JP3074655B2 - Prefilled syringe for two components - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a two-component prefilled syringe, and more particularly, the interior of a syringe is divided into two chambers, one of which contains a drug solution (including a solution).
The other chamber is a syringe in which a dry drug such as a drug solution or a powder formulation or a solid formulation is stored in advance, so that the sealed drug solution or the dry drug can be stored without deterioration, and the injection can be performed. The present invention relates to a two-component prefilled syringe capable of mixing a drug solution and a drug solution (or a dry drug) partitioned and sealed in two chambers.

[0002]

2. Description of the Related Art Some injectable drugs, such as solid preparations or powdered preparations, or amino acid solutions and glucose solutions, deteriorate and rapidly change when they are put into use. Some drugs lose their efficacy. Therefore, in order to make it possible to store these drugs for a long period of time and to aseptically prepare them aseptically at the time of use, the interior of a syringe has conventionally been divided into two chambers, and one chamber has a drug solution (dissolution medium). The other chamber employs a so-called two-component prefilled syringe in which a drug solution or a dry preparation such as a powder preparation or a solid preparation is stored in advance.

[0003] As such a two-component prefilled syringe, one in which a bypass can be provided between a sliding obturator (hereinafter, referred to as a partition wall gasket) that separates the syringe from the two chambers (Japanese Utility Model Publication No. 49-14465). Gazette
-22315, JP-B-2-32898, JP-A-60-72561, JP-A-61-48377.
Japanese Patent Application Laid-Open No. 59-155264, and a device in which a bypass is provided in a gasket itself for partition walls (JP-A-59-155264). (JP-A-58-212453).

In the syringe disclosed in Japanese Utility Model Publication No. 49-14465, a vertical groove-like structure is provided on the inner wall of the central portion of the injection cylinder, and the length of the gasket for the partition wall is shorter than the length of the vertical groove. The syringe disclosed in Japanese Patent Publication No. 54-22315 is a syringe in which a thin tube longer than the length of a gasket for a partition wall is fixed to an inner wall of a syringe barrel. The syringe described in Japanese Patent Publication No. 2-32898 is a front end of the syringe barrel. The inner wall of a portion adjacent to the partition wall is locally deformed over a length slightly longer than the length of the partition gasket. Also, Japanese Patent Application Laid-Open
In the double-compartment syringe disclosed in Japanese Patent Application Laid-Open No. 7-25661, a bypass zone is formed by protruding the inner wall of an injection tube outward or inward, and the length of the bypass zone is longer than the length of the gasket for the partition wall. ing. In addition, Japanese Unexamined Patent Publication
The two-drug syringe shown in Japanese Patent No.
It has the same configuration as the double-compartment syringe shown in JP-A-60-72561, except that the length of the bypass zone is shorter than the length of the gasket for the partition wall. A groove is provided in the rib on the far end side.

On the other hand, the medical multi-chamber container disclosed in Japanese Patent Application Laid-Open No. 58-212453 has a bypass plunger, a means for forming a seat in the bypass plunger,
A plunger rod having a distal end engaged in the seat portion, wherein when the bypass plunger is displaced forward in the tubular container, the distal end expands the disc-shaped base of the plunger in the radial direction, and a long stock available. During the period, the tubular container can be tightly sealed. The inflation pressure is then slightly reduced as the plunger rod moves rearward in the mixing process to facilitate movement of the plunger and flow of diluent around the plunger.

[0006] However, despite the many prior arts described above, it is possible to provide a long-term preservation of a two-component drug in which one or both components are in a liquid state, and it can be prepared aseptically and quickly at the time of use. In fact, there is still a need for a reliable and easy to manufacture syringe. .

[0007]

DISCLOSURE OF THE INVENTION The present invention has been made in view of the above circumstances, and enables a long-term preservation of a drug of two components, and is simple and easy to prepare aseptically when used. It is an object of the present invention to provide a syringe which is highly reliable and easy to manufacture.

[0008]

SUMMARY OF THE INVENTION According to the present invention, in order to solve the above-mentioned problems, a tip and an opening at a rear end of a syringe barrel are closed by a first sealing member and a second sealing member, respectively. A plunger having a third sealing member at the tip thereof is fluid-tightly inserted into a rod insertion hole formed in the axial direction of the second sealing member, and is fluid-tight by the third sealing member. In a syringe in which a drug solution and a drug solution or a dry drug are pre-filled in the two chambers partitioned by, the second sealing member and the third sealing member are slidable on the inner wall of the injection cylinder, The rod of the plunger is slidable on the inner wall of the rod insertion hole, and a sealing member compressing means is provided at the tip of the rod, and the third sealing member is moved by the sealing member compressing means. When the compression by the sealing member compressing means is released, the third sealing member is restored to its original size, separated from the inner wall of the syringe barrel, and communicates with the two chambers. The pre-filled syringe for two components constituted as described above is adopted. Here, the sealing member compression means has a compression member attached to the outer wall of the distal end portion of the rod, a threaded portion and a mounting portion, and is rotatably screwed to the distal end of the rod by a threaded portion having a small diameter. Preferably, the third sealing member has a thick lower edge portion sandwiched between the compression member and the mounting portion of the sealing member mounting member. Further, the second sealing member and the compression member of the sealing member compression means are provided with sealing member integration means for mutually engaging the two and integrating the second sealing member and the third sealing member. You may.

[0009]

According to the configuration of the present invention, the fluid-tight partitioned 2 is provided.
The communication between the two chambers is performed as shown in FIG. That is, FIG.
When the plunger 7 is rotated clockwise as shown in FIG.
Since the third sealing member 6 is mounted on the sealing member mounting member 13 and the third sealing member 6 is engaged with the inner wall of the syringe barrel 1 and does not move, the plunger 7 moves upward and the compression member is moved. The interval between the mounting member 16 and the mounting portion 16 of the sealing member mounting member 13 is widened, and the lower edge portion 17 of the third sealing member 6 is restored to its original size and separated from the inner wall of the syringe tube 1. A gap 18 is formed between the sealing members 6. Then, the chamber 19 surrounded by the second sealing member 5 and the third sealing member 6 of the syringe barrel 1
The chemical solution (including the dissolving solution) 10 contained in the container flows into the chamber 20 surrounded by the first sealing member 3 and the third sealing member 6,
The dry medicine 11 housed in the chamber 20 is dissolved (or mixed with the drug solution). After the two chambers 19 and 20 are communicated with each other, as shown in FIG. 4, the plunger 7 is pulled upward to attach the compression member 14 to the sealing member engaging hole 21 of the second sealing member 5, and the second The sealing member 5 and the third sealing member 6 are integrated. When the plunger 7 is rotated in the counterclockwise direction in this state, the plunger 7 moves downward this time, so that the interval between the compression member 14 and the mounting portion 16 of the sealing member mounting member 13 is narrowed, and the lower portion of the third sealing member 6 The rim portion 17 expands in diameter and closely adheres to the inner wall of the syringe barrel 1 to seal the inner wall of the syringe barrel 1 in a fluid-tight manner. When injecting a drug solution, the first sealing member 3 may be removed from the tip 2 and the plunger 7 may be moved downward.

[0010]

Next, an embodiment of the present invention will be described with reference to the drawings. FIG. 1 is a cross-sectional view showing one embodiment of the present invention, FIG. 2 is a cross-sectional view of a main part showing another embodiment, FIG. 3 is a diagram for explaining a communication operation of two partitioned chambers, and FIG. It is a figure explaining operation which unifies the 2nd sealing member and the 3rd sealing member. FIG. 5 is an explanatory view of the use situation of the prefilled syringe of the present invention. As shown in FIG. 1, the prefilled syringe of the present invention comprises a syringe 1 and a plunger 7 having a third sealing member 6 at the end inserted into the syringe 1.
A first sealing member 3 attached to the tip 2 at the distal end of the syringe barrel 1, and a second sealing member 5 inserted into the base end opening 4 of the syringe barrel 1. 5 has a rod insertion hole 9 formed in the axial direction. The third sealing member 6 is compressed and expanded in diameter by a sealing member compression means 12 provided at the tip of the rod 8 of the plunger 7, and partitions the inside of the syringe barrel 1 into two chambers 19 and 20. These two rooms 1
The communication between 9 and 20 is achieved by releasing the compression by the sealing member compression means 12.

The syringe barrel 1 has a tip 2 which is a drug solution outlet at the distal end and a flange 23 for hanging a finger at the base end, like a normal syringe barrel, and is made of a transparent synthetic resin such as It has a circular cross section made of polypropylene, polyester, polystyrene, polycarbonate, or the like. The opening of the chip 2 is closed by the first sealing member 3, the opening 4 on the flange 23 side is closed by the second sealing member 5, and the flange 23 is usually provided with a stopper 24. The stopper 24 prevents the second sealing member 5 from dropping from the syringe barrel 1.

The first sealing member 3 is generally made of a soft flexible resin such as polyethylene or soft vinyl chloride resin, butyl rubber, butadiene rubber, styrene-butadiene rubber,
As shown in FIG. 1, a rubber-like elastic body such as isoprene rubber, nitrile rubber, and ethylene-propylene rubber is used. A chamber 20 for accommodating the dry medicine 11 (or chemical solution) is formed between the third sealing member 6 and the third sealing member 6. On the other hand, the second sealing member 5
Is formed in a shape to be inserted into the opening 4 on the flange 23 side by using a rubber-like elastic body similar to the rubber-like elastic body generally used for the first sealing member 3. A chamber 19 for containing a chemical solution (including a solution) is formed between the member 6 and the member 6. The second sealing member 5 has a rod insertion hole 9 penetrating in the axial direction thereof, and the rod 8 of the plunger 7 is inserted in this hole in a fluid-tight manner.

If necessary, the second sealing member 5 is provided with a plunger 7 on the third sealing member 6 side so that the third sealing member 6 does not rotate when the plunger 7 is rotated counterclockwise. For example, a step (not shown, the compression member 14 is also provided with a step which engages with the compression member 14) of the distal end sealing member compression means 12 so as to engage with each other.
And the like may be provided. Further, if necessary, a sealing member integrating means for integrating the second sealing member 5 and the third sealing member 6 may be provided on the third sealing member 6 side of the second sealing member 5. As the sealing member integrating means, for example, the sealing member engaging hole 21 (to which the annular projection 26 of the compression member 14 is fitted) as shown in FIG. 1 or the sealing member screwing hole 27 as shown in FIG. (The external thread 28 of the compression member 14 is screwed).

A plunger 7 inserted into the syringe barrel 1 through the rod insertion hole 9 of the second sealing member 5 has a hollow rod 8 opened at the distal end and closed at the proximal end, and a hollow rod 8 at the distal end of the rod 8. It is provided with a sealing member compression means 12 provided, and has a third sealing member 6 at the tip. A flange 29 is provided at the base end of the rod 8 so as to be easily pressed by a finger. A rib is provided at a portion between the flange 29 and the second sealing member 5 so that the plunger 7 does not move carelessly. 25 may be provided.

The sealing member compressing means 12 is a means for compressing and expanding the third sealing member 6 (in order to compress and expand the diameter, the third sealing member 6 has rubber-like elasticity. The hollow portion 22 from the tip of the rod 8
And a compression member 14 attached to the outer wall at the tip of the rod 8. The sealing member mounting member 13 is connected to the third sealing member 6.
And a hollow portion 2 of the rod 8.
2 includes a screw portion 15 having a male screw 31 for screwing with a female screw 30 provided in the second screw 2. The third sealing member 6 mounted on the mounting portion 16 of the sealing member mounting member 13 is disposed such that its thick lower edge portion 17 is sandwiched between the compression member 14 and the mounting portion 16. Before use, the lower edge portion 17 of the third sealing member 6 is compressed and expanded by the compression member 14 and the mounting portion 16 as shown in FIG. When the two chambers 19 and 20 communicate with each other during use, the plunger 7 is rotated in a clockwise direction, so that the sealing member mounting member 13 does not move because it is fitted into the third sealing member 6. Moves upward to increase the distance between the sealing member mounting member 13 and the compression member 14, and the lower edge portion 17 of the third sealing member 6 by the two members 13 and 14.
Is released, the lower edge portion 17 is restored to its original size, separated from the inner wall of the syringe barrel 1, and a gap 18 is formed between the syringe barrel 1 and the third sealing member 6 ( (See FIG. 3).

The third sealing member 6 mounted on the sealing member mounting member 13 provided at the distal end of the plunger 7 is generally made of the same rubber-like elastic material as the second sealing member 5, and is used in the form of a gasket for a syringe. The lower edge portion 17 is screwed sufficiently longer than the thickness of the mounting portion 16 as shown in FIG. It extends in the direction of the part 15 and is thickened inward. Therefore, when the compression member 14 and the mounting portion 16 located so as to sandwich the lower edge portion 17 of the third sealing member 6 approach each other and change from the state of FIG. 3 to the state of FIG. 1, the third sealing member 6 is the compression member 14
Then, the diameter is increased by being pressed by the mounting portion 16 so as to be in close contact with the inner wall of the syringe barrel 1. On the other hand, when the compression member 14 and the mounting portion 16 are separated from each other and the state of FIG.
The lower edge portion 17 of the third sealing member 6 is released from the compression by the compression member 14 and the mounting portion 16 and is reduced in diameter (returns to its original size) and is separated from the inner wall of the syringe barrel 1.

Next, the use of the prefilled syringe of the present invention will be described with reference to FIG. Figure 5 before use
The two chambers 19 and 20 are fluid-tightly partitioned by the third sealing member 6 as shown in FIG. Where 10 is the solution, 11
Is a powdered drug. When the plunger 7 is rotated clockwise during use, the diameter of the second sealing member 6 is reduced (to the original size) as shown in FIG. 5B, and the two chambers 19 and 20 communicate with each other. The lysis solution 10 moves to the chamber 20. Next, the plunger 7 is moved up and down to thoroughly mix the solution 10 and the powdered medicine (C in FIG. 5), and if necessary, the plunger 7 is pulled up to raise the second sealing member 5 and the third sealing member 6. Are integrated (D in FIG. 5), the first sealing member 3 is removed, an injection needle, a connector, and the like are attached (E in FIG. 5), and when the plunger 7 is pressed, the drug solution can be discharged (FIG. 5). F).

In FIG. 5, the second sealing member 5 and the third sealing member 6 are integrated. However, since the second sealing member 5 can slide on the inner wall of the syringe barrel 1, the plunger 7 To bring the sealing members 5 and 6 into contact with each other, and then the plunger 7
Is rotated counterclockwise to expand the lower edge portion 17 of the third sealing member 6 again so as to be in close contact with the inner wall of the syringe barrel 1, so that the two sealing members 5 and 6 are not necessarily integrated. There is no. In this case, the second sealing member 5 is replaced with the third sealing member 6
And the plunger 7
To move with. When the drug is expensive, the amount of the drug solution remaining in the syringe barrel 1 is reduced, so that it takes time and effort. .

[0019]

As is apparent from the above description, the use of the prefilled syringe of the present invention enables long-term storage of a two-component drug in which one or both components are in a liquid state. Sometimes aseptically quickly 2
The two components can be mixed. Further, the operation is simple, and since no needle is used, there is no generation of foreign matter due to coring, and safe and highly reliable preparation is possible. Furthermore, since it does not have a complicated structure and has a small number of parts, it is easy to manufacture, and a prefilled syringe can be provided at a lower cost than conventional ones.

[Brief description of the drawings]

FIG. 1 is a sectional view showing one embodiment of the present invention.

FIG. 2 is a sectional view of a main part showing another embodiment of the present invention.

FIG. 3 is a view for explaining a communication operation of two partitioned chambers in the prefilled syringe of FIG. 1;

FIG. 4 is a diagram illustrating an operation of integrating the second sealing member and the third sealing member in the prefilled syringe of FIG.

FIG. 5 is an explanatory view of a use situation of the prefilled syringe of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Injection cylinder 2 Tip 3 1st sealing member 5 2nd sealing member 6 3rd sealing member 7 Plunger 8 Rod 9 Rod insertion hole 10 Chemical solution (solution) 11 Dry medicine (chemical solution) 12 Sealing member compression means 13 Sealing Member mounting member 14 Compression member 15 Threaded part 16 Mounting part 21 Sealing member engagement fossil (sealing member integration means) 24 Stopper 27 Sealing member screwing fossilization (sealing member integration means)

Claims (3)

(57) [Claims] 1. A plunger having a tip at a tip and an opening at a rear end of a syringe barrel closed by a first sealing member and a second sealing member, respectively, and a plunger having a third sealing member at the tip thereof. The third sealing member is fluid-tightly inserted into a rod insertion hole formed in the axial direction of the second sealing member.
A syringe in which two chambers partitioned in a fluid-tight manner by a sealing member are filled with a drug solution and a drug solution or a dry drug, respectively.
Sealing member is slidable on the inner wall of the syringe barrel, the rod of the plunger is slidable on the inner wall of the rod insertion hole, and a sealing member compressing means is provided at the tip of the rod, The third sealing member is compressed and expanded by the sealing member compression means, and when the compression by the sealing member compression means is released, the third sealing member is restored to its original size and injected. 2 away from the inner wall of the cylinder
A two-component prefilled syringe configured to communicate chambers. 2. A sealing member compression means having a compression member attached to an outer wall of a distal end portion of a rod, a threaded portion and a mounting portion, and a rotatable distal end of the rod at a threaded portion having a small diameter. 2. The two-component component according to claim 1, comprising a sealing member mounting member to be screwed, wherein a thick lower edge portion of the third sealing member is sandwiched between the compression member and the mounting portion of the sealing member mounting member. For prefilled syringes. 3. The second sealing member and the compression member of the sealing member compression means are engaged with each other to form the second sealing member and the third sealing member.
The two-component prefilled syringe according to claim 2, further comprising a sealing member integrating means for integrating the sealing member.