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WO2021255873A1 - Joint d'étanchéité et seringue utilisant ledit joint d'étanchéité - Google Patents

Joint d'étanchéité et seringue utilisant ledit joint d'étanchéité Download PDF

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Publication number
WO2021255873A1
WO2021255873A1 PCT/JP2020/023833 JP2020023833W WO2021255873A1 WO 2021255873 A1 WO2021255873 A1 WO 2021255873A1 JP 2020023833 W JP2020023833 W JP 2020023833W WO 2021255873 A1 WO2021255873 A1 WO 2021255873A1
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WO
WIPO (PCT)
Prior art keywords
sliding contact
ring
gasket
syringe
syringe barrel
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2020/023833
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English (en)
Japanese (ja)
Inventor
晃 四ツ辻
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
COKI ENGINEERING Inc
Original Assignee
COKI ENGINEERING Inc
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 COKI ENGINEERING Inc filed Critical COKI ENGINEERING Inc
Priority to JP2021512824A priority Critical patent/JP7012936B1/ja
Priority to PCT/JP2020/023833 priority patent/WO2021255873A1/fr
Publication of WO2021255873A1 publication Critical patent/WO2021255873A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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

Definitions

  • the present invention relates to a gasket having excellent slidability and sealing property, which is particularly effective for a large syringe such as for contrast media, and further relates to a syringe using this novel gasket.
  • the syringe Before attaching the injection needle or contrast agent injection tube, the syringe is a plastic or glass syringe barrel (cylindrical cylinder), a movable plunger rod (presser), and a gasket attached to the tip of the plunger rod. And a top cap attached to the mounting part of the syringe barrel, which are assembled and packaged.
  • the number of prefilled syringes in which an injection solution is pre-filled in a syringe barrel and packaged is increasing in recent years. Since prefilled syringes are stored for a long period of time and used in various environments, the gaskets of prefilled syringes are required to have a higher level of performance than those for ordinary syringes.
  • the performance required for the gasket, including the prefilled syringe is, for example, (a) Even if the gasket has been in contact with the injection solution for a long period of time, the quality of the injection solution does not change and it can be used safely. (b) For example, the sealing property can be ensured even for a highly permeable injection solution containing a surfactant, and the sealing property on the left is that the injection solution or its water becomes steam and the sliding contact surface of the gasket and the syringe.
  • the amount of water leaking from the minute gap between the inner peripheral surface due to capillarity this is called the liquid leakage amount
  • the amount of water in the injection liquid that has passed through the gasket and permeated to the outside this is water vapor).
  • the conventional gasket used for the inner surface of the syringe barrel and the above-mentioned ordinary syringe has a vulcanized rubber (butyl rubber) coated with silicone oil on the surface thereof. ) was the mainstream.
  • the vulcanized rubber gasket coated with silicone oil on its surface satisfies (b) and (c) at the same time because its sliding resistance is dramatically reduced to (5 to 8N) by the silicone oil.
  • the applied silicone oil comes into contact with the injection solution and aggregates or reacts with the active ingredient in the injection solution to change the quality of the silicone oil. It has been pointed out that this has an adverse effect on the human body, and that the use of silicone oil has a problem with the safety shown in (a).
  • FIG. 8 is an enlarged cross-sectional view of a portion corresponding to the X portion of FIG.
  • the gasket 200 described in Patent Document 1 is a slidable silicone rubber ring 290 (sliding silicone rubber ring 290) having a groove 280 provided on the entire outer circumference of a main body portion 260 made of polytetrafluoroethylene (hereinafter, also referred to as PTFE). The material will be described later).
  • the slidable silicone rubber ring 290 is in charge of smooth sliding contact with the inner peripheral surface 102 of the syringe barrel 100, and the water stoppage to the injection liquid 300 is such that the portion of the groove 280 on the liquid contact surface 240 side is formed into a thin brim.
  • the constructed barrel-shaped sliding contact piece 270 is in charge.
  • the thin-walled brim-shaped sliding contact piece 270 is in sliding contact with the inner peripheral surface 102 of the syringe barrel 100 over the entire circumference to stop water.
  • the outer peripheral surface of the flange-shaped sliding contact piece 270 that is in sliding contact over the entire circumference of the inner peripheral surface 102 of the syringe barrel 100 is referred to as a sliding contact surface 271.
  • the brim-shaped sliding contact piece 270 which is a part of the main body portion 260 made entirely of polytetrafluoroethylene, has the above-mentioned safety and water vapor impermeable (the water content of the injection solution 300 is contained inside the polytetrafluoroethylene). It does not pass as water vapor) and has excellent slidability with respect to the syringe barrel 100, but because it is hard in material, the width of the sliding contact surface 271 is wide, in other words, it is thick, and it is a brim-shaped sliding contact piece. The 270 does not bend and the sliding resistance increases. Therefore, the thickness of the flange-shaped sliding contact piece 270 is limited to 0.1 to 0.6 mm.
  • the flange-shaped sliding contact piece 270 is weak, the press-fitted flange-shaped sliding contact piece 270 bends with an appropriate contact pressure with respect to the syringe barrel 1, and the gasket 200 is pushed by the plunger. Then, since it moves with the appropriate contact pressure, the sliding resistance of this portion becomes negligibly small. As a result, the flange-shaped sliding contact piece 270 does not impair the slidability of the gasket 200 using the slidable silicone rubber ring 290.
  • such a thin flange-shaped sliding contact piece 270 has a relatively weak waist as described above, and when the gasket 200 is strongly pushed into the syringe barrel 100 by pushing the plunger rod, the flange-shaped sliding contact piece 270 becomes an injection liquid. There is a risk that the syringe barrel 100 will lose its pressure and bend significantly, and the sliding contact surface 271 will separate from the inner peripheral surface 102 of the syringe barrel 100, causing liquid leakage from this portion.
  • the entire back surface of the flange-shaped sliding contact piece 270 is brought into contact with the sliding silicone rubber ring 290, and the sliding silicone rubber ring 290 is used to back up the weakness of the waist of the thin-walled flange-shaped sliding contact piece 270. It has become.
  • the slidable silicone rubber ring 290 is made of a slidable silicone rubber obtained by adding spherical polymer polyethylene fine powder 291 to a silicone rubber base material 293 filled with silicone oil.
  • This slidable silicone rubber ring 290 exhibits a required sliding resistance of 8 N or less without applying silicone oil.
  • the silicone oil filled from the sliding silicone rubber ring 290 hardly exudes, but even if the silicone oil exudes, it has a flange shape located in front of the sliding silicone rubber ring 290 on the wetted side. Since the sliding contact piece 270 acts as a dam to prevent the exuded silicone oil from coming into contact with the injection liquid 300, safety is ensured.
  • the slidable silicone rubber which is the material of the slidable silicone rubber ring 290, has a water vapor permeability about 100 times larger than that of the material (polytetrafluoroethylene) of the main body portion 260 of the gasket 200, and is from the injection solution 300. Easy to pass water vapor. However, in this case, since the flange-shaped sliding contact piece 270 located in front of the contact liquid side blocks the injection liquid 300 and the sliding silicone rubber ring 290, it is more water-impermeable than polytetrafluoroethylene. Inferior slidable silicone rubber can be used for the slidable silicone rubber ring 290. From the above, it was considered that the combination of the thin-walled brim-shaped sliding contact piece 270 and the slidable silicone rubber ring 290 satisfies the performances (a) to (c) as a syringe.
  • the combination of the thin-walled brim-shaped sliding contact piece 270 and the slidable silicone rubber ring 290 as described above cannot cope with this.
  • the reason is that the fine gap between the sliding contact surface 271 of the thin-walled flange-shaped sliding contact piece 270 and the inner peripheral surface 102 of the syringe barrel 1 is filled with the injection liquid 300 or its water vapor (injection liquid or its water vapor in the present specification).
  • injection liquid or water vapor (Sometimes referred to simply as injection liquid or water vapor.) Although it is a very small amount, it permeates due to the capillary phenomenon, and further, this very small amount of injection liquid 300 penetrates into the inner peripheral surface 2 of the syringe barrel 1 and the sliding silicone rubber ring 290. This is because it penetrated between the sliding contact surface 292 and the sliding contact surface 292 by a capillary phenomenon, passed through the inside of the sliding silicone rubber ring 290, and reached the back surface of the sliding silicone rubber ring 290.
  • the back surface of the flange-shaped sliding contact piece 270 is backed up in contact with the sliding silicone rubber ring 290 over the entire surface.
  • the fine gap between the inner peripheral surface 2 of the syringe barrel 1 and the sliding contact surface 271 of the flange-shaped sliding contact piece 270 is the sliding contact surface between the inner peripheral surface 2 of the syringe barrel 1 and the sliding silicone rubber ring 290. It is directly in contact with and connected to the fine gap with 292.
  • the injection liquid 300 (or its steam) reaching the back side of the flange-shaped sliding contact piece 270 is directly applied to the inner peripheral surface 2 of the syringe barrel 1 and the sliding silicone rubber ring 290 by the vapor pressure of the filling chamber 300j of the injection liquid 300. It penetrates into the fine gap between the sliding contact surface 292 and the sliding contact surface 292 by capillarity. Then, the injection liquid 300 (or its water vapor) passes through the sliding silicone rubber ring 290 at the same time.
  • the present invention has been made in view of the problems of the conventional example, and the sealing property is not impaired not only in a small syringe but also in a large syringe, the sealing property is not impaired, the long-term storage is endured, and the material cost is significantly reduced.
  • the subject is the development of a gasket that can be used and the provision of a syringe using the gasket.
  • the present invention is a gasket 10 for a syringe that is press-fitted into a syringe barrel 1 and used in a sliding state.
  • a sliding contact ring 19 that is fitted into the concave groove 18 and is in sliding contact with the inner peripheral surface 2 of the syringe barrel 1.
  • the gasket 10 for a syringe is characterized in that a gap 20 is provided between the water stop ring 13 and the sliding contact ring 19 installed apart from each other.
  • the width W of the gap 20 provided between the waterproof ring 13 provided on the gasket 10 of the present invention and the sliding contact ring 19 is larger than 0.05 mm.
  • the waterproof ring 13 of the gasket 10 of the present invention is made of polytetrafluoroethylene, and one or a plurality of threads are in sliding contact with the inner peripheral surface 2 of the syringe barrel 1 on the entire outer peripheral surface of the waterproof ring 13. It is characterized in that a ridge 13t is formed.
  • the cross-sectional shape of the sliding contact protrusion 13t of the waterproof ring 13 of the gasket 10 of the present invention is characterized in that the wall thickness gradually decreases as it approaches the sliding contact surface 13s which is the outer peripheral surface (see FIG. 3). ..
  • the cross-sectional shape of the water stop groove 13 m which is recessed in the outer peripheral surface of the water stop ring 13 of the gasket 10 of the present invention over the entire circumference and forms the sliding contact protrusion 13t, is V-shaped or U-shaped. (See FIGS. 3 (a) and 3 (b)).
  • the prefilled syringe A of the present invention is composed of a syringe barrel 1 filled with an injection liquid 30 inside, the gasket 10 press-fitted into the syringe barrel 1, and a plunger rod 5 mounted on the gasket 10. It is characterized by being.
  • a small amount of injection liquid is formed by capillarity in a minute gap between the inner peripheral surface 2 of the syringe barrel 1 and the sliding contact surface 13s of the water blocking ring 13 which is in close contact with the inner peripheral surface 2 during long-term storage. 30 or its water vapor passes through to reach the void 20 on the back surface of the water stop ring 13.
  • the gasket 10 for a syringe of the present invention is provided with a gap 20 between the water stop ring 13 and the sliding contact ring 19 arranged apart from each other with a width larger than 0.05 mm.
  • the vapor pressure of the void 20 in the syringe barrel 1 containing a small amount of the injection liquid 30 or its water vapor is much smaller than the vapor pressure of the filling chamber 30j of the injection liquid 30 of the syringe barrel 1 in which the injection liquid 30 is filled. Therefore, a small amount of the injection liquid 30 that has entered the void 20 or the water vapor from the injection liquid 30 cannot pass through the sliding contact ring 19, and of course, it is between the inner peripheral surface 2 of the syringe barrel 1 and the sliding contact surface 19s of the sliding contact ring 19. Can not penetrate due to the capillary phenomenon, and even if a member having inferior water vapor permeability is used for the sliding contact ring 19, the sealing property of the prefilled syringe A can be significantly reduced as compared with the prior art.
  • the waterproof ring 13 of the gasket 10 of the present invention is made of polytetrafluoroethylene. That is, since the structure of the gasket 10 for the syringe of the present invention is such that only the water stop ring 13 can be composed of polytetrafluoroethylene, the main body portion 11 of the gasket 10 excluding the water stop ring 13 is inexpensive. It can be formed of a hard plastic having excellent chemical resistance, and the cost of the gasket 10 can be reduced. If a plurality of sliding contact protrusions 13t that are in sliding contact with the inner peripheral surface 2 of the syringe barrel 1 are formed on the entire circumference of the outer peripheral surface of the water stop ring 13, the sliding contact protrusions 13t are formed prior to the gap 20. It can enter the gap (water stop groove 13 m) between 13 tons and delay the intrusion into the void 20.
  • the cross-sectional shape of the sliding contact protrusion 13t of the waterproof ring 13 of the gasket 10 is such that the wall thickness gradually decreases as it approaches the sliding contact surface 13s which is the outer peripheral surface thereof, the gasket 10 is press-fitted into the syringe barrel 1. At this time, the portion near the sliding contact surface 13s is deformed by the pressing force and adheres to the inner peripheral surface 2 of the syringe barrel 1, while the base portion away from the sliding contact surface 13s does not deform and stands on its own, backing up as in the conventional example. Is no longer needed.
  • the gasket 10 is used for the syringe A of the present invention, the sealing property is not impaired for a long period of time, and the prefilled syringe A can be made suitable to satisfy the above criteria.
  • FIG. (A) Partially enlarged cross-sectional view of the syringe without the water stop ring
  • FIG. 1 is a cross-sectional view of the prefilled syringe A of the present invention taken out of the package.
  • the prefilled syringe A taken out of the package includes a gasket 10, a syringe barrel 1 filled with an injection solution 30, a plunger rod 5 attached to the gasket 10, and a top cap 8. ing.
  • the syringe barrel 1 is a cylindrical container, and a mounting portion 1b on which an injection needle (not shown) or a tube for injecting a contrast medium (not shown) is mounted is projected from the tip of the barrel body 1a, and a flange portion 1c for finger hooking is formed at the rear end.
  • the material of the syringe barrel 1 is a hard resin (for example, cycloolefin resin “hereinafter referred to as COP”), polypropylene (hereinafter referred to as PP), an ethylene norbornene copolymer (hereinafter referred to as COC), or glass. Etc. are used.
  • the plunger rod 5 is a rod-shaped member provided with a male screw portion 5a at the tip end and a finger rest portion 5b at the rear end.
  • a male screw to be screwed into the female screw hole 15 of the main body portion 11 described above is engraved on the outer peripheral surface of the male screw portion 5a of the plunger rod 5.
  • the material of the plunger rod 5 is made of a resin such as cyclic polyolefin, polycarbonate and polypropylene.
  • the top cap 8 is attached to the mounting portion 1b of the syringe barrel 1 to prevent the injection liquid 30 filled inside the syringe barrel 1 from leaking, and to prevent the injection liquid 30 from being contaminated with germs floating in the air. It is a sealing member for making.
  • the top cap 8 is composed of a truncated cone-shaped cap body 8a and an annular protrusion 8c extending from the top surface of the cap body 8a in the opening direction and having a fitting recess 8b into which the mounting portion 1b is fitted. ing.
  • the top cap 8 is formed of an elastomer in which a chemical resistant film (PTFE or PFA) is laminated on the inner peripheral surface.
  • the elastomer includes either "vulcanized rubber”, “thermosetting elastomer”, or “thermoplastic elastomer”.
  • the gasket 10 shown in FIG. 1 is composed of a main body portion 11, a water blocking ring 13, and a sliding contact ring 19, and the main body portion 11 is entirely composed of PP (polypropylene), ultrapolymer polyethylene, COP (cycloolefin polymer), and COC (ethylene). It is made of a hard, inexpensive and low water permeable material (hard plastic resistant to chemicals) that does not react with the injection solution 30 such as norbornene copolymer).
  • the hard plastic used in the present invention preferably has a shore A hardness of 70 or more (or a shore D hardness of 40 to 100 and a Rockwell M hardness of 40 to 70).
  • the main body portion 11 of the gasket 10 is columnar, and a female screw hole 15 for mounting the plunger rod 5 is screwed on the rear end surface.
  • the main body portion 11 is divided into a wetted end side tip portion 11a and a rod side rear end portion.
  • the outer diameter d of the tip portion 11a on the wetted side is formed to be slightly smaller than the inner diameter D of the syringe barrel 1, and the portion from the tip portion 11a on the wetted side to the rear end surface is formed in a tapered shape in which the diameter gradually decreases. .. This portion is referred to as a taper portion 17.
  • one concave groove 18 is recessed over the entire circumference of the outer peripheral surface. Then, the outer peripheral surface of the end portion on the wetted surface 14 side away from the concave groove 18 is cut in a stepped manner to form the ring mounting portion 12. Therefore, there is a partition wall 11k between the end surface of the concave groove 18 on the wetted surface 14 side and the end surface of the ring mounting portion 12 on the rod side.
  • the groove depth from the outer peripheral surface of the wetted end side tip portion 11a of the concave groove 18 is formed deeper than the cutting depth of the ring mounting portion 12.
  • the shape of the mounting surface of the ring mounting portion 12 is formed straight in the cross section when the main body portion 11 is cut in the axial direction, and the shape of the groove bottom of the concave groove 18 is the shape when the main body portion 11 is cut in the axial direction.
  • the cross section it is formed so as to be straight, bulged in an arc shape on the opening side of the concave groove 18, or dented on the contrary.
  • the outer peripheral shape of the soft sliding contact ring 19, which will be described later, fitted in the concave groove 18 follows the groove bottom of the concave groove 18.
  • the water stop ring 13 is cut from a round bar of polytetrafluoroethylene or a tubular material of polytetrafluoroethylene is cut into round slices at the width of the mounting surface of the ring mounting portion 12, and the outer peripheral surface thereof (that is, the sliding contact surface 13s) is cut. ) Is cut to form one sliding contact protrusion 13t as shown in FIG. 3A, and one water blocking groove 13m is recessed by cutting as shown in FIGS. 3B and 3C. However, there are those in which two sliding contact protrusions 13t are formed on both sides of the water blocking groove 13m, or those in which a plurality of water blocking grooves are provided, although not shown. These sliding contact protrusions 13t and water stop groove 13m are exaggerated compared to the actual ones for the sake of clarity.
  • the inner diameter of the water stop ring 13 is slightly smaller than the diameter of the mounting portion of the ring mounting portion 12, and the outer diameter thereof is the same as or slightly larger than the inner diameter D of the syringe barrel 1.
  • the water stop ring 13 expands according to the diameter of the mounting portion, and the expanded outer diameter becomes slightly larger than the inner diameter D of the syringe barrel 1.
  • the sliding contact surface 13s of the water stop ring 13 is of a size that slides into the inner peripheral surface 2 of the syringe barrel 1 in a liquidtight manner with almost no increase in sliding resistance.
  • the water stop ring 13 of FIG. 3A is cut into a trapezoidal or triangular cross section to form one sliding contact protrusion 13t, and in FIGS. 3B and 3C, a water stop groove 13m is formed on the outer peripheral surface. 13t of sliding contact protrusions are formed on both sides thereof. The outer peripheral surface of the sliding contact protrusion 13t is the sliding contact surface 13s.
  • Each cross-sectional shape has a shape in which the wall thickness gradually decreases as it approaches the sliding contact surface 13s, which is the outer peripheral surface.
  • the water stop groove 13 m has various types such as a semicircular cross section, a U shape, and a V cross section. Although not shown, two water stop grooves may be formed to form a W-shaped cross section.
  • the water stop groove 13m is formed narrow and shallow, and is exaggerated in the figure to facilitate understanding of its shape.
  • the contact pressure of the sliding contact protrusion 13t with the inner peripheral surface 2 of the syringe barrel 1 is important. This contact pressure is related to the width of the sliding contact surface 13s of the sliding contact protrusion 13t and the shape of the sliding contact protrusion 13t.
  • the cross-sectional shape of the water stop ring 13 becomes thinner as the wall thickness of the sliding contact protrusion 13t approaches the sliding contact surface 13s, and the cross-sectional shape of the thin sliding contact protrusion 13t becomes thinner in the vicinity of the sliding contact surface 13s. It becomes easy to crush and improves the liquidtightness with the inner peripheral surface 2 of the syringe barrel 1, secures the strength of the waist of the sliding contact protrusion 13t at the thick part away from the sliding contact protrusion 13t, and moves the gasket 10. The bending of the sliding contact protrusion 13t at the time is prevented. As a result, the sliding contact protrusion 13t becomes self-supporting, and backup as in the conventional example becomes unnecessary.
  • the width of the sliding contact surface 13s of the sliding contact protrusion 13t (the sliding contact width T in the case of one row and the sliding contact width in the case of two strips, respectively).
  • T1 and T2 are machined to a width of 0.1 to 0.6 mm (more preferably 0.1 to 0.3 mm) in the case of 1 row, and its sliding contact width T1 in the case of 2 rows. It is machined so that T2 has the same width and is 0.1 to 0.3 mm, respectively.
  • the total width T1 + T2 is 0.2 to 0.6 mm.
  • the material of the water stop ring 13 is polytetrafluoroethylene (PTFE).
  • PTFE polytetrafluoroethylene
  • This PTFE may be pure PTFE, but for example, fluorine such as polytetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (abbreviated as PFA) and tetrafluoroethylene-hexafluoropropylene copolymer which are crystallization inhibitors of PTFE. It is more preferable to use a modified product mixed with 1 to 15% by mass of the resin because it imparts elasticity to the water blocking ring 13.
  • PFA polytetrafluoroethylene-perfluoroalkyl vinyl ether copolymer
  • tetrafluoroethylene-hexafluoropropylene copolymer which are crystallization inhibitors of PTFE. It is more preferable to use a modified product mixed with 1 to 15% by mass of the resin because it imparts elasticity to the water blocking ring
  • the rubber base material constituting the sliding contact ring 19 is preferably one that has already been approved as a medical member, and examples thereof include “silicone rubber”. Here, it is filled with silicone oil to give it slidability.
  • This "silicone rubber” is a thermosetting resin.
  • silicone rubber exhibiting slidability examples include peroxide curable type and addition reaction curable type silicone rubber.
  • An appropriate amount of a curing catalyst is added to these clay-like polysiloxanes, a predetermined amount of silicone oil is added, and the mixture is kneaded with a kneader to form the clay-like polysiloxane. Further, if necessary, an appropriate amount (for example, 25%) of silica fine powder is added to adjust the hardness of the kneaded product. If necessary, for example, a predetermined amount of ultra-high molecular weight polyethylene fine powder is added.
  • the polyethylene resin that forms the fine particles of the fine powder is an ultrapolymer.
  • ultrapolymer For example, some have an average molecular weight of 1 to 3 million or more and reach 7 million.
  • ultrapolymer particles are not water permeable and do not adhere to most things.
  • the ultra-high molecular weight polyethylene does not melt even at high temperature because its molecular weight is so high, and retains its spherical morphology even when molded at high pressure.
  • the surface of the spherical ultra-high molecular weight polyethylene is relatively smooth, but some irregularities are also observed.
  • the range of the particle size of the spherical ultrapolymer fine particles contained in the fine powder is 10 to 300 ⁇ m. More preferably, it is 20 to 50 ⁇ m.
  • Silica fine powder is a powder made from silicon sand, and most of it is composed of silicon (SiO 2). It is added to the rubber substrate to adjust the hardness.
  • Silicone oil is generally a colorless and transparent liquid, has excellent heat resistance, cold resistance, and water resistance, and has little change in viscosity over a wide temperature range. In addition, it also has mold releasability, water repellency, defoaming property, and lubricity. There is compatibility between the silicone oil kneaded as described above and the rubber base material 19c, and if an appropriate amount is filled, the silicone oil is uniformly dispersed in the rubber base material 19c.
  • the compression mold capable of forming the sliding contact ring 19 is heated to, for example, 100 to 160 ° C., and the above-mentioned molding material (silica powder, silicone oil and, if necessary, an ultrahigh height added). (Silicone rubber kneaded with molecular PE powder added) is filled and heated and pressed to heat-crosslink in 1 to 10 minutes, and the desired sliding contact ring 19 is obtained.
  • the outer diameter of the sliding contact ring 19 is such that it adheres to the inner peripheral surface 2 of the syringe barrel 1 with liquidtightness.
  • the manufacturing method of the main body portion 11 of the gasket 10 will be described.
  • the chemical-resistant hard plastic as described above is applied to the main body portion 11 with respect to the injection liquid 30 filled in the syringe barrel 1. Then, in order to obtain the above shape, cutting by a lathe or injection molding is performed.
  • a water stop ring 13 that is in sliding contact with the inner peripheral surface 2 of the syringe barrel 1 is fitted into the ring mounting portion 12 by press fitting, and a sliding contact ring 19 that is in sliding contact with the inner peripheral surface 2 of the syringe barrel 1 is fitted in the concave groove 18. It is fitted.
  • a gap 20 having the same width as the partition wall 11k is provided between the water stop ring 13 and the sliding contact ring 19 over the entire circumference. The width of the gap 20 is 0.05 to 2 mm.
  • FIG. 6B corresponds to the invention described in Patent Document 1, and the sliding contact surface 13s of the sliding contact protrusion 13t of the water stop ring 13 and the syringe barrel 1
  • the sliding contact portion with the inner peripheral surface 2 and the sliding contact portion between the sliding contact surface 19s of the sliding contact ring 19 and the inner peripheral surface 2 of the syringe barrel 1 are in a state of being substantially connected, and the injection liquid 30 in the syringe barrel 1 is in a state of being substantially connected.
  • the steam pressure of the filling chamber 30j is applied to the sliding contact portion between the sliding contact surface 19s of the sliding contact ring 19 and the inner peripheral surface 2 of the syringe barrel 1.
  • the sealing property is impaired and the standard is not reached.
  • the width of the gap 20 is 0.05 mm or more, it is possible to prevent the capillary phenomenon at the sliding contact portion between the sliding contact ring 19 and the inner peripheral surface 2 of the syringe barrel 1.
  • the upper limit of the width of the gap 20 is not limited, but it is preferable that the gap 20 has a maximum width of 2 mm.
  • the injection liquid 30 (or its water vapor) is in the gap 20 on the back surface of the water stop ring 13 due to the above-mentioned capillary phenomenon during long-term storage. Although it is a very small amount, it leaks. Since the water stop ring 13 is separated from each other by at least 0.05 mm from the sliding contact ring 19, the fine gap between the inner peripheral surface 2 of the syringe barrel 1 and the sliding contact surface 13s of the water stop ring 13 is formed.
  • the injection liquid 30 (or its water vapor) that has permeated by the capillary phenomenon does not reach the minute gap between the inner peripheral surface 2 of the syringe barrel 1 and the sliding contact surface 19s of the sliding contact ring 19, and permeates from here by the capillary phenomenon. There is no. Since the volume of the void 20 from which the injection liquid 30 (or its water vapor) has leaked is much larger than the amount of leakage of the injection liquid 30 or the like, the vapor pressure of the leaked injection liquid 30 or the like in the void 20 is the injection liquid. It is much smaller than the steam pressure of the filling chamber 30j in the syringe barrel 1 filled with 30, and water such as the injection liquid 30 does not leak to the back surface thereof through the sliding contact ring 19. Further, if the water stop groove 13 m is formed as shown in FIGS. 3 (b) and 3 (c), the leaked injection liquid 30 or the like enters the water stop groove 13 m before entering the gap 20. , The sealing effect is further enhanced.
  • Example 6 and 7 are experimental examples of the sealing property of the water stop ring 13.
  • the test conditions are that the amount of water leaked from the injection solution 30 is 0.5% or less after storage for 3 months in an atmosphere of 40 ° C. and 50% humidity.
  • the dashed arrow indicates the flow of injection solution or water vapor.
  • the syringe used had a mass of 5 g in its contents. Therefore, the permissible amount of water leakage from this syringe is 0.025 g.
  • (A) is a gasket 10A in which the waterproof ring 13 is not provided and only the sliding contact ring 19 is provided in the main body portion 11 (Comparative Example 1).
  • the sliding contact ring 19 and the injection liquid 30 are in direct contact with each other in the gap 20o between the liquid contact side tip portion 11a of the main body portion 11 and the inner peripheral surface 2 of the syringe barrel 1. Therefore, the injection liquid 30 permeates the inside of the sliding contact ring 19 from this gap 20o and penetrates between the inner peripheral surface 2 of the syringe barrel 1 and the sliding contact surface 19s of the sliding contact ring 19 by a capillary phenomenon, and penetrates into the back surface thereof.
  • Reach. (B) is a gasket 10B of Comparative Example 2 corresponding to FIG. 8 in which the water stop ring 13 is brought into contact with the sliding contact ring 19 at the boundary portion indicated by the reference numeral 20s and no gap 20 is provided.
  • the injection liquid 30 permeates the fine gap between the sliding contact surface 13s of the water stop ring 13 and the inner peripheral surface 2 of the syringe barrel 1 by a capillary phenomenon, and reaches the back of the water stop ring 13.
  • a part of the permeated water stop ring 13 permeates the fine gap between the inner peripheral surface 2 of the syringe barrel 1 and the sliding contact surface 19s of the sliding contact ring 19 by a capillary phenomenon, and the rest permeates the inside of the sliding contact ring 19. Reach the back of the sliding contact ring.
  • (C) is an embodiment (gasket 10C) of the present invention in which the water stop ring 13 is separated from the sliding contact ring 19 and a gap 20 is provided between them.
  • the injection liquid 30 permeates the fine gap between the sliding contact surface 13s of the water stop ring 13 and the inner peripheral surface 2 of the syringe barrel 1 by a capillary phenomenon, and reaches the gap 20 behind the water stop ring 13. Since the volume of the void 20 is much larger than the leakage amount of the injection liquid 30, the vapor pressure of the leaked injection liquid 30 in the void 20 is the vapor pressure of the filling chamber 30j in the syringe barrel 1 in which the injection liquid 30 is filled. Much less than pressure.

Landscapes

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

Abstract

La présente invention concerne le problème consistant à développer un joint d'étanchéité présentant une excellente imperméabilité à la vapeur d'eau et une résistance au stockage à long terme, et, de plus, capable de réduire de manière drastique les coûts de matériau.　L'invention concerne un joint d'étanchéité (10) pour l'utilisation d'une seringue, qui est ajusté par pression dans un cylindre de seringue (1) à utiliser sous un état coulissant. La partie de corps principal (11) du joint d'étanchéité (10) est produite à partir d'une matière plastique dure résistant aux produits chimiques, est plus étroite que le diamètre interne (D) du cylindre de seringue (1), et comprend une rainure renfoncée (18) formée sur sa périphérie externe, et une portion d'ajustement d'anneau (12) formée à la portion d'extrémité sur son côté de surface de contact avec le liquide (14). Un anneau de contact coulissant (19) ajusté dans la rainure renfoncée (18) établit le contact coulissant avec la surface périphérique interne (2) du cylindre de seringue (1). Un anneau d'arrêt d'eau (13) est ajusté sur la portion d'ajustement d'anneau (12) et établit le contact coulissant avec la surface périphérique interne (2) du cylindre de seringue (1). Un espace (20) est prévu entre l'anneau d'arrêt d'eau (13) et l'anneau de contact coulissant (19).
PCT/JP2020/023833 2020-06-17 2020-06-17 Joint d'étanchéité et seringue utilisant ledit joint d'étanchéité Ceased WO2021255873A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2021512824A JP7012936B1 (ja) 2020-06-17 2020-06-17 ガスケット及び該ガスケットを使用した注射器
PCT/JP2020/023833 WO2021255873A1 (fr) 2020-06-17 2020-06-17 Joint d'étanchéité et seringue utilisant ledit joint d'étanchéité

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2020/023833 WO2021255873A1 (fr) 2020-06-17 2020-06-17 Joint d'étanchéité et seringue utilisant ledit joint d'étanchéité

Publications (1)

Publication Number Publication Date
WO2021255873A1 true WO2021255873A1 (fr) 2021-12-23

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PCT/JP2020/023833 Ceased WO2021255873A1 (fr) 2020-06-17 2020-06-17 Joint d'étanchéité et seringue utilisant ledit joint d'étanchéité

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JP (1) JP7012936B1 (fr)
WO (1) WO2021255873A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013500793A (ja) * 2009-07-31 2013-01-10 メドトロニック ミニメド インコーポレイテッド 貯蔵容器プランジャヘッドシステム及び方法
WO2014136138A1 (fr) * 2013-03-04 2014-09-12 有限会社コーキ・エンジニアリング Élément piston pour une seringue
WO2019043784A1 (fr) * 2017-08-29 2019-03-07 有限会社コーキ・エンジニアリング Joint d'étanchéité et seringue le comprenant

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013500793A (ja) * 2009-07-31 2013-01-10 メドトロニック ミニメド インコーポレイテッド 貯蔵容器プランジャヘッドシステム及び方法
WO2014136138A1 (fr) * 2013-03-04 2014-09-12 有限会社コーキ・エンジニアリング Élément piston pour une seringue
WO2019043784A1 (fr) * 2017-08-29 2019-03-07 有限会社コーキ・エンジニアリング Joint d'étanchéité et seringue le comprenant

Also Published As

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JP7012936B1 (ja) 2022-02-15
JPWO2021255873A1 (fr) 2021-12-23

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