JP2002210011A - Syringe - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a syringe improved so as to be capable of preventing not only the contact of an injection nozzle and a Luer-Lock with the open air but also the falling-of of an over-cap caused by the expansion of air remaining in the Luer-Lock at the time of heating or depressurization in sterilization treatment or the like. SOLUTION: The syringe is equipped with a syringe (1) the leading end of which is fitted with an injection nozzle (2) and cylindrical Luer-Lock (3), a nozzle cover part (51) and the over-cap (5) having a double-bottomed cylindrical structure in which a Luer-Lock cover part (52) is constituted. The over-cap (5) is constituted of a rubber with a hardness of 55-60 and a degassing groove (31) is provided to the outer peripheral surface of the Luer-Lock (3) over the range from the leading end of the Luer-Lock to the base end thereof.

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 luer-lock type syringe suitable for a pre-filled type (prefilled type) in which a syringe or the like is pre-filled with a drug or the like. The present invention relates to a syringe that can effectively prevent an overcap attached to a part from falling off during a sterilization process.

[0002]

2. Description of the Related Art A pre-filled syringe is manufactured by filling a syringe with a drug solution or the like, attaching an overcap to the tip of the syringe, sealing the syringe, and then sterilizing the syringe.
Many of the pre-filled syringes are provided with an injection nozzle and a cylindrical luer lock surrounding the injection nozzle at the tip, and the overcap is a double-bottomed cylindrical overcap, that is, an injection cap. An overcap provided with a small-diameter nozzle cover for nozzle coating and a large-diameter luer lock cover for luer lock coating is mounted.

[0003] Examples of the sterilization of the syringe as described above include a heat sterilization method and a decompression / sterilization gas replacement method. In any case, in such a sterilization treatment, the injection nozzle is attached when the overcap is attached. Since the air sealed in the luer lock gap expands, the overcap tends to fall off.

On the other hand, for example, Japanese Patent Laid-Open No. 2000-15
No. 7630 describes a technique relating to an “injection nozzle cap” (overcap) attached to a pre-filled syringe having a luer lock. Such an injection nozzle cap is a substantially bottomed cylindrical cap including a cylindrical leg portion and a top surface portion that are inserted into a gap between the injection nozzle and the cylindrical luer lock, and an outer peripheral surface of the cylindrical leg portion includes: An air flow passage communicating with the inside of the luer lock is formed.

The air flow passage is formed by a gap formed between a convex portion along the longitudinal direction of the cylindrical leg and the inner peripheral surface of the luer lock, or a concave groove along the longitudinal direction of the cylindrical leg. It is constituted by. The above injection nozzle cap,
The air that is confined in the gap between the injection nozzle and the luer lock at the time of mounting and that is pressurized and expanded when subjected to heat sterilization is opened to the outside through the air flow passage to prevent the air from dropping out of the injection nozzle.

[0006]

By the way, the above-mentioned "injection nozzle cap" can cover the injection nozzle, but since the external air enters the inside of the luer lock along the above-mentioned air flow passage, the luer lock is sterilized. There is a problem that the lock is again exposed to air, and there is a possibility that the lock may be contaminated when a device such as a syringe needle is attached. Therefore, in a conventional overcap having a double structure capable of covering both the injection nozzle and the luer lock, a means capable of effectively preventing falling off during sterilization is desired.

SUMMARY OF THE INVENTION It is an object of the present invention to prevent the injection nozzle and the luer lock from contacting the outside air, and to remove the overcap due to the pressure increase of the air remaining inside the luer lock when heated or decompressed by sterilization or the like. It is an object of the present invention to provide an improved syringe which can prevent the occurrence of a syringe.

[0008]

In order to solve the above-mentioned problems, a syringe according to the present invention is provided with an injection nozzle and a cylindrical luer lock surrounding the injection nozzle at the distal end, and the distal end of the injection nozzle extends from the luer lock. In a syringe including a protruding syringe and a double bottomed cylindrical structure overcap in which a small-diameter nozzle cover portion covering the injection nozzle and a large-diameter luer lock cover portion covering the luer lock are formed, The overcap has a hardness of 55-6
The luer lock is characterized by being provided with a deaeration groove on the outer peripheral surface of the luer lock from the distal end to the proximal end of the luer lock.

In the above-mentioned syringe, the specific groove provided on the outer peripheral surface of the luer lock, when the overcap is attached to the injection nozzle and the luer lock, the air inside the overcap and the air in the gap between the injection nozzle and the luer lock. To the outside to reduce the amount of residual air.
In addition, the overcap made of rubber having a specific hardness exerts stronger adhesion to the injection nozzle and the luer lock.

In the above-mentioned syringe, the length of the groove from the tip of the luer lock is determined by the length of the effective tip of the luer lock cover when the tip of the nozzle cover reaches the tip of the injection nozzle. It is preferable that the length is set to be longer than the position and shorter than the position of the effective distal end portion of the luer lock cover portion in a state in which the overcap is covered almost to the end.

The structure of the groove whose length is specified as described above is as follows:
In the operation of mounting the overcap, at least until the tip of the nozzle cover reaches the position where the tip of the nozzle cover reaches the tip of the injection nozzle, the air inside the overcap and the air in the gap between the injection nozzle and the luer lock are discharged to the outside. When the air is discharged and the overcap is almost completely covered, the luer lock is sealed by the luer lock cover to prevent external air from entering the luer lock along the groove.

[0012]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of a syringe according to the present invention will be described with reference to the drawings. FIG. 1 is a partially broken side view showing a structure of a main part of a syringe according to the present invention. 2 and 3 are longitudinal sectional views showing a deaeration function when the overcap is attached to the syringe according to the present invention.

The syringe according to the present invention is a syringe suitable for a pre-filled type (prefilled type) in which a syringe is pre-filled with a drug. As shown in FIG. Syringe (1) provided with a cylindrical luer lock (3) at its distal end and having a distal end of an injection nozzle (2) protruding from the luer lock (3), and a small-diameter nozzle cover for covering the injection nozzle (2) A large diameter luer lock cover part (52) covering the part (51) and the luer lock (3) is provided with a double bottomed cylindrical overcap (5) formed therein.

The syringe (1) is a cylindrical member formed of a resin material having high physicochemical properties such as high transparency and rigidity and excellent heat resistance and chemical resistance, preferably a material such as cyclic olefin plastics or polyethylene. However, it is not limited to these materials. The syringe (1) has the injection nozzle (2) and the luer lock (3) at the front end, and preferably has a finger hook (4) protruding like a flange at the rear end. The syringe (1) illustrated in the drawing is integrally injection-molded with the above-mentioned synthetic resin, but the syringe tip including the injection nozzle (2) and the luer lock (3) and the finger hook (4). May be made as separate members.

The injection nozzle (2) is provided at the tip of the syringe (1) along the center line of the syringe.
The injection nozzle (2) is usually equipped with a tube-shaped injection device (not shown) such as an injection needle or a cannula, except when a drug or the like is directly administered to a required site from the nozzle. In addition, the tip of the injection nozzle (2) is provided for facilitating the mounting of the overcap (5), and the tip (51A) of the inner periphery of the nozzle cover (51) of the overcap (5) described later. In order to efficiently discharge the air inside the nozzle cover portion (51), the taper is formed in a tapered shape having a diameter reduced toward the tip.

The luer lock (3) has an injection nozzle (2)
This is a mechanism for preventing the injection needle and the like attached to the device from falling off. Such a luer lock (3) forms a cylindrical portion surrounding the injection nozzle (2), and has a screw thread into which a flange portion protruding from the proximal end of a syringe needle or the like is screwed. It is formed on the inner peripheral surface of the part.

Although not shown, the syringe (1)
A plunger formed of an elastic body such as rubber or synthetic rubber and closely attached to the inner peripheral surface of the syringe (1) is inserted from the rear end of the syringe (1) in order to extrude the medicine filled in the syringe (1). A plunger rod for operating the plunger is attached to the rear end of the plunger in advance or at the time of use.

The overcap (5) is a nozzle cover (5) for covering the distal end portion of the injection nozzle (2).
1) and a luer lock cover (52) covering substantially the entire outer peripheral surface of the luer lock (3). In order to increase the fitting strength of each part of the tip of the syringe (1) to the overcap (5), that is, the injection nozzle (2) and the luer lock (3), the nozzle cover (5)
1) protrudes in a short axis annular shape inside the overcap (5), and the annular projecting portion is formed so as to be fittable in a gap between the injection nozzle (2) and the luer lock (3). ing.

When the overcap (5) is mounted, the mounting operation is facilitated, and a small gap is provided between the distal end of the injection nozzle (2) and the distal end (51A) of the nozzle cover (51). To form the nozzle cover (51)
Is formed in a tapered shape whose diameter is increased toward the tip (51A) of the nozzle cover.
Accordingly, in the operation of mounting the overcap (5), the air inside the nozzle cover (51) can be sufficiently discharged.

Further, the overcap (5) is made of rubber having a predetermined hardness as described later. Preferably, the fitting strength of the luer lock (3) to the luer lock cover (52) is further increased. Therefore, the inner diameter of the luer lock cover (52) is set to a size corresponding to 97.0 to 99.5% of the outer diameter of the luer lock (3).

According to the present invention, the syringe (1) is designed so that the overcap (5) does not float due to the pressure increase of the air remaining in the gap between the injection nozzle (2) and the luer lock (3) during the sterilization process. The overcap (5) is made of rubber having a hardness of 55 to 60 in order to obtain a strong adhesion of the overcap (5) to each part of the tip.

Examples of the rubber constituting the overcap (5) include synthetic rubber materials such as butyl rubber, polybutadiene rubber, polyisoprene rubber, ethylene propylene diene rubber, styrene butadiene rubber, acrylonitrile butadiene rubber, and epichlorohydrin rubber. However, butyl rubber, acrylonitrile-butadiene rubber, and epichlorohydrin rubber are preferable in that they have excellent gas permeability resistance, and butyl rubber further has no temperature dependency in gas permeability resistance, and has low elution and oxidation resistance. Is more preferred.

Further, in order to facilitate attachment of the overcap (5) at the time of manufacture and removal at the time of use, the inner surface of the overcap (5), specifically, the nozzle cover (51) and / or the luer lock cover. Department (5
It is preferable that a lubricating layer is formed on the inner surface of 2). Such a lubricating layer is usually composed of a fluororesin coating.

Further, in the syringe of the present invention, when the overcap (5) is attached to the distal end portion of the syringe (1), the amount of air remaining inside the overcap (5) is reduced. On the outer peripheral surface of 3), a deaeration groove (3
1) is provided.

When the overcap (5) is mounted, the air inside the overcap (5) is sufficiently exhausted, and when the overcap (5) is completely covered,
In order to prevent air from entering from outside, the length (L) of the groove (31) from the tip of the luer lock (3) is such that the tip (51A) of the nozzle cover (51) is the injection nozzle (2).
A luer lock cover that is longer than the position of the effective distal end of the luer lock cover (52) in a state where the overcap (5) is covered to a position reaching the distal end, and that the overcap (5) is covered almost to the end. The position is set to be shorter than the position of the effective distal end of the portion (52).

The tip (51A) of the nozzle cover (51) refers to the tip (open end) of the portion of the nozzle cover (51) that protrudes toward the tip of the nozzle (2). The effective tip of the luer lock cover (52) is a portion indicated by an arrow in the drawing. In the luer lock cover (52), the luer lock (3) is used.
It refers to the innermost part on the most distal end side (open end side of the syringe (1)) among the inner peripheral parts that are in close contact with the outer peripheral surface.

A plurality of, for example, three to six, degassing grooves (31) are usually provided in order to discharge the internal air more smoothly when the overcap (5) is mounted.
The depth of the groove (31) is usually set to 0.1 mm or more within the range of the thickness of the luer lock, and the width of the groove (31) (in the circumferential direction of the luer lock (3)). Is set to about 0.5 to 1.5 mm.

As shown in FIG. 2, in the syringe of the present invention, when the overcap (5) is attached to the tip of the syringe (1), the inside of the overcap (5) is formed by the deaeration groove (31). The amount of remaining air can be further reduced. That is, as shown in FIG. 2A, before the overcap (5) is attached, air has entered the inside of the overcap and the gap between the injection nozzle (2) and the luer lock (3). As shown in FIGS. 3 (b) to 3 (c), during the process of covering the overcap (5) to some extent, the above-described deaeration groove (31) provided on the outer peripheral surface of the luer lock (3) is replaced by the overcap ( The air inside 5) and the air in the gap between the injection nozzle (2) and the luer lock (3) are discharged to the outside.

At this time, as shown in FIGS. 2 (a) and 2 (b),
The length (L) of the groove (31) is equal to the luer lock cover part (5
2) The structure set longer than the effective tip position
At least the tip (51) of the nozzle cover (51)
Until the overcap (5) is covered until A) reaches the tip of the injection nozzle (2), the nozzle cover (5)
The air inside the overcap (5) including the air inside 1) and the air in the gap between the injection nozzle (2) and the luer lock (3) are discharged to the outside.

In the state shown in FIG. 2 (b), the tip of the injection nozzle (2) and the nozzle cover (51)
The inner peripheral portion of the injection taper has a tapered shape, and the distal end portion of the injection nozzle (2) and the distal end portion (5
1A), the air inside the nozzle cover (51) can be exhausted even when the nozzle cover (51) slightly covers the injection nozzle (2).

Further, the overcap (5) is put on, and as shown in FIG. 3 (c), the effective end of the luer lock cover (52) reaches a position exceeding the length (L) of the groove (31). Then, the inside of the overcap (5) is sealed.
Then, as shown in FIG. 3 (d), the shoulder (1
In a state in which the overcap (5) is covered until the tip of the luer lock cover (52) reaches 1), the tip side of the injection nozzle (2) is covered by the nozzle cover (51), and the luer lock cover ( 52) covers substantially the outer periphery of the luer lock (3). Moreover,
A nozzle cover part (51) projecting annularly into the inside of the overcap (5) fits into the gap between the injection nozzle (2) and the luer lock (3), and the tip of the luer lock (3) is covered. .

That is, as shown in FIG. 3 (d), the length (L) of the groove (31) in the state in which the overcap (5) is covered almost to the end is the luer lock cover (52).
When the overcap (5) is completely mounted, the groove (31) can be closed by the luer lock cover (52), and the external air can be blocked by the luer lock (5). 3) Prevent entry into the interior. The overcap (5) made of rubber having the above hardness exerts stronger adhesion to the injection nozzle (2) and the luer lock (3).

In other words, when the overcap (5) is completely mounted, the tip of the injection nozzle (2) and the luer lock (3), and the injection nozzle (2) and the luer lock (3) A small amount of air remains in a part of the gap, but in the syringe of the present invention, when the overcap (5) is put on the syringe (1) by the groove (31), the tip of the syringe (1) Air can be sufficiently exhausted in advance, the amount of remaining air can be further reduced, and the overcap (5) can be firmly attached due to its strong adhesion, and the injection nozzle (2) and the luer lock (3) Can be completely shielded from outside air.

Therefore, in the syringe of the present invention, even when the sterilization treatment for replacing the sterilization gas or the sterilization treatment by heating is performed after decompressing the external space in the vacuum chamber, the syringe (1) slightly remains at the distal end. The overcap (5) is not lifted by the relative pressure increase of the air, and the overcap (5) can be effectively prevented from falling off. Moreover, since the deaeration groove (31) is sealed by the luer lock cover (52) and is not exposed, the luer lock (3) and the inside thereof are not exposed to the outside air, and sterilization at the time of manufacturing is not performed. We can maintain state.

[0035]

According to the syringe of the present invention, the amount of air remaining at the tip of the syringe can be further reduced by the specific groove on the outer peripheral surface of the luer lock, and the overcap can be firmly attached due to its strong adhesion. Therefore, it is possible to effectively prevent the overcap from falling off even when sterilization is performed. And, by the structure of the groove having the specified length, the amount of air remaining at the tip of the syringe can be further reduced, and the effect of preventing the overcap from falling off can be further enhanced. Moreover, according to the syringe of the present invention, when the overcap is completely attached, the groove is not exposed, and the injection nozzle and the luer lock can be completely shielded from the outside air. It can be maintained in a sterilized state at the time of manufacture without being exposed to water. The syringe of the present invention as described above can be suitably used as a pre-filled syringe in which a syringe (eg, sodium hyaluronate injected into a joint) is pre-filled in a syringe.

[Brief description of the drawings]

FIG. 1 is a partially broken side view showing the structure of a main part of a syringe according to the present invention.

FIG. 2 is a longitudinal sectional view showing a deaeration function when an overcap is attached to the syringe according to the present invention.

FIG. 3 is a longitudinal sectional view showing a deaeration function when an overcap is attached to the syringe according to the present invention.

[Explanation of symbols]

 1: Syringe 2: Injection nozzle 3: Luer lock 31: Groove 5: Over cap 51: Nozzle cover 52: Luer lock cover

 ──────────────────────────────────────────────────続 き Continued on the front page (72) Inventor Takahaji Suzuki 3-38-2 Sumida, Sumida-ku, Tokyo Inside Daikyo Seiko Co., Ltd. (72) Inventor Hiroshi Togashi 3-382 Sumida, Sumida-ku, Tokyo No. F-term in Daikyo Seiko Co., Ltd. (reference) 4C066 AA07 BB01 CC01 DD08 EE14 FF05 GG13 KK14 KK16 NN01

Claims (5)

[Claims] 1. A syringe (1) having an injection nozzle (2) and a cylindrical luer lock (3) surrounding the injection nozzle (2) provided at a distal end thereof, and a distal end of the injection nozzle (2) protruding from the luer lock (3). And a double-ended cylindrical structure having a small-diameter nozzle cover (51) covering the injection nozzle (2) and a large-diameter luer lock cover (52) covering the luer lock (3). The overcap (5) is made of rubber having a hardness of 55 to 60, and the outer peripheral surface of the luer lock (3) is provided on the outer peripheral surface of the luer lock (3) from the distal end to the proximal end of the luer lock. A syringe for providing a deaeration groove (31) toward the syringe. 2. A groove (3) from a luer lock (3) tip.
1) The length of the luer lock cover (5) in a state where the overcap (5) is covered until the tip of the nozzle cover (51) reaches the tip of the injection nozzle (2).
2) The length of the luer lock cover portion (52) is set to be longer than the position of the effective distal end portion of (2) and shorter than the position of the effective distal end portion of the luer lock cover portion (52) in a state where the overcap (5) is covered almost to the end. The syringe according to claim 1. 3. The syringe according to claim 1, wherein a plurality of grooves (31) are provided. 4. The syringe according to claim 1, wherein the overcap (5) is made of butyl rubber. 5. The syringe according to claim 1, wherein a lubricating layer is formed on an inner surface of the overcap (5).