JP2642582B2 - Prefilled syringe - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION The present invention relates to a syringe-type container comprising a plurality of components, that is, a solid or liquid drug such as powder, microcapsules, granules and tablets, and a solution or dispersion thereof or another drug solution. Relates to so-called prefilled syringes, each of which is pre-filled in a separate chamber of the container.

[0002]

2. Description of the Related Art Among disposable syringes pre-filled with a drug, so-called prefilled syringes,
Conventionally, in a two-component prefilled syringe filled with a predetermined drug and a solution or dispersion thereof or another drug solution separated, as conventionally illustrated in FIG.
While inserting the plunger 32 with the rod from the rear end side in the cylindrical container 31 having the mounting portion of the injection needle at the tip,
A movable seal member 3 slidable in the axial direction in a container 31
3 to provide a first chamber 34 and a second chamber 34 on the front end side and the rear end side.
Each of the chambers is divided into chambers 35, and each of the chambers has a structure in which a drug or a solution is accommodated.
No. 9-14465).

In this type, the movable seal member 3
In the first chamber 34 on the distal end side from the top of FIG. 3, a discontinuous portion, usually an injection groove 36 projecting outward, is provided on the side wall of the container 31, and the plunger 32 is pushed in at the time of use, as shown in FIG. The movable seal member 33 is moved forward through the liquid in the second chamber 35 as described above, and when the movable seal member 33
The liquid in the second chamber 35 is caused to flow into the first chamber 34 via the plunger 32.
3 is pushed to push out the liquid after being dissolved, dispersed or mixed in the first chamber 34 from the tip.

The movable seal member 33 has a diameter slightly larger than the inner diameter of the container 31, and usually has a structure having a plurality of circular ribs 33a to reduce resistance during sliding. Consideration is given to maintain the liquid tightness between the second chamber 35 and the slidability in the container. The same applies to the sealing member of the plunger 32.

[0005]

By the way, in the conventional two-component prefilled syringe described above, the first
The chamber 34 is directly filled with the powder P, or the solution is filled and freeze-dried to obtain the powder P.
The chamber 35 is filled with a solution or dispersion L or the like to produce a product. When performing steam heating sterilization on the solution or dispersion L in the second chamber 35, as shown in FIG.
4 is filled with the powder agent P and the sealing member 3
It is not possible to sterilize the solution or dispersion L in the second chamber 35 by steam heating in the state in which the powder 7 is mounted in consideration of the thermal stability of the powder P. Also, as shown in FIG.
A method of filling the powder P in the first chamber 34 after steam-sterilizing the solution or dispersion L filled in the second chamber 35 is also conceivable. 3
The moisture adheres or permeates into the seal member 33 (generally made of rubber) that separates the seal member 5 from the resin member 5, resulting in insufficient drying.

Here, the powder injection is usually unstable when water is present.
The portion facing the chamber 34 side needs to be sufficiently dried, and generally heating is performed at 100 ° C. or more for several hours, but the thermal stability of the solution or dispersion L in the second chamber 35 In consideration of this, it is not possible to employ heating at 100 ° C. or more for several hours for drying the movable seal member 33 after steam-heat sterilization.

The present invention has been made in view of such circumstances, and after performing the above-mentioned heat sterilization of the solution or dispersion in the second chamber 35, the sealing member 33 is not subjected to any special treatment. The purpose is to provide a prefilled syringe that can ensure the stability of the powder or the like even when the powder or the like is filled in the first chamber 34 as it is. An object of the present invention is to provide a prefilled syringe that can easily disperse or mix an injection solution, or that can easily perform an operation for removing air from the injection solution, and that can inject the injection solution into a living body without loss.

[0008]

A structure for achieving the above object will be described with reference to FIG. 1 corresponding to an embodiment. In the present invention, the inside of a cylindrical container 1 is defined as a first chamber 4. The movable seal member 3 partitioning the second chamber 5 is divided into a front side 3a and a rear side 3a.
b, and the front end of the cylindrical container 1 is characterized by being opened so that the front movable seal member 3a can be inserted. Here, there may be a small gap between each of the movable seal members 3a and 3b on the front side and the rear side. In order to form this gap, an appropriate protrusion may be formed on at least one of the opposing surfaces of the front and rear movable seal members 3a and 3b.

Further, as shown in FIGS. 12 and 13, a plurality of circular ribs 300 are formed on the outer periphery of the movable seal members 3a and 3b on the front side and the rear side. Preferably, each of the ribs has a height substantially equal to that of each of the circular ribs 300, and has a structure in which a plurality of vertical ribs 301 are formed to partition an annular recess formed between the circular ribs 300. Here, substantially the same height includes the case where the vertical rib 301 is lower than the circular rib 300 by a predetermined dimension and the case where the vertical rib is higher than the circular rib 300, and also includes the case where both are exactly the same height. The structure combining the circular rib 300 and the vertical rib 301 can be similarly applied to the seal member 2a of the plunger 2. These ribs may have a sliding surface that is curved in the axial direction in order to improve sliding with respect to the cylindrical container 1. Further, it is desirable to make the depth of the recess between the circular ribs 300 as shallow as possible without impairing the slidability.

Further, between the cylindrical container 1 and the plunger 2, the front end of the movable seal member 3 a on the front side reaches forward from the front end of the discontinuous portion 6 by pressing the plunger 2, and the rear side. The rear end surface of the movable seal member 3b abuts against the front end surface of the plunger 2, and at least the rear half of the seal member of the plunger 2 does not enter the discontinuous portion 6 and keeps sliding against the inner wall of the cylindrical container 1. The container 1 and the plunger 2 are moved so that the plunger 2 temporarily stops at the
It is preferable to provide a locking mechanism and a release mechanism for the rod for pressing the rod. The plunger 2 is closed at a position where only the front end or only the rear end of the discontinuous portion 6 is closed.
Of course can be stopped.

The rod for pressing the plunger 2 may be fixed to the plunger 2 in advance, or may be configured to be detachable. Furthermore, the front end of the movable seal member 3a on the first chamber 4 side is formed in a convex curved shape toward the first chamber 4 side. The sealing member 7 whose end surface on the first chamber 4 side is formed in a concave curved surface shape facing the first chamber 4 side along the convex curved surface shape (FIGS. 8 and 9)
And a recess 7 in one of the end faces of the movable seal member 3a on the front side and the seal member 7 attached to the tip of the container 1 facing the first chamber 4 side.
a or 30a (see FIGS. 5 to 9).

Here, in the prefilled syringe of the present invention, a plunger is inserted from the rear end of a cylindrical container to which an injection needle can be attached at the distal end, and is movable between the distal end of the cylindrical container and the distal end of the plunger. Although the sealing member is inserted, the distal end portion of the cylindrical container referred to in the present specification truly includes the distal end of the container and the inside at a distance from the distal end of the container. Simply referred to as the tip portion.

[0013]

In the structure of the present invention, as shown in FIG.
The rear movable seal member 3 b is inserted into the cylindrical container 1, and the second chamber 5 is filled with a solution or dispersion such as distilled water for injection or physiological saline or other medical liquid L, and is heated by steam. After sterilization, the inner surface of the syringe in the first chamber 4 is dried. Thereafter, after inserting the front movable seal member 3a from the front end opening 1a of the cylindrical container 1, the solid or liquid medicine P (hereinafter, referred to as powder, microcapsule, granule, tablet, etc.) is inserted into the first chamber 4. (Referred to simply as drug P)
Further, it is possible to adopt a process of fixing the sealing member 7 to the tip of the cylindrical container 1 and closing the tip opening 1a, and moisture adheres or permeates to the rear movable sealing member 3b by steam heating sterilization. However, by inserting the movable seal member 3a on the front side to be inserted thereafter in a sufficiently dry state in advance, it is possible to prevent the transfer of moisture to the first chamber 4 containing the medicine P.

By providing a slight gap between the movable seal member 3a on the front side and the movable seal member 3b on the rear side, moisture in the second chamber 5 can be removed from the first chamber 4 during storage.
This is preferable because the period required until it enters the side becomes longer.

The movable ribs 3a and 3b or, in addition, circular ribs 3
When a structure in which 00 and the vertical rib 301 are combined is adopted,
Compared to a structure in which only a plurality of circular ribs 300 are provided, each seal member is provided at the discontinuous portion 6 of the cylindrical container 1 during administration.
, The amount of liquid that enters the recess between the circular ribs 300 when passing through is reduced, and the amount of injection liquid loss can be reduced.

A locking mechanism between the plunger 2 and the cylindrical container 1 and a releasing mechanism thereof have a function of facilitating an operation for ensuring mixing or dispersion of the two components before administration. That is, when the injection liquid is actually administered, the liquid L in the second chamber 5 is first dispersed such that the medicine P in the first chamber 4 and the liquid L in the second chamber 5 are uniformly dispersed or mixed. It is necessary to shake the syringe well in a state where it is almost completely injected into the chamber 4. The liquid in the second chamber 5 is supplied to the movable seal member 3a on the front side.
With the front end surface stopped short of the front end of the discontinuous portion 6,
When the rear surface of the movable seal member 3a comes into contact with the front surface of the plunger 2, it is almost completely injected into the first chamber 4. Therefore, the front surface of the plunger 2 reaches the rear surface of the movable seal member 3b by the pressing of the plunger 2, at least the distal end of the front movable seal member 3a reaches the front of the distal end portion of the discontinuous portion 6, and If a locking mechanism that stops the plunger 2 is provided at a position where the rear half of the plunger 2 does not enter the discontinuous portion 6 and keeps the sliding state with the inner wall of the cylindrical container 1, excessive movement of the movable seal member 3a Can be prevented, and the above-described operations such as mixing before administration can be ensured without spilling of the lysis solution. Then, when the mixing or the like is completed, the lock is released by the release mechanism, whereby administration to the living body becomes possible.

The front movable seal member 3a and the seal member 7 attached to the front end opening 1a of the cylindrical container 1.
The end faces facing the first chamber 4 side are formed as a convex curved surface and a concave curved surface facing the first chamber 4 side, respectively, so as to remove bubbles in the liquid mixed in the first chamber 4 at the time of administration. The air bubbles are concentrated in the upper central portion in the first chamber 4 with the air outlet facing upward, so that the air bleeding operation is facilitated and the simplicity of use is improved. A double-ended needle is mounted on the seal member 7 by forming a recess 30a or 7a in one of the front movable seal member 3a and the end face of the seal member 7 at the end of the container 1 facing the first chamber 4. Even if the rear end protrudes into the first chamber 4, the protruding portion enters the recess 7 a or 30 a, so that the amount (loss) of the injection solution remaining in the cylindrical container 1 during administration can be reduced. .

[0018]

FIG. 1 is a sectional view showing a basic structure of an embodiment of the present invention. The cylindrical container 1 has a uniform cylindrical shape as a whole except for an injection groove 6 described later, and both ends thereof are fully opened.

A plunger 2 with a rod is inserted from the rear end side of the cylindrical container 1 and has a
A movable seal member 3 for partitioning the inside of the container 1 into a first chamber 4 and a second chamber 5 is inserted, and the movable seal member 3 includes two movable seal members 3a and 3b.
Has been split. The front movable seal member 3a and the rear movable seal member 3a may be in contact with each other, or may have a predetermined gap as shown. For the purpose of providing such a gap, an appropriate protrusion may be formed on at least one of the opposing surfaces of the front movable seal member 3a and the rear movable seal member 3b.

A seal member 7 is attached to the distal end opening 1a of the cylindrical container 1. At the end of the cylindrical container 1, for example, a cap with a needle is attached, or a double-ended needle is attached via a holding member, and the rear end is pierced into the seal member 7 at the time of administering an injection solution to be described later. The injection needle is mounted by known means of passing through.

The first chamber 4 is filled with the powdered medicine P, and the second chamber 5 is filled with a solution or dispersion thereof or another kind of liquid L. 1
An injection groove 6 having a predetermined width and projecting outward is formed on a side wall of the chamber 4. The length of the injection groove 6 in the axial direction of the container 1 is set to be equal to the distance between the front movable seal member 3 a and the rear movable seal member 3 a. It is longer by a predetermined amount than the total thickness of the seal member 3b.
Further, the total axial length of the movable seal members 3a and 3b and the seal member of the plunger 2 is longer than the axial length of the injection groove 6 by a predetermined amount. The adjustment of the length can be easily performed by adjusting the length of the sealing member of the plunger 2.

When the embodiment of the present invention having the above-described structure is used, the plunger 2 with the rod is pressed to the distal end side by the same way as in the prior art, so that the front movable seal member is interposed through the liquid L in the second chamber 5. When the first movable chamber 3a and the rear movable seal member 3b move forward and reach the position where the injection groove 6 is formed, and the first chamber 4 and the second chamber 5 communicate with each other, the liquid L in the second chamber 5 becomes the first fluid. After the inflow into the chamber 4 and the inflow is completed and the tip of the plunger 2 abuts against the rear end of the rear movable seal member 3b, the plunger 2 is directly pressed to press the front movable seal member 3a and 3b. Is moved forward, at least the first half of the front movable seal member 3a reaches the front of the tip of the injection groove 6, and at least the second half of the seal member of the plunger 2 does not enter the injection groove 6, and the cylindrical container 1 Holding the sliding state on the inner wall of The press was stopped at that position, the tubular container 1
After mixing the medicines by shaking, the dissolved, dispersed or mixed injection liquid is ejected through an injection needle attached to the tip of the container 1.

Next, FIG. 2 shows the procedure of assembling including the filling of the powdered drug, the dissolving solution, and the like in the embodiment of the present invention as described above. First, as shown in (A), in a state where the rear movable seal member 3b is inserted into the cylindrical container 1, the second chamber 5 is closed.
Is filled with a solution, a dispersion, or a drug solution L, and the plunger 2 is inserted. In this state, after the solution, dispersion or chemical liquid L is subjected to steam heating sterilization, the inner surface of the first chamber 4 is dried. In the steam heating sterilization process, when the solution, dispersion, or chemical solution L in the second chamber 5 contains an active substance, a temperature at which the active substance is not destroyed, for example, a temperature of 50 to 60 ° C. or less. To process.

Thereafter, as shown in (B), the front movable seal member 3a is inserted through the distal end opening 1a of the cylindrical container 1 in a state of being sufficiently dried in advance, and is brought into close contact with the rear movable seal member 3b. Or close with a small gap. In this state, the first chamber 4 is opened from the tip opening 1a.
After filling the inside with the powdered drug P, the fixed seal member 7 is attached to the distal end opening 1a to obtain a two-component prefilled syringe having the structure shown in FIG.

In the above assembly procedure, the second
During the steam heating sterilization of the solution, dispersion or chemical liquid L in the chamber 5, moisture adheres or permeates the rear movable seal member 3b, but the front side dried after the steam heating sterilization and the drying / cooling process. By inserting the movable seal member 3a and then filling the first chamber 4 with the powdered medicine P, it is possible to prevent the transfer of moisture to the powdered medicine P side.

When a space is provided between the front and rear movable seal members 3a and 3b, moisture from the second chamber 5 side moves the rear movable seal member 3b in the storage state after assembly. The time required to enter the front-side movable seal member 3a after that becomes long, and the period until moisture reaches the medicine in the first chamber 4 can be lengthened.

As described above, the two-component prefilled syringe according to the present invention is used with the injection needle attached to the tip of the cylindrical container 1. A more specific configuration example of the seal member 7, the movable seal member 3a, and the like at the distal end opening 1a of the cylindrical container 1 will be described.

FIG. 3 is a sectional view showing an example in which a movable type is used as the sealing member 7 inserted into the opening at the tip end of the cylindrical container 1. In this example, a cap with a needle 8 is attached to the tip of the cylindrical container 1, and the needle with the needle 8 is fixed to the tip of a cup-shaped cap body 81,
Further, the main body 81 has a structure in which a groove 81a communicating with the injection needle 82 is formed on the inner periphery. Further, the main body 81 has a space 81b protruding from the front end opening 1a of the cylindrical container 1 by a predetermined length toward the front end side.
Can be entered.

In such a configuration, the plunger 2 with a rod is pressed at the time of use so that the solution, dispersion or other chemical solution in the second chamber 5 flows into the first chamber 4 through the injection groove 6. When the inflow is completed, or when the inflow is completed, as shown in FIG.
Move into the gap of the main body 81. In this state, when the plunger 2 with a rod is further pressed, the injection liquid dispersed or dissolved in the first chamber 4 causes the main body 81 of the cap 8 with a needle.
The injection needle 82 can be inserted into the injection needle 82 via the groove 81a formed in the injection needle 82. The cap with needle 8 may be either a cap attached with the injection needle 81 at the time of administration or a cap already attached before.

Also, instead of the above structure, the sealing member 7
Is disposed inside the container 1 at a distance from the tip of the cylindrical container 1, and when the liquid in the second chamber 5 has completely flowed into the first chamber 4 by pressing the plunger 2, the sealing member 7 You may comprise so that it may stay at the front-end | tip part of the container 1. By doing so, in combination with the function of the locking mechanism described below,
Since the front and rear of the first chamber 4 are completely sealed, even if the container 1 is vibrated during dissolution or dispersion, the liquid does not leak from anywhere.

FIG. 5 is a sectional view showing an example in which a non-movable type seal member is used. In this type, a cap 9 serving also as a needle holding member is attached to the tip of the cylindrical container 1, and the double-ended needle 10 is inserted to a predetermined position through the cap 9, whereby the rear end of the double-ended needle 10 is inserted. Have a structure that penetrates through the seal member 7 and projects into the first chamber 4.

In this structure, when the double-ended needle 10 is attached, the needle immediately communicates with the first chamber 4, and the injection solution dissolved or dispersed in the first chamber 4 is directly injected into the double-ended needle 10 as described above. Can be injected.

In the system using the double-ended needle 10, the rear end of the needle 10 penetrates through the seal member 7 and the first chamber 4.
As shown in FIG.
Recess 7a capable of accommodating the protrusion of the needle on the end face of the first chamber 4 side
Is formed so that the cylindrical container 1 can be used at the time of administration.
The amount (loss) of the injection solution remaining in the inside can be reduced.

In the system using the double-ended needle 10 as described above, the seal member 7 attached to the distal end portion 1a of the cylindrical container 1 and the end surface shape of the front movable seal member 3a are shown in FIG. In addition to the above, various combinations as exemplified by cross-sectional views in FIGS. 6 to 9 can be employed.

FIG. 6 shows an example of the seal member 7 shown in FIG.
A recess 7b is further formed on the end face on the distal end side of the seal member to facilitate the penetration of the seal member 7 when the double-ended needle 10 is mounted.

In the example of FIG. 7, a recess 7b for facilitating the penetration of the double-ended needle 10 is formed in the distal end face of the seal member 7, and the double-ended needle is formed in the distal end face of the front movable seal member 3a. A recess 30 for accommodating a projection allowance of the projection 10 toward the first chamber.
This is an example in which a is formed. In this case, since the rear end surface of the seal member 7 is flat, there is an advantage that the penetration check of the double-ended needle 10 is facilitated.

FIG. 8 shows an example of the rear end face (first
The end face of the movable seal member 3a on the front side (the end face of the first chamber 4) is formed as a concave curved surface facing the first chamber 4 side.
The end face of the double-sided needle 10) is formed into a convex curved surface facing the first chamber 4 side, and the end face of the movable seal member 3a on the front side accommodates the protrusion of the double-ended needle 10 toward the first chamber. This is an example in which a depression 30a is formed.

According to such a structure, 2
After the components are mixed to form an injection solution, prior to administration, when the distal end of the cylindrical container 1 is turned upward to remove bubbles in the injection solution, the bubbles in the injection solution are in the center of the concave curved surface of the sealing member 7. Since it concentrates on a part, air bubbles can be easily removed through the needle 10, and the size of the portion that contributes to improvement of the simplicity of use becomes large.

In such a case where the concave curved surface of the rear end surface of the seal member 7 and the convex curved surface of the distal end surface of the movable seal member 3a on the front side are combined, the recess for accommodating the projection allowance of the double-ended needle 10 is formed at the distal end of the seal member 7. 9 can also be formed on the side.
3 shows an example in which a concave portion 7a is provided on a concave curved surface of the rear end surface of the seal member 7.

FIGS. 6 to 9 show examples in which a flange is formed at the distal end of the seal member 7 to prevent the cylindrical container 1 from moving in close contact with the distal end surface. However, in any of the examples, it is not always necessary to form the flange portion, and the sealing member 7 may be formed by considering the outer dimensions of the sealing member 7 to such an extent that the sealing member 7 can be firmly attached to the inner peripheral surface of the cylindrical container 1. Can be prevented from moving.

Here, the seal member 7 at the distal end, the front and rear movable seal members 3a and 3b, and the seal member of the plunger 2 can all be made of elastomer, for example, synthetic rubber.

In the two-component prefilled syringe, the plunger 2 with a rod is pressed so that the two components are uniformly dissolved, dispersed or mixed in the first chamber 4 before the actual administration. It is necessary to temporarily stop the plunger 2 in a state where the liquid L in the liquid has almost completely flowed into the first chamber 4 and has not yet flowed out from the tip of the container 1, and shake the syringe well in this state. In addition, at the time of this vibration applying operation, the dissolved liquid or the dispersion liquid that has moved into the first chamber 4 flows back through the injection groove 6 and passes through the original second chamber 5 side, that is, beyond the plunger 2, and the cylindrical container 1. In order to prevent the plunger 2 from flowing out to the rear part, the operation of temporarily stopping the plunger 2 with the rod at an optimum position is not easy without skill, and the plunger 2 may be erroneously moved too far.

FIGS. 10 to 11 show an embodiment in which such an operation is facilitated. In the example shown in FIG. 10, a convex portion 101 that protrudes circumferentially inside the inner peripheral surface of the cylindrical container 1 is provided on the inner peripheral surface of the finger grip 100 attached to the rear end of the cylindrical container 1. At the same time, a plurality of projections 201 are formed on the same circumference at a predetermined position in the axial direction of the rod 20 of the plunger 2 with a rod. Each protrusion 2
The position where the rod 20 is formed on the axial direction is such that the front end surface of the front movable seal member 3a reaches forward from the front end portion of the injection groove 6 by the pressing of the plunger 2, and the rear movable seal member 3b When the rear end surface is in contact with the front end surface of the plunger 2 and the rear half of the plunger 2 does not enter the injection groove 6 and keeps a sliding state with the inner wall of the cylindrical container 1, the projection 201 is moved to the finger grip 100. Convex part 10 of
1 and the distance between the center axis of the rod 20 and the tip of each projection is determined by the finger grip 10
The protrusion 101 is slightly larger than the inner diameter of the protrusion 101.
Further, the material of the finger grip 100 is made of a flexible material such as a synthetic resin.

According to the above configuration, when the plunger 2 with a rod is pushed in from the non-use state of FIG. 10A, the front movable seal member 3a is injected as shown in FIG. Although it stops near the tip of the groove 6, when it is further pushed in, the plunger 2 stops temporarily due to the resistance caused by the projection 201 abutting the projection 101 as shown in FIG. In this state, the liquid in the second chamber 5 is completely injected into the first chamber 4, and both the front end and the rear end of the injection groove 6 are closed, so that backflow and loss of the liquid are completely prevented. Therefore, the two components are uniformly dissolved, dispersed or mixed by shaking the syringe in that state. Then plunger 2
By pushing the finger grip 100 firmly.
When the protrusion 201 is bent, the protrusion 201 passes through the convex portion 101, and the injection liquid after dissolution, dispersion, or mixing can be administered to a living body.

On the other hand, in the example shown in FIG. 11, a convex portion 101 is similarly formed on the inner peripheral surface of the finger grip 100 attached to the rear end portion of the cylindrical container 1.
As shown in FIG. 1B, as viewed from the axial direction, a plurality of notched grooves 102 are formed, and the same number of blades 202 are formed on the rod 20 of the plunger 2 with a rod. The distance from the center of the rod 20 to the tip of each blade 202 depends on the protrusion 10 of the finger grip 100.
1 is larger than the inner diameter and the finger grip 1
The distance between the center of 00 and the bottom surface of each cutout groove 102 is shorter than the distance between the center of 00 and the bottom of each notch groove 102. Further, the end surface position of the front end side of each blade 202 is such that the front end surface of the front movable seal member 3a reaches forward from the front end of the injection groove 6 by pressing the plunger 2,
In addition, the rear end surface of the rear side sealing member 3b is in contact with the front end surface of the plunger 2, and furthermore, the rear half of the plunger 2 does not enter the injection groove 6 and keeps sliding against the inner wall of the container 1. Is a position where the blade 202 is in contact with the rear end surface of the finger grip 100.

In the above configuration, in the state before use shown in (A), each blade 202 of the rod 20 does not coincide with the formation position of the notch groove 102 of the finger grip 100 as shown in (C). It is inserted into the cylindrical container 1 in such a state. Then, at the time of use, the plunger 2 with a rod is first pushed in with the state shown in FIG. As a result, while the liquid is moving, the front movable seal member 3a is stopped at the tip of the injection groove 6 as shown in (D).
The plunger 2 stops when the finger 2 contacts the rear end face of the finger grip 100. In this state, as described above, the liquid in the second chamber 5 is completely injected into the first chamber 4 and is prevented from flowing back through the injection groove 6, so that the syringe is shaken in this state. To dissolve the two components uniformly,
Disperse or mix. Thereafter, the plunger 2 with a rod is rotated to connect each blade 202 with each notch groove 102.
(F), the plunger 2 with rod can be pushed in as shown in FIG.
The injection solution after dispersion or mixing can be injected into a living body.

Incidentally, without adopting the structure shown in FIG. 10 or FIG. 11, a predetermined position in front of the tip of the injection groove 6, for example, 2 mm from the tip of the injection groove 6.
It is also effective to provide only a line-shaped mark along the circumferential direction on the outer or inner peripheral surface of the cylindrical container 1 at a position slightly forward. That is, when the plunger 2 is pressed so that the distal end surface of the front movable seal member 3a does not exceed the mark, the liquid in the second chamber 5 is almost completely injected into the first chamber 4, What is necessary is just to shake a syringe in that state.

In each of the embodiments described above,
The front and rear movable seal members 3a and 3
b, or a seal member provided at the tip of the plunger 2 with a rod has a structure in which a plurality of circumferentially projecting ribs, that is, a plurality of circular ribs, are provided on the outer peripheral surface thereof. The liquid-tightness between the chambers 5 or the liquid-tightness between the second chamber 5 and the outside of the container 1 is maintained, and the slidability in the container 1 is improved. In such a structure, when the movable sealing members 3a and 3b or the sealing member of the plunger 2 itself passes through the injection groove 6 by pressing the plunger 2 with a rod, the liquid accumulated in the injection groove 6 is filled with each seal. The liquid enters the annular recess formed between the circular ribs of the members 3a and 3b or the sealing member of the plunger 2, and the injection liquid is not administered by that amount, resulting in loss. In order to solve this problem, it is conceivable to make the recess shallow so as not to hinder the slidability of the seal member. However, measures for further reducing the loss will be described below.

FIG. 12 is a sectional view of an embodiment in which the measures are taken. The features of this embodiment are the shape of the front movable seal member 3a, the rear movable seal member 3b, and the shape of the seal member 2a of the plunger 2 with a rod, and the structure common to them is shown in an external perspective view in FIG. .

That is, the front movable seal member 3a, the rear movable seal member 3b, and the plunger 2 with the rod
Each of the seal members 2a has a plurality of circular ribs 300.
Is formed, and between each circular rib 300,
A plurality of vertical ribs 301 having substantially the same height as these are formed, and each vertical rib 301 divides a gap formed between the circular ribs 300 into a plurality of small gaps. .

In this example, four vertical ribs 301 are formed in each of the gaps at positions where the outer periphery of each of the seal members 3a, 3b and 2a is divided into four equal parts. Each gap is divided into four equal parts.

By adopting such a structure, the front movable seal member 3 is pressed by the plunger 2 with the rod.
a, when the rear movable seal member 3 b and the seal member 2 a of the plunger 2 pass through the injection groove 6, the injection solution is partitioned by the vertical rib 301 in the space between the circular ribs 300 via the injection groove 6. Into one of the small voids
Due to the presence of the vertical ribs 301, it is impossible to enter the adjacent small gaps. Therefore, in this example, the injection liquid remaining in the gaps of each seal member is about 1 / compared to the case where only the circular ribs 300 are provided. Decrease to 4.

The number of the vertical ribs 301 provided in each space between the circular ribs 300 is not limited to four, and may be any number of two or more. On the other hand, since the slidability of each seal member is reduced accordingly, it is desirable to select an appropriate number in consideration of these factors. In addition, vertical rib 3
01 may be formed only on the front and rear movable seal members 3a and 3b.

The front and rear movable seal members 3a and 3b,
And each circular rib 30 of the sealing member 2a of the plunger 2.
0 and the vertical rib 301 are formed so that the axial shape thereof is linear along the inner wall surface of the cylindrical container 1 as shown in the figure, and in order to further reduce the frictional resistance with the cylindrical container 1, A so-called crowning shape having a curved bulge as appropriate may be used.

[0055]

As described above, according to the present invention,
A movable seal member that divides the cylindrical container into a first chamber and a second chamber is divided into a front side and a rear side, and an opening through which the front movable seal member can be inserted is provided at the tip of the cylindrical container. With the structure, the second chamber side is filled with a solution, dispersion or chemical solution with the movable seal member on the rear side attached, sterilized by steam heating in that state, and then the inner surface of the syringe in the first chamber is dried. Then, after inserting the movable seal member on the front side in the dry state from the container tip opening, filling the first chamber with the drug, and fixing the seal member to the tip opening, a drug filling to assembling procedure is performed. Even if moisture adheres to or penetrates the rear movable seal member by steam heating sterilization of the solution, dispersion liquid or chemical solution in the second chamber, the moisture in the first chamber is not heated and dried later. Moisture transfer to drug Prevents Rukoto, based on a simple process, without compromising the stability of the drug, it has become possible to obtain a two-component prefilled syringe with a high yield.

Further, the front end of the movable seal member on the front side has a convex curved surface facing the first chamber, and the rear end surface of the seal member on the tip of the cylindrical container has a concave curved surface facing the first chamber. The operation of removing bubbles from the injection solution prior to the step is facilitated.

Further, the front end of the movable seal member on the front side reaches forward from the front end of the discontinuous portion of the cylindrical container by the pressing of the plunger, and the rear end face of the rear movable seal member and the front end face of the plunger. And a rod and a cylindrical container for pressing the plunger so that the plunger temporarily stops at a position where the latter half of the plunger does not enter the discontinuous portion and keeps sliding with the inner wall of the container. In addition to providing a locking mechanism between the two and the release mechanism, the work of uniformly dissolving, dispersing or mixing the two components prior to administration is facilitated, and at that time, the backflow of the liquid can be prevented. In addition, the simplicity of use can be greatly improved in combination with the simplification of the air bubble removing operation described above.

Further, the front side and the movable seal member,
Alternatively, in addition to the above, the seal member of the plunger with a rod is provided with a plurality of vertical ribs for partitioning the gap between the circular ribs, so that these seal members are injected into the gap between the circular ribs when passing through the discontinuous portion. The amount of liquid entering the liquid decreases, and the loss of administration of the injection liquid can be reduced.

Further, by forming a depression in one of the end faces of the movable seal member on the front side and the seal member attached to the tip of the container facing the first chamber, a double-ended needle can be used. The rear end of the needle is accommodated in the depression in the first chamber, which also reduces the amount of the injection liquid that remains in the first chamber and loses during administration.

[Brief description of the drawings]

FIG. 1 is a sectional view showing a basic configuration of an embodiment of the present invention.

FIG. 2 is an explanatory view of an assembling process including the filling of the drug and the like.

FIG. 3 is a cross-sectional view showing the configuration of a specific embodiment of the present invention when a movable type sealing member is used in the opening at the distal end of the cylindrical container.

FIG. 4 is an explanatory diagram of the operation when the example of FIG. 3 is used.

FIG. 5 is a cross-sectional view showing a configuration of another embodiment of the present invention in which a non-movable type sealing member is used for an opening at the distal end of a cylindrical container and a double-ended needle is used as an injection needle.

FIG. 6 is an explanatory view of a combination example of the shapes of the seal member 7 and the front movable seal member 3a in the type of FIG.

7 is an explanatory view of another example of the shape of the seal member 7 and the front movable seal member 3a of the type shown in FIG. 5;

8 is an explanatory view of still another combination example of the shapes of the seal member 7 and the front movable seal member 3a in the type of FIG.

9 is an explanatory view of still another combination example of the shape of the seal member 7 and the front movable seal member 3a in the type of FIG.

FIG. 10 is an explanatory diagram of an example of a locking mechanism and a releasing mechanism between the plunger with rod 2 and the cylindrical container 1 according to the present invention.

FIG. 11 is an explanatory view of another example of the locking mechanism between the plunger with rod 2 and the cylindrical container 1 and the releasing mechanism according to the present invention.

FIG. 12 is a cross-sectional view showing an example of the two-component prefilled syringe of the present invention in which a measure is taken to reduce the administration loss of the injection solution.

FIG. 13 is an external perspective view of each of the sealing members 3a, 3b and 2a.

FIG. 14 is a cross-sectional view showing a configuration of a conventional two-component prefilled syringe.

FIG. 15 is an explanatory diagram of its operation.

FIG. 16 is a diagram illustrating a procedure of a steam heating sterilization method for a solution, a dispersion, and the like in a second chamber 35 in a conventional two-component prefilled syringe.

FIG. 17 is an explanatory view showing a procedure of another steam heating sterilization method such as a solution or a dispersion in the second chamber 35 in the conventional two-component prefilled syringe.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Cylindrical container 1a Tip opening part 100 Finger grip 101 Projection 102 Notch 2 Plunger with rod 2a Seal member 20 Rod 201 Convex part 202 Blade 3 Movable seal member 3a Front movable seal member 3b Rear movable seal member 300 Round rib 301 Vertical rib 4 First chamber 5 Second chamber 6 Injection groove 7 Sealing member 7a Depression 8 Needle cap 81 Cap body 81a Groove 81b Void 82 Injection needle 9 Cap 10 Double-ended needle P Powder or other drug L Dissolving solution, dispersion or other Chemical solution

 ────────────────────────────────────────────────── ─── Continuation of the front page (56) References US Pat. No. 4,686,223 (US, A) US Pat. No. 4,822,340 (US, A) US Pat. No. 4,820,286 (US, A) US Pat. (DE, A)

Claims (11)

(57) [Claims] 1. A plunger to which a pressing rod can be attached is inserted from a rear end of a cylindrical container to which an injection needle can be attached at a distal end portion, and a plunger is provided between the distal end portion of the cylindrical container and the plunger. A slidable movable seal member is inserted,
The movable seal member divides the inside of the cylindrical container into a first chamber on the front end side and a second chamber on the rear end side, and a predetermined medicine is in the first chamber, and a dispersion and dissolution thereof are in the second chamber. A liquid or a chemical liquid is contained, and the liquid in the second chamber flows into the first chamber through a discontinuous portion formed on a side wall of the first chamber when the movable seal member slides and displaces due to pressing of the plunger. In the pre-filled syringe configured to disperse, dissolve, or mix the medicine, the movable seal member is divided into a front side and a rear side, and is configured as a double movable seal member that can slide independently. The discontinuous portion of the side wall is formed as a bypass whose axial length is longer than the total thickness of the double movable seal member, and the double movable seal member is combined with the double movable seal member by pressing the plunger. Ba The liquid in the second chamber flows into the first chamber when passing through the path, and the distal end of the cylindrical container is open so that the front movable seal member can be inserted. A prefilled syringe characterized by the above-mentioned. 2. The prefilled syringe according to claim 1, wherein the front and rear movable seal members are in close contact with each other. 3. The prefilled syringe according to claim 1, wherein the front and rear movable seal members are disposed adjacent to each other with a predetermined distance in the axial direction of the cylindrical container. 4. A projection for forming a gap between the front and rear movable seal members on at least one of the opposing surfaces of the front and rear movable seal members. The prefilled syringe according to claim 3, wherein the syringe is formed. 5. The front and rear movable seal members each have a plurality of circular ribs formed on an outer periphery thereof, and a space between the circular ribs is substantially equal to that of each circular rib. The prefilled syringe according to claim 1, 2, 3, or 4, wherein a plurality of vertical ribs having a height and partitioning an annular recess formed between the circular ribs are formed. . 6. The sealing member of the plunger has a plurality of circular ribs formed on an outer periphery thereof, and has a height substantially equal to each circular rib between the circular ribs. 5. A plurality of vertical ribs for partitioning an annular recess formed in the first and second portions are formed.
Or the prefilled syringe according to 5. 7. The pressing of the plunger causes the front end of the front movable seal member to reach forward from the front end of the discontinuous portion of the cylindrical container, and the rear end surface of the rear movable seal member to move forward. At a position where the plunger abuts against the distal end face of the plunger, and at least the rear half of the seal member of the plunger does not enter the discontinuous portion and maintains a sliding state with respect to the inner wall of the cylindrical container, the plunger temporarily stops. 7. A locking mechanism is provided between a rod for pushing the plunger and the cylindrical container, and a release mechanism is provided for the locking mechanism. The prefilled syringe according to 1. 8. A finger grip is mounted near a rear end of the cylindrical container, and the finger grip is formed with a convex portion projecting inward from an inner peripheral surface of the cylindrical container. A projection is formed at a predetermined position in the axial direction of the rod for pushing the plunger, and the projection of the rod and the projection are engaged with each other by pushing the rod to stop the plunger once, and The prefilled syringe according to claim 7, wherein the engagement is released by further pushing the rod. 9. A finger grip is mounted near a rear end of the cylindrical container, and a convex portion is formed on the finger grip so as to protrude inward from an inner peripheral surface of the cylindrical container. The projection has at least one notch extending in the radial direction, while the rod pushing the plunger has at least one blade extending in the radial direction corresponding to the notch. The blade and the projection are engaged with each other by pushing the rod, and the plunger stops once, and
In a state in which the rod is rotated with respect to the cylindrical container so that the position of the blade and the notch coincide with each other, the blade is configured to pass through the notch and disengage the engagement. The prefilled syringe according to claim 7, wherein 10. An end face of the movable seal member on the front side on the first chamber side is formed in a convex curved shape facing the first chamber side, and a tip of the cylindrical chamber is provided on a tip end of the cylindrical container. A sealing member having an end face formed in a concave curved surface shape facing the first chamber side along the convex curved surface shape is mounted. 10. The prefilled syringe according to claim 8, 8, or 9. 11. A dent is formed in one of the end faces of the movable seal member on the front side and the seal member attached to the tip of the container facing the first chamber. 1, 2, 3, 4, 5, 6, 7,
The prefilled syringe according to 8, 9, or 10.