JP2000342688A - Syringe - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a safe syringe with a gasket enhanced in slidability and a resin outer cylinder having sufficient germfree safety and operability even after high-pressure steam sterilization. SOLUTION: This syringe is formed of a resin outer cylinder, a resin pressing bar, and a gasket 4 disposed at the tip of the pressing bar. The gasket 4 is formed of a tip support 3A, a ring member 5, a separating member 6, and a fixed lid 7, and the tip support 3A is integrally formed as the tip of the pressing bar. The protruding rib of the gasket 4 forms the ring member 5. Since the ring member 5 is formed of a hard, dimensionally stable, slidable and non- adhesive fluorine resin, the resistance in the sliding contact with the inner surface of the outer cylinder is minimized. Further, the ring member 5 can be precisely worked because it is hard, and the sliding surface as the protruding rib can be formed into a sharp contact point, and proper slidability and sealing property can be ensured.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a syringe, and more particularly, to a syringe with improved slidability and safety of a gasket.

[0002]

2. Description of the Related Art In recent years, disposable syringes have been used from the viewpoint of infection prevention. In general, syringes using a resin outer cylinder are frequently used. Such a syringe includes an injection-molded outer cylinder, a resin presser bar, and a rubber gasket attached to the tip of the presser bar. Also,
There is also provided a syringe in which a drug solution is stored in a liquid-tight manner in the outer cylinder of the syringe in advance. By the way, a general-purpose resin that can be melt-molded is used for the resin outer cylinder. In particular, it is desired that the resin itself has transparency and heat resistance without contamination to a chemical solution or the like. The resin material of the outer cylinder is a general-purpose resin such as polyolefin resin, vinyl chloride, vinylidene chloride resin, polyester resin, polyvinyl alcohol resin, polyacrylonitrile resin, polyacrylic acid resin, and polyamide resin. . Above all, as such a resin, a polyolefin-based resin is desirable.
Medium- and low-density olefin resins such as high-density polyethylene and polypropylene; cyclic polyolefins; and copolymers of two or more of these. In particular, it has heat resistance,
In recent years, cyclic polyolefin-based resins and the like having no pollution have been frequently used.

[0003]

Generally, in a syringe using a resin outer cylinder, the slidability with a gasket is not sufficient. For this reason, a medical silicone oil or the like is applied or adsorbed to the gasket as a lubricant to improve the slidability between the gasket and the inner surface of the outer cylinder. However, if the amount of the lubricant to be applied to the gasket is not accurately provided in a sufficient amount, the slidability may not be sufficient, or if the amount is too large, the lubricant may adversely affect the injected body. is there. For this reason, it is desired to accurately apply a lubricant or the like to the gasket. Further, it is also desired to achieve low friction of the gasket to such an extent that slidability that does not require a lubricant can be obtained. Further, the gasket is formed with a ridge rib or the like on the outside thereof in order to ensure sufficient liquid tightness with the outer cylinder. However, it is technically difficult to form the ridge rib by integral molding on the gasket made of an elastic material so that the sliding contact portion with the inner surface of the outer cylinder is minimized (an acute angle), and it is economically difficult. It becomes difficult. Therefore, it is desired that the contact area of the ridge rib be accurately and minimized to enhance the sealing property and the sliding property together. Furthermore, in the case of a syringe containing a drug solution, there is a problem in that it is difficult to manufacture the syringe with a high-pressure steam after sealing the drug solution in a resin outer cylinder.
That is, during the heating period of the high-pressure steam sterilization process, the inner wall surface of the resin outer cylinder is in a state of being pressed by the gasket of the pusher. When such stress is applied during the heating period, the inner wall surface of the outer cylinder is dented. The inner diameter of the inner cylinder side of the outer cylinder with which the gasket comes into contact substantially increases. For this reason, after steam sterilization, the sealing function of the gasket is reduced, and the sliding property of the pusher during operation is disadvantageously deteriorated. If the sealing function of the gasket is reduced, the sterility of the medicinal syringe during storage is doubtful. Further, if the sliding property of the pusher is deteriorated, there is a problem that the usability of the syringe containing the chemical liquid is deteriorated. In particular, a problem is observed when a resin having a heat distortion temperature lower than the steam sterilization temperature, for example, a general-purpose polyolefin resin such as polypropylene or polyethylene is used as the outer cylinder. Therefore, the present invention enhances the slidability of the gasket and provides a safe syringe. In addition, the resin outer cylinder containing the chemical solution has safety and operation against sterility even after being subjected to high-pressure steam sterilization. An object of the present invention is to provide a syringe having a sufficient sex.

[0004]

According to the present invention, in a syringe comprising a resin outer cylinder, a gasket inserted into the outer cylinder comprises a support member and a ring member externally fitted to the support member. The above object has been achieved by providing a syringe characterized in that the ring member is a convex rib of the gasket which can press and slide against the inner wall surface of the outer cylinder. .

[0005] The outer cylinder of the above-mentioned syringe is made of a molded product made of resin. The outer cylinder is made of a thermoplastic general-purpose resin. Specific examples of the resin used for the outer cylinder include general-purpose resins such as polyolefin resin, vinyl chloride, vinylidene chloride resin, polyester resin, polyvinyl alcohol resin, polyacrylonitrile resin, polyacrylic resin, and polyamide resin. Resin. The outer cylinder wall may be formed of a single layer or a multilayer resin layer, and the resin layer may be a single resin or a mixed resin layer. It is desirable that the resin on the innermost surface of the outer cylinder wall, that is, the resin in direct contact with the chemical liquid, be a polyolefin-based resin with relatively low contamination. For example, low, middle, and high-density polyethylenes, lower olefin resins such as polypropylene, cyclic polyolefins, copolymers of two or more of these resins, and mixed resins thereof are exemplified.

A presser bar may be attached to the gasket inserted into the outer cylinder in advance, or the presser bar may be removed just before use. The gasket of the syringe according to the present invention includes a support member and a ring member. The material of the support member and the ring member of the gasket can be selected from fixed resin, elastic rubber, and thermoplastic elastomer. When a fixed resin is used for the ring member, the resin used for the ring member has some elasticity, the resin constituting the outer cylinder has some elasticity, or both have a slight elasticity. It has elasticity. In order for the ring member to slide while pressing on the inner surface of the outer cylinder, at least one of the following is necessary: the inner diameter of the outer cylinder is slightly widened, or the outer diameter of the ring member is slightly deformed to substantially reduce the outer diameter. It is because it is. However, if the ring member or the support member is an elastic material, the outer cylinder may be a resin that is not elastically deformed at all. The support member is usually formed with an engagement hole of a presser bar. The gasket is attached to the push bar through the engagement hole. When the ring member is externally fitted on the side peripheral surface of the support member, a groove is formed on the side peripheral surface in order to position the ring member, and the ring member is fitted into the groove. Is also good. If the support member does not need to be an elastic material, the support member may be formed integrally with the presser bar without the engagement hole.

The elastic material used for the support member and the ring member includes general-purpose rubbers and thermoplastic elastomers, such as natural rubber, isoprene, styrene butadiene rubber, butadiene rubber, chloroprene acrylo rubber, nitrile butadiene rubber, Examples thereof include butyl rubber, ethylene propylene rubber, urethane rubber, silicone rubber, fluorine rubber, chlorosulfonated polyethylene rubber, chlorinated polyethylene, acrylic rubber, epichlorohydrin rubber, polysulfide rubber, chlorinated butyl rubber, and neoprene. Particularly, for medical use, highly safe silicone rubber, fluororesin rubber, and the like can be given.

[0008] Examples of the fixed resin used for the support member and the ring member include a thermoplastic resin and a thermosetting resin. In the above support member, it is desirable to use a thermoplastic resin from the viewpoint of workability and the like. In the ring member, a thermoplastic resin or a thermosetting resin may be used, but a resin exhibiting low friction with the inner surface of the outer cylinder after processing is desirable. Examples of the thermoplastic resin include resins used for the above-described outer cylinder and the like. Examples of the thermosetting resin include a urea resin, a melamine resin, an alkyd resin, an acrylic resin, and an unsaturated polyethylene resin. Examples of the resin exhibiting low friction in the ring member include a fluororesin, an ultrahigh molecular weight polyethylene, an acrylic resin, and an unsaturated polyethylene resin.

The above-mentioned ring member of the syringe according to the present invention comprises:
The gasket is a convex rib which can press and slide on the inner wall surface of the outer cylinder. If the ring member in the gasket is provided separately from a main body such as a support member and the ring member is a fixed resin, the precision processing can be easily performed by itself. The contact area of the sliding portion with the outer cylinder can be reduced. In the case of the convex rib of the gasket in which the contact area at the sliding portion with the outer cylinder is minimized, low friction and sealing properties can be sufficiently exhibited during sliding. For this reason, when a resin material having extremely low friction is used for the ring member, it is not necessary to use a conventional lubricant such as silicone oil. Furthermore, even if the material of the ring member itself is relatively expensive, there is no problem economically.

A syringe according to a second aspect of the present invention is the syringe according to the first aspect, wherein a lubricant or a lubricating resin film is applied to a sliding portion of the ring member. When the lubricant is applied to the ring member, it is not necessary to apply the lubricant to the entire gasket as in the related art. That is,
If a lubricant is applied to a gasket by applying a lubricant, or spraying and adhering a lubricant to a mist, there is a possibility that excessive application, uneven coating or poor adhesion may occur. For this reason, the lubricant could not be accurately applied to the sliding portion of the gasket. However, in the present invention, since it is sufficient to apply only the ring member, the lubricant can be applied very accurately. Also, when a lubricating resin film is laminated on the ring member, the lamination can be easily performed because it does not cover the whole. As a lubricant,
Examples include semisolid liquid paraffins, olefins, and the like, or oils such as polyalkylene glycols, halogenated hydrocarbons, and silicones. In particular, silicone resins, oils and the like are desirable for medical use. Examples of the above-mentioned lubricating resin film include ultra-high molecular weight polyethylene, Teflon (polytetrafluoroethylene: manufactured by Mitsui Dupont Fluorochemicals), Neoflon FEP (tetrafluoroethylene / hexafluoropropylene copolymer: manufactured by Daikin), Aflon PFA ( (Tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer: manufactured by Asahi Glass Co., Ltd.).

According to a third aspect of the present invention, there is provided the syringe according to the second aspect, wherein a chemical solution is previously contained in the outer cylinder via the gasket, and the support member and the ring member are extendable. The support member is formed with an engagement hole with the presser bar inside the support member, and a variable member for changing the outer diameter of the support member and the ring member is provided in the engagement hole. The outer diameter of the ring member on the distal end side of the support member is changed to a large diameter by the variable member after steam sterilization of the inside chemical solution.

The syringe comprises a resin outer cylinder, a gasket, and a chemical. By the gasket, the chemical is stored in advance in the outer cylinder in a liquid-tight manner. That is,
The insertion opening of the pusher of the outer cylinder is sealed by the gasket, and the chemical solution is contained in the outer cylinder in a liquid-tight manner.
The chemical is steam sterilized in the outer cylinder together with the outer cylinder. The above-mentioned chemical liquid is a medical liquid such as a therapeutic drug, a test drug, a circulating liquid, a preservative liquid, and the like, and is a liquid that does not undergo any deterioration due to steam sterilization or the like at a high temperature.

In the syringe, the support member and the ring member are made of an extensible material. That is, the support member and the ring member are made of the elastic material described above. The support member has an engagement hole with the presser bar formed therein. Therefore, the support member is formed to be hollow. The variable member is disposed in the engagement hole, and the variable member increases the outer diameter of the support member and the ring member. The variable member may be used alone or may be formed integrally with the tip of the presser bar.

As a structure of the variable member for increasing the outer diameter on the distal end side of the support member, the variable member may push the inner surface of the wall on the distal end side in the support member in the radial direction of the member. Any structure that can be used may be used. Since the supporting member is made of an elastic material, when the inner surface of the wall on the distal end side is pressed by the variable member, the outer surface of the wall expands, and as a result, the outer diameter of the supporting member increases, and the ring member also increases in diameter. Just do it. The outer diameter of the ring member may be increased as long as the diameter can be increased after the sterilization of the chemical solution by steam. Here, the radial direction of the support member means a perpendicular direction when the insertion direction of the presser bar and the support member into the outer cylinder is the axial direction.

In the above-mentioned syringe containing a drug solution, a part of the ring member presses the inner surface of the resin outer cylinder during the heating period during the steam sterilization process, and the pressing causes the inner surface of the resin outer cylinder to be pressed. The portion is enlarged, and the sealing performance of the gasket is slightly deteriorated. However, in the above-mentioned syringe, after the steam sterilization (before storage, or immediately before use), the ring member on the distal end side on the insertion side of the gasket is made large in diameter by the variable member, and the gasket is The sealing property with the resin outer cylinder can be newly maintained at the tip end side. Therefore, the syringe containing a drug solution can safely maintain sterility or sealability during the storage period, particularly during use, after steam sterilization.

According to a fourth aspect of the present invention, there is provided the syringe with a medical solution according to the third aspect, wherein the variable member is provided so as to be able to move the engaging hole in the axial direction of the support member. The inner diameter of the mating hole is formed to be smaller than the outer diameter of the variable member inserted into the engagement hole, and the variable member moves from the proximal side to the distal side in the support member, so that the distal side of the gasket The outer diameter of the ring member can be changed to a large diameter.

The variable member is provided so as to be movable in the axial direction in the support member. When the variable member is relatively moved within the support member, the inner diameter of the support member is formed to be smaller than the outer diameter of the variable member. Can be. That is, if the variable member moves from the proximal side to the distal side in the support member after the steam sterilization process, the inner surface on the distal side of the support member is radially expanded by the variable member, and as a result, the elastic material The outer diameter of the support member at the tip end side becomes large, and the ring member made of an elastic material also becomes large. When the ring member on the distal end side has a large diameter, a sufficient sealing property is maintained by the support member even after steam sterilization as described above. Therefore, at first, the sealing property of the outer cylinder is maintained on the base end side of the gasket, and the sealing property of the outer cylinder is maintained on the distal end side of the gasket after steam sterilization. It is structurally preferable that the sealability is maintained by moving from the base end side to the front end side in this way, in order to maintain the sterility of the chemical solution.

According to a fifth aspect of the present invention, there is provided the syringe according to the fourth aspect, wherein a plurality of the ring members are provided, and an outer diameter Rb on the proximal end side and an outer diameter Rf on the distal end side of the gasket. And the outer diameter Rb1 on the proximal end side and the outer diameter Rf1 on the distal end side of the gasket before the movement of the variable member.
Rb1> Rf1, the outer diameter Rb1 of the base end of the gasket before the movement of the variable member and the outer diameter Rb of the base end of the gasket after the movement of the variable member.
The relationship between b2 and the outer diameter Rf2 on the distal end side is characterized in that Rf2 ≧ Rb1> Rb2.

The outer diameter Rb1 on the proximal end side of the gasket before the movement of the variable member, that is, before the steam sterilization treatment.
And the outer diameter Rf1 on the tip side is Rb1> Rf1. This means that before the steam sterilization and during the steam sterilization, the ribs, which are the ring members on the proximal end side, maintain the sealing property near the insertion opening of the pusher of the outer cylinder. Therefore, immediately after steam sterilization,
The inner surface of the outer cylinder pressed by the ring member on the base end side has a dent deformation. In the case of an outer cylinder made of a general-purpose resin material such as polypropylene or polyethylene, the heat deformation temperature of the resin is 110 ° C. or less, and therefore, the dent deformation often occurs on the inner surface in a long-term heating state during sterilization.

The outer diameter Rb1 on the base end side of the gasket before the movement of the variable member, the outer diameter Rb2 on the base end side of the gasket after the movement of the variable member, that is, after steam sterilization, and the front end side The relationship with the outer diameter Rf2 is as follows: Rf2 ≧
Rb1> Rb2. The relationship of Rf2 ≧ Rb1 ensures that the sealing property of the insertion opening of the pusher of the outer cylinder is sufficiently maintained by the ring member on the distal end side after the steam sterilization. Therefore, after steam sterilization, the pusher of the outer cylinder is surely secured by the leading end-side ring member on the insertion side, not by the depression of the outer cylinder pressed by the ring member on the proximal end side of the gasket. The insertion port is sealed. The relationship of Rb1> Rb2 indicates that the diameter of the ring member on the proximal end side becomes small after steam sterilization, and the pressing force on the inner surface of the outer cylinder is reduced. This enhances the slidability of the presser during use. If the proximal ring member does not reduce the pressing force against the inner surface of the outer cylinder, the proximal ring member is located within the dent deformation of the outer cylinder and becomes an obstacle to initial sliding. . Therefore, the syringe with a drug solution according to the present invention has sufficient sterility and operability after steam sterilization.

[0021]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of a syringe according to the present invention will be described below in detail with reference to the accompanying drawings. FIG. 1 is a side view of the syringe according to the first embodiment. FIG. 2 is a half sectional view of a gasket portion of the syringe according to the first embodiment. FIG. 3 is a side view of the syringe according to the second embodiment. FIG. 4 is a half sectional view of a syringe according to the second embodiment. FIG. 5 is a side sectional view of a syringe according to the third embodiment. 6A and 6B are half sectional views of the gasket of the syringe according to the third embodiment.
FIG. 7 is a side sectional view of a syringe according to a third embodiment before high-pressure steam sterilization. FIG. 8 is a cross-sectional view showing the relationship between the gasket and the outer cylinder wall of the syringe according to the third embodiment after autoclaving.

As shown in FIGS. 1 and 2, a syringe 1 according to a first embodiment comprises a resin outer cylinder 2 and a resin push bar 3.
And a gasket 4 provided at the tip of the presser bar 3. The outer cylinder 2 and the presser bar 3 are made of polypropylene. The outer cylinder 2 is an injection molded product, and has a gasket 4 and an insertion port 2A for the push bar 3 formed at a base end, and a discharge port 2B to which a syringe needle or the like is attached when used at the front end. The outer cylinder 2 has an inner diameter of 20.0 mm ± 0.2 mm. Usually, since the outer cylinder 2 is die-cut during molding,
The inner diameter of the outer cylinder 2 on the distal end side is slightly smaller than the inner diameter on the proximal end side.

The gasket 4 comprises a distal end support 3A, a ring member 5, a separating member 6, and a fixed lid 7,
The distal end support portion 3A is integrally formed as a distal end portion of the presser bar 3. The plurality of ring members 5 and the plurality of separation members 6 are alternately fitted to the distal end support portion 3A. The fixed lid 7 is thermally bonded to the distal end surface of the distal end support 3A, and the ring member 5 and the separation member 6 are fixed to the side peripheral surface of the distal end support 3A. The ring member 5 is made of a fluororesin (ethylene / tetrafluoroethylene copolymer) which is a low friction material,
The gasket 4 is formed as a convex rib. The angle θ of the sliding contact portion of the ring member 5 with the inner surface of the outer cylinder 2 is 30
° and its outer diameter is set to 20.3 mm ± 0.1 mm.

In the syringe 1 according to the first embodiment, the convex rib of the gasket 4 is the ring member 5. Since the ring member 5 is made of a hard, dimensionally stable, slidable and non-adhesive fluororesin, the ring member 5 has little resistance to sliding contact with the inner surface of the outer cylinder 2. In addition, since the ring member 5 is hard, accurate processing can be performed, and the sliding contact surface as the convex rib can be an acute contact point, so that appropriate slidability and sealability can be reliably obtained. It is desirable that the angle θ at the sliding portion of the ring member 5 be 45 ° or less, particularly 30 ° or less. During sliding, since the outer diameter of the ring member 5 is slightly larger than the inner diameter of the outer cylinder 2, the inner diameter of the outer cylinder 2 made of polypropylene slightly expands due to elastic deformation. Such expansion of the inner diameter can be suppressed within the range of the elastic deformation of the outer cylinder 2 made of polypropylene. At this point, the ring member 5 can exhibit accurate dimensional stability because it is separate from the support main body of the gasket 4.

Next, with regard to the syringe according to the second embodiment,
This will be described in detail with reference to FIGS. 3 and 4 of the accompanying drawings. The syringe 8 according to the second embodiment uses the same or similar structure and members as the syringe 1 according to the first embodiment. A detailed description of the syringe 8 according to the second embodiment regarding the same or similar structure and members as the syringe 8 according to the first embodiment will be omitted. The different point of the syringe 8 according to the second embodiment from the syringe 1 according to the first embodiment is a tip support portion 9A of the pusher 9 and an O-ring (ring member) 10. The O-ring 10 is made of an elastic material such as silicone rubber. The O-ring 10 is externally fitted to the tip support 9A, and the O-ring 10 is attached to the tip support 9A.
The outer peripheral portion is fitted approximately halfway into the groove 10A formed on the side peripheral surface of the main body. O-ring 10 is groove 1
The gasket 4 is positioned at the distal end support portion 9A via the liner 0A, and includes the distal end portion of the presser bar 9 and the O-ring 10. O-ring 10 is coated with silicone oil 13 as a lubricant.

In the syringe 8 according to the second embodiment, the O-ring 10 is applied by dipping in silicone oil, applying silicone oil, and atomizing and spraying the silicone oil. be able to. When applying such silicone oil, it is not necessary to apply it to the entire gasket 4. This allows an appropriate amount of silicone oil to be easily applied to the surface of the O-ring 10. For this reason, there is no excessive silicone oil applied, and the gasket 4 has high safety. On the other hand, when applying the silicone oil, regardless of whether dipping, spraying, or coating,
The surface of the O-ring 10 can be applied evenly. Therefore, the gasket 4 has sufficient slidability.

Further, since the O-ring 10 and the distal end support portion 9A are made of different members, the inner surface of the outer cylinder 2 is pressed only by the elastic force of the O-ring 10. The distal end support 9A does not elastically deform. Therefore, unlike the conventional gasket, the entire gasket does not contribute to the elastic pressing force, and only the O-ring 10 can apply an extremely accurate pressing force to the inner surface of the outer cylinder 2 and balance the sealing performance and the sliding performance. You can control well.

Next, the syringe according to the third embodiment will be described.
This will be described in detail with reference to FIGS. The syringe 11 according to the third embodiment uses the same or similar structure and members as the syringe 1 according to the first embodiment. The detailed description of the syringe 11 according to the third embodiment regarding the same or similar structure and members as those of the syringe 11 according to the first embodiment will be omitted.

As shown in FIGS. 5 to 8, a syringe 11 according to the third embodiment comprises an outer cylinder 12, a presser bar 14, and a drug solution 16.
And the gasket 1 attached to the tip of the push bar 14
8 The outer cylinder 12 is made of an injection molded product of polypropylene. The gasket 18 of the push bar 14 slides in the outer cylinder 12 in a liquid-tight manner. The gasket 18 includes silicone rings (ring members) 22, 24, 26 and a support body 28. The support body 28 is made of butyl rubber. The chemical solution 16 is stored in the outer cylinder 12 in a liquid-tight manner by a gasket 18 in advance.

As shown in FIGS. 6A and 6B, the support main body 28 of the gasket 18 is formed with an engagement hole 29 and is hollow. A variable member 30 made of a hard resin is provided in an engagement hole 29 of the support body 28. Support body 2
8, the silicone rings 22, 24, 26 are externally fitted with the silicone rings 22, 24, 26 being fitted about half into grooves 28A formed on the side peripheral surface of the support body 28. I have. Each silicone ring 22, 24, 2
6 is positioned on the support main body 28 via the groove 28A, and the gasket 18 is composed of the tip 15 of the presser bar 14, the support main body 28, and the silicone rings 22, 24, 26. Silicone oil is applied to the silicone rings 22, 24, and 26 as a lubricant.

Therefore, the silicone rings 22, 24, 2
6 functions as a rib for pressing the inner surface of the outer cylinder 12. The silicone rings 22, 24, and 26 have an outer diameter Rb on the proximal end side of the gasket 18, an outer diameter Rm on the intermediate portion (quasi-distal end side), and an outer diameter Rf on the distal end side. The variable member 30 changes the outer diameter Rf1 of the tip silicone ring 22 of the gasket 18 to the outer diameter Rf2.
Variable. Also, the outer diameter R of the intermediate silicone ring 24
m1 is changed to the outer diameter Rm2, and the outer diameter Rb1 of the proximal silicone ring 26 is changed to the outer diameter Rb2.

As shown in FIG. 6A, the variable member 3
Numeral 0 is provided so as to be movable in the axial direction in the support main body 28. The outer surface of the variable member 30 slides on the inner surface of the wall inside the support main body 28, and the inner diameter of the engagement hole 29 of the support main body 28 is formed smaller than the variable member 30 throughout. As shown in FIG. 6B, the chemical 1 in the outer cylinder 12
6 after the high-pressure steam sterilization (temperature 110 ° C.)
As a result, the outer diameters Rf and Rm of the tip silicone ring 22 and the intermediate silicone ring 24 of the gasket 18 are changed to large diameters.

The variable member 30 is moved by the tip 15 of the pusher 14 inserted into the gasket 18. A male screw is engraved on the outer surface of the distal end portion 15, and the distal end portion 15 is screwed to the mounting member 32 via the male screw.
The mounting member 32 is fixed to the support main body 28, so that the gasket 18 is supported by the distal end 15 of the presser bar 14 via the mounting member 32.

Therefore, depending on the degree of insertion of the distal end portion 15 by screwing, the variable member 30 relatively moves from the proximal end side to the distal end side in the support main body 28, and the outer diameter Rf1 of the distal end silicone ring 22 of the gasket 18 is changed. Further, the outer diameter Rm1 of the intermediate silicone ring 24 can be changed to a larger diameter. The outer diameter Rb1 of the proximal silicone ring 26 of the gasket 18 and the distal silicone ring 22 before the movement of the variable member 30
The relationship with the outer diameter Rf1 is Rb1> Rf1. The outer diameter Rb1 of the proximal silicone ring 26 of the gasket 18 before the movement of the variable member 30 and the proximal silicone ring 26 of the gasket 18 after the movement of the variable member 30
The relationship between the outer diameter Rb2 and the outer diameter Rf2 of the tip silicone ring 22 is Rf2 ≧ Rb1> Rb2.

Next, a syringe 1 containing a drug solution according to the third embodiment.
The manufacturing method 1 will be briefly described. As shown in FIG. 7, a gasket 18 is inserted into the outer cylinder 12 at a predetermined position. The gasket 18 has a variable member 30 and a mounting member 32 incorporated therein. The tip 15 of the presser bar 14 is attached to the mounting member 32.
Is inserted, and the variable member 30 is pressed against the distal end portion 15. The chemical solution 16 in the outer cylinder 12 is filled, and the discharge port 40 is sealed with a sealing cap 42. Chemical solution 1
Filling 6 is performed in a state where gas such as air does not substantially enter.

The assembled syringe 11 containing a drug solution is subjected to high-pressure steam sterilization at a temperature of 110 ° C. As shown in FIG. 8, during such steam sterilization, a depression 36 is formed on the inner surface of the outer cylinder 12 where the proximal silicone ring 26 of the gasket 18 contacts. For this reason, the outer cylinder 12 of the proximal silicone ring 26
The sealing performance on the inner surface of the metal is reduced. After autoclaving,
The distal end portion 15 of the presser bar 14 is screwed into the mounting member 32,
The variable member 30 is pushed by the tip 15. Thereby, the variable member 30 moves inside the support main body 28. The movement of the variable member 30 causes the distal end silicone ring 2 of the gasket 18 to move.
The second and intermediate silicone rings 24 abut the inner surface of the outer cylinder 12, and the insertion opening of the presser bar 14 is completely sealed by the gasket 18. Thereby, the manufacture of the syringe 11 with a drug solution of the third embodiment is completed.

In the syringe 11 with a drug solution according to the third embodiment, the proximal silicone ring 26 of the gasket 18 presses the inner surface of the resin outer cylinder 12 during the heating period during the high-pressure steam sterilization. A depression 36 is formed on the inner surface of the outer cylinder 12. For this reason, the sealing performance of the base end silicone ring 26 deteriorates. However, in the syringe 11, the support body 1
The variable member 30 in 8 is moved immediately after sterilization, and the variable member 30 is pushed into the distal end side of the engaging hole 29 of the support main body 28 having a small inner diameter, and presses the support main body 28 from the inside. The outer diameters Rf and Rm of the tip silicone ring 22 and the intermediate silicone ring 24 of the gasket 18 are increased.
Tip silicone ring 22 and intermediate silicone ring 2
When the outer diameters Rf and Rm of the gasket 4 are made larger, the sealing performance of the gasket 18 with respect to the outer cylinder 12 is increased by the silicone ring
And an intermediate silicone ring 24. As a result, even after the high-pressure steam sterilization treatment, the syringe 11 can safely maintain the drug solution 16 during the storage period.

Since the distal silicone ring 22, the intermediate silicone ring 24, and the proximal silicone ring 26 are formed on the outer surface of the wall of the gasket 18, the outer cylinder 12
The pressure on the inner surface of the gasket 18 can be concentrated, and the sealing performance of the gasket 18 can be improved. Further, the positions where the silicone rings 22, 24, 26 are pressed against the inner surfaces are also clear. The outer diameter Rb1 of the proximal silicone ring 26 of the gasket 18 before the movement of the variable member 30, the distal silicone ring 22, and the intermediate silicone ring 24
The relationship with the outer diameters Rf1 and Rm1 is Rb1> Rf1 and Rm1.
The gasket 18 after the movement of the variable member 30
The relationship between the outer diameters Rf2 and Rm2 of the tip silicone ring 22 and the intermediate silicone ring 24 is Rf2, Rm2 ≧ Rb1. This is because during the heating period of the autoclave,
Is achieved between the base silicone ring 26 and the inner surface. Further, the inner surface of the outer cylinder 12 is not deformed and expanded by the tip silicone ring 22 and the intermediate silicone ring 24. On the other hand, after the high-pressure steam sterilization, the tip silicone ring 22 and the intermediate silicone ring 24 are sterilized.
Thereby, the sealing property with the outer cylinder 12 is maintained.

After the steam sterilization, the outer diameter Rb2 of the proximal silicone ring 26 of the gasket 18 becomes smaller, and the outer diameter Rb satisfies Rb1> Rb2. The relationship of Rb1> Rb2 indicates that the diameter of the proximal silicone ring 26 became small after steam sterilization, and the pressing force on the inner surface of the outer cylinder 12 was reduced. This enhances the slidability of the presser bar 14 during use. The proximal silicone ring 26 reduces the pressing force against the inner surface of the outer cylinder 12, and does not cause an obstacle of initial sliding even if the proximal silicone ring 26 is located in the concave portion 36 of the outer cylinder 12. Therefore, the operability of the syringe 11 after the steam sterilization process is sufficient.

The gasket 18 is usually provided with the pressing bar 14.
Supported or attached to The attachment member 32 is attached to the gasket 18, and the attachment member 32 is screwed into the distal end portion 15 of the presser bar 14, thereby forming the gasket 18.
Are supported by the presser bar 14. Further, the distal end portion 15 penetrates through the mounting member 32 and is brought into contact with the variable member 30 so that the distal end portion 1
The variable member 30 is moved within the support main body 28 depending on the degree of screwing insertion of the fifth member 5 into the attachment member 32. For this reason, the moving operation of the variable member 30 is accurately performed, and the position after the movement is accurately fixed. And the gasket 18 can be reliably supported, and the operability during use is enhanced.

The drug solution was not previously stored in the outer cylinder of the syringe of the first embodiment and the second embodiment. However, the syringes of the first and second embodiments may be filled with a drug solution or the like in advance.

[0042]

As described above, the gasket inserted into the outer cylinder of the syringe according to the present invention comprises a support member and a ring member externally fitted to the support member. The convex ribs of the gasket, which can press the inner wall surface of the outer cylinder to make sliding contact, enhance the sliding property of the gasket, provide a safe syringe, and provide a syringe made of resin containing a chemical solution. In the case of a cylinder, even after being subjected to high-pressure steam sterilization, safety and operability against sterility are sufficiently exhibited.

[Brief description of the drawings]

FIG. 1 is a side view of a syringe according to a first embodiment.

FIG. 2 is a half sectional view of a gasket portion of the syringe according to the first embodiment.

FIG. 3 is a side view of a syringe according to a second embodiment.

FIG. 4 is a half sectional view of a syringe according to a second embodiment.

FIG. 5 is a side sectional view of a syringe according to a third embodiment.

FIGS. 6A and 6B are half sectional views of a gasket of a syringe according to a third embodiment.

FIG. 7 is a side sectional view of a syringe according to a third embodiment before high-pressure steam sterilization.

FIG. 8 is a cross-sectional view showing the relationship between the gasket and the outer cylinder wall of the syringe according to the third embodiment after high-pressure steam sterilization.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Syringe 2 Resin outer cylinder 2A Insertion port 2B Discharge port 3 Presser bar 3A Tip support part 4 Gasket 5 Ring member 6 Separation member 7 Fixing lid 8 Syringe 9 Presser bar 9A Tip support part 10 O-ring 10A Groove section 11 Syringe 12 Resin outer cylinder 14 Presser bar 15 Tip of presser bar 16 Chemical solution 18 Gasket 22, 24, 26 Silicone rubber ring 28 Support body 29 Engagement hole 30 Variable member 32 Mounting member 36 Depressed portion

Claims (5)

[Claims] In a syringe made of a resin outer cylinder, a gasket inserted into the outer cylinder comprises a support member and a ring member externally fitted to the support member. The gasket has a protruding rib which can press against the inner wall surface of the syringe to make sliding contact. 2. The syringe according to claim 1, wherein a lubricant or a lubricating resin film is applied to a sliding portion of the ring member. 3. A chemical solution is stored in the outer cylinder via the gasket in advance, the support member and the ring member are made of an extensible material, and the support member has an internal hole for engaging with a pusher bar. Is formed, and a variable member for changing the outer diameter of the support member and the ring member is provided in the engagement hole, and after the steam sterilization of the chemical solution in the outer cylinder, the distal end side of the support member by the variable member. 3. The syringe according to claim 1, wherein the outer diameter of the ring member is changed to a large diameter. 4. The variable member is provided so that the engagement hole can be moved in the axial direction of the support member, and the inner diameter of the engagement hole is smaller than the outer diameter of the variable member inserted into the engagement hole. Wherein the outer diameter of the ring member on the distal end side of the gasket can be changed to a large diameter by moving the variable member from the proximal end side to the distal end side in the support member. Item 4. The syringe according to Item 3. 5. The gasket according to claim 5, wherein a plurality of said ring members are provided and have a base end side outer diameter Rb and a tip end side outer diameter Rf, and the gasket base end side outer diameter before movement of said variable member. The relationship between Rb1 and the outer diameter Rf1 on the tip side is Rb1>
Rf1, the outer diameter Rb1 on the proximal end side of the gasket before the movement of the variable member, the outer diameter Rb2 on the proximal end side of the gasket after the movement of the variable member, and the outer diameter R on the distal end side.
The syringe according to claim 4, wherein the relationship with f2 is Rf2≥Rb1> Rb2.