JPH08280799A - Hermetic sealing type syringe - Google Patents

Abstract

PURPOSE: To provide a hermetic sealing type syringe which prevents the dissipation of water content from a polycarbonate syringe in which water component, such as prescribed medicinal liquid and distilled water, is enclosed. CONSTITUTION: This hermetic sealing type syringe has the syringe which consists of a polycarbonate cylinder 1 and a piston 2 loaded into this cylinder 1, a cap 4 which is fitted into a needle mounting part 11 at the front end of the cylinder 1 and hermetically seals the opening of this needle mounting part 11 and a hermetic packing material 5 which houses the syringe fitted with this cap 4. The inside of this hermetic packing material 5 is maintained in a reduced pressure state.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to a sealed syringe,
More specifically, the present invention relates to a polycarbonate syringe that prevents the permeation of water.

[0002]

2. Description of the Related Art A syringe is composed of a cylinder and a piston that is reciprocally mounted in the cylinder. Conventionally, the cylinder and the piston are mainly made of glass. By the way, in recent years, disposable syringes have been used in the fields of blood collection and the like in consideration of disease infection and the like.

To form a disposable syringe, it is preferable to use a resin molded product that can be mass-produced. However, since the syringe needs to be sterilized, it can withstand a high temperature atmosphere (for example, steam). Sterilization requires exposure to 121 ° C atmosphere for at least 20 minutes). Since the reliability of this point is insufficient for resin molded products,
At present, a cylinder made of glass having heat resistance capable of withstanding steam sterilization is used as a cylinder in contact with a chemical solution, and a piston made of resin is used in combination with this.

By the way, engineering plastics are known as resins having excellent transparency and heat resistance.
It is also possible to construct a syringe using this.
In view of this point, further considering economical efficiency, it can be expected that the syringe is made of polycarbonate.
However, polycarbonate has a large affinity for water vapor and permits the permeation of moisture, and a polycarbonate syringe enclosing a predetermined chemical liquid or distilled water has a problem that water permeation occurs.

[0005]

SUMMARY OF THE INVENTION An object of the present invention is to provide a hermetically sealed syringe in which moisture is prevented from being dissipated from a polycarbonate syringe in which moisture such as a predetermined chemical liquid or distilled water is sealed.

[0006]

Thus, according to the invention of "Claim 1" of the present application, a syringe (composed of a polycarbonate cylinder (1) and a piston (2) loaded in the cylinder (1) ( 3), a polycarbonate cap (4) which is fitted to the needle mounting part (11) at the tip of the cylinder (1) and seals the opening of the needle mounting part (11), and the cap (4) is fitted. An airtight pack material (5) for accommodating the filled syringe (3) is provided, and a hermetically sealed syringe (A) characterized in that the inside of the airtight pack material (5) is held under reduced pressure is provided. It

In the present invention, the cylinder (1) is made of polycarbonate. In this case, if a polycarbonate having a viscosity average molecular weight of 18,000 to 30,000 is selected as shown in the "claim 2" of the present application, injection molding is performed. It is preferable in that it can be easily manufactured in a large amount.

In the present invention, the piston (2) is preferably composed of the piston body (21) and the elastic seal material (22). In this case, it is preferable that the piston main body (21) is made of polycarbonate having a viscosity average molecular weight of 18,000 to 30,000, similarly to the cylinder (1), because it can be easily and mass-produced by injection molding.

The elastic seal material (22) is preferably an elastomer which can be injection-molded or injection-molded, and silicone rubber, urethane rubber, thermoplastic rubber or the like is preferably used in these respects.

In the present invention, the cap (4) has such a shape that it can be fitted into the needle mounting portion (11) at the tip of the cylinder (1). The material forming the cap (4) may be any material such as an elastomer, a thermoplastic resin, and a thermosetting resin, and is composed of a thermoplastic resin and a hard thermoplastic resin. It is preferable.
Examples of the hard thermoplastic resin include polycarbonate, methyl methacrylate, nylon, cyclic polyolefin and the like. In addition, among the above-mentioned hard thermoplastic resins, as shown in “Claim 3” of the present application, “1.6 × 10 ^{4 to} 3.2
A material having a tensile elastic modulus of × 10 ⁴ kgf / cm ² ”is preferable from the viewpoint of sealing property by press fitting and fitting property.

When a polycarbonate is used, it is preferable to select a polycarbonate having a viscosity average molecular weight of 18,000 to 30,000, as in the case of a cylinder, because it has the above-mentioned preferable physical properties and can be easily and mass produced by injection molding. preferable.

In the present invention, the airtight pack material (5) is
Any material may be used as long as it can maintain the reduced pressure state. Furthermore, as shown in "Claim 4" of the present application, the resin film (52) (5) is formed on both sides of the "vapor barrier film (51)".
It is preferable that the laminated material 3) is laminated. Here, the vapor barrier film means a film having impermeability to water molecules, and as such a film, an aluminum film is particularly preferable. In addition to the above vapor barrier property, it is more preferable if it has other barrier properties such as an oxygen barrier property and an ultraviolet barrier property.

When the above-mentioned three-layer laminated material is used, it is preferable to select the resin film (52) on the inner side that can be heat-welded. Examples of the heat-weldable film include, but are not limited to, preferred hot-melt adhesive films. The inside of the airtight pack material (5) is maintained in a reduced pressure state. The reduced pressure state is preferably 0.1 to 300 Torr, more preferably 20 Torr or less.

[0014]

According to the invention of "Claim 1" of the present application, the entire outer side of the syringe (3) in which moisture such as a predetermined chemical liquid or distilled water is enclosed becomes an airtight pack material (5) through a reduced pressure atmosphere. Since it is covered, the pack material (5) tightly adheres to the outer surface of the syringe (3), which prevents movement of the enclosed water through the syringe wall.

According to the invention of claim 2 of the present application,
Since the cylinder (1) is manufactured by injection molding, the manufacturing process is simplified and mass production is performed.

According to the invention of "Claim 3" of the present application,
Since the cap (4) is composed of a hard thermoplastic resin having a specific tensile modulus, it can be manufactured by injection molding, the manufacturing process is simplified and mass production is possible, and the sealing and fitting properties as a cap are good. Will be better.

According to the invention of claim 4 of the present application,
The outer surface of the syringe (3) is covered with resin film (52) (53) laminated on both sides of the vapor barrier film (51) through a pressure reducing layer so that it is covered in a tightly adhered state. Become. As a result, the depressurized state of the depressurized layer is maintained reliably and for a long period of time, and the laminate material almost completely prevents the permeation of water molecules.
The movement of the water enclosed in (3) through the syringe wall is hindered for a long time.

[0018]

The present invention will be described below with reference to the illustrated embodiments, but the present invention is not limited thereto. Example 1 FIG. 1 is a longitudinal sectional view of an example of a sealed syringe of the present invention, FIG.
FIG. 3 is a cross-sectional view of an example of the sealed syringe of the present invention. In these figures, the sealed syringe (A) is the cylinder (1).
And a syringe (3) consisting of a piston (2) loaded in the cylinder (1), a cap (4) attached to the tip of the cylinder (1), and a syringe to which the cap (4) is attached. (3)
It is mainly composed of an airtight pack material (5) for containing In addition, (Y) shows a chemical solution.

The cylinder (1) is made of polycarbonate and has a needle mounting portion (11) at the front end and a finger hook portion (1) at the rear end.
2) It has a normal shape in which the piston loading part (13) is formed between them. In the cylinder (1), the mold forming the cavity having the above shape is adjusted to 90 ° C., and a polycarbonate having a viscosity average molecular weight of 20,000 is used as a raw material under high pressure and high speed (for example, 1000 to 2000 kgf / cm ² , injection rate 50). ~ 1
It can be manufactured by injection molding at 50 ml / sec.

The piston (2) is composed of a piston body (21) and an elastic seal material (22) fitted to the piston body. The piston body (21) is made of polycarbonate and is composed of a hollow body whose rear end (21b) is open as shown in the figure, and three annular grooves (21a) are recessed on the outer peripheral surface thereof. ing. Then, the annular groove (21a) and the hollow portion (21c) communicate with each other through the communication hole (2
It is communicated by 1d). The piston body (21) is
Adjust the mold forming the cavity of the above shape to 90 ℃,
A polycarbonate having a viscosity average molecular weight of 20,000 can be injection-molded at high pressure and high speed. At this time, the communication hole (22a4) can be formed by providing a core in the molding die.

The elastic sealing material (22) is made of silicone rubber, and is provided in the hollow portion (21) of the piston body (21).
c), the communication hole (21d) and each annular groove (21a) are filled and hardened (or solidified), and the portion filled and hardened in each annular groove (21a) is the inner diameter of the cylinder (1). Is formed on the rib (22a) having a diameter substantially equal to or slightly larger than that. The elastic seal material (22) can be formed as follows. That is, the central axis of the cavity is aligned with the central axis of the piston body (21) in the die (not shown) that forms the cavity capable of giving the rib shape of the size described above. So that the temperature of the mold is adjusted to 120 ° C. and the silicone rubber is injected from the opening at the rear end (21b) of the piston body (21), the hollow portion (21c) is connected to the communication hole (21d). ) And is filled in each annular groove (21a). Cure after filling. Since the elastic seal material (22) can be formed by filling and curing (or solidifying) in the mold, various shapes can be selected for the cross-sectional shape of the rib (22a) from the viewpoint of sealing property. it can.

The cap (4) is made of polycarbonate and has a shape as shown in this figure in this example, and has a bottomed cylinder into which the needle mounting portion (11) at the tip of the cylinder (1) is inserted. It has an insertion hole (41) in the shape of a center, and an outer cylinder part (43) is connected to this insertion hole (41) via a connecting part (42). In the cap (4), the outer cylinder portion (43), the connecting portion (42) and the bottom portion (41a) of the insertion hole portion (41) are formed to have uniform wall thickness, but the insertion hole portion The wall thickness of the tubular portion (41b) of (41) is formed so as to gradually decrease from the bottom portion (41a) side to the opening portion (41c) side. Moreover, the insertion hole portion (41) is configured as a tapered hole, and the inner diameter of the hole near the bottom portion (41a) is slightly smaller than the outer diameter of the tip of the needle mounting portion (11) of the cylinder (1). Is adjusted to be

In the cap (4), the mold forming the cavity having the above shape is adjusted to 90 ° C., and a polycarbonate having a viscosity average molecular weight of 20,000 is used as a raw material for high pressure and high speed (for example, 500 to 1000 kgf / cm ² , It can be manufactured by injection molding at an injection rate of 50 to 100 ml / sec.

As shown in FIG. 3, the airtight pack material (5) is a laminate material in which an aluminum film (51) is used as an intermediate layer and resin films (52) and (53) are laminated on both surfaces of the aluminum film (51). The inner resin film (52) is a hot-melt adhesive film that can be heat-welded. The airtight pack material (5) is welded at three locations indicated by (5a) in FIGS. 1 and 2, and the inner atmosphere containing the syringe (3) is kept at a reduced pressure of 0.1 to 300 Torr. . Therefore, as shown in FIGS. 1 and 2, some space (5
Except for b), the pack materials (5) adhered to each other at both side edges (5c) in the width direction, and the pack material (5) was adhered and adhered to most of the outer wall of the cylinder (1). It is in such a state.

A water permeation test was conducted on the hermetically sealed syringe having the above-mentioned structure as follows. That is, in the structure of FIG. 1, 2 ml of pure water was filled instead of the chemical liquid (Y), and the mixture was left at a temperature of 40 ° C. and the amount of pure water lost was measured. The results are shown by (◇) in FIG. In addition, what is indicated by (Δ) in the same figure is a comparative example, which was measured with respect to a hermetically sealed syringe having the same configuration except that the hermetically sealed atmosphere is at normal pressure.

From the results shown in the figure, in the polycarbonate syringe (3) in which the end opening (opening of the needle mounting part) of the polycarbonate cylinder (1) is sealed with the polycarbonate cap (4), this syringe (3) Airtight pack material
It can be seen that by sealing the inside of (5) and maintaining the sealed atmosphere at a reduced pressure atmosphere, the moisture enclosed in the syringe (3) hardly diffuses through the wall of the cylinder (1).

The above results mean the discovery of an unexpected effect. That is, common sense considers that a chemical solution or distilled water is enclosed in a syringe made of a polycarbonate having a relatively large water permeability, and the outside of the syringe is kept in a reduced pressure atmosphere or in a normal pressure atmosphere. It is expected that the movement of water in the syringe to the outside atmosphere (water permeability phenomenon) will be accelerated as a matter of course, but a result contrary to this prediction is obtained. This is an epoch-making one discovered by the present inventors as a method of completely sealing and maintaining moisture in a container made of a material having relatively large water permeability such as polycarbonate.

[0028]

EFFECTS OF THE INVENTION According to the present invention, even a syringe made of polycarbonate having a relatively large water permeability and therefore capable of producing water permeability is housed in an airtight pack material and the inside of the pack is sealed. By maintaining the atmosphere in a reduced pressure, it is possible to prevent the penetration of water contained in the syringe. Therefore, it is possible to put the drug solution into the distribution process while the drug solution is sealed in the polycarbonate syringe. In addition, since the syringe can be made of polycarbonate, mass production is possible and it can be manufactured at low cost, and therefore a disposable syringe can be provided.

[Brief description of drawings]

FIG. 1 is a vertical sectional view of an example of a sealed syringe of the present invention.

FIG. 2 is a cross-sectional view of an example of the sealed syringe of the present invention.

FIG. 3 is a cross-sectional perspective view of a main part of an example of an airtight pack material used in the sealed syringe of the present invention.

FIG. 4 is a graph showing a water permeability test of an example of the sealed syringe of the present invention together with a comparative example.

[Explanation of symbols]

(A)… Sealed syringe (1)… Cylinder (2)… Piston (3)… Syringe (4)… Cap (5)… Airtight pack material (11)… Needle mounting part (21)… Piston body (22) ) ... Elastic sealing material (21a) ... Annular groove (21c) ... Hollow part (21d) ... Communication hole (51) ... Aluminum film (52), (53) ...
Resin film

 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Masami Kono 348 Showa Rubber Co., Ltd., Kashiwa City, Chiba Prefecture 348 (72) Inventor Suzuki ▲ Taku ▼ 348 Showa Rubber Co., Ltd., Kashiwa City, Chiba Prefecture 348 Showa Rubber Co., Ltd.

Claims (4)

[Claims] 1. A syringe comprising a polycarbonate cylinder and a piston loaded in the cylinder, a cap fitted to a needle mounting portion at the tip of the cylinder to seal an opening of the needle mounting portion, and the cap is covered. A hermetically sealed syringe, comprising: an airtight pack material that accommodates a fitted syringe, wherein the inside of the airtight pack material is held in a reduced pressure state. 2. The cylinder has a viscosity average molecular weight of 18,0.
The hermetically sealed syringe according to claim 1, which is composed of an injection molded product of polycarbonate of 00 to 30,000. 3. The cap is 1.6 × 10 ^{4 to} 3.2 × 10 ⁴
The sealed syringe according to claim 1 or 2, which is made of a molded product of a hard thermoplastic resin having a tensile elastic modulus of kgf / cm ² . 4. The hermetically sealed syringe according to claim 1, wherein the airtight pack material is a laminate material in which a resin film is laminated on both sides of a vapor barrier film.