WO2019189278A1 - Ensemble cylindre de seringue, emballage et seringue pré-remplie - Google Patents

Ensemble cylindre de seringue, emballage et seringue pré-remplie Download PDF

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Publication number
WO2019189278A1
WO2019189278A1 PCT/JP2019/013040 JP2019013040W WO2019189278A1 WO 2019189278 A1 WO2019189278 A1 WO 2019189278A1 JP 2019013040 W JP2019013040 W JP 2019013040W WO 2019189278 A1 WO2019189278 A1 WO 2019189278A1
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WO
WIPO (PCT)
Prior art keywords
barrel
syringe
needle
covering film
barrel assembly
Prior art date
Application number
PCT/JP2019/013040
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English (en)
Japanese (ja)
Inventor
滋晃 冨家
Original Assignee
テルモ株式会社
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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 WO2019189278A1 publication Critical patent/WO2019189278A1/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06Ampoules or carpules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/28Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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

Definitions

  • the present invention relates to a syringe barrel assembly equipped with a needle cap, a prefilled syringe using a syringe barrel assembly equipped with a needle cap, and a package containing a plurality of syringe barrel assemblies.
  • a syringe with a puncture needle fixed to the barrel tip is used as a small amount of syringe for drug administration such as an insulin syringe.
  • drug administration such as an insulin syringe.
  • Such a type of syringe is used as a prefilled syringe with a needle cap and filled with a medicine.
  • Patent Document 1 the applicant of the present application has proposed one shown in WO2014 / 141471 (Patent Document 1).
  • Patent Document 2 a special table 2017-538463 (Patent Document 2) has been proposed.
  • the syringe of Patent Document 2 has a longitudinal main body (2, 28, 29) having an interior (22, 228, 229) in which a pharmaceutical substance is disposed, and one longitudinal end of the main body (2, 28, 29). It has a connected needle and a hard needle shield (3, 38, 39) that encloses the needle, and the hard needle shield (3, 38, 39) is waterproof and steam-proof. Further, the hard needle shield (3, 38, 39) is provided with a waterproof vapor-resistant coating (338, 339, 349).
  • the hard needle shield (3, 38, 39) is provided with a waterproof vapor-resistant coating (338, 339, 349), but the heel coating (338, 339, 349) is formed of wax. In the same manner as in Patent Document 1, it cannot be confirmed whether or not it has been recapped.
  • an object of the present invention is a syringe barrel assembly to which a needle cap is attached, and after the needle cap has been removed, it can be easily confirmed that it has been attached again,
  • the present invention provides a prefilled syringe using a syringe barrel assembly and a package in which a plurality of syringe barrel assemblies are stored.
  • a barrel main body having a barrel portion that can be filled with a chemical solution, a needle fixing portion that protrudes from the tip of the barrel portion and has a smaller diameter than the barrel portion, and a puncture needle that is fixed to the needle fixing portion of the barrel main body
  • a barrel assembly for a syringe comprising: a barrel comprising: a needle cap that is attached to the needle fixing portion of the barrel and seals a needle tip of the puncture needle;
  • the barrel assembly includes an annular gap formed between a proximal end of the needle cap and the distal end of the barrel portion of the barrel body, and at least the barrel of the barrel body from the proximal end portion of the needle cap.
  • a heat-shrinkable tubular covering film provided to cover up to the tip of the part,
  • the cylindrical covering film includes a first part covering the needle cap side, a second part covering the barrel part side of the barrel main body, the first part, and the second part. And an annular recess recessed to enter into the annular gap,
  • the said annular recessed part is a barrel assembly for syringes formed by the heat shrink of the said cylindrical coating film.
  • a syringe barrel assembly as described above a gasket housed in the barrel and capable of liquid-tight sliding in the barrel, and a medicine filled in a space formed by the barrel and the gasket. Prefilled syringe provided.
  • a syringe barrel assembly package comprising the plurality of syringe barrel assemblies and a sheet-like lid member that hermetically seals an upper surface opening of the container body and is peelable.
  • FIG. 1 is a front view of a barrel assembly for a syringe according to an embodiment of the present invention.
  • 2 is a cross-sectional view taken along line AA in FIG.
  • FIG. 3 is a front view of a barrel assembly for a syringe according to another embodiment of the present invention.
  • FIG. 4 is a front view of a syringe barrel assembly according to another embodiment of the present invention.
  • FIG. 5 is a front view of a barrel assembly for a syringe according to another embodiment of the present invention.
  • FIG. 6 is a front view of a syringe barrel assembly according to another embodiment of the present invention.
  • FIG. 7 is a front view of a syringe barrel assembly according to another embodiment of the present invention.
  • FIG. 8 is a front view of a barrel assembly for a syringe according to another embodiment of the present invention.
  • FIG. 9 is an explanatory view for explaining the operation of the syringe barrel assembly of the embodiment shown in FIG.
  • FIG. 10 is an explanatory view for explaining the operation of the syringe barrel assembly of the embodiment shown in FIG.
  • FIG. 11 is a front view of a prefilled syringe using the syringe barrel assembly shown in FIG. 1.
  • FIG. 12 is a reference front view of the prefilled syringe shown in FIG. 13 is a cross-sectional view taken along line BB in FIG.
  • FIG. 14 is a front view of a syringe barrel assembly according to another embodiment of the present invention.
  • FIG. 9 is an explanatory view for explaining the operation of the syringe barrel assembly of the embodiment shown in FIG.
  • FIG. 10 is an explanatory view for explaining the operation of the syringe barrel assembly of the embodiment
  • FIG. 15 is an explanatory diagram for explaining the operation of the syringe barrel assembly of the embodiment shown in FIG.
  • FIG. 16 is a front view of a syringe barrel assembly according to another embodiment of the present invention.
  • FIG. 17 is an explanatory diagram for explaining the operation of the syringe barrel assembly of the embodiment shown in FIG. 16.
  • FIG. 18 is a front view of a syringe barrel assembly according to another embodiment of the present invention.
  • FIG. 19 is an explanatory view for explaining the operation of the syringe barrel assembly of the embodiment shown in FIG.
  • FIG. 20 is a front view of a syringe barrel assembly according to another embodiment of the present invention.
  • FIG. 21 is an explanatory diagram for explaining the operation of the syringe barrel assembly of the embodiment shown in FIG. 20.
  • FIG. 22 is a front view of a prefilled syringe using the syringe barrel assembly shown in FIG.
  • FIG. 23 is a perspective view of the package of the present invention.
  • FIG. 24 is an explanatory diagram for explaining the internal form of the package shown in FIG. 23.
  • FIG. 25 is a front view of the package shown in FIG. 26 is a plan view of the package shown in FIG. 27 is an enlarged sectional view taken along the line CC of FIG.
  • the barrel assembly 1 for a syringe of the present invention includes a barrel body 20 having a barrel portion 21 that can be filled with a chemical solution, and a needle fixing portion 22 that protrudes from the tip of the barrel portion 21 and has a smaller diameter than the barrel portion 21.
  • a barrel 2 having a puncture needle 6 fixed to the needle fixing portion 22 of the barrel main body 20 and a needle cap 3 attached to the needle fixing portion 22 of the barrel main body 20 and sealing the needle tip of the puncture needle 6 are provided. .
  • the barrel assembly 1 includes an annular gap 15 formed between the proximal end of the needle cap 3 and the distal end of the barrel 21 of the barrel main body 20, and at least the proximal end of the needle cap 3 to the barrel main body 20.
  • a heat-shrinkable tubular covering film 4 provided so as to cover the tip of the body portion 21.
  • the cylindrical covering film 4 includes a first part (cap side covering part) 41 covering the needle cap side, a second part (body side covering part) 42 covering the barrel part side of the barrel body, and a first part. 1 part 41 and the 2nd part 42 are connected, and the annular recessed part 43 dented so that it may enter in an annular space part is provided.
  • the annular recess 43 is formed by heat shrinkage of the cylindrical covering film.
  • the barrel assembly for syringes (in other words, the barrel with a puncture needle to which the cap is attached) 1 of the present invention includes a barrel 2 and a cap 3 attached to the barrel 2 as shown in FIGS. , And a cylindrical covering film 4 that covers the cap 3 and the barrel 2.
  • the syringe barrel assembly 1 includes a barrel body 20, a barrel 2 including a puncture needle 6 fixed to a distal end portion of the barrel body 20, and a barrel 2.
  • a needle cap 3 attached to the tip.
  • the syringe barrel assembly 1 includes an annular gap 15 formed between the proximal end of the needle cap 3 and the barrel body, and a cylindrical covering film 4 provided so as to cover the annular gap 15.
  • the cylindrical covering film 4 includes a first portion 41, a second portion 42, an annular recess 43 positioned on the annular gap 15, and the cylindrical covering film 4 on the cap side (first portion) and the body.
  • An annular breakable portion 44 is provided for separation on the part side (second portion).
  • the barrel 2 has a barrel 21 that can be filled with a chemical solution, and a barrel body that protrudes from the tip of the barrel 21 and has a needle fixing portion 22 that is smaller in diameter than the barrel 21.
  • 20 and a puncture needle 6 having a puncture needle tip 61 at the distal end and having a proximal end portion inserted and fixed to the needle fixing portion 22.
  • the puncture needle 6 has a puncture needle tip 61 at the tip.
  • the proximal end portion of the puncture needle 6 is inserted and fixed in the hollow portion of the needle fixing portion 22, and the inside of the puncture needle 6 communicates with the internal space of the barrel body 20.
  • the puncture needle 6 may be inserted into a hollow portion of the needle fixing portion 22 of the barrel body 20 molded in advance and fixed to the needle fixing portion 22 by an adhesive, heat welding, or the like. Alternatively, the puncture needle 6 may be fixed directly to the barrel body 20 by insert molding.
  • the needle fixing portion 22 has a cylindrical shape (hollow shape) into which the puncture needle 6 is inserted, and the puncture needle 6 has a proximal end portion of the needle fixing portion 22. It is inserted into the hollow part and fixed.
  • the barrel body 20 is transparent or translucent.
  • the barrel portion 21 of the barrel main body 20 is a substantially cylindrical (specifically, cylindrical) portion that accommodates the gasket 11 in a liquid-tight and slidable manner.
  • the needle fixing portion 22 protrudes forward from the distal end portion (shoulder portion) of the barrel main body and has a hollow cylindrical shape having a smaller diameter than the body portion 21.
  • Examples of the material for forming the barrel body 20 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate.
  • Various resins such as polyesters, cyclic olefin polymers, cyclic olefin copolymers, etc. are mentioned.
  • polypropylene and cyclic polyolefins are easy to mold and heat resistant. preferable.
  • a hollow one having a puncture needle tip 61 at the tip is used.
  • a metal is generally used. Stainless steel is preferred as the metal.
  • the needle cap 3 of this embodiment is housed in a closed distal end portion, an opening proximal end portion, a hollow portion having a puncture needle housing portion for housing a puncture needle, and a puncture needle housing portion. It comprises an elastic cap 7 having a pierceable portion into which a puncture needle tip of the puncture needle can be inserted, and a cylindrical cover member 8 mounted on the outside of the elastic cap 7.
  • the elastic cap 7 includes a closed distal end portion, an opening proximal end portion, a hollow portion having a puncture needle storage portion for storing the puncture needle 6, and a puncture needle 6 stored in the puncture needle storage portion.
  • the puncture needle tip 61 can be inserted and a sealable portion that seals the puncture needle storage portion by being in close contact with the needle fixing portion.
  • the elastic cap 7 is provided with the flange extended in a base end direction from the cylindrical main-body part and its base end. Then, by attaching the elastic cap 7 to the needle fixing portion 22 of the barrel 2, the puncture needle tip 61 is inserted into the insertable portion 73 of the elastic cap 7 and sealed.
  • the elastic cap 7 is made of an elastic material.
  • a material for forming the elastic cap 7 at least the pierceable portion 73 needs to be formed of an elastic material into which the needle tip portion of the puncture needle 6 can be inserted.
  • the elastic material into which the puncture needle can be inserted thermoplastic elastomers, for example, styrene elastomers such as SBS elastomer and SEBS elastomer, and olefin elastomers such as ethylene- ⁇ olefin copolymer elastomer are preferable.
  • the elastic material may be rubber such as butyl rubber, isoprene rubber, or silicone rubber.
  • the cylindrical cover member 8 is made of a thermoplastic material that is harder than the elastic cap 7. As shown in FIG. 2, the cylindrical cover member 8 is a cylindrical body having an elastic cap storage portion inside.
  • the cylindrical cover member 8 of this embodiment includes a side surface covering portion that covers the side surface of the elastic cap 7 and a front end covering portion that covers the closed front end portion of the elastic cap 7.
  • the needle cap 3 includes a protruding portion 33 provided on the outer surface, and the cylindrical covering film 4 covers the protruding portion 33 of the needle cap.
  • the needle cap 3 includes a recess or opening 32 provided on the outer surface, and the tubular covering film 4 covers the recess or opening 32 of the needle cap.
  • the cylindrical cover member 8 includes a plurality of projecting portions 33 and openings 32 formed on the outer surface of the side surface covering portion.
  • the cylindrical covering film 4 covers the portion where the protrusion 33 and the opening 32 are provided. For this reason, the cylindrical covering film 4 is provided with unevenness, which functions as a stopper.
  • the cylindrical cover member 8 of this embodiment includes a plurality of internal protrusions 83 provided on the inner surface of the base end portion.
  • the cylindrical cover member 8 extends obliquely from the inside of the base end portion (substantially the base end) of the cylindrical cover member 8 toward the central axis direction and the distal end direction of the cylindrical cover member 8.
  • a plurality of elastically deformable internal protrusions 83 having free ends at positions that do not reach the center are provided. And the free end of each internal protrusion part 83 can contact
  • a material harder than the forming material of the elastic cap 7 is used.
  • the forming material include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate, Various resins such as cyclic polyolefin may be mentioned.
  • the barrel assembly 1 for syringes of this invention is equipped with the cyclic
  • the barrel body 20 includes a tapered portion that extends from the body portion 21 while reducing the diameter in the distal direction. Further, the proximal end of the needle cap 3 does not house the tapered portion. For this reason, the distal end of the barrel 21 of the barrel body 20 and the proximal end of the needle cap 3 are slightly separated from each other, and an annular gap 15 is formed between the distal end of the barrel 21 of the barrel body 20 and the proximal end of the needle cap 3. Is formed.
  • the barrel assembly 1 for syringes of this Example is provided with the cylindrical coating
  • the cylindrical covering film 4 connects the first portion 41 that covers the needle cap 3, the second portion 42 that covers the barrel portion 21 of the barrel body, and the first portion 41 and the second portion 42.
  • an annular recess 43 that is recessed so as to enter the annular gap.
  • the annular recess 43 is formed by heat shrinkage of the cylindrical covering film.
  • the annular recess 43 functions as a stopper for the tubular covering film 4 from the barrel fitted with the cap.
  • the cylindrical covering film 4 is composed of a plurality of intermittently formed cuts, and a first portion (first portion) 41 covering the needle cap side and the barrel side of the barrel 2 And a second portion 42 for covering the cover film 4 have an annular breakable portion 44 for separating the cover film 4.
  • the breakable portion 44 is provided at a position close to the annular recess 43 or the annular recess 43 of the coating film 4.
  • the first portion 41 of the tubular covering film 4 covers almost the entire needle cap 3.
  • the first portion 41 of the cylindrical covering film 4 covers the protrusion 33 and the opening 32 formed on the outer surface of the needle cap 3 (specifically, the cylindrical cover member 8), Concavities and convexities are provided, and these also function as a stopper from the barrel to which the needle cap 3 of the cylindrical covering film 4 is attached. Further, the first portion 41 is also prevented from being detached from the needle cap 3 after the needle cap 3 is detached from the syringe barrel assembly 1.
  • the base end of the second portion 42 of the cylindrical covering film 4 is located on the base end side of a predetermined length from the tip of the cylindrical portion of the barrel body 20.
  • the distance from the annular recess 43 to the lower end of the second portion 42 varies depending on the size of the syringe barrel assembly 1, but is preferably 2 mm or more, and particularly preferably 10 to 30 mm.
  • the constituent material of the cylindrical covering film 4 it is preferable to use a material having heat shrinkability.
  • a material having heat shrinkability examples include polyesters such as polyvinyl chloride, polystyrene, polyethylene terephthalate and polybutylene terephthalate, polyolefins such as polyethylene and polypropylene, and polymer alloys containing these.
  • the cylindrical covering film 4 may be a stretched film formed of the above material.
  • the annular recess 43 can be easily formed in the cylindrical covering film 4. Further, when the film 4 is thermally contracted, the film 4 is deformed along the outer surface shape of the needle cap 3 (specifically, the cylindrical cover member 8), and thus is in close contact with these members. This prevents the needle cap 3 from being detached due to unintentional rotation.
  • the shrinkage rate (inner diameter shrinkage rate) of the cylindrical covering film 4 is preferably 5 to 10%.
  • the film 4 may be a single layer or a laminate of a plurality of layers.
  • the tubular covering film 4 includes an annular breakable portion 44 for separating the tubular covering film 4 into a cap side and a barrel side.
  • the tubular covering film 4 is broken at the annular breakable portion 44, so that the detachment operation is not hindered.
  • the needle cap 3 is gripped from the first portion 41 and slightly rotated while the second portion 42 is held with one hand. By pulling out, the cylindrical covering film 4 is separated at the annular breakable portion 44, and the needle cap 3 fitted with the first portion 41 is detached from the barrel 2.
  • the annular breakable portion 44 is intermittently formed by a plurality of cuts formed in an annular shape.
  • the annular breakable portion 44 of this embodiment is a linear one that is substantially orthogonal to the central axis of the syringe barrel assembly 1.
  • the annular breakable portion 44 may have a wavy shape or a wave shape (for example, a sine wave shape, a sawtooth wave shape, a triangular wave shape, a trapezoidal wave shape, or a rectangular wave shape).
  • the annular breakable portion 44 is formed of a so-called perforation.
  • the breaking portion 44 is formed in a straight line by a plurality of cut lines. In the drawing, each cut line has the same length and width (thickness), but may be different. Between each incision line, when the cap 3 is opened, an expected breakage part (non-incision part) having a length that breaks so that adjacent incision lines are connected is formed.
  • the annular breakable portion 44 is provided on the proximal end side from the annular recess 43. Specifically, the annular breakable portion 44 is provided in the second portion 42. In particular, in this embodiment, the annular breakable portion 44 is provided in the second portion 42 that is close to the annular recess 43 and located near the distal end portion of the barrel portion 21 of the barrel body 20.
  • the covering film may be provided with a deformation promoting cut 45 extending from the breakable portion 44 in the distal direction or the proximal direction.
  • the syringe barrel assembly 1a shown in FIG. 3 may be provided as the annular breakable portion.
  • the breakable portion includes an annular breakable portion 44a and a plurality of deformation promoting cuts extending from the annular breakable portion 44a in the axial direction and the distal end direction of the syringe barrel assembly 1a.
  • (Axial cut) 45 is provided.
  • the cut 45 extends substantially parallel to the central axis of the syringe barrel assembly 1a and extends in the distal direction.
  • the form of the annular breakable portion 44a is the same as that of the above-described annular breakable portion 44, and the arrangement position is substantially the same.
  • the tip side remains from the annular breakable portion 44a of the covering film including the annular recess 43 on the needle cap side. Furthermore, the broken end portion of the covering film 4a is broken by the deformation promoting cut 45, and it is very easy to recognize the existence of the breaking end portion of the covering film.
  • the deformation promoting cut 45 is not limited to the one parallel to the central axis of the syringe barrel assembly 1a as in the embodiment shown in FIG.
  • the syringe barrel assembly 1b shown in FIG. 4 may be provided.
  • the breakable portion includes an annular breakable portion 44b and a plurality of deformation-promoting cuts 45a extending obliquely in the axial direction of the syringe barrel assembly 1b from the annular breakable portion 44b. It has.
  • annular breakable portion 44b is the same as the annular breakable portion 44 described above, and the arrangement position is substantially the same. Further, the deformation promoting cut may be provided with both of the one parallel to the central axis of the syringe barrel assembly and the one extending obliquely with respect to the central axis.
  • the position of the annular breakable portion may be the position shown in the syringe barrel assembly 1c shown in FIG.
  • the breakable portion 44c is provided in the annular recess 43. Specifically, it is provided in the small diameter part (valley part) of the annular recess 43.
  • the form of the annular breakable portion 44c is the same as the annular breakable portion 44 described above.
  • the syringe barrel assembly 1c of this embodiment also includes a plurality of deformation promoting cuts 45 extending in the distal direction as provided in the syringe barrel assembly 1a, and the syringe barrel assembly 1b.
  • a plurality of deformation promoting cuts 45a extending in the distal direction as provided, and further, as deformation promoting cuts, extending in the distal direction parallel to the central axis of the syringe barrel assembly; It is also possible to provide both of them that extend obliquely in the distal direction.
  • the position of the annular breakable portion may be the position shown in the syringe barrel assembly 1d shown in FIG.
  • the breakable portion 44d is provided on the tip side from the annular recess 43.
  • the annular breakable portion 44 d is provided in the first portion 41.
  • the annular breakable portion 44 d is provided in the first portion 41 located near the annular recess 43 and located at the proximal end portion of the needle cap 3.
  • the form of the annular breakable portion 44d is the same as the annular breakable portion 44 described above.
  • the syringe barrel assembly 1e shown in FIG. 7 may be provided.
  • the basic configuration of the syringe barrel assembly 1e of this embodiment is the same as the syringe barrel assembly 1d shown in FIG. The difference is that in the tubular covering film 4e of this embodiment, the breakable portion includes a plurality of deformation promoting cuts 45b extending from the annular breakable portion 44e in the axial direction and the proximal direction of the syringe barrel assembly 1e. It is only a point to prepare.
  • the cut 45b extends substantially parallel to the central axis of the syringe barrel assembly 1e and extends in the proximal direction.
  • the form of the annular breakable portion 44e is the same as the annular breakable portion 44 described above.
  • the deformation promoting cut may extend from the annular breakable portion 44e in a base end direction and obliquely with respect to the axial direction of the syringe barrel assembly 1e. Further, the deformation promoting cut may be provided with both a parallel to the central axis of the syringe barrel assembly and an extension extending obliquely with respect to the central axis.
  • the form of the cylindrical covering film may be such that the syringe barrel assembly 1f of the embodiment shown in FIG. 8 is provided.
  • the cylindrical covering film 4f does not cover the entire needle cap 3.
  • the first portion 41 a of the cylindrical covering film 4 f covers a portion on the distal end side of a predetermined length from the proximal end of the needle cap 3.
  • the tip of the first portion 41 a is located between the lower end and the tip of the needle cap 3.
  • the distal end of the first portion 41 a is located on the lower end side from the central portion in the axial direction of the needle cap 3.
  • the breakable portion 44f of the syringe barrel assembly 1f of this embodiment the form of the breakable portion of all the embodiments described above can be used.
  • the prefilled syringe 10 of the present invention As shown in FIGS. 11 to 13, the prefilled syringe 10 of the present invention is housed in the above-described syringe barrel assembly 1 of the present invention and the barrel assembly 1 for syringes, and in the barrel assembly 1 for syringes. And a medicine 11 filled in a space formed by the syringe barrel assembly 1 and the gasket 11.
  • the syringe barrel assembly in the embodiment used for the prefilled syringe 10 includes a display label 5 attached to the outer surface of the barrel 2, and the tip portion of the display label 5 is an annular shape of the cylindrical covering film 4. It is located on the base end side from the breakable portion 44 and is fixed on the base end portion of the tubular covering film 4. Further, the puncture needle tip 61 of the puncture needle 6 is sealed with the needle cap 3.
  • the prefilled syringe 10 includes a plunger 9 attached to the gasket 11 or attached at the time of use.
  • the syringe barrel assembly 1 the syringe barrel assemblies of all the embodiments described above can be used.
  • the drug 12 is filled in a space formed by the barrel 2, the gasket 11, and the needle cap 3.
  • the medicine 12 to be filled may be any type, for example, high-concentration sodium chloride injection, minerals, heparin sodium aqueous solution, nitroglycerin, isosorbide nitrate, cyclosporine, benzodiazepines, antibiotics, vitamins ( Multivitamin preparations), various amino acids, antithrombotic agents such as heparin, insulin, antitumor agents, analgesics, cardiotonic agents, intravenous anesthetics, antiparkinson agents, ulcer treatment agents, corticosteroid agents, arrhythmia agents, correction Any electrolyte, antiviral agent, immunostimulant, etc. may be used.
  • the gasket 11 includes a main body portion extending at substantially the same outer diameter, and a plurality of annular ribs provided in the main body portion (in this embodiment, if two, two or more, As long as the liquid-tightness and slidability can be satisfied, the number may be appropriately set.) These ribs are in liquid-tight contact with the inner surface of the barrel 2. Further, the front end surface of the gasket 11 has a shape corresponding to the inner surface shape of the front end of the barrel 2 so that a gap is not formed as much as possible when the front end surface is in contact with the inner front end of the barrel 2.
  • the material for forming the gasket 11 includes elastic rubber (for example, isoprene rubber, butyl rubber, latex rubber, silicone rubber), synthetic resin (for example, styrene elastomer such as SBS elastomer and SEBS elastomer, ethylene- ⁇ olefin copolymer) It is preferable to use an olefin-based elastomer such as a combined elastomer.
  • the gasket 11 is provided with a recess extending inwardly from the base end portion, and this recess has a female thread shape, and is a male screw formed on the outer surface of the protruding portion 93 formed at the distal end portion of the plunger 9. It can be screwed to the part.
  • the plunger 9 is not detached from the gasket 11 by screwing them together.
  • the plunger 9 may be removed and attached at the time of use.
  • the plunger 9 includes a protruding portion 93 that protrudes in a cylindrical shape in front of the disk portion at the tip, and a male screw that is screwed into the concave portion of the gasket 11 is formed on the outer surface of the protruding portion.
  • the plunger 9 includes a main body portion 91 extending in the axial direction having a cross-shaped cross section, and a pressing disc portion 92 provided at the base end portion.
  • the prefilled syringe 10 includes a display label 5 attached to a barrel.
  • the display label 5 is attached to the outer surface of the barrel main body 20 of the barrel 2.
  • the display label 5 is preferably one that does not hinder the visibility of a scale display portion (not shown) attached to the surface of the barrel body 20.
  • the front end side of the display label 5 is located in the base end side from the cyclic
  • the prefilled syringe 10 includes an overlapping portion 52 in which the cylindrical covering film 4 and the display label 5 overlap each other.
  • the label main body 51 on the proximal end side with respect to the overlapping portion 52 is fixed to the outer surface of the cylindrical body portion 21 of the barrel main body 20 of the barrel 2.
  • the cylindrical covering film 4 is indirectly fixed to the barrel 2 by the overlapping portion 52 of the display label 5. For this reason, when the needle cap 3 is removed, the tubular covering film 4 is prevented from being detached from the barrel together with the needle cap 3 without breaking. Moreover, the breaking operation of the cylindrical covering film 4 is also easy.
  • the display label 5 is stuck to the barrel so as not to be peeled off, and a printing portion on which stored medicine related information is printed is provided on the surface.
  • stored medicine related information for example, a medicine name, concentration, filling amount, and the like are described. Specifically, “XX (drug name) ⁇ % injection syringe”, "XX (drug name) solution ⁇ % injection syringe”, “XX (drug name) ⁇ % injection syringe ⁇ ml” , “XX (drug name) solution ⁇ % injection syringe ⁇ ml” and the like are printed.
  • a syringe barrel assembly according to another embodiment of the present invention will be described with reference to FIG.
  • the difference between the syringe barrel assembly 100 of this embodiment and the syringe barrel assembly 1 described above is only in the form of a cylindrical covering film, and the barrel 2 and the needle cap 3 are the same as those described above. .
  • the barrel assembly for syringes (in other words, barrel with a puncture needle to which a cap is attached) 100 of this embodiment, as shown in FIG. 14, the barrel 2, the cap 3 attached to the barrel 2, and the cap 3 And a cylindrical covering film 104 for covering the barrel 2.
  • the cylindrical covering film 104 connects the first portion 41 that covers the needle cap side, the second portion 142 that covers the barrel side of the barrel body, and the first portion 41 and the second portion 142. And an annular recess 43 that is recessed so as to enter the annular gap 15.
  • the annular recess 43 is formed by heat shrinkage of the cylindrical covering film.
  • cylindrical covering film 104 of this embodiment does not have the annular breakable portion 44 provided in the above-described cylindrical covering film 4. For this reason, when the needle cap 3 is detached, the entire tubular covering film 104 is detached from the barrel 2 together with the needle cap 3.
  • the annular recess 43 or the vicinity of the annular recess 43 is deformed, specifically, wrinkles and twists are formed. Has become.
  • the needle cap is remounted (recap)
  • the presence of the annular recess 43 of the cylindrical covering film 104 mounted on the needle cap 3 and the second portion extending from the annular recess 43 ( The cylindrical portion 142) extending for a predetermined length can be easily visually recognized, and the recapping is repelled, and they become an obstacle to recapping.
  • the second portion 142 is shorter in the axial direction than the second portion 42 of the tubular covering film 4, so that the barrel body 20 can be easily detached from the body portion 21. It is supposed to be.
  • the matters other than the above of the cylindrical covering film 104 are the same as those of the cylindrical covering film 4 described above.
  • a coating film when a coating film is removed from the barrel 2 with the needle cap 3, it may deform
  • the base end of the second portion 142 may come into contact with the barrel and be deformed when reattached to the barrel.
  • the deformation promoting cut 145 extending in the distal direction from the base end of the covering film 114 (the base end of the second portion 142). May be provided.
  • the syringe barrel assembly 110 shown in FIG. 16 may be provided.
  • a plurality of deformation promoting portions extending in parallel to the central axis of the barrel from the base end of the covering film 114 (the base end of the second portion 142) to the distal end and in the vicinity of the annular recess 43 A notch 145 is provided.
  • the tubular covering film 124 of this embodiment includes a plurality of deformation promoting cuts 147 extending from the base end of the covering film 124 (the base end of the second portion 142) in the distal direction and obliquely with respect to the central axis of the barrel. ing.
  • the base end portion 148 of the covering film 124 is deformed. Such deformation of the base end portion 148 of the covering film 124 causes the recapping to occur, and they become an obstacle to recapping. Further, when recapped, the base end portion 148 of the covering film 124 is further deformed, so that it is easy to recognize that it has been recapped.
  • the base end 149 of the covering film 134 may be non-linear like the covering film 134 provided in the syringe barrel assembly 130 of the embodiment shown in FIG.
  • a wave shape as shown in FIG. 20 or a wave shape for example, a sine wave shape, a sawtooth wave shape, a triangular wave shape, a trapezoidal wave shape, a rectangular wave shape
  • a wave shape for example, a sine wave shape, a sawtooth wave shape, a triangular wave shape, a trapezoidal wave shape, a rectangular wave shape
  • the non-linear base end 149 of the covering film 134 is exposed at the end as shown in FIG.
  • the base end portion 149 of the covering film 134 having such a shape is sufficient for causing recapturing, and becomes an obstacle to recapping. Further, when recapped, the protruding portion of the base end portion 149 of the covering film 134 abuts on the barrel and deforms, so that it is easy to recognize that it has been recapped.
  • the cylindrical covering film may be provided in the syringe barrel assembly 1f of the embodiment shown in FIG.
  • the cylindrical covering film 4f does not cover the entire needle cap 3.
  • the first portion 41 a of the cylindrical covering film 4 f covers a portion on the distal end side of a predetermined length from the proximal end of the needle cap 3.
  • the tip of the first portion 41 a is located between the lower end and the tip of the needle cap 3.
  • the distal end of the first portion 41 a is located on the lower end side from the central portion in the axial direction of the needle cap 3.
  • the prefilled syringe 150 of the Example shown in FIG. 22 is demonstrated.
  • the prefilled syringe 150 of this embodiment is housed in the syringe barrel assembly 100 of the present invention described above and the syringe barrel assembly 100, and the syringe barrel assembly 100 is liquid-filled. It consists of a gasket 11 that can be slid closely, a syringe barrel assembly 100, and a medicine 12 filled in a space formed by the gasket 11.
  • the syringe barrel assembly 100 in the embodiment used for the prefilled syringe 150 includes a display label 105 attached to the outer surface of the barrel 2, and the tip of the display label 105 is attached to the cylindrical covering film 104. It is not fixed. For this reason, the display label 105 does not become an obstacle to the separation of the cylindrical covering film 104.
  • the distal end side of the display label 105 of this embodiment does not reach the proximal end of the cylindrical covering film 104, and no overlapping portion is formed.
  • the prefilled syringe 150 is the same as the prefilled syringe 10 described above except for the form of the tip of the label 105.
  • a cylindrical covering film it is not limited to the cylindrical covering film 104 mentioned above, The cylindrical covering films 114, 124, 134 mentioned above can be used.
  • the display label 105 is affixed to the barrel so that it cannot be peeled off, and a printing portion on which stored medicine related information is printed is provided on the surface.
  • stored medicine related information for example, a medicine name, concentration, filling amount, and the like are described. Specifically, "XX (drug name) ⁇ % injection syringe", "XX (drug name) solution ⁇ % injection syringe”, "XX (drug name) ⁇ % injection syringe ⁇ ml” , “XX (drug name) solution ⁇ % injection syringe ⁇ ml” and the like are printed.
  • a syringe barrel assembly package 200 containing a plurality of syringe barrel assemblies according to the present invention has a container body 202 having an open top surface and shape retention, and a plurality of syringes housed in the container body 202.
  • a lid member 203 a lid member 203.
  • the packaging body 200 of the present invention is held by a container body 202, a barrel holding member 204 that can hold a plurality of syringe barrel assemblies 1, and a barrel holding member 204.
  • the container body 202 has a tray-like shape having a predetermined depth having a certain degree of strength and shape retention, and is provided at the upper part of the main body 221 and the main body 221.
  • a barrel holding member holding portion 226 that is formed and holds the peripheral edge portion of the barrel holding member 204 that holds the plurality of barrel assemblies 1 for syringes, and an annular flange 224 provided in the upper surface opening.
  • annular flange 224 Furthermore, on the upper surface of the annular flange 224, an annular heat seal convex portion 225 for fixing to the sheet-like lid member 203 is provided. And the barrel holding member holding
  • the container body 202 has a certain degree of shape retention and rigidity.
  • the material for forming the container body 202 include polyolefin such as polypropylene and polyethylene, vinyl chloride resin, polystyrene / polypropylene resin, polyethylene / ionomer (for example, ethylene, styrene, fluorine) / polyethylene, polyester resin (for example, polyethylene) Terephthalate, polybutylene terephthalate, amorphous-polyethylene terephthalate), PP / EVOH / PP (laminate) and the like.
  • the thickness of the container body 202 is preferably about 0.05 to 4.00 mm, and more preferably 1.00 to 2.00 mm.
  • the barrel holding member 204 that can hold the plurality of syringe barrel assemblies 1 includes a substrate portion 241 and a plurality of cylindrical portions 242 that protrude above the substrate portion 241. ing.
  • a barrel holding opening 243 is formed in the cylindrical portion 242, and a gripping notch 244 is formed on the side of the substrate portion 241.
  • the inner diameters of the cylindrical portion 242 and the barrel holding opening 243 are larger than the outer diameter of the largest diameter portion of the syringe barrel assembly 1 to be held, and the syringe barrel assembly 1 to be held.
  • the flange portion 23 cannot pass through.
  • the syringe barrel assembly 1 penetrates the cylindrical portion 242 and the flange 23 of the syringe barrel assembly 1 is suspended by the barrel holding opening 243. It has become.
  • the lower end of the syringe barrel assembly 1 held by the barrel holding member 204 (the tip of the needle cap and the cylindrical covering film 4) does not come into contact with the bottom surface of the container body 202. ing. In other words, the bottom surface of the container body 202 and the lower end of the syringe barrel assembly 1 held by the barrel holding member 204 are separated from each other.
  • the sheet-like lid member 203 can be heat sealed to the container body 202.
  • a synthetic resin nonwoven fabric specifically, a nonwoven fabric made of a synthetic resin material such as polyolefin known as Tyvek (registered trademark), a synthetic resin porous membrane, or the like is suitable. Can be used.
  • the sheet-like cover member 203 is heat-sealed so that the peripheral part can be peeled off by the heat-sealing convex part 225 provided in the annular flange 224 of the container body 202.
  • the outer edge of the sheet-like lid member 203 is not heat-sealed to the annular flange 224 of the container body 202, and is easy to peel off.
  • angular part of the convex part 225 for heat seal functions as a peeling start part.
  • the sheet-like lid member 203 preferably has a thickness of about 0.05 to 1.00 mm, and more preferably about 0.10 to 0.50 mm.
  • the barrel assembly for a syringe of the present invention is as follows.
  • a barrel body that has a barrel portion that can be filled with a chemical solution, a needle fixing portion that protrudes from the tip of the barrel portion and has a smaller diameter than the barrel portion, and is fixed to the needle fixing portion of the barrel body.
  • a syringe barrel assembly comprising: a barrel provided with a puncture needle; and a needle cap attached to the needle fixing portion of the barrel and sealing a needle tip of the puncture needle,
  • the barrel assembly includes an annular gap formed between a proximal end of the needle cap and the distal end of the barrel portion of the barrel body, and at least the barrel of the barrel body from the proximal end portion of the needle cap.
  • a heat-shrinkable tubular covering film provided to cover up to the tip of the part,
  • the cylindrical covering film includes a first part covering the needle cap side, a second part covering the barrel part side of the barrel main body, the first part, and the second part. And an annular recess recessed to enter into the annular gap,
  • the said annular recessed part is a barrel assembly for syringes formed by the heat shrink of the said cylindrical coating film.
  • the barrel assembly for a syringe of the present invention includes a barrel body that can be filled with a chemical solution, a barrel body that protrudes from the distal end of the trunk portion, and a needle fixing portion that is smaller in diameter than the barrel portion, and a needle fixing portion of the barrel body And a needle cap that is attached to the needle fixing portion of the barrel and seals the needle tip of the puncture needle.
  • the barrel assembly includes an annular gap formed between the proximal end of the needle cap and the distal end of the barrel body, and at least from the proximal end of the needle cap to the distal end of the barrel body.
  • a heat-shrinkable cylindrical covering film provided so as to be covered.
  • the tubular covering film connects the first part covering the needle cap side, the second part covering the barrel part side of the barrel main body, the first part and the second part, and is annular. And an annular recess that is recessed so as to enter the gap.
  • the annular recess is formed by heat shrinkage of the cylindrical covering film.
  • the above embodiment may be as follows. (2) The barrel assembly for a syringe according to (1), wherein the cover film is deformed when the annular recess or the vicinity of the annular recess is deformed when removed from the barrel together with the needle cap. (3) The barrel assembly for a syringe according to (1), wherein the base film of the second portion is deformed when the covering film is removed from the barrel together with the needle cap. . (4) When the cover film is detached from the barrel together with the needle cap and then reattached to the barrel, the base end of the second portion comes into contact with the barrel and deforms. The barrel assembly for a syringe according to the above (1).
  • the covering film includes a plurality of intermittently formed incisions, and has an annular breakable portion for separating the covering film in the first portion and the second portion.
  • the barrel assembly for a syringe includes a display label attached to an outer surface of the barrel portion of the barrel, The syringe according to any one of (5) to (7), wherein a distal end portion of the display label is located on a proximal end side with respect to the breakable portion and is fixed on the proximal end portion of the covering film. Barrel assembly.
  • the needle cap includes a protrusion provided on an outer surface of the needle cap, and the covering film covers any one of the protrusions of the needle cap.
  • the needle cap includes a closed distal end portion, an opening proximal end portion, a hollow portion having a puncture needle storage portion for storing the puncture needle, and the needle of the puncture needle stored in the puncture needle storage portion
  • the prefilled syringe of the present invention is as follows. (11) The barrel assembly for a syringe according to any one of (1) to (10), a gasket that is housed in the barrel and is slidable in a liquid-tight manner in the barrel, the barrel, and the gasket A prefilled syringe provided with a medicine filled in the space formed by the above.
  • a prefilled syringe of the present invention includes the above barrel assembly for a syringe, a gasket that is housed in the barrel and is capable of sliding in a liquid-tight manner in the barrel, and a medicine filled in a space formed by the barrel and the gasket. Is provided. Also in this prefilled syringe, when the needle cap is removed from the barrel, the annular recess of the coating film remains on the needle cap side or the barrel side. For this reason, when the needle cap is reattached to the barrel, the shape of the annular recess of the covering film or the vicinity thereof is different from that before the needle shield is detached, so the fact that the needle cap has been once removed from the barrel is easy. Can be confirmed.
  • the package of the present invention is as follows. (12) A package containing a plurality of barrel assemblies for syringes according to any one of (1) to (10) above,
  • the packaging body has a container body having an open top surface and shape retention, a barrel holding member disposed in the container body and capable of holding the plurality of syringe barrel assemblies, and held by the barrel holding member.
  • a syringe barrel assembly package comprising the plurality of syringe barrel assemblies and a sheet-like lid member that hermetically seals an upper surface opening of the container body and is peelable.

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

Abstract

Un ensemble cylindre de seringue 1 est pourvu d'un cylindre 2 pourvu d'un corps de cylindre 20 et d'une aiguille de ponction 6 fixée à une partie d'extrémité distale du corps de cylindre 20, et d'un capuchon d'aiguille 3 monté sur une partie d'extrémité distale du cylindre. L'ensemble cylindre est pourvu d'une partie d'espace annulaire 15 formée entre le corps de cylindre et une partie d'extrémité proximale du capuchon d'aiguille, et d'un film de recouvrement cylindrique 4 disposé de façon à recouvrir la partie d'espace annulaire. Le film de revêtement cylindrique est pourvu d'une première partie 41 destinée à recouvrir un côté capuchon d'aiguille, d'une seconde partie 42 destinée à recouvrir un côté corps du cylindre, et d'un évidement annulaire 43 qui relie la première partie et la seconde partie et qui est en retrait de façon à entrer dans la partie d'espace annulaire.
PCT/JP2019/013040 2018-03-29 2019-03-26 Ensemble cylindre de seringue, emballage et seringue pré-remplie WO2019189278A1 (fr)

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JP2018066278 2018-03-29

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4374898A1 (fr) * 2022-11-23 2024-05-29 Becton Dickinson France Dispositif d'administration de médicament comprenant un adaptateur

Citations (8)

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Publication number Priority date Publication date Assignee Title
US5344404A (en) * 1993-08-13 1994-09-06 Becton, Dickinson And Company Syringe assembly having a non-resuable needle shield
JPH0852210A (ja) * 1994-08-11 1996-02-27 Fuji Seal Co Ltd 薬液入り注射器の包装体
JP2002541932A (ja) * 1999-04-14 2002-12-10 アムジェン インコーポレイテッド 不正取扱い証明付き注射器組立体
US20080202961A1 (en) * 2007-02-28 2008-08-28 Inviro Medical, Inc. Sterile packaging of medical devices with enhanced tamper evident, transportation, functional and disposal features
JP2011057247A (ja) * 2009-09-09 2011-03-24 Fuji Seal International Inc キャップシール包装体
JP2012510330A (ja) * 2008-12-02 2012-05-10 ベクトン ディキンソン フランス 改良型薬品容器
WO2014141470A1 (fr) * 2013-03-15 2014-09-18 テルモ株式会社 Ensemble seringue, emballage d'ensemble seringue, capuchon étanche pour cylindre externe et seringue pré-remplie
US20150217061A1 (en) * 2012-08-22 2015-08-06 Antares Pharma, Inc. Needle Shield

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5344404A (en) * 1993-08-13 1994-09-06 Becton, Dickinson And Company Syringe assembly having a non-resuable needle shield
JPH0852210A (ja) * 1994-08-11 1996-02-27 Fuji Seal Co Ltd 薬液入り注射器の包装体
JP2002541932A (ja) * 1999-04-14 2002-12-10 アムジェン インコーポレイテッド 不正取扱い証明付き注射器組立体
US20080202961A1 (en) * 2007-02-28 2008-08-28 Inviro Medical, Inc. Sterile packaging of medical devices with enhanced tamper evident, transportation, functional and disposal features
JP2012510330A (ja) * 2008-12-02 2012-05-10 ベクトン ディキンソン フランス 改良型薬品容器
JP2011057247A (ja) * 2009-09-09 2011-03-24 Fuji Seal International Inc キャップシール包装体
US20150217061A1 (en) * 2012-08-22 2015-08-06 Antares Pharma, Inc. Needle Shield
WO2014141470A1 (fr) * 2013-03-15 2014-09-18 テルモ株式会社 Ensemble seringue, emballage d'ensemble seringue, capuchon étanche pour cylindre externe et seringue pré-remplie

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4374898A1 (fr) * 2022-11-23 2024-05-29 Becton Dickinson France Dispositif d'administration de médicament comprenant un adaptateur
WO2024110416A1 (fr) * 2022-11-23 2024-05-30 Becton Dickinson France Dispositif d'administration de médicament comprenant un film adhésif

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