JPH078555A - Solution filling injector for mixing two-component - Google Patents

Abstract

PURPOSE:To provide a solution filling injector for mixing two components easy to assemble in which a chemical is hardly left, its elusion from a rubber stopper is minimized, an optional injecting agent can be selected, and a commercial injecting needle of an optional size can be used. CONSTITUTION:A solution filling injector for mixing two components is formed of a barrel filled with a solution S, a communication auxiliary tool 2 mounted on the top end outer wall of the barrel 1, and a communicating means 3 supported by the communication auxiliary tool 2. The top end opening 11 of the barrel 1 is sealed by a seal member 12, and the base end part is sealed by a gasket 4. A vial insert part 21 is formed on the upper part of the communication auxiliary tool 2, and the communicating means 3 is supported by the lower part of the communication auxiliary tool 2.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a syringe pre-filled with a solution suitable for preparing an injection by aseptically mixing an injection or the like and a solution thereof.

[0002]

BACKGROUND OF THE INVENTION Certain injectables rapidly lose their potency when they are ready for use, and are therefore often packaged as two components in two vials with pierceable stoppers. It has been mixed with a syringe or the like at the time of use. However, mixing operations with such syringes are problematic with regard to sterility. Therefore, in order to solve such a problem, a so-called syringe outer cylinder in which a cylindrical container having open both ends is filled with a drug solution, and both open ends are closed with rubber stoppers, and a drug solution A combination of a plunger rod for pushing out and a means for communicating the inside of the syringe outer cylinder with the injection needle has been proposed, and is known as a so-called prefilled syringe. The solution-filled syringe of the present invention is a prefilled syringe for two-component mixing, and includes a barrel (syringe outer cylinder) prefilled with a solution and a communication means, and the vial and the barrel are connected by the communication means at the time of use. It was made to be done. Many proposals have already been made for such a drug-filled syringe for mixing two components (JP-A-61-48377, JP-A-62-14863, JP-A-5-31189, etc.).

The drug solution-filled syringes disclosed in JP-A-61-48377 and JP-A-62-14863 are chambers on the far end side of a barrel (holding solid chemicals) partitioned by a stopper into two chambers. By forming a bypass area in the longitudinal direction in the chamber, the stopper is moved to the bypass area by moving the piston to the far end side, and the chamber at the near end side (containing the diluent)
The diluting solution of No. 5 is moved to the chamber on the far end side through a bypass, and the drug solution-filled syringe disclosed in JP-A-5-31189 is an injection needle at the tip of a syringe barrel filled with the first component. And the injection cylinder is slidably accommodated in the outer cylinder, and the second component chamber is airtightly fixed to the tip of the outer cylinder via a pierceable seal member. When the plunger is pressed, the sealing member of the second component chamber is pierced by the injection needle, and the communication between the injection cylinder filled with the first component and the second component chamber is achieved.

However, the former drug solution-filled syringe provided with a bypass area has a large contact area between the diluting solution and the rubber stopper, so that the elution from the rubber stopper increases, and the injection solution remains in the bypass. The drug solution-filled syringe, which has the drawbacks and the latter is connected to the second component chamber via the outer cylinder, is compact, but the injection needle is pierced into the seal member to seal the syringe. Therefore, the assembly work is troublesome, and since the injection needle is incorporated in advance, there is a drawback that an arbitrary injection needle cannot be selected. Further, all of these drug solution filling type injectors have a drawback that an arbitrary injection cannot be selected since the injection is pre-installed.

[0005]

SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances, and there is almost no residual drug solution, little elution from the rubber stopper, and an arbitrary injection can be selected. It is an object of the present invention to provide a solution-filled syringe for two-component mixing that is easy to perform. Another object of the present invention is to provide a solution-filled syringe for mixing two components, which can use a commercially available injection needle of any size.

[0006]

SUMMARY OF THE INVENTION In order to solve the above problems, the present invention is a tubular member having a tip end portion and a base end portion which are open at both ends and whose tip end opening is sealed by a sealing member. At the same time, the inner cavity on the base end side is sealed by a gasket slidably inserted from the base end opening, and the inner space between the sealing member and the gasket is filled with a dissolution liquid, and the upper part is provided. A tubular member having a lower portion with both ends opened, wherein a vial insertion portion is provided on the upper portion, and an opening end portion of the lower portion is slidably and detachably attached to an outer wall of a distal end portion of the barrel, and a communication assistant. A solution for mixing two components, which is contained in a lower portion of the communication auxiliary tool and is supported by the communication auxiliary tool, and which comprises a communication means for communicating the barrel and the vial inserted in the vial insertion portion. Uses a filling syringe. Further, preferably, the sealing member of the tip end opening is formed of a rubber elastic body, the communication aid is divided into an upper part and a lower part by a partition, and the vial is inserted when the vial is inserted on the upper side of the partition. A hollow puncture needle that pierces the rubber plug at the mouth of the
On the lower side of the partition wall, a tubular communication means support portion is provided so as to be coaxial with the puncture needle, and the communication means has an injection needle connection portion and a puncture needle at both ends on the same axis. The connection part is liquid-tightly inserted and supported by the communication part support part.

[0007]

According to the above-mentioned structure, to explain with reference to FIG. 1, the vial (not shown) is inserted into the vial insertion portion of the communication assisting tool from above with the plunger rod being in a downward state, for example. When pushed down, the rubber stopper of the vial is first pierced by the puncture needle provided on the partition wall, and at the same time, the communication assisting tool slides downward along the outer wall of the barrel. Then, the communication means supported by the communication assisting tool moves downward together with the communication assisting tool, and the puncture needle pierces the sealing member that seals the distal end opening of the barrel. Further, the communication means is engaged with the opening of the distal end portion of the barrel at the same time when the sealing member is pierced. Thus, the inside of the vial and the inside of the barrel are in fluid communication with each other via the puncture needle and the communication means, and the communication means is attached to the tip end opening of the barrel. Next, push the plunger rod to move the dissolved solution in the barrel into the vial (this operation is not necessarily required because the vial is pushed downward when the plunger rod is pressed against a desk etc.). No)), shake the drug solution-filled syringe well to mix the injection solution and the solution uniformly, then pull the plunger rod to suck the drug solution into the barrel, and then remove the communication aid from the barrel to establish the communication means. Since it is attached to the tip end opening of the barrel, it can be used as a syringe by connecting an injection needle to the injection needle connection portion.

[0008]

Embodiments of the present invention will now be described with reference to the drawings. 1 is a vertical cross-sectional view of a solution-filled syringe for two-component mixing according to an embodiment of the present invention, FIG. 2 is an enlarged vertical cross-sectional view of the communication aid shown in FIG. 1, and FIG. 3 is a plan view of FIG. 4, FIG. 4 is a bottom view of FIG. 2, FIG. 5 is an enlarged sectional view of the communicating means shown in FIG. 1, FIG. 6 is a plan view of FIG. 5, and FIG. 7 is an enlarged sectional view of a main part of the barrel shown in FIG. 8 is a vertical sectional view showing another embodiment of the communication aid, FIG. 9 is a vertical sectional view showing another embodiment of the barrel, and FIG. 10 is a vertical sectional view showing another embodiment of the communicating means. It is a figure. As shown in FIG. 1, the two-component mixing solution-filled syringe of the present invention comprises a barrel 1 filled with a solution S, a communication aid 2 attached to the outer wall of the distal end of the barrel 1, and a communication aid. It is composed of the communication means 3 supported by the auxiliary tool 2, and the tip end opening 1 of the barrel 1 is formed.
1 is sealed by a sealing member 12, and the base end is sealed by a gasket 4. A vial insertion portion 21 is provided on the upper part of the communication aid 2, and the communication means is supported on the lower part of the communication aid 2. Normally, the communication aid 2
The vial insertion portion 21 is shielded from outside air by a protective member such as a cover seal 6, and the plunger 5 is fixed to the gasket 4.

The barrel 1 is a tubular member having a front end portion and a base end portion, both ends of which are open, and is usually made of glass or transparent plastic such as polypropylene, polyethylene or polymethylpentene. Then, the tip end opening 11 of the barrel 1 is sealed by the sealing member 12, and the inner cavity on the base end side is sealed by the gasket 4 inserted from the base end opening 14, and is partitioned by the sealing member 12 and the gasket 4. The space of the barrel 1 thus filled is filled with the solution S in advance. The sealing member 12 is preferably a rubber stopper 121 and an aluminum caulking member 1 as shown in FIG.
When the communication means 3 shown in FIG. 10 is adopted, a rubber stopper 123 having a hole 124 in the central portion as shown in FIG. 9 and the hole 124 are sealed. The closing member 125 and the caulking member 126 made of aluminum are used. still,
As a material for forming the gasket 4 and the rubber plug, although it depends largely on compatibility with stored chemicals, natural rubber, synthetic rubber, thermoplastic elastomer or the like can be used, and natural rubber or butyl rubber is particularly preferable. Further, as the solution S, distilled water for injection or physiological saline is usually preferably used.

The communication aid 2 is a cylindrical container having an upper end and a lower end, both ends of which are open, and is usually made of a synthetic resin such as polypropylene, polyethylene, polyester, polyvinyl chloride, or ABS resin. The vial insertion portion 21 is provided on the upper part of the communication assisting tool 2, and a smooth portion of the vial is provided on a lower side of the vial insertion portion 21, that is, a portion which engages with a mouth portion of a vial (not shown). A plurality of ribs 22 are provided to assist the insertion and prevent the vial from being returned (called kickback) by the elastic force of the rubber stopper of the mouth. The upper open end of the communication aid 2 is usually formed on the flange 23, and the cover seal 6 or sterilized paper (not shown) made of synthetic resin such as polyethylene, polypropylene, or polyester is used to prevent contamination. It is hermetically closed by.
On the other hand, the opening end of the lower portion of the communication aid 2 is detachably attached to the outer wall 13 at the tip of the barrel 1 and slidable along the outer wall 13. Preferably, the space between the communication aid 2 and the barrel 1 is reduced. The airtightness of the seal member 7 attached to the packing attachment groove 28 of the outer wall 13 of the tip portion of the barrel 1 or the inner wall of the lower portion of the communication aid 2 as shown in FIG.
Guaranteed by (O-rings, etc.).

The communication aid 2 is preferably formed in a shape as shown in FIG. This is partitioned into an upper part and a lower part by a partition wall 24, and a hollow puncture needle 25 is projected on the upper side of the partition wall 24 so as to penetrate the partition wall 24, and a vial is inserted into the vial insertion part 21. The rubber stopper at the mouth of the vial is sometimes pierced by the puncture needle 25. Further, a tubular communication means support portion 26 is provided so as to project on the lower side of the partition wall 24 and coaxially with the puncture needle 25. The communication means support portion 26 has an injection needle connection portion 32 of the communication means 3 as shown in FIG. Can be inserted in a liquid-tight manner. In the communication assisting tool 2 having such a shape, the injection needle connection portion 32 of the communication means is a portion for connecting an injection needle (not shown), and like the tip of the injection cylinder, the outer diameter is tapered toward the tip. Due to the reduced diameter, the communication means support portion 26 is formed in a tubular shape having an inner diameter complementary to the outer diameter of the injection needle connection portion 32.

The communication aid 2 may be formed in a shape as shown in FIG. This is achieved by using a sealing member as shown in FIG. 9, that is, a sealing member including a rubber plug 123 having a hole 124 in the center, a closing body 125 for sealing the hole 124, and a caulking member 126 made of aluminum. It is used in combination with a closed vial and a communication means having a closing body dropout part 35 on the lower part as shown in FIG. 10, that is, on the side communicating with the vial, and the vial insertion part 21 is provided on the upper part of the communication aid 2. Provided and communication aid 2
In the lower part of the above, for example, an annular rib 27 as a means for supporting the communication means is provided in the vicinity of the vial insertion portion 21. Then, the hub 33 of the communication means 3 as shown in FIG. 10 is engaged with the annular rib 27.

The communication means 3 is arranged below the communication auxiliary tool 2 so as to be located between the vial insertion portion 21 and the sealing member 12 of the tip end opening 11 of the barrel 1. As the communicating means 3, those shown in FIG. 1 and FIG. 5 are preferably adopted, but those shown in FIG. 10 may be adopted. The communication means 3 shown in FIG. 5 has a hollow puncture needle 31 and a hollow injection needle connection portion 32 for inserting and inserting an injection needle coaxially at both ends thereof.
And a sealing member 1 including a rubber stopper 121 and a caulking member 122 made of aluminum as shown in FIG.
A barrel 1 having 2 and a septum 24 as shown in FIG.
It is adopted in combination with the communication assisting tool 2 provided with the puncture needle 25. The injection needle connecting portion 32 is formed in a shape in which the outer diameter is tapered toward the distal end like the tip of the injection cylinder, and is liquid-tightly inserted and supported in the communication means supporting portion 26 of the communication auxiliary tool 2. It Then, the puncture needle 31 and the injection needle connection portion 32
A hub 33 is provided at the boundary portion of, and an engaging arm 34 is provided at the outer peripheral edge of the hub 33 in the direction of the puncture needle 31. When the puncture needle 31 pierces the sealing member 12 of the barrel 1, the engaging arm 34 is fixed so firmly that its hook 36 engages with the neck 111 of the distal end opening 11 of the barrel 1 and cannot be easily removed. To be done.

The communication means 3 shown in FIG. 10 has a hollow closing body dropout portion 35 coaxially on its upper portion and an injection needle connecting portion 32 on its lower portion, and its lower portion as shown in FIG. 9, a communication assistant 2 having an annular rib 27 that engages with the hub 33 of the communication means 3, a rubber stopper 123 having a hole 124 in the central portion as shown in FIG. 9, and a closing body 125 for sealing the hole 124. And caulking member 12 made of aluminum
It is adopted in combination with the barrel 1 in which the end opening 11 is sealed by the sealing member 12 made of 6 and the vial (not shown) whose mouth is sealed by the sealing member as shown in FIG. Here, the closing body dropping portion 35 is liquid-tightly inserted into the hole 124 of the sealing member 12 of the barrel 1, and the closing body 125 is dropped from this hole 124. The injection needle connecting portion 32 in FIG. In addition to the function as the mounting portion of the closing body dropout portion 35,
For example, it is possible to insert the closure into a hole formed in a rubber stopper of a vial having a mouth sealed with a sealing member as shown in FIG. 9 and drop the closure from the hole. still,
The communication means 3 shown in FIG. 5 includes a barrel 1 as shown in FIG. 2, a communication auxiliary tool 2 as shown in FIG. 8, and a vial whose mouth is sealed by a sealing member as shown in FIG. It can also be used in combination with.

The closing body dropout portion 35 of the communication means 3 in FIG. 10 is a tubular or pipe-shaped projection having an outer diameter slightly larger than the diameter of the hole 124. When this is inserted into the hole 124 of the rubber plug 123. , The closure 1 closing the hole 124
25 is pushed out into the barrel 1 so that the communication means 3 communicates with the inside of the barrel 1. When the opening of the vial inserted into the vial insertion portion 21 is sealed with a sealing member as shown in FIG. 9, the puncture needle of the partition wall 24 in the communication aid 2 of FIG. It is also possible to replace 25 with the same as the closing body dropout portion 35.

Next, the use of the two-component mixing solution-filled syringe of the present invention will be described with reference to FIG. First, the cover seal 6 is removed from the upper opening of the communication aid 2, and a vial (not shown) is lightly inserted into the vial insertion portion 21 of the communication aid 2 with its mouth portion first. In this state, the rubber stopper of the vial is not yet pierced by the puncture needle 25. Next, push the vial downward with the plunger rod 5 down and standing on a desk, for example.
First, the puncture needle 2 in which the rubber stopper of the vial is provided in the partition wall 24
At the same time, the communication auxiliary tool 2 slides downward along the outer wall 13 of the distal end portion of the barrel 1. At this time, the communication means 3 supported by the communication auxiliary tool 2 moves downward together with the communication auxiliary tool 2, and the puncture needle 31 pierces the sealing member 12 for sealing the tip end opening 11 of the barrel 1. At the same time, the communication means 3 is connected to the front end opening 11 of the barrel 1.
Is engaged with. In this way, the inside of the vial and the inside of the barrel 1 are in fluid communication with each other via the puncture needle 25 and the communicating means 3, so that the dissolving solution S in the barrel 1 can be moved into the vial, and the gasket 4 is The solution S is pushed into the vial by being pushed by the plunger rod 5 and moves forward. Next, the drug solution-filled syringe is shaken well to uniformly mix the injection agent (not shown) and the solution S, and then the plunger rod 5 is pulled to suck the drug solution into the barrel 1, and then from the barrel 1. When the communication auxiliary tool 2 is removed, the communication means 3 remains attached to the tip end opening 11 of the barrel 1. Therefore, the injection needle connecting portion 32 of the communication assisting tool 2 has an injection needle of any size (not shown).
If it is connected, it can be used as it is for a patient as a syringe.

[0017]

As is apparent from the above description, by adopting the solution-filled syringe for mixing two-components of the present invention, there is almost no residual drug solution, so that expensive drug solution is not wasted. It is safe because there is little elution from the rubber stopper, and it is convenient because any injection can be selected and a commercially available injection needle of any size can be used.
Since it is easy to assemble, it is easy to operate, and so on.

[Brief description of drawings]

FIG. 1 is a longitudinal sectional view of a solution-filled syringe for mixing two components according to an embodiment of the present invention.

FIG. 2 is an enlarged vertical sectional view of the communication auxiliary tool shown in FIG.

FIG. 3 is a plan view of FIG.

FIG. 4 is a bottom view of FIG.

5 is an enlarged cross-sectional view of the communication means shown in FIG.

FIG. 6 is a plan view of FIG.

7 is an enlarged cross-sectional view of a main part of the barrel shown in FIG.

FIG. 8 is a vertical cross-sectional view showing another embodiment of the communication auxiliary tool.

FIG. 9 is a vertical sectional view showing another embodiment of the barrel.

FIG. 10 is a vertical sectional view showing another embodiment of the communication means.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Barrel 12 Sealing member 2 Communication aid 21 Vial insertion part 24 Partition wall 25 Puncture needle 26 Communication means support part 3 Communication means 31 Puncture needle 32 Injection needle connection part 35 Closure body dropout part 4 Gasket 5 Plunger rod

Claims (4)

[Claims] 1. A tubular member having a distal end portion and a proximal end portion, both ends of which are open, wherein the distal end opening is sealed by a sealing member, and the inner lumen on the proximal end side slides from the proximal end opening. It is a barrel that is sealed with a gasket that is inserted as much as possible, and that has a barrel filled with a solution in the inner space between the sealing member and the gasket, and a tubular member that has upper and lower portions and that has open ends and that has a vial at the top. A communication assisting tool provided with an insertion part, the lower opening end of which is slidably and detachably attached to the outer wall of the distal end portion of the barrel, and the communication assisting tool accommodated in the lower part of the communication assisting tool. A solution-filled syringe for two-component mixing, which is supported and comprises a communication means for communicating the barrel and the vial inserted into the vial insertion portion. 2. When the sealing member at the opening of the tip of the barrel is formed of a rubber-like elastic body, the communication aid is partitioned into upper and lower parts by a partition, and when a vial is attached to the upper side of the partition. A hollow puncture needle that penetrates the rubber stopper at the mouth of the vial is projected through the partition wall, and a tubular communication means support portion is projected on the lower side of the partition wall and coaxially with the puncture needle. The communication means has an injection needle connection portion and a puncture needle at both ends on the same axis, and the injection needle connection portion is liquid-tightly inserted and supported by the communication means support portion. 2. A solution-filled syringe for mixing two components according to 1. 3. A sealing member for opening the tip of the barrel comprises a rubber stopper having a hole in the center and a closing body for sealing the hole of the rubber stopper, and the communication auxiliary tool is partitioned into upper and lower parts by a partition wall, A hollow puncture needle, which penetrates the rubber stopper at the mouth of the vial when the vial is inserted into the upper side of the partition wall, projects through the partition wall, and has a tubular communication means on the lower side of the partition wall. A support portion is provided so as to project, and the communication means has an injection needle connecting portion and a closing body dropping portion for dropping the closing body at both ends on the same axis, and the injection needle connecting portion has the communication means. The solution-filled syringe for two-component mixing according to claim 1, which is liquid-tightly inserted and supported in the support portion. 4. The solution-filled syringe for mixing two-components according to claim 1, wherein a plunger and a rod are attached to the gasket.