JPH1033674A - Syringe - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a syringe which exerts no undesirable influence on a previously filled agent to be injected and can maintain sliding ability of a gasket or the like favorably. SOLUTION: In a syringe where an agent to be injected is previously accomodated in an outer cylinder, the outer cylinder 2 is formed by a resin material, a gasket 5 or a tap sliding in the outer cylinder is formed by an elastic tap member where a lubricant is applied, and an elastic tap member where a lubricant is not applied, and the elastic tap member where a lubricant is not applied is disposed on the side coming into contact with the agent to be injected.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a syringe pre-filled with an injection, and more particularly, to a syringe which is applied to a gasket or the like without adversely affecting the stored injection. The present invention relates to a syringe with improved slidability of a gasket.

[0002]

2. Description of the Related Art In recent years, in order to prevent medical accidents and to prevent hospital-acquired infections and the like as much as possible, sterile or aseptic pre-filled syringes have been filled with injections such as drugs or medicinal solutions. Syringes, commonly referred to as field syringes, have been proposed. In addition, a multi-component syringe in which an injection of two or more pharmaceutical ingredients is separately filled in the prefield syringe until the injection is also proposed. 2. Description of the Related Art Conventionally, a sealing cap is attached to a needle attachment port of an outer cylinder, a gasket of a plunger is inserted from a proximal end insertion opening of the outer cylinder, and an injection is contained in the gasket. When filling the injection into the outer cylinder, the gasket is first inserted into the outer cylinder to a predetermined position, and then the injection is filled from the needle mounting port of the outer cylinder, and after filling, the sealing cap is closed with the needle. Attached to the mounting opening. In this state, the syringe is subjected to autoclaving. In this case, since the injection is filled from the needle attachment port of the outer cylinder, the injection can be filled with little air in the outer cylinder. In some cases, an inner plug is provided in the outer cylinder, and an injection is filled between the gasket and the inner plug. As a device using such an inner plug, a multi-component prefield syringe in which a plurality of inner plugs and a bypass for liquid circulation are provided to separately fill a plurality of drug components has been proposed.

[0003]

However, the conventional syringe has the following problems. First, generally, a resin outer cylinder is used in addition to the glass outer cylinder. The resin outer cylinder has been frequently used recently because of the convenience of the incineration treatment. Further, since the inner wall surface of the resin outer cylinder is hydrophobic, a small amount of the injection does not wet the inner wall surface when the gasket slides. For this reason, a lubricant such as silicone oil is generally applied to a gasket of a disposable syringe beforehand. However,
When a lubricant is applied to a gasket in a prefield syringe containing an injection in advance, the lubricant adversely affects the injection. In particular, when an injection is subjected to autoclave sterilization, such adverse effects increase. Secondly, since the injection does not wet the inner wall surface as described above unless a lubricant is applied to the gasket or the like, a locking phenomenon occurs when the so-called gasket slides, and 3 to 4 kg / cm.
^{About 2} pressing forces are required. Therefore, the sliding operation of the gasket and the plunger cannot be performed smoothly.

Accordingly, an object of the present invention is to provide a syringe which does not adversely affect a pre-filled injection and which can maintain good slidability of a gasket or the like.

[0005]

The present invention relates to a syringe in which an injection is previously stored in an outer cylinder, wherein the outer cylinder is made of a resin material, The gasket or plug that slides in the outer cylinder is
It comprises an elastic plug member coated with a lubricant and an elastic plug member not coated with a lubricant, wherein the elastic plug member not coated with the lubricant is disposed on a side that comes into contact with the injection. The above object has been attained by providing a syringe as described above.

The outer cylinder is made of a transparent resin molding, and the resin molding may be a thermosetting resin or a thermoplastic resin. The resin molded article may have a single structure or a laminated structure of a plurality of materials. Examples of the thermosetting resin include a phenol resin, a urea resin, a melamine resin, an alkyd resin, an acrylic resin, an unsaturated polyester resin, a diallyl phthalate resin, a silicone resin, a furan resin, and a ketone resin. As the thermoplastic resin, polyethylene, polypropylene, 4-methylpentene-1, styrene resin,
Polyvinyl chloride, polyvinylidene chloride, polyvinyl alcohol, ethylene-vinyl acetate copolymer, ethylene-vinyl alcohol copolymer, polyacrylonitrile, cyclic gen-based polymer, acrylic resin, polyamide, polyester, polycarbonate, polyacetal, fluorine-based There are resins and the like. In particular, since the outer cylinder accommodates an injection, an olefin-based resin free of eluted substances such as chlorine and metal is desirable. Among them, polypropylene, 4-methylpentene-1, and cyclic gen-based heavyweight having heat resistance and transparency are preferable. A resin molded product made of a united product is desirable. In particular, when heating to 100 ° C. or more by autoclave sterilization or the like, it is possible to use an amorphous heat-resistant cyclic gen system such as cyclopentadiene, dicyclopentadiene, norbornadiene, and the like.
Methylpentene 1 and the like are desirable.

[0007] The outer cylinder may be one in which a base finger-holding portion and a tip needle mounting port are integrally formed, or a combination of a base finger-holding member, a tubular member, and a needle mounting port member. Good. However, the cylindrical portion of the outer cylinder or the inner wall of the cylindrical member is formed of at least the polyolefin resin. In addition, one or two or more inner plugs may be provided in the cylindrical portion or the cylindrical member in addition to the gasket, and the injection may be divided and filled with two or more drugs. Also, at least one of the injections is a drug solution, and in the case of a multi-drug component, it may be filled with a solid agent such as a powder. The gasket or the plug that slides in the outer cylinder during use includes an elastic plug member coated with a lubricant and an elastic plug member not coated with a lubricant. The elastic member may be any material that can press the inner wall surface and maintain the inner wall surface and the member in a liquid-tight and slidable manner. Specifically, the elastic member is made of a liquid-tight elastic material such as a thermoplastic elastomer or rubber. Preferably, it is a rubber stopper, and the rubber is desirably silicone rubber or the like. The lubricant is a lubricant that is interposed between the elastic member and the hydrophobic inner wall surface and reduces frictional resistance. As such a lubricant, silicone oil or the like that does not significantly affect chemicals and the like is desirable. The elastic plug member to which the lubricant is not applied and the elastic member to which the lubricant is applied may be connected to each other, or may not be connected. Alternatively, the elastic members may be separated from each other. However,
The elastic plug member to which the lubricant is not applied is disposed on the side that comes into contact with the injection. Further, the elastic plug member to which the lubricant is not applied may have a slightly poor liquid-tightness, as long as it has such a liquid-tightness that the lubricant does not pass to the injection side.

[0008] In the thus constructed syringe, there is no possibility that the lubricant mixes with the injection at the time of its storage or at the time of autoclave sterilization at the time of manufacture, and there is no risk that the injection will be adversely affected by the lubricant. In addition, injection is not performed after the injection is sucked into the outer cylinder from an ampoule or the like at the time of use. For this reason, in the operation, the possibility of nosocomial infection, wrong administration of the drug, and the like can be minimized. In addition, since the elastic plug member which is coated with the lubricant and occupies most of the gasket slides smoothly, the gasket does not lock when sliding.

A syringe according to a second aspect of the present invention aims to completely provide sterilization treatment of an injection in the syringe according to the first aspect. The outer cylinder is subjected to an autoclave sterilization treatment together with the injection. In such a case, the outer cylinder is limited to one having heat resistance and having sufficient deformation resistance to heat of 105 ° C. or more. The syringe according to claim 3 of the present invention shows a specific lubricant in the syringe according to claim 1 or 2, and in the syringe according to claim 3, the lubricant is silicone oil. Features. The silicone oil is preferably a dialkyl siloxane or the like, particularly low-grade dimethyl or diethyl siloxane.

[0010]

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 half sectional view of a first embodiment of a syringe according to the present invention. FIG.
(A) and (B) are half sectional views of the gasket and stopper of the syringe of FIG. 3 (A) and 3 (B) are half-side sectional views in which the gasket and the plug of the syringe of FIG. 1 are disassembled. FIG. 4 is a half sectional view of the syringe in use in FIG.

The syringe 1 of the first embodiment shown in FIGS.
Is a syringe in which the injection 3 is stored in the outer cylinder 2 in advance. The outer cylinder 2 is made of a resin material, and the gasket 5 and the stopper 6 sliding in the outer cylinder 2 are composed of elastic plug members 5A and 6B coated with a lubricant and elastic plug members 5B and 6B not coated with a lubricant. The elastic plug members 5B and 6B to which the lubricant is not applied are arranged on the side that comes into contact with the injection agent 3. To further explain the syringe 1 of the present embodiment, the outer cylinder 2 of the syringe 1 of the present embodiment has a cylindrical member 2A, a needle mounting member 2B,
Each member is made of a thermoplastic resin and is formed by injection molding. Tube member 2
The gasket 5 is disposed in a liquid-tight manner in the proximal opening of A, the stopper 6 is disposed in a liquid-tight manner in the distal opening, and the injection 3 is filled between the gasket 5 and the stopper 6. I have. The needle mounting member 2B is liquid-tightly connected to the distal end of the cylindrical member 2A, and a part of the inner wall surface of the needle mounting member 2B covers the outer wall surface of the distal end of the cylindrical member 2A. Needle mounting member 2B
Is formed with a small-diameter opening 7, and a needle 8 is attached to the opening 7. The finger holding member 2B is formed as a ring member having a flange portion 9, and the base end of the tubular member 2A is fitted into the finger holding member 2B. The gasket 5 is provided with a detachable rod 10.

The cylindrical member 2A of the outer cylinder 2 is made of a heat-resistant cyclic olefin resin, and the resin has a heat deformation temperature (ASTMD648, ASTMD648, 1.00 to 1.05 g / cm ³ ).
(4.6 kg / cm ² ) is used at a temperature of 110 ° C. or more, particularly 120 to 140 ° C. When such a heat-resistant resin is used as the tubular member 2A, there is little risk of thermal deformation even if the elastic force of the gasket 5 and the stopper 6 is always applied to the inner wall surface 4 during heating in the autoclave sterilization process. The mouth attachment member 2B and the finger hook member 2C are heat-resistant polypropylene moldings. In addition, each member of the outer cylinder 2 is not limited to the above resin, other polyolefin resin can be used, and the molding method is not limited to injection molding. The injection 3 is a medicine, a drug solution or the like conventionally stored in an ampoule or the like. The injection 3 is aseptically filled in the cylindrical member 2A. In the present embodiment, the injection 3 is thermally stable, and is autoclaved together with the cylindrical member 2A in order to increase sterilization assurance.

As shown in FIGS. 2 and 3, the gasket 5 and the stopper 6 are each made of two elastic plug members, and are made of silicone rubber having high slidability and liquid tightness. The gasket 5 includes a main elastic plug member 5A and a sub elastic plug member 5B, and the main elastic plug member 5A is formed with three ribs 11, 11, 11 that abut against the inner wall surface 4 of the cylindrical member 2A in a liquid-tight manner. As a result, the liquid tightness with the inner wall surface 4 is enhanced. A lubricant made of silicone oil is applied to the main elastic plug member 5A, and the lubricant reduces friction with the hydrophobic inner wall surface 4. A mounting hole 12 is formed in the main elastic plug member 5A, and the rod 10 is removably inserted into the mounting hole 12. The main elastic member 5A is also provided with a dovetail-shaped mounting hole 13.
The mounting projection 14 of the sub elastic plug member 5B is inserted into the second elastic plug member 5B. The auxiliary elastic plug member 5B is formed in a disk shape and has a relatively small thickness.
One side is arranged on the side that comes into contact with the injection 3. The sub-elastic member 5B is slightly less liquid-tight than the main elastic member 5A,
The diameter is set so as to minimize friction during sliding, while preventing the lubricant applied to the main elastic plug member 5B from flowing into the injection 3. The stopper 6 includes a main elastic plug member 6A and a sub elastic plug member 6B.
In A, three ribs 15, 15, 15 that are in liquid-tight contact with the inner wall surface 4 of the cylindrical member 6A are formed, and the liquid-tightness with the inner wall surface 4 is enhanced. A lubricant made of silicone oil is applied to the main elastic plug member 6A, and the lubricant reduces friction with the hydrophobic inner wall surface 4. The main elastic plug member 6A is provided with a dovetail-shaped mounting hole 16, into which the mounting projection 17 of the auxiliary elastic plug member 6B is inserted. Secondary elastic plug member 6B
Has a disk-like shape and is formed relatively thin, and one side has an injection 3
It is arranged on the side where it contacts. The auxiliary elastic member 6B is slightly inferior in liquid tightness to the main elastic member 6A, and is set to have a diameter such that friction during sliding is generated as little as possible. Agent 3 is prevented from flowing out.

Next, a method of manufacturing the syringe 1 of the present embodiment will be described in detail. The above-mentioned cyclic olefin resin is formed into a cylinder having a thickness of 4 mm and an inner diameter of 6 mm by injection molding. It is cut into a length of 80 mm to form a cylindrical member 2A. As shown in FIGS. 2 and 3, the main elastic plug members 5A and 6A and the
B and 6B are assembled into a gasket 5 and a stopper 6, respectively. The assembling gasket 5 is attached to the cylindrical member 2A, the injection solution 3 is filled through the sterilization filter, and the stopper 6 is further attached. Then, the injection solution 3 is subjected to autoclave sterilization together with the cylindrical member 2A. Sterilization temperature is 1
The temperature is set in the range of 05 ° C to 140 ° C, in particular, in the range of 105 ° C to 115 ° C in consideration of the resin material of the cylindrical member 2A. After attaching the needle attachment member 2B and the finger hook member 2C to the cylindrical member 2A, and further attaching the rod 10 to the gasket 5, the syringe 1 is placed in a packaging bag, and the entire syringe 1 is sterilized with gas.

The following features are observed during storage and use of the syringe 1 configured as described above. The injection 3 did not mix with the lubricant applied to the gasket 5 and the stopper 6 during storage or during autoclave sterilization during its production. Therefore, injection 3
Not affected by lubricant. When using the syringe 1, the needle 8 is attached to the needle attachment member 2B and the rod 10 is pressed as shown in FIG. As a result, the stopper 6 is pushed into the large-diameter inside of the needle attachment port 2B. Further, as shown in FIG. 3, when the rod 10 is pushed in, the injection 3 flows to the tip of the needle 8 through the outside of the stopper 6 as a passage. In this state, the injection needle 8 is pierced to the patient, and the injection solution 3 is administered. In this case, in the state shown in FIG.
Although the gasket 5 is stopped, in the syringe 1 of this embodiment, the gasket 5 smoothly slides on the inner wall surface 4 of the cylindrical member 2A again by pressing the rod 10. The pressing force of the rod 10 at the start of the sliding was about 1 kg / cm ² . On the other hand, when the lubricant is not applied to the main elastic plug member 5A of the gasket 5, a so-called locking phenomenon is felt, and the pressing force of the rod 10 at the start of the sliding is 5.
kg / cm ² . Although the effect of such a lubricant is not clear, since a small amount of lubricant can be interposed between the inner wall surface 4 and the gasket 5, this enhances the slidability. After the use of such a syringe 1, since no material such as glass is used, the incineration and disposal thereof become extremely simple.

In the syringe 1 of the above embodiment, the outer cylinder 2 is divided into three members, but the invention is not limited to this.
As in the case of the syringe 21 shown in FIG. 5, the outer cylinder 22 may be integrally formed together with the attachment port member and the finger hook member. Further, a rubber cap 24 may be provided in the mounting port 23. In the syringe 1 of the above embodiment, only the injection 3 is provided in the outer cylinder 2. However, as in the syringe 31 shown in FIG. , 36 may be separated and filled into a plurality of types. In this case, a flow bypass may be provided between the stoppers 33 and 34 so that the rear injection 35 mixes with the front injection 36 although not shown. For such a bypass, known means is used, and it may be a groove, a projection, or the like provided on the inner wall of the outer cylinder.

[0019]

As described above, in the syringe according to the present invention in which the injection is previously stored in the outer cylinder, the syringe in which the injection is previously stored in the outer cylinder is made of a resin material. The gasket or the plug that slides in the outer cylinder is composed of an elastic plug member coated with a lubricant and an elastic plug member not coated with a lubricant, and the elastic plug member not coated with the lubricant is An object of the present invention is to provide a syringe which is arranged on the side which comes into contact with the injection, so that it does not adversely affect the pre-filled injection and can maintain good sliding properties of a gasket or the like. And

[Brief description of the drawings]

FIG. 1 is a half sectional side view of a first embodiment of a syringe according to the present invention.

2 (A) and (B) are cross-sectional half-assembled views of a gasket and a stopper of the syringe of FIG. 1;

FIGS. 3A and 3B are exploded half sectional views of the gasket and stopper of the syringe of FIG. 1;

FIG. 4 is a half sectional view of the syringe of FIG. 1 in use. .

FIG. 5 is a half sectional view showing a modified example of the syringe of the first embodiment.

FIG. 6 is a half sectional view showing a modified example of the syringe of the first embodiment.

[Explanation of symbols]

1, 21, 31 Syringe 2, 22, 32 Outer tube 2A Tube member 2B Needle attachment port member 2C Finger catch member 3 Injection 4 Inner wall surface of tube member 5 Gasket 5A Main elastic plug member 5B Secondary elastic plug member 6 Stopper 7 Opening Part 8 Injection needle 9 Flange part 10 Rod 11 Rib 12 Rod or plunger mounting hole 13 Mounting hole 14 Projection

Claims (3)

[Claims] 1. A syringe in which an injection is previously stored in an outer cylinder, wherein the outer cylinder is made of a resin material, and a gasket or a plug which slides in the outer cylinder is an elastic stopper coated with a lubricant. A syringe comprising a member and an elastic plug member not coated with a lubricant, wherein the elastic plug member not coated with the lubricant is disposed on a side which comes into contact with the injection. 2. The method according to claim 1, wherein the outer cylinder is autoclaved together with the injection.
The syringe as described. 3. The syringe according to claim 1, wherein the lubricant is silicone oil.