WO2012101669A1 - Gasket for syringe and pre-filled syringe using same - Google Patents

Gasket for syringe and pre-filled syringe using same Download PDF

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Publication number
WO2012101669A1
WO2012101669A1 PCT/JP2011/000377 JP2011000377W WO2012101669A1 WO 2012101669 A1 WO2012101669 A1 WO 2012101669A1 JP 2011000377 W JP2011000377 W JP 2011000377W WO 2012101669 A1 WO2012101669 A1 WO 2012101669A1
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WO
WIPO (PCT)
Prior art keywords
gasket
syringe
cylinder
base member
piston
Prior art date
Application number
PCT/JP2011/000377
Other languages
French (fr)
Japanese (ja)
Inventor
晃 四ッ辻
Original Assignee
有限会社コーキ・エンジニアリング
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Publication date
Application filed by 有限会社コーキ・エンジニアリング filed Critical 有限会社コーキ・エンジニアリング
Priority to JP2012554476A priority Critical patent/JPWO2012101669A1/en
Priority to PCT/JP2011/000377 priority patent/WO2012101669A1/en
Publication of WO2012101669A1 publication Critical patent/WO2012101669A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—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
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31515—Connection of piston with piston rod

Definitions

  • the present invention relates to pharmaceutical, the syringe relates especially prefilled syringe using the same gasket and a suitable syringe prefilled syringes for use in administering a drug solution to a human body or animal in the medical field.
  • the cylinder which is the syringe barrel and chemical solution container, is prefilled with a chemical solution for injection, and the tip part to which the injection needle is attached is sealed and sealed with a cap and the rear end part of the cylinder is sealed with a gasket.
  • the cylinder is transported and stored in a sealed state, and when a drug solution is administered, an injection needle is attached to the tip of the cylinder, then a piston (push bar) is pushed in and the gasket is slid in the direction of the cylinder.
  • a piston push bar
  • Prefilled syringes are characterized by the fact that they can be administered in an accurate amount without misuse of the chemical solution, and the transfer of the chemical solution is unnecessary, and microbial contamination of the chemical solution caused by such work can be prevented. Because it has, it is not limited to the short-term use type that is used within one season (those that were not used during the season are discarded), such as vaccines for preventing influenza, as well as for disaster response stockpiling There is a demand for the development of prefilled syringes that can be used for long-term use types that are stored for several seasons.
  • the gasket is formed of butyl rubber.
  • the surface of the gasket is used. It is necessary to apply silicone grease to the inner surface of the cylinder, and the titer decreases due to the silicone grease adsorbing the active ingredient in the chemical solution, and the chemical solution is contaminated by the silicone fine particles in the silicone grease and this causes damage to the human body. Negative effects were seen as a problem.
  • a gasket 1 as shown in FIG. 8 has been developed (see, for example, Patent Document 1).
  • the gasket 1 has a resin film 3 laminated on the surface of the gasket body 2 to improve the slidability with respect to the cylinder 4 and eliminates the need to apply silicone grease to the inner surface of the cylinder 4, resulting from the silicone grease. The above problem is avoided.
  • the butyl rubber constituting the gasket body 2 contains a low-molecular-weight soluble component (contaminant) that causes contamination (contamination) of the chemical solution filled in the cylinder 4 and oozes out from the butyl rubber. Since the low molecular weight contaminants permeate the resin film 3 laminated on the surface of the gasket body 2 and contaminate the chemical solution, the quality maintenance period of the prefilled syringe using the gasket 1 of Patent Document 1 must be shortened. If it was a short-term use type, the gasket 1 could not be used for a long-term use type.
  • the gasket body 2 is made of “silicone rubber”, since the silicone rubber is a high molecular weight substance, even if the high molecular weight substance oozes out, it can pass through the resin film 3. Because there is no, there is no need to worry about chemical contamination. In addition, when silicone rubber is heated / pressurized and then returned to normal temperature / normal pressure, the deformation rate is about 2 to 3% compared to about 17% for butyl rubber. Even so, the gasket 1 is difficult to deform.
  • silicone rubber has a very high water permeability compared to butyl rubber, and when the gasket body 2 is made of silicone rubber and used in a prefilled syringe, the drug solution (or in the solution) filled in the prefilled syringe is used. Of water) permeate the resin film 3 and the gasket main body 2 made of silicone rubber and dissipate from the back surface 2a of the gasket main body 2 to the outside air. As a result, the amount of the chemical solution decreases during storage of the prefilled syringe, or the concentration of the chemical solution increases due to a decrease in only the water content in the chemical solution. There is a problem that the advantage of the prefilled syringe that “can be” is lost.
  • the present invention has been developed in view of such problems of the prior art. Therefore, as a matter of course, the main problem of the present invention is that the slidability with respect to the cylinder is good, and by using silicone rubber for the gasket body, the problem of the conventional gasket body made of butyl rubber is solved, Furthermore, it is an object of the present invention to provide an optimum gasket for a prefilled syringe by solving a problem caused by “water permeability” of silicone rubber.
  • the invention described in claim 1 is described as follows: “a gasket body 12 made of silicone rubber having a recess 16 formed on the back side X to which the piston P is attached; A slidable film 20 covering the sliding surface and the tip surface of the gasket body 12, and A base member 14 made of water-impermeable plastic and attached to the recess 16;
  • the base member 14 includes a base main body 15 that is fitted into the recess 16, a screw hole 18 that is provided on the back side X of the base main body 15 and into which a tip end portion of the piston P is screwed, and the base main body 15.
  • the syringe gasket 10 is provided so as to protrude from the peripheral edge on the back surface side X and has a flange 21 that covers the entire back surface peripheral edge portion 12 a of the gasket body 12.
  • the base member 14 made of water-impermeable plastic that is attached to the concave portion 16 is provided with the flange portion 21 that covers the entire rear surface peripheral edge portion 12 a of the gasket body 12.
  • the main body 15 prevents contact between the inner side surface 16a of the recess 16 and the outside air, and the flange portion 21 provided on the base member 14 makes contact between the entire back surface peripheral edge portion 12a of the gasket main body 12 and the outside air. Is preventing.
  • the gasket body 12 is formed of silicone rubber, there is no concern that the chemical solution is contaminated as in the conventional gasket made of butyl rubber, and the heat treatment is performed. However, since the gasket body 12 is not easily deformed, a gap is formed between the inner surface of the cylinder C and the chemical liquid spills out. On the contrary, the gasket 10 is tightly fitted into the cylinder C, and the gasket 10 does not move easily. Can be avoided.
  • the flange portion 21 properly guides the movement of the gasket 10, and the gasket There is no possibility of being pushed in the state in which the cylinder 10 is inclined in the cylinder C.
  • the “water-impermeable” of the water-impermeable plastic constituting the base member 14 is not limited to “no water permeability at all”, and the quality and quantity of the chemical solution in the syringe are within the quality assurance period of the prefilled syringe. “A slight amount of water permeability” that does not cause a problem is also included in the “non-water permeability” referred to in the present invention.
  • the invention described in claim 2 relates to an improvement of the syringe gasket 10 described in claim 1, “From the peripheral edge of the flange portion 21, a guide portion 24 is provided so as to project toward the distal end surface side, and the guide The back side X end portion of the gasket body 12 is fitted in the base recess 26 formed by the portion 24, the flange portion 21 and the base body 15. "
  • the male screw of the piston P is screwed into the screw hole 18 of the base member 14 and the gasket 10 is pushed in.
  • the outer peripheral surface of the guide portion 24 slides on the inner surface of the cylinder C, so that the gasket 10 can be more stably compared to the case where the guide portion 24 is guided by the peripheral end of the flange portion 21 as in claim 1. You will be able to guide the movement.
  • the tip surface of the gasket 10 receives the filling pressure of the chemical solution M.
  • the central portion of the gasket body 12 is recessed by the pressure applied to the center portion of the distal end surface (the portion corresponding to the base body 15 of the base member 14), and the opening of the recess 16 in the gasket body 12 is opened.
  • the base member 14 may be pushed out.
  • the X-side end of the back surface side of the gasket body 12 is fitted in the base concave portion 26 constituted by the guide portion 24, the flange portion 21, and the base body 15, so that the gasket is used as described above. Even if the tip surface of 10 receives the filling pressure of the chemical solution M, the opening of the recess 16 in the gasket body 12 can be prevented from opening, so that the possibility that the base member 14 is pushed out of the recess 16 can be avoided. become able to.
  • the invention described in claim 3 relates to the syringe gasket 10 described in claim 1 or 2, wherein “the slidable film 20 is a PTFE film, The joint surface between the gasket main body 12 and the PTFE film 20 is subjected to an adhesion improving process ”.
  • PTFE polytetrafluoroethylene, tetrafluoride
  • the PTFE film 20 is hardly adhesive and the bonding force with the silicone rubber constituting the gasket main body 12 is extremely weak, even if the PTFE film 20 is simply bonded to the gasket main body 12, the desired molded product is obtained.
  • the adhesion improving treatment is applied to the joint surface between the gasket main body 12 and the PTFE film 20, the hardly adhesive PTFE film 20 and the gasket main body 12 are molded. Can be firmly joined.
  • composition improvement treatment As described later, “disposition of the silica fine particle layer 22”, “chemical treatment with metallic sodium”, or “plasma treatment in an argon atmosphere” can be considered.
  • the invention described in claim 4 relates to the syringe gasket 10 described in claims 1 to 3, wherein “the base member 14 is any one selected from high-density polyethylene, polypropylene, cycloolefin polymer, and cyclic olefin copolymer”. It is made of a plastic material.
  • the slidable film covering the sliding surface of the gasket body ensures good slidability with respect to the cylinder, and the gasket body made of silicone rubber holds the conventional butyl rubber gasket body.
  • the back surface of the gasket body (the inner surface of the recess and the peripheral edge on the back surface around the recess) is covered with a non-permeable base member, so that the solution in the syringe (or in the solution) water) is by also solving problems caused by the "water-permeable" with silicone rubber to minimize the risk of being dissipated to the outside air, it was possible to provide an optimum gasket for the prefilled syringe.
  • FIG. 1 is a cross-sectional view showing a syringe gasket 10 of the present invention
  • FIG. 2 is a cross-sectional view showing a prefilled syringe A to which the syringe gasket 10 is applied.
  • the prefilled syringe A is generally composed of a syringe gasket 10 (hereinafter simply referred to as “gasket 10”), a cylinder C, a piston P, and a cap K.
  • gasket 10 a syringe gasket 10
  • cylinder C a cylinder C
  • piston P a piston
  • cap K a cap K
  • M is a chemical solution (injection solution) filled in the syringe A.
  • the gasket 10 is a slidable film laminated on the sliding surface of the gasket body 12, the base member 14, and the sliding surface of the gasket body 12 with the inner surface of the cylinder C and the tip surface facing the chemical M. 20.
  • the base member 14 is a substantially columnar member made of a non-permeable plastic having a softening point higher than that of the silicone rubber forming the gasket body 12, and as shown in FIG.
  • the main body 15 is provided on the back side X of the base main body 15, and is provided with a screw hole 18 into which the tip end portion of the piston P is screwed, and protrudes from the peripheral edge on the back side X of the base main body 15. It is comprised with the collar part 21 which covers the front surface of the back side peripheral edge part 12a.
  • the base member 14 is fitted into the concave portion 16 of the gasket body 12 in such a direction that the screw hole 18 opens to the outside (rear side X).
  • the outer diameter of the collar part 21 should just be set to the dimension which can cover the whole surface of the back surface side peripheral part 12a of the gasket main body 12 (it becomes a dimension substantially equal to the internal diameter of the cylinder C), and FIG.
  • the outer peripheral surface of the flange portion 21 may be covered with the slidable film 20 by setting it flush with the outer edge of the rear peripheral edge 12a of the gasket body 12, as shown in FIG.
  • the thickness of the slidable film 20 (and a silica fine particle layer 22 to be described later if necessary)
  • it is set to be flush with the outer surface of the slidable film 20, and the outer peripheral surface of the flange portion 21 is exposed. It is good also as an aspect which does.
  • the gasket 10 is attached by screwing the tip end portion of the piston P into the screw hole 18 of the base member 14.
  • the flange portion 21 properly guides the movement of the gasket 10, and there is no possibility that the gasket 10 is pushed in an oblique direction in the cylinder C.
  • any non-water-permeable plastic having a softening point higher than that of silicone rubber and exhibiting high adhesiveness with silicone rubber can be used, but it is highly versatile. It is preferred to use high density polyethylene (HDPE), polypropylene, cycloolefin polymer (COP), or cyclic olefin copolymer (COC).
  • HDPE high density polyethylene
  • COP cycloolefin polymer
  • COC cyclic olefin copolymer
  • a guide portion 24 that protrudes from the peripheral edge of the flange portion 21 toward the distal end surface side of the gasket 10, and is configured by the guide portion 24, the flange portion 21, and the base body 15. At least the back side X end of the gasket body 12 may be fitted into the recess 26 (in the illustrated embodiment, not only the gasket body 12 but also the back side X end of the slidable film 20 is fitted together. Yes.)
  • the tip surface of the gasket 10 receives the filling pressure of the chemical solution M.
  • the central portion of the gasket body 12 is recessed by the pressure applied to the center portion of the distal end surface (the portion corresponding to the base body 15 of the base member 14), and the opening of the recess 16 in the gasket body 12 is opened.
  • the base member 14 may be pushed out.
  • the X-side end of the back surface side of the gasket body 12 is fitted in the base concave portion 26 constituted by the guide portion 24, the flange portion 21, and the base body 15, so that the gasket is used as described above. Even if the tip surface of 10 receives the filling pressure of the chemical solution M, it is possible to prevent the opening of the recess 16 in the gasket body 12 from being opened. become able to.
  • the slidable film 20 (FIG. 1) is formed on the sliding surface of the gasket body 12 laminated on the sliding surface of the gasket body 12 with the inner surface of the cylinder C (that is, the outer peripheral side surface of the gasket body 12) and the front end surface.
  • a PTFE (polytetrafluoroethylene, tetrafluoroethylene) film 20 is used.
  • a material other than the PTFE film may be used as the slidable film 20, but in view of the purpose of imparting high slidability to the gasket 10, it is preferable to use a PTFE film as in this embodiment. is there.
  • the thickness of the PTFE film 20 is set to 20 ⁇ m or more and 80 ⁇ m or less before lamination on the gasket body 12. This is because when the thickness of the PTFE film 20 is less than 20 ⁇ m, it is difficult to obtain the PTFE film 20 economically, and conversely, when the thickness of the PTFE film 20 is greater than 80 ⁇ m, the elasticity of the gasket body 12 is sufficient. This is because it is impossible to obtain a reliable sealing property when it is exhibited.
  • the PTFE film 20 is laminated on the gasket body 12 by injection molding as will be described later (the thickness of the PTFE film 20 after lamination is 10 ⁇ m to 20 ⁇ m), and also inhibits the elasticity of the gasket body 12. In order to prevent this, it is preferable to exhibit an elongation of at least about 250 to 650% (more strictly speaking, elongation at break). If the elongation is 300% or less, the PTFE film 20 may be torn during molding (stretching) of the gasket 10 to be described later, so that the slidable film 20 is modified, crystallized, or oriented. It is more preferable to use a controlled PTFE film 20 having an elongation of 300% or more.
  • the manufacturing method of the PTFE film 20 can employ a method of forming PTFE into a sheet using a casting method, a method of forming PTFE into a block and then slicing with a blade, or skiving.
  • the PTFE film 20 is hardly adhesive and has a problem that the bonding force with the silicone rubber gasket main body 12 is extremely weak. Therefore, the bonding surface between the PTFE film 20 and the gasket main body 12 has “adhesion”.
  • the silica fine particle layer 22 is provided on the joint surface between the PTFE film 20 and the gasket body 12 as the “adhesion improving process”.
  • chemical treatment with metallic sodium or plasma treatment in an argon atmosphere may be performed.
  • the silica fine particle layer 22 includes a binder 22a and silica (SiO 2 ) fine particles 22b. Due to the affinity with the gasket main body 12 and the anchor effect that the silica fine particles 22b have, the hardly-adhesive PTFE film 20 and the gasket main body 12 Can be firmly joined.
  • the silica fine particles 22b constituting the silica fine particle layer 22 are bonded to the surface of the PTFE film 20 in a state where they are exposed to some extent from the binder 22a, and this exposed portion bites into the surface of the gasket main body 12 and exhibits an anchor effect. .
  • Specific examples of the method for forming the silica fine particle layer 22 on the surface of the PTFE film 20 include the following two methods.
  • the first method uses a PFA resin as the binder 22a for fixing the silica fine particles 22b to the surface of the PTFE film 20.
  • the silica fine particles 22b and a surfactant are mixed in an aqueous dispersion of the PFA resin.
  • the mixed dispersion obtained by stirring is uniformly coated on one side of the PTFE film 20 using a known coating method (for example, spray method or roll coating method), and introduced into a furnace (not shown) at 100 ° C.
  • the PFA resin is baked at 250 to 360 ° C. using an apparatus capable of maintaining the shape of the PTFE film 20.
  • the PFA resin as the binder 22a is integrated with the PTFE film 20, and the silica fine particles 22b can be firmly fixed to the surface of the PTFE film 20. Further, by firing in an apparatus capable of maintaining the above shape and in a temperature range, it is possible to prevent the elongation of the PTFE film 20 from being lowered, and as a result, the gasket 10 is preferably manufactured by compression molding or injection molding ( That is, the PTFE film 20 can be prevented from inhibiting the elasticity of the gasket body 12.
  • the second method is a method using a varnish in which perfluoro fluororesin and PFA powder are mixed as the binder 22a for fixing the silica fine particles 22b to the surface of the PTFE film 20.
  • the perfluoro fluororesin and the silica fine particles are used.
  • the varnish obtained by dispersing 22b in a perfluoro solvent for example, CT-solv.100 manufactured by Asahi Glass Co., Ltd.
  • a perfluoro solvent for example, CT-solv.100 manufactured by Asahi Glass Co., Ltd.
  • the thickness of the silica fine particle layer 22 formed by each method as described above is preferably in the range of 0.5 ⁇ m to 10 ⁇ m. This is because, within such a range, the PTFE film 20 and the elasticity of the gasket main body 12 can be firmly joined to each other without hindering the elasticity.
  • the average particle size of the silica fine particles 22b constituting the silica fine particle layer 22 is preferably in the range of 0.02 ⁇ m to 10 ⁇ m, more preferably in the range of 0.05 ⁇ m to 2 ⁇ m.
  • the average particle size of the silica fine particles 22b is less than 0.05 ⁇ m, it becomes difficult to handle the silica fine particles 22b and it is difficult to economically manufacture the silica fine particles 22b. This is because when the average particle diameter of the silica particles is larger than 10 ⁇ m, the specific surface area of the silica fine particles 22b becomes small and a sufficient anchoring effect cannot be exerted on the gasket body 12.
  • the cylinder C (FIG. 2) has a needle mounting portion c1 at the front end, a finger hooking portion c2 at the rear end, and a cylindrical chemical liquid filling portion c3 formed between them, and is formed of a cyclic polyolefin in this embodiment.
  • the shape of the cylinder C is not limited to that shown in the figure, and the material of the cylinder C can be polypropylene, glass, or the like.
  • the piston P is a rod-shaped member provided with a gasket mounting part p1 at the front end and a finger rest part p2 at the rear end.
  • a male screw that is screwed into the screw hole 18 of the base member 14 in the gasket 10 is formed in the gasket mounting portion p1 of the piston P.
  • the piston P is also made of resin such as cyclic polyolefin, polycarbonate, and polypropylene, glass, and the like, similar to the cylinder C described above.
  • the cap K is basically formed of the same material as the cylinder C, and the needle mounting part c1 of the cylinder C is airtightly covered, and the chemical liquid filled in the cylinder C leaks from the needle mounting part c1 undesirably. It has a role to prevent the release.
  • the procedure for manufacturing the prefilled syringe A as described above will be described focusing on the manufacturing procedure of the gasket 10 by insert molding.
  • the manufacturing method of the gasket 10 is not limited to the insert molding described below, and any method may be used.
  • the gasket 10 opens the mold Z (FIG. 7A), inserts a base member 14 molded in advance into a predetermined shape, and has a silica fine particle on the surface by the method described above.
  • the PTFE film 20 on which the layer 22 is formed is placed on the opening surface of the mold (FIG. 7B), and then the silicone rubber Y that is the raw material of the gasket body 12 is clamped in a predetermined state.
  • the desired PTFE film 20 is engraved in the mold.
  • the pre-filled syringe A is completed by fitting the manufactured gasket 10 into the cylinder C which has been molded in advance, and filling the chemical solution M from the tip of the cylinder C (needle mounting portion c1).
  • the non-water-permeable plastic base member 14 having the flange 21 is attached to the recess 16 of the gasket body 12, and the inner surface 16a of the recess 16 comes into contact with the outside air.
  • the flange portion 21 covers the entire surface of the back side peripheral portion 12a of the gasket body 12 and prevents the back side peripheral portion 12a from coming into contact with the outside air.
  • the gasket body 12 is formed of silicone rubber, there is no fear that the chemical solution is contaminated unlike the conventional gasket made of butyl rubber, and the gasket body 12 is not affected by heat sterilization. Since it is difficult to deform, it can be avoided that a gap is formed between the inner surface of the cylinder C and the chemical liquid spills out, or conversely, the gasket 10 is tightly fitted to the cylinder C and the gasket 10 is not easily moved.
  • the PTFE film 20 and the gasket body 12 can be firmly joined. As a result, it is possible to provide the gasket 10 that is extremely slidable with respect to the cylinder C and that does not have to worry about the PTFE film 20 being detached from the gasket body 12 due to vibration or impact.

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

Abstract

Provided is a gasket optimized for a pre-filled syringe, which has high sliding performance on a cylinder (C) by using a sliding film (20), deals with a problem of an existing gasket main body formed of isobutylene-isoprene rubber by using a gasket main body (12) formed of silicon rubber, and minimizes a concern that a liquid medicine (M) in the cylinder (C) (or moisture in the liquid medicine) may be dissipated to outside air and deals with a problem caused by permeability of the silicon rubber by covering a rear side (X) of the gasket main body (12) (an inner side surface (16a) of a concavity (16), and a rear-side circumferential edge portion (12a) near the concavity (16)) with a non-permeable plastic base body (15) and a flange portion (21).

Description

シリンジ用ガスケットおよびそれを用いたプレフィルドシリンジGasket for syringe and prefilled syringe using the same
　本発明は、医薬、医療分野において薬液を人体あるいは動物に投与する際に使用されるシリンジ、とりわけプレフィルドシリンジに好適なシリンジ用ガスケットおよびそれを用いたプレフィルドシリンジに関する。 The present invention relates to pharmaceutical, the syringe relates especially prefilled syringe using the same gasket and a suitable syringe prefilled syringes for use in administering a drug solution to a human body or animal in the medical field.
　注射筒兼薬液容器となるシリンダ内に、予め注射用の薬液を充填しておき、注射針が取り付けられる先端部分をキャップ等で密閉・封止するとともに、シリンダの後端部分をガスケットで密閉・封止した状態で輸送、保管し、薬液投与の際には当該シリンダの先端部分に注射針を取り付けた後、ピストン（押し棒）を押し込んでガスケットをシリンダの先端方向に摺動させることによりシリンダ内の薬液を投与する、いわゆるプレフィルドシリンジが近年多用されるようになってきている。 The cylinder, which is the syringe barrel and chemical solution container, is prefilled with a chemical solution for injection, and the tip part to which the injection needle is attached is sealed and sealed with a cap and the rear end part of the cylinder is sealed with a gasket. The cylinder is transported and stored in a sealed state, and when a drug solution is administered, an injection needle is attached to the tip of the cylinder, then a piston (push bar) is pushed in and the gasket is slid in the direction of the cylinder. In recent years, so-called prefilled syringes that administer internal chemical solutions have become widely used.
　プレフィルドシリンジは、薬液を誤用することなく正確な量で投与することができる点や、薬液の移し替え作業が不要であり、かかる作業に起因する薬液の微生物汚染等を防止できる点等に特徴を有していることから、インフルエンザ予防用ワクチンのように１シーズン内で使用される（シーズン中に使用されなかったものは廃棄される）短期使用タイプにとどまらず、災害時対応備蓄用のように数シーズン保管される長期使用タイプにまで対応できるプレフィルドシリンジの開発が求められている。 Prefilled syringes are characterized by the fact that they can be administered in an accurate amount without misuse of the chemical solution, and the transfer of the chemical solution is unnecessary, and microbial contamination of the chemical solution caused by such work can be prevented. Because it has, it is not limited to the short-term use type that is used within one season (those that were not used during the season are discarded), such as vaccines for preventing influenza, as well as for disaster response stockpiling There is a demand for the development of prefilled syringes that can be used for long-term use types that are stored for several seasons.
　ところで、従来のプレフィルドシリンジにおいて、ガスケットは、ブチルゴムで形成されており、このブチルゴム製のガスケットがシリンダの内面を摺動する際の「摺動性の悪さ」を改善するために、当該ガスケットの表面やシリンダの内面にシリコーングリスを塗布する必要があり、シリコーングリスが薬液中の有効成分を吸着してしまうことによる力価低下や、シリコーングリス中のシリコーン微粒子による薬液の汚染およびこれによる人体への悪影響が問題視されていた。 By the way, in the conventional prefilled syringe, the gasket is formed of butyl rubber. In order to improve the “poor slidability” when the gasket made of butyl rubber slides on the inner surface of the cylinder, the surface of the gasket is used. It is necessary to apply silicone grease to the inner surface of the cylinder, and the titer decreases due to the silicone grease adsorbing the active ingredient in the chemical solution, and the chemical solution is contaminated by the silicone fine particles in the silicone grease and this causes damage to the human body. Negative effects were seen as a problem.
　そこで、係る問題を解決すべく、図８に示すようなガスケット１が開発されている（例えば、特許文献１参照）。このガスケット１は、ガスケット本体２の表面に樹脂フィルム３を積層することにより、シリンダ４に対する摺動性を向上させ、シリンダ４の内面へのシリコーングリスの塗布を不要にして当該シリコーングリスに起因する上記問題を回避している。 Therefore, in order to solve such a problem, a gasket 1 as shown in FIG. 8 has been developed (see, for example, Patent Document 1). The gasket 1 has a resin film 3 laminated on the surface of the gasket body 2 to improve the slidability with respect to the cylinder 4 and eliminates the need to apply silicone grease to the inner surface of the cylinder 4, resulting from the silicone grease. The above problem is avoided.
特開平１０－３１４３０５号公報Japanese Patent Laid-Open No. 10-314305
　しかしながら、特許文献１のガスケット１をプレフィルドシリンジに使用するには幾つかの問題があった。 However, there are some problems in using the gasket 1 of Patent Document 1 for a prefilled syringe.
　すなわち、ガスケット本体２を構成するブチルゴムには、シリンダ４内に充填された薬液の汚染（コンタミネーション）の原因となる低分子量の可溶性成分（汚染物質）が存在しており、ブチルゴムから浸み出した低分子量汚染物質がガスケット本体２の表面に積層された樹脂フィルム３を透過して薬液を汚染することから、特許文献１のガスケット１を使用したプレフィルドシリンジの品質保持可能期間は短くならざるを得ず、短期使用タイプであればまだしも、長期使用タイプに当該ガスケット１を使用することができなかった。 That is, the butyl rubber constituting the gasket body 2 contains a low-molecular-weight soluble component (contaminant) that causes contamination (contamination) of the chemical solution filled in the cylinder 4 and oozes out from the butyl rubber. Since the low molecular weight contaminants permeate the resin film 3 laminated on the surface of the gasket body 2 and contaminate the chemical solution, the quality maintenance period of the prefilled syringe using the gasket 1 of Patent Document 1 must be shortened. If it was a short-term use type, the gasket 1 could not be used for a long-term use type.
　また、シリンダ４に薬液を充填した後、ガスケット１を当該シリンダ４に嵌め込んだ状態で加熱殺菌（例えば、１２０℃・２０分間の蒸気殺菌）を行ったとき、その熱によってブチルゴム製のガスケット本体２が変形してしまい、シリンダ４の内面との間で隙間が生じて薬液がこぼれ出たり、逆にシリンダ４に対するガスケット１の嵌め合い状態がきつくなってガスケット１が容易に動かなくなってしまうおそれがあった。 In addition, after filling the cylinder 4 with a chemical solution, when heat sterilization (for example, steam sterilization at 120 ° C. for 20 minutes) is performed with the gasket 1 fitted in the cylinder 4, the heat causes the butyl rubber gasket main body. 2 may be deformed, and a gap may be formed between the inner surface of the cylinder 4 and the chemical solution may spill out. On the contrary, the fitting state of the gasket 1 to the cylinder 4 may be tight and the gasket 1 may not move easily. was there.
　これに対し、ガスケット本体２を「シリコーンゴム」で構成すれば、シリコーンゴムは高分子量物質であることから、万一、当該高分子量物質が浸み出したとしても樹脂フィルム３を透過することがないので、薬液が汚染される心配がなくなる。また、シリコーンゴムを加温・加圧した後、常温・常圧に戻したときの変形率は、ブチルゴムが約１７％であるのに対し、２～３％と非常に小さいことから、加熱殺菌してもガスケット１が変形しにくくなる。 On the other hand, if the gasket body 2 is made of “silicone rubber”, since the silicone rubber is a high molecular weight substance, even if the high molecular weight substance oozes out, it can pass through the resin film 3. Because there is no, there is no need to worry about chemical contamination. In addition, when silicone rubber is heated / pressurized and then returned to normal temperature / normal pressure, the deformation rate is about 2 to 3% compared to about 17% for butyl rubber. Even so, the gasket 1 is difficult to deform.
　しかしながら、このような利点を有するシリコーンゴムであっても、シリンジ用のガスケット１に使用するには致命的な問題があった。 However, even silicone rubber having such advantages has a fatal problem when used for the gasket 1 for a syringe.
　すなわち、シリコーンゴムは、ブチルゴムに比べて非常に高い透水性を有しており、シリコーンゴムでガスケット本体２を構成し、プレフィルドシリンジに用いた場合、当該プレフィルドシリンジに充填された薬液（あるいは薬液中の水分）が樹脂フィルム３およびシリコーンゴム製のガスケット本体２を透過し、ガスケット本体２の背面２ａから外気に放散してしまう。この結果、プレフィルドシリンジの保管中に薬液量が減少し、あるいは薬液中の水分だけが減少することによって薬液の濃度が高くなってしまい、「薬液を誤用することなく正確な量で投与することができる」というプレフィルドシリンジの利点が失われるという問題があった。 That is, silicone rubber has a very high water permeability compared to butyl rubber, and when the gasket body 2 is made of silicone rubber and used in a prefilled syringe, the drug solution (or in the solution) filled in the prefilled syringe is used. Of water) permeate the resin film 3 and the gasket main body 2 made of silicone rubber and dissipate from the back surface 2a of the gasket main body 2 to the outside air. As a result, the amount of the chemical solution decreases during storage of the prefilled syringe, or the concentration of the chemical solution increases due to a decrease in only the water content in the chemical solution. There is a problem that the advantage of the prefilled syringe that “can be” is lost.
　本発明は、このような従来技術の問題点に鑑みて開発されたものである。それゆえに本発明の主たる課題は、シリンダに対する摺動性が良好であることは当然として、ガスケット本体にシリコーンゴムを使用することにより、従来のブチルゴム製ガスケット本体が抱えていた問題を解決するとともに、さらに、シリコーンゴムが有する「透水性」に起因する問題も解決することにより、プレフィルドシリンジ用として最適なガスケットを提供することにある。 The present invention has been developed in view of such problems of the prior art. Therefore, as a matter of course, the main problem of the present invention is that the slidability with respect to the cylinder is good, and by using silicone rubber for the gasket body, the problem of the conventional gasket body made of butyl rubber is solved, Furthermore, it is an object of the present invention to provide an optimum gasket for a prefilled syringe by solving a problem caused by “water permeability” of silicone rubber.
　請求項１に記載した発明は、「ピストンＰが取り付けられる背面側Ｘに凹部１６が形成された、シリコーンゴム製のガスケット本体１２と、
　前記ガスケット本体１２の摺動面および先端面を覆う摺動性フィルム２０と、
　前記凹部１６に取り付けられる、非透水性プラスチック製のベース部材１４とを備えており、
　前記ベース部材１４は、前記凹部１６に嵌め込まれるベース本体１５と、前記ベース本体１５の前記背面側Ｘに設けられ、前記ピストンＰの先端部が螺着されるネジ穴１８と、前記ベース本体１５における前記背面側Ｘの周縁から突設されており、前記ガスケット本体１２の背面側周縁部１２ａ全面を覆う鍔部２１とを有していることを特徴とするシリンジ用ガスケット１０」である。 The invention described in claim 1 is described as follows: “a gasket body 12 made of silicone rubber having a recess 16 formed on the back side X to which the piston P is attached;
A slidable film 20 covering the sliding surface and the tip surface of the gasket body 12, and
A base member 14 made of water-impermeable plastic and attached to the recess 16;
The base member 14 includes a base main body 15 that is fitted into the recess 16, a screw hole 18 that is provided on the back side X of the base main body 15 and into which a tip end portion of the piston P is screwed, and the base main body 15. The syringe gasket 10 ”is provided so as to protrude from the peripheral edge on the back surface side X and has a flange 21 that covers the entire back surface peripheral edge portion 12 a of the gasket body 12.
　この発明によれば、ガスケット本体１２は、シリコーンゴムで形成されており、外気に面する当該ガスケット本体１２の背面側Ｘ（＝ピストンＰが取り付けられる面側）には、凹部１６が設けられている。したがってこのままでは、ガスケット本体１２の摺動面および先端面を覆う摺動性フィルム２０を透過し、さらにガスケット本体１２（シリコーンゴム）を透過した薬液（あるいは薬液中の水分）は、当該凹部１６の内側面１６ａ、および当該凹部１６の周りの背面側周縁部１２ａから外気に放散されることになる。 According to this invention, the gasket body 12 is formed of silicone rubber, and the recess 16 is provided on the back side X of the gasket body 12 facing the outside air (= the surface side to which the piston P is attached). Yes. Therefore, as it is, the chemical solution (or moisture in the chemical solution) that has passed through the slidable film 20 covering the sliding surface and the front end surface of the gasket body 12 and further has passed through the gasket body 12 (silicone rubber) is retained in the recess 16. From the inner side surface 16a and the back side peripheral edge portion 12a around the concave portion 16, it is dissipated to the outside air.
　しかしながら、本発明では、凹部１６に取り付けられる非透水性プラスチック製のベース部材１４に、ガスケット本体１２の背面側周縁部１２ａの全面を覆う鍔部２１が設けられており、このベース部材１４におけるベース本体１５が、凹部１６の内側面１６ａと外気との接触を防止しているとともに、ベース部材１４に設けられた鍔部２１が、ガスケット本体１２の背面側周縁部１２ａの全面と外気との接触を防止している。 However, in the present invention, the base member 14 made of water-impermeable plastic that is attached to the concave portion 16 is provided with the flange portion 21 that covers the entire rear surface peripheral edge portion 12 a of the gasket body 12. The main body 15 prevents contact between the inner side surface 16a of the recess 16 and the outside air, and the flange portion 21 provided on the base member 14 makes contact between the entire back surface peripheral edge portion 12a of the gasket main body 12 and the outside air. Is preventing.
　これにより、シリンジＡ内の薬液（あるいは薬液中の水分）がガスケット本体１２を透過して外気に放散されるおそれを極小化することができる。 This makes it possible to minimize the possibility that the chemical solution in the syringe A (or the water in the chemical solution) permeates the gasket body 12 and is diffused to the outside air.
　もちろん、上述のように、ガスケット本体１２はシリコーンゴムで形成されていることから、ブチルゴム製の従来のガスケットのように薬液が汚染される心配がなく、かつ、加熱殺菌を行った場合であってもガスケット本体１２が変形し難いので、シリンダＣの内面との間で隙間が生じて薬液がこぼれ出たり、逆にシリンダＣに対するガスケット１０の嵌め合い状態がきつくなってガスケット１０が容易に動かなくなるのを回避できる。 Of course, as described above, since the gasket body 12 is formed of silicone rubber, there is no concern that the chemical solution is contaminated as in the conventional gasket made of butyl rubber, and the heat treatment is performed. However, since the gasket body 12 is not easily deformed, a gap is formed between the inner surface of the cylinder C and the chemical liquid spills out. On the contrary, the gasket 10 is tightly fitted into the cylinder C, and the gasket 10 does not move easily. Can be avoided.
　また、ベース部材１４のネジ穴１８にピストンＰの先端部を螺着してガスケット１０をシリンダＣ内に押し込んでいく際、鍔部２１がガスケット１０の動きを適正にガイドするようになり、ガスケット１０がシリンダＣ内で斜めに向いた状態で押し込まれるおそれがなくなる。 Further, when the tip end of the piston P is screwed into the screw hole 18 of the base member 14 and the gasket 10 is pushed into the cylinder C, the flange portion 21 properly guides the movement of the gasket 10, and the gasket There is no possibility of being pushed in the state in which the cylinder 10 is inclined in the cylinder C.
　さらに言えば、特許文献１のガスケット１では、ガスケット本体２（＝ブチルゴム）にピストン５を螺着するネジ穴６が形成されていたことから、螺着したピストン５を引っ張ったとき（例えば採血時）、可撓性を有するブチルゴムでできたネジ穴６の山６ａが引っ張り方向に撓んでピストン５がネジ穴６からすっぽ抜けるおそれがあったが、本発明では、ピストンＰが螺着されるネジ穴１８は、プラスチック製のベース部材１４に設けられていることから、螺着したピストンＰを引っ張ったとしても、ネジ穴１８の山が引っ張り方向に撓んでピストンＰがネジ穴１８からすっぽ抜けるおそれがない。 Furthermore, in the gasket 1 of Patent Document 1, since the screw hole 6 for screwing the piston 5 is formed in the gasket body 2 (= butyl rubber), when the screwed piston 5 is pulled (for example, during blood collection) ), There is a possibility that the crest 6a of the screw hole 6 made of flexible butyl rubber is bent in the pulling direction and the piston 5 is completely removed from the screw hole 6. In the present invention, the piston P is screwed. Since the screw hole 18 is provided in the plastic base member 14, even if the screwed piston P is pulled, the crest of the screw hole 18 bends in the pulling direction so that the piston P completely extends from the screw hole 18. There is no risk of falling out.
　なお、ベース部材１４を構成する非透水性プラスチックの「非透水性」は、「透水性が全く無いこと」だけに限られず、プレフィルドシリンジの品質保証期間であればシリンジ内の薬液の品質や量に問題が生じない程度の「微量の透水性」も、本発明にいう「非透水性」に含まれる。 The “water-impermeable” of the water-impermeable plastic constituting the base member 14 is not limited to “no water permeability at all”, and the quality and quantity of the chemical solution in the syringe are within the quality assurance period of the prefilled syringe. “A slight amount of water permeability” that does not cause a problem is also included in the “non-water permeability” referred to in the present invention.
　請求項２に記載した発明は、請求項１に記載したシリンジ用ガスケット１０の改良に関し、「前記鍔部２１の周縁からは、先端面側に向かうガイド部２４が突設されており、前記ガイド部２４と前記鍔部２１と前記ベース本体１５とで構成されたベース凹部２６に、前記ガスケット本体１２の背面側Ｘ端部が嵌め込まれている」ことを特徴とする。 The invention described in claim 2 relates to an improvement of the syringe gasket 10 described in claim 1, “From the peripheral edge of the flange portion 21, a guide portion 24 is provided so as to project toward the distal end surface side, and the guide The back side X end portion of the gasket body 12 is fitted in the base recess 26 formed by the portion 24, the flange portion 21 and the base body 15. "
　本発明によれば、上述した請求項１に係る発明の作用効果に加えて、図６に示すように、ベース部材１４のネジ穴１８にピストンＰの雄ねじを螺着してガスケット１０を押し込んでいく際、ガイド部２４の外周面がシリンダＣの内面を摺動することになるので、請求項１のように鍔部２１の周端でガイドする場合に比べて、さらに安定してガスケット１０の動きをガイドすることができるようになる。 According to the present invention, in addition to the operational effect of the first aspect of the present invention, as shown in FIG. 6, the male screw of the piston P is screwed into the screw hole 18 of the base member 14 and the gasket 10 is pushed in. When going, the outer peripheral surface of the guide portion 24 slides on the inner surface of the cylinder C, so that the gasket 10 can be more stably compared to the case where the guide portion 24 is guided by the peripheral end of the flange portion 21 as in claim 1. You will be able to guide the movement.
　さらに言えば、ガスケット１０が嵌め込まれたシリンダＣの先端（針装着部ｃ１）から薬液Ｍを充填する際、ガスケット１０の先端面は当該薬液Ｍの充填圧力を受けることになるが、ガスケット１０の先端面の中央部分（ベース部材１４のベース本体１５に対応する部分）に加わる圧力によってガスケット本体１２の中央部分が凹むとともに、当該ガスケット本体１２における凹部１６の開口が開かれることにより、凹部１６からベース部材１４が押し出されてしまうおそれがある。 Furthermore, when the chemical solution M is filled from the tip (needle mounting portion c1) of the cylinder C in which the gasket 10 is fitted, the tip surface of the gasket 10 receives the filling pressure of the chemical solution M. The central portion of the gasket body 12 is recessed by the pressure applied to the center portion of the distal end surface (the portion corresponding to the base body 15 of the base member 14), and the opening of the recess 16 in the gasket body 12 is opened. The base member 14 may be pushed out.
　しかしながら、本発明のガスケット１０では、ガイド部２４と鍔部２１とベース本体１５とで構成されたベース凹部２６にガスケット本体１２の背面側Ｘ端部が嵌り込んでいるので、上述のようにガスケット１０の先端面が薬液Ｍの充填圧力を受けたとしても、ガスケット本体１２における凹部１６の開口が開くのを防止することができるので、凹部１６からベース部材１４が押し出されるおそれを回避することができるようになる。 However, in the gasket 10 of the present invention, the X-side end of the back surface side of the gasket body 12 is fitted in the base concave portion 26 constituted by the guide portion 24, the flange portion 21, and the base body 15, so that the gasket is used as described above. Even if the tip surface of 10 receives the filling pressure of the chemical solution M, the opening of the recess 16 in the gasket body 12 can be prevented from opening, so that the possibility that the base member 14 is pushed out of the recess 16 can be avoided. become able to.
　請求項３に記載した発明は、請求項１または２に記載したシリンジ用ガスケット１０に関し、「前記摺動性フィルム２０は、ＰＴＦＥフィルムであり、
　前記ガスケット本体１２と前記ＰＴＦＥフィルム２０との接合面には、接着性改善処理が施されている」ことを特徴とする。 The invention described in claim 3 relates to the syringe gasket 10 described in claim 1 or 2, wherein “the slidable film 20 is a PTFE film,
The joint surface between the gasket main body 12 and the PTFE film 20 is subjected to an adhesion improving process ”.
　本発明では、ガスケット本体１２の摺動面および先端面を覆う摺動性フィルム２０として、高い摺動性（つまり、摺動時の抵抗が低い）を有するＰＴＦＥ（ポリテトラフルオロエチレン、四フッ化エチレン）フィルム２０が用いられていることから、シリンダＣに対するシリンジ用ガスケット１０の摺動性をより高くして、更に滑らかに摺動させることができる。 In the present invention, PTFE (polytetrafluoroethylene, tetrafluoride) having high slidability (that is, low resistance during sliding) is used as the slidable film 20 covering the sliding surface and the tip surface of the gasket body 12. Since the (ethylene) film 20 is used, the slidability of the syringe gasket 10 with respect to the cylinder C can be made higher and the sliding can be performed more smoothly.
　しかしながら、ＰＴＦＥフィルム２０は難接着性であり、ガスケット本体１２を構成するシリコーンゴムとの接合力が極めて弱いことから、単にＰＴＦＥフィルム２０をガスケット本体１２に接合しようとしても目的の成形品が得られないが、本発明のシリンジ用ガスケット１０では、ガスケット本体１２とＰＴＦＥフィルム２０との接合面に接着性改善処理が施されているので、難接着性のＰＴＦＥフィルム２０とガスケット本体１２とを成形時において強固に接合させることができる。 However, since the PTFE film 20 is hardly adhesive and the bonding force with the silicone rubber constituting the gasket main body 12 is extremely weak, even if the PTFE film 20 is simply bonded to the gasket main body 12, the desired molded product is obtained. However, in the syringe gasket 10 of the present invention, since the adhesion improving treatment is applied to the joint surface between the gasket main body 12 and the PTFE film 20, the hardly adhesive PTFE film 20 and the gasket main body 12 are molded. Can be firmly joined.
　この「接着性改善処理」としては、後述するように、「シリカ微粒子層２２の配設」、「金属ナトリウムによる化学処理」、あるいは「アルゴン雰囲気中でのプラズマ処理」が考えられる。 As the “adhesion improvement treatment”, as described later, “disposition of the silica fine particle layer 22”, “chemical treatment with metallic sodium”, or “plasma treatment in an argon atmosphere” can be considered.
　これにより、シリンダＣに対する摺動性が極めて高く、かつ、振動や衝撃によってガスケット本体１２からＰＴＦＥフィルム２０が外れる心配のないシリンジ用ガスケット１０を提供することができる。 Thus, it is possible to provide the syringe gasket 10 that has extremely high slidability with respect to the cylinder C and that does not cause the PTFE film 20 to be detached from the gasket body 12 due to vibration or impact.
　請求項４に記載した発明は、請求項１ないし３に記載したシリンジ用ガスケット１０に関し、「前記ベース部材１４は、高密度ポリエチレン、ポリプロピレン、シクロオレフィンポリマー、および環状オレフィン系コポリマーから選択されるいずれかのプラスチック材料で形成されている」ことを特徴とする。 The invention described in claim 4 relates to the syringe gasket 10 described in claims 1 to 3, wherein “the base member 14 is any one selected from high-density polyethylene, polypropylene, cycloolefin polymer, and cyclic olefin copolymer”. It is made of a plastic material.
　請求項５に記載した発明は、「薬液Ｍが充填されたシリンダＣと、
　前記シリンダＣを密封する請求項１ないし４のいずれかに記載されたシリンジ用ガスケット１０と、
　前記シリンジ用ガスケット１０を前記シリンダＣの先端に向けて押し込む、先端部が前記ネジ穴１８に螺着されたピストンＰとで構成されたプレフィルドシリンジＡ」である。 The invention described in claim 5 is described as follows: “Cylinder C filled with chemical M,
The syringe gasket 10 according to any one of claims 1 to 4, which seals the cylinder C;
The syringe gasket 10 is pushed toward the tip of the cylinder C, and the tip portion is a prefilled syringe A composed of a piston P screwed into the screw hole 18.
　本発明によれば、ガスケット本体の摺動面を覆う摺動性フィルムによってシリンダに対する良好な摺動性を確保するとともに、当該ガスケット本体をシリコーンゴムで形成することによって従来のブチルゴム製ガスケット本体が抱えていた問題を解決しつつ、さらに、ガスケット本体の背面（凹部の内側面、および凹部の周りの背面側周縁部）を非透水性のベース部材で覆うことにより、シリンジ内の薬液（あるいは薬液中の水分）が外気に放散されるおそれを極小化してシリコーンゴムが有する「透水性」に起因する問題も解決することにより、プレフィルドシリンジ用として最適なガスケットを提供することができた。 According to the present invention, the slidable film covering the sliding surface of the gasket body ensures good slidability with respect to the cylinder, and the gasket body made of silicone rubber holds the conventional butyl rubber gasket body. In addition, the back surface of the gasket body (the inner surface of the recess and the peripheral edge on the back surface around the recess) is covered with a non-permeable base member, so that the solution in the syringe (or in the solution) water) is by also solving problems caused by the "water-permeable" with silicone rubber to minimize the risk of being dissipated to the outside air, it was possible to provide an optimum gasket for the prefilled syringe.
本発明にかかるシリンジ用ガスケットを示す断面図である。It is sectional drawing which shows the gasket for syringes concerning this invention. 本発明にかかるシリンジ用ガスケットが適用されたプレフィルドシリンジを示す断面図である。It is sectional drawing which shows the prefilled syringe to which the gasket for syringes concerning this invention was applied. ベース部材を示す斜視図である。It is a perspective view which shows a base member. シリンジ用ガスケットの他の実施例（鍔部の外周面が露出）を示す断面図である。It is sectional drawing which shows the other Example (The outer peripheral surface of a collar part is exposed) of the gasket for syringes. シリンジ用ガスケットの他の実施例（ガイド部あり）を示す断面図である。It is sectional drawing which shows the other Example (with a guide part) of the gasket for syringes. 他の実施例（ガイド部あり）のシリンジ用ガスケットが適用されたプレフィルドシリンジを示す断面図である。It is sectional drawing which shows the prefilled syringe to which the gasket for syringes of another Example (with a guide part) was applied. シリンジ用ガスケットの製造手順の一例を示す図である。It is a figure which shows an example of the manufacturing procedure of the gasket for syringes. 従来技術を示す図である。It is a figure which shows a prior art.
　以下、本発明を適用したシリンジ用ガスケット１０について、図面を用いて説明する。図１は、本発明のシリンジ用ガスケット１０を示した断面図であり、図２は、当該シリンジ用ガスケット１０が適用されたプレフィルドシリンジＡを示した断面図である。 Hereinafter, the syringe gasket 10 to which the present invention is applied will be described with reference to the drawings. FIG. 1 is a cross-sectional view showing a syringe gasket 10 of the present invention, and FIG. 2 is a cross-sectional view showing a prefilled syringe A to which the syringe gasket 10 is applied.
　図２に示すように、プレフィルドシリンジＡは、大略、シリンジ用ガスケット１０（以下、単に「ガスケット１０」という。）と、シリンダＣと、ピストンＰと、キャップＫとで構成されている。なお、同図中のＭは、シリンジＡ内に充填された薬液（注射液）である。 2, the prefilled syringe A is generally composed of a syringe gasket 10 (hereinafter simply referred to as “gasket 10”), a cylinder C, a piston P, and a cap K. In the figure, M is a chemical solution (injection solution) filled in the syringe A.
　ガスケット１０は、図１に示すように、ガスケット本体１２と、ベース部材１４と、ガスケット本体１２におけるシリンダＣの内面との摺動面および薬液Ｍに面する先端面に積層された摺動性フィルム２０とで構成されている。 As shown in FIG. 1, the gasket 10 is a slidable film laminated on the sliding surface of the gasket body 12, the base member 14, and the sliding surface of the gasket body 12 with the inner surface of the cylinder C and the tip surface facing the chemical M. 20.
　ガスケット本体１２は、シリコーンゴムで形成された略円柱状の部材であり、その背面（＝ピストンＰが取り付けられる面）側Ｘには、ベース部材１４が取り付けられる略円柱状の凹部１６が形成されている。つまり、ガスケット本体１２の背面側Ｘには、凹部１６の内側面１６ａ、および凹部１６の周りの背面側周縁部１２ａが存在する。 The gasket main body 12 is a substantially columnar member formed of silicone rubber, and a substantially columnar recess 16 to which the base member 14 is attached is formed on the back surface (= surface to which the piston P is attached) side X. ing. That is, on the back side X of the gasket body 12, there are the inner side surface 16 a of the recess 16 and the back side peripheral edge 12 a around the recess 16.
　ベース部材１４は、ガスケット本体１２を形成するシリコーンゴムよりも軟化点の高い非透水性のプラスチックで形成された略円柱状の部材であって、図３に示すように、凹部１６に嵌め込まれるベース本体１５と、当該ベース本体１５の背面側Ｘに設けられ、ピストンＰの先端部が螺着されるネジ穴１８と、ベース本体１５における背面側Ｘの周縁から突設されており、ガスケット本体１２の背面側周縁部１２ａの前面を覆う鍔部２１とで構成されている。ベース部材１４は、当該ネジ穴１８が外部（背面側Ｘ）に開口する向きで、ガスケット本体１２の凹部１６に嵌め込まれている。 The base member 14 is a substantially columnar member made of a non-permeable plastic having a softening point higher than that of the silicone rubber forming the gasket body 12, and as shown in FIG. The main body 15 is provided on the back side X of the base main body 15, and is provided with a screw hole 18 into which the tip end portion of the piston P is screwed, and protrudes from the peripheral edge on the back side X of the base main body 15. It is comprised with the collar part 21 which covers the front surface of the back side peripheral edge part 12a. The base member 14 is fitted into the concave portion 16 of the gasket body 12 in such a direction that the screw hole 18 opens to the outside (rear side X).
　なお、鍔部２１の外径は、ガスケット本体１２の背面側周縁部１２ａの全面を覆うことのできる寸法に設定されていればよく（シリンダＣの内径にほぼ等しい寸法になる）、図１に示すように、ガスケット本体１２の背面側周縁部１２ａの外縁と面一に設定し、摺動性フィルム２０で当該鍔部２１の外周面を覆うような態様としてもよいし、図４に示すように、摺動性フィルム２０（および必要に応じて後述するシリカ微粒子層２２）の厚みを考慮して、当該摺動性フィルム２０の外面と面一に設定し、鍔部２１の外周面が露出するような態様としてもよい。 In addition, the outer diameter of the collar part 21 should just be set to the dimension which can cover the whole surface of the back surface side peripheral part 12a of the gasket main body 12 (it becomes a dimension substantially equal to the internal diameter of the cylinder C), and FIG. As shown, the outer peripheral surface of the flange portion 21 may be covered with the slidable film 20 by setting it flush with the outer edge of the rear peripheral edge 12a of the gasket body 12, as shown in FIG. Further, in consideration of the thickness of the slidable film 20 (and a silica fine particle layer 22 to be described later if necessary), it is set to be flush with the outer surface of the slidable film 20, and the outer peripheral surface of the flange portion 21 is exposed. It is good also as an aspect which does.
　このような鍔部２１を設けることにより、加熱殺菌時等の熱によってシリコーンゴムの変形可能温度までガスケット１０が昇温したとき、背面側Ｘからガスケット本体１２が膨出するのを防止できるとともに、ベース部材１４の側周面と鍔部２１とが協働して互いに異なる方向の「骨組み」となることから、鍔部２１を設けない場合に比べてシリコーンゴム（ガスケット本体１２）の変形をより確実に防止することができる。 By providing such a flange 21, it is possible to prevent the gasket body 12 from bulging from the back side X when the gasket 10 is heated to a deformable temperature of the silicone rubber by heat during heat sterilization or the like. Since the side peripheral surface of the base member 14 and the flange portion 21 cooperate to form a “frame” in different directions, the silicone rubber (gasket body 12) is more deformed than when the flange portion 21 is not provided. It can be surely prevented.
　また、鍔部２１の径は、シリンダＣの内径にほぼ等しい（鍔部２１の径が若干小さい）ことから、ベース部材１４のネジ穴１８にピストンＰの先端部を螺着してガスケット１０をシリンダＣ内に押し込んでいく際、鍔部２１がガスケット１０の動きを適正にガイドするようになり、ガスケット１０がシリンダＣ内で斜めに向いた状態で押し込まれるおそれがなくなる。 Further, since the diameter of the flange portion 21 is substantially equal to the inner diameter of the cylinder C (the diameter of the flange portion 21 is slightly smaller), the gasket 10 is attached by screwing the tip end portion of the piston P into the screw hole 18 of the base member 14. When pushing into the cylinder C, the flange portion 21 properly guides the movement of the gasket 10, and there is no possibility that the gasket 10 is pushed in an oblique direction in the cylinder C.
　さらに、ベース部材１４のネジ穴１８にピストンＰの雄ネジ（＝ガスケット装着部ｐ１）を螺着したとき、ガスケット装着部ｐ１の基面ｐ３（図２参照）と鍔部２１とが面接触することにより、ピストンＰをベース部材１４に対してより確実に固定することができる。 Furthermore, when the male screw (= gasket mounting portion p1) of the piston P is screwed into the screw hole 18 of the base member 14, the base surface p3 (see FIG. 2) of the gasket mounting portion p1 and the flange portion 21 are in surface contact. As a result, the piston P can be more securely fixed to the base member 14.
　ベース部材１４の材料としては、シリコーンゴムよりも軟化点が高く、かつ、シリコーンゴムと高い接着性を示す非透水性のプラスチックであればどのようなものでも使用可能であるが、汎用性の高い高密度ポリエチレン（ＨＤＰＥ）、ポリプロピレン、シクロオレフィンポリマー（ＣＯＰ）、あるいは環状オレフィン系コポリマー（ＣＯＣ）を使用することが好適である。 As the material of the base member 14, any non-water-permeable plastic having a softening point higher than that of silicone rubber and exhibiting high adhesiveness with silicone rubber can be used, but it is highly versatile. It is preferred to use high density polyethylene (HDPE), polypropylene, cycloolefin polymer (COP), or cyclic olefin copolymer (COC).
　また、図５に示すように、鍔部２１の周縁から、ガスケット１０の先端面側に向かうガイド部２４を突設し、当該ガイド部２４と鍔部２１とベース本体１５とで構成されたベース凹部２６に、少なくともガスケット本体１２の背面側Ｘ端部を嵌め込むようにしてもよい（図示実施例では、ガスケット本体１２だけでなく、摺動性フィルム２０の背面側Ｘ端部も一緒に嵌め込まれている。）。 Further, as shown in FIG. 5, a guide portion 24 that protrudes from the peripheral edge of the flange portion 21 toward the distal end surface side of the gasket 10, and is configured by the guide portion 24, the flange portion 21, and the base body 15. At least the back side X end of the gasket body 12 may be fitted into the recess 26 (in the illustrated embodiment, not only the gasket body 12 but also the back side X end of the slidable film 20 is fitted together. Yes.)
　この場合、図６に示すように、ベース部材１４のネジ穴１８にピストンＰの雄ねじを螺着してガスケット１０を押し込んでいく際、ガイド部２４の外周面がシリンダＣの内面を摺動することになるので、上述のように鍔部２１の周端でガイドする場合に比べて、さらに安定してガスケット１０の動きをガイドすることができるようになる。 In this case, as shown in FIG. 6, when the gasket 10 is pushed in by screwing the male screw of the piston P into the screw hole 18 of the base member 14, the outer peripheral surface of the guide portion 24 slides on the inner surface of the cylinder C. Therefore, the movement of the gasket 10 can be guided more stably as compared with the case where the guide is performed at the peripheral end of the flange portion 21 as described above.
　さらに言えば、ガスケット１０が嵌め込まれたシリンダＣの先端（針装着部ｃ１）から薬液Ｍを充填する際、ガスケット１０の先端面は当該薬液Ｍの充填圧力を受けることになるが、ガスケット１０の先端面の中央部分（ベース部材１４のベース本体１５に対応する部分）に加わる圧力によってガスケット本体１２の中央部分が凹むとともに、当該ガスケット本体１２における凹部１６の開口が開かれることにより、凹部１６からベース部材１４が押し出されてしまうおそれがある。 Furthermore, when the chemical solution M is filled from the tip (needle mounting portion c1) of the cylinder C in which the gasket 10 is fitted, the tip surface of the gasket 10 receives the filling pressure of the chemical solution M. The central portion of the gasket body 12 is recessed by the pressure applied to the center portion of the distal end surface (the portion corresponding to the base body 15 of the base member 14), and the opening of the recess 16 in the gasket body 12 is opened. The base member 14 may be pushed out.
　しかしながら、本発明のガスケット１０では、ガイド部２４と鍔部２１とベース本体１５とで構成されたベース凹部２６にガスケット本体１２の背面側Ｘ端部が嵌り込んでいるので、上述のようにガスケット１０の先端面が薬液Ｍの充填圧力を受けたとしても、ガスケット本体１２における凹部１６の開口が開くのを防止することができるので、凹部１６からベース部材１４が押し出されるおそれを回避することができるようになる。 However, in the gasket 10 of the present invention, the X-side end of the back surface side of the gasket body 12 is fitted in the base concave portion 26 constituted by the guide portion 24, the flange portion 21, and the base body 15, so that the gasket is used as described above. Even if the tip surface of 10 receives the filling pressure of the chemical solution M, it is possible to prevent the opening of the recess 16 in the gasket body 12 from being opened. become able to.
　摺動性フィルム２０（図１）は、ガスケット本体１２におけるシリンダＣの内面との摺動面（すなわち、ガスケット本体１２の外周側面）および先端面に積層された、ガスケット本体１２の摺動面に高い摺動性を付与するフィルムであり、本実施例では、ＰＴＦＥ（ポリテトラフルオロエチレン、四フッ化エチレン）フィルム２０が使用されている。もちろん、摺動性フィルム２０としてＰＴＦＥフィルム以外の材質を用いてもよいが、ガスケット１０に高い摺動性を付与するという目的に鑑みれば、本実施例のようにＰＴＦＥフィルムを用いるのが好適である。 The slidable film 20 (FIG. 1) is formed on the sliding surface of the gasket body 12 laminated on the sliding surface of the gasket body 12 with the inner surface of the cylinder C (that is, the outer peripheral side surface of the gasket body 12) and the front end surface. In this embodiment, a PTFE (polytetrafluoroethylene, tetrafluoroethylene) film 20 is used. Of course, a material other than the PTFE film may be used as the slidable film 20, but in view of the purpose of imparting high slidability to the gasket 10, it is preferable to use a PTFE film as in this embodiment. is there.
　ＰＴＦＥフィルム２０の厚みは、ガスケット本体１２への積層前において２０μｍ以上８０μｍ以下に設定されている。これは、ＰＴＦＥフィルム２０の厚みが２０μｍ未満の場合、ＰＴＦＥフィルム２０を経済的に得るのが困難になり、逆に、ＰＴＦＥフィルム２０の厚みが８０μｍより大きい場合、ガスケット本体１２の弾力性を十分に発揮させて確実な密閉性を得ることができなくなるからである。 The thickness of the PTFE film 20 is set to 20 μm or more and 80 μm or less before lamination on the gasket body 12. This is because when the thickness of the PTFE film 20 is less than 20 μm, it is difficult to obtain the PTFE film 20 economically, and conversely, when the thickness of the PTFE film 20 is greater than 80 μm, the elasticity of the gasket body 12 is sufficient. This is because it is impossible to obtain a reliable sealing property when it is exhibited.
　また、ＰＴＦＥフィルム２０は、後述するように射出成形にてガスケット本体１２に積層され（積層後におけるＰＴＦＥフィルム２０の厚みは、１０μｍ～２０μｍになる。）、また、ガスケット本体１２の弾力性を阻害しないようにするため、少なくとも２５０～６５０％程度の伸び（より厳密にいえば、破断伸度）を示すものが好適である。なお、伸び率が３００％以下の場合、後述するガスケット１０の成形時（延伸時）にＰＴＦＥフィルム２０が破れてしまうおそれがあることから、摺動性フィルム２０として、変性、結晶制御、あるいは配向制御を行った、伸び率が３００％以上のＰＴＦＥフィルム２０を用いるのが更に好適である。 The PTFE film 20 is laminated on the gasket body 12 by injection molding as will be described later (the thickness of the PTFE film 20 after lamination is 10 μm to 20 μm), and also inhibits the elasticity of the gasket body 12. In order to prevent this, it is preferable to exhibit an elongation of at least about 250 to 650% (more strictly speaking, elongation at break). If the elongation is 300% or less, the PTFE film 20 may be torn during molding (stretching) of the gasket 10 to be described later, so that the slidable film 20 is modified, crystallized, or oriented. It is more preferable to use a controlled PTFE film 20 having an elongation of 300% or more.
　なお、ＰＴＦＥフィルム２０の製法は、キャスト法を用いてＰＴＦＥをシート状に形成する方法、ＰＴＦＥをブロック状に成形した後、刃物でスライスする方法、あるいはスカイビング加工などを採用することができる。 In addition, the manufacturing method of the PTFE film 20 can employ a method of forming PTFE into a sheet using a casting method, a method of forming PTFE into a block and then slicing with a blade, or skiving.
　ところで、ＰＴＦＥフィルム２０は、難接着性であり、シリコーンゴム製のガスケット本体１２との接合力が極めて弱いという問題があることから、ＰＴＦＥフィルム２０とガスケット本体１２との接合面には、「接着性改善処理」を施すことが必要であり、本実施例では、この「接着性改善処理」として、ＰＴＦＥフィルム２０とガスケット本体１２との接合面にシリカ微粒子層２２が設けられている。もちろん、これに替えて、他の「接着性改善処理」として、金属ナトリウムによる化学処理や、アルゴン雰囲気中でのプラズマ処理を行ってもよい。 By the way, the PTFE film 20 is hardly adhesive and has a problem that the bonding force with the silicone rubber gasket main body 12 is extremely weak. Therefore, the bonding surface between the PTFE film 20 and the gasket main body 12 has “adhesion”. In this embodiment, the silica fine particle layer 22 is provided on the joint surface between the PTFE film 20 and the gasket body 12 as the “adhesion improving process”. Of course, instead of this, as another “adhesion improvement treatment”, chemical treatment with metallic sodium or plasma treatment in an argon atmosphere may be performed.
　シリカ微粒子層２２は、バインダー２２ａとシリカ（ＳｉＯ2）微粒子２２ｂとからなり、シリカ微粒子２２ｂが有する、ガスケット本体１２との親和性およびアンカー効果により、難接着性のＰＴＦＥフィルム２０とガスケット本体１２とを強固に接合させることができる。シリカ微粒子層２２を構成するシリカ微粒子２２ｂは、ＰＴＦＥフィルム２０の表面において、バインダー２２ａからある程度露出した状態で接着されるとともに、この露出した部分がガスケット本体１２の表面に食い込んでアンカー効果を発揮する。 The silica fine particle layer 22 includes a binder 22a and silica (SiO 2 ) fine particles 22b. Due to the affinity with the gasket main body 12 and the anchor effect that the silica fine particles 22b have, the hardly-adhesive PTFE film 20 and the gasket main body 12 Can be firmly joined. The silica fine particles 22b constituting the silica fine particle layer 22 are bonded to the surface of the PTFE film 20 in a state where they are exposed to some extent from the binder 22a, and this exposed portion bites into the surface of the gasket main body 12 and exhibits an anchor effect. .
　ＰＴＦＥフィルム２０の表面にこのシリカ微粒子層２２を形成する方法としては、具体的に以下の２つの方法が挙げられる。 Specific examples of the method for forming the silica fine particle layer 22 on the surface of the PTFE film 20 include the following two methods.
　１つ目の方法は、ＰＴＦＥフィルム２０の表面にシリカ微粒子２２ｂを固着させるバインダー２２ａとしてＰＦＡ樹脂を用いる方法で、具体的には、ＰＦＡ樹脂の水性分散液にシリカ微粒子２２ｂ及び界面活性剤を混合・攪拌して得た混合分散液を、公知の塗布方法(例えば、スプレー法やロール塗布法など)を用いてＰＴＦＥフィルム２０の片面に均一に塗布し、図示しない炉に導入して１００℃で乾燥した後、ＰＴＦＥフィルム２０の形状が保持できる装置を用いて２５０～３６０℃でＰＦＡ樹脂の焼成を行う。 The first method uses a PFA resin as the binder 22a for fixing the silica fine particles 22b to the surface of the PTFE film 20. Specifically, the silica fine particles 22b and a surfactant are mixed in an aqueous dispersion of the PFA resin. -The mixed dispersion obtained by stirring is uniformly coated on one side of the PTFE film 20 using a known coating method (for example, spray method or roll coating method), and introduced into a furnace (not shown) at 100 ° C. After drying, the PFA resin is baked at 250 to 360 ° C. using an apparatus capable of maintaining the shape of the PTFE film 20.
　これによりバインダー２２ａであるＰＦＡ樹脂がＰＴＦＥフィルム２０と一体化し、ＰＴＦＥフィルム２０の表面にシリカ微粒子２２ｂを強固に固着させることができる。又、上記形状が保持できる装置並びに温度範囲で焼成することにより、ＰＴＦＥフィルム２０の伸びが低下するのを防止することができ、その結果、圧縮成形或いは射出成形にて好適にガスケット１０が製造(すなわち共成形)できるようになると共に、ＰＴＦＥフィルム２０がガスケット本体１２の弾力性を阻害するのを防止することができる。 Thereby, the PFA resin as the binder 22a is integrated with the PTFE film 20, and the silica fine particles 22b can be firmly fixed to the surface of the PTFE film 20. Further, by firing in an apparatus capable of maintaining the above shape and in a temperature range, it is possible to prevent the elongation of the PTFE film 20 from being lowered, and as a result, the gasket 10 is preferably manufactured by compression molding or injection molding ( That is, the PTFE film 20 can be prevented from inhibiting the elasticity of the gasket body 12.
　２つ目の方法は、ＰＴＦＥフィルム２０の表面にシリカ微粒子２２ｂを固着させるバインダー２２ａとしてパーフルオロフッ素樹脂およびＰＦＡ粉末を混合したワニスを用いる方法で、具体的には、パーフルオロフッ素樹脂とシリカ微粒子２２ｂとをパーフルオロ溶剤(例えば、旭硝子(株)製のＣＴ－ｓｏｌｖ．１００など)に分散して得たワニスを、公知の塗布方法を用いてＰＴＦＥフィルム２０の片面に均一に塗布・乾燥・熱処理して形成する。かかる方法によれば、ＰＴＦＥフィルム２０の表面に効率よくシリカ微粒子層２２を形成することができる。 The second method is a method using a varnish in which perfluoro fluororesin and PFA powder are mixed as the binder 22a for fixing the silica fine particles 22b to the surface of the PTFE film 20. Specifically, the perfluoro fluororesin and the silica fine particles are used. The varnish obtained by dispersing 22b in a perfluoro solvent (for example, CT-solv.100 manufactured by Asahi Glass Co., Ltd.) is uniformly applied to one side of the PTFE film 20 using a known coating method, dried, It is formed by heat treatment. According to this method, the silica fine particle layer 22 can be efficiently formed on the surface of the PTFE film 20.
　ここで、上述のような各方法で形成されるシリカ微粒子層２２の厚みは、０．５μｍ～１０μｍの範囲内であることが好ましい。かかる範囲内であれば、ＰＴＦＥフィルム２０の伸びやガスケット本体１２の弾力性を阻害することなく、両者を強固に接合することができるからである。 Here, the thickness of the silica fine particle layer 22 formed by each method as described above is preferably in the range of 0.5 μm to 10 μm. This is because, within such a range, the PTFE film 20 and the elasticity of the gasket main body 12 can be firmly joined to each other without hindering the elasticity.
　また、シリカ微粒子層２２を構成するシリカ微粒子２２ｂの平均粒径は、０．０２μｍ～１０μｍの範囲内であるのが好ましく、より好ましくは０．０５μｍ～２μｍの範囲内である。シリカ微粒子２２ｂの平均粒径が０．０５μｍ未満の場合には、シリカ微粒子２２ｂの取扱いが困難になると共に、当該シリカ微粒子２２ｂを経済的に製造するのが困難になり、逆に、シリカ微粒子２２ｂの平均粒径が１０μｍより大きい場合には、当該シリカ微粒子２２ｂの比表面積が小さくなり、ガスケット本体１２に対して十分なアンカー効果を発揮できなくなるからである。 The average particle size of the silica fine particles 22b constituting the silica fine particle layer 22 is preferably in the range of 0.02 μm to 10 μm, more preferably in the range of 0.05 μm to 2 μm. When the average particle size of the silica fine particles 22b is less than 0.05 μm, it becomes difficult to handle the silica fine particles 22b and it is difficult to economically manufacture the silica fine particles 22b. This is because when the average particle diameter of the silica particles is larger than 10 μm, the specific surface area of the silica fine particles 22b becomes small and a sufficient anchoring effect cannot be exerted on the gasket body 12.
　シリンダＣは（図２）、先端に針装着部ｃ１、後端に指掛け部ｃ２、これらの間に円筒状の薬液充填部ｃ３が形成されており、本実施例では環状ポリオレフィンで形成されている。もちろん、シリンダＣの形状は図示したものに限られず、また、シリンダＣの材質には、ポリプロピレンやガラス等も使用することができる。 The cylinder C (FIG. 2) has a needle mounting portion c1 at the front end, a finger hooking portion c2 at the rear end, and a cylindrical chemical liquid filling portion c3 formed between them, and is formed of a cyclic polyolefin in this embodiment. . Of course, the shape of the cylinder C is not limited to that shown in the figure, and the material of the cylinder C can be polypropylene, glass, or the like.
　ピストンＰは、先端部にガスケット装着部ｐ１、後端に指当て部ｐ２が設けられたロッド状の部材である。このピストンＰのガスケット装着部ｐ１には、上述したガスケット１０におけるベース部材１４のネジ穴１８に螺着する雄ネジが形成されている。なお、このピストンＰも上述のシリンダＣと同様に、環状ポリオレフィン、ポリカーボネートおよびポリプロピレン等の樹脂やガラス等で構成されている。 The piston P is a rod-shaped member provided with a gasket mounting part p1 at the front end and a finger rest part p2 at the rear end. A male screw that is screwed into the screw hole 18 of the base member 14 in the gasket 10 is formed in the gasket mounting portion p1 of the piston P. The piston P is also made of resin such as cyclic polyolefin, polycarbonate, and polypropylene, glass, and the like, similar to the cylinder C described above.
　キャップＫは、基本的にシリンダＣと同じ材料で形成されており、シリンダＣの針装着部ｃ１を気密的に覆ってシリンダＣ中に充填された薬液が不所望に当該針装着部ｃ１から漏れ出すのを防止する役割を有している。 The cap K is basically formed of the same material as the cylinder C, and the needle mounting part c1 of the cylinder C is airtightly covered, and the chemical liquid filled in the cylinder C leaks from the needle mounting part c1 undesirably. It has a role to prevent the release.
　以上のようなプレフィルドシリンジＡを製造する手順について、インサート成形によるガスケット１０の製造手順を中心に説明する。もちろん、ガスケット１０の製造方法は、以下に示すインサート成形に限られず、どのような方法を用いてもよい。 The procedure for manufacturing the prefilled syringe A as described above will be described focusing on the manufacturing procedure of the gasket 10 by insert molding. Of course, the manufacturing method of the gasket 10 is not limited to the insert molding described below, and any method may be used.
　ガスケット１０は、図７に示すように、金型Ｚを開き（図７（ａ））、予め所定の形状に成形されたベース部材１４をインサートするとともに、上述したような方法で表面にシリカ微粒子層２２が形成されたＰＴＦＥフィルム２０を当該金型の開き面に載置し（図７（ｂ））、然る後、型締めした状態でガスケット本体１２の原料であるシリコーンゴムＹを所定の温度および圧力条件（温度＝２００℃～２３０℃、圧力＝５００～１０００kg/cm2が適切である。）で射出すると（図７（ｃ））、ＰＴＦＥフィルム２０が金型に刻まれた所望の形状（＝完成したガスケット１０の外形状）に延ばされるとともに、シリコーンゴムがベース部材１４およびシリカ微粒子層２２を介してＰＴＦＥフィルム２０と強固に接着することによってガスケット１０が成形される。そして、当該ガスケット１０を冷却した後、型開きして金型から取り出し、必要に応じて不要部をトリミングすることにより、ガスケット１０の製造が完了する。 As shown in FIG. 7, the gasket 10 opens the mold Z (FIG. 7A), inserts a base member 14 molded in advance into a predetermined shape, and has a silica fine particle on the surface by the method described above. The PTFE film 20 on which the layer 22 is formed is placed on the opening surface of the mold (FIG. 7B), and then the silicone rubber Y that is the raw material of the gasket body 12 is clamped in a predetermined state. When injected under temperature and pressure conditions (temperature = 200 ° C.-230 ° C., pressure = 500-1000 kg / cm 2 is appropriate) (FIG. 7 (c)), the desired PTFE film 20 is engraved in the mold. While extending to the shape (= the outer shape of the completed gasket 10), the silicone rubber is firmly bonded to the PTFE film 20 via the base member 14 and the silica fine particle layer 22, thereby the gasket. 10 is molded. Then, after the gasket 10 is cooled, the mold is opened and taken out from the mold, and unnecessary parts are trimmed as necessary, whereby the manufacture of the gasket 10 is completed.
　製造されたガスケット１０を、同じく予め成形しておいたシリンダＣに嵌め込み、当該シリンダＣの先端（針装着部ｃ１）から薬液Ｍを充填することにより、プレフィルドシリンジＡが完成する。 The pre-filled syringe A is completed by fitting the manufactured gasket 10 into the cylinder C which has been molded in advance, and filling the chemical solution M from the tip of the cylinder C (needle mounting portion c1).
　本実施例のガスケット１０によれば、鍔部２１を有する非透水性プラスチック製のベース部材１４がガスケット本体１２の凹部１６に取り付けられており、当該凹部１６の内側面１６ａが外気と接触するのを防止しているとともに、鍔部２１がガスケット本体１２の背面側周縁部１２ａの全面を覆って当該背面側周縁部１２ａが外気と接触するのを防止している。 According to the gasket 10 of the present embodiment, the non-water-permeable plastic base member 14 having the flange 21 is attached to the recess 16 of the gasket body 12, and the inner surface 16a of the recess 16 comes into contact with the outside air. In addition, the flange portion 21 covers the entire surface of the back side peripheral portion 12a of the gasket body 12 and prevents the back side peripheral portion 12a from coming into contact with the outside air.
　これにより、シリンジ内の薬液Ｍ（あるいは薬液中の水分）が外気に放散されるおそれを極小化することができる。 This makes it possible to minimize the risk of the chemical solution M (or the water in the chemical solution) in the syringe being released to the outside air.
　また、ガスケット本体１２はシリコーンゴムで形成されていることから、ブチルゴム製の従来のガスケットのように薬液が汚染される心配がなく、かつ、加熱殺菌を行った場合であってもガスケット本体１２が変形し難いので、シリンダＣの内面との間で隙間が生じて薬液がこぼれ出たり、逆にシリンダＣに対するガスケット１０の嵌め合い状態がきつくなってガスケット１０が容易に動かなくなるのを回避できる。 Further, since the gasket body 12 is formed of silicone rubber, there is no fear that the chemical solution is contaminated unlike the conventional gasket made of butyl rubber, and the gasket body 12 is not affected by heat sterilization. Since it is difficult to deform, it can be avoided that a gap is formed between the inner surface of the cylinder C and the chemical liquid spills out, or conversely, the gasket 10 is tightly fitted to the cylinder C and the gasket 10 is not easily moved.
　さらに言えば、特許文献１のガスケット１では、ガスケット本体２（＝ブチルゴム）にピストン５を螺着するネジ穴６が形成されていたことから、螺着したピストン５を引っ張ったとき（例えば採血時）、可撓性を有するブチルゴムでできたネジ穴６の山６ａが引っ張り方向に撓んでピストン５がネジ穴６からすっぽ抜けるおそれがあったが、本発明では、ピストンＰが螺着されるネジ穴１８は、プラスチック製のベース部材１４に設けられていることから、螺着したピストンＰを引っ張ったとしても、ネジ穴１８の山が引っ張り方向に撓んでピストンＰがネジ穴１８からすっぽ抜けるおそれがない。 Furthermore, in the gasket 1 of Patent Document 1, since the screw hole 6 for screwing the piston 5 is formed in the gasket body 2 (= butyl rubber), when the screwed piston 5 is pulled (for example, during blood collection) ), There is a possibility that the crest 6a of the screw hole 6 made of flexible butyl rubber is bent in the pulling direction and the piston 5 is completely removed from the screw hole 6. In the present invention, the piston P is screwed. Since the screw hole 18 is provided in the plastic base member 14, even if the screwed piston P is pulled, the crest of the screw hole 18 bends in the pulling direction so that the piston P completely extends from the screw hole 18. There is no risk of falling out.
　さらに、ＰＴＦＥフィルム２０とガスケット本体１２との接合面にシリカ微粒子層２２が設けられているので、シリカ微粒子２２ｂが有する、シリコーンゴム（＝ガスケット本体１２）との親和性およびアンカー効果により、難接着性のＰＴＦＥフィルム２０とガスケット本体１２とを強固に接合させることができる。これにより、シリンダＣに対する摺動性が極めて高く、かつ、振動や衝撃によってガスケット本体１２からＰＴＦＥフィルム２０が外れる心配のないガスケット１０を提供することができる。 Further, since the silica fine particle layer 22 is provided on the joint surface between the PTFE film 20 and the gasket main body 12, it is difficult to adhere due to the affinity with the silicone rubber (= gasket main body 12) of the silica fine particles 22b and the anchor effect. The PTFE film 20 and the gasket body 12 can be firmly joined. As a result, it is possible to provide the gasket 10 that is extremely slidable with respect to the cylinder C and that does not have to worry about the PTFE film 20 being detached from the gasket body 12 due to vibration or impact.
　Ａ　…プレフィルドシリンジ
　Ｃ　…シリンダ
　　ｃ１…針装着部
　　ｃ２…指掛け部
　　ｃ３…薬液充填部
　Ｐ　…ピストン
　Ｋ　…キャップ
　Ｘ　…背面側
　１０…ガスケット
　１２…ガスケット本体
　　１２ａ…背面側周縁部
　１４…ベース部材
　１５…ベース本体
　１６…凹部
　　１６ａ…凹部の内側面
　１８…ネジ穴
　２０…ＰＴＦＥフィルム（摺動性フィルム）
　２１…鍔部
　２２…シリカ微粒子層
　　２２ａ…バインダー
　　２２ｂ…シリカ微粒子
　２４…ガイド部
　２６…ベース凹部 A ... Prefilled syringe C ... Cylinder c1 ... Needle mounting part c2 ... Finger hook part c3 ... Chemical liquid filling part P ... Piston K ... Cap X ... Back side 10 ... Gasket 12 ... Gasket body 12a ... Back side peripheral part 14 ... Base member 15 ... Base body 16: Recess 16a ... Inner side surface of recess 18 ... Screw hole 20 ... PTFE film (sliding film)
DESCRIPTION OF SYMBOLS 21 ... Ridge part 22 ... Silica fine particle layer 22a ... Binder 22b ... Silica fine particle 24 ... Guide part 26 ... Base recessed part

Claims (5)

  1. 　ピストンが取り付けられる背面側に凹部が形成された、シリコーンゴム製のガスケット本体と、
    　前記ガスケット本体の摺動面および先端面を覆う摺動性フィルムと、
    　前記凹部に取り付けられる、非透水性プラスチック製のベース部材とを備えており、
    　前記ベース部材は、前記凹部に嵌め込まれるベース本体と、前記ベース本体の前記背面側に設けられ、前記ピストンの先端部が螺着されるネジ穴と、前記ベース本体における前記背面側の周縁から突設されており、前記ガスケット本体の背面側周縁部の全面を覆う鍔部とを有していることを特徴とするシリンジ用ガスケット。     A gasket body made of silicone rubber with a recess formed on the back side to which the piston is attached;
    A slidable film covering the sliding surface and the tip surface of the gasket body;
    A base member made of water-impermeable plastic attached to the recess,
    The base member protrudes from a base body that is fitted into the recess, a screw hole that is provided on the back side of the base body and into which a tip end portion of the piston is screwed, and a peripheral edge on the back side of the base body. A syringe gasket, comprising: a flange that covers the entire surface of the peripheral edge on the back side of the gasket body.
  2. 　前記鍔部の周縁からは、先端面側に向かうガイド部が突設されており、前記ガイド部と前記鍔部と前記ベース本体とで構成されたベース凹部に、前記ガスケット本体の背面側端部が嵌め込まれていることを特徴とする請求項１に記載のシリンジ用ガスケット。 From the peripheral edge of the flange portion, a guide portion is provided so as to project toward the front end surface side, and a back side end portion of the gasket main body is formed in a base recess formed by the guide portion, the flange portion, and the base body. The syringe gasket according to claim 1, wherein the gasket is fitted.
  3. 　前記摺動性フィルムは、ＰＴＦＥフィルムであり、
    　前記ガスケット本体と前記ＰＴＦＥフィルムとの接合面には、接着性改善処理が施されていることを特徴とする請求項１または２に記載のシリンジ用ガスケット。     The slidable film is a PTFE film,
    The gasket for syringes according to claim 1 or 2, wherein an adhesion improving process is performed on a joint surface between the gasket main body and the PTFE film.
  4. 　前記ベース部材は、高密度ポリエチレン、ポリプロピレン、シクロオレフィンポリマー、および環状オレフィン系コポリマーから選択されるいずれかのプラスチック材料で形成されていることを特徴とする請求項１ないし３のいずれかに記載のシリンジ用ガスケット。 4. The base member according to claim 1, wherein the base member is made of any plastic material selected from high-density polyethylene, polypropylene, cycloolefin polymer, and cyclic olefin-based copolymer. Syringe gasket.
  5. 　薬液が充填されたシリンダと、
    　前記シリンダを密封する請求項１ないし４のいずれかに記載されたシリンジ用ガスケットと、
    　前記シリンジ用ガスケットを前記シリンダの先端に向けて押し込む、先端部が前記ネジ穴に螺着されたピストンとで構成されたプレフィルドシリンジ。     A cylinder filled with a chemical,
    The syringe gasket according to any one of claims 1 to 4, wherein the cylinder is sealed;
    A prefilled syringe constituted by a piston having a distal end portion screwed into the screw hole, wherein the syringe gasket is pushed toward the distal end of the cylinder.
PCT/JP2011/000377 2011-01-25 2011-01-25 Gasket for syringe and pre-filled syringe using same WO2012101669A1 (en)

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Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2703025A1 (en) * 2012-08-30 2014-03-05 Sumitomo Rubber Industries, Ltd. Laminated gasket
JP2015066387A (en) * 2013-10-01 2015-04-13 株式会社根本杏林堂 Syringe, liquid medicine injection system, seal member, and method of manufacturing seal member
WO2016056038A1 (en) * 2014-10-07 2016-04-14 有限会社コーキ・エンジニアリング Slidable medical silicone rubber, gasket using said rubber, and prefilled syringe using said gasket
WO2016120565A1 (en) 2015-01-29 2016-08-04 Aptar Stelmi Sas Syringe plunger-stopper.
FR3032122A1 (en) * 2015-01-29 2016-08-05 Aptar Stelmi Sas PROCESS FOR PRODUCING A SYRINGE PISTON PLUG
CN107029318A (en) * 2017-06-02 2017-08-11 雷诺丽特恒迅包装科技（北京）有限公司 Disposable medical fluid injector
EP2781231A3 (en) * 2013-03-21 2017-11-15 Sumitomo Rubber Industries, Ltd. Gasket for pre-filled syringe
EP3278829A1 (en) * 2016-08-03 2018-02-07 Sumitomo Rubber Industries, Ltd. Medical syringe, gasket to be used for syringe, and gasket production method
US11406565B2 (en) 2015-03-10 2022-08-09 Regeneran Pharmaceuticals, Inc. Aseptic piercing system and method
EP3978050A4 (en) * 2019-06-03 2022-08-10 Coki Engineering Inc. Gasket, syringe provided with same, and method for producing gasket
US11547801B2 (en) 2017-05-05 2023-01-10 Regeneron Pharmaceuticals, Inc. Auto-injector
USD1007676S1 (en) 2021-11-16 2023-12-12 Regeneron Pharmaceuticals, Inc. Wearable autoinjector

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JP3665646B2 (en) * 1994-05-06 2005-06-29 アメルシャム ヘルス アクスイェ セルスカプ Syringe
JP2009505794A (en) * 2005-08-29 2009-02-12 ウェスト ファーマシューティカル サービシズ インコーポレイテッド Dual material plunger tip for syringe
JP2010142573A (en) * 2008-12-22 2010-07-01 Coki Engineering Inc Gasket for syringe, method for manufacturing the same, and prefilled syringe using the gasket
JP2010284438A (en) * 2009-06-15 2010-12-24 Terumo Corp Prefilled syringe

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JP3665646B2 (en) * 1994-05-06 2005-06-29 アメルシャム ヘルス アクスイェ セルスカプ Syringe
JP2009505794A (en) * 2005-08-29 2009-02-12 ウェスト ファーマシューティカル サービシズ インコーポレイテッド Dual material plunger tip for syringe
JP2010142573A (en) * 2008-12-22 2010-07-01 Coki Engineering Inc Gasket for syringe, method for manufacturing the same, and prefilled syringe using the gasket
JP2010284438A (en) * 2009-06-15 2010-12-24 Terumo Corp Prefilled syringe

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2703025A1 (en) * 2012-08-30 2014-03-05 Sumitomo Rubber Industries, Ltd. Laminated gasket
JP2014047828A (en) * 2012-08-30 2014-03-17 Sumitomo Rubber Ind Ltd Laminate gasket
EP2781231A3 (en) * 2013-03-21 2017-11-15 Sumitomo Rubber Industries, Ltd. Gasket for pre-filled syringe
JP2015066387A (en) * 2013-10-01 2015-04-13 株式会社根本杏林堂 Syringe, liquid medicine injection system, seal member, and method of manufacturing seal member
WO2016056038A1 (en) * 2014-10-07 2016-04-14 有限会社コーキ・エンジニアリング Slidable medical silicone rubber, gasket using said rubber, and prefilled syringe using said gasket
FR3032123A1 (en) * 2015-01-29 2016-08-05 Aptar Stelmi Sas SYRINGE CAP-PISTON.
FR3032122A1 (en) * 2015-01-29 2016-08-05 Aptar Stelmi Sas PROCESS FOR PRODUCING A SYRINGE PISTON PLUG
WO2016120565A1 (en) 2015-01-29 2016-08-04 Aptar Stelmi Sas Syringe plunger-stopper.
US11406565B2 (en) 2015-03-10 2022-08-09 Regeneran Pharmaceuticals, Inc. Aseptic piercing system and method
EP3278829A1 (en) * 2016-08-03 2018-02-07 Sumitomo Rubber Industries, Ltd. Medical syringe, gasket to be used for syringe, and gasket production method
US11547801B2 (en) 2017-05-05 2023-01-10 Regeneron Pharmaceuticals, Inc. Auto-injector
CN107029318A (en) * 2017-06-02 2017-08-11 雷诺丽特恒迅包装科技（北京）有限公司 Disposable medical fluid injector
EP3978050A4 (en) * 2019-06-03 2022-08-10 Coki Engineering Inc. Gasket, syringe provided with same, and method for producing gasket
USD1007676S1 (en) 2021-11-16 2023-12-12 Regeneron Pharmaceuticals, Inc. Wearable autoinjector

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