WO2012101669A1 - Joint pour seringue et seringue préremplie l'utilisant - Google Patents

Joint pour seringue et seringue préremplie l'utilisant 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
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English (en)
Japanese (ja)
Inventor
晃 四ッ辻
Original Assignee
有限会社コーキ・エンジニアリング
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 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 PCT/JP2011/000377 priority Critical patent/WO2012101669A1/fr
Priority to JP2012554476A priority patent/JPWO2012101669A1/ja
Publication of WO2012101669A1 publication Critical patent/WO2012101669A1/fr

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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

La présente invention concerne un joint optimisé pour une seringue préremplie, qui présente une performance de glissement élevée sur un cylindre (C) grâce à l'utilisation d'un film de glissement (20), traite le problème d'un corps principal de joint existant formé d'un caoutchouc d'isobutylène-isoprène grâce à l'utilisation d'un corps principal de joint (12) formé d'un caoutchouc de silicone et minimise le risque qu'un médicament liquide (M) dans le cylindre (C) (ou que l'humidité dans le médicament liquide) puisse se dissiper dans l'air extérieur et traite le problème causé par la perméabilité du caoutchouc de silicone grâce au recouvrement d'une face arrière (X) du corps principal de joint (12) (une surface latérale intérieure (16a) d'une concavité (16), et une portion d'arête circonférentielle de face arrière (12a) près de la concavité (16)), avec un corps de base en plastique non perméable (15) et une partie formant rebord (21).
PCT/JP2011/000377 2011-01-25 2011-01-25 Joint pour seringue et seringue préremplie l'utilisant WO2012101669A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/JP2011/000377 WO2012101669A1 (fr) 2011-01-25 2011-01-25 Joint pour seringue et seringue préremplie l'utilisant
JP2012554476A JPWO2012101669A1 (ja) 2011-01-25 2011-01-25 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

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PCT/JP2011/000377 WO2012101669A1 (fr) 2011-01-25 2011-01-25 Joint pour seringue et seringue préremplie l'utilisant

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Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2703025A1 (fr) * 2012-08-30 2014-03-05 Sumitomo Rubber Industries, Ltd. Joint d'étanchéité stratifié
JP2015066387A (ja) * 2013-10-01 2015-04-13 株式会社根本杏林堂 シリンジ、薬液注入システム、シール部材及びシール部材の製造方法
WO2016056038A1 (fr) * 2014-10-07 2016-04-14 有限会社コーキ・エンジニアリング Caoutchouc de silicone médical coulissant, joint d'étanchéité utilisant ledit caoutchouc et seringue préremplie utilisant ledit joint d'étanchéité
WO2016120565A1 (fr) 2015-01-29 2016-08-04 Aptar Stelmi Sas Bouchon-piston de seringue.
FR3032122A1 (fr) * 2015-01-29 2016-08-05 Aptar Stelmi Sas Procede de fabrication d'un bouchon-piston de seringue.
CN107029318A (zh) * 2017-06-02 2017-08-11 雷诺丽特恒迅包装科技（北京）有限公司 一次性药液注射器
EP2781231A3 (fr) * 2013-03-21 2017-11-15 Sumitomo Rubber Industries, Ltd. Joint d'étanchéité pour seringue préremplie
EP3278829A1 (fr) * 2016-08-03 2018-02-07 Sumitomo Rubber Industries, Ltd. Seringue médicale, joint à utiliser pour la seringue et procédé de production de joint
US11406565B2 (en) 2015-03-10 2022-08-09 Regeneran Pharmaceuticals, Inc. Aseptic piercing system and method
EP3978050A4 (fr) * 2019-06-03 2022-08-10 Coki Engineering Inc. Joint, seringue pourvue de celui-ci, et méthode de production d'un joint
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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Cited By (14)

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EP2703025A1 (fr) * 2012-08-30 2014-03-05 Sumitomo Rubber Industries, Ltd. Joint d'étanchéité stratifié
JP2014047828A (ja) * 2012-08-30 2014-03-17 Sumitomo Rubber Ind Ltd 積層ガスケット
EP2781231A3 (fr) * 2013-03-21 2017-11-15 Sumitomo Rubber Industries, Ltd. Joint d'étanchéité pour seringue préremplie
JP2015066387A (ja) * 2013-10-01 2015-04-13 株式会社根本杏林堂 シリンジ、薬液注入システム、シール部材及びシール部材の製造方法
WO2016056038A1 (fr) * 2014-10-07 2016-04-14 有限会社コーキ・エンジニアリング Caoutchouc de silicone médical coulissant, joint d'étanchéité utilisant ledit caoutchouc et seringue préremplie utilisant ledit joint d'étanchéité
FR3032122A1 (fr) * 2015-01-29 2016-08-05 Aptar Stelmi Sas Procede de fabrication d'un bouchon-piston de seringue.
FR3032123A1 (fr) * 2015-01-29 2016-08-05 Aptar Stelmi Sas Bouchon-piston de seringue.
WO2016120565A1 (fr) 2015-01-29 2016-08-04 Aptar Stelmi Sas Bouchon-piston de seringue.
US11406565B2 (en) 2015-03-10 2022-08-09 Regeneran Pharmaceuticals, Inc. Aseptic piercing system and method
EP3278829A1 (fr) * 2016-08-03 2018-02-07 Sumitomo Rubber Industries, Ltd. Seringue médicale, joint à utiliser pour la seringue et procédé de production de joint
US11547801B2 (en) 2017-05-05 2023-01-10 Regeneron Pharmaceuticals, Inc. Auto-injector
CN107029318A (zh) * 2017-06-02 2017-08-11 雷诺丽特恒迅包装科技（北京）有限公司 一次性药液注射器
EP3978050A4 (fr) * 2019-06-03 2022-08-10 Coki Engineering Inc. Joint, seringue pourvue de celui-ci, et méthode de production d'un joint
USD1007676S1 (en) 2021-11-16 2023-12-12 Regeneron Pharmaceuticals, Inc. Wearable autoinjector

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