WO2016051989A1 - シリンジ用組立体、プレフィルドシリンジ、穿刺針付外筒用シールキャップおよびシリンジ用組立体包装体 - Google Patents
シリンジ用組立体、プレフィルドシリンジ、穿刺針付外筒用シールキャップおよびシリンジ用組立体包装体 Download PDFInfo
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- WO2016051989A1 WO2016051989A1 PCT/JP2015/073417 JP2015073417W WO2016051989A1 WO 2016051989 A1 WO2016051989 A1 WO 2016051989A1 JP 2015073417 W JP2015073417 W JP 2015073417W WO 2016051989 A1 WO2016051989 A1 WO 2016051989A1
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- WIPO (PCT)
- Prior art keywords
- puncture needle
- outer cylinder
- seal cap
- distal end
- syringe
- Prior art date
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Classifications
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3293—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle hub
-
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- 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
- A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
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- 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
- A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
-
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- 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
- A61M5/008—Racks for supporting syringes or needles
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- 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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
- A61M2005/3107—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle for needles
- A61M2005/3109—Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin
-
- A—HUMAN NECESSITIES
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
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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
- A61M2209/00—Ancillary equipment
- A61M2209/06—Packaging for specific medical equipment
Definitions
- the present invention relates to a syringe assembly, a prefilled syringe, a seal cap for an outer cylinder with a puncture needle, and a syringe assembly package.
- a syringe with a puncture needle fixed to the distal end portion of an outer cylinder is used as a syringe for administering a small amount of medicine such as an insulin syringe.
- a syringe for administering a small amount of medicine such as an insulin syringe.
- a syringe which filled the chemical
- seal caps capable of needle tip sealing for example, those disclosed in Patent Document 1 (Special Table 2010-534546) and Patent Document 2 (USP 6719732) have been proposed.
- the seal cap (shield 10) of Patent Document 1 covers the end of a syringe (a part of which is shown in FIG. 2 of Patent Document 1).
- the distal end of the syringe 3 includes a hub 2 to which the needle 6 is fixed.
- the shield 10 has an open proximal end 11, a closed distal end 12, and a wall 13 that extends from the proximal end 11 to the closed distal end 12.
- the inner surface 14 of the wall 13 defines a cavity 15 that houses a portion of the distal end of the syringe 3.
- a portion 14a of the inner surface 14 is in contact with the hub 2 at the distal end of the syringe 3. It has become.
- the seal cap (device for protecting a syringe needle) of Patent Document 2 includes an elastic needle cap 20 extending in the longitudinal direction between an open base end 22 and a closed end 24, It has an inner housing 26 delimited by lateral walls 28 and end walls 30. Further, formed between the first and second portions 40 and the second portion 42 of the housing 26 to expand inwardly at the end of the second portion 42 toward the proximal end 22.
- An annular bead 70 (rib) is provided.
- the bead 70 is provided with four slots 72 extending in the longitudinal direction.
- This type of prefillable syringe with a needle is often provided as a so-called prefilled syringe in which a syringe is filled with a chemical solution.
- the above-described seal cap having a function of sealing the needle tip of the outer cylinder is attached.
- the seal cap is often formed of a rubber material having elasticity that can be punctured by the needle tip for sealing the needle tip.
- a static eliminator ionizer
- ozone is generated from the ionizer.
- the resistance to ozone may be low, and the seal cap may deteriorate in the production process as described above.
- ozone is present in an amount of about 20 to 40 ppb even in a normal environment, there is a possibility that deterioration due to ozone may occur even in a normal environment.
- the present inventor has found that, in the presence of ozone, in particular, a stressed portion such as a fitting portion with the outer cylinder deteriorates, and cracks or cracks may occur.
- a stressed portion such as a fitting portion with the outer cylinder deteriorates, and cracks or cracks may occur.
- addition of an additive to rubber was also studied to prevent deterioration, the possibility of drug modification in the prefilled syringe due to the additive cannot be denied. Therefore, it is desirable to impart ozone resistance without using additives as much as possible.
- the needle cap disclosed in Patent Document 3 is formed of a rubber composition for a needle cap that protects a needle attached to the tip of a syringe barrel in which 70 to 100% by mass of the base polymer is ethylene propylene diene rubber. .
- the thing of patent document 3 is excellent in the point that ozone degradation does not arise.
- the seal cap forming material may adhere to the outer surface of the needle tip of the puncture needle as will be described later.
- the syringe assembly as described above is provided in a state where a seal cap is attached to the outer cylinder and a puncture needle is inserted into the seal cap.
- the state in which the puncture needle is inserted into the seal cap in other words, the state in which the outer surface of the distal end portion of the puncture needle is in close contact with the forming material of the seal cap has a certain degree of use until manufacture, transportation and storage including sterilization. It will continue for a period of time.
- a puncture needle is coated with silicone to reduce resistance during piercing. Nevertheless, when the seal cap is detached from the outer cylinder due to the storage environment or the like, the seal cap forming material may adhere to the outer surface of the puncture needle. Such adhesion of the seal cap forming material to the puncture needle is an undesirable factor in increasing the piercing resistance.
- an object of the present invention is to provide a syringe that is resistant to ozone without using additives as much as possible, and has little adhesion to the puncture needle of the seal cap forming material even after a certain period of time has elapsed before use.
- Assembly, prefilled syringe, seal cap for outer cylinder with puncture needle, and assembly package for syringe are provided.
- An assembly for a syringe comprising an outer cylinder provided with a seal cap attached to the outer cylinder, The seal cap includes a closed distal end portion, an opening proximal end portion, a puncture needle attachment portion accommodating portion that is located on the distal end side of the opening proximal end portion and accommodates the distal end portion of the puncture needle attachment portion, and the puncture needle attachment
- the seal cap is formed of a rubber composition having a mixture of butyl
- a sealing cap for an outer cylinder with a puncture needle attached to an outer cylinder comprising: The seal cap includes a closed distal end portion, an opening proximal end portion, a puncture needle attaching portion accommodating portion that is located on the distal end side of the opening proximal end portion and accommodates the puncture needle attaching portion, and a puncture needle attaching portion accommodating portion.
- the seal cap is a seal cap for an outer cylinder with a puncture needle which is formed of a rubber composition having a mixture of butyl rubber and diene rubber as a base polymer.
- a syringe assembly package housing a plurality of the above-described syringe assemblies
- the packaging body includes a container body having an open top surface and shape retention, an outer cylinder holding member capable of holding the plurality of syringe assemblies, and a plurality of syringes held by the outer cylinder holding member.
- An assembly package for a syringe which is provided with a vent having sterilization gas flow and is sterilized under high pressure steam.
- FIG. 1 is a front view of a prefilled syringe according to an embodiment of the present invention.
- 2 is a cross-sectional view taken along line AA in FIG.
- FIG. 3 is an enlarged cross-sectional view of the syringe assembly of the present invention used in the prefilled syringe of FIGS. 1 and 2.
- 4 is an enlarged front view of a seal cap for an outer cylinder with a puncture needle of the present invention used in the prefilled syringe of FIGS. 1 and 2 and the syringe assembly of FIG.
- FIG. 5 is a bottom view of the outer cap seal cap with a puncture needle shown in FIG. 6 is an enlarged sectional view taken along line BB in FIG.
- FIG. 7 is a front view of an outer cylinder used in the prefilled syringe of FIGS. 1 and 2 and the syringe assembly of FIG.
- FIG. 8 is an enlarged sectional view taken along the line CC of FIG. 9 is a perspective view of the outer cylinder shown in FIG.
- FIG. 10 is an explanatory view for explaining the operation of the seal cap for an outer cylinder with a puncture needle of the present invention.
- FIG. 11 is a perspective view of the assembly package for a syringe of the present invention.
- FIG. 12 is an explanatory diagram for describing an internal configuration of the assembly assembly package for a syringe illustrated in FIG. 11.
- FIG. 13 is a front view of the syringe assembly package shown in FIG. 11.
- FIG. 14 is a plan view of the syringe assembly package shown in FIG. 13.
- FIG. 15 is an enlarged sectional view taken along line DD of FIG.
- the prefilled syringe 1 of the present invention includes a syringe assembly 10, a gasket 4 that is housed in the syringe assembly 10 and that can be liquid-tightly slid within the syringe assembly 10, and the syringe assembly 10. It consists of the medicine 8 filled in the space formed by the gasket 4.
- the syringe assembly (in other words, an outer cylinder with a puncture needle fitted with a cap) 10 of the present invention includes an outer cylinder main body portion 21 having a puncture needle fixing portion 22 at the tip, and a puncture needle tip 61 at the tip.
- the outer cylinder 2 includes a puncture needle 6 having a proximal end portion fixed to the puncture needle fixing portion 22, and a seal cap 3 attached to the outer cylinder 2.
- the seal cap 3 includes a closed distal end portion 31, an opening proximal end portion 32, a tubular hollow portion 30 that extends to the distal end side from the opening proximal end portion 32 and can accommodate the puncture needle fixing portion 22, and a hollow portion
- the puncture needle tip 61 of the puncture needle 6 inserted into the puncture needle 6 is provided with a puncturable portion 33 into which the puncture needle tip 61 can be inserted.
- the seal cap 3 is formed of a rubber composition using a mixture of butyl rubber and diene rubber as a base polymer. Furthermore, the seal cap 3 is attached to the outer cylinder 10, and the puncture needle tip 61 of the puncture needle 6 is inserted into the insertable portion 33 of the seal cap 3.
- the prefilled syringe 1 includes a syringe assembly 10 including an outer tube 2 and a seal cap 3 attached to the outer tube 2 so as to seal the needle tip of the puncture needle, A gasket 4 housed in the syringe assembly 10 and slidable in a liquid-tight manner in the syringe assembly 10, and a medicine 8 filled in a space formed by the syringe assembly 10 and the gasket 4; And a plunger 5 attached to the gasket 4 or attached at the time of use.
- the medicine 8 is filled in a space formed by the outer cylinder 2, the gasket 4, and the seal cap 3.
- the drug 8 to be filled may be any one, for example, any drug that is usually used as an injection, such as protein drugs such as antibodies, peptide drugs such as hormones, nucleic acid drugs, Cellular medicines, blood products, vaccines to prevent various infectious diseases, anticancer agents, anesthetics, narcotics, antibiotics, steroids, protease inhibitors, heparin, glucose injections such as glucose, sodium chloride and lactic acid Examples include electrolyte correction injection solutions such as potassium, vitamins, fat emulsions, contrast agents, and stimulants.
- the outer cylinder 2 is provided at the outer cylinder main body portion 21, a cylindrical (hollow) puncture needle fixing portion 22 provided at the distal end portion of the outer cylinder main body portion 21, and a proximal end portion of the outer cylinder main body portion 21.
- a puncture needle 6 having a proximal end portion fixed to the puncture 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 puncture needle fixing portion 22, and the inside of the puncture needle 6 communicates with the internal space 20 of the outer cylinder 2.
- the puncture needle 6 is in a state where a portion (base end portion not including the base end) slightly on the front end side from the base end is embedded in the puncture needle fixing portion 22 of the outer cylinder 2. For this reason, the hollow part of the puncture needle fixing
- a metal hollow needle having a cutting edge at the tip is used.
- a lubricant is applied to at least the needle tip 61 of the puncture needle 6. Although it does not specifically limit as a lubricant, For example, a silicone oil is mentioned. By using this, a reduction in puncture resistance at the time of puncture can be expected.
- the puncture needle 6 may be inserted into a hollow portion of the puncture needle fixing portion 22 of the outer cylinder 2 formed in advance and fixed to the puncture needle fixing portion 22 with an adhesive, heat welding, or the like.
- the puncture needle 6 may be fixed directly to the outer cylinder 2 by insert molding.
- the puncture needle fixing portion 22 becomes a cylindrical shape (hollow shape) into which the puncture needle 6 is inserted, and the base end portion of the puncture needle 6 is a puncture needle fixing portion. 22 is inserted into the hollow portion and fixed.
- the outer cylinder 2 is transparent or translucent.
- the outer cylinder main body 21 is a substantially cylindrical part that accommodates the gasket 4 in a liquid-tight and slidable manner.
- the puncture needle fixing portion 22 protrudes forward from the distal end portion (shoulder portion) of the outer cylinder main body and has a hollow cylindrical shape having a smaller diameter than the outer cylinder main body. Further, as shown in FIGS. 7 and 8, the puncture needle fixing portion 22 is provided with a head 24 provided at the distal end and a short taper provided at the proximal end of the head 24 and having a diameter reduced toward the proximal end.
- the head portion 24 is formed with a recess 26 that is recessed from the distal end surface toward the proximal end side, and a hollow conical portion that is located in the recess 26 and has a vertex on the distal end side.
- a plurality of grooves extending in the axial direction of the outer cylinder 2 are formed on the outer surface of the connecting portion 27.
- the recessed part 25 may not be a taper shape but the shape simply reduced in diameter so that a level
- the connecting portion 27 may be omitted, and the base end portion of the concave portion (tapered reduced diameter portion 25) and the distal end portion of the outer cylinder main body portion 21 may be directly connected.
- the head 24 may have a hollow columnar shape (cylindrical shape) in which the recess 26 and the conical portion are omitted.
- the recess 25 is preferably an annular recess as in this embodiment.
- Examples of the material for forming the outer cylinder 2 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate.
- Various resins such as polyester such as polyester, cyclic olefin polymer, and cyclic olefin copolymer are mentioned. Among them, resins such as polypropylene, cyclic olefin polymer, and cyclic olefin copolymer are preferable because they are easy to mold and have heat resistance.
- As the puncture needle 6, a hollow one having a puncture needle tip 61 at the tip is used.
- a material for forming the puncture needle 6 a metal is generally used. Stainless steel is preferred as the metal.
- the gasket 4 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 the slidability can be satisfied, the number may be set as appropriate. Further, the tip surface of the gasket 4 has a shape corresponding to the shape of the inner surface of the distal end of the outer cylinder 2 so as not to form a gap as much as possible between the two when contacting the inner surface of the distal end of the outer cylinder 2.
- the material for forming the gasket 4 includes elastic rubber (eg, isoprene rubber, butyl rubber, latex rubber, silicone rubber), synthetic resin (eg, 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.
- elastic rubber eg, isoprene rubber, butyl rubber, latex rubber, silicone rubber
- synthetic resin eg, styrene elastomer such as SBS elastomer and SEBS elastomer, ethylene- ⁇ olefin copolymer
- an olefin-based elastomer such as a combined elastomer.
- the gasket 4 is provided with a recess extending inward from the base end portion, and this recess has a female screw shape and is formed on the outer surface of the protruding portion 52 formed at the distal end portion of the plunger 5. It can be screwed with the male thread.
- the plunger 5 is not detached from the gasket 4 by screwing them together. The plunger 5 may be removed and attached at the time of use. Further, the plunger 5 includes a protruding portion 52 that protrudes in a cylindrical shape forward from the disk portion at the tip, and an external thread that is screwed into the recessed portion of the gasket 4 is formed on the outer surface of the protruding portion.
- the plunger 5 includes a main body 51 extending in the axial direction having a cross-shaped cross section, and a pressing disk 53 provided at the base end.
- An outer cylinder seal cap 3 with a puncture needle of the present invention includes an outer cylinder main body 21, a cylindrical puncture needle fixing part 22 provided at the tip of the outer cylinder main body 21 and having a head 24, A puncture needle tip 61 is provided at the tip, and a puncture needle 6 having a proximal end portion inserted into and fixed to the puncture needle fixing portion 22 is mounted and used.
- the seal cap 3 includes a closed distal end portion 31, an opening proximal end portion 32, and a puncture needle fixing portion storage portion that is located on the distal end side of the opening proximal end portion 32 and stores the puncture needle fixing portion 22.
- 35 and a hollow portion 30 having a tapered puncture needle storage portion 34 continuous to the tip of the puncture needle fixing portion storage portion 35, and a puncture needle tip 61 of the puncture needle 6 stored in the puncture needle storage portion 34
- a pierceable portion 33 that can be inserted and a protrusion 36 formed on the inner surface of the puncture needle fixing portion storage portion 35 are provided.
- the seal cap 3 attached to the outer cylinder 2 has at least a part of the hollow part 30 (specifically, the puncture needle fixing part storage part 35 which is a part of the hollow part and its part). 3) is in a state of being pushed outward by the puncture needle fixing portion 22 housed in the hollow portion 30 as shown in FIG. 3.
- the seal cap 3 is formed of a rubber composition using a mixture of butyl rubber and diene rubber as a base polymer.
- the butyl rubber and diene rubber in the rubber composition are preferably crosslinked. Crosslinking can be performed by adding a crosslinking agent capable of crosslinking each rubber material. A catalyst can also be added as needed.
- the diene rubber is preferably a butadiene rubber as a main component. Further, 100% butadiene rubber may be used, 70% or more is preferably butadiene rubber, and more preferably 30% or more is butadiene rubber.
- butadiene rubbers such as styrene-butadiene rubber, acrylonitrile-butadiene rubber, acrylonitrile butadiene isoprene rubber, butadiene-acrylic acid ester rubber, hydrogenated styrene-butadiene rubber, etc. are preferable in addition to the butadiene rubber described above.
- the ratio of butyl rubber to diene rubber in the base polymer is preferably 7: 3 to 4: 6, and particularly preferably 5: 5 to 6: 4.
- the rubber composition may contain a filler in addition to the base polymer.
- the filler is not particularly limited in the present invention, and those usually used in rubber compositions such as inorganic fillers and organic fillers can be appropriately used.
- organic filler carbon materials such as graphite, carbon black and carbon fibers, aromatic polyamide fibers, aromatic polyamide pulp fibers, glass fibers, and the like are used.
- the above-mentioned fillers can be used alone or in a blend of two or more.
- the ratio of the base polymer to the filler in the rubber composition is preferably 5: 5 to 8: 2, and particularly preferably 6: 4 to 7: 3.
- the mold release agent is mix
- the compounding amount of the release agent is preferably 0.3 to 5 parts by weight, more preferably 0.3 to 3 parts by weight with respect to 100 parts by weight of the base polymer.
- mold release agents include higher fatty acid amides such as stearic acid amide, oleic acid amide, and palmitic acid amide, higher fatty acid esters such as ethyl oleate, higher aliphatic amines such as stearylamine and oleylamine, esters of fatty alcohols, Although paraffin etc. are mentioned, it is not limited to these.
- the seal cap material of the present invention can contain a pigment such as carbon black or titanium oxide as a colorant, and paraffin oil or the like as a plasticizer, if necessary.
- the sticking suppression coating 9 that suppresses sticking to the outer surface of the puncture needle attachment portion 22 of the outer cylinder 2 is provided at least on the inner surface of the puncture needle attachment portion storage portion 35. I have.
- the sticking suppression film 9 may be formed not only on the entire inner surface of the puncture needle attachment portion storage portion 35 but only on a portion that is in close contact with the outer surface of the puncture needle attachment portion 22.
- the sticking suppression film 9 is formed on the entire inner surface of the puncture needle storage portion 34. For this reason, even if the puncture needle tip 61 of the puncture needle 6 comes into contact with the inner surface of the puncture needle storage portion 34, it does not stick. Thus, when the seal cap 3 is attached to the puncture needle mounting portion 22 of the outer cylinder 2, the puncture needle tip 61 of the puncture needle 6 that has entered the puncture needle storage portion 34 is placed on the inner surface of the puncture needle storage portion 34. Without sticking, it is guided to the distal end (small diameter distal end portion 34a) of the puncture needle storage portion 34 and is reliably inserted into the insertable portion 33.
- the sticking suppression coating 9 is formed on the entire inner surface of the puncture needle attachment portion introducing portion 38, so that the puncture needle attachment portion 22 enters the puncture needle attachment portion introduction portion 38.
- the outer surface of the puncture needle attachment portion 22 does not stick to the inner surface of the puncture needle attachment portion introduction portion 38. Thereby, the seal cap 3 can be smoothly attached to the puncture needle mounting portion 22 of the outer cylinder 2.
- the seal cap 3 is attached to the distal end portion (puncture needle mounting portion 22) of the outer cylinder 2, and the puncture needle tip of the puncture needle 6 is provided.
- 61 is inserted into the insertable portion 33 of the seal cap 3 and sealed in a liquid-tight state, and the recess 25 is located on the proximal end side of the head 24 of the puncture needle attachment portion 22 and the puncture needle attachment portion storage portion.
- the projecting portion 36 formed on the inner surface of 35 is engaged, and the inner surface of the puncture needle mounting portion storage portion 35 and the outer surface of the puncture needle mounting portion 22 are in close contact with each other.
- the seal cap 3 attached to the outer cylinder 2 has at least a part of the hollow part 30 (specifically, the puncture needle fixing part storage part 35 which is a part of the hollow part and its part). 3) is in a state of being pushed outward by the puncture needle fixing portion 22 housed in the hollow portion 30 as shown in FIG. 3.
- the syringe assembly 10 can be in a state in which the inner surface of the puncture needle attachment portion storage portion 35 and the outer surface of the puncture needle attachment portion 22 are in close contact via the sticking suppression coating 9.
- the outer cap 2 is kept in contact with the sticking suppression coating 9 in this manner, the outer cylinder 2 is stored with the seal cap 3 attached, and the sterilization is accompanied by a pressure load such as high-pressure steam sterilization or ethylene oxide gas sterilization. Even if it performs, sticking with the inner surface of the puncture needle attachment part accommodating part 35 and the outer surface of the puncture needle attachment part 22 can be suppressed.
- the prefilled syringe 1 of the present invention is in a state where the inner surface of the puncture needle attachment portion storage portion 35 and the outer surface of the puncture needle attachment portion 22 are in close contact via the sticking suppression coating 9. Even when stored with the seal cap 3 attached thereto and when sterilization with pressure load such as high-pressure steam sterilization or ethylene oxide gas sterilization is performed, the inner surface of the puncture needle mounting portion storage portion 35 and the puncture needle mounting portion 22 Sticking to the outer surface can be suppressed.
- the sticking suppression film 9 is formed on the inner surface of the puncture needle mounting portion storage part 35.
- the present invention is not limited to this. It may be formed on the outer surface of puncture needle mounting portion 22. Further, the sticking suppression film may be formed on both the inner surface of the puncture needle attachment portion storage portion 35 of the seal cap 3 and the outer surface of the puncture needle attachment portion 22 of the outer cylinder 2. And it is preferable that the assembly for syringes is sterilized by high-pressure steam or ethylene oxide gas.
- the seal cap 3 used in the present invention has gas permeability
- the syringe assembly to which the seal cap 3 is attached has a cutting edge of the puncture needle inserted into the seal cap with high-pressure steam and ethylene oxide gas. Whole sterilization including is possible. As the sterilization, high-pressure steam sterilization is particularly preferable.
- polytetrafluoroethylene tetrafluoroethylene
- PFA perfluoroalkyl vinyl ether copolymer resin
- FEP tetrafluoroethylene / hexafluoropropylene copolymer
- PCTFE fluoroethylene
- PVDF polyvinylidene fluoride
- silicon-based resins such as silicone polymer coatings formed with a liquid coating agent based on reactive silicone oil, polyparaxylylene, diamond-like And carbon.
- the sticking-inhibiting polymerization coating is preferably a silicone polymerization coating formed by a liquid coating agent mainly composed of reactive silicone oil. Since the liquid coating agent composed mainly of reactive silicone oil is liquid, it can be easily and reliably applied to the inner surface of the seal cap 3 (puncture needle mounting portion storage portion 35) and polymerized at room temperature or by heating. Since the silicone polymerized film is formed (including cross-linking), it is possible to easily and reliably form the sticking-suppressing polymerized film on the inner surface of the seal cap 3 (puncture needle mounting part storage part 35).
- the seal cap 3 is attached to the puncture needle fixing portion 22 of the outer cylinder 2.
- the seal cap 3 puncture needle mounting portion storage portion 35
- the deformation follows the deformation, and the seal cap 3 (puncture needle) It is difficult to peel off from the inner surface of the mounting portion storage portion 35).
- the inside of the head portion 24 is recessed to form an annular head portion.
- reactive silicone oil examples include silanol groups, amino groups, epoxy groups, alicyclic epoxy groups, carbinol groups, methacryl groups, polyether groups, mercapto groups, carboxyl groups, and phenol groups. Can be mentioned at both ends. Among these, polydimethylsiloxane having silanol groups at both ends is preferable. When a polysiloxane having silanol groups at both ends is used, this reactive silicone oil condensate has a chemically stable siloxane bond throughout the main chain, and the drug 8 filled in the outer cylinder 2. It is possible to form a silicone polymer film that hardly interacts with (for example, drug adsorption).
- the seal cap 3 is attached to the distal end portion (puncture needle fixing portion 22) of the outer cylinder 2, and the puncture needle tip of the puncture needle 6 is provided.
- 61 is inserted into the insertable portion 33 of the seal cap 3 and sealed in a liquid-tight state, and the concave portion 25 (the base end portion of the head portion 24) of the puncture needle fixing portion 22 and the puncture needle fixing portion storage portion 35 are provided.
- the protruding portion 36 formed on the inner surface is engaged, and the inner surface of the puncture needle fixing portion storage portion 35 and the outer surface of the puncture needle fixing portion 22 are in close contact with each other via the sticking suppression coating 9. .
- at least the puncture needle fixing part storage part 35 is in a state of being pushed outward by the puncture needle fixing part 22.
- the inner surface form of the seal cap 3 of this embodiment will be described.
- the seal cap 3 includes a protrusion 36 provided on the inner surface located on the distal end side by a predetermined length from the opening base end portion 32.
- the protruding portion 36 has a most protruding vertex portion 36a, and an inclined portion (tapered portion) 36b extending from the vertex portion 36a in the distal direction and gradually decreasing in the protruding height in the distal direction.
- the protruding portion 36 is an annular protruding portion
- the inclined portion 36b is a tapered portion in which the inner diameter of the puncture needle fixing portion storage portion 35 is reduced in the distal direction.
- the inner diameter of the puncture needle fixing portion storage portion 35 at the apex portion 36a is slightly smaller than the outer diameter of the head 24 of the puncture needle fixing portion 22 of the outer cylinder 2.
- the distal side inclined portion 36 b extends to the distal side from the concave portion 25 in a state where the seal cap 3 is attached to the puncture needle fixing portion 22 of the outer cylinder 2.
- the inner diameter of the puncture needle fixing part storage part 35 at least at the tip part of the tip side inclined part 36 b is slightly smaller than the outer diameter of the head part 24 of the puncture needle fixing part 22 of the outer cylinder 2.
- the protruding portion 36 further extends from the apex portion 36a toward the opening end (base end), and the protruding height is the opening end (base end).
- a proximal-side inclined portion 36c that gradually decreases in the direction is provided.
- the puncture needle fixing portion storage portion 35 has a predetermined length (specifically, the puncture needle storage portion 34) from the distal end portion of the distal end side inclined portion 36b of the protruding portion 36 toward the distal end.
- a straight line portion 36d extending to the base end portion.
- the inner diameter of the puncture needle fixing portion storage portion 35 in the straight portion 36d is constant and slightly smaller than the outer diameter of the head 24 of the puncture needle fixing portion 22 of the outer cylinder 2. For this reason, when the seal cap 3 is attached to the puncture needle fixing portion 22 of the outer cylinder 2, the straight portion 36 d is pressed against the outer surface of the head 24 via the sticking suppression coating 9 and is in close contact therewith. . In addition, since the straight portion 36d is pressed against the outer surface of the head 24 via the sticking suppression coating 9, at least the puncture needle fixing portion storage portion 35 is in a state of being pushed outward by the head 24. Yes.
- the base end portion of the distal side inclined portion 36b of the protruding portion 36 of the seal cap 3 is located around the concave portion 25 of the puncture needle fixing portion 22 of the outer cylinder 2, and the distal end side inclined portion 36b
- the inner diameter of the puncture needle fixing part storage part 35 at least in the vicinity of the base end part is slightly smaller than the outer diameter of the annular recess 25. Therefore, the tip side inclined portion 36 b of the protruding portion 36 of the seal cap 3 is pressed against the outer surface of the concave portion 25 through the sticking suppression coating 9 and is in close contact therewith. Thereby, the unintentional detachment
- the concave portion 25 is formed on a proximal end side of the head portion 24 and includes a tapered reduced diameter portion that decreases in diameter toward the proximal direction.
- the hollow portion 30 is formed from the opening proximal end portion 32 of the seal cap 3 to the proximal end of the puncture needle fixing portion accommodating portion 35 (projecting portion 36), and has substantially the same inner diameter.
- An extending puncture needle fixing portion introducing portion 38 is provided.
- the puncture needle fixing part introduction part 38 has an inner diameter slightly larger than the maximum inner diameter of the puncture needle fixing part storage part 35 and is slightly larger than the outer diameter of the head 24 of the puncture needle fixing part 22 of the outer cylinder 2. It has become. For this reason, it functions as an introduction part of the puncture needle fixing part 22 when the seal cap 3 is attached to the puncture needle fixing part 22 of the outer cylinder 2.
- the puncture needle fixing portion introducing portion 38 has an annular standing surface 39 that stands up toward the opening proximal end portion 32 at the boundary with the proximal end of the puncture needle fixing portion accommodating portion 35 (projecting portion 36). Yes. Therefore, when the distal end portion of the outer cylinder 2 is inserted into the puncture needle fixing portion introducing portion 38 of the seal cap 3, the puncture needle fixing portion 22 of the outer cylinder 2 enters the puncture needle fixing portion introducing portion 38. Thereafter, as shown in FIG. 10, the annular distal end surface of the head 24 of the puncture needle fixing portion 22 comes into contact with the annular standing surface 39, and in this state, the puncture needle 6 is attached to the seal cap 3. It becomes substantially parallel to the central axis, and enters a state where it enters the small-diameter tip portion 34 a of the puncture needle storage portion 34.
- a gripping flange 37 is formed on the base end of the seal cap 3 so as to project outwardly in an annular shape, and the flange 37 is provided with an annular recess 71.
- the position of the distal end side of the flange 37 is located on the distal end side from the annular standing surface 39 of the hollow portion 30 and is near the apex portion 36a of the protrusion 36 (in the case shown in FIG. 32 side).
- the manufacturing method of the seal cap of the present invention includes an outer cylinder main body having a puncture needle fixing portion at the distal end, a puncture needle tip having a puncture needle fixing portion at the distal end, and a proximal end portion inserted into and fixed to the puncture needle fixing portion.
- hook provided with is attached.
- the manufacturing method of the seal cap of the present invention is capable of insertion into which a cylindrical hollow portion that accommodates a puncture needle fixing portion of an outer cylinder with a needle and a puncture needle tip of a puncture needle inserted into the hollow portion can be inserted And a step of preparing a seal cap formed of a rubber composition comprising a mixture of butyl rubber and diene rubber as a base polymer, and an ozone contact step of exposing the seal cap to an ozone high concentration environment Is to do.
- the process of preparing the seal cap can be performed, for example, by inserting a cylindrical hollow portion for storing the puncture needle fixing portion of the outer cylinder with a needle and a puncture needle tip of the puncture needle inserted into the hollow portion.
- a seal cap body having a configuration as shown in FIGS. 4 to 6 is prepared.
- the seal cap body is prepared by using the rubber composition described above as a seal cap forming material.
- an ozone contact process is performed in which the seal cap is exposed to an ozone high concentration environment.
- a high ozone concentration environment for example, in a corona discharge static electricity removal environment, in an ozone sterilizer, in a clean room that is sterilized with ozone, or in a space that uses an air purifier that generates ozone (for example, a hospital). is there. If the seal cap and the outer cylinder with the seal cap attached are charged with static electricity, dust or the like during the manufacturing process may be adsorbed. For this reason, the static electricity is removed by setting the manufacturing process as a static electricity removal environment.
- the static electricity removal environment can be formed, for example, by introducing ions generated using a corona discharge ionizer together with clean air during the manufacturing process.
- ozone is generated together with ions, so that the outer cylinder with the seal cap attached comes into contact with ozone.
- the seal cap includes the ozone-resistant outer surface coating layer, so that deterioration due to ozone is suppressed. For this reason, there is very little deterioration of the cap resulting from the ozone contact process.
- the electrostatic removal environment is not limited to the corona discharge method (which may be either a voltage application method or a self-discharge method), and may be an AC discharge method, a DC discharge method, a pulse discharge method, or the like. Also good.
- seal cap materials butyl rubber (manufactured by Nippon Butyl Co., Ltd., HT-1066), butadiene rubber (manufactured by JSR, BR01), filler (silica: manufactured by Tosoh Silica Co., Ltd., VN3, talc: manufactured by Nippon Talc Co., Ltd., K-1) ) And stearamide as a release agent were prepared. Then, according to the blending ratio shown in Table 1, a crosslinking agent and a catalyst were blended and kneaded by a closed kneader to obtain an unvulcanized rubber blend. A seal cap having a shape as shown in FIG. 2 was produced by crosslinking the unvulcanized rubber compound by pressurizing and heating using a predetermined molding die.
- Example 1 Adhesion confirmation test
- Adherence confirmation tests were performed on 100 sterilized syringe assemblies of Examples 1 to 3 and Comparative Examples 1 and 2 prepared as described above.
- the seal cap was removed from each syringe assembly, and the presence or absence of sticking of the seal cap forming material in the vicinity of the needle tip of the puncture needle was counted using an optical microscope.
- the results are shown in Table 4.
- Table 4 in the adhesion test column, ⁇ indicates no adhesion (zero sticking of the needle shield rubber piece larger than 0.03 mm 2 on the blade edge), and x indicates adhesion (greater than 0.03 mm 2 on the blade edge). 1 or more of the needle shield rubber pieces are fixed. From this experiment, it was confirmed that in the syringe assembly using the seal cap of the example of the present invention, the material for forming the seal cap did not adhere to the puncture needle even after sterilization.
- Example 2 Water vapor permeability measurement
- the unvulcanized rubber compounds of Examples 1 to 3 and Comparative Examples 1 and 2 produced as described above were vulcanized and molded into sheets, and the water vapor permeability was measured for each sheet.
- the water vapor permeability was measured by performing a water vapor test at 125 ° C. based on “Plastics—Film and Sheet—How to Obtain Water Vapor Permeability” described in JIS K7129 (Revised 2008/03/20). The results were as shown in Table 3. From this experiment, it was confirmed that the seal cap material of the example had good water vapor permeability.
- Example 4 Ozone resistance test
- the vulcanized rubber and the vulcanized rubber described in JIS K 6249 are described. The test was carried out based on "Thermoplastic rubber-Determination of ozone resistance”.
- Table 3 When each seal cap was confirmed after exposure, the results shown in Table 3 were obtained.
- ⁇ indicates ozone resistance (no deterioration in appearance due to ozone deterioration was observed), and X indicates no ozone resistance (interior deterioration due to ozone deterioration was observed). Show. And it has confirmed that the seal cap of an Example has ozone tolerance.
- Example 5 Piercing resistance test
- the piercing resistance was measured for each of the 20 sterilized Examples 1 to 3 and Comparative Example 1 and 2 syringe assemblies prepared as described above.
- the results were as shown in Table 3.
- the needle tip after puncturing had sufficient piercing property.
- the assembly for a syringe of the present invention is as follows. (1) An outer cylinder main body, a puncture needle mounting portion provided at the distal end of the outer cylinder main body, a puncture needle tip at the distal end, and a proximal end fixed to the puncture needle mounting An assembly for a syringe comprising an outer cylinder provided with a puncture needle, and a seal cap attached to the outer cylinder,
- the seal cap includes a closed distal end portion, an opening proximal end portion, a puncture needle attachment portion accommodating portion that is located on the distal end side of the opening proximal end portion and accommodates the distal end portion of the puncture needle attachment portion, and the puncture needle attachment
- the seal cap
- the seal cap is formed of a rubber composition having a mixture of butyl rubber and diene rubber as a base polymer, the outer surface portion of the portion that is pressed from the inside particularly when mounted on the outer cylinder The occurrence of deterioration, cracks and cracks due to contact with ozone is small.
- the inner surface of the puncture needle mounting portion housing portion of the seal cap and the outer surface of the puncture needle mounting portion of the outer cylinder are in close contact with each other, but have good water vapor permeability. Therefore, it exhibits good autoclave sterilization.
- the seal cap forming material does not adhere to the outer surface of the puncture needle.
- the above embodiment may be as follows.
- the puncture needle is a hollow needle having the puncture needle tip at a distal end, and is in communication with the inside of the outer cylinder main body at a base end portion.
- An assembly for a syringe according to 1. (8) The syringe assembly according to (7), wherein the seal cap is in a state in which an inner surface of the puncture needle mounting portion storage portion and an outer surface of the puncture needle mounting portion of the outer cylinder are in close contact with each other.
- the prefilled syringe of the present invention is as follows. (9) The syringe assembly according to any one of the above (1) to (8), a gasket that is housed in the outer cylinder and that can slide in a liquid-tight manner in the outer cylinder, and the outer cylinder; A prefilled syringe comprising a medicine filled in a space formed by the gasket.
- the seal cap for an outer cylinder with a puncture needle of the present invention is as follows. (10) An outer cylinder main body, a puncture needle mounting portion provided at the distal end of the outer cylinder main body, a puncture needle tip at the distal end, and a proximal end fixed to the puncture needle mounting A seal cap for an outer cylinder with a puncture needle attached to an outer cylinder comprising a puncture needle,
- the seal cap includes a closed distal end portion, an opening proximal end portion, a puncture needle attaching portion accommodating portion that is located on the distal end side of the opening proximal end portion and accommodates the puncture needle attaching portion, and a puncture needle attaching portion accommodating portion.
- the seal cap is a seal cap for an outer cylinder with a puncture needle which is formed of a rubber composition having a mixture of butyl rubber and diene rubber as a base polymer.
- the above embodiment may be as follows. (11) The seal cap for an outer cylinder with a puncture needle according to (10), wherein the diene rubber is mainly composed of butadiene rubber. (12) The seal cap for an outer cylinder with a puncture needle according to (10), wherein the diene rubber is butadiene rubber. (13) The seal for an outer cylinder with a puncture needle according to any one of the above (10) to (12), wherein the seal cap includes a sticking suppression surface formed on an inner surface of the puncture needle attachment portion storage portion. cap.
- the assembly package for a syringe of the present invention is as follows. (14) A syringe assembly package housing the syringe assembly according to any one of (1) to (8) above,
- the packaging body includes a container body having an open top surface and shape retention, an outer cylinder holding member capable of holding the plurality of syringe assemblies, and a plurality of syringes held by the outer cylinder holding member.
- An assembly package for a syringe which is provided with a vent having sterilization gas flow and is sterilized under high pressure steam.
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Abstract
Description
外筒本体部と、前記外筒本体部の先端部に設けられた穿刺針取付部と、先端に穿刺用針先を有し、前記穿刺針取付部に基端部が固定された穿刺針とを備える外筒と、前記外筒に装着されたシールキャップとからなるシリンジ用組立体であって、
前記シールキャップは、閉塞先端部と、開口基端部と、前記開口基端部より先端側に位置し前記穿刺針取付部の先端部を収納する穿刺針取付部収納部と、前記穿刺針取付部収納部の先端と連続し前記穿刺針を収納する穿刺針収納部とを有する中空部と、前記穿刺針収納部に収納された前記穿刺針の前記穿刺用針先が刺入可能な刺入可能部とを備え、さらに、
前記シールキャップは、ブチルゴムとジエン系ゴムとの混合物をベースポリマーとするゴム組成物により形成され、かつ、前記シールキャップは、前記外筒に装着され、前記穿刺用針先が前記シールキャップの前記刺入可能部に刺入された状態となっているシリンジ用組立体。
上記のシリンジ用組立体と、前記外筒内に収納されかつ前記外筒内を液密に摺動可能なガスケットと、前記外筒と前記ガスケットにより形成された空間内に充填された薬剤とからなるプレフィルドシリンジ。
外筒本体部と、前記外筒本体部の先端部に設けられた穿刺針取付部と、先端に穿刺用針先を有し、前記穿刺針取付部に基端部が固定された穿刺針とを備える外筒に装着される穿刺針付外筒用シールキャップであって、
前記シールキャップは、閉塞先端部と、開口基端部と、前記開口基端部より先端側に位置し前記穿刺針取付部を収納する穿刺針取付部収納部と前記穿刺針取付部収納部の先端と連続し前記穿刺針を収納する穿刺針収納部とを有する中空部と、前記穿刺針収納部に収納された前記穿刺針の前記穿刺用針先が刺入可能な刺入可能部と、前記穿刺針取付部収納部の内面に形成された突出部とを備え、さらに、
前記シールキャップは、ブチルゴムとジエン系ゴムとの混合物をベースポリマーとするゴム組成物により形成されている穿刺針付外筒用シールキャップ。
複数の上記のシリンジ用組立体を収納したシリンジ用組立体包装体であって、
前記包装体は、上面が開口し、かつ保形性を有する容器体と、複数の前記シリンジ用組立体を保持可能な外筒保持部材と、前記外筒保持部材に保持された複数のシリンジ用組立体と、前記容器体の上面開口を気密に封止するとともに剥離可能なシート状蓋部材とを備え、さらに、前記包装体は、前記容器体もしくは前記蓋部材に設けられた菌不透過性かつ滅菌ガス流通性を有する通気部を備え、高圧蒸気滅菌されているシリンジ用組立体包装体。
本発明のプレフィルドシリンジ1は、シリンジ用組立体10と、シリンジ用組立体10内に収納され、かつシリンジ用組立体10内を液密に摺動可能なガスケット4と、シリンジ用組立体10とガスケット4により形成された空間内に充填された薬剤8とからなる。
そして、シールキャップ3は、閉塞先端部31と、開口基端部32と、開口基端部32より先端側に延び、穿刺針固定部22を収納可能な筒状の中空部30と、中空部30内に挿入された穿刺針6の穿刺用針先61が刺入可能な刺入可能部33とを備える。そして、シールキャップ3は、ブチルゴムとジエン系ゴムとの混合物をベースポリマーとするゴム組成物により形成されている。さらに、シールキャップ3は、外筒10に装着され、穿刺針6の穿刺用針先61がシールキャップ3の刺入可能部33に刺入された状態となっている。
充填される薬剤8としては、どのようなものでもよいが、例えば、通常注射剤として使用される薬剤であれば何でもよく、例えば抗体等の蛋白質性医薬品、ホルモン等のペプチド性医薬品、核酸医薬品、細胞医薬品、血液製剤、各種感染症を予防するワクチン、抗がん剤、麻酔薬、麻薬、抗生物質、ステロイド剤、蛋白質分解酵素阻害剤、ヘパリン、ブドウ糖等の糖質注射液、塩化ナトリウムや乳酸カリウム等の電解質補正用注射液、ビタミン剤、脂肪乳剤、造影剤、覚せい剤等が挙げられる。
穿刺針6は、先端に穿刺用針先61を有する。穿刺針6の基端部は、穿刺針固定部22の中空部内に挿入されかつ固定されるとともに、穿刺針6の内部は、外筒2の内部空間20と連通している。言い換えれば、穿刺針6は、基端より若干先端側となる部分(基端を含まない基端部)が、外筒2の穿刺針固定部22に埋設した状態となっている。このため、穿刺針固定部22の中空部は、消失している。穿刺針6としては、先端に刃先を有する金属製中空針が用いられている。さらに、この実施例では、穿刺針6の少なくとも針先61には、潤滑剤が塗布されている。潤滑剤としては、特に限定されないが、例えば、シリコーンオイルが挙げられる。これを用いることにより、穿刺時における刺通抵抗の低減が期待できる。
穿刺針6としては、先端に穿刺用針先61を有する中空状のものが用いられる。穿刺針6の形成材料としては、金属が一般的である。金属としては、ステンレス鋼が好適である。
本発明の穿刺針付外筒用シールキャップ3は、外筒本体部21と、外筒本体部21の先端部に設けられ、かつ、頭部24を有する筒状の穿刺針固定部22と、先端に穿刺用針先61を有し、穿刺針固定部22に基端部が挿入されかつ固定された穿刺針6とを備える外筒に装着されて用いられるものである。
さらに、本発明のシールキャップ材料には、必要に応じて、着色剤としてカーボンブラックや酸化チタン等の顔料、可塑剤としてパラフィンオイル等を含めることができる。
そして、シリンジ用組立体は、高圧蒸気滅菌またはエチレンオキサイドガス滅菌されていることが好ましい。なお、本発明にて用いるシールキャップ3は、ガス透過性を有するため、それを装着したシリンジ組立体は、高圧蒸気、エチレンオキサイドガスにて、シールキャップに刺入している穿刺針の刃先を含む全体の滅菌が可能である。なお、滅菌としては、高圧蒸気滅菌が特に好ましい。
このシールキャップ3は、開口基端部32より所定長先端側に位置する内面に設けられた突出部36を備えている。突出部36は、最も突出した頂点部36aと、頂点部36aより先端方向に向かって延びかつ突出高さが先端方向に向かって漸次低下する傾斜部(テーパー部)36bとを有している。特に、この実施例は、突出部36が、環状突出部となっており、傾斜部36bは、穿刺針固定部収納部35の内径が先端方向に向かって縮径するテーパー部となっている。
また、この実施例では、凹部25は、頭部24の基端側に設けられ、基端方向に向かって縮径するテーパー状縮径部からなる。これにより、シールキャップ3を外筒2から離脱させる際、シールキャップ3の突出部36が、凹部25に沿って外側に45拡げられ、頭部24を乗り越え易くなる。
本発明のシールキャップの製造方法は、先端に穿刺針固定部を有する外筒本体と、先端に穿刺用針先を有し、穿刺針固定部に基端部が挿入されかつ固定された穿刺針とを備える針付き外筒に装着されるシールキャップの製造方法である。
本発明のシールキャップの製造方法は、針付き外筒の穿刺針固定部を収納する筒状の中空部と、中空部内に挿入される穿刺針の穿刺用針先が刺入可能な刺入可能部とを備え、かつ、ブチルゴムとジエン系ゴムとの混合物をベースポリマーとするゴム組成物により形成されたシールキャップを準備する工程と、シールキャップをオゾン高濃度環境下に暴露するオゾン接触工程とを行うものである。
シールキャップ本体の準備は、シールキャップの形成材料として上述したゴム組成物を用いて作製されたものを準備する。また、シールキャップ本体として、上述のゴム組成物を用い、かつ、塑性部の穿刺針取付部収納部の内面に張付抑制被膜を有するものを準備してもよい。
オゾン高濃度環境下は、例えば、コロナ放電方式の静電気除去環境、オゾン殺菌器内、オゾン殺菌しているクリーンルーム内、オゾンが発生する空気清浄機を使用している空間(例えば、病院)などである。シールキャップおよびシールキャップ装着済み外筒が静電気に帯電していると、製造工程中の塵等を吸着するおそれがある。このため、製造工程を静電気除去環境とし、静電気の除去が行われる。静電気除去環境は、例えば、コロナ放電式イオナイザを用いて発生させたイオンを、清浄な空気と共に製造工程中に導入することにより形成することができる。コロナ放電時には、イオンと共にオゾンが発生するため、シールキャップ装着済み外筒が、オゾンに接触することになる。しかし、本願発明のシールキャップ装着済み外筒では、上述したように、シールキャップは、耐オゾン性外面被覆層を備えるため、オゾンによる劣化が抑制されている。このため、オゾン接触工程に起因するキャップの劣化がきわめて少ない。なお、静電除去環境は、コロナ放電方式(電圧印加式又は自己放電式のいずれであってもよい)に限定されるものではなく、AC放電方式、DC放電方式、パルス放電方式などであってもよい。
上記のように作製した滅菌済みの実施例1ないし3および比較例1および2のシリンジ組立体各100本について、固着確認試験を行った。試験は、各シリンジ組立体より、シールキャップを取り外し、光学顕微鏡を用いて、穿刺針の針先付近におけるシールキャップ形成材料の固着の有無をカウントした。その結果を表4に示す。なお、表4中の固着試験欄における、○は、固着なし(刃先に0.03mm2より大きい針シールドゴム片の固着が0本)、×は、固着あり(刃先に0.03mm2より大きい針シールドゴム片の固着が1本以上)であることを示す。この実験により、本発明の実施例のシールキャップを用いたシリンジ組立体では、滅菌後においても、シールキャップの形成材料が、穿刺針に固着しないことが確認できた。
上記のように作製した実施例1ないし3および比較例1および2の未加硫のゴム配合物をシート状に加硫・成形し、各シートについて、水蒸気透過度を測定した。水蒸気透過度の測定は、JIS K7129(2008/03/20改定)に記載されている「プラスチック-フィルム及びシート-水蒸気透過度の求め方」に基づき、125℃における水蒸気試験を実施した。結果は、表3に示す通りであった。この実験により、実施例のシールキャップ材料は、良好な水蒸気透過性を有するものであることが確認できた。
上述したように作製した滅菌済みの実施例1ないし3および比較例1および2のシールキャップおよび針付外筒を用い、かつ、各シールキャップ内に、BI菌(2.7×106CFU/ml)を封入後、外筒に装着したシリンジ組立体各20個を作製した。なお、装着時にシールキャップ内の内圧が上昇する為、シールキャップの開口部付近を変形させることにより外筒、シールキャップ間に隙間を作り、内圧解除を行った。そして、シールキャップの装着後、オートクレーブ処理(123℃、80分)を行った。滅菌後、7日間培地処理を行ったところ、表3に示す結果となった。なお、表3中の滅菌性欄における、○は、滅菌できた(全て菌死滅)、×は、滅菌できず(全ての菌が死滅せず)を示す。実施例のシールキャップはオートクレーブ滅菌性を有することが確認できた。
上記のように作製した滅菌済みの実施例1ないし3および比較例1および2のシリンジ組立体各10本について、JIS K 6249(2004/03/20改定)に記載されている「加硫ゴム及び熱可塑性ゴム-耐オゾン性の求め方」に基づき、試験を実施した。暴露後、各シールキャップを確認したところ、表3のような結果が得られた。なお、表3中における、○は、オゾン耐性あり(オゾン劣化に伴う外観上の劣化が認められなかった)、×は、オゾン耐性なし(オゾン劣化に伴う外観上の劣化が認められた)を示す。そして、実施例のシールキャップは、オゾン耐性を有することが確認できた。
上記のように作製した滅菌済みの実施例1ないし3および比較例1および2のシリンジ組立体各20本について、刺通抵抗を測定した。シールキャップを取り外し、オートグラフを用いて、シリコーンゴム(t=0.5mm)に対する刺通抵抗を測定した。結果は、表3に示す通りであった。なお、刺通抵抗は低い方が好ましいと言える。
実施例のシールキャップを用いたものにおいて、穿刺後の針先は、十分な刺通性を有することが確認できた。
(1) 外筒本体部と、前記外筒本体部の先端部に設けられた穿刺針取付部と、先端に穿刺用針先を有し、前記穿刺針取付部に基端部が固定された穿刺針とを備える外筒と、前記外筒に装着されたシールキャップとからなるシリンジ用組立体であって、
前記シールキャップは、閉塞先端部と、開口基端部と、前記開口基端部より先端側に位置し前記穿刺針取付部の先端部を収納する穿刺針取付部収納部と、前記穿刺針取付部収納部の先端と連続し前記穿刺針を収納する穿刺針収納部とを有する中空部と、前記穿刺針収納部に収納された前記穿刺針の前記穿刺用針先が刺入可能な刺入可能部とを備え、さらに、
前記シールキャップは、ブチルゴムとジエン系ゴムとの混合物をベースポリマーとするゴム組成物により形成され、かつ、前記シールキャップは、前記外筒に装着され、前記穿刺用針先が前記シールキャップの前記刺入可能部に刺入された状態となっているシリンジ用組立体。
(2) 前記シリンジ用組立体は、高圧蒸気滅菌されている上記(1)に記載のシリンジ用組立体。
(3) 前記ジエン系ゴムは、ブタジエンゴムを主成分とするものである上記(1)または(2)に記載のシリンジ用組立体。
(4) 前記ジエン系ゴムは、ブタジエンゴムである上記(1)または(2)に記載のシリンジ用組立体。
(5) 前記ゴム組成物は、フィラーを含有している上記(1)ないし(4)のいずれかに記載のシリンジ用組立体。
(6) 前記ゴム組成物における前記ブチルゴムおよび前記ジエン系ゴムは、架橋している上記(1)ないし(5)のいずれかに記載のシリンジ用組立体。
(7) 前記穿刺針は、先端に前記穿刺用針先を有する中空針であり、かつ、基端部にて前記外筒本体部内と連通している上記(1)ないし(6)のいずれかに記載のシリンジ用組立体。
(8) 前記シールキャップは、前記穿刺針取付部収納部の内面と前記外筒の前記穿刺針取付部の外面が密着した状態となっている上記(7)に記載のシリンジ用組立体。
(9) 上記(1)ないし(8)のいずれかに記載のシリンジ用組立体と、前記外筒内に収納されかつ前記外筒内を液密に摺動可能なガスケットと、前記外筒と前記ガスケットにより形成された空間内に充填された薬剤とからなるプレフィルドシリンジ。
(10) 外筒本体部と、前記外筒本体部の先端部に設けられた穿刺針取付部と、先端に穿刺用針先を有し、前記穿刺針取付部に基端部が固定された穿刺針とを備える外筒に装着される穿刺針付外筒用シールキャップであって、
前記シールキャップは、閉塞先端部と、開口基端部と、前記開口基端部より先端側に位置し前記穿刺針取付部を収納する穿刺針取付部収納部と前記穿刺針取付部収納部の先端と連続し前記穿刺針を収納する穿刺針収納部とを有する中空部と、前記穿刺針収納部に収納された前記穿刺針の前記穿刺用針先が刺入可能な刺入可能部と、前記穿刺針取付部収納部の内面に形成された突出部とを備え、さらに、
前記シールキャップは、ブチルゴムとジエン系ゴムとの混合物をベースポリマーとするゴム組成物により形成されている穿刺針付外筒用シールキャップ。
(11) 前記ジエン系ゴムは、ブタジエンゴムを主成分とするものである上記(10)に記載の穿刺針付外筒用シールキャップ。
(12) 前記ジエン系ゴムは、ブタジエンゴムである上記(10)に記載の穿刺針付外筒用シールキャップ。
(13) 前記シールキャップは、前記穿刺針取付部収納部の内面に形成された張付抑制面を備えている上記(10)ないし(12)のいずれかに記載の穿刺針付外筒用シールキャップ。
(14) 複数の上記(1)ないし(8)のいずれかに記載のシリンジ用組立体を収納したシリンジ用組立体包装体であって、
前記包装体は、上面が開口し、かつ保形性を有する容器体と、複数の前記シリンジ用組立体を保持可能な外筒保持部材と、前記外筒保持部材に保持された複数のシリンジ用組立体と、前記容器体の上面開口を気密に封止するとともに剥離可能なシート状蓋部材とを備え、さらに、前記包装体は、前記容器体もしくは前記蓋部材に設けられた菌不透過性かつ滅菌ガス流通性を有する通気部を備え、高圧蒸気滅菌されているシリンジ用組立体包装体。
Claims (14)
- 外筒本体部と、前記外筒本体部の先端部に設けられた穿刺針取付部と、先端に穿刺用針先を有し、前記穿刺針取付部に基端部が固定された穿刺針とを備える外筒と、前記外筒に装着されたシールキャップとからなるシリンジ用組立体であって、
前記シールキャップは、閉塞先端部と、開口基端部と、前記開口基端部より先端側に位置し前記穿刺針取付部の先端部を収納する穿刺針取付部収納部と、前記穿刺針取付部収納部の先端と連続し前記穿刺針を収納する穿刺針収納部とを有する中空部と、前記穿刺針収納部に収納された前記穿刺針の前記穿刺用針先が刺入可能な刺入可能部とを備え、さらに、
前記シールキャップは、ブチルゴムとジエン系ゴムとの混合物をベースポリマーとするゴム組成物により形成され、かつ、前記シールキャップは、前記外筒に装着され、前記穿刺用針先が前記シールキャップの前記刺入可能部に刺入された状態となっていることを特徴とするシリンジ用組立体。 - 前記シリンジ用組立体は、高圧蒸気滅菌されている請求項1に記載のシリンジ用組立体。
- 前記ジエン系ゴムは、ブタジエンゴムを主成分とするものである請求項1または2に記載のシリンジ用組立体。
- 前記ジエン系ゴムは、ブタジエンゴムである請求項1または2に記載のシリンジ用組立体。
- 前記ゴム組成物は、フィラーを含有している請求項1ないし4のいずれかに記載のシリンジ用組立体。
- 前記ゴム組成物における前記ブチルゴムおよび前記ジエン系ゴムは、架橋している請求項1ないし5のいずれかに記載のシリンジ用組立体。
- 前記穿刺針は、先端に前記穿刺用針先を有する中空針であり、かつ、基端部にて前記外筒本体部内と連通している請求項1ないし6のいずれかに記載のシリンジ用組立体。
- 前記シールキャップは、前記穿刺針取付部収納部の内面と前記外筒の前記穿刺針取付部の外面が密着した状態となっている請求項7に記載のシリンジ用組立体。
- 請求項1ないし8のいずれかに記載のシリンジ用組立体と、前記外筒内に収納されかつ前記外筒内を液密に摺動可能なガスケットと、前記外筒と前記ガスケットにより形成された空間内に充填された薬剤とからなることを特徴とするプレフィルドシリンジ。
- 外筒本体部と、前記外筒本体部の先端部に設けられた穿刺針取付部と、先端に穿刺用針先を有し、前記穿刺針取付部に基端部が固定された穿刺針とを備える外筒に装着される穿刺針付外筒用シールキャップであって、
前記シールキャップは、閉塞先端部と、開口基端部と、前記開口基端部より先端側に位置し前記穿刺針取付部を収納する穿刺針取付部収納部と前記穿刺針取付部収納部の先端と連続し前記穿刺針を収納する穿刺針収納部とを有する中空部と、前記穿刺針収納部に収納された前記穿刺針の前記穿刺用針先が刺入可能な刺入可能部と、前記穿刺針取付部収納部の内面に形成された突出部とを備え、さらに、
前記シールキャップは、ブチルゴムとジエン系ゴムとの混合物をベースポリマーとするゴム組成物により形成されていることを特徴とする穿刺針付外筒用シールキャップ。 - 前記ジエン系ゴムは、ブタジエンゴムを主成分とするものである請求項10に記載の穿刺針付外筒用シールキャップ。
- 前記ジエン系ゴムは、ブタジエンゴムである請求項10に記載の穿刺針付外筒用シールキャップ。
- 前記シールキャップは、前記穿刺針取付部収納部の内面に形成された張付抑制面を備えている請求項10ないし12のいずれかに記載の穿刺針付外筒用シールキャップ。
- 複数の請求項1ないし8のいずれかに記載のシリンジ用組立体を収納したシリンジ用組立体包装体であって、
前記包装体は、上面が開口し、かつ保形性を有する容器体と、複数の前記シリンジ用組立体を保持可能な外筒保持部材と、前記外筒保持部材に保持された複数のシリンジ用組立体と、前記容器体の上面開口を気密に封止するとともに剥離可能なシート状蓋部材とを備え、さらに、前記包装体は、前記容器体もしくは前記蓋部材に設けられた菌不透過性かつ滅菌ガス流通性を有する通気部を備え、高圧蒸気滅菌されていることを特徴とするシリンジ用組立体包装体。
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JPWO2018062441A1 (ja) * | 2016-09-28 | 2019-07-25 | テルモ株式会社 | シリンジ用組立体、プレフィルドシリンジ、穿刺針付外筒用シールキャップおよびシリンジ用組立体包装体 |
EP3520845A4 (en) * | 2016-09-28 | 2020-06-24 | Terumo Kabushiki Kaisha | SYRINGE ARRANGEMENT, PRE-FILLED SYRINGE, LOCKING CAP FOR CYLINDERS WITH POINTING NEEDLE AND SYRINGE ARRANGEMENT PACKAGING |
JP7058466B2 (ja) | 2017-01-06 | 2022-04-22 | 住友ゴム工業株式会社 | ノズルキャップ及び医療用プレフィルドシリンジ |
Also Published As
Publication number | Publication date |
---|---|
JP6858561B2 (ja) | 2021-04-14 |
US20170203052A1 (en) | 2017-07-20 |
CN107106786A (zh) | 2017-08-29 |
EP3202447A4 (en) | 2018-06-13 |
CN107106786B (zh) | 2024-04-26 |
EP3202447A1 (en) | 2017-08-09 |
JPWO2016051989A1 (ja) | 2017-07-13 |
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