[go: up one dir, main page]

WO2013089105A1 - Pre-filled syringe cylindrical body, pre-filled syringe puncture instrument, pre-filled syringe injection apparatus, and pre-filled syringe - Google Patents

Pre-filled syringe cylindrical body, pre-filled syringe puncture instrument, pre-filled syringe injection apparatus, and pre-filled syringe Download PDF

Info

Publication number
WO2013089105A1
WO2013089105A1 PCT/JP2012/082075 JP2012082075W WO2013089105A1 WO 2013089105 A1 WO2013089105 A1 WO 2013089105A1 JP 2012082075 W JP2012082075 W JP 2012082075W WO 2013089105 A1 WO2013089105 A1 WO 2013089105A1
Authority
WO
WIPO (PCT)
Prior art keywords
puncture member
puncture
outer cylinder
prefilled syringe
cylindrical body
Prior art date
Application number
PCT/JP2012/082075
Other languages
French (fr)
Japanese (ja)
Inventor
等 沖原
伸吾 小山
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 WO2013089105A1 publication Critical patent/WO2013089105A1/en

Links

Images

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
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • 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
    • 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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • 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
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • 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
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/344—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets
    • A61M5/345—Adaptors positioned between needle hub and syringe nozzle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A61M2005/2474—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase with movable piercing means, e.g. ampoule remains fixed or steady

Definitions

  • the present invention relates to a cylindrical body for a prefilled syringe, a puncture device for a prefilled syringe, an injector for a prefilled syringe, and a prefilled syringe.
  • the prefilled syringe is provided in a state where it is filled with a medical liquid such as a drug solution or a drug solution.
  • a medical liquid such as a drug solution or a drug solution.
  • a prefilled syringe for example, there is a prefilled syringe whose tip is sealed with a cap to which a double-ended needle can be attached.
  • a puncture member having a double-ended needle is attached at the time of use.
  • Patent Document 1 Japanese Patent Publication No. 2010-540122, WO2009-043000, US2012-0209171.
  • the present invention provides a cylindrical body for a prefilled syringe, a puncture tool for a prefilled syringe, a syringe for a prefilled syringe, and a prefilled syringe, in which the sealing member of the prefilled syringe is prevented from being loosened.
  • a cylindrical body for a prefilled syringe to which a puncture member comprising a puncture member main body having a joint portion can be mounted, wherein the puncture member mounting portion is screwed with the puncture member side threaded portion After the threaded portion, the
  • a puncture device for a prefilled syringe that is attachable to and detachable from the puncture member mounting portion of the cylindrical body for a prefilled syringe, wherein the puncture device is mounted with the hollow needle having the needle portions at both ends, and the hollow needle.
  • the puncture member including the puncture member main body having the puncture member side screwing portion and the puncture member side engaging portion, which is detachable from the puncture member mounting portion, and detachably stores the puncture member.
  • a storage member, and the storage member and the puncture member further include a rotational force transmitting portion that transmits a rotational force applied to the storage member to the puncture member, and the storage member includes the puncture member.
  • a puncture device for a prefilled syringe which is detached from the puncture member by pulling in a distal direction after the member is mounted on the puncture member mounting portion.
  • Syringe comprising a prefilled syringe outer cylinder which is a cylindrical body for the prefilled syringe, a slidable gasket housed in the outer cylinder, and a plunger attached to or attached to the rear end of the gasket
  • a syringe for a prefilled syringe comprising a main body, the puncture member that can be attached to and detached from the puncture member mounting portion of the prefilled syringe outer cylinder, and a puncture device that detachably accommodates the puncture member.
  • the puncture member mounting portion includes the cylindrical body side screwing portion and the cylindrical body side engaging portion, and the puncture member is screwed to the cylindrical body side screwing portion.
  • the engaging portion, the tubular body side threaded portion and the puncture member side threaded portion are engaged with each other, and then engaged with the tubular body side engaging portion, and the puncture member side engagement for restricting retraction of the threaded engagement.
  • the storage member and the puncture member have a rotational force transmitting portion that transmits the rotational force applied to the storage member to the puncture member, and the storage member is attached to the puncture member mounting portion by the puncture member After being done, the prefilled syringe injector that is detached from the puncture member by pulling in the distal direction.
  • the prefilled syringe which consists of said syringe for prefilled syringes, and the chemical
  • FIG. 1 is an external view of a prefilled syringe and a prefilled syringe syringe of the present invention.
  • FIG. 2 is an enlarged longitudinal sectional view of a syringe body used for the prefilled syringe of the present invention.
  • FIG. 3 is an enlarged longitudinal sectional view of the prefilled syringe puncture device of the present invention.
  • FIG. 4 is a front view of an outer cylinder used in the prefilled syringe cylinder, the prefilled syringe, and the prefilled syringe injector of the present invention.
  • 5 is a right side view of the outer cylinder shown in FIG. 6 is an enlarged plan view of the outer cylinder shown in FIG.
  • FIG. 7 is a perspective view of the outer cylinder shown in FIG.
  • FIG. 8 is an enlarged front view of an outer cylinder sealing member used in the tubular body for prefilled syringe, the prefilled syringe, and the syringe for prefilled syringe of the present invention.
  • FIG. 9 is a right side view of the outer cylinder sealing member shown in FIG.
  • FIG. 10 is a longitudinal sectional view of the outer cylinder sealing member shown in FIG.
  • FIG. 11 is a perspective view of the outer cylinder sealing member shown in FIG. 8 as viewed from above.
  • 12 is a perspective view of the outer cylinder sealing member shown in FIG. 8 as viewed from below.
  • FIG. 9 is a right side view of the outer cylinder sealing member shown in FIG.
  • FIG. 10 is a longitudinal sectional view of the outer cylinder sealing member shown in FIG.
  • FIG. 11 is a perspective view of the outer cylinder sealing member shown in FIG. 8 as viewed from above.
  • 12
  • FIG. 13 is an enlarged front view of a puncture member used in the prefilled syringe puncture device of the present invention.
  • FIG. 14 is a left side view of the puncture member shown in FIG. 15 is a longitudinal sectional view of the puncture member shown in FIG. 16 is a longitudinal sectional view of the puncture member shown in FIG. 17 is a perspective view of the puncture member shown in FIG.
  • FIG. 18 is an enlarged front view of a storage member used for the prefilled syringe puncture device of the present invention.
  • 19 is a vertical cross-sectional view of the storage member shown in FIG.
  • FIG. 20 is an enlarged front view of a plunger used in the prefilled syringe and the prefilled syringe syringe of the present invention.
  • FIG. 21 is a longitudinal sectional view of a gasket used in the prefilled syringe and the prefilled syringe syringe of the present invention.
  • FIG. 22 is an explanatory diagram for explaining constituent members used in the prefilled syringe and the prefilled syringe syringe of the present invention.
  • FIG. 23 is an explanatory diagram for explaining the operation of the prefilled syringe and the prefilled syringe syringe of the present invention.
  • FIG. 24 is an explanatory diagram for explaining the operation of the prefilled syringe and the prefilled syringe syringe of the present invention.
  • FIG. 22 is an explanatory diagram for explaining constituent members used in the prefilled syringe and the prefilled syringe syringe of the present invention.
  • FIG. 23 is an explanatory diagram for explaining the operation of the prefilled syringe and the prefilled syringe sy
  • FIG. 25 is an explanatory diagram for explaining the operation of the prefilled syringe and the prefilled syringe syringe of the present invention.
  • FIG. 26 is an explanatory diagram for explaining the operation of the prefilled syringe and the prefilled syringe syringe of the present invention.
  • FIG. 27 is an explanatory diagram for explaining the operation of the prefilled syringe and the prefilled syringe syringe of the present invention.
  • FIG. 28 is an enlarged external view of an outer cylinder sealing member of another example used for the prefilled syringe and the prefilled syringe syringe of the present invention.
  • FIG. 29 is an enlarged external view of an outer cylinder sealing member of another example used in the prefilled syringe and the prefilled syringe injector of the present invention.
  • FIG. 30 is an enlarged external view of another example of the outer cylinder sealing member used in the prefilled syringe and the prefilled syringe injector of the present invention.
  • FIG. 31 is an enlarged external view of the distal end side portion of the outer cylinder of another example used in the prefilled syringe and the prefilled syringe syringe of the present invention.
  • FIG. 32 is a longitudinal sectional view of the outer cylinder shown in FIG.
  • FIG. 33 is an explanatory diagram for explaining a prefilled syringe holder which is a tubular body for a prefilled syringe according to the present invention.
  • the cylindrical body for prefilled syringes, the prefilled syringe, and the syringe for prefilled syringes of the present invention will be described based on examples shown in the drawings.
  • the cylindrical body for prefilled syringes of the present invention (for example, the prefilled syringe outer cylinders 4 and 4a and the prefilled syringe holder 100) has puncture member mounting portions 50, 40a and 102 as shown in FIGS.
  • a hollow needle 61 having needle portions 61a and 61b at both ends and a hollow needle 61 is attached to the puncture member mounting portions 50, 40a and 102, and is detachable from the puncture member side screwing portion 85 and puncture.
  • the puncture member 6 provided with the puncture member main body 60 which has the member side engaging part 86 can be mounted
  • the cylindrical body for prefilled syringes of the present invention is applied to, for example, an outer cylinder for prefilled syringes and a holder for prefilled syringes.
  • the prefilled syringe outer cylinder to which the prefilled syringe tubular body of the present invention is applied has an outer puncture member mounting portion 50 in which the opening 48 of the distal end portion 41 is sealed by a seal member.
  • a hollow needle 61 that is a cylinder and has a needle part at both ends (specifically, a needle part 61a for puncture at one end and a needle part 61b for a seal member at the other end) at both ends;
  • the puncture member 6 equipped with the needle 61 and detachable from the puncture member mounting portion 50 and having the puncture member main body 60 having the puncture member side screwing portion 85 and the puncture member side engaging portion 86 can be attached.
  • the puncture member mounting portion 50 is formed after the cylindrical body side screwing portion 52 that can be screwed with the puncture member side screwing portion 85, and the cylindrical body side screwing portion 52 and the puncture member side screwing portion 85 are screwed together.
  • a tubular body side engaging portion 53 that engages with the puncture member side engaging portion 86 and restricts the backward movement of the screwing.
  • the puncture member is attached to the prefilled syringe outer cylinder by screwing and engagement, the puncture member is loosened at the time of administration operation of the prefilled syringe. There is no leakage due to looseness.
  • prefilled syringe 1 injector for prefilled syringe
  • the prefilled syringe outer cylinder uses the above-mentioned prefilled syringe outer cylinder.
  • the prefilled syringe 1 (injector for prefilled syringe) of the present invention includes a prefilled syringe outer cylinder, a slidable gasket 8 housed in the outer cylinder, and a plunger attached to or attachable to the rear end of the gasket 8. 9, a hollow needle 61 having a puncture needle portion 61 a at one end and a seal needle piercing needle portion 61 b at the other end, a hollow needle 61 attached, and the outer cylinder sealing member 5
  • the puncture member 3 includes a puncture member 6 having a detachable puncture member body 60 and a storage member 7 that detachably accommodates the puncture member 6.
  • the puncture member mounting portion 50 includes a cylindrical body side screwing portion 52 and a cylindrical body side engaging portion 53, and the puncture member 6 is piercing member side screw that can be screwed with the cylindrical body side screwing portion 52. After the mating portion 85 and the two screwing portions 52 and 85 are screwed together, the mating portion 85 is engaged with the tubular body side engaging portion 53 and includes a puncture member side engaging portion 86 that regulates the progress and retreat of the screwing. . And in the prefilled syringe 1 of this invention, the chemical
  • FIG. The difference between the prefilled syringe and the syringe for the prefilled syringe is whether or not the medicine is filled.
  • the prefilled syringe outer cylinder 4 of the illustrated embodiment is constituted by an outer cylinder main body 40 and an outer cylinder sealing member 5 attached to the tip portion thereof.
  • the puncture member mounting portion 50 is configured by the outer cylinder sealing member 5.
  • the outer cylinder sealing member 5 includes the puncture member mounting portion 50.
  • the distal end portion 41 and the outer cylinder sealing member 5 of the outer cylinder main body 40 are detached and rotated from the outer cylinder sealing member 5 attached to the distal end portion 41.
  • the outer cylinder sealing member 5 includes a cylindrical body side screwing part (in other words, a sealing member side screwing part) 52 and a cylindrical body side engaging part.
  • the puncture member 6 includes a puncture member side screwing portion 85 that can be screwed with the cylindrical body side screwing portion 52, and two screwing portions screwed together. Then, the storage member 7 and the puncture member 6 are attached to the storage member 7. The storage member 7 and the puncture member 6 are provided to the storage member 7. Rotation force transmitting portions 65 and 74 that transmit the rotational force to the puncture member 6 are provided. After being, by pulling in the distal direction, which is assumed to from piercing member 6, disengaged.
  • the prefilled syringe 1 and the syringe for prefilled syringe of the present invention are composed of a syringe body 2 and a puncture tool 3, both of which are not mounted, and a mounting operation is performed during use. Further, a cap (not shown) may be attached to the syringe body 2 at the distal end portion of the outer cylinder (specifically, the outer cylinder sealing member 5 attached to the distal end portion of the outer cylinder main body 40). . This cap is removed before the puncture tool 3 is mounted.
  • the syringe body 2 includes a prefilled syringe outer cylinder 4 including an outer cylinder main body 40 and an outer cylinder sealing member 5 that seals a distal end portion 41 of the outer cylinder main body 40, and a gasket accommodated in the outer cylinder main body 40. 8, a drug 11 stored (filled) in an outer cylinder main body 40 sealed by the outer cylinder sealing member 5 and the gasket 8, and a plunger 9 attached to the gasket 8.
  • the plunger 9 may be attached to the gasket 8 at the time of use without being attached to the gasket in advance.
  • the outer cylinder main body 40 includes a main body portion 45, a distal end portion 41, and a flange 46.
  • the main body 45 has a substantially cylindrical shape and has a liquid storage space inside.
  • the tip portion 41 protrudes from the shoulder portion of the main body portion 45 in the tip direction.
  • the distal end portion 41 includes a distal end opening 48 for discharging a chemical solution or the like in the outer cylinder and cannot be connected to a medical device having a connection portion to a nozzle portion conforming to the ISO standard. That is, it is not a luer taper shape that the tip of a normal syringe has.
  • the distal end portion 41 includes a large diameter portion 44 formed at a boundary portion with the main body portion 45, and a concave portion 47 (specifically, Two concavities facing each other) and near the tip of the intermediate portion 42 of the tip 41 (a portion having a smaller diameter than the enlarged diameter portion 44 and a diameter larger than the most distal portion) (in other words, near the central portion in the axial direction of the tip 41).
  • the protruding portion 43 (specifically, two protruding portions facing each other) is provided.
  • tip part 41 is equipped with the small diameter part at the front-end
  • the protrusion part 43 is extended predetermined length in the circumferential direction.
  • the two recesses 47 extend a predetermined length in the axial direction.
  • the two protrusions 43 and the two recesses 47 are provided so as not to overlap in the axial direction.
  • each recessed portion 47 and each protruding portion 43 are shifted from each other by approximately 90 degrees with respect to the central axis of the distal end portion 41.
  • tip part 41 of the outer cylinder main body 40 comprises the engaging part for outer cylinder sealing member detachment
  • a restricting engaging portion is formed.
  • the flange 46 is an elliptical donut-shaped disk portion formed so as to protrude in the vertical direction from the entire rear end circumference of the outer cylinder main body 40.
  • the flange 46 includes two gripping portions facing each other as shown in FIGS.
  • the outer cylinder main body 40 is a cylindrical body made of a transparent or translucent material, if necessary, made of a material having low oxygen permeability and water vapor permeability. Examples of a material for forming the outer cylinder main body 40 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene.
  • polyesters such as terephthalate and cyclic polyolefins
  • resins such as polypropylene and cyclic polyolefins are preferred because they are easy to mold and have heat resistance.
  • tip part 41 of the outer cylinder main body 40 is sealed by the outer cylinder sealing member 5 mentioned later.
  • the gasket 8 includes a main body portion 81 whose front end is closed and extends with substantially the same outer diameter, and a plurality of annular ribs 82 and 83 provided on the main body portion.
  • the rib is in liquid-tight contact with the inner surface of the main body 45 of the outer cylinder main body 40.
  • the gasket 8 As a material for forming the gasket 8, elastic rubber (for example, butyl rubber, latex rubber, silicone rubber, styrene-butadiene rubber, isoprene rubber, etc.), thermoplastic elastomer (for example, SBS elastomer, SEBS elastomer, SEPS elastomer, styrene, etc.) It is preferable to use olefin-based elastomers such as olefin-based elastomers and ethylene- ⁇ -olefin copolymer elastomers).
  • the gasket 8 is provided with a recess extending inward from the rear end thereof, and this recess serves as a plunger mounting portion 84.
  • the plunger mounting portion 84 has a female screw shape, and can be screwed with a male screw portion 93 formed on the outer surface of the gasket mounting portion 92 formed at the distal end portion of the plunger 9.
  • the plunger 9 is attached to the gasket 8 by screwing them together.
  • the plunger 9 includes a gasket mounting portion 92 provided at the distal end portion, a main body portion 91 extending in the axial direction having a cross-shaped cross section, a flat plate portion 95 provided at the distal end of the main body portion, and a main body.
  • a pressing portion 94 provided at the rear end portion of the portion 91 and reinforcing ribs 96 and 98 provided in the middle of the main body portion 91 are provided.
  • a male screw portion 93 that is screwed with the plunger mounting portion 84 is formed on the outer surface of the gasket mounting portion 92.
  • the plunger 9 is connected to the gasket 8 when the plunger mounting portion 84 and the male threaded portion 93 of the gasket mounting portion 92 are screwed together.
  • vitamin agents total vitamin agents
  • various amino acids such as heparin, insulin, antibiotics, antitumor agents, analgesics, cardiotonics, intravenous anesthesia Agents, anti-Parkinson agents, ulcer treatment agents, corticosteroid agents, arrhythmia agents, hormone preparations, interferon preparations, human immunoglobulin preparations, blood coagulation factor preparations, vaccine preparations, and other protein preparations.
  • the outer cylinder sealing member 5 includes a main body 51 having a puncture member mounting portion 50 and a seal member 10 housed in the main body 51.
  • the seal member 10 is for sealing the opening at the tip of the outer cylinder main body.
  • the main body 51 having the puncture member mounting portion 50 is a cylindrical body, and has a small-diameter opening 57 provided at the distal end, a flange 55 provided at the proximal end, and a window 53 provided at the side.
  • a cylindrical body-side threaded portion 52 provided on the outer surface on the distal end side from the window portion 53, a distal end side from the flange portion 55 and a proximal end side from the window portion 53.
  • the formed ribs 59 (a plurality of circumferential ribs), the excessive rotation restricting ribs 88 (specifically, two ribs facing each other) provided on the side of the opening 57, and the base end of the main body 51
  • a protrusion 58 (specifically, two protrusions facing each other) extending in the axial direction is provided on the inner surface of the head.
  • the window 53 is for accommodating and engaging the protrusion 43 of the outer cylinder main body 40, and extends a predetermined length in the circumferential direction. .
  • the protrusion 43 of the outer cylinder main body 40 enters and engages the window 53 of the outer cylinder sealing member 5, thereby preventing the outer cylinder sealing member from being detached from the outer cylinder main body 40, and turning. It also regulates. Therefore, in the prefilled syringe 3 of this embodiment, the outer cylinder sealing member 5 is mounted so as not to be detached from the outer cylinder main body 40.
  • the protruding portion 58 provided on the inner surface of the proximal end portion of the outer cylinder sealing member 5 enters the concave portion 47 of the outer cylinder main body 40. And are engaged. For this reason, the outer cylinder sealing member 5 cannot rotate with respect to the outer cylinder main body 40. Therefore, by rotating the outer cylinder main body 40, the outer cylinder sealing member 5 follows and rotates. Therefore, the window portion 53 of the outer cylinder sealing member 5 constitutes an outer cylinder sealing member detachment restricting engagement portion on the cylindrical body side, and the projecting portion 58 is an outer cylinder sealing member rotation restriction on the cylindrical body side.
  • the engagement part is constituted.
  • a cylindrical body side screwing portion 52 is provided on the outer surface of the distal end side portion of the main body 51 having the puncture member mounting portion 50.
  • the cylindrical body side screwing portion 52 is formed by two spiral ribs. Further, a bulging portion 52a is formed at the central portion of the spiral rib, and a bulging portion 52b is also formed at the terminal portion of the spiral rib.
  • An excessive rotation restricting rib 88 (specifically, two ribs facing each other) is provided on the distal end surface of the outer cylinder sealing member 5.
  • the cylindrical body side screwing portion 52 is screwed with a puncture member side screwing portion 85 described later.
  • outer cylinder sealing member 5 of this embodiment two flat portions 54 facing each other are provided on the side of the base end portion side, so that the outer cylinder sealing member 5 can be easily held.
  • the material for forming the outer cylinder sealing member include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, Various resins such as polyesters such as polyethylene terephthalate and cyclic polyolefins can be mentioned. Among them, resins such as polypropylene and cyclic polyolefins are preferred because they are easy to mold and have heat resistance.
  • the seal member 10 is accommodated in the distal end portion of the main body 51 having the puncture member mounting portion 50, seals the opening 57, and the outer cylinder sealing member 5 is attached to the outer cylinder main body 40 as shown in FIG. In a state where the front end portion 41 is mounted, the front end opening 48 of the outer cylinder main body 40 is sealed in a liquid-tight manner.
  • the seal member 10 is formed of an elastic member that can seal the tip opening of the tip portion 41 of the outer cylinder main body 40 in a liquid-tight manner and that can be pierced with a seal member piercing needle portion 61b of the puncture member 6 described later. Further, the seal member 10 may include a protruding portion that enters the outer cylinder main body 40.
  • tip part of the outer cylinder main body 40 can be reduced.
  • a material for forming the sealing member it is preferable to use, for example, natural rubber, isoprene rubber, butadiene rubber, fluororubber, silicone rubber or other synthetic rubber, or thermoplastic elastomer such as olefin elastomer or styrene elastomer.
  • the prefilled syringe puncture device 3 of the present invention can be attached to and detached from the puncture member mounting portions 50, 40a, 102 of the above-mentioned prefilled syringe cylindrical body, and further has needle portions at both ends (specifically, puncture at one end).
  • the puncture member 6 includes a puncture member main body 60 having a puncture member side engagement portion 86 and a storage member 7 that detachably accommodates the puncture member 6. Furthermore, the storage member 7 and the puncture member 6 are provided with rotational force transmitting portions 65 and 74 that transmit the rotational force applied to the storage member 7 to the puncture member 6, and the storage member 7 includes the outer tube. After being attached to the sealing member 5, it is detached from the puncture member 6 by pulling in the distal direction.
  • the puncture device 3 includes a storage member 7 and a puncture member 6 stored in the storage member 7.
  • the storage member 7 has a cap shape with one end closed as shown in FIGS. 3, 18 and 19.
  • the storage member 7 includes a cylindrical main body portion 71, a closing portion 75 formed at the front end portion thereof, a small diameter portion 73 formed at the front end side portion of the main body portion 71, and a flange 72 formed at the rear end portion. I have.
  • a plurality of bulging portions 74 are provided on the inner surface of the central portion of the main body in the axial direction.
  • the storage member 7 stores the entire puncture member 6. In particular, the storage member stores the puncture member so that the blade surface of the hollow needle of the puncture member is not exposed.
  • the puncture member 6 includes a puncture member main body 60 and a hollow needle 61 fixed to the puncture member main body 60 as shown in FIGS. 3 and 13 to 17.
  • the puncture member main body 60 is a cylindrical body having a hollow needle fixing portion having a small diameter at the distal end portion and an outer cylinder sealing member accommodating portion at the proximal end side portion.
  • the outer cylinder sealing member housing portion includes an outer cylinder sealing member mounting portion to which the outer cylinder sealing member 5 of the syringe body 2 can be mounted.
  • the outer tube sealing member mounting portion includes a puncture device side screwing portion 85 that is screwed with a cylindrical body side screwing portion 52 provided on the outer surface of the outer tube sealing member 5.
  • the puncture member 6 includes an opening 64 (specifically, two openings facing each other), and protrudes obliquely (short spiral) protruding inward from the bottom of the opening 64.
  • the rib 85 forms a puncture device side threaded portion.
  • the puncture member 6 includes a protrusion 86 (specifically, two protrusions facing each other) provided on the inner surface in the vicinity of the central portion in the axial direction (slightly from the base end). The protrusion 86 extends a predetermined length in the circumferential direction. Then, when the puncture member 6 is attached to the outer cylinder sealing member 5, the protrusion 86 enters and engages in the window 53 of the outer cylinder sealing member 5, as shown in FIG.
  • the mounting state of the puncture member 6 to the outer cylinder main body 40 becomes stable, the rotation of the puncture member in the direction in which the screwing is retracted is regulated, the careless loosening of the puncture member, and the separation from the outer cylinder. To prevent.
  • the puncture member 6 of this embodiment includes an annular recess 87 provided on the inner surface near the base end.
  • the ribs 59 a plurality of circumferential ribs
  • the outer cylinder sealing member 5 of this embodiment is located closer to the proximal end side of the outer cylinder sealing member 5 than the first cylindrical body side engaging portion 53 and the first cylindrical body side engaging portion 53.
  • the puncture member 6 is provided with a second tubular body side engaging portion (arc-shaped rib) 59, and the puncture member 6 includes a first puncture member side engaging portion 86 that engages with the first tubular body side engaging portion 53, and A second puncture member side engagement portion (annular recess) 87 that is positioned on the proximal end side of the puncture member 6 with respect to the first puncture member side engagement portion 86 and engages with the second cylindrical body side engagement portion 59. It has. Further, a concave portion 67 (specifically, two concave portions facing each other) is provided on the outer surface of the central portion of the main body 60 in the axial direction.
  • the distal end portion of the main body 60 has a small diameter portion 62, and a bulging portion 65 (specifically, faces the outer surface of the small diameter portion 62 that extends in the axial direction. 2 bulges).
  • the bulging portion 65 enters and engages between the plurality of bulging portions 74 formed on the inner surface of the central portion in the axial direction of the storage member 7 described above. As a result, the puncture member 6 is prevented from idling in the state of being stored in the storage member 7, and rotates by following the rotation of the storage member 7.
  • the bulging portion 65 of the puncture member 6 and the plurality of bulging portions 74 formed on the inner surface of the central portion in the axial direction of the storage member 7 constitute a rotational force transmitting portion.
  • the puncture member 6 includes a protruding portion 89 (specifically, two bulging portions facing each other) provided on the inner surface of the distal end of the small diameter portion 62.
  • the protruding portion 89 comes into contact with the excessive rotation regulating rib 88 provided on the distal end surface of the outer cylinder sealing member 5 after the cylindrical body side screwing portion 52 and the puncture member side screwing portion 85 are screwed together. And preventing excessive rotation of the puncture member.
  • the hollow needle 61 is fixed to the hollow needle fixing portion 63 of the puncture member main body 60 with an adhesive 68, and has needle portions at both ends. Specifically, one end side of the hollow needle 61 protrudes from the fixed portion 63 to the distal end side, and a puncture needle portion 61 a for living body is provided at the distal end, and the other end side of the hollow needle 61 is punctured from the fixed portion 73. 6 is protruded inward, and a sealing member piercing needle portion 61b capable of piercing the sealing member of the outer cylinder sealing member 5 is provided at an end thereof.
  • the hollow needle 61 extends substantially parallel to the central axis of the puncture member body 60.
  • the storage member 7 can be attached to the puncture member 6 again after being detached from the puncture member 6, and the storage member 7 attached to the puncture member 6 again. Is rotated in the direction in which the screwing of the cylindrical body side screwing portion 52 and the puncture member side screwing portion 85 is retracted, the engagement between the cylindrical body side engaging portion and the puncture member side engaging portion is released.
  • the puncture device 3 can be detached from the syringe body 2 with the puncture member 9 stored in the storage member 7.
  • the cylindrical body side screwing portion 52 and the puncture member side screwing portion 85 are formed after the seal member piercing needle portion 61b of the hollow needle 61 pierces the seal member 10, It arrange
  • the protrusion part 76 may comprise by the protrusion part 76 provided in the outer surface of the small diameter part of the sealing member main body 51.
  • the inner surface of the screwing portion 85 of the puncture member 6 is provided with a recess (not shown) that receives the protrusion 76.
  • the projecting portion 76 is formed between the spiral ribs.
  • an outer cylinder sealing member 5b shown in FIG. You may comprise by the small protrusion 77 provided in the front end surface and the position close
  • an outer cylinder sealing member 5c shown in FIG. You may comprise by the small protrusion 79 provided in the flat part 54 of the side surface. In this case, the puncture member 6 is provided on the inner surface and includes a recess (not shown) for housing the small protrusion 79.
  • the puncture member mounting portion is constituted by the outer cylinder sealing member 5.
  • the present invention is not limited to this, and the puncture member mounting portion 40a of the prefilled syringe outer cylinder 4a, which is the prefilled syringe cylindrical body shown in FIGS. It may be formed directly at the tip. Therefore, the prefilled syringe outer cylinder 4 a of this embodiment does not include the outer cylinder sealing member 5.
  • the prefilled syringe outer cylinder 4a which is the prefilled syringe cylindrical body of this embodiment, is sealed by a sealing member 10a through which the opening of the puncture member mounting portion 40a can be pierced by the needle portion 61b of the puncture member 6. Yes.
  • the seal member 10a is accommodated in the distal end portion 41a of the outer cylinder 4a.
  • the seal member 10a has an annular groove, engages with an annular rib 49 protruding from the inner surface of the tip portion 41a, and movement within the tip portion is restricted.
  • a member manufactured by injection molding or the like may be mounted on the outer cylinder main body, or may be formed in the outer cylinder main body by insert molding or two-color molding.
  • the puncture member mounting portion 40a is a cylindrical portion, like the outer cylinder sealing member 5 described above, and has a small-diameter opening 48 provided at the tip and a recess 53a (specifically, provided on the side portion).
  • a small-diameter opening 48 provided at the tip and a recess 53a (specifically, provided on the side portion).
  • the cylindrical body side screwing portion (in other words, the outer cylinder side screwing portion) 52 provided on the outer surface on the distal end side from the concave portion 53a.
  • an excessive rotation restricting rib 88 (specifically, two ribs facing each other).
  • the cylindrical body side screwing portion 52 is formed by two spiral ribs.
  • the puncture member 6 includes the protrusions 86 (specifically, two protrusions facing each other) provided on the inner surface in the vicinity of the central portion in the axial direction (slightly from the base end). The protrusion 86 extends a predetermined length in the circumferential direction.
  • the protrusion 86 enters and engages with the recess 53a of the puncture member mounting portion 40a.
  • the mounting state of the puncture member 6 to the outer cylinder 4a becomes stable, the rotation of the puncture member in the direction in which the screwing is retracted is restricted, and the puncture member is unintentionally loosened and detached from the outer cylinder. To prevent.
  • the cylindrical body for prefilled syringes of the present invention is a holder 100 that can be attached to a prefilled syringe 110 whose tip is sealed with a seal member that can be pierced by the needle portion of the puncture member, as shown in FIG. There may be.
  • the prefilled syringe holder 100 is a cylindrical body having a main body portion 101 and a puncture member mounting portion 102 provided at the distal end portion thereof.
  • the holder 100 is a cylindrical body that can receive a pre-prefilled syringe inside, in other words, can be attached to the pre-filled syringe 110.
  • FIG. 33 the cylindrical body for prefilled syringe 110.
  • the prefilled syringe 110 used in the holder 100 fixes the outer cylinder 111, a seal member 112 that seals the distal end portion thereof, and the seal member 112 to the distal end of the outer cylinder 111.
  • a fixing member 114, a gasket 113 that can slide in a liquid-tight manner in the outer cylinder 111, and a medicine 115 filled in the outer cylinder 111 are provided.
  • a plunger 130 capable of pressing the rear end of the gasket 113 is used.
  • the plunger 130 includes a shaft portion 131, a gasket pressing portion 132 that presses the rear end portion of the gasket 113 provided at the tip of the shaft portion 131, and an operation pressing portion 133 provided at the rear end of the shaft portion 131. I have. In this pre-prefilled syringe, the plunger can press the gasket, but is not attached to the gasket.
  • tip part of the main-body part 101 of the holder 100 for prefilled syringes is a cylindrical part similarly to the puncture member mounting part 50 mentioned above, and the opening 104 provided in the front-end
  • the concave portion 105 (specifically, two concave portions facing each other) provided in the side portion, the cylindrical body side screwing portion 103 provided on the outer surface on the distal end side from the concave portion 105, and the distal end surface of the puncture member mounting portion 102 And an excessive rotation restricting rib 106 (specifically, two ribs facing each other).
  • the cylindrical body side screwing portion 103 is formed by two helical ribs.
  • a bulging portion (not shown) is formed at the central portion of the spiral rib, and a bulging portion (not shown) is also formed at the terminal portion of the spiral rib.
  • the cylindrical body side screwing portion 103 is screwed with the puncture member side screwing portion 85 of the puncture member 6 described above.
  • the said recessed part 105 forms the cylindrical body side engaging part.
  • a flange 109 is formed at the rear end of the main body 101.
  • the operation of the prefilled syringe 1 of the present invention will be described with reference to FIGS. 1 to 3 and FIGS. 22 to 27.
  • the syringe body 2 is sealed with an outer cylinder sealing member 5 attached to the tip, and the puncture device 3 is punctured in the storage member 7.
  • the member 6 is housed, and the syringe body 2 and the puncture device 3 are not attached.
  • the outer cylinder sealing member 5 is attached to the distal end portion 41 of the outer cylinder main body 40 so that it cannot rotate and cannot be detached.
  • the puncture member 6 is in a state of rotating in the storage member 7 with the rotation of the storage member 7.
  • the tip side portion of the prefilled syringe 1 of the present invention is composed of a tip portion 41 of the outer cylinder main body 40, an outer cylinder sealing member 5, a puncture member 6 and a storage member 7 as shown in FIG.
  • the puncture member side engaging portion (on the inner surface of the puncture member 6 in the vicinity of the central portion in the axial direction (slightly from the base end)) (
  • the protruding portion 86 enters and engages with the cylindrical body side engaging portion (window portion) 53 of the outer cylinder sealing member 5. Since there is some resistance during this engagement, the operator can recognize the end of the mounting operation and prevent overtightening.
  • the rib 59 of the outer cylinder sealing member 5 is formed in the annular recess 87 provided on the inner surface near the proximal end of the puncture member 6 at the same time or slightly before the above engagement.
  • the small diameter portion 62 of the puncture member 6 is interposed between the plurality of bulging portions 74 formed on the inner surface of the central portion in the axial direction of the storage member 7 by attaching the storage member 7 to the syringe body.
  • the bulging portion 65 provided on the outer surface of the first member enters, engages, and becomes the state of FIG. 24 again. Although it may be discarded in this state, the puncture device 3 may be detached from the syringe body and discarded separately. In this case, when the storage member 7 is rotated in the direction opposite to the arrow in FIG.
  • the joint portion (projecting portion) 86 is separated from the tubular body side engaging portion (window portion) 53 of the outer cylinder sealing member 5, and the rib 59 of the outer cylinder sealing member 5 is inserted from the annular recess 87 of the puncture member 6.
  • the puncture member 6 is detached from the syringe body 2 in a state of being accommodated in the accommodation member 7. In addition, even if this puncture tool detachment operation is performed, the outer cylinder sealing member 5 does not detach from the outer cylinder.
  • the cylindrical body for prefilled syringes of the present invention is as follows. (1) A cylindrical body having a puncture member mounting portion, a hollow needle having needle portions at both ends, and the hollow needle is mounted and detachable from the puncture member mounting portion, and the puncture member side screwing portion and puncture A tubular body for a prefilled syringe to which a puncture member comprising a puncture member main body having a member side engagement portion can be attached,
  • the puncture member mounting portion includes: a cylindrical body side screwing portion that can be screwed with the puncture member side screwing portion; and the cylindrical body side screwing portion and the puncture member side screwing portion that are screwed together,
  • a tubular body for a prefilled syringe having a tubular body-side engaging portion that engages with a member-side engaging portion and restricts the backward movement of screwing.
  • the puncture member is attached to the prefilled syringe tubular body by screwing and engagement.
  • the puncture member does not loosen during the syringe administration operation, etc., and there is no liquid leakage due to the loosening.
  • the cylindrical body for a prefilled syringe is an outer cylinder for a prefilled syringe, and the outer cylinder for a prefilled syringe seals an outer cylinder body having a tip portion provided with an opening, and an opening of the tip portion. And an outer cylinder sealing member attached to the distal end portion of the outer cylinder main body, and the puncture member mounting portion is constituted by the outer cylinder sealing member.
  • tip part of the said outer cylinder main body and the said outer cylinder sealing member have the control part which controls the detachment
  • the distal end portion of the outer cylinder main body and the outer cylinder sealing member have a rotation restricting engagement portion and a detachment restricting engagement portion as the restricting portion.
  • the cylindrical body for a prefilled syringe is an outer cylinder for a prefilled syringe, the puncture member mounting portion of the prefilled syringe outer cylinder has an opening of the puncture member mounting portion, and the needle portion of the puncture member
  • the cylindrical body for a prefilled syringe according to the above (1) which is sealed by a sealing member that can be pierced by the above.
  • the cylindrical body for a prefilled syringe is a holder that can be attached to a prefilled syringe whose tip is sealed by a seal member that can be pierced by the needle portion of the puncture member. Cylindrical body for prefilled syringe.
  • the prefilled syringe puncture device of the present invention is as follows. (6) A prefilled syringe puncture device detachable from the puncture member mounting portion of the prefilled syringe tubular body according to any one of (1) to (5) above,
  • the puncture device includes the hollow needle having the needle portions at both ends, the hollow needle is mounted, is detachable from the puncture member mounting portion, and the puncture member side screwing portion and the puncture member side engaging portion are
  • the puncture member having the puncture member main body and a storage member for detachably storing the puncture member, and the storage member and the puncture member receive a rotational force applied to the storage member.
  • the storage member has a rotational force transmitting portion that transmits to the puncture member, and the storage member is detached from the puncture member by pulling in the distal direction after the puncture member is mounted on the puncture member mounting portion.
  • a prefilled syringe puncture device For this reason, the mounting operation to the cylindrical body for prefilled syringe is easy, and the puncture member is mounted to the cylindrical body for prefilled syringe by screwing and engagement. The puncture member does not loosen. Furthermore, after administration of the medicine by the prefilled syringe, the puncture tool can be easily detached from the prefilled syringe cylindrical body by re-inserting the storage member into the puncture member and rotating in the direction in which the screwing is released. it can.
  • the syringe for prefilled syringes of the present invention is as follows. (7) A prefilled syringe outer cylinder which is a cylindrical body for a prefilled syringe according to any one of (2) to (4) above, a slidable gasket housed in the outer cylinder, A syringe body provided with a plunger attached to or attachable to a rear end, the puncture member detachably attached to the puncture member mounting portion of the prefilled syringe outer cylinder, and a storage member for detachably storing the puncture member
  • a prefilled syringe syringe comprising a puncture device comprising:
  • the puncture member mounting portion includes the cylindrical body side screwing portion and the cylindrical body side engaging portion, and the puncture member is screwed to the cylindrical body side screwing portion so that the puncture member side screwing is possible.
  • the puncture member side engaging portion that engages with the cylindrical body side engaging portion and regulates the backward movement of the screwing after the cylindrical portion, the cylindrical body side screwed portion and the puncture member side screwed portion are screwed together
  • the storage member and the puncture member have a rotational force transmitting portion that transmits a rotational force applied to the storage member to the puncture member
  • the storage member has the puncture member A syringe for a prefilled syringe that is detached from the puncture member by being pulled in the distal direction after being mounted on the puncture member mounting portion.
  • the puncture member is attached to the syringe body by screwing and engagement, so that the puncture member is used during the prefilled syringe administration operation (for example, when the storage member is removed). There is no loosening and there is no leakage due to the loosening.
  • the storage member can be attached to the puncture member again, and the storage member attached again to the puncture member is connected to the tubular body side screwing portion and the puncture member.
  • the engagement between the cylindrical body side engaging part and the puncturing member side engaging part is released, and the puncturing member is placed in the storage member.
  • the cylindrical body side screwing portion and the puncture member side screwing portion are arranged so that the cylindrical body side screwing portion and the puncture member side after the needle portion of the hollow needle pierces the seal member.
  • the puncture member mounting portion includes a first cylindrical body side engaging portion and a second cylindrical body side engaging portion that is located closer to the proximal end side or the distal end side of the puncture member mounting portion than the first cylindrical body side engaging portion.
  • a cylindrical body side engaging portion; and the puncture member includes a first puncture member side engaging portion that engages with the first cylindrical body side engaging portion, and the first puncture member side engaging portion.
  • the puncture member mounting portion includes an excessive rotation restricting rib, and the puncture member is engaged with the cylindrical body side screwing portion and the puncture member side screwing portion, and then the excessive rotation restriction rib.
  • the prefilled syringe of the present invention is as follows. (12) A prefilled syringe comprising the prefilled syringe injector according to any one of (7) to (11) above and a medicine stored in the syringe body.

Landscapes

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

Abstract

A pre-filled syringe (1) is formed from: a syringe main body (2) further comprising an outer cylinder main body (40), and an outer cylinder sealing member (5) provided with a seal member (10); and a puncture instrument (3), further comprising a puncture member (6) having a hollow needle (61) provided with a puncture needle part (61a) on one end and a seal member puncture needle part (61b) on another end, and a housing member (7) which detachably houses the puncture member (6). The outer cylinder and the outer cylinder sealing member further comprise restriction parts which restrict the detachment and rotation of the outer cylinder sealing member. The outer cylinder sealing member and the puncture member respectively further comprise screw parts, and latch parts which latch and restrict the forward and reverse screw movement after the screw parts screw together. The housing member further comprises a rotation force transmission part to the puncture part which is housed therein.

Description

プレフィルドシリンジ用筒状体、プレフィルドシリンジ用穿刺具、プレフィルドシリンジ用注射器およびプレフィルドシリンジCylindrical body for prefilled syringe, puncture device for prefilled syringe, syringe for prefilled syringe and prefilled syringe
　本発明は、プレフィルドシリンジ用筒状体、プレフィルドシリンジ用穿刺具、プレフィルドシリンジ用注射器およびプレフィルドシリンジに関する。 The present invention relates to a cylindrical body for a prefilled syringe, a puncture device for a prefilled syringe, an injector for a prefilled syringe, and a prefilled syringe.
　プレフィルドシリンジは、薬液、薬剤溶解液などの医療用液体が充填された状態にて提供される。そして、プレフィルドシリンジとしては、例えば、先端部が、両頭針が装着可能なキャップによりシールされたものがあり、このようなタイプのプレフィルドシリンジには、両頭針を有する穿刺部材が、使用時に装着される。また、両頭針を有する穿刺部材およびその装着形態としては、特許文献１（特表２０１０－５４０１２２号公報、ＷＯ２００９－０４３０００、ＵＳ２０１２－０２０９１７１）に示すようなものもある。 The prefilled syringe is provided in a state where it is filled with a medical liquid such as a drug solution or a drug solution. As a prefilled syringe, for example, there is a prefilled syringe whose tip is sealed with a cap to which a double-ended needle can be attached. In such a prefilled syringe, a puncture member having a double-ended needle is attached at the time of use. The Further, as a puncture member having a double-ended needle and its mounting form, there are also those shown in Patent Document 1 (Japanese Patent Publication No. 2010-540122, WO2009-043000, US2012-0209171).
特表２０１０－５４０１２２号公報（ＷＯ２００９－０４３０００、ＵＳ２０１２－０２０９１７１）Japanese Translation of PCT International Publication No. 2010-540122 (WO2009-043000, US2012-0209171)
　特許文献１のものでは、穿刺部材を螺合のみによって装着するため、装着後、プレフィルドシリンジの投与操作時等に、螺合が緩み、液漏れする可能性がある。 In the case of Patent Document 1, since the puncture member is attached only by screwing, there is a possibility that the screwing loosens and leaks during the administration operation of the prefilled syringe after the attachment.
　本発明の目的は、先端部が封止部材によりシールされたシリンジの封止部材への両頭針を有する穿刺部材の装着操作および離脱操作が容易であり、かつ、穿刺部材の装着操作時に、シリンジの封止部材がゆるむことがなく、緩みに起因する液漏れを防止したプレフィルドシリンジ用筒状体、プレフィルドシリンジ用穿刺具、プレフィルドシリンジ用注射器およびプレフィルドシリンジを提供するものである。 It is an object of the present invention to facilitate the attaching and detaching operation of a puncture member having a double-ended needle to the sealing member of a syringe whose tip is sealed by the sealing member, and at the time of the attaching operation of the puncture member The present invention provides a cylindrical body for a prefilled syringe, a puncture tool for a prefilled syringe, a syringe for a prefilled syringe, and a prefilled syringe, in which the sealing member of the prefilled syringe is prevented from being loosened.
　上記目的を達成するものは、以下のものである。
　穿刺部材装着部を有する筒状体であり、両端に針部を有する中空針と、前記中空針を装着し、前記穿刺部材装着部に着脱可能かつ、穿刺部材側螺合部と穿刺部材側係合部とを有する穿刺部材本体とを備える穿刺部材が装着可能であるプレフィルドシリンジ用筒状体であって、前記穿刺部材装着部は、前記穿刺部材側螺合部と螺合可能な筒状体側螺合部と、前記筒状体側螺合部と前記穿刺部材側螺合部が螺合した後、前記穿刺部材側係合部と係合し、螺合の後退を規制する筒状体側係合部とを有するプレフィルドシリンジ用筒状体。 What achieves the above object is as follows.
A cylindrical body having a puncture member mounting portion, a hollow needle having needle portions at both ends, and the hollow needle is mounted and detachable from the puncture member mounting portion, and the puncture member side screwing portion and the puncture member side engagement A tubular body for a prefilled syringe to which a puncture member comprising a puncture member main body having a joint portion can be mounted, wherein the puncture member mounting portion is screwed with the puncture member side threaded portion After the threaded portion, the tubular body side threaded portion, and the puncture member side threaded portion are threaded together, the tubular body side engagement that engages with the puncture member side engaging portion and restricts the backward movement of the threaded engagement. And a cylindrical body for a prefilled syringe.
　また、上記目的を達成するものは、以下のものである。
　上記のプレフィルドシリンジ用筒状体の前記穿刺部材装着部に着脱可能なプレフィルドシリンジ用穿刺具であって、前記穿刺具は、両端に前記針部を有する前記中空針と、前記中空針を装着し、前記穿刺部材装着部に着脱可能かつ、前記穿刺部材側螺合部と前記穿刺部材側係合部とを有する前記穿刺部材本体とを備える前記穿刺部材と、前記穿刺部材を離脱可能に収納する収納部材とを備え、さらに、前記収納部材と前記穿刺部材は、前記収納部材に付与された回転力を前記穿刺部材に伝達する回転力伝達部を有し、かつ、前記収納部材は、前記穿刺部材が前記穿刺部材装着部に装着された後、先端方向に引くことにより、前記穿刺部材より、離脱するものであるプレフィルドシリンジ用穿刺具。 Moreover, what achieves the said objective is as follows.
A puncture device for a prefilled syringe that is attachable to and detachable from the puncture member mounting portion of the cylindrical body for a prefilled syringe, wherein the puncture device is mounted with the hollow needle having the needle portions at both ends, and the hollow needle. The puncture member including the puncture member main body having the puncture member side screwing portion and the puncture member side engaging portion, which is detachable from the puncture member mounting portion, and detachably stores the puncture member. A storage member, and the storage member and the puncture member further include a rotational force transmitting portion that transmits a rotational force applied to the storage member to the puncture member, and the storage member includes the puncture member. A puncture device for a prefilled syringe, which is detached from the puncture member by pulling in a distal direction after the member is mounted on the puncture member mounting portion.
　また、上記目的を達成するものは、以下のものである。
　上記のプレフィルドシリンジ用筒状体であるプレフィルドシリンジ用外筒と、前記外筒内に収納された摺動可能なガスケットと、該ガスケットの後端に取り付けられたもしくは取り付け可能なプランジャとを備えるシリンジ本体と、前記プレフィルドシリンジ用外筒の前記穿刺部材装着部に着脱可能な前記穿刺部材と、前記穿刺部材を離脱可能に収納する収納部材とを備える穿刺具とからなるプレフィルドシリンジ用注射器であって、前記穿刺部材装着部は、前記筒状体側螺合部と前記筒状体側係合部とを有し、前記穿刺部材は、前記筒状体側螺合部と螺合可能な前記穿刺部材側螺合部と、前記筒状体側螺合部と前記穿刺部材側螺合部が螺合した後、前記筒状体側係合部と係合し、螺合の後退を規制する前記穿刺部材側係合部とを有し、前記収納部材と前記穿刺部材は、前記収納部材に付与された回転力を前記穿刺部材に伝達する回転力伝達部を有し、かつ、前記収納部材は、前記穿刺部材が前記穿刺部材装着部に装着された後、先端方向に引くことにより、前記穿刺部材より、離脱するものであるプレフィルドシリンジ用注射器。 Moreover, what achieves the said objective is as follows.
Syringe comprising a prefilled syringe outer cylinder which is a cylindrical body for the prefilled syringe, a slidable gasket housed in the outer cylinder, and a plunger attached to or attached to the rear end of the gasket A syringe for a prefilled syringe comprising a main body, the puncture member that can be attached to and detached from the puncture member mounting portion of the prefilled syringe outer cylinder, and a puncture device that detachably accommodates the puncture member. The puncture member mounting portion includes the cylindrical body side screwing portion and the cylindrical body side engaging portion, and the puncture member is screwed to the cylindrical body side screwing portion. The engaging portion, the tubular body side threaded portion and the puncture member side threaded portion are engaged with each other, and then engaged with the tubular body side engaging portion, and the puncture member side engagement for restricting retraction of the threaded engagement. And having said part The storage member and the puncture member have a rotational force transmitting portion that transmits the rotational force applied to the storage member to the puncture member, and the storage member is attached to the puncture member mounting portion by the puncture member After being done, the prefilled syringe injector that is detached from the puncture member by pulling in the distal direction.
　また、上記目的を達成するものは、以下のものである。
　上記のプレフィルドシリンジ用注射器と、前記シリンジ本体内に収納された薬剤とからなるプレフィルドシリンジ。 Moreover, what achieves the said objective is as follows.
The prefilled syringe which consists of said syringe for prefilled syringes, and the chemical | medical agent accommodated in the said syringe main body.
図１は、本発明のプレフィルドシリンジおよびプレフィルドシリンジ用注射器の外観図である。FIG. 1 is an external view of a prefilled syringe and a prefilled syringe syringe of the present invention. 図２は、本発明のプレフィルドシリンジに使用されるシリンジ本体の拡大縦断面図である。FIG. 2 is an enlarged longitudinal sectional view of a syringe body used for the prefilled syringe of the present invention. 図３は、本発明のプレフィルドシリンジ用穿刺具の拡大縦断面図である。FIG. 3 is an enlarged longitudinal sectional view of the prefilled syringe puncture device of the present invention. 図４は、本発明のプレフィルドシリンジ用筒状体、プレフィルドシリンジおよびプレフィルドシリンジ用注射器に使用される外筒の正面図である。FIG. 4 is a front view of an outer cylinder used in the prefilled syringe cylinder, the prefilled syringe, and the prefilled syringe injector of the present invention. 図５は、図４に示した外筒の右側面図である。5 is a right side view of the outer cylinder shown in FIG. 図６は、図４に示した外筒の拡大平面図である。6 is an enlarged plan view of the outer cylinder shown in FIG. 図７は、図４に示した外筒の斜視図である。7 is a perspective view of the outer cylinder shown in FIG. 図８は、本発明のプレフィルドシリンジ用筒状体、プレフィルドシリンジおよびプレフィルドシリンジ用注射器に使用される外筒封止部材の拡大正面図である。FIG. 8 is an enlarged front view of an outer cylinder sealing member used in the tubular body for prefilled syringe, the prefilled syringe, and the syringe for prefilled syringe of the present invention. 図９は、図８に示した外筒封止部材の右側面図である。FIG. 9 is a right side view of the outer cylinder sealing member shown in FIG. 図１０は、図８に示した外筒封止部材の縦断面図である。FIG. 10 is a longitudinal sectional view of the outer cylinder sealing member shown in FIG. 図１１は、図８に示した外筒封止部材の上方から見た斜視図である。FIG. 11 is a perspective view of the outer cylinder sealing member shown in FIG. 8 as viewed from above. 図１２は、図８に示した外筒封止部材の下方から見た斜視図である。12 is a perspective view of the outer cylinder sealing member shown in FIG. 8 as viewed from below. 図１３は、本発明のプレフィルドシリンジ用穿刺具に用いられる穿刺部材の拡大正面図である。FIG. 13 is an enlarged front view of a puncture member used in the prefilled syringe puncture device of the present invention. 図１４は、図１３に示した穿刺部材の左側面図である。FIG. 14 is a left side view of the puncture member shown in FIG. 図１５は、図１３に示した穿刺部材の縦断面図である。15 is a longitudinal sectional view of the puncture member shown in FIG. 図１６は、図１４に示した穿刺部材の縦断面図である。16 is a longitudinal sectional view of the puncture member shown in FIG. 図１７は、図１３に示した穿刺部材の斜視図である。17 is a perspective view of the puncture member shown in FIG. 図１８は、本発明のプレフィルドシリンジ用穿刺具に用いられる収納部材の拡大正面図である。FIG. 18 is an enlarged front view of a storage member used for the prefilled syringe puncture device of the present invention. 図１９は、図１８に示した収納部材の縦断面図である。19 is a vertical cross-sectional view of the storage member shown in FIG. 図２０は、本発明のプレフィルドシリンジおよびプレフィルドシリンジ用注射器に使用されるプランジャの拡大正面図である。FIG. 20 is an enlarged front view of a plunger used in the prefilled syringe and the prefilled syringe syringe of the present invention. 図２１は、本発明のプレフィルドシリンジおよびプレフィルドシリンジ用注射器に使用されるガスケットの縦断面図である。FIG. 21 is a longitudinal sectional view of a gasket used in the prefilled syringe and the prefilled syringe syringe of the present invention. 図２２は、本発明のプレフィルドシリンジおよびプレフィルドシリンジ用注射器に使用される構成部材を説明するための説明図である。FIG. 22 is an explanatory diagram for explaining constituent members used in the prefilled syringe and the prefilled syringe syringe of the present invention. 図２３は、本発明のプレフィルドシリンジおよびプレフィルドシリンジ用注射器の作用を説明するための説明図である。FIG. 23 is an explanatory diagram for explaining the operation of the prefilled syringe and the prefilled syringe syringe of the present invention. 図２４は、本発明のプレフィルドシリンジおよびプレフィルドシリンジ用注射器の作用を説明するための説明図である。FIG. 24 is an explanatory diagram for explaining the operation of the prefilled syringe and the prefilled syringe syringe of the present invention. 図２５は、本発明のプレフィルドシリンジおよびプレフィルドシリンジ用注射器の作用を説明するための説明図である。FIG. 25 is an explanatory diagram for explaining the operation of the prefilled syringe and the prefilled syringe syringe of the present invention. 図２６は、本発明のプレフィルドシリンジおよびプレフィルドシリンジ用注射器の作用を説明するための説明図である。FIG. 26 is an explanatory diagram for explaining the operation of the prefilled syringe and the prefilled syringe syringe of the present invention. 図２７は、本発明のプレフィルドシリンジおよびプレフィルドシリンジ用注射器の作用を説明するための説明図である。FIG. 27 is an explanatory diagram for explaining the operation of the prefilled syringe and the prefilled syringe syringe of the present invention. 図２８は、本発明のプレフィルドシリンジおよびプレフィルドシリンジ用注射器に使用される他の例の外筒封止部材の拡大外観図である。FIG. 28 is an enlarged external view of an outer cylinder sealing member of another example used for the prefilled syringe and the prefilled syringe syringe of the present invention. 図２９は、本発明のプレフィルドシリンジおよびプレフィルドシリンジ用注射器に使用される他の例の外筒封止部材の拡大外観図である。FIG. 29 is an enlarged external view of an outer cylinder sealing member of another example used in the prefilled syringe and the prefilled syringe injector of the present invention. 図３０は、本発明のプレフィルドシリンジおよびプレフィルドシリンジ用注射器に使用される他の例の外筒封止部材の拡大外観図である。FIG. 30 is an enlarged external view of another example of the outer cylinder sealing member used in the prefilled syringe and the prefilled syringe injector of the present invention. 図３１は、本発明のプレフィルドシリンジおよびプレフィルドシリンジ用注射器に使用される他の例の外筒の先端側部分の拡大外観図である。FIG. 31 is an enlarged external view of the distal end side portion of the outer cylinder of another example used in the prefilled syringe and the prefilled syringe syringe of the present invention. 図３２は、図３１に示した外筒の縦断面図である。FIG. 32 is a longitudinal sectional view of the outer cylinder shown in FIG. 図３３は、本発明のプレフィルドシリンジ用筒状体であるプレフィルドシリンジ用ホルダーを説明するための説明図である。FIG. 33 is an explanatory diagram for explaining a prefilled syringe holder which is a tubular body for a prefilled syringe according to the present invention.
　以下、本発明のプレフィルドシリンジ用筒状体、プレフィルドシリンジおよびプレフィルドシリンジ用注射器を図面に示す実施例に基づいて説明する。
　本発明のプレフィルドシリンジ用筒状体（例えば、プレフィルドシリンジ用外筒４，４ａ、プレフィルドシリンジ用ホルダー１００）は、図２、図３３に示すように、穿刺部材装着部５０，４０ａ、１０２を有する筒状体であり、両端に針部６１ａ，６１ｂを有する中空針６１と、中空針６１を装着し、穿刺部材装着部５０，４０ａ、１０２に着脱可能かつ、穿刺部材側螺合部８５と穿刺部材側係合部８６とを有する穿刺部材本体６０とを備える穿刺部材６が装着可能である。そして、穿刺部材装着部は、穿刺部材側螺合部８５と螺合可能な筒状体側螺合部５２と、筒状体側螺合部５２と穿刺部材側螺合部８５が螺合した後、穿刺部材側係合部８６と係合し、螺合の後退を規制する筒状体側係合部５３とを有している。 Hereinafter, the cylindrical body for prefilled syringes, the prefilled syringe, and the syringe for prefilled syringes of the present invention will be described based on examples shown in the drawings.
The cylindrical body for prefilled syringes of the present invention (for example, the prefilled syringe outer cylinders 4 and 4a and the prefilled syringe holder 100) has puncture member mounting portions 50, 40a and 102 as shown in FIGS. A hollow needle 61 having needle portions 61a and 61b at both ends and a hollow needle 61 is attached to the puncture member mounting portions 50, 40a and 102, and is detachable from the puncture member side screwing portion 85 and puncture. The puncture member 6 provided with the puncture member main body 60 which has the member side engaging part 86 can be mounted | worn. Then, after the puncture member mounting portion is threadedly engaged with the puncture member side screwing portion 85, the cylindrical body side screwing portion 52, and the cylindrical body side screwing portion 52 and the puncture member side screwing portion 85 are screwed. It has a cylindrical body side engaging portion 53 that engages with the puncture member side engaging portion 86 and regulates the backward movement of the screwing.
　本発明のプレフィルドシリンジ用筒状体は、例えば、プレフィルドシリンジ用外筒、プレフィルドシリンジ用ホルダーに応用される。
　そして、本発明のプレフィルドシリンジ用筒状体を応用したプレフィルドシリンジ用外筒は、図２に示すように、先端部４１の開口４８がシール部材により封止された穿刺部材装着部５０を有する外筒であり、かつ、穿刺部材装着部５０に、両端に針部（具体的には、一端に穿刺用針部６１ａを他端にシール部材刺通用針部６１ｂ）を有する中空針６１と、中空針６１を装着し、穿刺部材装着部５０に着脱可能かつ、穿刺部材側螺合部８５と穿刺部材側係合部８６とを有する穿刺部材本体６０とを備える穿刺部材６が装着可能である。そして、穿刺部材装着部５０は、穿刺部材側螺合部８５と螺合可能な筒状体側螺合部５２と、筒状体側螺合部５２と穿刺部材側螺合部８５が螺合した後、穿刺部材側係合部８６と係合し、螺合の後退を規制する筒状体側係合部５３とを有している。 The cylindrical body for prefilled syringes of the present invention is applied to, for example, an outer cylinder for prefilled syringes and a holder for prefilled syringes.
As shown in FIG. 2, the prefilled syringe outer cylinder to which the prefilled syringe tubular body of the present invention is applied has an outer puncture member mounting portion 50 in which the opening 48 of the distal end portion 41 is sealed by a seal member. A hollow needle 61 that is a cylinder and has a needle part at both ends (specifically, a needle part 61a for puncture at one end and a needle part 61b for a seal member at the other end) at both ends; The puncture member 6 equipped with the needle 61 and detachable from the puncture member mounting portion 50 and having the puncture member main body 60 having the puncture member side screwing portion 85 and the puncture member side engaging portion 86 can be attached. The puncture member mounting portion 50 is formed after the cylindrical body side screwing portion 52 that can be screwed with the puncture member side screwing portion 85, and the cylindrical body side screwing portion 52 and the puncture member side screwing portion 85 are screwed together. And a tubular body side engaging portion 53 that engages with the puncture member side engaging portion 86 and restricts the backward movement of the screwing.
　本発明のプレフィルドシリンジ用外筒を用いたプレフィルドシリンジ用注射器では、穿刺部材は螺合および係合によりプレフィルドシリンジ用外筒に装着されるため、プレフィルドシリンジの投与操作時等に、穿刺部材が緩むことがなく、緩みに起因する液漏れがない。 In the prefilled syringe syringe using the prefilled syringe outer cylinder of the present invention, since the puncture member is attached to the prefilled syringe outer cylinder by screwing and engagement, the puncture member is loosened at the time of administration operation of the prefilled syringe. There is no leakage due to looseness.
　そして、本発明のプレフィルドシリンジ１（プレフィルドシリンジ用注射器）は、上記のプレフィルドシリンジ用外筒を用いるものである。 And the prefilled syringe 1 (injector for prefilled syringe) of the present invention uses the above-mentioned prefilled syringe outer cylinder.
　本発明のプレフィルドシリンジ１（プレフィルドシリンジ用注射器）は、プレフィルドシリンジ用外筒と、外筒内に収納された摺動可能なガスケット８と、ガスケット８の後端に取り付けられたもしくは取り付け可能なプランジャ９とを備えるシリンジ本体２と、一端に穿刺用針部６１ａを他端にシール部材刺通用針部６１ｂを有する中空針６１と、中空針６１を装着し、かつ、外筒封止部材５に着脱可能な穿刺部材本体６０とを有する穿刺部材６と、穿刺部材６を離脱可能に収納する収納部材７とを備える穿刺具３とからなる。 The prefilled syringe 1 (injector for prefilled syringe) of the present invention includes a prefilled syringe outer cylinder, a slidable gasket 8 housed in the outer cylinder, and a plunger attached to or attachable to the rear end of the gasket 8. 9, a hollow needle 61 having a puncture needle portion 61 a at one end and a seal needle piercing needle portion 61 b at the other end, a hollow needle 61 attached, and the outer cylinder sealing member 5 The puncture member 3 includes a puncture member 6 having a detachable puncture member body 60 and a storage member 7 that detachably accommodates the puncture member 6.
　そして、穿刺部材装着部５０は、筒状体側螺合部５２と筒状体側係合部５３とを有し、穿刺部材６は、筒状体側螺合部５２と螺合可能な穿刺部材側螺合部８５と、２つの螺合部５２，８５が螺合した後、筒状体側係合部５３と係合し、螺合の進行および後退を規制する穿刺部材側係合部８６とを備える。
　そして、本発明のプレフィルドシリンジ１では、シリンジ本体２内に薬剤１１が収納されている。プレフィルドシリンジとプレフィルドシリンジ用注射器の相違は、薬剤の充填の有無である。 The puncture member mounting portion 50 includes a cylindrical body side screwing portion 52 and a cylindrical body side engaging portion 53, and the puncture member 6 is piercing member side screw that can be screwed with the cylindrical body side screwing portion 52. After the mating portion 85 and the two screwing portions 52 and 85 are screwed together, the mating portion 85 is engaged with the tubular body side engaging portion 53 and includes a puncture member side engaging portion 86 that regulates the progress and retreat of the screwing. .
And in the prefilled syringe 1 of this invention, the chemical | medical agent 11 is accommodated in the syringe main body 2. FIG. The difference between the prefilled syringe and the syringe for the prefilled syringe is whether or not the medicine is filled.
　また、図示する実施例のプレフィルドシリンジ用外筒４は、外筒本体４０とその先端部に装着された外筒封止部材５により構成されている。穿刺部材装着部５０は、外筒封止部材５により構成されている。言い換えれば、外筒封止部材５が、穿刺部材装着部５０を備えている。また、この実施例のプレフィルドシリンジ用外筒４では、外筒本体４０の先端部４１および外筒封止部材５は、先端部４１に装着された外筒封止部材５の離脱および回動を規制する規制部４３，４７，５３，５８を備えており、外筒封止部材５は、筒状体側螺合部（言い換えれば、封止部材側螺合部）５２と筒状体側係合部（言い換えれば、封止部材側係合部）５３とを備え、穿刺部材６は、筒状体側螺合部５２と螺合可能な穿刺部材側螺合部８５と、２つの螺合部が螺合した後、筒状体側係合部５３と係合し、螺合の後退を規制する穿刺部材側係合部８６とを備え、収納部材７と穿刺部材６は、収納部材７に付与された回転力を穿刺部材６に伝達する回転力伝達部６５、７４を備え、かつ、収納部材７は、穿刺部材６が外筒封止部材５に装着された後、先端方向に引くことにより、穿刺部材６より、離脱するものとなっている。 Further, the prefilled syringe outer cylinder 4 of the illustrated embodiment is constituted by an outer cylinder main body 40 and an outer cylinder sealing member 5 attached to the tip portion thereof. The puncture member mounting portion 50 is configured by the outer cylinder sealing member 5. In other words, the outer cylinder sealing member 5 includes the puncture member mounting portion 50. Moreover, in the prefilled syringe outer cylinder 4 of this embodiment, the distal end portion 41 and the outer cylinder sealing member 5 of the outer cylinder main body 40 are detached and rotated from the outer cylinder sealing member 5 attached to the distal end portion 41. The outer cylinder sealing member 5 includes a cylindrical body side screwing part (in other words, a sealing member side screwing part) 52 and a cylindrical body side engaging part. (In other words, the sealing member side engaging portion) 53, the puncture member 6 includes a puncture member side screwing portion 85 that can be screwed with the cylindrical body side screwing portion 52, and two screwing portions screwed together. Then, the storage member 7 and the puncture member 6 are attached to the storage member 7. The storage member 7 and the puncture member 6 are provided to the storage member 7. Rotation force transmitting portions 65 and 74 that transmit the rotational force to the puncture member 6 are provided. After being, by pulling in the distal direction, which is assumed to from piercing member 6, disengaged.
　本発明のプレフィルドシリンジ１およびプレフィルドシリンジ用注射器は、シリンジ本体２と、穿刺具３とからなり、両者は、装着されない状態となっており、使用時に装着操作が行われる。また、シリンジ本体２には、外筒の先端部（具体的には、外筒本体４０の先端部に装着された外筒封止部材５）にキャップ（図示せず）を装着してもよい。このキャップは、穿刺具３の装着操作前に取り外される。
　シリンジ本体２は、外筒本体４０と、外筒本体４０の先端部４１を封止する外筒封止部材５とからなるプレフィルドシリンジ用外筒４と、外筒本体４０内に収納されたガスケット８と、外筒封止部材５とガスケット８により密封された外筒本体４０内に収納（充填）された薬剤１１と、ガスケット８に装着されたプランジャ９とを備える。なお、プランジャ９は、予めガスケットに装着されておらず、使用時にガスケット８に装着するものであってもよい。
　外筒本体４０は、図１、図２、図４および図２２に示すように、本体部４５と、先端部４１と、フランジ４６とを備える。本体部４５は、ほぼ円筒状となっており、内部に液体収納空間を有している。 The prefilled syringe 1 and the syringe for prefilled syringe of the present invention are composed of a syringe body 2 and a puncture tool 3, both of which are not mounted, and a mounting operation is performed during use. Further, a cap (not shown) may be attached to the syringe body 2 at the distal end portion of the outer cylinder (specifically, the outer cylinder sealing member 5 attached to the distal end portion of the outer cylinder main body 40). . This cap is removed before the puncture tool 3 is mounted.
The syringe body 2 includes a prefilled syringe outer cylinder 4 including an outer cylinder main body 40 and an outer cylinder sealing member 5 that seals a distal end portion 41 of the outer cylinder main body 40, and a gasket accommodated in the outer cylinder main body 40. 8, a drug 11 stored (filled) in an outer cylinder main body 40 sealed by the outer cylinder sealing member 5 and the gasket 8, and a plunger 9 attached to the gasket 8. The plunger 9 may be attached to the gasket 8 at the time of use without being attached to the gasket in advance.
As shown in FIGS. 1, 2, 4, and 22, the outer cylinder main body 40 includes a main body portion 45, a distal end portion 41, and a flange 46. The main body 45 has a substantially cylindrical shape and has a liquid storage space inside.
　先端部４１は、本体部４５の肩部より先端方向に突出している。先端部４１は、外筒内の薬液等を排出するための先端開口４８を備えるとともに、ＩＳＯ規格に適合したノズル部への接続部を有する医療用具への接続が不能となっている。つまり、通常のシリンジの先端部が有するルアーテーパー状となっていない。
　特に、この実施例の外筒本体４０では、先端部４１は、本体部４５との境界部に形成された拡径部４４と、拡径部４４に形成された凹部４７（具体的には、向かい合う２つの凹部）と、先端部４１の中間部４２（拡径部４４より小径かつ最先端部より大径の部分）の先端付近（言い換えれば、先端部４１の軸方向中央部付近）に設けられた突出部４３（具体的には、向かい合う２つの突出部）が設けられている。そして、先端部４１は、先端に小径部を備えており、その先端に開口４８が形成されている。
　そして、この実施例の外筒本体４０では、突出部４３は、周方向に所定長延びるものとなっている。また、２つの凹部４７は、軸方向に所定長延びるものとなっている。２つの突出部４３と２つの凹部４７は、軸方向に重ならないように設けられている。特に、この外筒では、各凹部４７と各突出部４３は、先端部４１の中心軸に対して、ほぼ９０度ずれたものとなっている。
　そして、外筒本体４０の先端部４１の突出部４３は、外筒側の外筒封止部材離脱規制用係合部を構成し、凹部４７は、外筒側の外筒封止部材回動規制用係合部を構成している。 The tip portion 41 protrudes from the shoulder portion of the main body portion 45 in the tip direction. The distal end portion 41 includes a distal end opening 48 for discharging a chemical solution or the like in the outer cylinder and cannot be connected to a medical device having a connection portion to a nozzle portion conforming to the ISO standard. That is, it is not a luer taper shape that the tip of a normal syringe has.
In particular, in the outer cylinder main body 40 of this embodiment, the distal end portion 41 includes a large diameter portion 44 formed at a boundary portion with the main body portion 45, and a concave portion 47 (specifically, Two concavities facing each other) and near the tip of the intermediate portion 42 of the tip 41 (a portion having a smaller diameter than the enlarged diameter portion 44 and a diameter larger than the most distal portion) (in other words, near the central portion in the axial direction of the tip 41). The protruding portion 43 (specifically, two protruding portions facing each other) is provided. And the front-end | tip part 41 is equipped with the small diameter part at the front-end | tip, and the opening 48 is formed in the front-end | tip.
And in the outer cylinder main body 40 of this Example, the protrusion part 43 is extended predetermined length in the circumferential direction. The two recesses 47 extend a predetermined length in the axial direction. The two protrusions 43 and the two recesses 47 are provided so as not to overlap in the axial direction. In particular, in this outer cylinder, each recessed portion 47 and each protruding portion 43 are shifted from each other by approximately 90 degrees with respect to the central axis of the distal end portion 41.
And the protrusion part 43 of the front-end | tip part 41 of the outer cylinder main body 40 comprises the engaging part for outer cylinder sealing member detachment | limiting regulation on the outer cylinder side, and the recessed part 47 rotates the outer cylinder sealing member on the outer cylinder side. A restricting engaging portion is formed.
　フランジ４６は、外筒本体４０の後端全周より垂直方向に突出するように形成された楕円ドーナツ状の円盤部である。フランジ４６は、図４ないし図７に示すように向かい合う２つの把持部を備えている。
　外筒本体４０は、透明もしくは半透明材料により、必要に応じて、酸素透過性、水蒸気透過性の少ない材料により形成された筒状体である。
　外筒本体４０の形成材料としては、例えば、ポリプロピレン、ポリエチレン、ポリスチレン、ポリアミド、ポリカーボネート、ポリ塩化ビニル、ポリ－（４－メチルペンテン－１）、アクリル樹脂、アクリロニトリル－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、環状ポリオレフィン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耐熱性があることから、ポリプロピレン、環状ポリオレフィンのような樹脂が好ましい。
　また、外筒本体４０の先端部４１は、後述する外筒封止部材５によりシールされている。 The flange 46 is an elliptical donut-shaped disk portion formed so as to protrude in the vertical direction from the entire rear end circumference of the outer cylinder main body 40. The flange 46 includes two gripping portions facing each other as shown in FIGS.
The outer cylinder main body 40 is a cylindrical body made of a transparent or translucent material, if necessary, made of a material having low oxygen permeability and water vapor permeability.
Examples of a material for forming the outer cylinder main body 40 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene. Various resins such as polyesters such as terephthalate and cyclic polyolefins may be mentioned. Among them, resins such as polypropylene and cyclic polyolefins are preferred because they are easy to mold and have heat resistance.
Moreover, the front-end | tip part 41 of the outer cylinder main body 40 is sealed by the outer cylinder sealing member 5 mentioned later.
　ガスケット８は、図２、図２１に示すように、先端が閉塞するとともに、ほぼ同一外径にて延びる本体部８１と、この本体部に設けられた複数の環状リブ８２，８３を備え、これらリブが、外筒本体４０の本体部４５の内面に液密に接触する。
　ガスケット８の形成材料としては、弾性を有するゴム（例えば、ブチルゴム、ラテックスゴム、シリコーンゴム、スチレン－ブタジエンゴム、イソプレンゴムなど）、熱可塑性エラストマー（例えば、ＳＢＳエラストマー、ＳＥＢＳエラストマー、ＳＥＰＳエラストマー等のスチレン系エラストマー、エチレン－αオレフィン共重合体エラストマー等のオレフィン系エラストマーなど）等を使用することが好ましい。
　そして、ガスケット８には、その後端部より内部に延びる凹部が設けられ、この凹部が、プランジャ装着部８４となっている。具体的には、プランジャ装着部８４は、雌ねじ状となっており、プランジャ９の先端部に形成されたガスケット装着部９２の外面に形成された雄ねじ部９３と螺合可能となっている。両者が螺合することにより、プランジャ９は、ガスケット８に装着される。 As shown in FIGS. 2 and 21, the gasket 8 includes a main body portion 81 whose front end is closed and extends with substantially the same outer diameter, and a plurality of annular ribs 82 and 83 provided on the main body portion. The rib is in liquid-tight contact with the inner surface of the main body 45 of the outer cylinder main body 40.
As a material for forming the gasket 8, elastic rubber (for example, butyl rubber, latex rubber, silicone rubber, styrene-butadiene rubber, isoprene rubber, etc.), thermoplastic elastomer (for example, SBS elastomer, SEBS elastomer, SEPS elastomer, styrene, etc.) It is preferable to use olefin-based elastomers such as olefin-based elastomers and ethylene-α-olefin copolymer elastomers).
The gasket 8 is provided with a recess extending inward from the rear end thereof, and this recess serves as a plunger mounting portion 84. Specifically, the plunger mounting portion 84 has a female screw shape, and can be screwed with a male screw portion 93 formed on the outer surface of the gasket mounting portion 92 formed at the distal end portion of the plunger 9. The plunger 9 is attached to the gasket 8 by screwing them together.
　プランジャ９は、図２０に示すように、先端部に設けられたガスケット装着部９２と、断面十字状の軸方向に延びる本体部９１と、本体部の先端に設けられた平板部９５と、本体部９１の後端部に設けられた押圧部９４と、本体部９１の途中に設けられた補強用リブ９６，９８を備えている。この実施例のプランジャでは、ガスケット装着部９２の外面には、プランジャ装着部８４と螺合する雄ねじ部９３が形成されている。そして、プランジャ装着部８４とガスケット装着部９２の雄ねじ部９３が螺合することにより、プランジャ９は、ガスケット８に接続される。
　外筒本体４０内に充填される薬剤１１としては、ビタミン剤（総合ビタミン剤）、各種アミノ酸、ヘパリンのような抗血栓剤、インシュリン、抗生物質、抗腫瘍剤、鎮痛剤、強心剤、静注麻酔剤、抗パーキンソン剤、潰瘍治療剤、副腎皮質ホルモン剤、不整脈用剤、ホルモン製剤、インターフェロン製剤、ヒト免疫グロブリン製剤、血液凝固因子製剤、ワクチン製剤などのタンパク製剤等が挙げられる。 As shown in FIG. 20, the plunger 9 includes a gasket mounting portion 92 provided at the distal end portion, a main body portion 91 extending in the axial direction having a cross-shaped cross section, a flat plate portion 95 provided at the distal end of the main body portion, and a main body. A pressing portion 94 provided at the rear end portion of the portion 91 and reinforcing ribs 96 and 98 provided in the middle of the main body portion 91 are provided. In the plunger of this embodiment, a male screw portion 93 that is screwed with the plunger mounting portion 84 is formed on the outer surface of the gasket mounting portion 92. The plunger 9 is connected to the gasket 8 when the plunger mounting portion 84 and the male threaded portion 93 of the gasket mounting portion 92 are screwed together.
As the medicine 11 filled in the outer cylinder main body 40, vitamin agents (total vitamin agents), various amino acids, antithrombotic agents such as heparin, insulin, antibiotics, antitumor agents, analgesics, cardiotonics, intravenous anesthesia Agents, anti-Parkinson agents, ulcer treatment agents, corticosteroid agents, arrhythmia agents, hormone preparations, interferon preparations, human immunoglobulin preparations, blood coagulation factor preparations, vaccine preparations, and other protein preparations.
　外筒封止部材５は、図８ないし図１２、図２２に示すように、穿刺部材装着部５０を有する本体部５１と、本体部５１内に収納されたシール部材１０とを備える。シール部材１０は、外筒本体の先端部の開口を封止するためのものである。
　穿刺部材装着部５０を有する本体部５１は、筒状体であり、先端に設けられた小径の開口部５７と、基端に設けられたフランジ部５５と、側部に設けられた窓部５３（具体的には、向かい合う２つの窓部）と、窓部５３より先端側の外面に設けられた筒状体側螺合部５２と、フランジ部５５より先端側かつ窓部５３より基端側に形成されたリブ５９（複数の周方向リブ）と、開口部５７の側部に設けられた過剰回転規制用リブ８８（具体的には、向かい合う２つのリブ）と、本体部５１の基端部の内面に設けられた軸方向に延びる突出部５８（具体的には、向かい合う２つの突出部）を備えている。 As shown in FIGS. 8 to 12 and 22, the outer cylinder sealing member 5 includes a main body 51 having a puncture member mounting portion 50 and a seal member 10 housed in the main body 51. The seal member 10 is for sealing the opening at the tip of the outer cylinder main body.
The main body 51 having the puncture member mounting portion 50 is a cylindrical body, and has a small-diameter opening 57 provided at the distal end, a flange 55 provided at the proximal end, and a window 53 provided at the side. (Specifically, two window portions facing each other), a cylindrical body-side threaded portion 52 provided on the outer surface on the distal end side from the window portion 53, a distal end side from the flange portion 55 and a proximal end side from the window portion 53. The formed ribs 59 (a plurality of circumferential ribs), the excessive rotation restricting ribs 88 (specifically, two ribs facing each other) provided on the side of the opening 57, and the base end of the main body 51 A protrusion 58 (specifically, two protrusions facing each other) extending in the axial direction is provided on the inner surface of the head.
　この実施例の外筒封止部材５では、窓部５３は、外筒本体４０の突出部４３を収納し、かつ係合するためのものであり、周方向に所定長延びるものとなっている。外筒本体４０の突出部４３が、外筒封止部材５の窓部５３に進入し、係合することにより、外筒本体４０から外筒封止部材が離脱することを防止し、回動も規制している。よって、この実施例のプレフィルドシリンジ３では、外筒封止部材５は、外筒本体４０より離脱不能に装着されている。
　また、外筒封止部材５が外筒本体４０に装着された状態では、外筒封止部材５の基端部の内面に設けられた突出部５８は、外筒本体４０の凹部４７に進入し、係合している。このため、外筒封止部材５は、外筒本体４０に対して回転不能となっている。よって、外筒本体４０を回転させることにより、外筒封止部材５は、追従し回転する。
　よって、外筒封止部材５の窓部５３は、筒状体側の外筒封止部材離脱規制用係合部を構成し、突出部５８は、筒状体側の外筒封止部材回動規制用係合部を構成している。 In the outer cylinder sealing member 5 of this embodiment, the window 53 is for accommodating and engaging the protrusion 43 of the outer cylinder main body 40, and extends a predetermined length in the circumferential direction. . The protrusion 43 of the outer cylinder main body 40 enters and engages the window 53 of the outer cylinder sealing member 5, thereby preventing the outer cylinder sealing member from being detached from the outer cylinder main body 40, and turning. It also regulates. Therefore, in the prefilled syringe 3 of this embodiment, the outer cylinder sealing member 5 is mounted so as not to be detached from the outer cylinder main body 40.
Further, in a state where the outer cylinder sealing member 5 is mounted on the outer cylinder main body 40, the protruding portion 58 provided on the inner surface of the proximal end portion of the outer cylinder sealing member 5 enters the concave portion 47 of the outer cylinder main body 40. And are engaged. For this reason, the outer cylinder sealing member 5 cannot rotate with respect to the outer cylinder main body 40. Therefore, by rotating the outer cylinder main body 40, the outer cylinder sealing member 5 follows and rotates.
Therefore, the window portion 53 of the outer cylinder sealing member 5 constitutes an outer cylinder sealing member detachment restricting engagement portion on the cylindrical body side, and the projecting portion 58 is an outer cylinder sealing member rotation restriction on the cylindrical body side. The engagement part is constituted.
　そして、穿刺部材装着部５０を有する本体部５１の先端側部分の外面には、筒状体側螺合部５２が設けられている。この実施例では、筒状体側螺合部５２は、２本の螺旋状リブにより形成されている。また、螺旋状リブの中央部には、膨出部５２ａが形成されており、螺旋状リブの終端部にも膨出部５２ｂが形成されている。そして、外筒封止部材５の先端面には、過剰回転規制用リブ８８（具体的には、向かい合う２つのリブ）が設けられている。筒状体側螺合部５２は、後述する穿刺部材側螺合部８５と螺合する。
　また、この実施例の外筒封止部材５では、基端部側側部に、向かい合う２つの平坦部５４を備えており、外筒封止部材５の把持を容易としている。
　外筒封止部材の形成材料としては、例えば、ポリプロピレン、ポリエチレン、ポリスチレン、ポリアミド、ポリカーボネート、ポリ塩化ビニル、ポリ－（４－メチルペンテン－１）、アクリル樹脂、アクリロニトリル－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、環状ポリオレフィン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耐熱性があることから、ポリプロピレン、環状ポリオレフィンのような樹脂が好ましい。
　シール部材１０は、穿刺部材装着部５０を有する本体部５１の先端部内に収納され、開口部５７を封止するとともに、図２に示すように、外筒封止部材５が外筒本体４０の先端部４１に装着された状態では、外筒本体４０の先端開口４８を液密に密封する。シール部材１０としては、外筒本体４０の先端部４１の先端開口を液密に密封可能かつ後述する穿刺部材６のシール部材刺通用針部６１ｂが刺通可能な弾性部材により形成されている。また、シール部材１０は、外筒本体４０内に進入する突出部を備えるものであってもよい。このようにすることにより、外筒本体４０の先端部内に形成されるデッドボリュームを減少させることができる。
　シール部材の形成材料としては、例えば、天然ゴム、イソプレンゴム、ブタジエンゴム、フッ素ゴム、シリコーンゴム等の合成ゴム、オレフィン系エラストマーやスチレン系エラストマー等の熱可塑性エラストマー等を使用することが好ましい。 A cylindrical body side screwing portion 52 is provided on the outer surface of the distal end side portion of the main body 51 having the puncture member mounting portion 50. In this embodiment, the cylindrical body side screwing portion 52 is formed by two spiral ribs. Further, a bulging portion 52a is formed at the central portion of the spiral rib, and a bulging portion 52b is also formed at the terminal portion of the spiral rib. An excessive rotation restricting rib 88 (specifically, two ribs facing each other) is provided on the distal end surface of the outer cylinder sealing member 5. The cylindrical body side screwing portion 52 is screwed with a puncture member side screwing portion 85 described later.
Moreover, in the outer cylinder sealing member 5 of this embodiment, two flat portions 54 facing each other are provided on the side of the base end portion side, so that the outer cylinder sealing member 5 can be easily held.
Examples of the material for forming the outer cylinder sealing member include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, Various resins such as polyesters such as polyethylene terephthalate and cyclic polyolefins can be mentioned. Among them, resins such as polypropylene and cyclic polyolefins are preferred because they are easy to mold and have heat resistance.
The seal member 10 is accommodated in the distal end portion of the main body 51 having the puncture member mounting portion 50, seals the opening 57, and the outer cylinder sealing member 5 is attached to the outer cylinder main body 40 as shown in FIG. In a state where the front end portion 41 is mounted, the front end opening 48 of the outer cylinder main body 40 is sealed in a liquid-tight manner. The seal member 10 is formed of an elastic member that can seal the tip opening of the tip portion 41 of the outer cylinder main body 40 in a liquid-tight manner and that can be pierced with a seal member piercing needle portion 61b of the puncture member 6 described later. Further, the seal member 10 may include a protruding portion that enters the outer cylinder main body 40. By doing in this way, the dead volume formed in the front-end | tip part of the outer cylinder main body 40 can be reduced.
As a material for forming the sealing member, it is preferable to use, for example, natural rubber, isoprene rubber, butadiene rubber, fluororubber, silicone rubber or other synthetic rubber, or thermoplastic elastomer such as olefin elastomer or styrene elastomer.
　次に、本発明のプレフィルドシリンジ用穿刺具３について、図３、図１３ないし図１９を参照して説明する。
　本発明のプレフィルドシリンジ用穿刺具３は、上記のプレフィルドシリンジ用筒状体の穿刺部材装着部５０、４０ａ、１０２に着脱可能であり、さらに、両端に針部（具体的には、一端に穿刺用針部６１ａを他端にシール部材刺通用針部６１ｂ）を有する中空針６１と、中空針６１を装着し、穿刺部材装着部５０、４０ａ、１０２に着脱可能かつ、穿刺部材側螺合部８５と穿刺部材側係合部８６とを有する穿刺部材本体６０とを備える穿刺部材６と、穿刺部材６を離脱可能に収納する収納部材７とを備える。さらに、収納部材７と穿刺部材６は、収納部材７に付与された回転力を穿刺部材６に伝達する回転力伝達部６５、７４を備え、かつ、収納部材７は、穿刺部材６が外筒封止部材５に装着された後、先端方向に引くことにより、穿刺部材６より、離脱するものとなっている。
　穿刺具３は、収納部材７と、収納部材７内に収納された穿刺部材６とからなる。
　収納部材７は、図３、図１８および図１９に示すような一端が閉塞したキャップ状のものである。収納部材７は、筒状本体部７１と、その先端部に形成された閉塞部７５と、本体部７１の先端側部分に形成された小径部７３と、後端部に形成されたフランジ７２を備えている。そして、本体部の軸方向中央部の内面には、複数の膨出部７４が設けられている。収納部材７は、穿刺部材６の全体を収納する。特に、収納部材は、穿刺用部材の中空針の刃面が露出しないように、穿刺部材を収納している。 Next, the prefilled syringe puncture device 3 of the present invention will be described with reference to FIGS. 3 and 13 to 19.
The prefilled syringe puncture device 3 of the present invention can be attached to and detached from the puncture member mounting portions 50, 40a, 102 of the above-mentioned prefilled syringe cylindrical body, and further has needle portions at both ends (specifically, puncture at one end). A hollow needle 61 having a sealing member piercing needle portion 61b) at the other end of the needle portion 61a, and a hollow needle 61 attached to the puncture member attachment portion 50, 40a, 102, and a puncture member side screwing portion The puncture member 6 includes a puncture member main body 60 having a puncture member side engagement portion 86 and a storage member 7 that detachably accommodates the puncture member 6. Furthermore, the storage member 7 and the puncture member 6 are provided with rotational force transmitting portions 65 and 74 that transmit the rotational force applied to the storage member 7 to the puncture member 6, and the storage member 7 includes the outer tube. After being attached to the sealing member 5, it is detached from the puncture member 6 by pulling in the distal direction.
The puncture device 3 includes a storage member 7 and a puncture member 6 stored in the storage member 7.
The storage member 7 has a cap shape with one end closed as shown in FIGS. 3, 18 and 19. The storage member 7 includes a cylindrical main body portion 71, a closing portion 75 formed at the front end portion thereof, a small diameter portion 73 formed at the front end side portion of the main body portion 71, and a flange 72 formed at the rear end portion. I have. A plurality of bulging portions 74 are provided on the inner surface of the central portion of the main body in the axial direction. The storage member 7 stores the entire puncture member 6. In particular, the storage member stores the puncture member so that the blade surface of the hollow needle of the puncture member is not exposed.
　穿刺部材６は、図３、図１３ないし図１７に示すように、穿刺部材本体６０と、穿刺部材本体６０に固定された中空針６１とを備える。
　穿刺部材本体６０は、先端部に小径となった中空針固定部を有し、基端側部分に外筒封止部材収納部を有する筒状体である。外筒封止部材収納部は、シリンジ本体２の外筒封止部材５が装着可能な外筒封止部材装着部を備えている。
　具体的には、外筒封止部材装着部は、外筒封止部材５の外面に設けられた筒状体側螺合部５２と螺合する穿刺具側螺合部８５を備えている。
　この実施例では、穿刺部材６は、開口部６４（具体的には、向かい合う２つの開口部）を備え、開口部６４の底部より内方に向かって突出する斜め（短い螺旋状）に突出するリブ８５により、穿刺具側螺合部が形成されている。
　また、穿刺部材６は、軸方向中央部付近（やや基端部より）の内面に設けられた突出部８６（具体的には、向かい合う２つの突出部）を備えている。突出部８６は、周方向に所定長延びるものとなっている。そして、この突出部８６は、穿刺部材６が外筒封止部材５に装着されたとき、図２６に示すように、外筒封止部材５の窓部５３内に進入し、係合する。これにより、穿刺部材６の外筒本体４０への装着状態が安定なものとなり、螺合が後退する方向への穿刺部材の回転を規制し、不用意な穿刺部材の緩み、外筒からの離脱を防止する。 The puncture member 6 includes a puncture member main body 60 and a hollow needle 61 fixed to the puncture member main body 60 as shown in FIGS. 3 and 13 to 17.
The puncture member main body 60 is a cylindrical body having a hollow needle fixing portion having a small diameter at the distal end portion and an outer cylinder sealing member accommodating portion at the proximal end side portion. The outer cylinder sealing member housing portion includes an outer cylinder sealing member mounting portion to which the outer cylinder sealing member 5 of the syringe body 2 can be mounted.
Specifically, the outer tube sealing member mounting portion includes a puncture device side screwing portion 85 that is screwed with a cylindrical body side screwing portion 52 provided on the outer surface of the outer tube sealing member 5.
In this embodiment, the puncture member 6 includes an opening 64 (specifically, two openings facing each other), and protrudes obliquely (short spiral) protruding inward from the bottom of the opening 64. The rib 85 forms a puncture device side threaded portion.
The puncture member 6 includes a protrusion 86 (specifically, two protrusions facing each other) provided on the inner surface in the vicinity of the central portion in the axial direction (slightly from the base end). The protrusion 86 extends a predetermined length in the circumferential direction. Then, when the puncture member 6 is attached to the outer cylinder sealing member 5, the protrusion 86 enters and engages in the window 53 of the outer cylinder sealing member 5, as shown in FIG. As a result, the mounting state of the puncture member 6 to the outer cylinder main body 40 becomes stable, the rotation of the puncture member in the direction in which the screwing is retracted is regulated, the careless loosening of the puncture member, and the separation from the outer cylinder. To prevent.
　また、この実施例の穿刺部材６では、基端部付近の内面に設けられた環状凹部８７を備えている。穿刺部材６が外筒封止部材５に装着されたとき、外筒封止部材５のリブ５９（複数の周方向リブ）が、環状凹部８７内に進入することにより、両者が係合し、穿刺部材６の外筒本体４０からの離脱を防止している。
　よって、この実施例の外筒封止部材５は、第１の筒状体側係合部５３と第１の筒状体側係合部５３より、外筒封止部材５の基端側に位置する第２の筒状体側係合部（円弧状リブ）５９を備え、穿刺部材６は、第１の筒状体側係合部５３と係合する第１の穿刺部材側係合部８６と、第１の穿刺部材側係合部８６より、穿刺部材６の基端側に位置し、第２の筒状体側係合部５９と係合する第２の穿刺部材側係合部（環状凹部）８７を備えている。また、本体６０の軸方向中央部の外面には、凹部６７（具体的には、向かい合う２つの凹部）を備えている。 In addition, the puncture member 6 of this embodiment includes an annular recess 87 provided on the inner surface near the base end. When the puncture member 6 is mounted on the outer cylinder sealing member 5, the ribs 59 (a plurality of circumferential ribs) of the outer cylinder sealing member 5 enter the annular recess 87, so that both are engaged. The puncture member 6 is prevented from being detached from the outer cylinder main body 40.
Therefore, the outer cylinder sealing member 5 of this embodiment is located closer to the proximal end side of the outer cylinder sealing member 5 than the first cylindrical body side engaging portion 53 and the first cylindrical body side engaging portion 53. The puncture member 6 is provided with a second tubular body side engaging portion (arc-shaped rib) 59, and the puncture member 6 includes a first puncture member side engaging portion 86 that engages with the first tubular body side engaging portion 53, and A second puncture member side engagement portion (annular recess) 87 that is positioned on the proximal end side of the puncture member 6 with respect to the first puncture member side engagement portion 86 and engages with the second cylindrical body side engagement portion 59. It has. Further, a concave portion 67 (specifically, two concave portions facing each other) is provided on the outer surface of the central portion of the main body 60 in the axial direction.
　また、この実施例の穿刺部材６は、本体６０の先端側部分は、小径部６２となっており、小径部６２の外面には、軸方向に延びる膨出部６５（具体的には、向かい合う２つの膨出部）を備えている。そして、この膨出部６５は、上述した収納部材７の軸方向中央部の内面に形成された複数の膨出部７４間に進入し、係合する。これにより、穿刺部材６は、収納部材７に収納された状態での空転が規制され、収納部材７を回転させることにより、追従し回転する。これら穿刺部材６の膨出部６５と、収納部材７の軸方向中央部の内面に形成された複数の膨出部７４により、回転力伝達部が構成されている。
　さらに、穿刺部材６は、図１５に示すように、小径部６２の先端内面に設けられた突出部８９（具体的には、向かい合う２つの膨出部）を備えている。この突出部８９は、筒状体側螺合部５２と穿刺部材側螺合部８５が螺合した後に、外筒封止部材５の先端面に設けられた過剰回転規制用リブ８８と当接するものであり、穿刺部材の過剰回転を防止する。 Further, in the puncture member 6 of this embodiment, the distal end portion of the main body 60 has a small diameter portion 62, and a bulging portion 65 (specifically, faces the outer surface of the small diameter portion 62 that extends in the axial direction. 2 bulges). The bulging portion 65 enters and engages between the plurality of bulging portions 74 formed on the inner surface of the central portion in the axial direction of the storage member 7 described above. As a result, the puncture member 6 is prevented from idling in the state of being stored in the storage member 7, and rotates by following the rotation of the storage member 7. The bulging portion 65 of the puncture member 6 and the plurality of bulging portions 74 formed on the inner surface of the central portion in the axial direction of the storage member 7 constitute a rotational force transmitting portion.
Further, as shown in FIG. 15, the puncture member 6 includes a protruding portion 89 (specifically, two bulging portions facing each other) provided on the inner surface of the distal end of the small diameter portion 62. The protruding portion 89 comes into contact with the excessive rotation regulating rib 88 provided on the distal end surface of the outer cylinder sealing member 5 after the cylindrical body side screwing portion 52 and the puncture member side screwing portion 85 are screwed together. And preventing excessive rotation of the puncture member.
　中空針６１は、穿刺部材本体６０の中空針固定部６３に、固着剤６８により固定されており、両端に針部を備えている。具体的には、中空針６１は、一端側が固定部６３より先端側に突出し、先端に、生体への穿刺用針部６１ａを備え、中空針６１の他端側は、固定部７３より穿刺部材６の内方に突出し、その端部に外筒封止部材５のシール部材を刺通可能なシール部材刺通用針部６１ｂを備えている。また、中空針６１は、 穿刺部材本体６０の中心軸にほぼ平行に延びるものとなっている。
　そして、この実施例のプレフィルドシリンジおよびプレフィルドシリンジ用注射器では、収納部材７は、穿刺部材６より離脱後、再度穿刺部材６に装着可能であり、かつ、穿刺部材６に再度装着された収納部材７を筒状体側螺合部５２と穿刺部材側螺合部８５との螺合が後退する方向に回転させることにより、筒状体側係合部と穿刺部材側係合部との係合が解除され、収納部材７内に穿刺部材９を収納した状態にて、穿刺具３をシリンジ本体２より離脱可能となっている。 The hollow needle 61 is fixed to the hollow needle fixing portion 63 of the puncture member main body 60 with an adhesive 68, and has needle portions at both ends. Specifically, one end side of the hollow needle 61 protrudes from the fixed portion 63 to the distal end side, and a puncture needle portion 61 a for living body is provided at the distal end, and the other end side of the hollow needle 61 is punctured from the fixed portion 73. 6 is protruded inward, and a sealing member piercing needle portion 61b capable of piercing the sealing member of the outer cylinder sealing member 5 is provided at an end thereof. The hollow needle 61 extends substantially parallel to the central axis of the puncture member body 60.
In the prefilled syringe and the prefilled syringe syringe of this embodiment, the storage member 7 can be attached to the puncture member 6 again after being detached from the puncture member 6, and the storage member 7 attached to the puncture member 6 again. Is rotated in the direction in which the screwing of the cylindrical body side screwing portion 52 and the puncture member side screwing portion 85 is retracted, the engagement between the cylindrical body side engaging portion and the puncture member side engaging portion is released. The puncture device 3 can be detached from the syringe body 2 with the puncture member 9 stored in the storage member 7.
　さらに、プレフィルドシリンジおよびプレフィルドシリンジ用注射器では、筒状体側螺合部５２および穿刺部材側螺合部８５は、中空針６１のシール部材刺通用針部６１ｂが、シール部材１０を刺通した後、筒状体側螺合部５２と穿刺部材側螺合部８５との螺合が開始されるように配置されている。
　また、外筒封止部材５と穿刺部材６に設けられる螺合の後退を規制する係合部としては、上述のものに限定されるものではなく、例えば、図２８に示す外筒封止部材５ａのように、封止部材本体５１の小径部の外面に設けた突出部７６により構成してもよい。この場合、穿刺部材６の螺合部８５の内面には、上記突出部７６を受け入れる凹部（図示せず）を備えるものとなる。なお、この実施例の外筒封止部材５ａでは、突出部７６は、螺旋状リブ間に形成されている。 Further, in the prefilled syringe and the prefilled syringe syringe, the cylindrical body side screwing portion 52 and the puncture member side screwing portion 85 are formed after the seal member piercing needle portion 61b of the hollow needle 61 pierces the seal member 10, It arrange | positions so that the screwing of the cylindrical body side screwing part 52 and the puncture member side screwing part 85 may be started.
Moreover, as an engaging part which controls the retraction | retraction of the screwing provided in the outer cylinder sealing member 5 and the puncture member 6, it is not limited to the above-mentioned thing, For example, the outer cylinder sealing member shown in FIG. Like 5a, you may comprise by the protrusion part 76 provided in the outer surface of the small diameter part of the sealing member main body 51. FIG. In this case, the inner surface of the screwing portion 85 of the puncture member 6 is provided with a recess (not shown) that receives the protrusion 76. In the outer cylinder sealing member 5a of this embodiment, the projecting portion 76 is formed between the spiral ribs.
　さらに、外筒封止部材５と穿刺部材６に設けられる螺合の後退を規制する係合部としては、例えば、図２９に示す外筒封止部材５ｂのように、封止部材本体５１の先端面に、かつ、過剰回転規制用リブ８８と近接する位置に設けられた小突起７７により構成してもよい。この場合、過剰回転規制用リブ８８と小突起７７との間に、穿刺部材６の突出部８９が収納される。
　さらに、外筒封止部材５と穿刺部材６に設けられる螺合の後退を規制する係合部としては、例えば、図３０に示す外筒封止部材５ｃのように、封止部材本体５１の側面の平坦部５４に設けられた小突起７９により構成してもよい。この場合、穿刺部材６は、内面に設けられ、上記小突起７９を収納する凹部（図示せず）を備えるものとなる。 Furthermore, as an engaging portion for restricting the backward movement of the screwing provided in the outer cylinder sealing member 5 and the puncture member 6, for example, an outer cylinder sealing member 5b shown in FIG. You may comprise by the small protrusion 77 provided in the front end surface and the position close | similar to the rib 88 for excessive rotation control. In this case, the protruding portion 89 of the puncture member 6 is accommodated between the excessive rotation restricting rib 88 and the small protrusion 77.
Further, as an engaging portion for restricting the backward movement of the screwing provided in the outer cylinder sealing member 5 and the puncture member 6, for example, an outer cylinder sealing member 5c shown in FIG. You may comprise by the small protrusion 79 provided in the flat part 54 of the side surface. In this case, the puncture member 6 is provided on the inner surface and includes a recess (not shown) for housing the small protrusion 79.
　上述した実施例のプレフィルドシリンジ用外筒、プレフィルドシリンジ用注射器およびプレフィルドシリンジでは、穿刺部材装着部は、外筒封止部材５により構成されている。しかし、このようなものに限定されるものではなく、図３１および図３２に示すプレフィルドシリンジ用筒状体であるプレフィルドシリンジ用外筒４ａのように、穿刺部材装着部４０ａが、外筒４ａの先端部に直接形成されているものであってもよい。よって、この実施例のプレフィルドシリンジ用外筒４ａは、外筒封止部材５を備えていない。
　そして、この実施例のプレフィルドシリンジ用筒状体であるプレフィルドシリンジ用外筒４ａは、穿刺部材装着部４０ａの開口が穿刺部材６の針部６１ｂにより刺通可能なシール部材１０ａにより封止されている。具体的には、この実施例の外筒４ａでは、シール部材１０ａは、外筒４ａの先端部４１ａ内に収納されている。シール部材１０ａは、環状溝を有し、先端部４１ａ内の内面より突出する環状リブ４９と係合し、先端部内での移動が規制されている。シール部材１０ａとしては、射出成形などにより製造したものを外筒本体に装着したもの、また、インサート成形、二色成形などにより、外筒本体内に形成されたものであってもよい。 In the prefilled syringe outer cylinder, the prefilled syringe injector, and the prefilled syringe of the embodiment described above, the puncture member mounting portion is constituted by the outer cylinder sealing member 5. However, the present invention is not limited to this, and the puncture member mounting portion 40a of the prefilled syringe outer cylinder 4a, which is the prefilled syringe cylindrical body shown in FIGS. It may be formed directly at the tip. Therefore, the prefilled syringe outer cylinder 4 a of this embodiment does not include the outer cylinder sealing member 5.
The prefilled syringe outer cylinder 4a, which is the prefilled syringe cylindrical body of this embodiment, is sealed by a sealing member 10a through which the opening of the puncture member mounting portion 40a can be pierced by the needle portion 61b of the puncture member 6. Yes. Specifically, in the outer cylinder 4a of this embodiment, the seal member 10a is accommodated in the distal end portion 41a of the outer cylinder 4a. The seal member 10a has an annular groove, engages with an annular rib 49 protruding from the inner surface of the tip portion 41a, and movement within the tip portion is restricted. As the sealing member 10a, a member manufactured by injection molding or the like may be mounted on the outer cylinder main body, or may be formed in the outer cylinder main body by insert molding or two-color molding.
　また、穿刺部材装着部４０ａは、上述した外筒封止部材５と同様に、筒状部であり、先端に設けられた小径の開口４８と、側部に設けられた凹部５３ａ（具体的には、向かい合う２つの凹部）と、凹部５３ａより先端側の外面に設けられた筒状体側螺合部（言い換えれば、外筒側螺合部）５２と、穿刺部材装着部４０ａの先端面に設けられた過剰回転規制用リブ８８（具体的には、向かい合う２つのリブ）とを備えている。筒状体側螺合部５２は、２本の螺旋状リブにより形成されている。また、螺旋状リブの中央部には、膨出部５２ａが形成されており、螺旋状リブの終端部にも膨出部（図示せず）５２ｂが形成されている。筒状体側螺合部５２は、上述した穿刺部材６の穿刺部材側螺合部８５と螺合する。また、上記凹部５３ａは、筒状体側係合部（言い換えれば、外筒側係合部）を形成している。
　そして、上述したように、穿刺部材６は、軸方向中央部付近（やや基端部より）の内面に設けられた突出部８６（具体的には、向かい合う２つの突出部）を備えている。突出部８６は、周方向に所定長延びるものとなっている。そして、この突出部８６は、穿刺部材６が穿刺部材装着部４０ａに装着されたとき、穿刺部材装着部４０ａの上記の凹部５３ａ内に進入し、係合する。これにより、穿刺部材６の外筒４ａへの装着状態が安定なものとなり、螺合が後退する方向への穿刺部材の回転を規制し、不用意な穿刺部材の緩み、外筒からの離脱を防止する。 The puncture member mounting portion 40a is a cylindrical portion, like the outer cylinder sealing member 5 described above, and has a small-diameter opening 48 provided at the tip and a recess 53a (specifically, provided on the side portion). Are provided on the distal end surface of the puncture member mounting portion 40a, the two concave portions facing each other, the cylindrical body side screwing portion (in other words, the outer cylinder side screwing portion) 52 provided on the outer surface on the distal end side from the concave portion 53a. And an excessive rotation restricting rib 88 (specifically, two ribs facing each other). The cylindrical body side screwing portion 52 is formed by two spiral ribs. Further, a bulging portion 52a is formed at the central portion of the spiral rib, and a bulging portion (not shown) 52b is also formed at the terminal portion of the spiral rib. The cylindrical body side screwing portion 52 is screwed with the puncture member side screwing portion 85 of the puncture member 6 described above. Moreover, the said recessed part 53a forms the cylindrical body side engaging part (in other words, an outer cylinder side engaging part).
As described above, the puncture member 6 includes the protrusions 86 (specifically, two protrusions facing each other) provided on the inner surface in the vicinity of the central portion in the axial direction (slightly from the base end). The protrusion 86 extends a predetermined length in the circumferential direction. When the puncture member 6 is mounted on the puncture member mounting portion 40a, the protrusion 86 enters and engages with the recess 53a of the puncture member mounting portion 40a. Thereby, the mounting state of the puncture member 6 to the outer cylinder 4a becomes stable, the rotation of the puncture member in the direction in which the screwing is retracted is restricted, and the puncture member is unintentionally loosened and detached from the outer cylinder. To prevent.
　また、本発明のプレフィルドシリンジ用筒状体は、図３３に示すような、先端部が穿刺部材の針部により刺通可能なシール部材による封止されたプレフィルドシリンジ１１０に装着可能なホルダー１００であってもよい。
　このプレフィルドシリンジ用ホルダー１００は、本体部１０１と、その先端部に設けられた穿刺部材装着部１０２を有する筒状体である。ホルダー１００は、図３３に示すように、内部にプレプレフィルドシリンジを受入可能、言い換えれば、プレフィルドシリンジ１１０に装着可能な筒状体である。そして、このホルダー１００に使用されるプレフィルドシリンジ１１０は、図３３に示すように、外筒１１１と、その先端部を封止するシール部材１１２と、シール部材１１２を外筒１１１の先端に固定する固定部材１１４と、外筒１１１内を液密に摺動可能なガスケット１１３と、外筒１１１内に充填された薬剤１１５とを備えている。また、使用時（薬剤投与時）には、ガスケット１１３の後端部を押圧可能なプランジャ１３０が使用される。プランジャ１３０は、シャフト部１３１と、シャフト部１３１の先端に設けられたガスケット１１３の後端部を押圧するガスケット押圧部１３２と、シャフト部１３１の後端に設けられた操作用押圧部１３３とを備えている。なお、このプレプレフィルドシリンジでは、プランジャは、ガスケットを押圧可能であるものの、ガスケットには、装着されないものとなっている。
　そして、プレフィルドシリンジ用ホルダー１００の本体部１０１の先端部に設けられた穿刺部材装着部１０２は、上述した穿刺部材装着部５０と同様に、筒状部であり、先端に設けられた開口１０４と、側部に設けられた凹部１０５（具体的には、向かい合う２つの凹部）と、凹部１０５より先端側の外面に設けられた筒状体側螺合部１０３と、穿刺部材装着部１０２の先端面に設けられた過剰回転規制用リブ１０６（具体的には、向かい合う２つのリブ）とを備えている。筒状体側螺合部１０３は、２本の螺旋状リブにより形成されている。また、螺旋状リブの中央部には、膨出部（図示せず）が形成されており、螺旋状リブの終端部にも膨出部（図示せず）が形成されている。筒状体側螺合部１０３は、上述した穿刺部材６の穿刺部材側螺合部８５と螺合する。また、上記凹部１０５は、筒状体側係合部を形成している。さらに、この実施例のプレフィルドシリンジ用ホルダー１００では、本体部１０１の後端にフランジ１０９が形成されている。 Moreover, the cylindrical body for prefilled syringes of the present invention is a holder 100 that can be attached to a prefilled syringe 110 whose tip is sealed with a seal member that can be pierced by the needle portion of the puncture member, as shown in FIG. There may be.
The prefilled syringe holder 100 is a cylindrical body having a main body portion 101 and a puncture member mounting portion 102 provided at the distal end portion thereof. As shown in FIG. 33, the holder 100 is a cylindrical body that can receive a pre-prefilled syringe inside, in other words, can be attached to the pre-filled syringe 110. As shown in FIG. 33, the prefilled syringe 110 used in the holder 100 fixes the outer cylinder 111, a seal member 112 that seals the distal end portion thereof, and the seal member 112 to the distal end of the outer cylinder 111. A fixing member 114, a gasket 113 that can slide in a liquid-tight manner in the outer cylinder 111, and a medicine 115 filled in the outer cylinder 111 are provided. In use (during drug administration), a plunger 130 capable of pressing the rear end of the gasket 113 is used. The plunger 130 includes a shaft portion 131, a gasket pressing portion 132 that presses the rear end portion of the gasket 113 provided at the tip of the shaft portion 131, and an operation pressing portion 133 provided at the rear end of the shaft portion 131. I have. In this pre-prefilled syringe, the plunger can press the gasket, but is not attached to the gasket.
And the puncture member mounting part 102 provided in the front-end | tip part of the main-body part 101 of the holder 100 for prefilled syringes is a cylindrical part similarly to the puncture member mounting part 50 mentioned above, and the opening 104 provided in the front-end | tip The concave portion 105 (specifically, two concave portions facing each other) provided in the side portion, the cylindrical body side screwing portion 103 provided on the outer surface on the distal end side from the concave portion 105, and the distal end surface of the puncture member mounting portion 102 And an excessive rotation restricting rib 106 (specifically, two ribs facing each other). The cylindrical body side screwing portion 103 is formed by two helical ribs. Further, a bulging portion (not shown) is formed at the central portion of the spiral rib, and a bulging portion (not shown) is also formed at the terminal portion of the spiral rib. The cylindrical body side screwing portion 103 is screwed with the puncture member side screwing portion 85 of the puncture member 6 described above. Moreover, the said recessed part 105 forms the cylindrical body side engaging part. Further, in the prefilled syringe holder 100 of this embodiment, a flange 109 is formed at the rear end of the main body 101.
　次に、本発明のプレフィルドシリンジ１の作用を図１ないし図３、図２２ないし図２７を用いて説明する。
　本発明のプレフィルドシリンジ１は、図１ないし図３に示すように、シリンジ本体２は、先端部に外筒封止部材５が装着され封止され、穿刺具３は、収納部材７内に穿刺部材６を収納した状態であり、かつ、シリンジ本体２と穿刺具３は、装着されていない状態となっている。
　また、外筒封止部材５は、図２に示すように、外筒本体４０の先端部４１に回動不能かつ離脱不能に装着されている。また、穿刺部材６は、収納部材７内に、収納部材７の回転とともに回転する状態となっている。
　本発明のプレフィルドシリンジ１の先端側部分は、図２２に示すように、外筒本体４０の先端部４１，外筒封止部材５，穿刺部材６，収納部材７により構成されている。 Next, the operation of the prefilled syringe 1 of the present invention will be described with reference to FIGS. 1 to 3 and FIGS. 22 to 27.
In the prefilled syringe 1 of the present invention, as shown in FIGS. 1 to 3, the syringe body 2 is sealed with an outer cylinder sealing member 5 attached to the tip, and the puncture device 3 is punctured in the storage member 7. The member 6 is housed, and the syringe body 2 and the puncture device 3 are not attached.
Further, as shown in FIG. 2, the outer cylinder sealing member 5 is attached to the distal end portion 41 of the outer cylinder main body 40 so that it cannot rotate and cannot be detached. Further, the puncture member 6 is in a state of rotating in the storage member 7 with the rotation of the storage member 7.
The tip side portion of the prefilled syringe 1 of the present invention is composed of a tip portion 41 of the outer cylinder main body 40, an outer cylinder sealing member 5, a puncture member 6 and a storage member 7 as shown in FIG.
　そして、使用時には、図２３に示すように、シリンジ本体２に、穿刺具３を押し込むことにより、穿刺部材６の中空針６１のシール部材刺通用針部６１ｂが、外筒封止部材５のシール部材１０を刺通する。その後、図２３に示すように、穿刺具３を回転（シリンジ本体２を回転させてもよい）させることにより、筒状体側螺合部（螺旋状リブ）５２と穿刺部材側螺合部８５との螺合が開始される。そして、螺合を進行させていくと、図２６および図２７に示すように、穿刺部材６の軸方向中央部付近（やや基端部より）の内面に設けられた穿刺部材側係合部（突出部）８６が、外筒封止部材５の筒状体側係合部（窓部）５３に進入し、係合する。この係合の際に、多少の抵抗があるため、作業者は、装着操作の終了を認識し、過剰締め付けを防止できる。なお、この実施例のプレフィルドシリンジ１では、上記の係合と同時もしくは若干前に、穿刺部材６の基端部付近の内面に設けられた環状凹部８７に、外筒封止部材５のリブ５９（複数の周方向リブ）が、進入し、係合するものとなっており、この係合の際にも、多少の抵抗がある。よって、２つの係合機構を備えているため、より確実に、作業者は、装着操作の終了を認識し、過剰締め付けを防止できる。シリンジ本体２への穿刺具３の装着が完了すると、図２４の状態となり、この状態において、収納部材７を先端方向（矢印方向）に引くことにより、収納部材７が、離脱し、図２５に示すように、穿刺部材６および穿刺用針部６１ａが露出し、投与準備が完了する。そして、この実施例のプレフィルドシリンジ１では、穿刺部材は、シリンジ本体（プレフィルドシリンジ用外筒）に螺合かつ係合した状態にて装着されるので、投与中などに意図せずに螺合が緩む方向への回転が穿刺部材に付与されることがあっても、係合していることにより、意図しない緩みを生じることがない。また、過剰締め付けにより、螺合が解除できなくなることを、過剰回転規制用リブ８８により確実に防止している。 In use, as shown in FIG. 23, by pushing the puncture device 3 into the syringe body 2, the sealing member piercing needle portion 61 b of the hollow needle 61 of the puncture member 6 is sealed with the outer cylinder sealing member 5. The member 10 is pierced. Thereafter, as shown in FIG. 23, the puncture tool 3 is rotated (the syringe body 2 may be rotated), whereby the cylindrical body side screwing portion (spiral rib) 52 and the puncture member side screwing portion 85 Screwing is started. Then, as the screwing proceeds, as shown in FIGS. 26 and 27, the puncture member side engaging portion (on the inner surface of the puncture member 6 in the vicinity of the central portion in the axial direction (slightly from the base end)) ( The protruding portion 86 enters and engages with the cylindrical body side engaging portion (window portion) 53 of the outer cylinder sealing member 5. Since there is some resistance during this engagement, the operator can recognize the end of the mounting operation and prevent overtightening. In the prefilled syringe 1 of this embodiment, the rib 59 of the outer cylinder sealing member 5 is formed in the annular recess 87 provided on the inner surface near the proximal end of the puncture member 6 at the same time or slightly before the above engagement. (Several circumferential ribs) enter and engage, and there is some resistance even during this engagement. Therefore, since the two engagement mechanisms are provided, the operator can more reliably recognize the end of the mounting operation and prevent excessive tightening. When the attachment of the puncture device 3 to the syringe body 2 is completed, the state shown in FIG. 24 is obtained. In this state, the storage member 7 is detached by pulling the storage member 7 in the distal direction (arrow direction). As shown, the puncture member 6 and the puncture needle 61a are exposed and preparation for administration is completed. In the prefilled syringe 1 of this embodiment, the puncture member is mounted in a state where it is screwed and engaged with the syringe main body (prefilled syringe outer cylinder). Even if rotation in the loosening direction is applied to the puncture member, unintentional loosening does not occur due to the engagement. Further, the excessive rotation restricting rib 88 reliably prevents screwing from being released due to excessive tightening.
　そして、投与操作が終了後、収納部材７をシリンジ本体に装着することにより、収納部材７の軸方向中央部の内面に形成された複数の膨出部７４間に、穿刺部材６の小径部６２の外面に設けられた膨出部６５が進入し、係合し、再び、図２４の状態となる。この状態にて廃棄してもよいが、穿刺具３をシリンジ本体より離脱して、別々に廃棄してもよい。この場合には、収納部材７を図２３の矢印と逆方向（筒状体側螺合部５２と穿刺部材側螺合部８５間の螺合が後退する方向）に回転させると、穿刺部材側係合部（突出部）８６は、外筒封止部材５の筒状体側係合部（窓部）５３より、離脱し、穿刺部材６の環状凹部８７より、外筒封止部材５のリブ５９も離脱し、穿刺部材６は、収納部材７に収納された状態にて、シリンジ本体２より離脱する。なお、この穿刺具離脱操作を行っても、外筒封止部材５は、外筒より離脱しない。 After the administration operation is completed, the small diameter portion 62 of the puncture member 6 is interposed between the plurality of bulging portions 74 formed on the inner surface of the central portion in the axial direction of the storage member 7 by attaching the storage member 7 to the syringe body. The bulging portion 65 provided on the outer surface of the first member enters, engages, and becomes the state of FIG. 24 again. Although it may be discarded in this state, the puncture device 3 may be detached from the syringe body and discarded separately. In this case, when the storage member 7 is rotated in the direction opposite to the arrow in FIG. 23 (the direction in which the screwing between the cylindrical body side screwing portion 52 and the puncture member side screwing portion 85 is retracted), The joint portion (projecting portion) 86 is separated from the tubular body side engaging portion (window portion) 53 of the outer cylinder sealing member 5, and the rib 59 of the outer cylinder sealing member 5 is inserted from the annular recess 87 of the puncture member 6. The puncture member 6 is detached from the syringe body 2 in a state of being accommodated in the accommodation member 7. In addition, even if this puncture tool detachment operation is performed, the outer cylinder sealing member 5 does not detach from the outer cylinder.
　本発明のプレフィルドシリンジ用筒状体は、以下のものである。
　（１）　穿刺部材装着部を有する筒状体であり、両端に針部を有する中空針と、前記中空針を装着し、前記穿刺部材装着部に着脱可能かつ、穿刺部材側螺合部と穿刺部材側係合部とを有する穿刺部材本体とを備える穿刺部材が装着可能であるプレフィルドシリンジ用筒状体であって、
　前記穿刺部材装着部は、前記穿刺部材側螺合部と螺合可能な筒状体側螺合部と、前記筒状体側螺合部と前記穿刺部材側螺合部が螺合した後、前記穿刺部材側係合部と係合し、螺合の後退を規制する筒状体側係合部とを有するプレフィルドシリンジ用筒状体。
　このため、本発明のプレフィルドシリンジ用筒状体をプレフィルドシリンジ用外筒もしくはプレフィルドシリンジ用ホルダーに用いた場合、穿刺部材は螺合および係合によりプレフィルドシリンジ用筒状体に装着されるため、プレフィルドシリンジの投与操作時等に、穿刺部材が緩むことがなく、緩みに起因する液漏れがない。 The cylindrical body for prefilled syringes of the present invention is as follows.
(1) A cylindrical body having a puncture member mounting portion, a hollow needle having needle portions at both ends, and the hollow needle is mounted and detachable from the puncture member mounting portion, and the puncture member side screwing portion and puncture A tubular body for a prefilled syringe to which a puncture member comprising a puncture member main body having a member side engagement portion can be attached,
The puncture member mounting portion includes: a cylindrical body side screwing portion that can be screwed with the puncture member side screwing portion; and the cylindrical body side screwing portion and the puncture member side screwing portion that are screwed together, A tubular body for a prefilled syringe having a tubular body-side engaging portion that engages with a member-side engaging portion and restricts the backward movement of screwing.
Therefore, when the prefilled syringe tubular body of the present invention is used for the prefilled syringe outer cylinder or the prefilled syringe holder, the puncture member is attached to the prefilled syringe tubular body by screwing and engagement. The puncture member does not loosen during the syringe administration operation, etc., and there is no liquid leakage due to the loosening.
　そして、本発明の実施形態としては、以下のものであってもよい。
　（２）　前記プレフィルドシリンジ用筒状体は、プレフィルドシリンジ用外筒であり、前記プレフィルドシリンジ用外筒は、開口が設けられた先端部を有する外筒本体と、前記先端部の開口を封止するためのシール部材を収納し、かつ、前記外筒本体の前記先端部に装着された外筒封止部材とを備え、前記穿刺部材装着部は、前記外筒封止部材により構成されており、かつ、前記外筒本体の先端部および前記外筒封止部材は、前記外筒本体に装着された前記外筒封止部材の離脱および回動を規制する規制部を有している上記（１）に記載のプレフィルドシリンジ用筒状体。
　（３）　前記外筒本体の先端部および前記外筒封止部材は、前記規制部として、回動規制用係合部および離脱規制用係合部を有している上記（２）に記載のプレフィルドシリンジ用筒状体。
　（４）　前記プレフィルドシリンジ用筒状体は、プレフィルドシリンジ用外筒であり、前記プレフィルドシリンジ用外筒の前記穿刺部材装着部は、前記穿刺部材装着部の開口が、前記穿刺部材の前記針部により刺通可能なシール部材により封止されている上記（１）に記載のプレフィルドシリンジ用筒状体。
　（５）　前記プレフィルドシリンジ用筒状体は、先端部が前記穿刺部材の前記針部により刺通可能なシール部材により封止されたプレフィルドシリンジに装着可能なホルダーである上記（１）に記載のプレフィルドシリンジ用筒状体。 And as an embodiment of the present invention, the following may be sufficient.
(2) The cylindrical body for a prefilled syringe is an outer cylinder for a prefilled syringe, and the outer cylinder for a prefilled syringe seals an outer cylinder body having a tip portion provided with an opening, and an opening of the tip portion. And an outer cylinder sealing member attached to the distal end portion of the outer cylinder main body, and the puncture member mounting portion is constituted by the outer cylinder sealing member. And the front-end | tip part of the said outer cylinder main body and the said outer cylinder sealing member have the control part which controls the detachment | leave and rotation of the said outer cylinder sealing member with which the said outer cylinder main body was mounted | worn ( The cylindrical body for prefilled syringes as described in 1).
(3) The distal end portion of the outer cylinder main body and the outer cylinder sealing member have a rotation restricting engagement portion and a detachment restricting engagement portion as the restricting portion. Cylindrical body for prefilled syringe.
(4) The cylindrical body for a prefilled syringe is an outer cylinder for a prefilled syringe, the puncture member mounting portion of the prefilled syringe outer cylinder has an opening of the puncture member mounting portion, and the needle portion of the puncture member The cylindrical body for a prefilled syringe according to the above (1), which is sealed by a sealing member that can be pierced by the above.
(5) The cylindrical body for a prefilled syringe is a holder that can be attached to a prefilled syringe whose tip is sealed by a seal member that can be pierced by the needle portion of the puncture member. Cylindrical body for prefilled syringe.
　本発明のプレフィルドシリンジ用穿刺具は、以下のものである。
　（６）　上記（１）ないし（５）のいずれかに記載のプレフィルドシリンジ用筒状体の前記穿刺部材装着部に着脱可能なプレフィルドシリンジ用穿刺具であって、
　前記穿刺具は、両端に前記針部を有する前記中空針と、前記中空針を装着し、前記穿刺部材装着部に着脱可能かつ、前記穿刺部材側螺合部と前記穿刺部材側係合部とを有する前記穿刺部材本体とを備える前記穿刺部材と、前記穿刺部材を離脱可能に収納する収納部材とを備え、さらに、前記収納部材と前記穿刺部材は、前記収納部材に付与された回転力を前記穿刺部材に伝達する回転力伝達部を有し、かつ、前記収納部材は、前記穿刺部材が前記穿刺部材装着部に装着された後、先端方向に引くことにより、前記穿刺部材より、離脱するものであるプレフィルドシリンジ用穿刺具。
　このため、プレフィルドシリンジ用筒状体への装着操作が容易であり、かつ、穿刺部材は螺合および係合によりプレフィルドシリンジ用筒状体に装着されるため、プレフィルドシリンジの投与操作時等に、穿刺部材が緩むことがない。さらに、プレフィルドシリンジによる薬剤の投与後、再度収納部材を穿刺部材に被嵌し、螺合が解除する方向に回転させることにより、容易に、プレフィルドシリンジ用筒状体より穿刺具を離脱させることができる。 The prefilled syringe puncture device of the present invention is as follows.
(6) A prefilled syringe puncture device detachable from the puncture member mounting portion of the prefilled syringe tubular body according to any one of (1) to (5) above,
The puncture device includes the hollow needle having the needle portions at both ends, the hollow needle is mounted, is detachable from the puncture member mounting portion, and the puncture member side screwing portion and the puncture member side engaging portion are The puncture member having the puncture member main body and a storage member for detachably storing the puncture member, and the storage member and the puncture member receive a rotational force applied to the storage member. The storage member has a rotational force transmitting portion that transmits to the puncture member, and the storage member is detached from the puncture member by pulling in the distal direction after the puncture member is mounted on the puncture member mounting portion. A prefilled syringe puncture device.
For this reason, the mounting operation to the cylindrical body for prefilled syringe is easy, and the puncture member is mounted to the cylindrical body for prefilled syringe by screwing and engagement. The puncture member does not loosen. Furthermore, after administration of the medicine by the prefilled syringe, the puncture tool can be easily detached from the prefilled syringe cylindrical body by re-inserting the storage member into the puncture member and rotating in the direction in which the screwing is released. it can.
　本発明のプレフィルドシリンジ用注射器は、以下のものである。
　（７）　上記（２）ないし（４）のいずれかに記載のプレフィルドシリンジ用筒状体であるプレフィルドシリンジ用外筒と、前記外筒内に収納された摺動可能なガスケットと、該ガスケットの後端に取り付けられたもしくは取り付け可能なプランジャとを備えるシリンジ本体と、前記プレフィルドシリンジ用外筒の前記穿刺部材装着部に着脱可能な前記穿刺部材と、前記穿刺部材を離脱可能に収納する収納部材とを備える穿刺具とからなるプレフィルドシリンジ用注射器であって、
　前記穿刺部材装着部は、前記筒状体側螺合部と前記筒状体側係合部とを有し、前記穿刺部材は、前記筒状体側螺合部と螺合可能な前記穿刺部材側螺合部と、前記筒状体側螺合部と前記穿刺部材側螺合部が螺合した後、前記筒状体側係合部と係合し、螺合の後退を規制する前記穿刺部材側係合部とを有し、前記収納部材と前記穿刺部材は、前記収納部材に付与された回転力を前記穿刺部材に伝達する回転力伝達部を有し、かつ、前記収納部材は、前記穿刺部材が前記穿刺部材装着部に装着された後、先端方向に引くことにより、前記穿刺部材より、離脱するものであるプレフィルドシリンジ用注射器。
　このため、本発明のプレフィルドシリンジ用注射器では、穿刺部材は螺合および係合によりシリンジ本体に装着されるため、プレフィルドシリンジの投与操作時等（例えば、収納部材離脱作業時）に、穿刺部材が緩むことがなく、緩みに起因する液漏れがない。 The syringe for prefilled syringes of the present invention is as follows.
(7) A prefilled syringe outer cylinder which is a cylindrical body for a prefilled syringe according to any one of (2) to (4) above, a slidable gasket housed in the outer cylinder, A syringe body provided with a plunger attached to or attachable to a rear end, the puncture member detachably attached to the puncture member mounting portion of the prefilled syringe outer cylinder, and a storage member for detachably storing the puncture member A prefilled syringe syringe comprising a puncture device comprising:
The puncture member mounting portion includes the cylindrical body side screwing portion and the cylindrical body side engaging portion, and the puncture member is screwed to the cylindrical body side screwing portion so that the puncture member side screwing is possible. The puncture member side engaging portion that engages with the cylindrical body side engaging portion and regulates the backward movement of the screwing after the cylindrical portion, the cylindrical body side screwed portion and the puncture member side screwed portion are screwed together And the storage member and the puncture member have a rotational force transmitting portion that transmits a rotational force applied to the storage member to the puncture member, and the storage member has the puncture member A syringe for a prefilled syringe that is detached from the puncture member by being pulled in the distal direction after being mounted on the puncture member mounting portion.
For this reason, in the syringe for prefilled syringes of the present invention, the puncture member is attached to the syringe body by screwing and engagement, so that the puncture member is used during the prefilled syringe administration operation (for example, when the storage member is removed). There is no loosening and there is no leakage due to the loosening.
　そして、本発明の実施形態としては、以下のものであってもよい。
　（８）　前記収納部材は、前記穿刺部材より離脱後、再度前記穿刺部材に装着可能であり、かつ、前記穿刺部材に再度装着された前記収納部材を前記筒状体側螺合部と前記穿刺部材側螺合部との螺合が後退する方向に回転させることにより、前記筒状体側係合部と前記穿刺部材側係合部との係合が解除され、前記収納部材内に前記穿刺部材を収納した状態にて、前記穿刺具を前記シリンジ本体より離脱可能である上記（７）に記載のプレフィルドシリンジ用注射器。
　（９）　前記筒状体側螺合部および前記穿刺部材側螺合部は、前記中空針の前記針部が、前記シール部材を刺通した後、前記筒状体側螺合部と前記穿刺部材側螺合部との螺合が開始されるように配置されている上記（７）または（８）に記載のプレフィルドシリンジ用注射器。
　（１０）　前記穿刺部材装着部は、第１の筒状体側係合部と、前記第１の筒状体側係合部より前記穿刺部材装着部の基端側もしくは先端側に位置する第２の筒状体側係合部を備え、前記穿刺部材は、前記第１の筒状体側係合部と係合する第１の穿刺部材側係合部と、前記第１の穿刺部材側係合部より前記穿刺部材の基端側もしくは先端側に位置し、前記第２の筒状体側係合部と係合する第２の穿刺部材側係合部を備えている上記（７）ないし（９）のいずれかに記載のプレフィルドシリンジ用注射器。
　（１１）　前記穿刺部材装着部は、過剰回転規制用リブを有し、前記穿刺部材は、前記筒状体側螺合部と前記穿刺部材側螺合部との螺合した後に、前記過剰回転規制用リブと当接する突出部を有している上記（７）ないし（１０）のいずれかに記載のプレフィルドシリンジ用注射器。 And as an embodiment of the present invention, the following may be sufficient.
(8) After the storage member is detached from the puncture member, the storage member can be attached to the puncture member again, and the storage member attached again to the puncture member is connected to the tubular body side screwing portion and the puncture member. By rotating in a direction in which the screwing with the side screwing part moves backward, the engagement between the cylindrical body side engaging part and the puncturing member side engaging part is released, and the puncturing member is placed in the storage member. The syringe for a prefilled syringe according to (7), wherein the puncture device can be detached from the syringe main body in a stored state.
(9) The cylindrical body side screwing portion and the puncture member side screwing portion are arranged so that the cylindrical body side screwing portion and the puncture member side after the needle portion of the hollow needle pierces the seal member. The syringe for a prefilled syringe according to (7) or (8), which is arranged so that screwing with the screwing portion is started.
(10) The puncture member mounting portion includes a first cylindrical body side engaging portion and a second cylindrical body side engaging portion that is located closer to the proximal end side or the distal end side of the puncture member mounting portion than the first cylindrical body side engaging portion. A cylindrical body side engaging portion; and the puncture member includes a first puncture member side engaging portion that engages with the first cylindrical body side engaging portion, and the first puncture member side engaging portion. The above-mentioned (7) to (9), further comprising a second puncture member side engagement portion that is located on the proximal end side or the distal end side of the puncture member and engages with the second cylindrical body side engagement portion. The syringe for a prefilled syringe according to any one of the above.
(11) The puncture member mounting portion includes an excessive rotation restricting rib, and the puncture member is engaged with the cylindrical body side screwing portion and the puncture member side screwing portion, and then the excessive rotation restriction rib. The syringe for a prefilled syringe according to any one of the above (7) to (10), which has a protruding portion that comes into contact with the rib for use.
　本発明のプレフィルドシリンジは、以下のものである。
　（１２）　上記（７）ないし（１１）のいずれかに記載のプレフィルドシリンジ用注射器と、前記シリンジ本体内に収納された薬剤とからなるプレフィルドシリンジ。 The prefilled syringe of the present invention is as follows.
(12) A prefilled syringe comprising the prefilled syringe injector according to any one of (7) to (11) above and a medicine stored in the syringe body.

Claims (12)

  1. 穿刺部材装着部を有する筒状体であり、両端に針部を有する中空針と、前記中空針を装着し、前記穿刺部材装着部に着脱可能かつ、穿刺部材側螺合部と穿刺部材側係合部とを有する穿刺部材本体とを備える穿刺部材が装着可能であるプレフィルドシリンジ用筒状体であって、
    　前記穿刺部材装着部は、前記穿刺部材側螺合部と螺合可能な筒状体側螺合部と、前記筒状体側螺合部と前記穿刺部材側螺合部が螺合した後、前記穿刺部材側係合部と係合し、螺合の後退を規制する筒状体側係合部とを有することを特徴とするプレフィルドシリンジ用筒状体。     A cylindrical body having a puncture member mounting portion, a hollow needle having needle portions at both ends, and the hollow needle is mounted and detachable from the puncture member mounting portion, and the puncture member side screwing portion and the puncture member side engagement A puncture member provided with a puncture member main body having a joint portion is a cylindrical body for a prefilled syringe that can be attached,
    The puncture member mounting portion includes: a cylindrical body side screwing portion that can be screwed with the puncture member side screwing portion; and the cylindrical body side screwing portion and the puncture member side screwing portion that are screwed together, A tubular body for a prefilled syringe, characterized by having a tubular body side engaging portion that engages with a member side engaging portion and restricts the backward movement of screwing.
  2. 前記プレフィルドシリンジ用筒状体は、プレフィルドシリンジ用外筒であり、前記プレフィルドシリンジ用外筒は、開口が設けられた先端部を有する外筒本体と、前記先端部の開口を封止するためのシール部材を収納し、かつ、前記外筒本体の前記先端部に装着された外筒封止部材とを備え、前記穿刺部材装着部は、前記外筒封止部材により構成されており、かつ、前記外筒本体の先端部および前記外筒封止部材は、前記外筒本体に装着された前記外筒封止部材の離脱および回動を規制する規制部を有している請求項１に記載のプレフィルドシリンジ用筒状体。 The cylindrical body for a prefilled syringe is an outer cylinder for a prefilled syringe, and the outer cylinder for a prefilled syringe is for sealing an outer cylinder body having a tip portion provided with an opening, and an opening of the tip portion. An outer cylinder sealing member that accommodates a seal member and is mounted on the distal end portion of the outer cylinder main body, the puncture member mounting portion is constituted by the outer cylinder sealing member, and The distal end portion of the outer cylinder main body and the outer cylinder sealing member have a restricting portion that restricts detachment and rotation of the outer cylinder sealing member mounted on the outer cylinder main body. Cylindrical body for prefilled syringe.
  3. 前記外筒本体の先端部および前記外筒封止部材は、前記規制部として、回動規制用係合部および離脱規制用係合部を有している請求項２に記載のプレフィルドシリンジ用筒状体。 3. The prefilled syringe cylinder according to claim 2, wherein the distal end portion of the outer cylinder main body and the outer cylinder sealing member have a rotation restricting engagement portion and a detachment restricting engagement portion as the restricting portion. The state.
  4. 前記プレフィルドシリンジ用筒状体は、プレフィルドシリンジ用外筒であり、前記プレフィルドシリンジ用外筒の前記穿刺部材装着部は、前記穿刺部材装着部の開口が、前記穿刺部材の前記針部により刺通可能なシール部材により封止されている請求項１に記載のプレフィルドシリンジ用筒状体。 The cylindrical body for a prefilled syringe is an outer cylinder for a prefilled syringe, and the puncture member mounting portion of the prefilled syringe outer tube is pierced by the needle portion of the puncture member. The cylindrical body for prefilled syringes according to claim 1, which is sealed by a possible sealing member.
  5. 前記プレフィルドシリンジ用筒状体は、先端部が前記穿刺部材の前記針部により刺通可能なシール部材により封止されたプレフィルドシリンジに装着可能なホルダーである請求項１に記載のプレフィルドシリンジ用筒状体。 2. The prefilled syringe cylinder according to claim 1, wherein the prefilled syringe cylindrical body is a holder that can be attached to a prefilled syringe whose tip is sealed by a seal member that can be pierced by the needle portion of the puncture member. The state.
  6. 請求項１に記載のプレフィルドシリンジ用筒状体の前記穿刺部材装着部に着脱可能なプレフィルドシリンジ用穿刺具であって、
    　前記穿刺具は、両端に前記針部を有する前記中空針と、前記中空針を装着し、前記穿刺部材装着部に着脱可能かつ、前記穿刺部材側螺合部と前記穿刺部材側係合部とを有する前記穿刺部材本体とを備える前記穿刺部材と、前記穿刺部材を離脱可能に収納する収納部材とを備え、さらに、前記収納部材と前記穿刺部材は、前記収納部材に付与された回転力を前記穿刺部材に伝達する回転力伝達部を有し、かつ、前記収納部材は、前記穿刺部材が前記穿刺部材装着部に装着された後、先端方向に引くことにより、前記穿刺部材より、離脱するものであることを特徴とするプレフィルドシリンジ用穿刺具。     A puncture device for a prefilled syringe that can be attached to and detached from the puncture member mounting portion of the tubular body for a prefilled syringe according to claim 1,
    The puncture device includes the hollow needle having the needle portions at both ends, the hollow needle is mounted, is detachable from the puncture member mounting portion, and the puncture member side screwing portion and the puncture member side engaging portion are The puncture member having the puncture member main body and a storage member for detachably storing the puncture member, and the storage member and the puncture member receive a rotational force applied to the storage member. The storage member has a rotational force transmitting portion that transmits to the puncture member, and the storage member is detached from the puncture member by pulling in the distal direction after the puncture member is mounted on the puncture member mounting portion. A puncture device for a prefilled syringe, characterized by being a thing.
  7. 請求項２に記載のプレフィルドシリンジ用筒状体であるプレフィルドシリンジ用外筒と、前記外筒内に収納された摺動可能なガスケットと、該ガスケットの後端に取り付けられたもしくは取り付け可能なプランジャとを備えるシリンジ本体と、前記プレフィルドシリンジ用外筒の前記穿刺部材装着部に着脱可能な前記穿刺部材と、前記穿刺部材を離脱可能に収納する収納部材とを備える穿刺具とからなるプレフィルドシリンジ用注射器であって、
    　前記穿刺部材装着部は、前記筒状体側螺合部と前記筒状体側係合部とを有し、前記穿刺部材は、前記筒状体側螺合部と螺合可能な前記穿刺部材側螺合部と、前記筒状体側螺合部と前記穿刺部材側螺合部が螺合した後、前記筒状体側係合部と係合し、螺合の後退を規制する前記穿刺部材側係合部とを有し、前記収納部材と前記穿刺部材は、前記収納部材に付与された回転力を前記穿刺部材に伝達する回転力伝達部を有し、かつ、前記収納部材は、前記穿刺部材が前記穿刺部材装着部に装着された後、先端方向に引くことにより、前記穿刺部材より、離脱するものであることを特徴とするプレフィルドシリンジ用注射器。     A prefilled syringe outer cylinder which is the cylindrical body for a prefilled syringe according to claim 2, a slidable gasket housed in the outer cylinder, and a plunger attached to or attachable to the rear end of the gasket For a prefilled syringe comprising: a syringe body including: a puncture member that is detachable from the puncture member mounting portion of the prefilled syringe outer cylinder; and a storage member that removably accommodates the puncture member. A syringe,
    The puncture member mounting portion includes the cylindrical body side screwing portion and the cylindrical body side engaging portion, and the puncture member is screwed to the cylindrical body side screwing portion so that the puncture member side screwing is possible. The puncture member side engaging portion that engages with the cylindrical body side engaging portion and regulates the backward movement of the screwing after the cylindrical portion, the cylindrical body side screwed portion and the puncture member side screwed portion are screwed together And the storage member and the puncture member have a rotational force transmitting portion that transmits a rotational force applied to the storage member to the puncture member, and the storage member has the puncture member A syringe for a prefilled syringe, which is detached from the puncture member by being pulled in a distal direction after being mounted on the puncture member mounting portion.
  8. 前記収納部材は、前記穿刺部材より離脱後、再度前記穿刺部材に装着可能であり、かつ、前記穿刺部材に再度装着された前記収納部材を前記筒状体側螺合部と前記穿刺部材側螺合部との螺合が後退する方向に回転させることにより、前記筒状体側係合部と前記穿刺部材側係合部との係合が解除され、前記収納部材内に前記穿刺部材を収納した状態にて、前記穿刺具を前記シリンジ本体より離脱可能である請求項７に記載のプレフィルドシリンジ用注射器。 The storage member can be reattached to the puncture member after being detached from the puncture member, and the storage member reattached to the puncture member is engaged with the cylindrical body side screwing portion and the puncture member side screwing. By rotating in a direction in which the screwing with the part moves backward, the engagement between the tubular body side engaging part and the puncture member side engaging part is released, and the puncture member is stored in the storage member The syringe for a prefilled syringe according to claim 7, wherein the puncture device can be detached from the syringe body.
  9. 前記筒状体側螺合部および前記穿刺部材側螺合部は、前記中空針の前記針部が、前記シール部材を刺通した後、前記筒状体側螺合部と前記穿刺部材側螺合部との螺合が開始されるように配置されている請求項７に記載のプレフィルドシリンジ用注射器。 The cylindrical body-side threaded portion and the puncture member-side threaded portion are configured such that, after the needle portion of the hollow needle has pierced the seal member, the cylindrical body-side threaded portion and the puncture member-side threaded portion The syringe for prefilled syringes of Claim 7 arrange | positioned so that screwing may be started.
  10. 前記穿刺部材装着部は、第１の筒状体側係合部と、前記第１の筒状体側係合部より前記穿刺部材装着部の基端側もしくは先端側に位置する第２の筒状体側係合部を備え、前記穿刺部材は、前記第１の筒状体側係合部と係合する第１の穿刺部材側係合部と、前記第１の穿刺部材側係合部より前記穿刺部材の基端側もしくは先端側に位置し、前記第２の筒状体側係合部と係合する第２の穿刺部材側係合部を備えている請求項７に記載のプレフィルドシリンジ用注射器。 The puncture member mounting portion includes a first cylindrical body side engaging portion and a second cylindrical body side located closer to the proximal end side or the distal end side of the puncture member mounting portion than the first cylindrical body side engaging portion. The puncture member includes an engagement portion, and the puncture member includes a first puncture member side engagement portion that engages with the first tubular body side engagement portion, and the puncture member from the first puncture member side engagement portion. The syringe for a prefilled syringe according to claim 7, further comprising a second puncture member side engagement portion that is located on the proximal end side or the distal end side of the first engagement portion and engages with the second tubular body side engagement portion.
  11. 前記穿刺部材装着部は、過剰回転規制用リブを有し、前記穿刺部材は、前記筒状体側螺合部と前記穿刺部材側螺合部との螺合した後に、前記過剰回転規制用リブと当接する突出部を有している請求項７に記載のプレフィルドシリンジ用注射器。 The puncture member mounting portion has an excessive rotation restricting rib, and the puncture member is screwed with the tubular body side screwing portion and the puncture member side screwing portion, and then the excessive rotation restriction rib and The syringe for a prefilled syringe according to claim 7, which has a protruding portion that comes into contact.
  12. 請求項７に記載のプレフィルドシリンジ用注射器と、前記シリンジ本体内に収納された薬剤とからなることを特徴とするプレフィルドシリンジ。 A prefilled syringe comprising the prefilled syringe injector according to claim 7 and a medicine stored in the syringe body.
PCT/JP2012/082075 2011-12-15 2012-12-11 Pre-filled syringe cylindrical body, pre-filled syringe puncture instrument, pre-filled syringe injection apparatus, and pre-filled syringe WO2013089105A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2011274758 2011-12-15
JP2011-274758 2011-12-15

Publications (1)

Publication Number Publication Date
WO2013089105A1 true WO2013089105A1 (en) 2013-06-20

Family

ID=48612552

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2012/082075 WO2013089105A1 (en) 2011-12-15 2012-12-11 Pre-filled syringe cylindrical body, pre-filled syringe puncture instrument, pre-filled syringe injection apparatus, and pre-filled syringe

Country Status (1)

Country Link
WO (1) WO2013089105A1 (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105873626A (en) * 2013-10-24 2016-08-17 美国安进公司 Injector and method of assembly
US10537681B2 (en) 2011-10-14 2020-01-21 Amgen Inc. Injector and method of assembly
US10850037B2 (en) 2013-03-22 2020-12-01 Amgen Inc. Injector and method of assembly

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0231763A (en) * 1988-06-24 1990-02-01 Habley Medical Technol Corp Hypodermic injector and combination of needle canula and canula lock
WO2009043000A1 (en) * 2007-09-27 2009-04-02 Becton, Dickinson And Company Cartridge for powder and liquid drug

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0231763A (en) * 1988-06-24 1990-02-01 Habley Medical Technol Corp Hypodermic injector and combination of needle canula and canula lock
WO2009043000A1 (en) * 2007-09-27 2009-04-02 Becton, Dickinson And Company Cartridge for powder and liquid drug

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10537681B2 (en) 2011-10-14 2020-01-21 Amgen Inc. Injector and method of assembly
US10537682B2 (en) 2011-10-14 2020-01-21 Amgen Inc. Injector and method of assembly
US11058821B2 (en) 2011-10-14 2021-07-13 Amgen Inc. Injector and method of assembly
US11110225B2 (en) 2011-10-14 2021-09-07 Amgen Inc. Injector and method of assembly
US11129941B2 (en) 2011-10-14 2021-09-28 Amgen Inc. Method of assembling and filling a drug delivery device
US11160931B2 (en) 2011-10-14 2021-11-02 Amgen Inc. Method of assembling and filling a drug delivery device
US11273260B2 (en) 2011-10-14 2022-03-15 Amgen Inc. Injector and method of assembly
US11298463B2 (en) 2011-10-14 2022-04-12 Amgen Inc. Method of assembling and filling a drug delivery device
US10850037B2 (en) 2013-03-22 2020-12-01 Amgen Inc. Injector and method of assembly
US11759571B2 (en) 2013-03-22 2023-09-19 Amgen Inc. Injector and method of assembly
CN105873626A (en) * 2013-10-24 2016-08-17 美国安进公司 Injector and method of assembly
US11097055B2 (en) 2013-10-24 2021-08-24 Amgen Inc. Injector and method of assembly

Similar Documents

Publication Publication Date Title
JP5670242B2 (en) Drug preparation tool
JP5865498B2 (en) Liquid dosing device
WO2011125475A1 (en) Syringe
JP6031113B2 (en) Prefilled syringe outer cylinder, puncture tool for prefilled syringe, prefilled syringe, and prefilled syringe administration preparation method
JP2011194045A (en) Medicine administration appliance
JP6486276B2 (en) Syringe outer cylinder with puncture function, syringe with puncture function and prefilled syringe with puncture function
JP5416529B2 (en) Drug administration device and drug administration device with drug container installed
JP4156791B2 (en) Prefilled syringe and prefilled syringe
WO2013089105A1 (en) Pre-filled syringe cylindrical body, pre-filled syringe puncture instrument, pre-filled syringe injection apparatus, and pre-filled syringe
JP2014200504A (en) Medicine preparation device
JP2012010930A (en) Medicine administration appliance
WO2011132657A1 (en) Liquid-medicine dosing device
JP5113412B2 (en) Prefilled syringe
JP4156790B2 (en) Prefilled syringe and prefilled syringe
JP5411729B2 (en) Drug administration device
JP6360470B2 (en) Liquid dosing device
WO2018173925A1 (en) Female syringe and syringe kit
JP4004106B2 (en) Chemical injection device
JP3668293B2 (en) Injection container
JP4299509B2 (en) Prefilled syringe and prefilled syringe
JP6031114B2 (en) Prefilled syringe outer cylinder, puncture tool for prefilled syringe, and prefilled syringe
JP6255163B2 (en) Drug preparation tool
JPH0767961A (en) Injection syringe
JP2004049803A (en) Two component mixing type pre-filled syringe
WO2014033865A1 (en) Medicine administration device

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 12857079

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 12857079

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: JP