JPH0731680A - Two component mixing type prefilled syringe - Google Patents

Abstract

PURPOSE:To make the amt. of chem. liq. comparatively large and to perform dissolving operation by one operation by inserting a gasket sliding regulating cylinder and a cylindrical vial with a bottom into a barrel in a prefilled syringe wherein a chemical and a soln. are airtightly stored and they are mixed when they are used. CONSTITUTION:The syringe has a barrel 1 with a flange 2 on the outer periphery of its rear end and the first gasket 3 is inserted therein. In addition, a gasket sliding regulating cylinder 5 the rear end of which is fitted to the flange 2 and a vial 7 the apex of which is opened and which has a cylindrical shape with a bottom are inserted into the barrel 1 and the second gasket 8 is inserted into the vial 7. This vial 7 is held in the sliding regulating cylinder 5 by means of a holder 9. In addition, a needle 6 with both heads is held in the gasket sliding regulating cylinder 5 and a communicating needle 15 with a piercing needle 16 and a Luer chip 17 is held by means of a cap 19 and a space between the gasket 3 and an apex sealing material 12 is dividedly formed as a chemical room 4 wherein a powder chemical is placed.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a two-component mixed type prefilled syringe. More specifically, the present invention relates to a prefilled syringe in which a drug and a solution thereof are stored in an airtight and aseptic state before administration and are mixed for use.

[0002]

2. Description of the Related Art One example of a conventional prefilled syringe is disclosed in Japanese Patent Laid-Open No. 31189/1993. In this prefilled syringe, an injection needle 141 is fixed to the tip, a plunger 145 is slidably inserted from a rear end opening, and an injection cylinder 149 filled with a powdered drug P inside and a rear end. The distal end of the injection cylinder 149 is slidably inserted through the opening, and the outer cylinder 120 having the seal member 111 pierceable through the distal opening is attached, and the seal member 111.
The second component chamber 110, which is airtightly attached to the distal end portion of the outer cylinder 120 with the dissolution liquid L contained therein, and the rear end opening of the outer cylinder 120, is detachably attached to the second component chamber 110. Outer cylinder
In cooperation with 120, a cover 150 that hermetically covers the syringe barrel 149 and the plunger 145 is provided.

When the above prefilled syringe is used, the cover 150 is pushed with a strong force to break the base of the cover 150 at the notch 153, the plunger 145 is pushed together with the cover 150, and the sealing member 111 is pushed by the injection needle 141. Puncture. In this way, the solution in the second component chamber 110 is made aspirable, and the plunger 147 of the syringe 140 is once pulled back in the opposite direction to remove the solution from the syringe barrel 14.
Introduce into 9 and dissolve powder drug. Then remove the barrel 120 and cover 150 from the syringe body to
Set it to 0 and use it as a syringe.

[0004]

In the conventional prefilled syringe described above, it is possible to separately and aseptically store the powder drug and the solution until administration, and mix the powder formulation and the solution for injection before use. However, it has the following drawbacks. Since the outer cylinder 120 and the cover 150 are large in the diameter direction and bulky as compared with the size of the syringe main body, the amount of the liquid medicine cannot be increased despite the large occupied volume. It is also disadvantageous in terms of storage space. During the lysing operation, the plunger 145 of the syringe must be pushed in and then pulled back. In other words, since the operation method is bidirectional, the operation is troublesome. Since the injection needle 141 is fixed in advance, any kind of injection needle cannot be used.

In view of the above-mentioned circumstances, the present invention is a two-component mixture which has a slim shape, can take a large amount of liquid medicine, can be easily dissolved in one direction, and can use any kind of injection needle. An object is to provide a mold prefilled syringe.

[0006]

DISCLOSURE OF THE INVENTION A two-component mixed type prefilled syringe of the present invention includes a barrel having a front end closed with a sealing material and a rear end opened, and a flange attached to the outer periphery of the rear end, and the barrel. First gasket having a thin puncture portion slidably inserted therein and a cylindrical gasket slidably inserted into the barrel and having a rear end releasably engaged with the flange. A sliding control tube, a bottomed cylindrical vial with an open end, a second gasket slidably inserted into the vial to form a thin puncture portion, and the vial's tip facing the barrel side. A holder that can be inserted into the gasket slide restriction cylinder and is temporarily held in the gasket slide restriction cylinder.
One needle facing the first gasket and the other needle facing the second
A double-ended needle directed to the gasket, a communicating needle having a piercing needle formed at one end and a luer tip formed at the other end, and the communicating needle with the piercing needle of the communicating needle facing the sealing material at the tip of the barrel. A first drug chamber containing a powdered drug between the first gasket of the barrel and the sealing material at the tip, and a second drug containing a solution in the vial. It is characterized by being a room.

Further, in the present invention, the flange and the gasket regulating cylinder are engaged with each other so as not to move in the axial direction when no external force is applied, and disengaged when an artificial operation force is applied. Second engagement means provided with one engagement means, and engaged with each other between the flange and the holder so as not to move axially in the state where no external force is applied, and disengaged when an artificial operation force is applied. It is preferable that the engaging force of the second engaging means is set to be weaker than the engaging force of the first engaging means.

[0008]

In the present invention, when the holder is pushed, the vial is pushed into the barrel and the first gasket and the second gasket are punctured by the double-ended needle, whereby the dissolved solution in the second chamber passes through the double-ended needle to make the first Enter the drug chamber and dilute and dissolve the powdered drug. Next, the cap is pushed into the barrel, the sealing material at the tip of the barrel is punctured with the communicating needle, and then the cap is pulled out, and an arbitrary injection needle is attached to the luer tip. Then, when the holder is further pushed in the same direction as the above, the dissolved drug solution in the first drug chamber is discharged from the injection needle, so that it can be injected into the end portion. Then, the first engaging means and the second
When the engaging means is provided, first, the second engaging means is disengaged, the second gasket is punctured by the double-ended needle, and then the first engaging means is disengaged to perform the injection operation. The order of operations that can be performed is guaranteed.

In the case of the present invention, the outer diameter dimension is determined by the vial and the flange at the rear end thereof, and the vial has a small diameter, and the diameter of the flange need only be slightly thicker than the vial, resulting in an overall slim structure and occupying the entire prefilled syringe. The amount of liquid medicine can be increased relative to the volume. Further, since the dissolution and the subsequent injection operation can be performed by pushing the holder in the same direction, the operation is simple and easy. further,
Since any type of injection needle can be attached to the luer tip of the communication needle, the injection operation becomes easier.

[0010]

Embodiments of the present invention will now be described with reference to the drawings. First, a schematic configuration will be described with reference to FIG. Reference numeral 1 is a barrel, which is a glass cylindrical member, whose tip is formed into a neck 11 having a reduced diameter, whose tip opening is closed by a rubber stopper 12, and which is wound by an aluminum caulking member 13. It has been tightened. The rubber stopper 12 corresponds to the sealing material in the claims. The rear end of the barrel 1 is opened, and a flange 2 made of synthetic resin is firmly attached to the outer periphery of the rear end. A first gasket 3 is slidably inserted inside the barrel 1, and the gasket 3 and the sealing material 12 are
Between them and is a first medicine chamber 4 for containing the powdered medicine P.
A cylindrical gasket slide restriction cylinder 5 is inserted inside the barrel 1, and a rear end of the slide restriction cylinder 5 is engaged with the flange 2.

Reference numeral 7 denotes a bottomed cylindrical vial having an open end, which is generally made of glass. This vial 7
A second gasket 8 is slidably inserted into the interior of the container, and the internal space closed by the second gasket 8 is a second chemical chamber 10 filled with the solution L. The vial 7 is inserted and supported inside a holder 9,
The holder 9 can be inserted into the sliding regulation tube 5.

A communicating needle 15 with a cap is attached to the tip of the barrel 1. The communicating needle 15 has a piercing needle 16 formed at one end and a luer tip formed at the other end.
It is composed of 17 and an engaging claw 18. Cap 19 is a communicating needle
Protecting 15 and piercing needle 16 unless artificial force is applied
Holds the tip of the barrel 1 so as not to puncture the sealing material 12, and is also a member that also serves as a push-down tool for the communication needle 15 when puncturing. The communicating needle 15 and the cap 19 are substantially the same as those described in Japanese Patent Application No. 5-78972 filed by the present applicant.

Further details of the above arrangement are shown in FIG.
It will be explained based on. The first gasket 3 is made of rubber,
A cavity 31 is formed in the inside thereof, and a thin puncture portion 32 is formed in the upper portion of the cavity 31. The slide restricting cylinder 5 is a cylindrical member whose one end is closed, and a holding wall 51 for temporarily holding a double-ended needle 6, which will be described later, is formed on a closing wall 50 on the front end side. An annular protrusion 52 is formed on the outer periphery of the holding portion 51, and the annular protrusion 52 is fitted into the cavity 31 of the first gasket 3 properly and is connected to the first gasket 3.

The double-ended needle 6 has a large-diameter portion 61 in the center, and one needle 62 and the other needle 63 extending in opposite directions from both ends thereof.
Is equipped with. Both ends of the large-diameter portion 61 are shoulders 64 and 65, and a small protrusion 66 for engagement is formed in the middle of one needle 62. The holding portion 51 of the sliding regulation tube 5 has a through hole at the center.
53 is formed, and one needle 62 of the double-ended needle 6 is inserted and held. Therefore, the double-ended needle 6 is positioned and held inside the sliding regulation tube 5. Then, the one needle 62 does not move in the state where the external force is not applied in the holding portion 51, and allows the movement in the axial direction when an artificial operation force is applied, so that the small protrusion 66 is provided on the inner wall of the holding portion 51. Engagement recesses 54 are formed to engage with.

An annular projection is formed on the outer periphery of the rear end of the slide regulating cylinder 5.
55 is formed and fitted in the annular recess 21 formed on the inner peripheral surface of the flange 2. As a result, the first engaging means 22 is formed. An annular convex portion 23 is formed on the inner peripheral surface of the flange 2, and an annular concave portion 91 formed on the outer peripheral surface of the holder 9 is fitted into the annular convex portion 23. As a result, the second engaging means 24 is formed. The engagement force of the second engagement means 24 is set to be weaker than that of the first engagement means 22, and when the holder 9 is pushed in, the engagement of the second engagement means 24 is first disengaged. . The second gasket 8 is a rubber stopper having a thin puncture portion 81 formed in the center.

Next, a method of using the prefilled syringe having the above structure will be described with reference to FIGS. First, as shown in FIG. 3, the holder 9 is pushed in the direction of arrow a. This operation can be performed by hanging the forefinger and the middle finger on the flange 2 and pushing the thumb against the rear end of the holder 9 as in the known syringe. When the holder 9 is pushed in, the engagement between the annular convex portion 23 and the annular concave portion 91 of the second engaging means 24 having a weak engaging force is released,
The holder 9 and the vial 7 are inserted into the slide regulation tube 5. In the process of inserting the vial 7, the second gasket 8 is punctured by the needle 63 of the double-ended needle 6, and then the second gasket 8 is inserted.
When it hits the shoulder portion 65 of the large diameter portion 61, since the second drug chamber 10 is filled with the incompressible liquid, the pushing force is transmitted to the double-ended needle 6 and, as a result, The engagement between the protrusion 66 and the engagement recess 54 of the slide regulating member 5 is released. Then, when the double-ended needle 6 is further pushed in, the first gasket 3 is punctured by the needle 62 of the double-ended needle 6. 3 shows the double-ended needle 6 with the first gasket 3
And the second gasket 8 is punctured.

Then, as shown in FIG. 4, when the holder 9 is further pushed in the direction of the arrow a, the solution in the vial 7 is pushed out toward the first drug chamber 4 as shown by the arrow b. Here, when the entire syringe is shaken several times, the powder drug P in the first drug chamber 4 is diluted and dissolved with the solution L to form the drug solution PL. Next, as shown in FIG. 5, the cap 19 is once pushed down in the direction of the arrow c, and the sealing material 12 is applied by the needle portion 16 of the communicating needle 15.
Puncture. In this state, the engaging claw 18 fits into the neck portion 11 of the barrel 1 and cannot come off. Then, the cap 19 is pulled out in the direction opposite to the direction of the arrow c.

Then, as shown in FIG. 6, the communication needle 15
Attach the hub 21 of any injection needle 20 to the tip 17 of the. This completes the preparation for injection. After this, the holder 9 may be pushed further in the direction of arrow a, as in a normal syringe. Then, the annular projection 55 of the first engaging means 22 and the annular recess 21 are disengaged, and the first gasket 3 is pushed deeper, so that the drug solution PL in the first drug chamber 4 is pushed out from the injection needle 20. . As a result, the drug solution PL can be injected into the nursing department.

Next, the advantages of the above embodiment will be listed. Although the diameter of the flange 2 is larger than that of the barrel 1, the diameter of the flange 2 is not so large as that of the barrel 1, so that the first drug chamber 4 and the second drug chamber 10 account for the entire volume occupied by the prefilled syringe. The volume of the liquid can be made large and the amount of the chemical liquid can be made as large as possible. In addition, the slim form is convenient for storage. The melting operation can be performed only by one-direction operation of pushing the holder 9 in the direction of the arrow a, and the pull-back operation in the opposite direction is not required, so the operation is simple. Since the communication needle 15 provided with the tip 17 is used, any kind of injection needle can be used.

[0020]

According to the present invention, there is provided a two-component mixed type prefilled syringe which is slim and can take a large amount of liquid medicine, can be easily dissolved in one direction, and can be used with any kind of injection needle. can do.

[Brief description of drawings]

FIG. 1 is a vertical cross-sectional view of a two-component mixed type prefilled syringe according to an embodiment of the present invention.

FIG. 2 is an enlarged sectional view of a main part of the prefilled syringe shown in FIG.

FIG. 3 is an explanatory view of a dissolving operation of the prefilled syringe shown in FIG.

FIG. 4 is an explanatory view of a dissolving operation of the prefilled syringe shown in FIG.

5 is an explanatory view of a dissolving operation of the prefilled syringe shown in FIG.

6 is an explanatory diagram of an injection operation of the prefilled syringe shown in FIG.

FIG. 7 is a vertical cross-sectional view of a conventional two-component mixed prefilled syringe.

[Explanation of symbols]

1 barrel 2 flange 3
1st gasket 4 1st chemical chamber 5 Sliding control cylinder 6
Double-ended needle 7 Vial 8 Second gasket 9
Holder 10 Second drug chamber 22 First engaging means 24
Second engaging means

Claims (2)

[Claims] 1. A barrel having a front end closed with a sealing material and a rear end opened, and a flange attached to the outer periphery of the rear end, and a puncture thin portion formed slidably inserted into the barrel. A first gasket, a cylindrical gasket slide restriction cylinder slidably inserted into the barrel and having a rear end releasably engaged with the flange, and a bottomed cylindrical shape with an open end. A vial, a second gasket slidably inserted into the vial and having a thin puncture portion formed therein, and a holder that holds the tip of the vial toward the barrel side and can be inserted into the gasket slide restriction cylinder. And a double-ended needle that is temporarily held in the gasket slide restriction cylinder, one needle is directed to the first gasket, and the other needle is directed to the second gasket, and a piercing needle is formed at one end and the other end is formed. The lure tip is shaped And a cap for holding the communicating needle so that the communicating needle can be pierced toward the sealing material at the tip of the barrel, and the first gasket of the barrel and the sealing material at the tip. A two-component mixed prefilled syringe, characterized in that a space between the two is a first drug chamber containing a powdered drug, and the inside of the vial is a second drug chamber containing a solution. 2. A first engagement means between the flange and the gasket regulating cylinder, which engage with each other so as not to move in the axial direction when no external force is applied, and which is disengaged when an artificial operation force is applied. Provided, between the flange and the holder, engaged with each other so as not to move in the axial direction when no external force is applied,
Second engagement means is provided which is disengaged when an artificial operation force is applied, and the engagement force of the second engagement means is set to be weaker than the engagement force of the first engagement means. The two-component mixed prefilled syringe according to claim 1.