WO2011068131A1 - Prefilled syringe - Google Patents

Prefilled syringe Download PDF

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Publication number
WO2011068131A1
WO2011068131A1 PCT/JP2010/071510 JP2010071510W WO2011068131A1 WO 2011068131 A1 WO2011068131 A1 WO 2011068131A1 JP 2010071510 W JP2010071510 W JP 2010071510W WO 2011068131 A1 WO2011068131 A1 WO 2011068131A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
outer cylinder
prefilled syringe
double
container
Prior art date
Application number
PCT/JP2010/071510
Other languages
French (fr)
Japanese (ja)
Inventor
信之介 大津
淳一 小川
智紀 岡山
浩一 立川
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2011068131A1 publication Critical patent/WO2011068131A1/en

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Classifications

    • 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
    • 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
    • A61M5/2425—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 compression of deformable ampoule or carpule wall
    • 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
    • A61M5/2455—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
    • A61M5/2459—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 upon internal pressure increase, e.g. pierced or burst
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
    • 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

Definitions

  • the present invention relates to a prefilled syringe containing a chemical solution.
  • the upper skin layer refers to the epidermis and dermis (dermis layer) of the skin.
  • a type of syringe that is used with a chemical cartridge mounted thereon is known (for example, see Patent Document 2).
  • this syringe is used with a chemical cartridge and a double-ended needle attached to the syringe body.
  • the syringe body is repeatedly used a plurality of times by performing sterilization treatment, and the drug solution cartridge and the double-ended needle are used only once and are disposable. For this reason, the syringe main body does not need to have a structure capable of maintaining the sterility of the syringe body, and is not actually capable of maintaining the sterility.
  • the conventional dental syringe is a type that is used with a chemical cartridge attached, it is possible to prevent the waste of the chemical solution, but it is necessary to attach a double-ended needle to the syringe body during use. Takes time and effort.
  • the conventional dental syringe cannot be applied to a prefilled syringe in which a double-ended needle is attached in advance because the syringe body does not have a structure capable of maintaining the sterility of the syringe body.
  • An object of the present invention is to prevent the waste of a chemical solution, to easily and quickly prepare for administration of the chemical solution, and to easily and surely puncture the puncture needle to the target puncture depth.
  • the present invention provides an outer cylinder having a distal end and a proximal end, A chemical container having a gasket that can slide within the main body of the chemical liquid container, the chemical liquid is stored in a space surrounded by the main body of the chemical liquid container and the gasket, and is movable with respect to the outer cylinder A chemical container; A pressing portion for moving and operating the chemical container; A puncture needle having one end capable of puncturing a living body and the other end communicating with the inside of the main body of the drug solution container; A needle support portion provided on the distal end side of the outer cylinder and supporting the puncture needle; A contact portion that is provided on the distal end side of the outer cylinder and spaced from the needle tip of the puncture needle in the radial direction, and can contact the surface of
  • the puncture needle is preferably the prefilled syringe according to the above (1), which is a double-ended needle.
  • the prefilled syringe of the present invention it is preferable that the prefilled syringe has a ventilation means for opening the space inside the outer cylinder to the outside.
  • the venting means is configured such that the space inside the contact portion by the protection member is released and the contact portion is in contact with the surface of the living body, It is preferable to open the in-cylinder space to the outside.
  • the ventilation means is formed in the needle support portion, and includes a first ventilation hole that communicates the space inside the outer cylinder and the space inside the contact portion, and the contact portion. It is preferable to have a second ventilation hole that is formed and communicates between the space inside the contact portion and the outside in the contact state.
  • the second vent hole is a side hole formed in a side wall of the contact portion.
  • the protection member is detachably attached to the contact portion, and closes the second vent hole, whereby the space inside the outer cylinder and the space inside the contact portion. It is preferable that the sterility is maintained.
  • the chemical solution container is accommodated in the outer cylinder.
  • the chemical solution container is installed so as to protrude outward from the base end side of the outer cylinder.
  • the puncture needle is a double-ended needle
  • the chemical solution container seals a space surrounded by the main body of the chemical solution container and the gasket, and has a sealing portion through which the needle tip on the proximal end side of the double-ended needle can be pierced, It is preferable that the proximal end side of the double-ended needle is configured so that the proximal end side of the double-ended needle communicates with the inside of the main body of the drug solution container by penetrating the sealing portion.
  • the puncture needle is a double-ended needle
  • the body of the chemical solution container has a cylindrical shape
  • the gasket is provided on the base end side of the main body of the chemical solution container
  • the chemical liquid container seals a space surrounded by the main body of the chemical liquid container and the gasket, and has a sealing portion on the distal end side of the main body of the chemical liquid container through which the needle tip on the proximal end side of the double-ended needle can be pierced.
  • the chemical solution container moves in the distal direction with respect to the outer cylinder, and the needle tip on the proximal end side of the double-ended needle pierces the sealing portion, and then the gasket is It is preferable that the chemical solution is configured to move in the distal direction with respect to the main body of the chemical solution container and to discharge the chemical solution from the tip of the tip of the double-ended needle.
  • the puncture needle is a double-ended needle
  • the proximal end side of the double-ended needle is configured to communicate with the inside of the main body of the chemical solution container when the needle tip on the proximal end side of the double-ended needle pierces the gasket.
  • the puncture needle is a double-ended needle
  • the main body of the chemical solution container has a bottomed cylindrical part having a bottom on the base end side
  • the gasket is provided on the distal end side of the main body of the chemical container
  • the prefilled syringe further has a gasket abutting portion that is located in the space inside the outer cylinder and can abut against the gasket;
  • the chemical solution container moves in the distal direction with respect to the outer cylinder, the needle tip on the proximal end side of the double-ended needle pierces the gasket, and then the gasket is
  • the chemical solution is configured to come into contact with the gasket contact portion, move in the proximal direction with respect to the main body of the chemical solution container, and to discharge the chemical solution from the tip end on the distal end side of the double-ended needle.
  • the distal end surface of the contact portion is located on the proximal end side with respect to the needle tip of the puncture needle.
  • the needle support portion has a convex portion that supports the puncture needle and can come into contact with the surface of the living body.
  • FIG. 1 is a partial longitudinal sectional view showing a first embodiment (a state in which a protective member is removed) of a prefilled syringe of the present invention.
  • FIG. 2 is a partial longitudinal sectional view showing a state in which the protective member of the prefilled syringe shown in FIG. 1 is mounted.
  • FIG. 3 is a partial longitudinal sectional view for explaining a method of using the prefilled syringe shown in FIG.
  • FIG. 4 is a partial longitudinal sectional view for explaining a method of using the prefilled syringe shown in FIG.
  • FIG. 5 is a partial longitudinal sectional view for explaining a method of using the prefilled syringe shown in FIG. FIG.
  • FIG. 6 is a partial longitudinal sectional view showing a second embodiment of the prefilled syringe of the present invention.
  • FIG. 7 is a longitudinal sectional view showing a third embodiment of the prefilled syringe of the present invention.
  • FIG. 8 is a longitudinal cross-sectional view which shows the part by the side of the front end in 4th Embodiment of the prefilled syringe of this invention.
  • the present invention can be applied to a prefilled syringe that administers various chemicals to a living body, in the following embodiment, the present invention is typically applied to a prefilled syringe that administers a vaccine. Will be described.
  • FIG. 1 is a partial longitudinal sectional view showing a first embodiment of the prefilled syringe of the present invention (a state in which a protective member is removed)
  • FIG. 2 is a partial longitudinal section showing a state in which the protective member of the prefilled syringe shown in FIG.
  • FIGS. 3 to 5 are partial longitudinal sectional views for explaining a method of using the prefilled syringe shown in FIG.
  • FIGS. 1 to 5 the upper side in FIGS. 1 to 5 is described as “base end”, the lower side is “tip”, the right side is “right”, and the left side is “left”. 4 and 5, the illustration of the living body is omitted.
  • the prefilled syringe 1 includes an outer cylinder (syringe outer cylinder) 2, a chemical liquid container 7 movable with respect to the outer cylinder 2, and the chemical liquid container 7 in the axial direction of the outer cylinder 2 ( A pusher (pressing portion) 3 that is moved along the longitudinal direction), a double-ended needle (puncture needle) 6, a needle support portion 4 that supports the double-ended needle 6, and a double-ended needle 6 on the distal end side of the outer cylinder 2.
  • a pusher (pressing portion) 3 that is moved along the longitudinal direction
  • a double-ended needle (puncture needle) 6 a needle support portion 4 that supports the double-ended needle 6, and a double-ended needle 6 on the distal end side of the outer cylinder 2.
  • a contact portion 5 provided so as to surround the needle tip 61 on the distal end side and capable of contacting the surface of the living body, a seal member 74 that seals between the outer cylinder 2 and the chemical solution container 7, and a protection member (cap) 8 and.
  • the outer cylinder 2 is a cylindrical member, which is a cylindrical member in the illustrated configuration. And in this embodiment, the chemical
  • FIG. 1 is a cylindrical member, which is a cylindrical member in the illustrated configuration.
  • medical solution container 7 is accommodated in this outer cylinder 2.
  • the constituent material of the outer cylinder 2 is not particularly limited.
  • resins such as styrene copolymers, polyesters such as polyethylene terephthalate, butadiene-styrene copolymers, and polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12) can be mentioned.
  • Resin such as polypropylene, cyclic polyolefin, polyester, and poly- (4-methylpentene-1) is preferable because it is easy to mold.
  • the constituent material of the outer cylinder 2 is substantially transparent in order to ensure internal visibility.
  • the chemical liquid container 7 seals a space surrounded by the container main body (main body of the chemical liquid container) 71, a gasket 72 that can slide in the container main body 71, and the container main body 71 and the gasket 72, and is fixed to the container main body 71. And a sealed portion 73. And the chemical
  • the container body 71 has a cylindrical shape, and in the illustrated configuration, has a cylindrical shape.
  • the gasket 72 is provided on the proximal end side of the container body 71, and the sealing portion 73 is provided on the distal end side of the container body 71. Yes.
  • the constituent material of the container main body 71 is substantially transparent in order to ensure internal visibility.
  • a scale not shown is formed on the outer peripheral surface of the container main body 71. Thereby, the quantity of the chemical
  • the gasket 72 is connected to the tip of the pusher 3.
  • the gasket 72 is fixed to the pusher 3 in advance.
  • the present invention is not limited to this.
  • the gasket 72 is configured to be connected to the pusher 3 at the time of use. Also good.
  • the gasket 72 and the pusher 3 may not be connected to each other, but the gasket 72 may be pushed by the tip surface of the pusher 3.
  • the material constituting the gasket 72 is not particularly limited.
  • various rubber materials such as natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, silicone rubber, polyurethane, polyester, polyamide, Examples thereof include elastic materials such as various thermoplastic elastomers such as olefins and styrenes, or mixtures thereof.
  • the gasket 72 only needs to have at least an outer peripheral portion made of the elastic material as described above.
  • the gasket 72 has a core portion (not shown) made of a resin material.
  • positioned so that it may cover may be used.
  • the sealing portion 73 is configured such that the needle tip 62 on the proximal end side of the double-ended needle 6 can be pierced.
  • the constituent material of the sealing portion 73 is not particularly limited.
  • the same constituent material as that of the gasket 72 can be used.
  • the amount of the chemical solution stored in the space 75 is not particularly limited, but is preferably about 0.02 to 2.0 mL, and more preferably about 0.05 to 0.8 mL. That is, the prefilled syringe 1 is particularly suitable when such a small amount of drug solution is administered.
  • the seal member 74 is a member that seals between the outer cylinder 2 and the chemical liquid container 7, and is provided on the outer cylinder 2 side or the chemical liquid container 7 side. In the illustrated configuration, the seal member 74 is fixed to the outer peripheral surface of the container main body 71.
  • the seal member 74 is composed of ribs provided so as to protrude laterally from the outer peripheral surface of the container main body 71, and is provided over the entire circumference of the container main body 71.
  • the end of the seal member 74 on the outer cylinder 2 side is in close contact with the inner peripheral surface of the outer cylinder 2 over the entire circumference thereof, whereby the inner peripheral surface of the outer cylinder 2 and the chemical container 7
  • the space between the outer peripheral surface of the container body 71 is hermetically sealed.
  • the chemical liquid container 7 can smoothly slide in the outer cylinder 2 by the seal member 74.
  • the constituent material of the seal member 74 is not particularly limited.
  • the same constituent material as that of the gasket 72 can be used.
  • the seal member 74 may be fixed to the inner peripheral surface of the outer cylinder 2 instead of the outer peripheral surface of the container body 71. Further, the seal member 74 may be integrally formed with the outer cylinder 2 (for example, integral molding or the like).
  • the pusher 3 has a rod-like main body 31 whose cross section is, for example, a cross or circular shape, and a gasket 72 is fixed to the tip of the main body 31 as described above. That is, the pusher 3 is connected to the chemical solution container 7 and provided at the base end (base end portion) of the chemical solution container 7.
  • a disc-shaped flange 32 is formed at the base end of the main body 31.
  • the method for fixing the gasket 72 to the main body 31 is not particularly limited.
  • a male screw is formed on the main body 31, and a female screw that is screwed to the male screw is formed on the gasket 72. And the like.
  • the constituent material of the pusher 3 is not particularly limited, but for example, the same constituent material as that of the outer cylinder 2 can be used.
  • the double-ended needle 6 has a sharp needle tip 61 that can pierce a living body on the distal end side, and a sharp needle tip 62 that can pierce the sealing portion 73 of the drug solution container 7 on the proximal end side. Then, the proximal end side of the double-ended needle 6 is configured to pierce the sealing portion 73 so that the proximal end side of the double-ended needle 6 communicates with the inside of the container main body 71.
  • the double-ended needle 6 one having a size of 26 to 33 G (outer diameter: 0.2 to 0.45 mm) according to the ISO medical needle tube standard (ISO9626: 1991 / Amd.1: 2001 (E)) is used. It is preferable to use one having a size of 30 to 33G.
  • a blade edge having a blade surface is formed on each of the distal end side and the proximal end side of the double-ended needle 6, and the axial length of the double-ended needle 6 on the distal end side blade surface (hereinafter referred to as “bevel length”).
  • B is preferably 1.4 mm (adult) or less, which is the thinnest thickness of the upper skin layer, and is a bevel length when a short bevel is formed on a 33G double-ended needle (puncture needle). It is preferable that it is 0.5 mm or more. That is, the bevel length B is preferably set within a range of 0.5 to 1.4 mm.
  • the bevel length B is more preferably 0.9 mm (child) or less, which is the thinnest thickness of the upper skin layer. That is, the bevel length B is more preferably set within a range of 0.5 to 0.9 mm.
  • the depth (puncture depth) punctured into the upper skin portion of the double-ended needle 6 is the length of the portion of the double-ended needle 6 that protrudes from the distal end surface of the convex portion 42 described later (hereinafter referred to as “projected length”). Say) determined by L.
  • the thickness of the upper skin portion corresponds to the depth from the surface of the skin to the dermis layer, and is generally 0.5 to 3.0 mm. Therefore, the protruding length L of the double-ended needle 6 is 0.5 to 3.0 mm. It is preferable to set within the range.
  • the administration site of influenza vaccine is generally the deltoid muscle.
  • the thickness of the upper skin layer in the pediatric deltoid muscle is 0.9 to 1.6 mm, and the upper skin thickness in the adult deltoid muscle is 1.4 to 2.6 mm in the distal portion.
  • the central portion is 1.4 to 2.5 mm, and the proximal portion is 1.5 to 2.5 mm.
  • the protruding length L of the double-ended needle 6 can be set within a range of 0.9 to 1.4 mm.
  • the constituent material of the double-ended needle 6 is not particularly limited.
  • various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, superelastic alloy such as Ni-Ti alloy, and various hard materials such as polyphenylene sulfide. Resin material etc. are mentioned.
  • the needle support portion 4 has a base portion 40 and a convex portion 42 fixed to the center portion of the tip surface of the base portion 40, and is fixed to the tip end of the outer cylinder 2.
  • the base portion 40 has a disk shape
  • the convex portion 42 has a cylindrical shape.
  • the tip surface of the convex portion 42 is a part that comes into contact with the surface (skin) of the living body when a drug solution is administered (when the double-ended needle 6 is punctured).
  • the base 40 and the convex part 42 may be formed integrally.
  • the needle support portion 4 may be formed integrally with the outer cylinder 2.
  • the double-ended needle 6 is fixed to the center portion of the needle support portion 4 and is supported by the base portion 40 and the convex portion 42, and the needle tip 61 on the tip side is located on the tip side from the needle support portion 4,
  • the proximal end needle tip 62 is located closer to the proximal end side than the needle support portion 4. Since the needle support part 4 has the convex part 42, when the double-ended needle 6 is punctured into a predetermined part of the living body, the convex part 42 comes into contact with the epidermis, and thereby the epidermis is brought into contact with the axis of the double-ended needle 6.
  • the needle tip 61 of the double-ended needle 6 can be punctured so as to be perpendicular to the epidermis.
  • the distance S from the outer peripheral edge (outer peripheral surface) of the convex portion 42 to the outer peripheral surface of the double-ended needle 6 is preferably set to 1.4 mm or less, and is set within a range of 0.3 to 1.4 mm. Is more preferable.
  • This distance S 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 distance S is set so that the size of the tip surface of the convex portion 42 is sufficiently smaller than the blisters formed on the upper skin layer and does not hinder the formation of the blisters. Thereby, it can prevent that the chemical
  • the base 40 of the needle support portion 4 has a portion that comes into contact with the epidermis when the double-ended needle 6 is punctured.
  • the abutment portion 5 and the double-ended needle 6 press the epidermis by pressing the abutment portion 5 against the epidermis until the portion of the base 40 that abuts the epidermis abuts the epidermis.
  • the distance Y from the distal end surface (lower end surface) of the base 40 to the distal end surface of the contact portion 5 is such that when the double-ended needle 6 is punctured, the contact portion 5 and the double-ended needle 6 press the epidermis with an appropriate pressing force.
  • the double-ended needle 6 is set so as to be punctured with certainty.
  • This distance Y is appropriately determined based on the inner diameter d of the contact portion 5 and the distance X from the outer wall surface (outer peripheral surface) of the base portion 40 to the outer wall surface (outer peripheral surface) of the contact portion 5. For example, when the inner diameter d is 11 mm and the distance X is 0.5 mm, the distance Y is preferably set within a range of 0.75 to 2.6 mm.
  • the pressing force with which the contact portion 5 and the double-ended needle 6 press the epidermis is reliably transmitted (guided) to the epidermis by the base 40, and the needle tip 61 of the double-ended needle 6 is reliably positioned on the upper skin portion. be able to.
  • the needle support portion 4 is formed with a vent hole (first vent hole) 41 penetrating the needle support portion 4.
  • the vent hole 41 is formed at a position where the convex portion 42 is not provided in the base portion 40.
  • the vent hole 41 allows communication between the outer cylinder inner space 21 surrounded by the outer cylinder 2, the needle support portion 4, and the seal member 74 and the space 52 inside the contact portion 5 described later.
  • the number of vent holes 41 is one in the present embodiment, but is not limited to this and may be plural.
  • the thing similar to the constituent material of the said outer cylinder 2 can be used.
  • the abutting portion 5 has a cylindrical shape, a cylindrical shape in the illustrated configuration, and is fixed to the tip surface (tip portion) of the base portion 40 of the needle support portion 4.
  • the contact portion 5 is provided away from the needle tip 61 on the distal end side of the double-ended needle 6 in the radial direction of the double-ended needle 6.
  • the distal end surface of the abutting portion 5 is located on the proximal side with respect to the distal end side 61 of the double-ended needle 6 and on the proximal side with respect to the distal end surface of the convex portion 42.
  • the front end surface of the contact portion 5 may be located at the same position as the front end surface of the convex portion 42 (on the same plane as the front end surface of the convex portion 42) in the axial direction of the double-ended needle 6. You may be located in the front end side rather than the front end surface of the convex part 42. FIG. Also in these cases, the double-ended needle 6 can be maintained in a posture perpendicular to the epidermis.
  • the distance r between the tip surface of the contact portion 5 and the tip surface of the convex portion 42 in the axial direction of the double-ended needle 6 is 1.3 mm. It is preferable to set as follows.
  • the distance T from the inner wall surface (inner circumferential surface) of the contact portion 5 to the outer peripheral edge of the convex portion 42 is preferably set to 4 mm or more, and there is no particular upper limit.
  • the distance T is preferably set to 15 mm or less in consideration of the thinness of the child's arm and the like. That is, the distance T is preferably set within a range of 4 to 15 mm.
  • the inner diameter d of the contact portion 5 is preferably set to a value equal to or larger than the diameter of the blister formed in the upper skin layer.
  • the distance S from the outer periphery of the convex part 42 to the outer peripheral surface of the double-ended needle 6 is 0.3 mm or more, the convex part 42 does not enter the skin. Therefore, considering the preferable value (4 mm or more) of the distance T from the inner wall surface of the contact part 5 to the outer peripheral edge of the convex part 42 and the preferable value (0.3 mm or more) of the distance S, the contact part 5
  • the inner diameter d is preferably set to 9 mm or more.
  • the tip surface of the contact portion 5 and the tip surface of the convex portion 42 are brought into contact with the epidermis in the target region of the living body, Press with strength.
  • the epidermis of the part that is not in contact with the tip surface of the contact part 5 on the inner side of the contact part 5 rises in a mountain shape, and the epidermis of the part that is in contact with the tip surface of the convex part 42 is the double-ended needle 6.
  • the needle tip 61 on the tip side of the double-ended needle 6 is punctured into the living body.
  • the puncture depth of the double-ended needle 6 is such that the positional relationship between the double-ended needle 6 and the epidermis is regulated by the front end surface of the contact portion 5 and the front end surface of the convex portion 42 being in contact with the epidermis. Become deep.
  • the state shown in FIG. 3A is a state before reaching the state shown in FIG.
  • vent hole 51 penetrating the abutting portion 5 is formed in the abutting portion 5.
  • the vent hole 51 allows the space 52 inside the contact portion 5 to communicate with the outside in a contact state in which the tip surface of the contact portion 5 contacts the surface of the living body. Therefore, the vent hole 51 and the vent hole 41 of the needle support portion 4 constitute a vent means for opening the outer cylinder space 21 to the outside.
  • vent hole 51 is a side hole formed in the side wall of the contact portion 5, and is arranged on the proximal end side of the contact portion 5 in the illustrated configuration.
  • the vent hole 51 is blocked by a skin that swells in a mountain shape when the distal end surface of the abutment portion 5 is pressed against the epidermis in the target region of the living body. This can be prevented.
  • vent holes 51 is one in the present embodiment, the number is not limited to this and may be plural.
  • the protection member 8 is a member that seals the space 52 inside the contact portion 5, and is detachably attached to the contact portion 5 in an unused state.
  • the protective member 8 has a bottomed cylindrical shape having a bottom portion on the distal end side, and has a bottomed cylindrical shape in the configuration shown in the drawing. Is closed, and the space 52 inside the contact portion 5 is hermetically sealed.
  • the space 52 inside the contact portion 5 is hermetically sealed by the protection member 8, and the seal member 74 provides a space between the inner peripheral surface of the outer cylinder 2 and the outer peripheral surface of the container main body 71.
  • the seal member 74 provides a space between the inner peripheral surface of the outer cylinder 2 and the outer peripheral surface of the container main body 71.
  • the protective member 8 is removed from the contact portion 5 as shown in FIG. Thereby, sealing of the space 52 inside the contact part 5 is cancelled
  • FIG. 3B in the contact state in which the space 52 inside the contact part 5 is released and the tip surface of the contact part 5 is in contact with the surface of the living body, the contact is made.
  • the vent hole 51 of the portion 5 and the vent hole 41 of the needle support portion 4 the outer cylinder inner space 21 and the space 52 inside the contact portion 5 are opened to the outside.
  • a vent hole (third vent hole) 43 penetrating the base portion 40 may be formed.
  • the vent hole 43 opens the outer cylinder inner space 21 and the space 52 inside the contact portion 5 to the outside.
  • the ventilation means is constituted by the ventilation holes 41, 43 and 51.
  • 3C corresponds to FIG. 3A
  • FIG. 3D corresponds to FIG. 3B.
  • the number of the vent holes 43 is one in the illustrated configuration, but is not limited to this and may be plural.
  • the protective member 8 is attached to the contact part 5, and as described above, the outer cylinder inner space 21 and the space 52 inside the contact part 5. The sterility is maintained, whereby the sterility of the double-ended needle 6 is maintained.
  • the prefilled syringe 1 When using the prefilled syringe 1, first, as shown in FIG. 1, the protective member 8 is removed from the contact portion 5 of the prepared prefilled syringe 1. Thereby, the preparation for administering the drug solution is completed. As described above, the prefilled syringe 1 can easily and quickly prepare for the administration of the drug solution.
  • the front end surface of the contact portion 5 and the front end surface of the convex portion 42 are, for example, It is brought into contact with the epidermis at the site to which a drug solution such as an arm is administered and pressed with a predetermined strength.
  • a drug solution such as an arm
  • the epidermis of the part that is not in contact with the tip surface of the contact part 5 on the inner side of the contact part 5 rises in a mountain shape, and the epidermis of the part that is in contact with the tip surface of the convex part 42 is the double-ended needle 6.
  • the needle tip 61 on the tip side of the double-ended needle 6 is punctured into the living body.
  • the needle tip 61 reaches the dermis by restricting the positional relationship between the double-ended needle 6 and the epidermis by the contact portion 5 and the convex portion 42.
  • the needle tip 61 of the double-ended needle 6 can be punctured into the dermis easily and reliably.
  • the gasket 72 slides in the distal direction in the container body 71, and the chemical solution in the chemical solution container 7 passes through the double-ended needle 6, It is discharged from the needle tip 61 and administered to the target site.
  • the chemical liquid container 7 in which a necessary amount of the chemical liquid is stored is provided, so that waste of the chemical liquid can be prevented and it is economical.
  • the chemical solution container 7 and the double-ended needle 6 are installed in advance, and the sterilized state of the outer cylinder inner space 21 in which the double-ended needle 6 is arranged and the space 52 inside the contact portion 5 is not used. Since it is held, preparation for administration of the drug solution can be performed easily and quickly by simply removing the protective member 8.
  • the positional relationship between the double-ended needle 6 and the epidermis is regulated by the tip surface of the abutment portion 5 and the tip surface of the convex portion 42 coming into contact with the epidermis.
  • the double-ended needle 6 can be punctured to a target puncture depth.
  • the vent holes 41 and 51 are provided. Therefore, when the pusher 3 is moved in the distal direction, the outer cylinder inner space 21 and the inner space 52 of the contact portion 5 are respectively An increase in pressure can be prevented, so that the moving operation of the pusher 3 can be performed easily and smoothly.
  • the prefilled syringe 1 can be easily assembled. That is, when the vent holes 41 and 51 are not provided, the outer cylinder inner space 21 is hermetically sealed. Therefore, when the chemical container 7 provided with the seal member 74 is inserted into the outer cylinder 2, although the process of depressurizing the space 21 is required, the prefilled syringe 1 does not require the depressurization process, takes less time, and can be assembled quickly.
  • the ventilation holes 41 and 51 are provided as ventilation means.
  • the ventilation holes are not limited thereto.
  • a vent hole (not shown) that communicates with each other may be provided.
  • the vent hole is a side hole formed in the side wall of the distal end portion of the outer cylinder 2, and is located on the distal end side with respect to the seal member 74 in a state where the chemical liquid container 7 is in contact with the needle support portion 4. Is preferred.
  • a sterilizing filter that allows air to pass but does not allow bacteria to pass through is provided in the vent hole.
  • FIG. 6 is a partial longitudinal sectional view showing a second embodiment of the prefilled syringe of the present invention.
  • the upper side in FIG. 6 is “base end”, the lower side is “tip”, the right side is “right”, and the left side is “left”.
  • the axial length of the outer cylinder 2 is set shorter than the axial length of the chemical liquid container 7. Further, the seal member 74 is fixed to the proximal end portion of the container main body 71 of the chemical solution container 7. And the chemical
  • the gasket 72 is disposed in the middle of the container main body 71, in the illustrated configuration, closer to the tip than the center of the container main body 71. Accordingly, when the pusher 3 is moved (pressed), the container body 71 serves as a guide for the pusher 3 and can be easily moved.
  • a lubricant is applied to the inner surface of the outer cylinder 2 so that the chemical container 7 can be easily inserted into the outer cylinder 2.
  • the axial length of the outer cylinder 2 is shorter than that in the first embodiment, it is possible to reduce labor and time for applying the lubricant to the inner surface of the outer cylinder 2 when assembling the prefilled syringe 1. This makes it possible to assemble easily and quickly.
  • the seal member 74 may be fixed to the inner peripheral surface of the outer cylinder 2 instead of the outer peripheral surface of the container body 71. Further, the seal member 74 may be integrally formed with the outer cylinder 2 (for example, integral molding or the like).
  • FIG. 7 is a longitudinal sectional view showing a third embodiment of the prefilled syringe of the present invention.
  • the upper side in FIG. 7 is referred to as “base end”, the lower side as “tip”, the right side as “right”, and the left side as “left”.
  • the chemical liquid container 7 in the prefilled syringe 1 of the third embodiment, has a container main body 71 and a gasket 72 that can slide in the container main body 71.
  • the container main body 71 has a partition part (bottom part) 77 that partitions the inside of the container main body 71 into a distal end portion and a proximal end portion in the middle of the axial direction. That is, the container main body 71 has a bottomed cylindrical portion having a bottom portion constituted by the partitioning portion 77 on the proximal end side, and has a bottomed cylindrical portion in the illustrated configuration, and a gasket. 72 is provided at the distal end (front end side) of the container body 71. And the chemical
  • the position of the partition portion 77 of the container main body 71 is the intermediate portion (substantially intermediate position) in the axial direction of the container main body 71 in the configuration shown in the figure, but is not limited to this, for example, in the proximal direction or the distal direction It may be shifted by a predetermined distance, or may be the proximal end portion of the container body 71 in the axial direction.
  • a flange 32 is provided at the base end portion of the container main body 71 as a pressing portion for moving and operating the chemical liquid container 7 along the axial direction (longitudinal direction) of the outer cylinder 2.
  • the container main body 71 and the flange 32 are integrally formed.
  • the present invention is not limited to this, and for example, the container main body 71 and the flange 32 are configured as separate members, and these are adhesives. May be joined by adhesion or fusion.
  • the prefilled syringe 1 has a gasket abutting portion 9 that is located in the outer cylinder inner space 21 and can abut against the gasket 72.
  • the gasket contact portion 9 has a cylindrical shape and is installed at the center of the proximal end surface of the needle support portion 4.
  • the double-ended needle 6 is inserted through the gasket contact portion 9, and the proximal end side needle tip 62 is located on the proximal end side with respect to the gasket contact portion 9.
  • the chemical container 7 moves in the distal direction with respect to the outer cylinder.
  • the needle tip 62 on the proximal end side of the double-ended needle 6 penetrates the gasket 72 of the chemical solution container 7, and the proximal end side of the double-ended needle 6 communicates with the inside of the container main body 71.
  • the gasket 72 can move in the proximal direction with respect to the container body 71.
  • the gasket 72 comes into contact with the gasket contact portion 9 and slides in the proximal direction in the container body 71, and the chemical solution in the chemical solution container 7 passes through the double-ended needle 6, It is discharged from the needle tip 61 on the distal end side and administered to a target site.
  • the seal member 74 may be fixed to the inner peripheral surface of the outer cylinder 2 instead of the outer peripheral surface of the container body 71. Further, as shown in FIG. 7B, the seal member 74 may be integrally formed with the outer cylinder 2 (for example, integral molding or the like).
  • the distal end portion of the pusher (pressing portion) 3 is fixed to the proximal end portion of the container main body 71 can also be adopted.
  • the container main body 71 and the pusher 3 or its main-body part 31 may be integrally formed.
  • the base end portion of the chemical solution container 7 may be used as it is as the pressing portion. That is, the base end portion of the container main body 71 may also serve as the pressing portion.
  • FIG. 8 is a longitudinal cross-sectional view which shows the part by the side of the front end in 4th Embodiment of the prefilled syringe of this invention.
  • the upper side in FIG. 8 is “base end”, the lower side is “tip”, the right side is “right”, and the left side is “left”.
  • the distal end portion of the outer cylinder 2 constitutes a contact portion 5.
  • a rib 22 is provided on the inner peripheral surface of the distal end portion of the outer cylinder 2 over the entire circumference of the outer cylinder 2 as a positioning portion for positioning the needle support portion 4. In addition, the rib 22 may be provided partially.
  • the needle support portion 4 is fixed to the inner peripheral surface of the distal end portion of the outer cylinder 2.
  • the base portion 40 of the needle support portion 4 has a bottomed cylindrical shape having a bottom portion on the proximal end side, and has a bottomed cylindrical shape in the illustrated configuration.
  • the protective member 8 is mounted inside the contact portion 5.
  • the protective member 8 is made of an elastic material and is in close contact with the contact portion 5 with certainty.
  • the needle support 4 when the needle support 4 is fixed to the outer cylinder 2, the needle support 4 is inserted into the outer cylinder 2 from the tip thereof. At this time, the needle support portion 4 is in contact with the rib 22 of the outer cylinder 2, whereby the needle support portion 4 is positioned with respect to the outer cylinder 2. Then, the needle support portion 4 is fixed to the outer cylinder 2 by adhesion or fusion with an adhesive.
  • the present invention may be a combination of any two or more configurations of the above embodiments.
  • the cap was used as the protection member 8 which seals the space 52 inside the contact part 5, in this invention, it is not limited to this, For example, a film etc. may be used. .
  • prefilled syringe of the present invention is not limited to vaccine administration, and can be applied to prefilled syringes for administering various chemical solutions.
  • the present invention since there is a chemical solution container in which a required amount of chemical solution is stored, waste of the chemical solution can be prevented. And since the drug solution container and the puncture needle are installed in advance and the aseptic condition of the necessary part such as the space around the puncture needle is kept unused, the drug solution can be administered easily and quickly. Preparation can be done. In addition, since the contact portion is provided, the puncture needle can be punctured to the target puncture depth easily and reliably when the drug solution is administered. Therefore, it has industrial applicability.

Abstract

A prefilled syringe (1) is provided with an outer tube (2), a medical liquid container (7) in which a medical liquid is previously contained and which can move relative to the outer tube (2), a pusher (3) which moves and operates the medical liquid container (7), a double-headed needle (6), a needle support section (4) which supports the double-headed needle (6), a contact section (5) which is provided to the front end of the outer tube (2) so as to surround the needle tip (61) located at the front end of the double-headed needle (6) and which can make contact with the surface of a living body, a seal member (74) which seals between the outer tube (2) and the medical liquid container (7), and a protective member (8). An air passage hole (41) is formed in the needle support section (4), and an air passage hole (51) is formed in the contact section (5). In a not-yet-used state, the protective member (8) is attached to the contact section (5) to keep aseptic the space (21) within the outer tube and the space (52) inside the contact section (5).

Description

プレフィルドシリンジPrefilled syringe
　本発明は、薬液を収納したプレフィルドシリンジに関するものである。 The present invention relates to a prefilled syringe containing a chemical solution.
　インフルエンザ等の感染症を予防するワクチンを投与する予防接種の多くは、皮下注射により行われるが、特に、小児は、じっとせずに動くことがあり、また、皮膚が柔らかいため、シリンジの穿刺針を目標とする穿刺深さに穿刺することができない虞がある。 Many vaccinations that administer vaccines to prevent infections such as influenza are performed by subcutaneous injection. In particular, children may move without stabbing, and the skin is soft, so the puncture needle of a syringe There is a possibility that puncture cannot be performed at the puncture depth targeted.
　そこで、このような課題を解決するために、穿刺針のハブに、その穿刺針を囲むように筒状体を設けてなる穿刺針組立体が提案されている（例えば、特許文献１参照）。この穿刺針組立体によれば、筒状体の先端が表皮に当接することにより、穿刺針と表皮との位置関係が規制され、穿刺針を目標とする穿刺深さに穿刺することができる。 Therefore, in order to solve such problems, there has been proposed a puncture needle assembly in which a tubular body is provided on a puncture needle hub so as to surround the puncture needle (see, for example, Patent Document 1). According to this puncture needle assembly, when the tip of the cylindrical body abuts on the epidermis, the positional relationship between the puncture needle and the epidermis is regulated, and the puncture needle can be punctured to a target puncture depth.
　しかしながら、従来のシリンジでは、予防接種の際、１回毎に、ワクチンをシリンジ内に吸引する等の準備をする必要があり、準備に手間と時間とを要し、また、準備の際等に、ワクチンを無駄にしてしまうことがある。 However, with conventional syringes, it is necessary to make preparations such as sucking the vaccine into the syringe at the time of vaccination, and it takes time and effort to prepare. , Vaccines can be wasted.
　なお、ワクチンを、皮下ではなく、免疫担当細胞が多く存在する皮膚上層部に投与することにより、そのワクチンの投与量を減らすことが期待されている。なお、前記皮膚上層部は、皮膚のうち、表皮および真皮（真皮層）を指す。 It is expected that the dose of the vaccine is reduced by administering the vaccine to the upper skin layer where many immunocompetent cells are present, not subcutaneously. The upper skin layer refers to the epidermis and dermis (dermis layer) of the skin.
　ところで、歯科用のシリンジとして、薬液カートリッジを装着して使用するタイプのシリンジが知られている（例えば、特許文献２参照）。このシリンジは、使用の際、シリンジ本体に対し、薬液カートリッジおよび両頭針をそれぞれ装着して用いる。また、シリンジ本体は、滅菌処理を施すことにより複数回繰り返し使用され、薬液カートリッジおよび両頭針は、一回のみ使用され、使い捨てとされる。このため、シリンジ本体は、その内部の無菌状態を保持できる構造を有している必要はなく、実際、無菌状態を保持できるようにはなっていない。 By the way, as a dental syringe, a type of syringe that is used with a chemical cartridge mounted thereon is known (for example, see Patent Document 2). In use, this syringe is used with a chemical cartridge and a double-ended needle attached to the syringe body. In addition, the syringe body is repeatedly used a plurality of times by performing sterilization treatment, and the drug solution cartridge and the double-ended needle are used only once and are disposable. For this reason, the syringe main body does not need to have a structure capable of maintaining the sterility of the syringe body, and is not actually capable of maintaining the sterility.
　前記従来の歯科用のシリンジは、薬液カートリッジを装着して使用するタイプであるので、薬液の無駄を防止できるが、使用の際、シリンジ本体に対し、両頭針を装着する必要があるので、準備に手間と時間とを要する。 Since the conventional dental syringe is a type that is used with a chemical cartridge attached, it is possible to prevent the waste of the chemical solution, but it is necessary to attach a double-ended needle to the syringe body during use. Takes time and effort.
　また、前記従来の歯科用のシリンジは、シリンジ本体がその内部の無菌状態を保持できる構造を有していないので、予め両頭針が取り付けられているタイプのプレフィルドシリンジに適用することはできない。 The conventional dental syringe cannot be applied to a prefilled syringe in which a double-ended needle is attached in advance because the syringe body does not have a structure capable of maintaining the sterility of the syringe body.
特開２０００－３７４５６号公報JP 2000-37456 A 特開２００２－１５９５７５号公報JP 2002-159575 A
　本発明の目的は、薬液の無駄を防止でき、容易かつ迅速に薬液の投与の準備を行うことができ、また、容易かつ確実に穿刺針を目標の穿刺深さに穿刺することができるプレフィルドシリンジを提供することにある。
　上記目的を達成するために、本発明は、先端と基端とを有する外筒と、
　薬液容器であって、該薬液容器の本体内で摺動し得るガスケットを有し、前記薬液容器の本体と前記ガスケットとで囲まれる空間に薬液が収納され、前記外筒に対して移動可能な薬液容器と、
　前記薬液容器を移動操作する押圧部と、
　一端に生体を穿刺可能な針先を有し、他端が前記薬液容器の本体の内部に連通可能な穿刺針と、
　前記外筒の先端側に設けられ、前記穿刺針を支持する針支持部と、
　前記外筒の先端側に、前記穿刺針の針先から半径方向に離間して設けられ、生体の表面に当接し得る当接部と、
　前記外筒と前記薬液容器との間を封止するシール部材と、
　前記当接部の内側の空間を封止する保護部材とを備え、
　前記外筒と前記針支持部と前記シール部材とで囲まれる外筒内空間と、前記当接部の内側の空間との無菌状態が、未使用の状態で保持されていることを特徴とするプレフィルドシリンジである。 An object of the present invention is to prevent the waste of a chemical solution, to easily and quickly prepare for administration of the chemical solution, and to easily and surely puncture the puncture needle to the target puncture depth. Is to provide.
In order to achieve the above object, the present invention provides an outer cylinder having a distal end and a proximal end,
A chemical container having a gasket that can slide within the main body of the chemical liquid container, the chemical liquid is stored in a space surrounded by the main body of the chemical liquid container and the gasket, and is movable with respect to the outer cylinder A chemical container;
A pressing portion for moving and operating the chemical container;
A puncture needle having one end capable of puncturing a living body and the other end communicating with the inside of the main body of the drug solution container;
A needle support portion provided on the distal end side of the outer cylinder and supporting the puncture needle;
A contact portion that is provided on the distal end side of the outer cylinder and spaced from the needle tip of the puncture needle in the radial direction, and can contact the surface of a living body;
A sealing member for sealing between the outer cylinder and the chemical solution container;
A protective member for sealing the space inside the contact portion,
The aseptic condition of the outer cylinder inner space surrounded by the outer cylinder, the needle support part and the seal member and the space inside the contact part is maintained in an unused state. It is a prefilled syringe.
　本発明のプレフィルドシリンジでは、前記穿刺針は、両頭針である上記（１）に記載のプレフィルドシリンジであるのが好ましい。
　本発明のプレフィルドシリンジでは、前記外筒内空間を外部に開放する通気手段を有するのが好ましい。 In the prefilled syringe of the present invention, the puncture needle is preferably the prefilled syringe according to the above (1), which is a double-ended needle.
In the prefilled syringe of the present invention, it is preferable that the prefilled syringe has a ventilation means for opening the space inside the outer cylinder to the outside.
　本発明のプレフィルドシリンジでは、前記通気手段は、前記保護部材による前記当接部の内側の空間の封止が解除され、前記当接部が生体の表面に当接した当接状態で、前記外筒内空間を外部に開放するものであるのが好ましい。 In the prefilled syringe of the present invention, the venting means is configured such that the space inside the contact portion by the protection member is released and the contact portion is in contact with the surface of the living body, It is preferable to open the in-cylinder space to the outside.
　本発明のプレフィルドシリンジでは、前記通気手段は、前記針支持部に形成され、前記外筒内空間と前記当接部の内側の空間とを連通する第１の通気孔と、前記当接部に形成され、前記当接状態で前記当接部の内側の空間と外部とを連通する第２の通気孔とを有するのが好ましい。 In the prefilled syringe of the present invention, the ventilation means is formed in the needle support portion, and includes a first ventilation hole that communicates the space inside the outer cylinder and the space inside the contact portion, and the contact portion. It is preferable to have a second ventilation hole that is formed and communicates between the space inside the contact portion and the outside in the contact state.
　本発明のプレフィルドシリンジでは、前記第２の通気孔は、前記当接部の側壁に形成された側孔であるのが好ましい。 In the prefilled syringe of the present invention, it is preferable that the second vent hole is a side hole formed in a side wall of the contact portion.
　本発明のプレフィルドシリンジでは、前記保護部材は、前記当接部に離脱可能に装着され、前記第２の通気孔を閉鎖し、これにより、前記外筒内空間および前記当接部の内側の空間の無菌状態が保持されるよう構成されているのが好ましい。 In the prefilled syringe of the present invention, the protection member is detachably attached to the contact portion, and closes the second vent hole, whereby the space inside the outer cylinder and the space inside the contact portion. It is preferable that the sterility is maintained.
　本発明のプレフィルドシリンジでは、前記薬液容器は、前記外筒内に収納されているのが好ましい。 In the prefilled syringe of the present invention, it is preferable that the chemical solution container is accommodated in the outer cylinder.
　本発明のプレフィルドシリンジでは、前記薬液容器は、前記外筒の基端側から外部に突出するように設置されているのが好ましい。 In the prefilled syringe of the present invention, it is preferable that the chemical solution container is installed so as to protrude outward from the base end side of the outer cylinder.
　本発明のプレフィルドシリンジでは、前記穿刺針は、両頭針であり、
　前記薬液容器は、前記薬液容器の本体と前記ガスケットとで囲まれる空間を封止し、前記両頭針の基端側の針先が刺通し得る封止部を有しており、
　前記両頭針の基端側の針先が前記封止部を刺通することにより、該両頭針の基端側が前記薬液容器の本体の内部に連通するよう構成されているのが好ましい。 In the prefilled syringe of the present invention, the puncture needle is a double-ended needle,
The chemical solution container seals a space surrounded by the main body of the chemical solution container and the gasket, and has a sealing portion through which the needle tip on the proximal end side of the double-ended needle can be pierced,
It is preferable that the proximal end side of the double-ended needle is configured so that the proximal end side of the double-ended needle communicates with the inside of the main body of the drug solution container by penetrating the sealing portion.
　本発明のプレフィルドシリンジでは、前記穿刺針は、両頭針であり、
　前記薬液容器の本体は、筒状をなし、
　前記ガスケットは、前記薬液容器の本体の基端側に設けられ、
　前記薬液容器は、前記薬液容器の本体と前記ガスケットとで囲まれる空間を封止し、前記両頭針の基端側の針先が刺通し得る封止部を前記薬液容器の本体の先端側に有しており、
　前記押圧部を先端方向に押圧すると、前記薬液容器が前記外筒に対して先端方向に移動し、前記両頭針の基端側の針先が前記封止部を刺通し、この後、前記ガスケットが前記薬液容器の本体に対して先端方向に移動して、前記両頭針の先端側の針先から前記薬液が排出されるよう構成されているのが好ましい。 In the prefilled syringe of the present invention, the puncture needle is a double-ended needle,
The body of the chemical solution container has a cylindrical shape,
The gasket is provided on the base end side of the main body of the chemical solution container,
The chemical liquid container seals a space surrounded by the main body of the chemical liquid container and the gasket, and has a sealing portion on the distal end side of the main body of the chemical liquid container through which the needle tip on the proximal end side of the double-ended needle can be pierced. And
When the pressing portion is pressed in the distal direction, the chemical solution container moves in the distal direction with respect to the outer cylinder, and the needle tip on the proximal end side of the double-ended needle pierces the sealing portion, and then the gasket is It is preferable that the chemical solution is configured to move in the distal direction with respect to the main body of the chemical solution container and to discharge the chemical solution from the tip of the tip of the double-ended needle.
　本発明のプレフィルドシリンジでは、前記穿刺針は、両頭針であり、
　前記両頭針の基端側の針先が前記ガスケットを刺通することにより、該両頭針の基端側が前記薬液容器の本体の内部に連通するよう構成されているのが好ましい。 In the prefilled syringe of the present invention, the puncture needle is a double-ended needle,
It is preferable that the proximal end side of the double-ended needle is configured to communicate with the inside of the main body of the chemical solution container when the needle tip on the proximal end side of the double-ended needle pierces the gasket.
　本発明のプレフィルドシリンジでは、前記穿刺針は、両頭針であり、
　前記薬液容器の本体は、基端側に底部を有する有底筒状をなす部位を有し、
　前記ガスケットは、前記薬液容器の本体の先端側に設けられ、
　当該プレフィルドシリンジは、さらに、前記外筒内空間に位置し、前記ガスケットに当接し得るガスケット当接部を有しており、
　前記押圧部を先端方向に押圧すると、前記薬液容器が前記外筒に対して先端方向に移動し、前記両頭針の基端側の針先が前記ガスケットを刺通し、この後、前記ガスケットが、前記ガスケット当接部に当接し、前記薬液容器の本体に対して基端方向に移動して、前記両頭針の先端側の針先から前記薬液が排出されるよう構成されているのが好ましい。 In the prefilled syringe of the present invention, the puncture needle is a double-ended needle,
The main body of the chemical solution container has a bottomed cylindrical part having a bottom on the base end side,
The gasket is provided on the distal end side of the main body of the chemical container,
The prefilled syringe further has a gasket abutting portion that is located in the space inside the outer cylinder and can abut against the gasket;
When the pressing portion is pressed in the distal direction, the chemical solution container moves in the distal direction with respect to the outer cylinder, the needle tip on the proximal end side of the double-ended needle pierces the gasket, and then the gasket is It is preferable that the chemical solution is configured to come into contact with the gasket contact portion, move in the proximal direction with respect to the main body of the chemical solution container, and to discharge the chemical solution from the tip end on the distal end side of the double-ended needle.
　本発明のプレフィルドシリンジでは、前記当接部の先端面は、前記穿刺針の針先よりも基端側に位置するのが好ましい。 In the prefilled syringe of the present invention, it is preferable that the distal end surface of the contact portion is located on the proximal end side with respect to the needle tip of the puncture needle.
　本発明のプレフィルドシリンジでは、前記針支持部は、前記穿刺針を支持すると共に、生体の表面に当接し得る凸部を有するのが好ましい。 In the prefilled syringe of the present invention, it is preferable that the needle support portion has a convex portion that supports the puncture needle and can come into contact with the surface of the living body.
図１は、本発明のプレフィルドシリンジの第１実施形態（保護部材を取り外した状態）を示す部分縦断面図である。FIG. 1 is a partial longitudinal sectional view showing a first embodiment (a state in which a protective member is removed) of a prefilled syringe of the present invention. 図２は、図１に示すプレフィルドシリンジの保護部材を装着した状態を示す部分縦断面図である。FIG. 2 is a partial longitudinal sectional view showing a state in which the protective member of the prefilled syringe shown in FIG. 1 is mounted. 図３は、図１に示すプレフィルドシリンジの使用方法を説明するための部分縦断面図である。FIG. 3 is a partial longitudinal sectional view for explaining a method of using the prefilled syringe shown in FIG. 図４は、図１に示すプレフィルドシリンジの使用方法を説明するための部分縦断面図である。FIG. 4 is a partial longitudinal sectional view for explaining a method of using the prefilled syringe shown in FIG. 図５は、図１に示すプレフィルドシリンジの使用方法を説明するための部分縦断面図である。FIG. 5 is a partial longitudinal sectional view for explaining a method of using the prefilled syringe shown in FIG. 図６は、本発明のプレフィルドシリンジの第２実施形態を示す部分縦断面図である。FIG. 6 is a partial longitudinal sectional view showing a second embodiment of the prefilled syringe of the present invention. 図７は、本発明のプレフィルドシリンジの第３実施形態を示す縦断面図である。FIG. 7 is a longitudinal sectional view showing a third embodiment of the prefilled syringe of the present invention. 図８は、本発明のプレフィルドシリンジの第４実施形態における先端側の部分を示す縦断面図である。FIG. 8: is a longitudinal cross-sectional view which shows the part by the side of the front end in 4th Embodiment of the prefilled syringe of this invention.
　以下、本発明のプレフィルドシリンジを添付図面に示す好適な実施形態に基づいて詳細に説明する。 Hereinafter, the prefilled syringe of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
　なお、本発明は、生体に対して各種の薬液を投与するプレフィルドシリンジに適用することができるが、下記の実施形態では、代表的に、本発明を、ワクチンを投与するプレフィルドシリンジに適用した場合について説明する。 Although the present invention can be applied to a prefilled syringe that administers various chemicals to a living body, in the following embodiment, the present invention is typically applied to a prefilled syringe that administers a vaccine. Will be described.
　＜第１実施形態＞
　図１は、本発明のプレフィルドシリンジの第１実施形態（保護部材を取り外した状態）を示す部分縦断面図、図２は、図１に示すプレフィルドシリンジの保護部材を装着した状態を示す部分縦断面図、図３～図５は、それぞれ、図１に示すプレフィルドシリンジの使用方法を説明するための部分縦断面図である。 <First Embodiment>
FIG. 1 is a partial longitudinal sectional view showing a first embodiment of the prefilled syringe of the present invention (a state in which a protective member is removed), and FIG. 2 is a partial longitudinal section showing a state in which the protective member of the prefilled syringe shown in FIG. FIGS. 3 to 5 are partial longitudinal sectional views for explaining a method of using the prefilled syringe shown in FIG.
　なお、以下では、図１～図５中の上側を「基端」、下側を「先端」、右側を「右」、左側を「左」として説明を行う。また、図４および図５においては、生体の図示を省略する。 In the following description, the upper side in FIGS. 1 to 5 is described as “base end”, the lower side is “tip”, the right side is “right”, and the left side is “left”. 4 and 5, the illustration of the living body is omitted.
　図１および図２に示すように、プレフィルドシリンジ１は、外筒（シリンジ外筒）２と、外筒２に対して移動可能な薬液容器７と、薬液容器７を外筒２の軸方向（長手方向）に沿って移動操作する押し子（押圧部）３と、両頭針（穿刺針）６と、両頭針６を支持する針支持部４と、外筒２の先端側に両頭針６の先端側の針先６１を囲むように設けられ、生体の表面に当接し得る当接部５と、外筒２と薬液容器７との間を封止するシール部材７４と、保護部材（キャップ）８とを備えている。 As shown in FIGS. 1 and 2, the prefilled syringe 1 includes an outer cylinder (syringe outer cylinder) 2, a chemical liquid container 7 movable with respect to the outer cylinder 2, and the chemical liquid container 7 in the axial direction of the outer cylinder 2 ( A pusher (pressing portion) 3 that is moved along the longitudinal direction), a double-ended needle (puncture needle) 6, a needle support portion 4 that supports the double-ended needle 6, and a double-ended needle 6 on the distal end side of the outer cylinder 2. A contact portion 5 provided so as to surround the needle tip 61 on the distal end side and capable of contacting the surface of the living body, a seal member 74 that seals between the outer cylinder 2 and the chemical solution container 7, and a protection member (cap) 8 and.
　外筒２は、筒状、図示の構成では円筒状の部材で構成されている。そして、本実施形態では、薬液容器７は、この外筒２内に収納されている。 The outer cylinder 2 is a cylindrical member, which is a cylindrical member in the illustrated configuration. And in this embodiment, the chemical | medical solution container 7 is accommodated in this outer cylinder 2. FIG.
　外筒２の構成材料としては、特に限定されないが、例えば、ポリ塩化ビニル、ポリエチレン、ポリプロピレン、環状ポリオレフィン、ポリスチレン、ポリ－（４－メチルペンテン－１）、ポリカーボネート、アクリル樹脂、アクリルニトリル－ブタジエン－スチレン共重合体、ポリエチレンテレフタレート等のポリエステル、ブタジエン－スチレン共重合体、ポリアミド（例えば、ナイロン６、ナイロン６・６、ナイロン６・１０、ナイロン１２）のような各種樹脂が挙げられるが、その中でも、成形が容易であるという点で、ポリプロピレン、環状ポリオレフィン、ポリエステル、ポリ－（４－メチルペンテン－１）のような樹脂が好ましい。なお、外筒２の構成材料は、内部の視認性を確保するために、実質的に透明であることが好ましい。 The constituent material of the outer cylinder 2 is not particularly limited. For example, polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene- Various resins such as styrene copolymers, polyesters such as polyethylene terephthalate, butadiene-styrene copolymers, and polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12) can be mentioned. Resin such as polypropylene, cyclic polyolefin, polyester, and poly- (4-methylpentene-1) is preferable because it is easy to mold. In addition, it is preferable that the constituent material of the outer cylinder 2 is substantially transparent in order to ensure internal visibility.
　薬液容器７は、容器本体（薬液容器の本体）７１と、容器本体７１内で摺動し得るガスケット７２と、容器本体７１とガスケット７２とで囲まれる空間を封止し、容器本体７１に固定された封止部７３とを有している。そして、容器本体７１とガスケット７２と封止部７３とで囲まれる空間７５に、予め薬液が液密（気密）に収納されている。この空間７５は、ガスケット７２および封止部７３により気密的に封止された密閉空間であり、無菌状態が保持されている。 The chemical liquid container 7 seals a space surrounded by the container main body (main body of the chemical liquid container) 71, a gasket 72 that can slide in the container main body 71, and the container main body 71 and the gasket 72, and is fixed to the container main body 71. And a sealed portion 73. And the chemical | medical solution is beforehand stored in the space 75 enclosed by the container main body 71, the gasket 72, and the sealing part 73 in liquid-tight (airtight). This space 75 is a hermetically sealed space hermetically sealed by the gasket 72 and the sealing portion 73, and is maintained in a sterile state.
　容器本体７１は、筒状、図示の構成では円筒状をなしており、ガスケット７２は、容器本体７１の基端側に設けられ、封止部７３は、容器本体７１の先端側に設けられている。 The container body 71 has a cylindrical shape, and in the illustrated configuration, has a cylindrical shape. The gasket 72 is provided on the proximal end side of the container body 71, and the sealing portion 73 is provided on the distal end side of the container body 71. Yes.
　容器本体７１の構成材料としては、特に限定されないが、例えば、前記外筒２の構成材料と同様のものを用いることができる。なお、容器本体７１の構成材料は、内部の視認性を確保するために、実質的に透明であることが好ましい。 Although it does not specifically limit as a constituent material of the container main body 71, For example, the thing similar to the constituent material of the said outer cylinder 2 can be used. In addition, it is preferable that the constituent material of the container main body 71 is substantially transparent in order to ensure internal visibility.
　また、容器本体７１の外周面には、図示しない目盛りが形成されている。これにより、内部に収納されている薬液の量を把握することができる。 Further, a scale not shown is formed on the outer peripheral surface of the container main body 71. Thereby, the quantity of the chemical | medical solution accommodated in the inside can be grasped | ascertained.
　また、ガスケット７２は、押し子３の先端に連結されている。なお、本実施形態では、ガスケット７２は、予め、押し子３に固定されているが、これに限らず、例えば、ガスケット７２が、使用時に、押し子３に連結されるように構成されていてもよい。さらに、ガスケット７２と押し子３とが連結する構成ではなく、押し子３の先端面によりガスケット７２が押されるように構成されていてもよい。 The gasket 72 is connected to the tip of the pusher 3. In the present embodiment, the gasket 72 is fixed to the pusher 3 in advance. However, the present invention is not limited to this. For example, the gasket 72 is configured to be connected to the pusher 3 at the time of use. Also good. Further, the gasket 72 and the pusher 3 may not be connected to each other, but the gasket 72 may be pushed by the tip surface of the pusher 3.
　ガスケット７２の構成材料としては、特に限定されないが、例えば、天然ゴム、ブチルゴム、イソプレンゴム、ブタジエンゴム、スチレン－ブタジエンゴム、シリコーンゴムのような各種ゴム材料や、ポリウレタン系、ポリエステル系、ポリアミド系、オレフィン系、スチレン系等の各種熱可塑性エラストマー、あるいはそれらの混合物等の弾性材料が挙げられる。 The material constituting the gasket 72 is not particularly limited. For example, various rubber materials such as natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, silicone rubber, polyurethane, polyester, polyamide, Examples thereof include elastic materials such as various thermoplastic elastomers such as olefins and styrenes, or mixtures thereof.
　なお、ガスケット７２は、その少なくとも外周部が前述のような弾性材料で構成されていればよく、例えば、樹脂材料で構成された芯部（図示せず）を有し、この芯部の外周を覆うように弾性材料が配置された構成のものでもよい。 The gasket 72 only needs to have at least an outer peripheral portion made of the elastic material as described above. For example, the gasket 72 has a core portion (not shown) made of a resin material. The thing of the structure by which the elastic material is arrange | positioned so that it may cover may be used.
　また、封止部７３は、両頭針６の基端側の針先６２が刺通し得るよう構成されている。この封止部７３構成材料としては、特に限定されないが、例えば、前記ガスケット７２の構成材料と同様のものを用いることができる。 Further, the sealing portion 73 is configured such that the needle tip 62 on the proximal end side of the double-ended needle 6 can be pierced. The constituent material of the sealing portion 73 is not particularly limited. For example, the same constituent material as that of the gasket 72 can be used.
　また、薬液容器７の空間７５に収納される薬液としては、本実施形態では、例えば、インフルエンザ等の各種の感染症を予防する各種のワクチンが挙げられるが、本発明では、ワクチンには限定されない。なお、ワクチン以外では、例えば、ブドウ糖等の糖質注射液、塩化ナトリウムや乳酸カリウム等の電解質補正用注射液、ビタミン剤、抗生物質注射液、造影剤、ステロイド剤、蛋白質分解酵素阻害剤、脂肪乳剤、抗癌剤、麻酔薬、覚せい剤、麻薬、ヘパリンカルシウム、抗体医薬等が挙げられる。 Moreover, as a chemical | medical solution accommodated in the space 75 of the chemical | medical solution container 7, in this embodiment, although various vaccines which prevent various infections, such as influenza, are mentioned, in this invention, it is not limited to a vaccine. . In addition to 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.
　また、空間７５に収納される薬液の量（空間７５の体積）は、特に限定されないが、例えば、０．０２～２．０ｍＬ程度が好ましく、０．０５～０．８ｍＬ程度がより好ましい。すなわち、プレフィルドシリンジ１は、特に、このような少量の薬液を投与する場合に好適なものである。 The amount of the chemical solution stored in the space 75 (volume of the space 75) is not particularly limited, but is preferably about 0.02 to 2.0 mL, and more preferably about 0.05 to 0.8 mL. That is, the prefilled syringe 1 is particularly suitable when such a small amount of drug solution is administered.
　シール部材７４は、外筒２と薬液容器７との間を封止する部材であり、外筒２側または薬液容器７側に設けられている。図示の構成では、シール部材７４は、容器本体７１の外周面に固定されている。 The seal member 74 is a member that seals between the outer cylinder 2 and the chemical liquid container 7, and is provided on the outer cylinder 2 side or the chemical liquid container 7 side. In the illustrated configuration, the seal member 74 is fixed to the outer peripheral surface of the container main body 71.
　このシール部材７４は、容器本体７１の外周面から側方に突出するように設けられたリブで構成されており、容器本体７１の全周に亘って設けられている。そして、シール部材７４の外筒２側の端部は、外筒２の内周面に、その全周に亘って密着しており、これにより、外筒２の内周面と薬液容器７の容器本体７１の外周面との間が気密的に封止されている。また、このシール部材７４により、外筒２内で薬液容器７が円滑に摺動することができる。 The seal member 74 is composed of ribs provided so as to protrude laterally from the outer peripheral surface of the container main body 71, and is provided over the entire circumference of the container main body 71. The end of the seal member 74 on the outer cylinder 2 side is in close contact with the inner peripheral surface of the outer cylinder 2 over the entire circumference thereof, whereby the inner peripheral surface of the outer cylinder 2 and the chemical container 7 The space between the outer peripheral surface of the container body 71 is hermetically sealed. In addition, the chemical liquid container 7 can smoothly slide in the outer cylinder 2 by the seal member 74.
　シール部材７４の構成材料としては、特に限定されないが、例えば、前記ガスケット７２の構成材料と同様のものを用いることができる。 The constituent material of the seal member 74 is not particularly limited. For example, the same constituent material as that of the gasket 72 can be used.
　なお、シール部材７４は、容器本体７１の外周面ではなく、外筒２の内周面に固定されていてもよい。また、シール部材７４は、外筒２と一体的に成形されていてもよい（例えば、一体成形等）。 The seal member 74 may be fixed to the inner peripheral surface of the outer cylinder 2 instead of the outer peripheral surface of the container body 71. Further, the seal member 74 may be integrally formed with the outer cylinder 2 (for example, integral molding or the like).
　押し子３は、横断面が、例えば十文字状または円形状をなす棒状の本体部３１を有しており、前述したように、この本体部３１の先端にガスケット７２が固定されている。すなわち、押し子３は、薬液容器７に接続され、その薬液容器７の基端（基端部）に設けられる。 The pusher 3 has a rod-like main body 31 whose cross section is, for example, a cross or circular shape, and a gasket 72 is fixed to the tip of the main body 31 as described above. That is, the pusher 3 is connected to the chemical solution container 7 and provided at the base end (base end portion) of the chemical solution container 7.
　また、本体部３１の基端には、円盤状のフランジ３２が形成されている。なお、本体部３１にガスケット７２を固定する方法は、特に限定されず、例えば、本体部３１に雄ネジを形成し、ガスケット７２に、その雄ネジに螺合する雌ネジを形成し、その両者を螺合させる方法等が挙げられる。 Further, a disc-shaped flange 32 is formed at the base end of the main body 31. The method for fixing the gasket 72 to the main body 31 is not particularly limited. For example, a male screw is formed on the main body 31, and a female screw that is screwed to the male screw is formed on the gasket 72. And the like.
　押し子３の構成材料としては、特に限定されないが、例えば、前記外筒２の構成材料と同様のものを用いることができる。 The constituent material of the pusher 3 is not particularly limited, but for example, the same constituent material as that of the outer cylinder 2 can be used.
　両頭針６は、先端側に生体を穿刺可能な鋭利な針先６１を有し、基端側に薬液容器７の封止部７３を刺通可能な鋭利な針先６２を有している。そして、両頭針６の基端側の針先６２が、封止部７３を刺通することにより、その両頭針６の基端側が容器本体７１の内部に連通するよう構成されている。 The double-ended needle 6 has a sharp needle tip 61 that can pierce a living body on the distal end side, and a sharp needle tip 62 that can pierce the sealing portion 73 of the drug solution container 7 on the proximal end side. Then, the proximal end side of the double-ended needle 6 is configured to pierce the sealing portion 73 so that the proximal end side of the double-ended needle 6 communicates with the inside of the container main body 71.
　両頭針６としては、ＩＳＯの医療用針管の基準（ＩＳＯ９６２６：１９９１／Ａｍｄ．１：２００１（Ｅ））で２６～３３Ｇのサイズ（外径：０．２～０．４５ｍｍ）のものを使用することが好ましく、３０～３３Ｇのサイズのものを使用することがより好ましい。 As the double-ended needle 6, one having a size of 26 to 33 G (outer diameter: 0.2 to 0.45 mm) according to the ISO medical needle tube standard (ISO9626: 1991 / Amd.1: 2001 (E)) is used. It is preferable to use one having a size of 30 to 33G.
　両頭針６の先端側および基端側にはそれぞれ刃面を有する刃先が形成されており、その先端側の刃面における両頭針６の軸方向の長さ（以下、「ベベル長」と言う）Ｂは、皮膚上層部の最薄の厚さである１．４ｍｍ（成人）以下であることが好ましく、また、３３Ｇの両頭針（穿刺針）に短ベベルを形成したときのベベル長である約０．５ｍｍ以上であることが好ましい。すなわち、ベベル長Ｂは、０．５～１．４ｍｍの範囲内に設定されることが好ましい。 A blade edge having a blade surface is formed on each of the distal end side and the proximal end side of the double-ended needle 6, and the axial length of the double-ended needle 6 on the distal end side blade surface (hereinafter referred to as “bevel length”). B is preferably 1.4 mm (adult) or less, which is the thinnest thickness of the upper skin layer, and is a bevel length when a short bevel is formed on a 33G double-ended needle (puncture needle). It is preferable that it is 0.5 mm or more. That is, the bevel length B is preferably set within a range of 0.5 to 1.4 mm.
　さらに、ベベル長Ｂは、皮膚上層部の最薄の厚さである０．９ｍｍ（小児）以下であることがより好ましい。すなわち、ベベル長Ｂは、０．５～０．９ｍｍの範囲内に設定されることがより好ましい。 Furthermore, the bevel length B is more preferably 0.9 mm (child) or less, which is the thinnest thickness of the upper skin layer. That is, the bevel length B is more preferably set within a range of 0.5 to 0.9 mm.
　また、両頭針６の皮膚上層部に穿刺される深さ（穿刺深さ）は、両頭針６の後述する凸部４２の先端面から突出している部位の長さ（以下、「突出長」と言う）Ｌにより決定される。 Further, the depth (puncture depth) punctured into the upper skin portion of the double-ended needle 6 is the length of the portion of the double-ended needle 6 that protrudes from the distal end surface of the convex portion 42 described later (hereinafter referred to as “projected length”). Say) determined by L.
　皮膚上層部の厚さは、皮膚の表面から真皮層までの深さに相当し、概ね０．５～３．０ｍｍであるので、両頭針６の突出長Ｌは、０．５～３．０ｍｍの範囲内に設定されることが好ましい。 The thickness of the upper skin portion corresponds to the depth from the surface of the skin to the dermis layer, and is generally 0.5 to 3.0 mm. Therefore, the protruding length L of the double-ended needle 6 is 0.5 to 3.0 mm. It is preferable to set within the range.
　ところで、インフルエンザワクチンの投与部位は、一般に、三角筋である。小児の三角筋における皮膚上層部の厚さは、０．９～１．６ｍｍであり、また、成人の三角筋における皮膚上層部の厚さは、遠位部では、１．４～２．６ｍｍ、中央部では、１．４～２．５ｍｍ、近位部では、１．５～２．５ｍｍである。これらを考慮すると、プレフィルドシリンジ１を三角筋にワクチンを投与する際に使用する場合には、両頭針６の突出長Ｌは、０．９～１．４ｍｍの範囲内に設定することができる。 By the way, the administration site of influenza vaccine is generally the deltoid muscle. The thickness of the upper skin layer in the pediatric deltoid muscle is 0.9 to 1.6 mm, and the upper skin thickness in the adult deltoid muscle is 1.4 to 2.6 mm in the distal portion. The central portion is 1.4 to 2.5 mm, and the proximal portion is 1.5 to 2.5 mm. Considering these, when the prefilled syringe 1 is used when administering a vaccine to the deltoid muscle, the protruding length L of the double-ended needle 6 can be set within a range of 0.9 to 1.4 mm.
　両頭針６の構成材料としては、特に限定されないが、例えば、ステンレス鋼、アルミニウムまたはアルミニウム合金、チタンまたはチタン合金、Ｎｉ－Ｔｉ合金等の超弾性合金等の各種金属材料、ポリフェニレンサルファイド等の各種硬質樹脂材料等が挙げられる。 The constituent material of the double-ended needle 6 is not particularly limited. For example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, superelastic alloy such as Ni-Ti alloy, and various hard materials such as polyphenylene sulfide. Resin material etc. are mentioned.
　針支持部４は、基部４０と、基部４０の先端面の中央部に固定された凸部４２とを有し、外筒２の先端に固定されている。図示の構成では、基部４０は、円盤状をなし、凸部４２は、円柱状をなしている。凸部４２の先端面は、薬液を投与する際（両頭針６を穿刺する際）、生体の表面（表皮）に当接する部位であり、その先端面の形状は、両頭針６の軸に対して垂直な平面である。なお、基部４０と凸部４２とが一体的に形成されていてもよい。また、針支持部４は、外筒２と一体的に形成されていてもよい。 The needle support portion 4 has a base portion 40 and a convex portion 42 fixed to the center portion of the tip surface of the base portion 40, and is fixed to the tip end of the outer cylinder 2. In the illustrated configuration, the base portion 40 has a disk shape, and the convex portion 42 has a cylindrical shape. The tip surface of the convex portion 42 is a part that comes into contact with the surface (skin) of the living body when a drug solution is administered (when the double-ended needle 6 is punctured). Vertical plane. In addition, the base 40 and the convex part 42 may be formed integrally. Further, the needle support portion 4 may be formed integrally with the outer cylinder 2.
　両頭針６は、この針支持部４の中央部に固定され、基部４０および凸部４２により支持されており、その先端側の針先６１は、針支持部４よりも先端側に位置し、基端側の針先６２は、針支持部４よりも基端側に位置している。針支持部４が前記凸部４２を有することにより、両頭針６を生体の所定部位に穿刺する際、凸部４２が表皮に当接し、これにより、その表皮を両頭針６の軸に対して垂直でかつ平らにすることができ、これによって、両頭針６の針先６１を表皮に対して垂直になるように穿刺することができる。 The double-ended needle 6 is fixed to the center portion of the needle support portion 4 and is supported by the base portion 40 and the convex portion 42, and the needle tip 61 on the tip side is located on the tip side from the needle support portion 4, The proximal end needle tip 62 is located closer to the proximal end side than the needle support portion 4. Since the needle support part 4 has the convex part 42, when the double-ended needle 6 is punctured into a predetermined part of the living body, the convex part 42 comes into contact with the epidermis, and thereby the epidermis is brought into contact with the axis of the double-ended needle 6. The needle tip 61 of the double-ended needle 6 can be punctured so as to be perpendicular to the epidermis.
　凸部４２の外周縁（外周面）から両頭針６の外周面までの距離Ｓは、１．４ｍｍ以下に設定されることが好ましく、０．３～１．４ｍｍの範囲内に設定されることがより好ましい。この距離Ｓは、皮膚上層部へ薬液を投与することで形成される水疱に圧力が加わることを考慮して設定される。すなわち、距離Ｓは、凸部４２の先端面の大きさが、皮膚上層部に形成される水疱よりも十分に小さく、その水疱の形成を妨げない程度の大きさになるように設定される。これにより、凸部４２が両頭針６の周囲の表皮を押圧した際に投与された薬液が漏れてしまうことを防止することができる。 The distance S from the outer peripheral edge (outer peripheral surface) of the convex portion 42 to the outer peripheral surface of the double-ended needle 6 is preferably set to 1.4 mm or less, and is set within a range of 0.3 to 1.4 mm. Is more preferable. This distance S 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 distance S is set so that the size of the tip surface of the convex portion 42 is sufficiently smaller than the blisters formed on the upper skin layer and does not hinder the formation of the blisters. Thereby, it can prevent that the chemical | medical solution administered when the convex part 42 pressed the epidermis around the double-headed needle 6 leaks.
　また、針支持部４の基部４０は、両頭針６を穿刺する際に表皮に当接する部位を有している。両頭針６を穿刺する際は、その基部４０の表皮に当接する部位が表皮に当接するまで、当接部５を表皮に押し付けることにより、当接部５および両頭針６が表皮を押圧する力を所定値以上に確保することができる。これにより、両頭針６の凸部４２の先端面から突出している部位（突出長Ｌに相当する部位）が、確実に皮膚内に穿刺される。 Further, the base 40 of the needle support portion 4 has a portion that comes into contact with the epidermis when the double-ended needle 6 is punctured. When the double-ended needle 6 is punctured, the abutment portion 5 and the double-ended needle 6 press the epidermis by pressing the abutment portion 5 against the epidermis until the portion of the base 40 that abuts the epidermis abuts the epidermis. Can be secured above a predetermined value. Thereby, the site | part (part corresponding to the protrusion length L) which protrudes from the front end surface of the convex part 42 of the double-ended needle 6 is reliably punctured in the skin.
　また、基部４０の先端面（下端面）から当接部５の先端面までの距離Ｙは、両頭針６を穿刺する際に当接部５および両頭針６が適切な押圧力で表皮を押圧し、その両頭針６が確実に穿刺されるように設定される。この距離Ｙは、当接部５の内径ｄと、基部４０の外壁面（外周面）から当接部５の外壁面（外周面）までの距離Ｘとに基づいて適宜決定される。例えば、内径ｄが１１ｍｍ、距離Ｘが０．５ｍｍの場合は、距離Ｙは、０．７５～２．６ｍｍの範囲内に設定されることが好ましい。これにより、当接部５および両頭針６が表皮を押圧する押圧力が、基部４０によりその表皮へ確実に伝達（案内）され、両頭針６の針先６１を皮膚上層部へ確実に位置させることができる。 The distance Y from the distal end surface (lower end surface) of the base 40 to the distal end surface of the contact portion 5 is such that when the double-ended needle 6 is punctured, the contact portion 5 and the double-ended needle 6 press the epidermis with an appropriate pressing force. The double-ended needle 6 is set so as to be punctured with certainty. This distance Y is appropriately determined based on the inner diameter d of the contact portion 5 and the distance X from the outer wall surface (outer peripheral surface) of the base portion 40 to the outer wall surface (outer peripheral surface) of the contact portion 5. For example, when the inner diameter d is 11 mm and the distance X is 0.5 mm, the distance Y is preferably set within a range of 0.75 to 2.6 mm. As a result, the pressing force with which the contact portion 5 and the double-ended needle 6 press the epidermis is reliably transmitted (guided) to the epidermis by the base 40, and the needle tip 61 of the double-ended needle 6 is reliably positioned on the upper skin portion. be able to.
　また、針支持部４には、その針支持部４を貫通する通気孔（第１の通気孔）４１が形成されている。図示の構成では、通気孔４１は、基部４０における凸部４２のない位置に形成されている。この通気孔４１により、外筒２と針支持部４とシール部材７４とで囲まれる外筒内空間２１と、後述する当接部５の内側の空間５２とが連通する。なお、通気孔４１の数は、本実施形態では、１つであるが、これに限らず、複数であってもよい。 Further, the needle support portion 4 is formed with a vent hole (first vent hole) 41 penetrating the needle support portion 4. In the illustrated configuration, the vent hole 41 is formed at a position where the convex portion 42 is not provided in the base portion 40. The vent hole 41 allows communication between the outer cylinder inner space 21 surrounded by the outer cylinder 2, the needle support portion 4, and the seal member 74 and the space 52 inside the contact portion 5 described later. The number of vent holes 41 is one in the present embodiment, but is not limited to this and may be plural.
　針支持部４の構成材料としては、特に限定されないが、例えば、前記外筒２の構成材料と同様のものを用いることができる。 Although it does not specifically limit as a constituent material of the needle support part 4, For example, the thing similar to the constituent material of the said outer cylinder 2 can be used.
　当接部５は、筒状、図示の構成では円筒状をなし、針支持部４の基部４０の先端面（先端部）に固定されている。この場合、当接部５は、両頭針６の先端側の針先６１からその両頭針６の半径方向に離間して設けられている。 The abutting portion 5 has a cylindrical shape, a cylindrical shape in the illustrated configuration, and is fixed to the tip surface (tip portion) of the base portion 40 of the needle support portion 4. In this case, the contact portion 5 is provided away from the needle tip 61 on the distal end side of the double-ended needle 6 in the radial direction of the double-ended needle 6.
　当接部５の先端面は、両頭針６の先端側の針先６１よりも基端側で、かつ、凸部４２の先端面よりも基端側に位置している。両頭針６を穿刺する際は、まず、凸部４２の先端面が表皮に当接し、その後、当接部５の先端面が表皮に当接する。このように当接部５の先端面が表皮に当接することで、プレフィルドシリンジ１が安定し、両頭針６を表皮に対して垂直な姿勢に保つことができる。 The distal end surface of the abutting portion 5 is located on the proximal side with respect to the distal end side 61 of the double-ended needle 6 and on the proximal side with respect to the distal end surface of the convex portion 42. When puncturing the double-ended needle 6, first, the tip surface of the convex portion 42 comes into contact with the epidermis, and then the tip surface of the contact portion 5 comes into contact with the epidermis. Thus, the prefilled syringe 1 is stabilized by the front end surface of the contact portion 5 being in contact with the epidermis, and the double-ended needle 6 can be maintained in a posture perpendicular to the epidermis.
　なお、当接部５の先端面は、両頭針６の軸方向において、凸部４２の先端面と同じ位置（凸部４２の先端面と同一平面上）に位置していてもよく、また、凸部４２の先端面よりも先端側に位置していてもよい。これらの場合も両頭針６を表皮に対して垂直な姿勢に保つことができる。 The front end surface of the contact portion 5 may be located at the same position as the front end surface of the convex portion 42 (on the same plane as the front end surface of the convex portion 42) in the axial direction of the double-ended needle 6. You may be located in the front end side rather than the front end surface of the convex part 42. FIG. Also in these cases, the double-ended needle 6 can be maintained in a posture perpendicular to the epidermis.
　また、当接部５を表皮に押し付けた際の表皮の盛り上がりを考慮すると、両頭針６の軸方向における当接部５の先端面と凸部４２の先端面との距離ｒは、１．３ｍｍ以下に設定されることが好ましい。 Further, in consideration of the swelling of the skin when the contact portion 5 is pressed against the skin, the distance r between the tip surface of the contact portion 5 and the tip surface of the convex portion 42 in the axial direction of the double-ended needle 6 is 1.3 mm. It is preferable to set as follows.
　また、当接部５の内壁面（内周面）から凸部４２の外周縁までの距離Ｔは、４ｍｍ以上に設定されることが好ましく、特に上限はない。しかしながら、距離Ｔに対応して当接部５の外径が大きくなるので、その距離Ｔが大き過ぎると、小児のような細い腕に両頭針６を穿刺する場合には、当接部５の先端面全体を表皮に当接させることが難しくなる。このため、距離Ｔは、小児の腕の細さ等を考慮して、１５ｍｍ以下に設定されることが好ましい。すなわち、距離Ｔは、４～１５ｍｍの範囲内に設定されることが好ましい。 The distance T from the inner wall surface (inner circumferential surface) of the contact portion 5 to the outer peripheral edge of the convex portion 42 is preferably set to 4 mm or more, and there is no particular upper limit. However, since the outer diameter of the contact portion 5 increases corresponding to the distance T, if the distance T is too large, when the double-ended needle 6 is punctured into a thin arm such as a child, the contact portion 5 It becomes difficult to bring the entire tip surface into contact with the epidermis. Therefore, the distance T is preferably set to 15 mm or less in consideration of the thinness of the child's arm and the like. That is, the distance T is preferably set within a range of 4 to 15 mm.
　また、当接部５の内径ｄは、皮膚上層部に形成される水疱の直径と同等であるか、または、その直径よりも大きい値に設定されることが好ましい。なお、凸部４２の外周縁から両頭針６の外周面までの距離Ｓが０．３ｍｍ以上であれば、その凸部４２が皮膚内に進入することはない。したがって、当接部５の内壁面から凸部４２の外周縁までの距離Ｔの好適値（４ｍｍ以上）と、前記距離Ｓの好適値（０．３ｍｍ以上）とを考慮すると、当接部５の内径ｄは、９ｍｍ以上に設定されることが好ましい。 Further, the inner diameter d of the contact portion 5 is preferably set to a value equal to or larger than the diameter of the blister formed in the upper skin layer. In addition, if the distance S from the outer periphery of the convex part 42 to the outer peripheral surface of the double-ended needle 6 is 0.3 mm or more, the convex part 42 does not enter the skin. Therefore, considering the preferable value (4 mm or more) of the distance T from the inner wall surface of the contact part 5 to the outer peripheral edge of the convex part 42 and the preferable value (0.3 mm or more) of the distance S, the contact part 5 The inner diameter d is preferably set to 9 mm or more.
　薬液を投与する際は、図３（ａ）および（ｂ）に示すように、この当接部５の先端面および凸部４２の先端面を生体の対象部位における表皮に当接させ、所定の強さで押し付ける。これにより、当接部５の内側における当接部５の先端面に当接していない部位の表皮が山状に盛り上がると共に、凸部４２の先端面に当接している部位の表皮が両頭針６の軸に対して垂直でかつ平らになり、両頭針６の先端側の針先６１が生体に穿刺される。両頭針６の穿刺深さは、当接部５の先端面および凸部４２の先端面が表皮に当接することで、両頭針６と表皮との位置関係が規制されることにより、目標の穿刺深さとなる。なお、図３（ａ）に示す状態は、図３（ｂ）に示す状態に至る前の状態である。 When administering the drug solution, as shown in FIGS. 3 (a) and 3 (b), the tip surface of the contact portion 5 and the tip surface of the convex portion 42 are brought into contact with the epidermis in the target region of the living body, Press with strength. As a result, the epidermis of the part that is not in contact with the tip surface of the contact part 5 on the inner side of the contact part 5 rises in a mountain shape, and the epidermis of the part that is in contact with the tip surface of the convex part 42 is the double-ended needle 6. The needle tip 61 on the tip side of the double-ended needle 6 is punctured into the living body. The puncture depth of the double-ended needle 6 is such that the positional relationship between the double-ended needle 6 and the epidermis is regulated by the front end surface of the contact portion 5 and the front end surface of the convex portion 42 being in contact with the epidermis. Become deep. The state shown in FIG. 3A is a state before reaching the state shown in FIG.
　また、当接部５には、その当接部５を貫通する通気孔（第２の通気孔）５１が形成されている。この通気孔５１により、当接部５の先端面が生体の表面に当接した当接状態で、当接部５の内側の空間５２と、外部とを連通させることができる。したがって、この通気孔５１および前記針支持部４の通気孔４１により、外筒内空間２１を外部に開放する通気手段が構成される。 Further, a vent hole (second vent hole) 51 penetrating the abutting portion 5 is formed in the abutting portion 5. The vent hole 51 allows the space 52 inside the contact portion 5 to communicate with the outside in a contact state in which the tip surface of the contact portion 5 contacts the surface of the living body. Therefore, the vent hole 51 and the vent hole 41 of the needle support portion 4 constitute a vent means for opening the outer cylinder space 21 to the outside.
　また、通気孔５１は、当接部５の側壁に形成された側孔であり、図示の構成では、当接部５の基端側に配置されている。通気孔５１を基端側に配置することにより、当接部５の先端面を生体の対象部位における表皮に押し付けた際に山状に盛り上がった表皮で、その通気孔５１が塞がれてしまうことを防止することができる。 Further, the vent hole 51 is a side hole formed in the side wall of the contact portion 5, and is arranged on the proximal end side of the contact portion 5 in the illustrated configuration. By disposing the vent hole 51 on the base end side, the vent hole 51 is blocked by a skin that swells in a mountain shape when the distal end surface of the abutment portion 5 is pressed against the epidermis in the target region of the living body. This can be prevented.
　なお、通気孔５１の数は、本実施形態では、１つであるが、これに限らず、複数であってもよい。 In addition, although the number of the vent holes 51 is one in the present embodiment, the number is not limited to this and may be plural.
　当接部５の構成材料としては、特に限定されないが、例えば、前記外筒２の構成材料と同様のものを用いることができる。 Although it does not specifically limit as a constituent material of the contact part 5, For example, the thing similar to the constituent material of the said outer cylinder 2 can be used.
　保護部材８は、図２に示すように、当接部５の内側の空間５２を封止する部材であり、未使用の状態では、当接部５に離脱可能に装着されている。 As shown in FIG. 2, the protection member 8 is a member that seals the space 52 inside the contact portion 5, and is detachably attached to the contact portion 5 in an unused state.
　この保護部材８は、先端側に底部を有する有底の筒状、図示の構成では有底の円筒状をなしており、保護部材８が当接部５に装着されることにより、通気孔５１が閉鎖され、当接部５の内側の空間５２が気密的に封止されるように構成されている。 The protective member 8 has a bottomed cylindrical shape having a bottom portion on the distal end side, and has a bottomed cylindrical shape in the configuration shown in the drawing. Is closed, and the space 52 inside the contact portion 5 is hermetically sealed.
　未使用の状態では、保護部材８で当接部５の内側の空間５２が気密的に封止され、前記シール部材７４で外筒２の内周面と容器本体７１の外周面との間が気密的に封止されることにより、外筒内空間２１および当接部５の内側の空間５２が密閉され、その外筒内空間２１および空間５２の無菌状態が保持されている。 In an unused state, the space 52 inside the contact portion 5 is hermetically sealed by the protection member 8, and the seal member 74 provides a space between the inner peripheral surface of the outer cylinder 2 and the outer peripheral surface of the container main body 71. By sealing hermetically, the outer cylinder inner space 21 and the space 52 inside the contact portion 5 are sealed, and the outer cylinder inner space 21 and the space 52 are maintained in a sterile state.
　また、プレフィルドシリンジを使用する際は、保護部材８は、図１に示すように、当接部５から取り外される。これにより、当接部５の内側の空間５２の封止が解除される。図３（ｂ）に示すように、この当接部５の内側の空間５２の封止が解除され、当接部５の先端面が生体の表面に当接した当接状態においては、当接部５の通気孔５１および針支持部４の通気孔４１により、外筒内空間２１および当接部５の内側の空間５２は、外部に開放される。 Further, when the prefilled syringe is used, the protective member 8 is removed from the contact portion 5 as shown in FIG. Thereby, sealing of the space 52 inside the contact part 5 is cancelled | released. As shown in FIG. 3B, in the contact state in which the space 52 inside the contact part 5 is released and the tip surface of the contact part 5 is in contact with the surface of the living body, the contact is made. By the vent hole 51 of the portion 5 and the vent hole 41 of the needle support portion 4, the outer cylinder inner space 21 and the space 52 inside the contact portion 5 are opened to the outside.
　ここで、図３（ｃ）および（ｄ）に示すように、針支持部４の基部４０の外周部、すなわち、基部４０における外筒２および当接部５よりも外周側（外側）の部位に、その基部４０を貫通する通気孔（第３の通気孔）４３が形成されていてもよい。これにより、図３（ｄ）に示すように、当接部５の先端面が生体の表面に当接した当接状態において、生体の表面と基部４０の外周面とが密着したとしても、その通気孔４３により、外筒内空間２１および当接部５の内側の空間５２は、外部に開放される。なお、この場合は、通気孔４１、４３および５１により、通気手段が構成される。また、図３（ｃ）は、図３（ａ）に対応し、図３（ｄ）は、図３（ｂ）に対応している。なお、通気孔４３の数は、図示の構成では、１つであるが、これに限らず、複数であってもよい。 Here, as shown in FIGS. 3C and 3D, the outer peripheral portion of the base portion 40 of the needle support portion 4, that is, the outer peripheral side (outside) portion of the base portion 40 with respect to the outer cylinder 2 and the contact portion 5. Further, a vent hole (third vent hole) 43 penetrating the base portion 40 may be formed. Thereby, as shown in FIG. 3 (d), even when the front surface of the contact portion 5 is in contact with the surface of the living body, even if the surface of the living body and the outer peripheral surface of the base portion 40 are in close contact with each other, The vent hole 43 opens the outer cylinder inner space 21 and the space 52 inside the contact portion 5 to the outside. In this case, the ventilation means is constituted by the ventilation holes 41, 43 and 51. 3C corresponds to FIG. 3A, and FIG. 3D corresponds to FIG. 3B. The number of the vent holes 43 is one in the illustrated configuration, but is not limited to this and may be plural.
　保護部材８の構成材料としては、特に限定されないが、例えば、前記外筒２の構成材料や、前記ガスケット７２の構成材料と同様のものを用いることができる。 Although it does not specifically limit as a constituent material of the protection member 8, For example, the thing similar to the constituent material of the said outer cylinder 2 and the constituent material of the said gasket 72 can be used.
　なお、このプレフィルドシリンジ１では、必要な各部が滅菌された後、当接部５に保護部材８が装着され、前述したように、外筒内空間２１および当接部５の内側の空間５２の無菌状態が保持され、これにより、両頭針６の無菌状態が保持される。 In the prefilled syringe 1, after each necessary part is sterilized, the protective member 8 is attached to the contact part 5, and as described above, the outer cylinder inner space 21 and the space 52 inside the contact part 5. The sterility is maintained, whereby the sterility of the double-ended needle 6 is maintained.
　次に、プレフィルドシリンジ１の使用方法の一例について説明する。
　［１］　プレフィルドシリンジ１を使用する際は、まず、図１に示すように、用意したプレフィルドシリンジ１の当接部５から保護部材８を取り外す。これにより、薬液を投与する準備が完了する。このように、このプレフィルドシリンジ１では、容易かつ迅速に、薬液の投与の準備を行うことができる。 Next, an example of how to use the prefilled syringe 1 will be described.
[1] When using the prefilled syringe 1, first, as shown in FIG. 1, the protective member 8 is removed from the contact portion 5 of the prepared prefilled syringe 1. Thereby, the preparation for administering the drug solution is completed. As described above, the prefilled syringe 1 can easily and quickly prepare for the administration of the drug solution.
　［２］　次に、図３（ａ）および（ｂ）（または図３（ｃ）および（ｄ））に示すように、当接部５の先端面および凸部４２の先端面を、例えば、腕等の薬液を投与する部位における表皮に当接させ、所定の強さで押し付ける。これにより、当接部５の内側における当接部５の先端面に当接していない部位の表皮が山状に盛り上がると共に、凸部４２の先端面に当接している部位の表皮が両頭針６の軸に対して垂直でかつ平らになり、両頭針６の先端側の針先６１が生体に穿刺される。この際、当接部５および凸部４２により、両頭針６と表皮との位置関係が規制されることによって、針先６１は、真皮に到達する。このように、このプレフィルドシリンジ１では、容易かつ確実に、両頭針６の針先６１を真皮に穿刺することができる。 [2] Next, as shown in FIGS. 3A and 3B (or FIGS. 3C and 3D), the front end surface of the contact portion 5 and the front end surface of the convex portion 42 are, for example, It is brought into contact with the epidermis at the site to which a drug solution such as an arm is administered and pressed with a predetermined strength. As a result, the epidermis of the part that is not in contact with the tip surface of the contact part 5 on the inner side of the contact part 5 rises in a mountain shape, and the epidermis of the part that is in contact with the tip surface of the convex part 42 is the double-ended needle 6. The needle tip 61 on the tip side of the double-ended needle 6 is punctured into the living body. At this time, the needle tip 61 reaches the dermis by restricting the positional relationship between the double-ended needle 6 and the epidermis by the contact portion 5 and the convex portion 42. Thus, with this prefilled syringe 1, the needle tip 61 of the double-ended needle 6 can be punctured into the dermis easily and reliably.
　［３］　次に、押し子３のフランジ３２に指を当て、押し子３を先端方向に押圧、すなわち移動操作する。これにより、図４に示すように、薬液容器７が外筒２内で、その外筒に対して先端方向に移動する。この際、薬液容器７は、シール部材７４を介し、外筒２の内面に沿って円滑に摺動する。そして、両頭針６の基端側の針先６２が薬液容器７の封止部７３を刺通し、両頭針６の基端側が容器本体７１の内部に連通する。これにより、ガスケット７２が容器本体７１に対して先端方向に移動し得るようになる。なお、薬液容器７は、針支持部４に当接して止まる。 [3] Next, a finger is applied to the flange 32 of the pusher 3, and the pusher 3 is pressed in the distal direction, that is, moved. As a result, as shown in FIG. 4, the chemical solution container 7 moves in the distal direction in the outer cylinder 2 with respect to the outer cylinder. At this time, the chemical solution container 7 smoothly slides along the inner surface of the outer cylinder 2 via the seal member 74. The needle tip 62 on the proximal end side of the double-ended needle 6 penetrates the sealing portion 73 of the chemical solution container 7, and the proximal end side of the double-ended needle 6 communicates with the inside of the container main body 71. As a result, the gasket 72 can move in the distal direction with respect to the container body 71. In addition, the chemical | medical solution container 7 contact | abuts to the needle support part 4, and stops.
　さらに押し子３を先端方向に押圧すると、図４に示すように、ガスケット７２が容器本体７１内で先端方向に摺動し、薬液容器７内の薬液が両頭針６内を通り、先端側の針先６１から排出され、目的の部位に投与される。 When the pusher 3 is further pressed in the distal direction, as shown in FIG. 4, the gasket 72 slides in the distal direction in the container body 71, and the chemical solution in the chemical solution container 7 passes through the double-ended needle 6, It is discharged from the needle tip 61 and administered to the target site.
　ここで、このプレフィルドシリンジ１では、図３（ｂ）に示すように、通気孔４１および５１が設けられているので、押し子３を先端方向に移動操作する際、外筒内空間２１の空気は、通気孔４１、当接部５の内側の空間５２および通気孔５１を経て外部に排出される。また、図３（ｄ）に示すように、さらに通気孔４３が設けられている場合は、押し子３を先端方向に移動操作する際、外筒内空間２１の空気は、通気孔４１、当接部５の内側の空間５２および通気孔５１を経て、または、さらに通気孔４３を経て、外部に排出される。これにより、外筒内空間２１および当接部５の内側の空間５２のそれぞれの圧力の上昇を防止することができる。これによって、前記押し子３の移動操作を容易かつ円滑に行うことができ、また、薬液の投与が終了した後、押し子３から手を離したとしても、その押し子３が基端方向に移動してしまうことを防止することができる。 Here, in this prefilled syringe 1, as shown in FIG. 3 (b), since air holes 41 and 51 are provided, when the pusher 3 is moved in the distal direction, the air in the outer cylinder inner space 21 is moved. Is discharged to the outside through the vent hole 41, the space 52 inside the abutting portion 5 and the vent hole 51. Further, as shown in FIG. 3 (d), when the vent hole 43 is further provided, when the pusher 3 is moved in the distal direction, the air in the outer cylinder inner space 21 flows into the vent hole 41. The air is discharged to the outside through the space 52 and the vent hole 51 inside the contact portion 5 or through the vent hole 43. Thereby, it is possible to prevent an increase in pressure in each of the outer cylinder inner space 21 and the space 52 inside the contact portion 5. Thereby, the moving operation of the pusher 3 can be performed easily and smoothly. Even if the hand is released from the pusher 3 after the administration of the chemical solution is finished, the pusher 3 is moved in the proximal direction. It can prevent moving.
　以上説明したように、このプレフィルドシリンジ１によれば、必要量の薬液が収納された薬液容器７を有しているので、薬液の無駄を防止することができ、経済的である。 As described above, according to the prefilled syringe 1, the chemical liquid container 7 in which a necessary amount of the chemical liquid is stored is provided, so that waste of the chemical liquid can be prevented and it is economical.
　また、予め、薬液容器７および両頭針６が設置されており、未使用の状態で、両頭針６が配置されている外筒内空間２１および当接部５の内側の空間５２の無菌状態が保持されているので、保護部材８を取り外すだけの操作で、容易かつ迅速に、薬液の投与の準備を行うことができる。 In addition, the chemical solution container 7 and the double-ended needle 6 are installed in advance, and the sterilized state of the outer cylinder inner space 21 in which the double-ended needle 6 is arranged and the space 52 inside the contact portion 5 is not used. Since it is held, preparation for administration of the drug solution can be performed easily and quickly by simply removing the protective member 8.
　また、薬液を投与する際は、当接部５の先端面および凸部４２の先端面が表皮に当接することにより、両頭針６と表皮との位置関係が規制され、これにより、容易かつ確実に、両頭針６を目標の穿刺深さに穿刺することができる。 In addition, when the drug solution is administered, the positional relationship between the double-ended needle 6 and the epidermis is regulated by the tip surface of the abutment portion 5 and the tip surface of the convex portion 42 coming into contact with the epidermis. In addition, the double-ended needle 6 can be punctured to a target puncture depth.
　そして、このプレフィルドシリンジ１では、通気孔４１および５１が設けられているので、押し子３を先端方向に移動操作する際、外筒内空間２１および当接部５の内側の空間５２のそれぞれの圧力の上昇を防止することができ、これにより、前記押し子３の移動操作を容易かつ円滑に行うことができる。 In the prefilled syringe 1, the vent holes 41 and 51 are provided. Therefore, when the pusher 3 is moved in the distal direction, the outer cylinder inner space 21 and the inner space 52 of the contact portion 5 are respectively An increase in pressure can be prevented, so that the moving operation of the pusher 3 can be performed easily and smoothly.
　また、通気孔４１および５１が設けられているので、プレフィルドシリンジ１の組み立てを容易に行うことができる。すなわち、通気孔４１および５１が設けられていない場合は、外筒内空間２１は密閉されているので、シール部材７４が設けられた薬液容器７を外筒２内に挿入する際、外筒内空間２１を減圧する工程を必要とするが、このプレフィルドシリンジ１では、前記減圧工程が不要であり、手間がかからず、迅速に、組み立てを行うことができる。 Further, since the vent holes 41 and 51 are provided, the prefilled syringe 1 can be easily assembled. That is, when the vent holes 41 and 51 are not provided, the outer cylinder inner space 21 is hermetically sealed. Therefore, when the chemical container 7 provided with the seal member 74 is inserted into the outer cylinder 2, Although the process of depressurizing the space 21 is required, the prefilled syringe 1 does not require the depressurization process, takes less time, and can be assembled quickly.
　ここで、本実施形態では、通気手段として通気孔４１および５１を設けたが、本発明では、これに限定されず、通気手段として、例えば、外筒２に、外筒内空間２１とと外部とを連通する通気孔（図示せず）を設けてもよい。この通気孔は、外筒２の先端部の側壁に形成された側孔であり、薬液容器７が針支持部４に当接した状態で、シール部材７４よりも先端側に位置していることが好ましい。 Here, in the present embodiment, the ventilation holes 41 and 51 are provided as ventilation means. However, in the present invention, the ventilation holes are not limited thereto. A vent hole (not shown) that communicates with each other may be provided. The vent hole is a side hole formed in the side wall of the distal end portion of the outer cylinder 2, and is located on the distal end side with respect to the seal member 74 in a state where the chemical liquid container 7 is in contact with the needle support portion 4. Is preferred.
　また、前記通気孔には、空気を通過させ、菌を通過させない除菌用のフィルターが設けられていることが好ましい。 In addition, it is preferable that a sterilizing filter that allows air to pass but does not allow bacteria to pass through is provided in the vent hole.
　なお、前記外筒２に通気孔を設ける場合、さらに、前記通気孔４１または前記通気孔５１を設けてもよい。 In addition, when providing the said outer cylinder 2 with a vent hole, you may provide the said vent hole 41 or the said vent hole 51 further.
　＜第２実施形態＞
　図６は、本発明のプレフィルドシリンジの第２実施形態を示す部分縦断面図である。なお、以下では、図６中の上側を「基端」、下側を「先端」、右側を「右」、左側を「左」として説明を行う。 Second Embodiment
FIG. 6 is a partial longitudinal sectional view showing a second embodiment of the prefilled syringe of the present invention. In the following description, the upper side in FIG. 6 is “base end”, the lower side is “tip”, the right side is “right”, and the left side is “left”.
　以下、第２実施形態について、前述した第１実施形態との相違点を中心に説明し、同様の事項については、その説明を省略する。 Hereinafter, the second embodiment will be described with a focus on differences from the first embodiment described above, and description of similar matters will be omitted.
　図６に示すように、第２実施形態のプレフィルドシリンジ１では、外筒２の軸方向の長さが、薬液容器７の軸方向の長さよりも短く設定されている。また、また、シール部材７４は、薬液容器７の容器本体７１の基端部に固定されている。そして、薬液容器７は、外筒２の基端側から外部に突出するように設置されている。 As shown in FIG. 6, in the prefilled syringe 1 of the second embodiment, the axial length of the outer cylinder 2 is set shorter than the axial length of the chemical liquid container 7. Further, the seal member 74 is fixed to the proximal end portion of the container main body 71 of the chemical solution container 7. And the chemical | medical solution container 7 is installed so that it may protrude outside from the base end side of the outer cylinder 2. As shown in FIG.
　また、ガスケット７２は、容器本体７１の途中、図示の構成では、容器本体７１の中央よりも先端側に配置されている。これにより、押し子３を移動操作（押圧）する際、容器本体７１が押し子３のガイドとなり、その移動操作を容易に行うことができる。 Further, the gasket 72 is disposed in the middle of the container main body 71, in the illustrated configuration, closer to the tip than the center of the container main body 71. Accordingly, when the pusher 3 is moved (pressed), the container body 71 serves as a guide for the pusher 3 and can be easily moved.
　ここで、プレフィルドシリンジ１を組み立てる際は、外筒２内に容易に薬液容器７を挿入することができるように、例えば、外筒２の内面に潤滑剤を塗布するが、このプレフィルドシリンジ１によれば、第１実施形態に比べ、外筒２の軸方向の長さが短いので、プレフィルドシリンジ１を組み立てる際に、外筒２の内面に潤滑剤を塗布する手間および時間を減少させることができ、これにより、容易かつ迅速に組み立を行うことができる。 Here, when assembling the prefilled syringe 1, for example, a lubricant is applied to the inner surface of the outer cylinder 2 so that the chemical container 7 can be easily inserted into the outer cylinder 2. According to this, since the axial length of the outer cylinder 2 is shorter than that in the first embodiment, it is possible to reduce labor and time for applying the lubricant to the inner surface of the outer cylinder 2 when assembling the prefilled syringe 1. This makes it possible to assemble easily and quickly.
　また、このプレフィルドシリンジ１によれば、前述した第１実施形態と同様の効果が得られる。 Moreover, according to this prefilled syringe 1, the same effect as 1st Embodiment mentioned above is acquired.
　なお、シール部材７４は、容器本体７１の外周面ではなく、外筒２の内周面に固定されていてもよい。また、シール部材７４は、外筒２と一体的に成形されていてもよい（例えば、一体成形等）。 The seal member 74 may be fixed to the inner peripheral surface of the outer cylinder 2 instead of the outer peripheral surface of the container body 71. Further, the seal member 74 may be integrally formed with the outer cylinder 2 (for example, integral molding or the like).
　＜第３実施形態＞
　図７は、本発明のプレフィルドシリンジの第３実施形態を示す縦断面図である。なお、以下では、図７中の上側を「基端」、下側を「先端」、右側を「右」、左側を「左」として説明を行う。 <Third Embodiment>
FIG. 7 is a longitudinal sectional view showing a third embodiment of the prefilled syringe of the present invention. In the following description, the upper side in FIG. 7 is referred to as “base end”, the lower side as “tip”, the right side as “right”, and the left side as “left”.
　以下、第３実施形態について、前述した第２実施形態との相違点を中心に説明し、同様の事項については、その説明を省略する。 Hereinafter, the third embodiment will be described with a focus on differences from the second embodiment described above, and description of similar matters will be omitted.
　図７（ａ）に示すように、第３実施形態のプレフィルドシリンジ１では、薬液容器７は、容器本体７１と、容器本体７１内で摺動し得るガスケット７２とを有している。 7A, in the prefilled syringe 1 of the third embodiment, the chemical liquid container 7 has a container main body 71 and a gasket 72 that can slide in the container main body 71.
　容器本体７１は、その軸方向の途中に、その容器本体７１の内部を先端側の部位と基端側の部位とに仕切る仕切部（底部）７７を有している。すなわち、容器本体７１は、前記仕切部７７で構成される底部を基端側に有する有底の筒状をなす部位、図示の構成では有底の円筒状をなす部位を有しており、ガスケット７２は、容器本体７１の先端部（先端側）に設けられている。そして、容器本体７１とガスケット７２とで囲まれる空間７６に、予め薬液が液密（気密）に収納されている。この空間７６は、ガスケット７２により気密的に封止された密閉空間であり、無菌状態が保持されている。 The container main body 71 has a partition part (bottom part) 77 that partitions the inside of the container main body 71 into a distal end portion and a proximal end portion in the middle of the axial direction. That is, the container main body 71 has a bottomed cylindrical portion having a bottom portion constituted by the partitioning portion 77 on the proximal end side, and has a bottomed cylindrical portion in the illustrated configuration, and a gasket. 72 is provided at the distal end (front end side) of the container body 71. And the chemical | medical solution is beforehand stored in the space 76 enclosed by the container main body 71 and the gasket 72 liquid-tightly (airtight). This space 76 is a hermetically sealed space hermetically sealed by the gasket 72 and is maintained in a sterile state.
　なお、容器本体７１の仕切部７７の位置は、図示の構成では、容器本体７１の軸方向の中間部（ほぼ中間位置）であるが、これに限らず、例えば、基端方向または先端方向に所定距離ずれていてもよく、また、容器本体７１の軸方向の基端部であってもよい。 The position of the partition portion 77 of the container main body 71 is the intermediate portion (substantially intermediate position) in the axial direction of the container main body 71 in the configuration shown in the figure, but is not limited to this, for example, in the proximal direction or the distal direction It may be shifted by a predetermined distance, or may be the proximal end portion of the container body 71 in the axial direction.
　また、容器本体７１の基端部には、薬液容器７を外筒２の軸方向（長手方向）に沿って移動操作する押圧部として、フランジ３２が設けられている。なお、図示の構成では、容器本体７１とフランジ３２とは、一体的に形成されているが、これに限らず、例えば、容器本体７１とフランジ３２とを別部材で構成し、これらを接着剤により接着または融着等で接合してもよい。 Further, a flange 32 is provided at the base end portion of the container main body 71 as a pressing portion for moving and operating the chemical liquid container 7 along the axial direction (longitudinal direction) of the outer cylinder 2. In the illustrated configuration, the container main body 71 and the flange 32 are integrally formed. However, the present invention is not limited to this, and for example, the container main body 71 and the flange 32 are configured as separate members, and these are adhesives. May be joined by adhesion or fusion.
　また、プレフィルドシリンジ１は、外筒内空間２１に位置し、ガスケット７２に当接し得るガスケット当接部９を有している。このガスケット当接部９は、筒状をなし、針支持部４の基端面の中央部に設置されている。そして、両頭針６は、ガスケット当接部９を挿通しており、その基端側の針先６２は、ガスケット当接部９よりも基端側に位置している。 The prefilled syringe 1 has a gasket abutting portion 9 that is located in the outer cylinder inner space 21 and can abut against the gasket 72. The gasket contact portion 9 has a cylindrical shape and is installed at the center of the proximal end surface of the needle support portion 4. The double-ended needle 6 is inserted through the gasket contact portion 9, and the proximal end side needle tip 62 is located on the proximal end side with respect to the gasket contact portion 9.
　このプレフィルドシリンジでは、フランジ３２を先端方向に押圧すると、薬液容器７が外筒に対して先端方向に移動する。そして、両頭針６の基端側の針先６２が薬液容器７のガスケット７２を刺通し、両頭針６の基端側が容器本体７１の内部に連通する。これにより、ガスケット７２が容器本体７１に対して基端方向に移動し得るようになる。 In this prefilled syringe, when the flange 32 is pressed in the distal direction, the chemical container 7 moves in the distal direction with respect to the outer cylinder. The needle tip 62 on the proximal end side of the double-ended needle 6 penetrates the gasket 72 of the chemical solution container 7, and the proximal end side of the double-ended needle 6 communicates with the inside of the container main body 71. As a result, the gasket 72 can move in the proximal direction with respect to the container body 71.
　さらにフランジ３２を先端方向に押圧すると、ガスケット７２が、ガスケット当接部９に当接し、容器本体７１内で基端方向に摺動し、薬液容器７内の薬液が両頭針６内を通り、先端側の針先６１から排出され、目的の部位に投与される。 When the flange 32 is further pressed in the distal direction, the gasket 72 comes into contact with the gasket contact portion 9 and slides in the proximal direction in the container body 71, and the chemical solution in the chemical solution container 7 passes through the double-ended needle 6, It is discharged from the needle tip 61 on the distal end side and administered to a target site.
　このプレフィルドシリンジ１によれば、前述した第２実施形態と同様の効果が得られる。 According to this prefilled syringe 1, the same effect as the second embodiment described above can be obtained.
　そして、このプレフィルドシリンジ１では、第１実施形態および第２実施形態に比べ、薬液容器７において封止部７３が不要であるので、その薬液容器７の構造を簡素化することができ、プレフィルドシリンジ１を容易かつ迅速に製造することができる。 And in this prefilled syringe 1, since the sealing part 73 is unnecessary in the chemical | medical solution container 7, compared with 1st Embodiment and 2nd Embodiment, the structure of the chemical | medical solution container 7 can be simplified, and a prefilled syringe 1 can be manufactured easily and quickly.
　なお、シール部材７４は、容器本体７１の外周面ではなく、外筒２の内周面に固定されていてもよい。また、シール部材７４は、図７（ｂ）に示すように、外筒２と一体的に成形されていてもよい（例えば、一体成形等）。 The seal member 74 may be fixed to the inner peripheral surface of the outer cylinder 2 instead of the outer peripheral surface of the container body 71. Further, as shown in FIG. 7B, the seal member 74 may be integrally formed with the outer cylinder 2 (for example, integral molding or the like).
　また、容器本体７１の基端部に押し子（押圧部）３の先端部を固定した構成を採用することもできる。なお、容器本体７１と、押し子３またはその本体部３１とは、一体的に形成されていてもよい。 Further, a configuration in which the distal end portion of the pusher (pressing portion) 3 is fixed to the proximal end portion of the container main body 71 can also be adopted. In addition, the container main body 71 and the pusher 3 or its main-body part 31 may be integrally formed.
　また、薬液容器７（容器本体７１）の基端部をそのまま押圧部として用いてもよい。すなわち、容器本体７１の基端部が押圧部を兼ねていてもよい。 Further, the base end portion of the chemical solution container 7 (container main body 71) may be used as it is as the pressing portion. That is, the base end portion of the container main body 71 may also serve as the pressing portion.
　＜第４実施形態＞
　図８は、本発明のプレフィルドシリンジの第４実施形態における先端側の部分を示す縦断面図である。なお、以下では、図８中の上側を「基端」、下側を「先端」、右側を「右」、左側を「左」として説明を行う。 <Fourth embodiment>
FIG. 8: is a longitudinal cross-sectional view which shows the part by the side of the front end in 4th Embodiment of the prefilled syringe of this invention. In the following description, the upper side in FIG. 8 is “base end”, the lower side is “tip”, the right side is “right”, and the left side is “left”.
　以下、第４実施形態について、前述した第１実施形態との相違点を中心に説明し、同様の事項については、その説明を省略する。 Hereinafter, the fourth embodiment will be described with a focus on differences from the first embodiment described above, and descriptions of similar matters will be omitted.
　図８に示すように、第４実施形態のプレフィルドシリンジ１では、外筒２の先端部が、当接部５を構成している。また、外筒２の先端部の内周面には、針支持部４を位置決めする位置決め部として、リブ２２が外筒２の全周に亘って設けられている。なお、リブ２２は、部分的に設けられていてもよい。 As shown in FIG. 8, in the prefilled syringe 1 of the fourth embodiment, the distal end portion of the outer cylinder 2 constitutes a contact portion 5. A rib 22 is provided on the inner peripheral surface of the distal end portion of the outer cylinder 2 over the entire circumference of the outer cylinder 2 as a positioning portion for positioning the needle support portion 4. In addition, the rib 22 may be provided partially.
　また、針支持部４は、外筒２の先端部の内周面に固定されている。この針支持部４の基部４０は、基端側に底部を有する有底の筒状、図示の構成では有底の円筒状をなしいる。 Further, the needle support portion 4 is fixed to the inner peripheral surface of the distal end portion of the outer cylinder 2. The base portion 40 of the needle support portion 4 has a bottomed cylindrical shape having a bottom portion on the proximal end side, and has a bottomed cylindrical shape in the illustrated configuration.
　また、未使用の状態では、保護部材８は、当接部５の内側に装着されている。この保護部材８は、弾性材料で構成されており、確実に当接部５に密着するようになっている。 In the unused state, the protective member 8 is mounted inside the contact portion 5. The protective member 8 is made of an elastic material and is in close contact with the contact portion 5 with certainty.
　ここで、針支持部４を外筒２に固定する際は、針支持部４を外筒２の先端からその内部に挿入する。この際、針支持部４が外筒２のリブ２２に当接することで、外筒２に対する針支持部４の位置決めがなされる。そして、針支持部４を外筒２に対して、接着剤による接着または融着等により、固着する。 Here, when the needle support 4 is fixed to the outer cylinder 2, the needle support 4 is inserted into the outer cylinder 2 from the tip thereof. At this time, the needle support portion 4 is in contact with the rib 22 of the outer cylinder 2, whereby the needle support portion 4 is positioned with respect to the outer cylinder 2. Then, the needle support portion 4 is fixed to the outer cylinder 2 by adhesion or fusion with an adhesive.
　このプレフィルドシリンジ１によれば、前述した第１実施形態と同様の効果が得られる。 According to this prefilled syringe 1, the same effect as the first embodiment described above can be obtained.
　そして、このプレフィルドシリンジ１では、外筒２の先端部が当接部５を兼ねるので、部品点数の削減および構造の簡素化を図ることができ、プレフィルドシリンジ１を容易かつ迅速に製造することができる。 And in this prefilled syringe 1, since the front-end | tip part of the outer cylinder 2 serves as the contact part 5, the number of parts can be reduced and the structure can be simplified, and the prefilled syringe 1 can be manufactured easily and quickly. it can.
　なお、この第４実施形態は、第２実施形態および第３実施形態にも適用することができる。 Note that the fourth embodiment can also be applied to the second embodiment and the third embodiment.
　以上、本発明のプレフィルドシリンジを、図示の実施形態に基づいて説明したが、本発明はこれに限定されるものではなく、各部の構成は、同様の機能を有する任意の構成のものに置換することができる。また、本発明に、他の任意の構成物が付加されていてもよい。 As mentioned above, although the prefilled syringe of this invention was demonstrated based on embodiment of illustration, this invention is not limited to this, The structure of each part is substituted by the thing of the arbitrary structures which have the same function. be able to. In addition, any other component may be added to the present invention.
　また、本発明は、前記各実施形態のうちの、任意の２以上の構成を組み合わせたものであってもよい。 Further, the present invention may be a combination of any two or more configurations of the above embodiments.
　また、前記実施形態では、当接部５の内側の空間５２を封止する保護部材８として、キャップを用いたが、本発明では、これに限定されず、例えば、フィルム等を用いてもよい。 Moreover, in the said embodiment, although the cap was used as the protection member 8 which seals the space 52 inside the contact part 5, in this invention, it is not limited to this, For example, a film etc. may be used. .
　また、本発明のプレフィルドシリンジの用途は、ワクチンの投与には限定されず、各種の薬液を投与するプレフィルドシリンジに適用することができる。 The use of the prefilled syringe of the present invention is not limited to vaccine administration, and can be applied to prefilled syringes for administering various chemical solutions.
　本発明によれば、必要量の薬液が収納された薬液容器を有しているので、薬液の無駄を防止することができる。そして、予め、薬液容器および穿刺針が設置されており、未使用の状態で、穿刺針の周囲の空間等の必要部位の無菌状態が保持されているので、容易かつ迅速に、薬液の投与の準備を行うことができる。
　また、当接部が設けられているので、薬液を投与する際、容易かつ確実に穿刺針を目標の穿刺深さに穿刺することができる。したがって産業上の利用可能性を有する。 According to the present invention, since there is a chemical solution container in which a required amount of chemical solution is stored, waste of the chemical solution can be prevented. And since the drug solution container and the puncture needle are installed in advance and the aseptic condition of the necessary part such as the space around the puncture needle is kept unused, the drug solution can be administered easily and quickly. Preparation can be done.
In addition, since the contact portion is provided, the puncture needle can be punctured to the target puncture depth easily and reliably when the drug solution is administered. Therefore, it has industrial applicability.

Claims (11)

  1. 　先端と基端とを有する外筒と、
    　薬液容器であって、該薬液容器の本体内で摺動し得るガスケットを有し、前記薬液容器の本体と前記ガスケットとで囲まれる空間に薬液が収納され、前記外筒に対して移動可能な薬液容器と、
    　前記薬液容器を移動操作する押圧部と、
    　一端に生体を穿刺可能な針先を有し、他端が前記薬液容器の本体の内部に連通可能な穿刺針と、
    　前記外筒の先端側に設けられ、前記穿刺針を支持する針支持部と、
    　前記外筒の先端側に、前記穿刺針の針先から半径方向に離間して設けられ、生体の表面に当接し得る当接部と、
    　前記外筒と前記薬液容器との間を封止するシール部材と、
    　前記当接部の内側の空間を封止する保護部材とを備え、
    　前記外筒と前記針支持部と前記シール部材とで囲まれる外筒内空間と、前記当接部の内側の空間との無菌状態が、未使用の状態で保持されていることを特徴とするプレフィルドシリンジ。     An outer cylinder having a distal end and a proximal end;
    A chemical container having a gasket that can slide within the main body of the chemical liquid container, the chemical liquid is stored in a space surrounded by the main body of the chemical liquid container and the gasket, and is movable with respect to the outer cylinder A chemical container;
    A pressing portion for moving and operating the chemical container;
    A puncture needle having a needle tip capable of puncturing a living body at one end and the other end communicating with the inside of the main body of the drug solution container;
    A needle support portion provided on the distal end side of the outer cylinder and supporting the puncture needle;
    A contact portion that is provided on the distal end side of the outer cylinder and spaced from the needle tip of the puncture needle in the radial direction, and can contact the surface of a living body;
    A sealing member for sealing between the outer cylinder and the chemical solution container;
    A protective member for sealing the space inside the contact portion,
    The aseptic condition of the outer cylinder inner space surrounded by the outer cylinder, the needle support part and the seal member and the space inside the contact part is maintained in an unused state. Prefilled syringe.
  2. 　前記穿刺針は、両頭針である請求項１に記載のプレフィルドシリンジ。 The prefilled syringe according to claim 1, wherein the puncture needle is a double-ended needle.
  3. 　前記外筒内空間を外部に開放する通気手段を有する請求項１または２に記載のプレフィルドシリンジ。 The prefilled syringe according to claim 1 or 2, further comprising a ventilation means for opening the space in the outer cylinder to the outside.
  4. 　前記通気手段は、前記保護部材による前記当接部の内側の空間の封止が解除され、前記当接部が生体の表面に当接した当接状態で、前記外筒内空間を外部に開放するものである請求項３に記載のプレフィルドシリンジ。 The ventilation means opens the space inside the outer cylinder to the outside in a contact state in which the space inside the contact portion by the protection member is released and the contact portion is in contact with the surface of the living body. The prefilled syringe according to claim 3.
  5. 　前記通気手段は、前記針支持部に形成され、前記外筒内空間と前記当接部の内側の空間とを連通する第１の通気孔と、前記当接部に形成され、前記当接状態で前記当接部の内側の空間と外部とを連通する第２の通気孔とを有する請求項４に記載のプレフィルドシリンジ。 The ventilation means is formed in the needle support portion, and is formed in the contact portion and a first ventilation hole that communicates the space inside the outer cylinder and the space inside the contact portion. The prefilled syringe according to claim 4, further comprising a second ventilation hole that communicates the space inside the contact portion with the outside.
  6. 　前記第２の通気孔は、前記当接部の側壁に形成された側孔である請求項５に記載のプレフィルドシリンジ。 The prefilled syringe according to claim 5, wherein the second vent hole is a side hole formed in a side wall of the contact portion.
  7. 　前記保護部材は、前記当接部に離脱可能に装着され、前記第２の通気孔を閉鎖し、これにより、前記外筒内空間および前記当接部の内側の空間の無菌状態が保持されるよう構成されている請求項５または６に記載のプレフィルドシリンジ。 The protective member is detachably attached to the contact portion, and closes the second vent hole, whereby the sterility of the space inside the outer cylinder and the space inside the contact portion is maintained. The prefilled syringe according to claim 5 or 6 configured as described above.
  8. 　前記穿刺針は、両頭針であり、
    　前記薬液容器の本体は、筒状をなし、
    　前記ガスケットは、前記薬液容器の本体の基端側に設けられ、
    　前記薬液容器は、前記薬液容器の本体と前記ガスケットとで囲まれる空間を封止し、前記両頭針の基端側の針先が刺通し得る封止部を前記薬液容器の本体の先端側に有しており、
    　前記押圧部を先端方向に押圧すると、前記薬液容器が前記外筒に対して先端方向に移動し、前記両頭針の基端側の針先が前記封止部を刺通し、この後、前記ガスケットが前記薬液容器の本体に対して先端方向に移動して、前記両頭針の先端側の針先から前記薬液が排出されるよう構成されている請求項１ないし７のいずれかに記載のプレフィルドシリンジ。     The puncture needle is a double-ended needle,
    The body of the chemical solution container has a cylindrical shape,
    The gasket is provided on the base end side of the main body of the chemical solution container,
    The chemical liquid container seals a space surrounded by the main body of the chemical liquid container and the gasket, and has a sealing portion on the distal end side of the main body of the chemical liquid container through which the needle tip on the proximal end side of the double-ended needle can be pierced. And
    When the pressing portion is pressed in the distal direction, the chemical solution container moves in the distal direction with respect to the outer cylinder, and the needle tip on the proximal end side of the double-ended needle pierces the sealing portion, and then the gasket is The prefilled syringe according to any one of claims 1 to 7, wherein the prefilled syringe is configured so as to move in a distal direction with respect to a main body of the chemical liquid container and to discharge the chemical liquid from a needle tip on a distal end side of the double-ended needle.
  9. 　前記穿刺針は、両頭針であり、
    　前記薬液容器の本体は、基端側に底部を有する有底筒状をなす部位を有し、
    　前記ガスケットは、前記薬液容器の本体の先端側に設けられ、
    　当該プレフィルドシリンジは、さらに、前記外筒内空間に位置し、前記ガスケットに当接し得るガスケット当接部を有しており、
    　前記押圧部を先端方向に押圧すると、前記薬液容器が前記外筒に対して先端方向に移動し、前記両頭針の基端側の針先が前記ガスケットを刺通し、この後、前記ガスケットが、前記ガスケット当接部に当接し、前記薬液容器の本体に対して基端方向に移動して、前記両頭針の先端側の針先から前記薬液が排出されるよう構成されている請求項１ないし７のいずれかに記載のプレフィルドシリンジ。     The puncture needle is a double-ended needle,
    The main body of the chemical solution container has a bottomed cylindrical part having a bottom on the base end side,
    The gasket is provided on the distal end side of the main body of the chemical container,
    The prefilled syringe further has a gasket abutting portion that is located in the space inside the outer cylinder and can abut against the gasket;
    When the pressing portion is pressed in the distal direction, the chemical solution container moves in the distal direction with respect to the outer cylinder, the needle tip on the proximal end side of the double-ended needle pierces the gasket, and then the gasket is 8. The device is configured to contact a gasket contact portion, move in a proximal direction with respect to a main body of the drug solution container, and discharge the drug solution from a tip end on a distal end side of the double-ended needle. A prefilled syringe according to any one of the above.
  10. 　前記当接部の先端面は、前記穿刺針の針先よりも基端側に位置する請求項１ないし９のいずれかに記載のプレフィルドシリンジ。 The prefilled syringe according to any one of claims 1 to 9, wherein a distal end surface of the contact portion is located on a proximal end side with respect to a needle tip of the puncture needle.
  11. 　前記針支持部は、前記穿刺針を支持すると共に、生体の表面に当接し得る凸部を有する請求項１ないし１０のいずれかに記載のプレフィルドシリンジ。 The prefilled syringe according to any one of claims 1 to 10, wherein the needle support portion has a convex portion that supports the puncture needle and can contact the surface of a living body.
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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8882706B2 (en) 2009-12-04 2014-11-11 Becton, Dickinson And Company Pen needle removal device for a drug delivery device
EP3403729A1 (en) * 2017-05-17 2018-11-21 Sulzer Mixpac AG Discharger, static piston and method of discharging
EP3403730A1 (en) * 2017-05-17 2018-11-21 Sulzer Mixpac AG Discharger and method of discharging
CN110662706A (en) * 2017-05-17 2020-01-07 苏尔寿混合技术有限公司 Container, discharger and method for assembling a discharger
WO2023110893A1 (en) * 2021-12-15 2023-06-22 Sanofi Assembly for an injection device, injection device comprising such an assembly, medicament container for such an assembly, and method for producing such a medicament container

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Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8882706B2 (en) 2009-12-04 2014-11-11 Becton, Dickinson And Company Pen needle removal device for a drug delivery device
US9861760B2 (en) 2009-12-04 2018-01-09 Becton, Dickinson And Company Pen needle removal device for a drug delivery device
US10744273B2 (en) 2009-12-04 2020-08-18 Becton, Dickinson And Company Pen needle removal device for a drug delivery device
US11786670B2 (en) 2009-12-04 2023-10-17 Becton, Dickinson And Company Pen needle removal device for a drug delivery device
EP3403729A1 (en) * 2017-05-17 2018-11-21 Sulzer Mixpac AG Discharger, static piston and method of discharging
EP3403730A1 (en) * 2017-05-17 2018-11-21 Sulzer Mixpac AG Discharger and method of discharging
WO2018210922A1 (en) * 2017-05-17 2018-11-22 Sulzer Mixpac Ag Discharger, static piston and method of discharging
WO2018210916A1 (en) * 2017-05-17 2018-11-22 Sulzer Mixpac Ag Discharger and method of discharging
CN110612166A (en) * 2017-05-17 2019-12-24 苏尔寿混合技术有限公司 Drain and method for draining
CN110612167A (en) * 2017-05-17 2019-12-24 苏尔寿混合技术有限公司 Drain, static piston and draining method
CN110662706A (en) * 2017-05-17 2020-01-07 苏尔寿混合技术有限公司 Container, discharger and method for assembling a discharger
WO2023110893A1 (en) * 2021-12-15 2023-06-22 Sanofi Assembly for an injection device, injection device comprising such an assembly, medicament container for such an assembly, and method for producing such a medicament container

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