JPH07136264A - Two component prefilled syringe - Google Patents

Abstract

(57) [Summary] [Purpose] Assembling is easy and the efficiency of assembling work can be improved. Also, an injection needle selected arbitrarily can be used, and sterilization of the solution after filling is possible. A two-component mixed prefilled syringe is provided. [Structure] A drug container 1 and a solution container 2 are coaxially and fluid-tightly connected. The chemical container 1 has a chemical liquid outlet 11 at the tip.
Is sealed with a rubber cap 12, and the opening at the rear end is sealed with a first gasket 14.
A bypass groove 13 is formed in the longitudinal direction in the vicinity of. The opening of the front end and the rear end of the dissolution liquid container 2 is sealed by a second gasket 21 and a third gasket 22, respectively. When the entire first gasket 14 and the second gasket 21 enter the bypass zone 15 in a state of being in close contact with each other, the chamber 23 in which the solution is stored and the chamber 18 in which the dry formulation is stored form the bypass groove 13. It becomes a communication state through.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to a two-component mixed prefilled syringe. More specifically, the present invention relates to a drug prefilling syringe in which a drug and a solution thereof are kept airtight and aseptically before administration and are mixed at the time of use.

[0002]

2. Description of the Related Art As an example of a conventional two-component mixed prefilling syringe, there is one disclosed in Japanese Patent Laid-Open No. 5-31189 and Japanese Patent Publication No. 5-27426. Japanese Patent Laid-Open No. 5-31189 discloses an injection needle for a syringe containing a powdered drug and a container containing a dissolution liquid, which are housed in a cylindrical member and arranged in series, and which contains a powdered drug when used. Is a two-component mixed prefilled syringe in which a rubber stopper of a container containing a solution is pierced so that the two communicate with each other, and the one described in Japanese Patent Publication No. 5-27426 has a bypass passage. A two-component mixed prefilled syringe in which the inside of the syringe barrel is divided into two chambers by a rubber stopper capable of sliding the inner wall of the syringe barrel, and each chamber is filled with a different drug.

However, the above-mentioned Japanese Unexamined Patent Publication No. 5-31189.
The one described in Japanese Patent Publication has the drawbacks that many assembly steps are required because of the large number of parts and that the injection needle cannot be arbitrarily selected because it is incorporated inside. Further, in the method disclosed in Japanese Patent Publication No. 5-27426, since the powder drug and the dissolution liquid must be separately pre-filled in the same syringe, not only the assembly process is not easy, but also the dissolution liquid after the filling is It had the drawback that it could not be sterilized.

[0004]

SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances, and it is easy to assemble, the efficiency of assembly work can be improved, and an arbitrarily selected injection needle is used. It is also an object of the present invention to provide a two-component mixed prefilled syringe capable of sterilization of a solution after filling and capable of easily mixing a powder drug and a solution.

[0005]

In order to solve the above-mentioned problems, the present invention is a cylindrical container in which a dry drug is housed, and the chemical liquid pouring port at the tip is sealed by a sealing member. A first gasket in which an opening at the rear end is sealed by a first gasket slidable on the inner wall of the container, and a bypass groove is formed in the longitudinal direction of the inner wall of the container in the vicinity of the first gasket. A container, and a cylindrical container containing a solution therein, the second gasket and the third gasket having openings at the front and rear ends slidable on the inner walls of the container and the first container, respectively. The second container, which is sealed with a gasket,
A syringe in which the rear end of the first container and the front end of the second container are coaxially and fluid-tightly connected so as to be continuous, wherein the bypass groove includes the first gasket and the second gasket. The length in which the chamber between the second gasket and the third gasket is in communication with the dry preparation chamber through the bypass groove when entering the zone of the bypass groove in the close contact state. A two-component mixed pre-filled syringe is used.

Incidentally, even if the plunger is fixed to the third gasket in advance, a connecting means for attaching the plunger to the third gasket may be provided so that the plunger can be attached at the time of use. The drug solution outlet may be formed in a tip shape into which an injection needle can be fitted and sealed with a rubber cap, or the drug solution outlet may be formed in the mouth of a vial and sealed with a rubber stopper.

[0007]

According to the above construction, when the plunger is pushed while the chemical liquid outlet of the first container is closed by the sealing member (see FIGS. 1 and 6, the chemical liquid outlet of FIG. If the sealing member is a removable rubber cap, it is necessary to put the rubber cap down and put it on a desk or the like so that the rubber cap as the sealing member does not come off). The second gasket and the third gasket of the second container move in the direction of the first container with the dissolving liquid sandwiched therebetween, and further move forward along with the first gasket of the first container to bypass. Reach the zone. Then the entire first gasket enters the bypass zone,
When the sealed state of the first container by the gasket is broken, the air between the first gasket and the second gasket moves through the bypass groove to the space containing the dry drug, and the second gasket moves toward the first gasket. They move and the two come into close contact.

When the plunger is further pushed, the first gasket and the second gasket, which are in close contact with each other, move integrally to enter the bypass zone, and the sealed state of the first container by the first gasket and the second gasket is broken. , First
And the second container communicate with each other via the bypass groove. Then, the first gasket and the second gasket stop in the bypass zone, and the dissolved liquid between the second gasket and the third gasket can move through the bypass groove to the chamber containing the dry drug. The gasket moves toward the second gasket (see FIG. 4). Then, when the third gasket moves to a position where it closely adheres to the second gasket and all the dissolved liquid moves to the chamber containing the dry chemical, the first, second and third gaskets move integrally in the chemical liquid pouring direction. As such, the lumen of the first container is resealed by at least the first gasket (see Figure 5). If the syringe is shaken in this state, the dry drug in the first container and the solution can be mixed well.

In use, in the case of a two-component mixed prefilled syringe as shown in FIG. 1, the rubber cap of the drug solution outlet may be removed and an injection needle may be attached to the drug solution outlet (see FIG. 5). In the case of a two-component mixed prefilled syringe as shown in FIG. 6, an injection needle (hereinafter, referred to as a double-ended needle) having blade edges at both ends may be attached to the drug solution outlet (see FIG. 7, at this time, a rubber stopper). Is pierced by one of the injection needles).

[0010]

Embodiments of the present invention will now be described with reference to the drawings. 1 is a vertical cross-sectional view of a two-component mixed prefilled syringe according to an embodiment of the present invention (dry drug and solution are omitted), and FIG. 2 is a vertical cross-sectional view of the first container shown in FIG. FIG. 3, FIG. 3 is a longitudinal sectional view of the second container shown in FIG. 1, FIG. 4 is a view showing a state in which the first container and the second container are communicated with each other in FIG. 1, and FIG. 5 is a state immediately before injection. It is a figure. 6 is a longitudinal sectional view showing a first container according to another embodiment of the present invention, and FIG. 7 shows a state in which a double-ended needle is attached to the drug solution outlet of the two-component mixed prefilled syringe of FIG. It is a figure.

As shown in FIGS. 1 to 7, the syringe of the present invention comprises a cylindrical drug container 1 containing a dry drug D therein.
And a cylindrical solution container 2 in which the solution S is contained is coaxially and fluid-tightly connected, and the drug container 1 has a drug solution spout 11 sealed at the tip by a sealing member. The opening at the rear end is sealed with the first gasket 14, and the bypass groove 13 is formed in the longitudinal direction in the vicinity of the first gasket 14. On the other hand, the opening of the front end and the rear end of the dissolution liquid container 2 is sealed by the second gasket 21 and the third gasket 22, respectively. The length of the bypass groove 13 is set such that when the entire first gasket 14 and the second gasket 21 enter the bypass zone 15 in a closely contacted state, the chamber 23 containing the solution S and the dry preparation D are The accommodated chamber 18 is formed so as to be in communication with each other via the bypass groove 13.

The first container is the drug container 1, which is usually formed of glass into a cylindrical shape. The tip of the drug container 1 is a drug solution outlet 11, and the drug solution outlet 11 is usually reduced in diameter to form a tip of an injector as shown in FIG.
It is formed like a mouth of a vial as shown in FIG. At the open rear end, an engaging flange 1 that engages with a fixture described later.
6 is provided. The drug container 1 contains a dry formulation such as a freeze-dried formulation or a powder formulation, and the drug solution outlet 11 is a sealing member (a rubber cap 12 in the case of the tip-shaped drug solution outlet 11 as shown in FIG. 1). 6, a rubber stopper 17 is used in the case of the vial-shaped chemical liquid pouring outlet 11 as shown in FIG. 6) is closed fluid-tightly, and the opening at the rear end is sealed by the first gasket 14. . In the case of the drug solution outlet 11 as shown in FIG. 1, a normal injection needle 61 as shown in FIG. 5 is connected to the drug solution outlet 11, and the drug solution outlet 11 as shown in FIG. In some cases, a double-ended needle type injection needle 62 is connected.

The bypass groove 13 is formed on the inner wall of the medicine container 1 first.
It is a groove provided in the vicinity of the gasket 14, and the first gasket 14 and the second gasket 21 of the dissolution liquid container 2 are in close contact with each other and integrally formed in the longitudinal direction, that is, the bypass zone. The chamber 23 containing the dissolving liquid and the chamber 18 containing the dry chemical are in communication with each other via the bypass groove 13 when the entire structure moves into the bypass zone 15 and moves into the bypass zone 15. Can be decided. That is, in FIG. 1, when the plunger 3 is pushed with the chemical solution outlet 11 kept closed, the drug container 1 with the second gasket 21 and the third gasket 22 of the solution container 2 sandwiching the solution therebetween. , And further forward with the first gasket 14 of the drug container 1 to reach the bypass zone 15. And the first gasket 1
When the whole 4 enters the bypass zone 15 and the sealed state of the drug container 1 by the first gasket 14 is broken, the air between the first gasket 14 and the second gasket 21 passes through the bypass groove 13 to contain the dry drug. Move to room 18
The second gasket 21 moves in the direction of the first gasket 14 and the two are in close contact with each other.

When the plunger 3 is further pushed, the first gasket 14 and the second gasket 21 that are in close contact move integrally, and the whole enters the bypass zone 15, and the drug container 1 by the first gasket 14 and the second gasket 21.
The sealed state of is broken, and the drug container 1 and the solution container 2 communicate with each other via the bypass groove 13. Then, as shown in FIG. 4, the first gasket 14 and the second gasket 21 stop in the bypass zone 15, and the solution S in the chamber 23 between the second gasket 21 and the third gasket 22 passes through the bypass groove 13. When moved to the chamber 18 containing the dry chemical D, the third gasket 22 moves toward the second gasket 21. Then, when the third gasket 22 moves to a position in which the second gasket 21 comes into close contact with the second gasket 21 and the dissolved liquid S moves to the chamber 18 in which all the dry chemicals D are stored, the first, second and third gaskets 14, 21, 22. Moves integrally in the direction of the drug solution outlet 11, and the inner cavity of the drug container 1 is resealed by at least the first gasket 14 as shown in FIG. If the syringe is shaken in this state, the dry drug D in the chamber 18 and the solution S can be mixed well.

The second container is the solution container 2 and is usually made of glass or transparent synthetic resin. The openings at both ends of the dissolution liquid container 2 are sealed with a second gasket 21 and a third gasket 22, respectively.
The chamber 23 in between contains a dissolving solution. The shapes of both ends of the solution container 2 differ depending on the method of connecting the drug container 1 and the solution container 2. For example, in the example shown in FIG.
An engagement flange 24 is provided at the tip of the solution container 2. A packing 5 is sandwiched between the rear end of the drug container 1 and the front end of the dissolution liquid container 2, and is fixed between the side walls 41 and 42 of the fixing device 4 by a fixing device 4 made of an annular member having a “U” -shaped cross section. Fix the combined flanges 16 and 24 so as to sandwich them,
Both containers 1 and 2 are connected. In this case, the solution container 2
A flange 25 for hanging a finger is provided at the rear end. Further, in the example shown in FIG. 6, a "T" -shaped engaging means 26 is provided concentrically toward the outside at the tip of the dissolution liquid container 2, and a male screw 27 is provided on the outer peripheral wall thereof. Has been. The engaging means 26 has a top surface 48 having a through hole 49 formed therein and is screwed with a fastener nut-shaped fixing member 45 having an internal thread 47 formed on the inner wall of the skirt.
An O-ring 55 is fitted into a recess between the side wall 6 and the side wall of the front end of the solution container 2. When the O-ring 55 is fitted in the recess between the engaging means 26 and the side wall of the end of the solution container 2, the rear end of the drug container 1 and the end of the solution container 2 are aligned and the fixture 45 is tightened. Thus, the flange 16 of the drug container 1 is pressed against the tip of the dissolution liquid container 2, and the two containers 1 and 2 are strongly connected. The flange 25 at the rear end of the solution container 2 may be omitted, and a flange 46 for putting a finger on the fixture 45 may be provided as shown in FIG.

The material for forming the first, second and third gaskets may be the same as the gasket for a normal syringe,
For example, butyl rubber, isoprene rubber, olefin elastomer, etc. are preferably adopted. In addition, the rear end surface of the first gasket 14 and the front end surface of the second gasket 21,
The rear end surface of the gasket 21 and the front end surface of the third gasket 22 are formed in a planar shape or a complementary shape so that they can substantially contact each other. The plunger 3 may be attached to the third gasket 22 of the dissolution liquid container 2 in advance, but a coupling means such as a fitting recess 27 as shown in FIGS. 3 and 6 is provided at the rear end of the third gasket 22, The plunger 3 may be connected at the time of use.

[0017]

As is apparent from what has been described above, the two-component mixed prefilled syringe of the present invention can exert the following effects. Since the drug container and the solution container are separately manufactured and integrally connected with the fixture, the solution after filling can be sterilized. Since the injection needle is not pre-fixed, an arbitrarily selected injection needle can be used. Since the structure is simple, assembly is easy and the efficiency of assembly work can be improved. The solution and the dry drug can be mixed by a simple operation of simply pushing the third gasket with the plunger.

[Brief description of drawings]

FIG. 1 is a vertical cross-sectional view of a two-component mixed prefilled syringe according to an embodiment of the present invention (dry drug and solution are omitted).

FIG. 2 is a vertical sectional view of the first container shown in FIG.

FIG. 3 is a vertical cross-sectional view of the second container shown in FIG.

FIG. 4 is a diagram showing a state in which the first container and the second container in FIG. 1 are communicated with each other.

FIG. 5 is a diagram showing a state immediately before injection.

FIG. 6 is a vertical cross-sectional view showing another embodiment of the present invention (the dry drug and the solution are omitted).

7 is a view showing a state in which a double-ended needle is attached to the drug solution outlet of the two-component mixed prefilled syringe of FIG.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Chemical | medical agent container 11 Chemical liquid pouring outlet 12 Rubber cap 13 Bypass groove 14 1st gasket 17 Rubber stopper 2 Dissolved liquid container 21 2nd gasket 22 3rd gasket 26 Engaging means 3 Plunger 4, 45 Fixing tool 5 Packing 55 O-ring

 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Tetsuji Miyamoto 3-9-3 Honjo-nishi, Kita-ku, Osaka Within Nissho Co., Ltd. (72) Inventor Kenji Himejima 3-9-3 Honjo-nishi, Kita-ku, Osaka Stock company Nissho

Claims (5)

[Claims] 1. A cylindrical container having a dry drug contained therein, wherein a chemical liquid spout at the tip is sealed by a sealing member, and an opening at the rear end is slidable on the inner wall of the container. A first container which is sealed with a first gasket and has a bypass groove formed in the longitudinal direction of the inner wall of the container in the vicinity of the first gasket; and a cylindrical container in which a dissolving liquid is contained. And a second container in which openings at the front end and the rear end are sealed with a second gasket and a third gasket capable of sliding on the inner walls of the container and the first container, respectively.
A syringe in which the rear end of the first container and the front end of the second container are coaxially and fluid-tightly connected so as to be continuous, wherein the bypass groove includes the first gasket and the second gasket. The length in which the chamber between the second gasket and the third gasket is in communication with the dry preparation chamber through the bypass groove when entering the zone of the bypass groove in the close contact state. A two-component mixed prefilled syringe characterized in that 2. The two-component mixed prefilled syringe according to claim 1, wherein the plunger is previously fixed to the third gasket. 3. A two-component prefilled syringe according to claim 1, wherein the third gasket is provided with a coupling means for attaching the plunger. 4. The two-component mixed prefilled syringe according to claim 1, wherein the drug solution outlet is formed in a tip shape into which an injection needle can be fitted and is sealed with a rubber cap. 5. The two-component mixed prefilling syringe according to claim 1, wherein the drug solution spout is formed in the shape of a mouth of a vial and is sealed with a rubber stopper.