 mm. Thereby, it can prevent that blister formation is inhibited by pressure being applied to the blister from the inner wall surface of the stable part 13.
  • the distance T from the inner wall surface of the stable portion 13 to the periphery of the needle protruding surface 12a is not particularly limited as long as it is 4 mm or more. However, when the distance T is increased, the outer diameter of the stable portion 13 is increased, so that it is difficult to bring the entire end surface 13a of the stable portion 13 into contact with the skin when the needle tube 3 is inserted into a thin arm like a child. . For this reason, the distance T is preferably set to 15 mm as a maximum in consideration of the thinness of the child's arm.
  • the adjusting unit 12 does not enter the skin. Therefore, considering the distance T (4 mm or more) from the inner wall surface of the stable portion 13 to the periphery of the needle protruding surface 12a and the diameter (about 0.3 mm) of the needle protruding surface 12a, the inner diameter d of the stable portion 13 is 9 mm or more. Can be set.
  • a second ventilation hole 19 penetrating from the outer peripheral surface to the inner peripheral surface of the stable portion 13 is formed in the stable portion 13.
  • the first ventilation hole 18 and the second ventilation hole 19 constitute a ventilation means for opening the internal space 20 to the outside.
  • the shape of the stable part 13 is not limited to a cylindrical shape, and may be formed in a rectangular tube shape such as a rectangular column or a hexagonal column having a cylindrical hole at the center.
  • the guide portion 14 which is a pressing standard part is demonstrated.
  • the guide portion 14 is provided on the side surface portion of the hub body 11.
  • the guide portion 14 is formed as a flange in a ring shape protruding from the side surface portion of the hub main body 11 in the radially outward direction of the hub main body 11.
  • the guide portion 14 protrudes substantially perpendicular to the outer peripheral surface of the stable portion 13.
  • the guide part 14 has the contact surface 14a which contacts skin.
  • the contact surface 14 a is a plane that is substantially parallel to the end surface 13 a of the stabilizing portion 13.
  • the distance from the contact surface 14a of the guide portion 14 to the end surface 13a of the stable portion 13 is set so that the needle tube 3, the stable portion 13 and the needle tube 3 can puncture the skin with an appropriate pressing force. Has been.
  • this length is referred to as “guide height y”.
  • an appropriate pressing force of the needle tube 3 and the stabilizing portion 13 is, for example, 3 to 20N.
  • the user can be guided by the guide portion 14 with the pressing force applied to the skin by the needle tube 3 and the stabilizing portion 13, and the first needle tip 9 and the blade surface 9 a of the needle tube 3 can be securely attached to the upper skin portion. Therefore, it is possible to provide the user with a sense of security.
  • the guide portion height y is the length x from the protruding end surface of the guide portion 14 to the outer peripheral surface of the stable portion 13 (hereinafter referred to as guide portion length). X). ) Is set as appropriate.
  • the guide height y is set in the range of 2.3 to 6.6 mm when the guide length x is 3.0 mm, for example.
  • the sealing member contact portion 15 is provided at the central portion of the other end surface 11 b opposite to the one end surface 11 a of the hub body 11.
  • the sealing member contact portion 15 is configured as a convex portion that protrudes in a substantially cylindrical shape in the axial direction of the hub body 11.
  • the needle tube 3 passes through the sealing member contact portion 15, and the second needle tip 10 of the needle tube 3 protrudes from the end surface of the sealing member contact portion 15.
  • the axis of the needle tube 3 and the axes of the adjusting portion 12 and the sealing member abutting portion 15 coincide.
  • the object can be achieved even if the axis of the needle tube 3 and the axis of the sealing member contact portion 15 do not coincide.
  • the shape of the sealing member contact part 15 is not limited to a substantially cylindrical shape.
  • the sealing member abutting portion 15 only needs to have a shape that presses the sealing member 23 described later, and may be formed in, for example, a substantially semicircular shape or a prismatic shape.
  • the sealing member abutting portion 15 is disposed in an internal space 20 formed by the tube hole 2 a of the outer cylinder 2 and the needle hub 4 when the needle hub 4 closes the opening on one end side of the outer cylinder 2. ing.
  • the chemical liquid container 5 has a substantially cylindrical container body 21, a pressing part 22 pressed by a user, and a chemical liquid storage part 6 in which the chemical liquid is enclosed.
  • the chemical solution container 5 is inserted into the cylindrical hole 2 a of the outer cylinder 2. Further, one end side of the container main body 21 is formed as the pressing portion 22, and the other end side of the container main body 21 is formed as the chemical solution storage portion 6. Further, the diameter of the container body 21 is formed smaller than the diameter of the cylindrical hole 2 a of the outer cylinder 2.
  • the pressing part 22 is provided on one end side of the container body 21 in the axial direction. Further, the pressing portion 22 is formed as a flange protruding outward in the radial direction of the container body 21. And when the pressing part 22 is pressed by the user, the container main body 21 moves in the cylindrical hole 2a of the outer cylinder 2 along the axial direction.
  • the chemical solution storage 6 is provided on the other end side of the container body 21 in the axial direction.
  • the chemical solution storage portion 6 is a concave portion that is recessed in a substantially cylindrical shape from the other end surface of the container body 21 in the axial direction.
  • medical solution M is accommodated in the chemical
  • the diameter of the opening of the chemical solution storage unit 6 is set to be substantially the same as or slightly larger than the diameter of the sealing member contact part 15.
  • a sealing member 23 is attached to the chemical solution storage unit 6 so as to close the opening. Therefore, the chemical solution M is sealed in a chemical solution space 25 surrounded by the chemical solution storage unit 6 and the sealing member 23.
  • the chemical solution space 25 is a sealed space hermetically sealed by the sealing member 23 and is maintained in a sterile state.
  • a needle housing recess 23a that is continuous with the piercing hole through which the second needle tip 10 is pierced is formed at the substantially central portion of the surface of the sealing member 23 that faces the bottom surface of the chemical solution storage section 6.
  • a cross section of the needle housing recess 23 a in a direction orthogonal to the axial direction of the sealing member 23 is formed larger than the outer diameter of the needle tube 3.
  • the gas in the chemical solution storage unit 6 is replaced with helium gas H indicating a specific example of a rare gas.
  • the helium gas H is sealed in a chemical solution space 25 surrounded by the chemical solution storage unit 6 and the sealing member 23 in the same manner as the chemical solution M.
  • the rare gas is a low-reactivity gas, it does not react with the chemical solution M filled in the chemical solution storage unit 6. Therefore, the medicinal solution M can be stored in the medicinal solution storage unit 6 without impairing the medicinal effect of the medicinal solution M.
  • helium gas H is present only in 0.0005% in the earth's atmosphere.
  • medical solution storage part 6 is replaced after the replacement
  • FIG. 1 an example in which helium (He) is used as a rare gas has been described.
  • the present invention is not limited to this.
  • various other rare gases such as neon (Ne) and argon (Ar) are used. May be.
  • the sealing member 23 is pressed in the sealing member abutting portion 15 of the needle hub 4 during use and slides in the chemical solution storage portion 6 in the axial direction.
  • the sealing member 23 is punctured into the second needle tip 10 of the needle tube 3.
  • the amount of the chemical solution M stored in the chemical solution space 25 is not particularly limited, but is preferably about 0.02 to 2.0 mL, and more preferably about 0.05 to 0.8 mL. preferable. That is, the prefilled syringe 1 is particularly suitable when such a small amount of drug solution is administered.
  • the material of the sealing member 23 is not particularly limited, but is preferably made of an elastic material in order to improve the liquid tightness with the chemical solution storage unit 6.
  • an elastic material such as natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, silicone rubber, isobutylene rubber, and various thermoplastics such as polyurethane, polyester, polyamide, olefin, and styrene.
  • An elastic material such as an elastomer or a mixture thereof can be used.
  • the sealing member 23 only needs to have at least an outer peripheral portion made of an elastic material as described above.
  • the sealing member 23 has a core portion (not shown) made of a resin material.
  • positioned so that outer periphery may be covered may be sufficient.
  • a material excellent in gas permeability filled in the chemical solution storage unit 6 for example, a resin such as a cyclic polyolefin, is used as in the case of the outer cylinder 2 described above. It is preferable to use it.
  • medical solution container is substantially transparent in order to ensure internal visibility.
  • a scale may be formed on the outer peripheral surface of the chemical solution storage section 6 of the chemical solution container 5. Thereby, the quantity of the chemical
  • a seal member 24 is attached to the outer peripheral surface of the container main body 21 on the side of the chemical solution storage section 6.
  • the seal member 24 is an O-ring, and is continuously provided on the outer peripheral surface of the container body 21 along the circumferential direction. Further, the seal member 24 and the container body 21 may be formed by two-color molding.
  • the sealing member 24 closely_contact
  • the material of the sealing member 24 is not particularly limited, but the same material as the sealing member 23 can be used.
  • the cap 7 is a member that seals the space surrounding the first needle tip 9 of the needle tube 3, the adjustment portion 12 and the stabilization portion 13 of the needle hub 4.
  • the cap 7 is detachably attached to the stable portion 13 of the needle hub 4 in an unused state.
  • the cap 7 is formed in a bottomed cylindrical shape having a bottom on the tip side, in this example, a bottomed cylindrical shape.
  • the second vent hole 19 and the inside of the cap 7 are sealed by attaching the side surface of the cap 7 to the outer peripheral surface of the stabilizing portion 13. Thereby, the sterility of the internal space 20 and the cap 7 is maintained.
  • the cap 7 is removed from the needle hub 4, and the sealing of the first needle tip 9 of the needle tube 3 is released. Further, the second vent hole 19 of the needle hub 4 is opened. As a result, as shown in FIG. 2, in the state where the stable portion 13 is in contact with the skin, the space surrounded by the stable portion 13 and the skin and the internal space by the first vent hole 18 and the second vent hole 19. 20 can be opened to the outside.
  • the material of the cap 7 is not particularly limited.
  • the same material as that of the outer cylinder 2 and the material of the chemical solution container 5 described above may be used.
  • the cap 7 is removed from the stable portion 13 of the needle hub 4. Thereby, the sealing of the first needle tip 9 of the needle tube 3 is released and the second vent hole 19 of the needle hub 4 is opened.
  • air venting it has been necessary to perform so-called air venting in which the gas contained in the chemical solution space 25 is discharged from the needle tube 3 to the outside. At this time, since the chemical solution is discharged together with the gas, there is a problem that a part of the chemical solution is wasted.
  • the gas in the chemical solution storage unit 6 is replaced with helium gas H.
  • This helium gas H is a gas excellent in resin permeability.
  • the chemical solution storage portion 6 for storing the helium gas H is formed of a resin having excellent gas permeability. Therefore, the helium gas H stored in the chemical solution storage unit 6 permeates through the chemical solution storage unit 6 over time, and the amount thereof decreases. As a result, the amount of gas contained in the chemical solution space 25 can be extremely reduced.
  • the end face 13a of the stable portion 13 is made to face the skin. Thereby, the first needle tip 9 of the needle tube 3 is opposed to the skin to be punctured.
  • the prefilled syringe 1 is moved substantially perpendicularly to the skin, the needle tube 3 is punctured into the skin, and the end surface 13a of the stabilizing portion 13 is pressed against the skin.
  • the needle protruding surface 12a of the adjusting portion 12 and the end surface 13a of the stabilizing portion 13 are located on the same plane. Thereby, the needle projecting surface 12a of the adjusting unit 12 can contact the skin and deform the skin flatly, and the first needle tip 9 of the needle tube 3 can be punctured into the skin by the projecting length L.
  • the stable portion 13 is pressed until the contact surface 14a of the guide portion 14 contacts the skin.
  • the length of the guide portion height y is set so that the needle tube 3 and the stable portion 13 can puncture the skin with an appropriate pressing force. Therefore, the force that presses the skin by the stabilizing portion 13 becomes a predetermined value. Therefore, the pressing force of the stable portion 13 can be guided to the user, and the stable portion 13 can be pressed against the skin with an appropriate pressing force, and the first needle tip 9 and the blade surface 9a of the needle tube 3 can be connected. It can be surely located in the upper skin part.
  • the guide portion 14 serves as a mark for guiding the pressing force of the stable portion 13, so that the first needle tip 9 of the needle tube 3 can be reliably positioned on the upper skin portion, and can be reliably placed in the upper skin portion. It is possible to administer the drug solution to the user and improve the user's sense of security.
  • the stabilizing portion 13 comes into contact with the skin, the needle tube 3 can be stabilized and the needle tube 3 can be punctured straight into the skin. Therefore, the blurring which arises in the needle tube 3 can be prevented, and the chemical liquid can be administered stably.
  • the first needle tip 9 may not stick into the skin even if it is brought into contact with the skin.
  • the stable portion 13 is pressed against the skin and the skin is pushed down in the vertical direction, the skin inside the stable portion 13 is pulled and tension is applied to the skin. Therefore, the skin is less likely to escape with respect to the first needle tip 9 of the needle tube 3, so that the stable portion 13 also has an effect that the first needle tip 9 is more likely to pierce the skin.
  • the protruding length L is set in the range of 0.5 to 3.0 mm, the first needle tip 9 and the blade surface 9a of the needle tube 3 are surely located in the upper skin layer.
  • the adjustment unit 12 is fixed in close contact with the periphery of the needle tube 3 so that no gap is generated between the adjustment unit 12 and a portion of the needle tube 3 that passes through the adjustment unit 12.
  • the skin around the needle tube 3 can be deformed flat when the needle protruding surface 12a of the adjusting unit 12 is brought into contact with the skin.
  • the needle tube 3 can be punctured into the skin by the protruding length L, and the first needle tip 9 of the needle tube 3 can be reliably positioned in the upper skin layer.
  • the user presses the pressing portion 22 and slides the inside of the cylindrical hole 2 a along the axial direction of the outer cylinder 2 with the container body 21 and the chemical liquid storage section 6 enclosing the chemical liquid M.
  • the sealing member contact portion 15 of the needle hub 4 contacts the sealing member 23.
  • the second needle tip 10 of the needle tube 3 is punctured into the sealing member 23.
  • the liquid passing through the chemical liquid M stored in the chemical liquid storage section 6 and the needle tube 3 is completed.
  • the needle hub 4 is provided with a first ventilation hole 18 and a second ventilation hole 19.
  • the air in the internal space 20 is discharged to the outside through the first vent hole 18 and the second vent hole 19. Therefore, it is possible to prevent the pressure in the space surrounded by the internal space 20 and the stable portion 13 and the skin from rising. Thereby, the movement operation of the chemical
  • the sealing member 23 is pushed into the chemical solution storage portion 6 by the sealing member contact portion 15. Then, the sealing member 23 slides along the axial direction in the chemical solution storage unit 6, so that the chemical solution M in the chemical solution storage unit 6 passes through the second needle tip 10 of the needle tube 3, and the first It is discharged from the needle tip 9 into the living body.
  • the second needle tip 10 is housed in the needle housing recess 23 a and does not protrude from the surface of the sealing member 23 to the bottom surface side of the chemical solution container 5. For this reason, the sealing member 23 is brought into contact with the bottom surface of the chemical solution container 5 without generating a gap.
  • the needle projecting surface 12a of the adjusting portion 12 and the inner diameter d of the stabilizing portion 13 are set to appropriate sizes, the injected medicinal solution can be prevented from leaking out of the body, and the medicinal solution can be surely put into the upper skin layer. Can be administered. Thereby, administration of the chemical
  • FIG.3 and FIG.4 is sectional drawing which shows the assembly procedure of the prefilled syringe 1 of this example.
  • the chemical solution M is filled into the chemical solution space 25 of the chemical solution storage unit 6 provided in the container main body 21.
  • the nozzle 29 for discharging the chemical solution M is inserted into the chemical solution storage unit 6.
  • medical solution M is inject
  • helium gas H is blown into the chemical solution space 25 of the chemical solution storage unit 6 filled with the chemical solution M to replace the gas in the chemical solution storage unit 6 with the helium gas H.
  • the helium gas H is an extremely light gas having a small molecular weight as compared with a gas component in the atmosphere. Therefore, it is easy to disperse
  • the helium gas H is a rare gas that is present in the atmosphere in an extremely small amount, it can be easily confirmed whether the gas in the chemical solution storage unit 6 has been replaced with the helium gas H after the replacement. Thereby, it is possible to further improve the safety of the prefilled syringe 1.
  • the sealing member 23 is attached so that the opening of the chemical
  • the helium gas H is a gas excellent in resin permeability
  • the container main body 21 forming the chemical solution storage unit 6 is also formed of a resin excellent in gas permeability. Therefore, after the sealing member 23 is plugged, the helium gas H sealed in the chemical solution space 25 permeates through the chemical solution storage unit 6 over time. And the quantity of helium gas H in the chemical
  • the chemical solution container 5 in which the chemical solution M and the helium gas H shown in FIG. 4B are sealed in the chemical solution space 25 is inserted from the opening on the outer cylinder 2 opposite to the opening where the needle hub 4 is mounted. Thereby, the assembly of the prefilled syringe 1 is completed.
  • the chemical container 5 may be inserted into the cylindrical hole 2a of the outer cylinder 2 before the needle hub 4 is attached to the outer cylinder 2.
  • the present invention is not limited to the embodiment described above and shown in the drawings, and various modifications can be made without departing from the scope of the invention described in the claims.
  • the present invention is not limited to this and is connected to a connector provided in a prefilled syringe for subcutaneous administration or a medical device.
  • the present invention can be applied to various other prefilled syringes such as possible prefilled syringes.
  • the cylindrical hole of the outer cylinder may be configured as the chemical solution storage portion and the sealing member may be provided in the pressing portion, or the chemical solution storage portion and the pressing portion may be configured as separate members.
  • the needle tube does not need to use a double-ended needle, and may be a needle tube having only the first needle tip punctured into the living body.
  • the size of the needle tube is not limited to 22 gauge to 33 gauge, and is appropriately selected according to the purpose.
  • SYMBOLS 1 Prefilled syringe, 2 ... Outer cylinder, 2a ... Tube hole, 3 ... Needle tube, 4 ... Needle hub, 5 ... Chemical solution container, 6 ... Chemical solution storage part, 11 ... Hub main body, 12 ... Adjustment part, 12a ... Needle protrusion surface , 13 ... Stabilizing part, 13a ... End face, 14 ... Guide part, 21 ... Container body, 22 ... Pressing part, 23 ... Sealing member, 24 ... Seal member, 25 ... Chemical solution space, B ... Bevel length, L ...
  • Projection length S: distance from the peripheral edge of the needle protruding surface to the peripheral surface of the needle tube
  • T distance from the inner wall surface of the stable portion to the outer peripheral surface of the adjusting portion
  • x guide portion length
  • y guide portion height
  • d inner diameter M ... Chemical liquid
  • H Helium gas (rare gas)

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Afin de faciliter, lorsqu'un gaz à l'intérieur d'une section de stockage de médicament liquide est libéré, la confirmation de la libération du gaz, une seringue pré-remplie (1) comprend un tube extérieur (2), un récipient pour médicament liquide (5), la section de stockage du médicament liquide (6), et un élément d'étanchéité (23). La section de stockage du médicament liquide (6) stocke un médicament liquide (M), et le gaz présent à l'intérieur de la section de stockage de médicament liquide (6) est un gaz rare (H). L'élément d'étanchéité (23) renferme le médicament liquide (M) et le gaz rare (H) qui sont stockés à l'intérieur de la section de stockage de médicament liquide (6).
PCT/JP2011/057468 2010-03-31 2011-03-25 Seringue pré-remplie et procédé d'assemblage de la seringue pré-remplie WO2011125562A1 (fr)

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JP2010082581 2010-03-31
JP2010-082581 2010-03-31

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021101794A1 (fr) * 2019-11-19 2021-05-27 Eli Lilly And Company Systèmes d'administration de médicament comprenant des fermetures mobiles

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005204678A (ja) * 2004-01-19 2005-08-04 Terumo Corp プレフィルドシリンジ製造方法、プレフィルドシリンジ製造用治具およびプレフィルドシリンジ製造装置
JP2005527249A (ja) * 2001-09-12 2005-09-15 ベクトン・ディキンソン・アンド・カンパニー ペンデバイスに基づいた薬物投与のためのマイクロ針および該マイクロ針の使用法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005527249A (ja) * 2001-09-12 2005-09-15 ベクトン・ディキンソン・アンド・カンパニー ペンデバイスに基づいた薬物投与のためのマイクロ針および該マイクロ針の使用法
JP2005204678A (ja) * 2004-01-19 2005-08-04 Terumo Corp プレフィルドシリンジ製造方法、プレフィルドシリンジ製造用治具およびプレフィルドシリンジ製造装置

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021101794A1 (fr) * 2019-11-19 2021-05-27 Eli Lilly And Company Systèmes d'administration de médicament comprenant des fermetures mobiles
US12005235B2 (en) 2019-11-19 2024-06-11 Eli Lilly And Company Drug delivery systems including displaceable closures

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