JPH07148261A - Two-component prefilled injector - Google Patents

Abstract

PURPOSE:To provide a two-component prefilled injector which is easy to assemble, contributes to an improvement in efficiency of assembly operation, permits the use of an arbitrarily selected injection needle and is capable of sterilizing a dissolving soln. after filling. CONSTITUTION:A cylindrical drug container 1 in which a dry drug is housed and a cylindrical dissolving liquid container 2 in which the dissolving liquid is housed are housed in a cylindrical holder 3 and are liquidtightly connected coaxially. The drug container 1 has a medical liquid injecting port 11 hermetically sealed by a hermetic sealing means at its front end and the opening at its rear end is hermetically closed by a first gasket 14. A bypass groove 13 is formed longitudinally in proximity to the first gasket 14. On the other hand, the openings at the front and rear ends of the dissolving liquid container 2 are hermetically sealed by a second gasket 21 and a third gasket 22 respectively. A chamber 23 and a chamber 18 communicate via the bypass groove 13 when the first gasket 14 and the second gasket 21 completely enter the inside of a bypass zone 15.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to a two-component 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 An example of a conventional two-component pre-filled syringe is disclosed in Japanese Patent Application Laid-Open No. 5-31189 and Japanese Patent Publication No. 5-27426. JP-A-5
-31189 discloses a solution in which a syringe containing a powdered drug and a container containing a solution are contained in a cylindrical member and arranged in series, and a syringe of the syringe containing the powdered drug is used at the time of use. A two-component prefilled syringe in which a rubber plug of a container containing
Further, in the one disclosed in Japanese Patent Publication No. 5-27426, the inside of an injection cylinder having a bypass passage is divided into two chambers by a rubber stopper capable of sliding the inner wall of the injection cylinder, and each chamber is different. A two-component prefilled syringe filled with 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. It is easy to assemble, the efficiency of assembly work can be improved, and an arbitrarily selected injection needle is used. In addition, it is an object of the present invention to provide a two-component prefilled syringe capable of sterilizing 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. A second container sealed with a gasket,
A cylindrical holder for accommodating the first container and the second container and supporting and fixing them coaxially is provided, and a rear end of the first container and a tip end of the second container are fluidized in the holder. The second gasket and the third gasket are closely connected and when the bypass groove enters the zone of the first bypass groove in the state where the first gasket and the second gasket are in close contact with each other. A two-component pre-filled syringe is employed, characterized in that the chamber between the two is formed to have a length such that it is in communication with the chamber of the dry preparation via the bypass groove.

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. Furthermore, the tip of the holder may be formed to be smaller than the inner diameter of the body of the drug container and larger than the outer diameter of the drug solution outlet, and a pressing tool for pressing the second container to the tip side may be provided at the rear end of the holder. Of course, a flange for hanging a finger at the time of injection may be provided on the rear end of the holder or on the pressing tool.

[0007]

According to the above construction, if the plunger is pushed while the chemical liquid outlet of the first container is closed by the sealing member (see FIGS. 1 and 4, 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 dissolution liquid sandwiched therebetween. At this time, since the first gasket and the second gasket are in close contact with each other, the first gasket of the first container also moves integrally with the second gasket of the second container to reach the bypass zone. When the first gasket and the second gasket move integrally and enter the bypass zone as a whole, the sealed state of the first container by the first gasket and the second gasket is broken, so that the first container and the second gasket are broken. The container communicates via the bypass groove. The first gasket and the second gasket then stop in the bypass zone and the second gasket
The dissolution liquid between the gasket and the third gasket is allowed to move to the chamber containing the dry drug through the bypass groove, so that the third gasket moves toward the second gasket (see FIG. 2). 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 3). If the syringe is shaken in this state, the dry drug in the first container and the solution can be mixed well.

In the case of use, in the case of a two-component 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. 2). In the case of a two-component pre-filled syringe as shown in FIG. 4, 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. 5, at this time, the rubber stopper is an injection) Is pierced by one of the needles).

[0010]

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

As shown in FIGS. 1 to 5, the syringe of the present invention is a cylindrical drug container 1 containing a dry drug D therein.
The cylindrical solution container 2 having the solution S contained therein is housed in the cylindrical holder 3 and fluid-tightly connected coaxially. The drug container 1 has a drug solution outlet 11 sealed at the tip by a sealing member, the opening at the rear end is sealed by a first gasket 14, and the bypass groove 13 is provided in the longitudinal direction in the vicinity of the first gasket 14. Are formed. on the other hand,
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. 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 the bypass groove 13
Are formed so as to be in communication with each other.

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. The opened rear end is provided with a sealing flange 16 that is in close contact with the front end of the solution container 2 that is the second container. The drug container 1 contains a dry drug such as a freeze-dried preparation and a powdered preparation, 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). , A rubber stopper 17 is adopted in the case of the vial-shaped chemical liquid pouring outlet 11 as shown in FIG. 4) is fluid-tightly closed, 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 71 as shown in FIG. 3 is connected to the drug solution outlet 11 so that the drug solution outlet 11 as shown in FIG. In this case, a double-ended needle type injection needle 72 as shown in FIG. 5 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 5 is pushed in a state in which the chemical liquid outlet 11 is closed, the drug container 1 with the second gasket 21 and the third gasket 22 of the dissolution liquid container 2 sandwiching the dissolution liquid therebetween. Move in the direction of. This time,
The first gasket 14 of the medicine container 1 is also the second gasket 14 of the dissolution liquid container 2.
Bypass with the gasket 21 by moving integrally with the gasket 21.
Reach

When the first gasket 14 and the second gasket 21 which are in close contact with each other move integrally and enter the bypass zone 15, the first gasket 14 and the second gasket 21
The sealed state of the drug container 1 by the gasket 21 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. 2, the first gasket 14 and the second gasket 21 stop in the bypass zone 15,
Chamber 23 between second gasket 21 and third gasket 22
Solution S moves to the chamber 18 containing the dry drug D through the bypass groove 13, and the third gasket 22 moves toward the second gasket 21. Then, the third gasket 22 moves to a position where the third gasket 22 comes into close contact with the second gasket 21,
When the solution S is moved to the chamber 18 containing all the dry medicine D, the first, second and third gaskets 14, 21 and 22 are integrally moved in the direction of the chemical solution pouring port 11 as shown in FIG. So that the lumen of the drug container 1 is at least the first gasket 14
Resealed by. 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 dissolution liquid S is stored in the chamber 23 between them. On the tip side of the solution container 2, a flange 2 for sealing is provided close to the tip.
4 is provided, and an O-ring 6 is attached to the tip end side of the flange 24. The O-ring 6 is provided with a flange 16 at the rear end of the drug container 1 and a flange 24 at the tip of the solution container 2 when the drug container 1 and the solution container 2 are supported and fixed in a holder 3 described later. The space is sealed.

The holder 3 is a container for accommodating the drug container 1 and the solution container 2 and supporting and fixing the rear end of the drug container 1 and the tip of the solution container 2 coaxially and fluid-tightly. , Formed of a flexible resin into a tubular shape. The holder 3 has a narrowed tip such that the inner diameter is smaller than the outer diameter of the drug container 1 so that the drug container 1 does not fall off the tip,
That is, the holder 3 of FIG. 1 that has the narrowed portion 31 and is paired with the pressing tool 4 to be described later is provided with the male screw 32 as a coupling means for fixing the pressing tool 4 to the rear end portion. . By pressing the rear end of the solution container 2 with the pressing tool 4, the drug container 1 is supported by the narrowed portion 31 at the tip of the holder 3 and the flange 24 of the solution container 2, and the solution container 2 is The container 1 is supported by a flange 16 and a pressing tool 4, and both containers 1 and 2 are fluid-tightly sealed by an O-ring 6.

The pressing tool 4 is a cap-shaped member having a through hole 46 for allowing the plunger 5 to pass therethrough on the top surface 45, and has a flange 41 for hanging a finger on the rear end thereof. A skirt 42 concentrically provided on the inside with a pressing portion 44 for pressing the rear end of the solution container 2 and on the outside with a coupling means (female screw) 43 for engaging the holder 3 on its inner wall.
Are formed. The pressing tool 4 is not always necessary. For example, as shown in FIG. 6, a slit 36 for absorbing a dimensional error is provided in the longitudinal direction of the narrowed portion 31,
A slit 38 for inserting the drug container 1 and the dissolution liquid container 2 is provided in the longitudinal direction of the rear end portion, and a holder 35 having an undercut 37 on the inner wall thereof is adopted. You may make it engage with the undercut 37 of the holder 3. Here, when the holder 35 is adopted, an undercut 3 is formed at the rear end of the solution container 2.
It goes without saying that it is necessary to provide a flange (not shown) that engages with 7.

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 5 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 25 as shown in FIG. 4 is provided at the rear end of the third gasket 22,
The plunger 5 may be connected at the time of use.

[0017]

As is apparent from the above description, the two-component 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 prefilled syringe according to an embodiment of the present invention (dry drug and solution are omitted).

FIG. 2 is a view showing a state in which a first container and a second container are communicated with each other in FIG.

FIG. 3 is a diagram showing a state immediately before injection in FIG.

FIG. 4 is a vertical cross-sectional view showing another embodiment of the present invention (the dry drug and the solution are omitted).

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

FIG. 6 is a vertical sectional view showing another embodiment of the holder. [Brief description of drawings]

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 chemical | medical agent container 11 chemical | medical solution pouring outlet 12 rubber cap 13 bypass groove 14 1st gasket 17 rubber stopper 2 melt | dissolution liquid container 21 2nd gasket 22 3rd gasket 3 holder 4 pressing tool 5 plunger 6 O-ring

Claims (8)

[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. A second container having openings at the front end and the rear end sealed by a second gasket and a third gasket capable of sliding on the inner walls of the container and the first container, respectively;
A cylindrical holder for accommodating the first container and the second container and supporting and fixing them coaxially is provided, and a rear end of the first container and a tip end of the second container are fluidized in the holder. The second gasket and the third gasket are closely connected and when the bypass groove enters the zone of the first bypass groove in the state where the first gasket and the second gasket are in close contact with each other. A two-component prefilled syringe, characterized in that the chamber between is formed in a length such that it is in communication with the chamber of the dry formulation via the bypass groove. 2. The two-component prefilled syringe of claim 1, wherein the plunger is pre-fixed to the third gasket. 3. A two-component prefilled syringe according to claim 1, wherein the third gasket is provided with coupling means for attaching the plunger. 4. The two-component 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 prefilled syringe according to claim 1, wherein the drug solution spout is formed in a mouth shape of a vial and is sealed with a rubber stopper. 6. The holder has a tip formed to be smaller than the inner diameter of the body of the drug container and larger than the outer diameter of the drug solution outlet, and a pressing tool for pressing the second container toward the tip side is provided at the rear end of the holder. A two-component prefilled syringe according to any one of claims 1 to 5. 7. The two-component prefilled syringe according to claim 1, wherein a flange is provided at the rear end of the holder. 8. The two-component prefilled syringe according to claim 6, wherein the pressing tool is provided with a flange.