JP3141372B2 - Two-component prefilled syringe - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to a two-component prefilled syringe. More specifically, the present invention relates to a drug prefilled syringe in which a drug and a solution thereof are hermetically and aseptically stored before administration, and are mixed at the time of use.

[0002]

2. Description of the Related Art Examples of conventional two-component prefilled syringes include those described in Japanese Patent Application Laid-Open No. Hei 5-31189 and Japanese Patent Publication No. Hei 5-27426. JP 5
Japanese Patent No. 31189 discloses a syringe containing a powdered drug and a container containing a dissolving solution, which are accommodated in a cylindrical member and arranged in series, and the dissolving solution is used by a syringe needle containing the powdered drug at the time of use. A two-component prefilled syringe that pierces the rubber stopper of the container containing
In the device described in Japanese Patent Publication No. Hei 5-27426, the inside of a syringe having a bypass is divided into two chambers by a rubber stopper slidable on the inner wall of the syringe. It is a two-component prefilled syringe filled with a drug.

[0003] However, Japanese Patent Application Laid-Open No. 5-31189 describes
The one described in the publication has many drawbacks, such as requiring many assembly steps because of the large number of parts, and being unable to arbitrarily select an injection needle because the injection needle is incorporated therein. Further, in the device described in Japanese Patent Publication No. 5-27426, since the powdered drug and the dissolving solution must be separately pre-filled in the same syringe, not only the assembling process is not easy, but also the dissolving solution after filling is used. It had the disadvantage 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 and can improve the efficiency of the assembling operation. In addition, the present invention uses an arbitrarily selected injection needle. It is another 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 powdered drug and a solution.

[0005] In order to solve the above-mentioned problems, the present invention provides a cylindrical container in which a dry medicine is accommodated, in which a chemical solution outlet at the front end is sealed by a sealing member and an opening at a rear end is provided. A first container in which the inner wall of the container is sealed with a slidable first gasket and a bypass groove is formed in the longitudinal direction of the inner wall of the container in proximity to the first gasket; A cylindrical container containing a liquid, wherein the openings at the front and rear ends are sealed with a second gasket and a third gasket that can slide on the inner walls of the container and the first container, respectively. A second container and the tip is the medicine
Smaller than the inner diameter of the body of the drug container and outside the drug solution outlet
Diameter, and the second end
And a cylindrical holder for accommodating and supporting and fixing the first container and the second container coaxially, the pressing member being provided with a pressing tool for pressing the container toward the front end side . A rear end and a front end of the second container are fluid-tightly connected in the holder, and the bypass groove is formed in a zone of the bypass groove in a state where the first gasket and the second gasket are in close contact with each other. A two-component gasket, wherein a chamber between the second gasket and the third gasket is formed to have a length communicating with the chamber of the dried preparation via the bypass groove when the gasket enters the chamber. Uses a pre-filled syringe.

The plunger may be fixed to the third gasket in advance, or may be provided with a coupling means for attaching the plunger to the third gasket so that the plunger can be attached at the time of use. Alternatively, 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 shape of a vial opening and sealed with a rubber stopper. Even better
In addition, a flange for putting a finger at the time of injection may be provided at the rear end of the holder, or may be provided at the pressing tool.

[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 4; In the case where the sealing member is a removable rubber cap, it is necessary to put the rubber cap down 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 toward the first container with the solution interposed therebetween. At this time, since the first gasket and the second gasket are in close contact, 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 first gasket and the second gasket break the sealed state of the first container. The container communicates via a bypass groove. Then, the first gasket and the second gasket stop in the bypass zone,
The third gasket moves in the direction of the second gasket as the solution between the gasket and the third gasket can move through the bypass groove to the chamber containing the dried drug (see FIG. 2). Then, when the third gasket moves to a position where it comes into close contact with the second gasket, and all of the dissolved liquid moves to the chamber containing the dried chemical, the first, second, and third gaskets move integrally in the direction of the chemical liquid outlet. As such, the lumen of the first container is resealed by at least the first gasket (see FIG. 3). If the syringe is shaken in this state, the dry medicine and the solution in the first container can be mixed well.

In use, in the case of a two-component prefilled syringe as shown in FIG. 1, the rubber cap of the drug solution outlet is removed and an injection needle is attached to the drug solution outlet (see FIG. 2). In the case of a two-component prefilled syringe as shown in FIG. 4, an injection needle (hereinafter, referred to as a double-ended needle) having cutting edges at both ends may be attached to the drug solution outlet (see FIG. 5, at this time, a rubber stopper is used for injection). Penetrated by one of the needles).

[0010]

Next, embodiments of the present invention will be described with reference to the drawings. FIG. 1 is a longitudinal sectional view of a two-component prefilled syringe according to one embodiment of the present invention (a dry medicine and a 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. FIG. 4 is a longitudinal 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 a drug solution outlet of the two-component prefilled syringe of FIG. 4, and FIG. 6 is a holder. FIG. 11 is a view showing another embodiment of the present invention.

As shown in FIGS. 1 to 5, the syringe of the present invention has a cylindrical medicine container 1 containing a dry medicine D therein.
And a cylindrical solution container 2 in which a solution S is accommodated in a cylindrical holder 3 and connected coaxially and fluid-tightly. The medicine container 1 has a medicine solution outlet 11 sealed at a front end with a sealing member, and an opening at a rear end is sealed with a first gasket 14. Are formed. on the other hand,
The opening at the front end and the rear end of the solution container 2 is sealed with a second gasket 21 and a third gasket 22, respectively. The length of the bypass groove 13 is such that 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 containing the solution S and the dry preparation D The housed chamber 18 is the bypass groove 13
Are formed so as to be in communication with each other.

The first container is a medicine container 1, which is usually formed of glass in a cylindrical shape. The tip of the drug container 1 is a drug solution outlet 11 which is usually reduced in diameter and is shaped like a syringe tip as shown in FIG.
The vial is formed 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 medicine container 1 contains a dry medicine such as a lyophilized preparation or a powder preparation, and a chemical liquid outlet 11 is a sealing member (a rubber cap 12 in the case of a chip-shaped chemical liquid outlet 11 as shown in FIG. 1). A rubber stopper 17 is employed in the case of a vial mouth-shaped chemical liquid outlet 11 as shown in FIG. 4), which is closed in a fluid-tight manner, and the opening at the rear end is sealed with a first gasket 14. . In the case of the chemical liquid outlet 11 as shown in FIG. 1, a normal injection needle 71 as shown in FIG. 3 is connected to the chemical liquid outlet 11 and the chemical liquid 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 by a first
A groove provided in the vicinity of the gasket 14, in which 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 of the bypass groove 13, that is, a bypass zone. 15 so that when the whole body enters the bypass zone 15, the chamber 23 containing the lysing solution and the chamber 18 containing the dry medicine are in communication with each other via the bypass groove 13. It is decided. That is, in FIG. 1, when the plunger 5 is pushed with the chemical solution outlet 11 kept closed, when the second gasket 21 and the third gasket 22 of the solution container 2 sandwich the solution between them, Move in the direction of. At this time,
The first gasket 14 of the medicine container 1 is also the second gasket 14 of the solution container 2.
The bypass zone 15 moves integrally with the gasket 21.
Reach

When the first gasket 14 and the second gasket 21 that have come into close contact with each other move integrally and enter the bypass zone 15, the first gasket 14 and the second gasket 21
The gasket 21 breaks the sealed state of the medicine container 1, and the medicine container 1 and the solution container 2 communicate with each other through the bypass groove 13. Then, the first gasket 14 and the second gasket 21 stop in the bypass zone 15 as shown in FIG.
The chamber 23 between the second gasket 21 and the third gasket 22
Is moved to the chamber 18 containing the dry medicine D through the bypass groove 13, and the third gasket 22 moves in the direction of the second gasket 21. Then, the third gasket 22 moves to a position where it comes into close contact with the second gasket 21,
When all of the solution S moves to the chamber 18 containing the dry medicine D, the first, second, and third gaskets 14, 21, and 22 move integrally in the direction of the chemical solution outlet 11, as shown in FIG. As described above, the lumen of the medicine container 1 has at least the first gasket 14.
Resealed by. If the syringe is shaken in this state, the dry medicine D and the solution S in the chamber 18 can be mixed well.

The second container is a dissolving solution container 2, which is usually made of glass or transparent synthetic resin. The openings at both ends of the solution container 2 are sealed with a second gasket 21 and a third gasket 22, respectively.
The solution S is accommodated in the chamber 23 between them. A flange 2 for sealing is provided on the tip side of the solution container 2 near the tip.
The O-ring 6 is attached to the front end side of the flange 24. When the medicine container 1 and the solution container 2 are supported and fixed in the holder 3 to be described later, the O-ring 6 forms the flange 16 at the rear end of the medicine container 1 and the flange 24 at the front end of the solution container 2. The space between them is sealed.

The holder 3 accommodates the medicine container 1 and the solution container 2, and supports and fixes the rear end of the medicine container 1 and the front end of the solution container 2 coaxially and fluid-tightly. , Formed into a tubular shape by a flexible resin. The holder 3 has a tip narrowed so 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 from the tip,
That is, in the holder 3 of FIG. 1 which has the constricted portion 31 and is combined with the pressing tool 4 described later, the male screw 32 is provided at the rear end as a connecting means for fixing the pressing tool 4. . When the rear end of the solution container 2 is pressed by the pressing tool 4, the medicine 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 the flange 16 and the pressing tool 4, and the containers 1 and 2 are fluid-tightly sealed by the O-ring 6.

The pressing member 4 is a cap-shaped member having a through hole 46 for passing the plunger 5 through the top surface 45. The pressing member 4 has a flange 41 at the rear end for hooking a finger. Concentrically, on the inside, a pressing portion 44 for pressing the rear end of the solution container 2, and on the outside, a skirt 42 provided with coupling means (female screw) 43 for engaging the holder 3 on its inner wall.
Are formed. Note that the pressing tool 4 is not always necessary. For example, as shown in FIG. 6, a slit 36 for absorbing a dimensional error in the longitudinal direction of the constricted portion 31 is provided.
A slit 38 for inserting the medicine container 1 and the solution container 2 is provided in the longitudinal direction of the rear end, and a holder 35 provided with an undercut 37 on its inner wall is employed. You may make it engage with the undercut 37 of the holder 3. Here, when the holder 35 is adopted, the undercut 3
Needless to say, it is necessary to provide a flange (not shown) which engages with the flange 7.

The material for forming the first, second, and third gaskets may be the same as the gasket of an ordinary syringe.
For example, butyl rubber, isoprene rubber, olefin elastomer, and the like are suitably used. 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 completely contact each other. The plunger 5 may be attached to the third gasket 22 of the solution container 2 in advance, but a coupling means such as a fitting recess 25 as shown in FIG.
The plunger 5 may be connected when used.

[0017]

As is apparent from the above description, the two-component prefilled syringe of the present invention has the following effects. Since the medicine container and the solution container are manufactured separately and connected integrally 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, the assembling is easy and the efficiency of the assembling operation can be improved. The dissolving solution and the dry chemical can be mixed by a simple operation of simply pushing the third gasket with the plunger.

[Brief description of the drawings]

FIG. 1 is a longitudinal sectional view of a two-component pre-filled syringe according to one embodiment of the present invention (a dry medicine and a solution are omitted).

FIG. 2 is a diagram showing a state in which a first container and a second container are communicated with each other in FIG. 1;

FIG. 3 is a diagram showing a state immediately before injection in FIG. 1;

FIG. 4 is a longitudinal sectional view showing another embodiment of the present invention (a dry medicine and a solution are omitted).

5 is a view showing a state in which a double-ended needle is attached to a drug solution outlet of the two-component prefilled syringe of FIG. 4;

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

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Drug container 11 Chemical liquid outlet 12 Rubber cap 13 Bypass groove 14 First gasket 17 Rubber stopper 2 Dissolution liquid container 21 Second gasket 22 Third gasket 3 Holder 4 Pressing tool 5 Plunger 6 O-ring

──────────────────────────────────────────────────続 き Continued on the front page (58) Field surveyed (Int.Cl. ⁷ , DB name) A61M 5/28 A61M 5/31

Claims (7)

(57) [Claims] 1. A cylindrical container in which a dry medicine is accommodated, wherein a chemical solution outlet at a front end is sealed with a sealing member, and an opening at a rear end is slidable on an inner wall of the container. A first container in which a bypass groove is formed in a longitudinal direction of an inner wall of the container in close proximity to the first gasket and a cylindrical container in which a solution is accommodated; A second container having an opening at a front end and a rear end sealed with a second gasket and a third gasket slidable on inner walls of the container and the first container, respectively;
The tip is smaller than the inside diameter of the body of the drug container and
It is formed to be larger than the outer diameter of the
At the rear end, a pressing tool for pressing the second container toward the front end is provided.
Vignetting comprising, housing the first container and the second container comprises a cylindrical holder which supports fixed coaxially, the tip of the rear end and the second vessel of the first container When the bypass groove enters the zone of the bypass groove in a state where the first gasket and the second gasket are in close contact with each other while being fluid-tightly connected in the holder.
2-component pre-filled syringe, characterized in that the chamber between said second gasket and the third gasket is formed to a length to be the chamber communication with the dry formulation through the bypass channel. 2. The two-component prefilled syringe according to claim 1, wherein the plunger is pre-fixed to the third gasket. 3. The two-component prefilled syringe according to claim 1, further comprising coupling means for attaching the plunger to the third gasket. 4. The two-component prefilled syringe according to claim 1, wherein the drug solution outlet is formed in a tip shape into which a syringe 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 outlet is formed in the shape of the mouth of the vial and sealed with a rubber stopper. 6. A flange is provided at a rear end of the holder.
A two-component pre-filled syringe according to claim 5 . 7. A claim comprising a flange provided on the pusher 5
2. The two-component prefilled syringe according to item 1.