WO2018062496A1 - Seringue pré-remplie et seringue - Google Patents

Seringue pré-remplie et seringue Download PDF

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Publication number
WO2018062496A1
WO2018062496A1 PCT/JP2017/035506 JP2017035506W WO2018062496A1 WO 2018062496 A1 WO2018062496 A1 WO 2018062496A1 JP 2017035506 W JP2017035506 W JP 2017035506W WO 2018062496 A1 WO2018062496 A1 WO 2018062496A1
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WO
WIPO (PCT)
Prior art keywords
syringe
outer cylinder
cap
pusher
preparation
Prior art date
Application number
PCT/JP2017/035506
Other languages
English (en)
Japanese (ja)
Inventor
飯渕るり子
有延学
桝田多恵子
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
Priority to JP2018542937A priority Critical patent/JP6895446B2/ja
Publication of WO2018062496A1 publication Critical patent/WO2018062496A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms

Definitions

  • the present invention includes a syringe outer cylinder in which a preparation discharge port is formed at the distal end, a pusher provided in the syringe outer cylinder, and a cap that can be attached to and detached from the distal end of the syringe outer cylinder.
  • the present invention relates to a prefilled syringe and a syringe.
  • compositions used as pharmaceuticals or medical devices for example, have thixotropic properties, are solid at the time of storage, but become liquefied by stirring and can be injected into a living body with a syringe. is there.
  • the present invention has been made in view of such problems, and can easily stir the formulation, reduce storage space and prevent leakage of the formulation from the storage space for storing the formulation.
  • An object of the present invention is to provide a prefilled syringe and a syringe that can be used.
  • a prefilled syringe according to the present invention includes a syringe outer cylinder in which a preparation discharge port is formed at a distal end, a pusher provided in the syringe outer cylinder, and the syringe outer cylinder.
  • a prefilled syringe comprising a cap that can be attached to and detached from the tip, and a preparation made of a thixotropic substance or a dispersion solution
  • the pusher includes a cylindrical pusher outer cylinder, and an outer pusher A pusher main body that slides inside the cylinder, and the pusher outer cylinder is provided on an outer peripheral portion of the pusher outer cylinder, and is a liquid-tight seal between the inner peripheral surface of the syringe outer cylinder A seal member that slides on the inner peripheral surface of the syringe outer cylinder, and a formulation flow port that is provided at a distal end portion of the pusher and through which the formulation passes, and the pusher body is , While forming a liquid-tight seal with the inner peripheral surface of the pusher outer cylinder, A gasket that slides on the inner peripheral surface of the child outer cylinder, a rod portion having a tip connected to the gasket, and a pressing portion provided at a base end portion of the rod portion,
  • the preparation flows from the storage space through the preparation circulation port into the syringe outer cylinder, and the pusher outer cylinder is moved against the syringe outer cylinder. It is characterized by sliding in the proximal direction.
  • the preparation is passed from the storage space through the preparation circulation port in the syringe outer cylinder (on the outer side of the pusher outer cylinder in the syringe outer cylinder). Can be moved to a certain outer area).
  • the preparation in the outer region can be moved into the pusher outer cylinder via the preparation distribution port. Thereby, the stirring operation of a formulation can be performed easily.
  • the pusher outer cylinder is provided in the syringe outer cylinder, and the cap seals the drug product distribution port and the drug product discharge port in a liquid-tight manner. The leakage of the preparation can be prevented.
  • the cap seals the formulation discharge port in a liquid-tight state in a state where the formulation circulation port is opened from an initial position where the formulation distribution port and the formulation discharge port are sealed in a liquid-tight manner. It may be possible to displace the product discharge port continuously and liquid-tightly while being displaced from the initial position to the agitation position.
  • the storage space communicates with the inside of the syringe outer cylinder through the preparation flow port by displacing the cap from the initial position to the stirring position. For this reason, the formulation in the storage space can be easily moved to the outer region by pressing the pressing portion of the rod portion.
  • a first screw portion is formed at the distal end portion of the syringe outer cylinder, and the cap includes a cap main body capable of closing the preparation circulation port and the preparation discharge port, and the cap main body. And a cap cover formed with a second screw portion that is fixed and can be screwed into the first screw portion.
  • the cap can be easily displaced from the initial position to the stirring position by rotating the cap cover.
  • the first screw portion and the second screw portion may be screwed together with the cap positioned at the stirring position.
  • the cap can be prevented from being displaced from the stirring position during the stirring operation of the preparation.
  • the syringe outer cylinder is provided with a syringe side engaging portion, and the cap is engaged with the syringe side engaging portion when the cap is displaced from the initial position to the stirring position. You may have the cap side engaging part to do.
  • the user can easily grasp that the cap has been displaced from the initial position to the stirring position by engaging the syringe side engaging portion and the cap side engaging portion. Moreover, it can suppress that a cap rotates easily during the stirring operation of a formulation with the engaging force of a syringe side engaging part and a cap side engaging part.
  • the syringe-side engagement portion and the cap-side engagement portion are engaged with each other in a state where the cap is located at the initial position, and the engagement is performed as the cap is rotated in the opening direction.
  • the match may be released.
  • one of the syringe side engaging portion and the cap side engaging portion is a convex portion
  • one of the syringe side engaging portion and the cap side engaging portion is the A concave portion that can be engaged with the convex portion
  • the configurations of the syringe side engaging portion and the cap side engaging portion can be simplified.
  • the said syringe side engaging part is provided in the outer peripheral surface of the said syringe outer cylinder, and at least any one of the said convex part and the said recessed part is a said 1st thread part and a said 2nd thread part.
  • An inclined surface inclined outward in the radial direction of the syringe outer cylinder may be formed in a rotational direction in which tightening is loosened.
  • the engagement between the syringe side engaging portion and the cap side engaging portion can be easily released by the rotation of the cap.
  • the said syringe side engaging part has a 1st engaging part and a 2nd engaging part provided in the position which 180 degree phase shifted
  • the cap side engaging portion has a third engaging portion and a fourth engaging portion provided at positions shifted in phase by 180 ° in the circumferential direction of the cap body, and the cap is positioned at the initial position.
  • the third engagement portion engages with the first engagement portion
  • the fourth engagement portion engages with the second engagement portion
  • the cap is located at the stirring position.
  • the third engagement portion may engage with the second engagement portion
  • the fourth engagement portion may engage with the first engagement portion.
  • the user can more easily grasp that the cap has been displaced from the initial position to the stirring position.
  • the said syringe side engaging part has a 1st recessed part and a 2nd recessed part formed in the outer peripheral surface of the said syringe outer cylinder,
  • the said cap side engaging part is a said 1st recessed part and A convex portion that can be inserted into the second concave portion is provided, and a spiral groove that guides the convex portion from the first concave portion to the second concave portion may be formed on an outer peripheral surface of the syringe outer cylinder.
  • the convex portion when the cap is displaced from the initial position to the stirring position, the convex portion can be easily guided from the first concave portion to the second concave portion by the spiral groove.
  • the syringe according to the present invention is a syringe for a prefilled syringe filled with a preparation, a syringe outer cylinder having a preparation discharge port formed at the tip, a pusher provided in the syringe outer cylinder, A cap that can be attached to and detached from the tip of the syringe outer cylinder, and the pusher includes a cylindrical pusher outer cylinder, and a pusher body that slides inside the pusher outer cylinder, The pusher outer cylinder is provided on the outer peripheral portion of the pusher outer cylinder, and forms a liquid-tight seal with the inner peripheral surface of the syringe outer cylinder, while the inner peripheral surface of the syringe outer cylinder is formed.
  • a pressing portion provided at a proximal end portion of the rod portion, and the cap from the initial position for liquid-tightly sealing the formulation distribution port and the formulation discharge port,
  • the product outlet is continuously displaceable from the initial position to the agitation position while being displaceable to the agitation position that seals the formulation outlet in a liquid-tight manner in a state where the drug product outlet is open. It can be sealed in a liquid-tight manner, and the preparation can be stored in a storage space surrounded by the cap, the pusher outer cylinder, and the gasket.
  • a prefilled syringe in which the storage space is filled with the preparation using the syringe having such a configuration, a prefilled syringe having the same effects as the above-described prefilled syringe can be obtained.
  • the storage space communicates with the inside of the syringe outer cylinder through the preparation flow port by displacing the cap from the initial position to the stirring position. For this reason, when the storage space is filled with the preparation, the preparation in the storage space can be easily moved to the outer region by pressing the pressing portion of the rod portion.
  • the preparation can be easily stirred by pressing the presser main body or the presser outer cylinder. Moreover, since the pusher outer cylinder is provided in the syringe outer cylinder, the leakage of the preparation from the storage space can be prevented while reducing the storage space for the prefilled syringe.
  • FIG. 5 is a longitudinal sectional view taken along line VV in FIG. 4.
  • FIG. 6 is a transverse sectional view taken along line VI-VI in FIG. 5. It is a longitudinal cross-sectional view of the syringe at the time of storage before a formulation is filled.
  • FIG. 16 is a transverse sectional view taken along line XVII-XVII in FIG. 15.
  • the prefilled syringe 10A according to the first embodiment of the present invention is prepared by prefilling the syringe 11A with a preparation F that needs to be stirred at the time of use.
  • the prefilled syringe 10A includes a syringe outer cylinder 12, a pusher 14 provided in the syringe outer cylinder 12, and a cap 16 that can be attached to and detached from the distal end portion of the syringe outer cylinder 12. I have.
  • the syringe outer cylinder 12 includes a cylindrical body portion 18, a tapered portion 20 that decreases in diameter from the distal end of the body portion 18 toward the distal end, a distal end tubular portion 22 that projects from the distal end of the tapered portion 20 in the distal end direction,
  • drum 18 are provided.
  • the body part 18, the taper part 20, the tip cylinder part 22, the syringe side connection part 24, and the flange part 26 are integrally formed.
  • the inner diameter of the body portion 18 is formed constant over the entire length.
  • the distal end cylindrical portion 22 is a cylindrical member that forms a preparation discharge port 28 that communicates with the body portion 18, and is configured as a luer connector.
  • the syringe side connecting portion 24 is a luer lock that protrudes concentrically with the distal end cylindrical portion 22 from the distal end portion of the body portion 18 to the distal end side, and has an internal thread portion 30 (first threaded portion) formed on the inner peripheral surface.
  • the cap 16 and the injection needle 140 can be attached to and detached from the syringe-side connection portion 24.
  • a syringe side engaging portion 32 with which a cap side engaging portion 106 described later of the cap 16 is engaged is provided on the outer peripheral surface of the syringe side connecting portion 24.
  • the syringe side engaging portion 32 includes a first concave portion 34 (first engaging portion) and a second concave portion 36 (second engaging portion) formed at positions shifted in phase by 180 ° in the circumferential direction of the syringe side connecting portion 24. ).
  • the first recess 34 is formed in a substantially rectangular shape in plan view and extends along the axial direction of the syringe outer cylinder 12.
  • the second recess 36 is formed in the same manner as the first recess 34.
  • the flange portion 26 has a pair of finger hook portions 38 and 40 that protrude radially outward from the base end portion of the body portion 18 in opposite directions.
  • the width in the longitudinal direction of the flange portion 26 is set to a width that is larger than the width in the short-side direction and that allows a person to hang a finger.
  • a plurality of convex anti-slip portions 42 are provided on the front end surface of each finger-hanging portion 38, 40.
  • the constituent material of the syringe outer cylinder 12 is not particularly limited.
  • polyolefin such as polypropylene, polyurethane, polyethylene, cyclic olefin polymer, cyclic olefin copolymer, polymethylpentene 1, polyester, nylon, polycarbonate, polymethyl methacrylate (PMMA).
  • PEI Polyetherimide
  • PEEK polyethersulfone
  • PES polyetheretherketone
  • fluororesin polyphenylene sulfide
  • PPS polyacetal resin
  • other metallic materials such as stainless steel, It may be formed of glass or the like.
  • the pusher 14 includes a pusher outer cylinder 44 slidably provided on the inner peripheral surface of the syringe outer cylinder 12, and a pusher main body 46 provided in the pusher outer cylinder 44.
  • the pusher outer cylinder 44 includes a cylindrical pusher body portion 48, a pusher taper portion 50 that decreases in diameter from the front end of the pusher body portion 48, and a pusher taper portion 50 that protrudes in the front end direction.
  • a pusher outer cylinder flange portion 54 provided at a proximal end portion of the pusher body portion 48.
  • the presser body portion 48, the presser taper portion 50, the presser tip tube portion 52, and the presser outer tube flange portion 54 are integrally formed.
  • the constituent material of the pusher outer cylinder 44 is the same as the constituent material of the syringe outer cylinder 12.
  • the inner diameter of the presser body 48 is formed to be constant over the entire length.
  • Two annular seal grooves 58 in the axial direction in which a seal member 56 that slides in the axial direction in a liquid-tight manner is provided on the inner peripheral surface of the body 18 at the distal end of the outer surface of the pusher body 48. Is formed. That is, the seal member 56 forms a liquid-tight seal with the inner peripheral surface of the body portion 18.
  • the presser body 48 is formed to be longer than the body 18.
  • the taper angle of the presser taper portion 50 is substantially the same as the taper angle of the taper portion 20.
  • the pusher distal end cylindrical portion 52 has a cylindrical member having a preparation distribution port 60 at the distal end that communicates the inside of the pusher body 48 and the outer region 12a of the pusher outer tube 44 in the syringe outer tube 12 (see FIG. 9). It is.
  • the pusher outer cylinder flange portion 54 has a pair of finger hook portions 62 and 64 that protrude radially outward from the base end portion of the pusher body portion 48 in opposite directions.
  • the finger hook 62 faces the finger hook 38 of the syringe outer cylinder 12
  • the finger hook 64 faces the finger hook 40 of the syringe outer cylinder 12.
  • a plurality of convex anti-slip portions 66 are provided on both sides of each finger-hanging portion 62, 64.
  • the distal end side of the pusher main body 46 in the pusher outer cylinder 44 is filled with the preparation F.
  • the preparation F for example, a thixotropic substance that is solid in a state before stirring and is liquefied by stirring, a dispersion solution such as a colloidal solution, or the like can be used.
  • the presser body 46 includes a gasket 68 that slides axially in a liquid-tight manner on the inner peripheral surface of the presser body 48, a rod portion 70 that is connected to the gasket 68 and extends in the axial direction, and a rod portion. 70 and a pressing portion 72 provided at the base end portion.
  • the gasket 68 forms a liquid-tight seal with the inner peripheral surface of the pusher body 48.
  • the gasket 68 is made of an elastic material, and the front end surface 74 of the gasket 68 is formed in a taper shape, and the taper angle thereof is substantially the same as the taper angle of the presser taper portion 50.
  • the pressing part 72 is configured in a disc shape (see FIGS. 1 and 2). The diameter of the pressing portion 72 is smaller than the longitudinal dimension of the pusher outer cylinder flange portion 54.
  • the cap 16 has a cap body 76, a cap cover 78 fixed to the cap body 76, and an outer cover 80 that covers the cap cover 78.
  • Examples of the constituent material of the cap body 76 include rubber or synthetic resin.
  • the rubber for example, isoprene rubber, butyl rubber, latex rubber, silicone rubber and the like can be used.
  • the synthetic resin for example, a styrene elastomer, an olefin elastomer, or the like can be used.
  • the cap body 76 includes a columnar mounting portion 82 that forms a base end portion, an intermediate portion 84 that is provided on the distal end side of the mounting portion 82, and a large-diameter portion 86 that is connected to the intermediate portion 84 and forms the distal end portion.
  • the mounting portion 82 includes a mounting base 88 that can be fitted into the distal end cylindrical portion 22, and an annular portion 90 that protrudes from the base end surface of the mounting base 88.
  • the outer peripheral surface of the mounting portion 82 is in liquid-tight contact with the inner peripheral surface of the tip tube portion 22, and the inner peripheral surface of the annular portion 90 is liquid-contacted with the outer peripheral surface of the pusher tip tube portion 52. Close contact.
  • the base end surface of the mounting base portion 88 constitutes a sealing portion that comes into liquid-tight contact with the distal end surface of the pusher distal end cylindrical portion 52.
  • a bulging portion 92 that can be inserted into the pusher distal end cylindrical portion 52 is provided in the approximate center of the base end surface of the mounting portion 82.
  • An annular fixing groove 94 is formed on the outer peripheral surface of the intermediate portion 84.
  • the cap cover 78 can be made of, for example, a resinous material exemplified as a constituent material of the syringe outer cylinder 12. The same applies to the outer cover 80.
  • the cap cover 78 has a cylindrical cap cover body 96 that covers the large-diameter portion 86 and a cap-side connection in which a male screw portion 98 (second screw portion) that can be screwed into the female screw portion 30 of the syringe-side connecting portion 24 is formed. Part 100.
  • a fixing portion 102 that fits into the fixing groove 94 protrudes radially inward (see FIG. 4).
  • two fixing holes 104 penetrating in the thickness direction are formed at positions 180 degrees out of phase in the circumferential direction.
  • the cap side connection part 100 is configured in a cylindrical shape and covers the intermediate part 84 and the mounting part 82.
  • the distal end tubular portion 22 can be inserted between the cap-side connecting portion 100 and the mounting portion 82.
  • the outer cover 80 has a cylindrical shape and is longer in the axial direction than the cap cover 78.
  • the outer cover 80 includes a cap side engaging portion 106 that can be engaged with the syringe side engaging portion 32, and two fixing claws 108 that are fitted in the fixing holes 104 of the cap cover main body 96.
  • the cap-side engagement portion 106 includes a first engagement claw 110 (third engagement) provided at a position that is 180 degrees out of phase in the circumferential direction of the outer cover 80. Part) and the second engagement claw 112 (fourth engagement part).
  • the first engaging claw 110 includes a first plate-like piece 116 formed by forming a substantially U-shaped slit 114 (see FIG. 1) in the outer cover 80, and a radial direction from the first plate-like piece 116. And a first convex portion 118 projecting inward.
  • the first plate-like piece 116 extends along the axial direction of the outer cover 80.
  • the first convex portion 118 is provided at the base end portion of the first plate-like piece 116 and can be inserted into the first concave portion 34 and the second concave portion 36.
  • the length of the first convex portion 118 along the axial direction of the cap 16 is shorter than the length of the first concave portion 34 and the second concave portion 36 along the axial direction of the cap 16.
  • the first convex portion 118 is inclined in the radially outward direction (the outer peripheral surface side of the outer cover 80) in the rotational direction (arrow R direction in FIG. 6) in which the tightening of the male screw portion 98 with respect to the female screw portion 30 is loosened.
  • An inclined surface 120 is formed.
  • the first inclined surface 120 is configured as a convex curved surface, but may be a flat surface.
  • the second engagement claw 112 is configured in the same manner as the first engagement claw 110, and a second plate-shaped piece 124 configured by forming a substantially U-shaped slit 122 in the outer cover 80; And a second convex portion 126 projecting radially inward from the second plate-like piece 124.
  • the second convex portion 126 is formed with a second inclined surface 128 that is inclined radially outward (on the outer peripheral surface side of the outer cover 80) in the direction of arrow R.
  • the fixing claw 108 includes a plate-like piece 132 formed by forming a substantially U-shaped slit 130 in the outer cover 80, and a radially inward direction from the plate-like piece 132. And a nail body 134 protruding toward the surface.
  • the plate-like piece 132 extends along the axial direction of the outer cover 80.
  • the claw body 134 is located at the base end of the plate-like piece 132 and is fitted in the fixing hole 104.
  • the prefilled syringe 10A according to the present embodiment is basically configured as described above. Next, a method of using the prefilled syringe 10A will be described.
  • the preparation F is stored in the storage space S surrounded by the cap 16, the pusher body 46, and the gasket 68.
  • the preparation F may not be stored in the storage space S. That is, the syringe 11 ⁇ / b> A including the syringe outer cylinder 12, the pusher 14, and the cap 16 is stored, and immediately before use, the pusher main body 46 is pulled out from the pusher outer cylinder 44, and the preparation F is placed in the pusher outer cylinder 44.
  • the prefilled syringe 10 ⁇ / b> A in which the storage space S is filled with the preparation F may be configured by filling and inserting the pusher main body 46 into the pusher outer cylinder 44 again.
  • the pusher outer tube 44 is inserted into the syringe outer tube 12 and the pusher main body 46 is inserted into the pusher outer tube 44 during storage in FIG. 3. That is, the pusher outer cylinder 44 is positioned at the forefront of the syringe outer cylinder 12, and the outer surface of the pusher taper portion 50 is in liquid-tight contact with the inner surface of the taper portion 20.
  • the cap 16 is positioned at the initial position of the unopened state, and the drug product distribution port 60 and the drug product discharge port 28 are liquid-tightly sealed by the cap body 76, and more than the gasket 68 in the pusher outer cylinder 44.
  • the preparation F is stored in the storage space S on the distal end side. That is, the distal end surface of the pusher distal end cylindrical portion 52 comes into liquid-tight contact with the proximal end surface of the mounting base 88 and the outer peripheral surface of the pusher distal end tubular portion 52 comes into liquid tight contact with the inner peripheral surface of the annular portion 90, The inner peripheral surface of the tip tube portion 22 is in liquid-tight contact with the outer peripheral surface of the mounting portion 82. Further, as shown in FIG. 5, the first convex portion 118 is inserted into the first concave portion 34 and the second convex portion 126 is inserted into the second concave portion 36.
  • the preparation F When administering the preparation F to a living body, first, the preparation F is agitated. Specifically, the user picks the outer cover 80 with his / her fingers, and rotates the cap 16 in a direction (arrow R direction in FIG. 6) in which tightening of the male screw portion 98 with respect to the female screw portion 30 is loosened. Then, the first inclined surface 120 rides on the edge of the first concave portion 34 and the second inclined surface 128 rides on the edge of the second concave portion 36, and the first plate-like piece 116 is elastically deformed and the first convex portion. 118 is pulled out of the first recess 34 and the second plate-like piece 124 is elastically deformed, so that the second convex portion 126 is pulled out of the second concave portion 36.
  • the cap 16 is displaced from the initial position to the stirring position, and the formulation flow port 60 is opened in a state where the formulation discharge port 28 is liquid-tightly sealed to the cap body 76.
  • the cap body 76 continuously and liquid-tightly seals the preparation discharge port 28 while the cap 16 is displaced from the initial position to the stirring position.
  • the annular tube 90 of the cap body 76 is pulled out from the pusher distal tube portion 52, and the distal end tube is in a state where the outer peripheral surface of the annular portion 90 is in liquid-tight contact with the distal end portion of the inner peripheral surface of the distal tube portion 22.
  • the inside of the portion 22 and the inside of the pusher tip cylindrical portion 52 communicate with each other.
  • the user hangs the index finger and the middle finger of the right hand on the surface of the distal end side of the finger hooking portion 62 of the pusher outer cylinder 44 and the left index finger and the middle finger on the distal end side of the finger hooking portion 64 of the pusher outer cylinder 44.
  • Hang on the face the base end side surface of the pressing portion 72 is pressed in the distal direction with the thumb while pulling the finger hanging portion 62 and the finger hanging portion 64 in the proximal direction with the index finger and the middle finger.
  • the gasket 68 slides liquid-tightly in the pusher outer tube 44 in the distal direction, so that the preparation F in the pusher outer tube 44 is introduced into the distal tube part 22 through the preparation flow port 60.
  • the preparation discharge port 28 is liquid-tightly sealed by the cap body 76, the preparation F does not leak to the outside of the syringe outer cylinder 12.
  • the gasket 68 is displaced in the distal direction with respect to the pusher outer tube 44 and the pusher outer tube 44 is outside the syringe. It is displaced in the proximal direction with respect to the cylinder 12, and the preparation F in the pusher outer cylinder 44 moves to the outer region 12a of the pusher outer cylinder 44 in the syringe outer cylinder 12 through the preparation flow port 60 (FIG. 9). reference).
  • the relative displacement between the pusher main body 46 and the pusher outer cylinder 44 stops at the position where the front end surface 74 of the gasket 68 and the inner surface of the pusher taper portion 50 are in contact (see FIG. 10).
  • the user hangs the index finger and middle finger of the right hand on the surface of the finger hook portion 38 of the syringe outer cylinder 12 and the index finger and middle finger of the left hand on the tip side of the finger hook portion 40 of the syringe outer cylinder 12.
  • the right hand thumb presses the base end side surface of the finger hooking portion 62 of the pusher outer cylinder 44 in the front end direction
  • the left hand thumb presses the base end surface of the finger hooking portion 64 of the pusher outer cylinder 44 in the front end direction. Press on.
  • the pusher outer cylinder 44 is displaced in the distal direction with respect to the syringe outer cylinder 12, and the preparation F in the outer region 12 a flows into the pusher outer cylinder 44 through the preparation flow port 60.
  • the distal end surface 74 of the gasket 68 is pressed in the proximal direction by the preparation F, and the pusher body 46 is displaced in the proximal direction with respect to the pusher outer cylinder 44.
  • the preparation discharge port 28 is blocked by the cap body 76, the preparation F does not leak to the outside of the syringe outer cylinder 12.
  • the preparation F is sufficiently stirred by moving the preparation F a plurality of times between the inside of the pusher outer cylinder 44 and the outer region 12a.
  • the tip surface 74 of the gasket 68 is brought into contact with the inner surface of the presser taper portion 50 as shown in FIG. That is, the entire amount of the preparation F is moved to the outer region 12 a of the syringe outer cylinder 12.
  • the surface on the distal end side of the pressing portion 72 is in contact with or close to the surface on the proximal end side of the pusher outer cylinder flange portion 54.
  • the user further rotates the cap 16 in the arrow R direction.
  • the first inclined surface 120 rides on the edge of the second recess 36
  • the second inclined surface 128 rides on the edge of the first recess 34
  • the first protrusion 118 comes out of the second recess 36
  • the second protrusion The part 126 comes out of the first recess 34.
  • the cap 16 is removed from the syringe outer cylinder 12, and the injection needle 140 is attached to the front-end
  • the injection needle 140 includes a hollow needle body 142 and a male screw portion 144 that is provided at the proximal end portion of the needle body 142 and can be screwed into the female screw portion 30 of the syringe side connection portion 24. Needle hub 146.
  • the lock member 150 includes two substantially rectangular plate-like portions 152 and 154 facing each other, and a connecting portion 156 that connects one side portions of these plate-like portions 152 and 154.
  • the plate-like portion 152 has a circular hole 158 having a shape corresponding to the arc shape of the outer peripheral surface of the pusher outer cylinder 44, and the diameter is increased in a tapered shape from the circular hole 158 to the other side portion of the plate-like portion 152.
  • An extended introduction hole 160 is formed.
  • the distance between the plate-like portion 152 and the plate-like portion 154 is set to be the same as or slightly larger than the dimension obtained by adding the thickness of the pusher outer cylinder flange portion 54 to the thickness of the pressing portion 72.
  • Such a locking member 150 has the pusher outer cylinder 44 in the circular hole 158 via the introduction hole 160 of the plate-like portion 152 in a state where the plate-like portion 154 is in contact with or close to the surface on the proximal end side of the pressing portion 72. Is inserted into the pusher 14 by inserting. As a result, the axial movement of the pusher main body 46 relative to the pusher outer cylinder 44 is restricted.
  • the user punctures the needle body 142 into the patient (living body), for example, hangs the index finger of the right hand on the surface of the finger hook portion 38 of the syringe outer cylinder 12, and the middle finger of the right hand is the finger hook portion of the syringe outer cylinder 12.
  • the plate-like portion 154 of the lock member 150 is pressed in the distal direction with the thumb of the right hand in a state where it is hung on the surface on the distal end side of 40.
  • the preparation F in the outer region 12a does not return into the pusher outer cylinder 44, It is administered to the patient via the preparation discharge port 28 and the needle body 142.
  • the cap 16 is displaced from the initial position to the stirring position, and the pusher main body 46 is pressed, whereby the preparation F in the pusher outer cylinder 44 is transferred to the syringe outer cylinder 12 via the preparation flow port 60. It can be moved to the outer region 12a of the pusher outer cylinder 44 inside. Further, by pressing the pusher outer cylinder 44 in the distal direction, the preparation F in the outer region 12a can be moved into the pusher outer cylinder 44 via the preparation flow port 60. Thereby, the stirring operation of the preparation F can be easily performed.
  • the pusher outer cylinder 44 is provided in the syringe outer cylinder 12 in an unused state, and the cap 16 seals the formulation distribution port 60 and the formulation discharge port 28 in a liquid-tight manner, the prefilled syringe 10A (syringe The leakage of the preparation F from the storage space S can be prevented while reducing the storage space of 11A).
  • the male threaded portion 98 of the cap-side connecting portion 100 is screwed into the female threaded portion 30 of the syringe-side connecting portion 24. Therefore, by rotating the cap 16, the cap 16 Can be easily displaced from the initial position to the stirring position.
  • the cap during the stirring operation of the preparation F is performed. It can suppress that 16 displaces from a stirring position.
  • the syringe outer cylinder 12 is formed with the first recess 34 and the second recess 36 of the syringe side engagement portion 32, and the outer cover 80 is the first engagement claw of the cap side engagement portion 106. 110 and a second engaging claw 112. Then, at the initial position of the cap 16, the first convex portion 118 of the first engaging claw 110 is inserted into the first concave portion 34 and the second convex portion 126 of the second engaging claw 112 is inserted into the second concave portion 36. Has been.
  • the cap 16 when the cap 16 is displaced from the initial position to the stirring position, the first convex portion 118 is inserted into the second concave portion 36 and the second convex portion 126 is inserted into the first concave portion 34. Thereby, the user can easily grasp that the cap 16 has been displaced from the initial position to the stirring position. Further, the cap 16 is prevented from rotating during the stirring operation of the preparation F by the engaging force between the first convex portion 118 and the second concave portion 36 and the engaging force between the second convex portion 126 and the first concave portion 34. it can.
  • the rotation of the cap 16 causes the syringe side of the cap side engaging portion 106.
  • the engagement of the engagement portion 32 can be easily released.
  • the prefilled syringe 10A is not limited to the configuration described above.
  • an inclined surface that is inclined radially outward toward the arrow R direction may be formed at the edge of the first recess 34.
  • the first inclined surface 120 of the first convex portion 118 may be omitted.
  • the inclined surface which inclines radially outward toward the arrow R direction may be formed in the edge part of the 2nd recessed part 36.
  • the second inclined surface 128 of the second convex portion 126 may be omitted.
  • the syringe side engaging portion 32 has a concave portion, and the cap side engaging portion 106 has a convex portion.
  • the syringe side engaging part 32 may have a convex part, and the cap side engaging part 106 may have a concave part.
  • the prefilled syringe 10B is prepared by prefilling the syringe 11B with a preparation F that needs to be stirred at the time of use.
  • the prefilled syringe 10 ⁇ / b> B includes a syringe outer cylinder 170, a pusher 14, and a cap 172.
  • a spiral groove 174 having a constant depth and width formed on the outer peripheral surface of the syringe-side connection portion 24 is formed in the syringe-side connection portion 24 of the syringe outer cylinder 170.
  • the spiral groove 174 has a first deep groove portion 176 (first concave portion) provided at a start end thereof (an end portion in the proximal direction of the syringe outer cylinder 170) and 180 in the circumferential direction with respect to the first deep groove portion 176.
  • a second deep groove portion 178 (second concave portion) provided at a position out of phase is formed, and a shallow groove portion 180 extending from the first deep groove portion 176 to the tip of the syringe side connection portion 24 is formed.
  • the first deep groove portion 176 and the second deep groove portion 178 function as the syringe side engaging portion 181.
  • the depth dimension of the first deep groove portion 176 is the same as the depth dimension of the second deep groove portion 178 and is deeper than the depth dimension of the shallow groove portion 180.
  • the cap 172 includes a cap body 76, a cap cover 78, and an outer cover 182.
  • the outer cover 182 is configured in a cylindrical shape, and includes a cap side engaging portion 184 that can be engaged with the syringe side engaging portion 181 and two fixed claws 108.
  • the cap-side engaging portion 184 includes a plate-like piece 188 formed by forming a substantially U-shaped slit 186 on the outer cover 182, and a convex portion projecting radially inward from the plate-like piece 188. 190.
  • the plate-like piece 188 extends along the circumferential direction of the outer cover 182.
  • the convex portion 190 is provided at the extending end portion of the plate-like piece 188 and can be inserted into the first deep groove portion 176 and the second deep groove portion 178.
  • the width dimension of the convex portion 190 along the axial direction of the outer cover 182 is substantially the same as or slightly smaller than the groove width of the spiral groove 174.
  • the convex portion 190 is formed with an inclined surface 192 that is inclined radially outward (on the outer peripheral surface side of the outer cover 182) in the rotational direction in which the female screw portion 30 of the male screw portion 98 is loosened. ing.
  • the inclined surface 192 is configured as a flat surface, but may be a convex curved surface.
  • the formulation circulation port 60 and the formulation discharge port 28 are liquid-tightly sealed by the cap body 76 with the cap 172 positioned at the unopened initial position, and the convex portion 190 is the first. 1 is inserted into the deep groove 176.
  • the convex portion 190 rotates in the circumferential direction in the spiral groove 174 and is inserted into the second deep groove portion 178, and the plate-like piece 188. Returns to its original shape.
  • the cap 172 is displaced from the initial position to the stirring position, and the preparation distribution port 60 is opened in a state where the preparation discharge port 28 is liquid-tightly sealed to the cap body 76.
  • the cap 172 is further rotated in the direction of arrow R. Then, the inclined surface 192 rides on the edge of the second deep groove portion 178, the plate-like portion is elastically deformed, and the convex portion 190 comes out of the second deep groove portion 178.
  • the convex portion 190 is inserted into the shallow groove portion 180 and the screwing of the male screw portion 98 and the female screw portion 30 is released.
  • the subsequent procedure is the same as that of the prefilled syringe 10A of the first embodiment described above.
  • the convex portion 190 when the cap 172 is displaced from the initial position to the stirring position, the convex portion 190 can be guided from the first deep groove portion 176 to the second deep groove portion 178 by the spiral groove 174. Thereby, the convex part 190 can be reliably inserted into the second deep groove part 178.
  • the prefilled syringe 10B is not limited to the configuration described above.
  • an inclined surface that is inclined radially outward toward the arrow R direction is formed at the edge of the first deep groove 176, and the diameter of the edge of the second deep groove 178 is increased toward the arrow R.
  • An inclined surface inclined outward in the direction may be formed.
  • the inclined surface 192 of the convex portion 190 may be omitted.
  • the prefilled syringe according to the present invention is not limited to the above-described embodiment, and various configurations can be adopted without departing from the gist of the present invention.

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

Cette seringue pré-remplie (10A) comprend un cylindre de seringue (12), un piston (14) et un capuchon (16). Le piston (14) a un cylindre de piston (44), qui a un orifice d'écoulement de formulation (60) formé sur une extrémité distale de celui-ci, et un corps de piston (46). Une formulation (F) est stockée dans un espace de stockage (S) entouré par le capuchon (16), le cylindre de piston (44) et un joint d'étanchéité (68). En pressant une partie de pression (72) d'une partie tige (70) de manière distale, la formulation passe à travers l'orifice d'écoulement de formulation (60) à partir de l'espace de stockage (S) et s'écoule dans le cylindre de seringue (12), et le cylindre de piston (44) coulisse de manière proximale par rapport au cylindre de seringue (12).
PCT/JP2017/035506 2016-09-30 2017-09-29 Seringue pré-remplie et seringue WO2018062496A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2018542937A JP6895446B2 (ja) 2016-09-30 2017-09-29 プレフィルドシリンジ及びシリンジ

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JP2016194314 2016-09-30
JP2016-194314 2016-09-30

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Publication Number Publication Date
WO2018062496A1 true WO2018062496A1 (fr) 2018-04-05

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JP (1) JP6895446B2 (fr)
WO (1) WO2018062496A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5898932U (ja) * 1981-12-28 1983-07-05 市川　今朝登 注射筒
JP2008544821A (ja) * 2005-06-30 2008-12-11 マリンクロッド・インコーポレイテッド 二重チャンバシリンジ
JP2014028041A (ja) * 2012-07-31 2014-02-13 Yoshino Kogyosho Co Ltd 混合噴出器
WO2015038281A1 (fr) * 2013-09-16 2015-03-19 Zoetis Llc Assemblage pour distribution séquentielle de substances, et méthodes associées

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5898932U (ja) * 1981-12-28 1983-07-05 市川　今朝登 注射筒
JP2008544821A (ja) * 2005-06-30 2008-12-11 マリンクロッド・インコーポレイテッド 二重チャンバシリンジ
JP2014028041A (ja) * 2012-07-31 2014-02-13 Yoshino Kogyosho Co Ltd 混合噴出器
WO2015038281A1 (fr) * 2013-09-16 2015-03-19 Zoetis Llc Assemblage pour distribution séquentielle de substances, et méthodes associées

Also Published As

Publication number Publication date
JPWO2018062496A1 (ja) 2019-07-11
JP6895446B2 (ja) 2021-06-30

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