JP4144027B2 - Two-component prefilled syringe - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a two-component mixed type prefilled syringe. The prefilled syringe of the present invention can be mixed by aseptically mixing two components and then inhaling other components if necessary.
[0002]
[Prior art]
Many injections are chemically unstable in a liquid state, and such a drug needs to be mixed with a solution (including a drug) immediately before use. A prefilled syringe is a chemical solution that is chemically unstable in such a liquid state, and can be used as a chemical solution by aseptically mixing it with a solution pre-filled in the syringe at the time of use. In recent years, it has been widely used because the mixing operation of the solution is easy and there is no mixing of foreign matter such as glass or rubber fragments.
[0003]
As prefilled syringes, one-pack type and two-pack type are mainly used in the past, but the conventional two-pack type is one that cannot draw a gasket after mixing the chemicals, Other chemicals could not be mixed by inhalation. Therefore, in the medical field, for example, it may be necessary to continuously administer vitamins and other drugs depending on the patient. In such a case, it is inconvenient because it is not possible to complete a single administration. The patient suffered a great deal because of the two injections.
[0004]
Therefore, as a solution to the above problem, a prefilled syringe has been proposed in which a gasket can be pulled after mixing of chemicals and other chemicals can be sucked and mixed (Patent Document 1). This one has a first syringe with a first gasket inserted into its lumen, and a tip portion fitted into the first gasket and a second gasket inserted into its lumen. It consists of a second syringe, and by rotating the second syringe in the first gasket, the hole provided in the first gasket and the hole provided in the tip of the second syringe In addition, the inner space of the first gasket communicates with the inner space of the second gasket.
However, this product has not yet been put into practical use, possibly due to the cost and the alignment of the hole.
[0005]
[Patent Document 1]
JP 10-337321 A (paragraph number 0008-0034, FIG. 1)
[0006]
[Problems to be solved by the invention]
The present invention has been made in view of the above circumstances, and after mixing the two components aseptically, if necessary, it is possible to inhale and mix other components and mix the two components with good operability. The purpose is to provide a prefilled syringe of a reasonable price.
[0007]
[Means for Solving the Problems]
In order to solve the above-mentioned problems, the present inventors have intensively studied and inserted a drug container having a plunger function into a normal prefilled syringe filled with a solution, and interposed a communication means between the two containers. Thus, the present inventors have completed the present invention by conceiving that both containers need only be able to communicate with each other using this communication means. That is, the present invention includes a first barrel having a distal tip at the distal end and a flange at the proximal end, and a fluid-tight and slidably inserted into the lumen of the first barrel, and is dissolved at the distal end side of the lumen. A gasket member for defining a liquid chamber; and a plunger-like container slidably inserted into a lumen of the first barrel adjacent to the gasket member, the gasket member being disposed on the shaft. It has a through-hole penetrating the member, and has a puncture needle inserted into the through-hole at its base end, and the puncture needle has a chemical liquid passage communicating with the through-hole, and the chemical liquid passage is punctured The plunger-like container is closed by a rubber shaft attached to a needle, and the plunger-like container is attached to the mouth of the second barrel and sealed with the mouth of the second barrel. The lumen of the first barrel A first gasket that is partitioned and slidable in the lumen; and a liquid-tight and slidably inserted into the lumen of the second barrel; and a drug chamber is defined on a distal end side of the lumen. A second gasket provided with a plunger coupling means at its end, and when the plunger-like container is advanced, the first gasket is pierced by a puncture needle of the gasket member, and the solution chamber and the medicine The present invention relates to a two-component mixed type prefilled syringe in which a chamber is in fluid communication and a first barrel and a second barrel are engaged at a position where advance of a plunger-like container is stopped.
Here, in order to engage the first barrel and the second barrel at a position where the advance of the plunger-like container is stopped, for example, a stopper is provided on the outer periphery of the proximal end of the second barrel, The stopper and the first barrel may be engaged at a position where the forward movement is stopped. With this configuration, kickback by the rubber shaft can be prevented, and the plunger-like container can be prevented from retreating when the second gasket is retracted. In the prefilled syringe of the present invention, the opening at the proximal end of the second barrel may be closed with sterilized paper in order to maintain sterility in the second barrel.
[0008]
DETAILED DESCRIPTION OF THE INVENTION
Next, embodiments of the present invention will be described with reference to the drawings.
FIG. 1 is a longitudinal sectional view showing an embodiment of the prefilled syringe of the present invention. Moreover, FIG. 2 is explanatory drawing of the use condition of the prefilled syringe shown in FIG.
As shown in FIG. 1, the prefilled syringe of the present invention is inserted into the first barrel 1, the gasket member 2 that is inserted into the first barrel 1 to define the solution chamber 13, and the first barrel 1. A plunger-shaped container P. The gasket member 2 has a through hole 23 on the shaft, and a puncture needle 22 to which a rubber shaft 24 is attached is provided on the base end side of the through hole 23. The plunger-like container P includes a second barrel 3, a first gasket 4, and a second gasket 5 that is inserted into the second barrel 3 and defines a medicine chamber 32. When the plunger-like container P is advanced, the first gasket 4 is pierced by the puncture needle 22, the solution chamber 13 and the medicine chamber 32 are in fluid communication, and the first position is stopped at the position where the advance of the plunger-like container P is stopped. The barrel 1 and the second barrel 3 are engaged.
[0009]
The first barrel 1 is a cylindrical member formed of a transparent plastic having chemical resistance such as polypropylene, polyethylene, cyclic polyolefin, and methylpentene resin, or glass, and a nozzle-shaped tip 11 is provided at the tip. An injection needle (not shown) can be connected. The base end of the first barrel 1 is open, and a flange 12 is provided on the outer periphery of the first barrel 1 for hanging a finger during injection.
A gasket member 2 and a plunger-like container P are inserted into the lumen of the first barrel 1 in this order from the open end, and the solution chamber 13 is defined on the distal end side of the first barrel 1 by the gasket member 2. It is installed.
[0010]
The gasket member 2 includes a gasket portion 21 and a puncture needle 22 provided at the base end thereof. The gasket portion 21 is generally formed of a rubber elastic material such as natural rubber or synthetic rubber such as butyl rubber, isoprene rubber, or elastomer, and a through hole 23 penetrating the gasket member 2 is provided on the shaft. Yes. The through hole 23 has a narrow distal end side and a wide proximal end side, and a proximal end portion 224 of the puncture needle 22 is inserted into the wide proximal end side. The puncture needle 22 is a tubular member made of plastic, for example, polypropylene, ABS resin, polystyrene or the like. For example, as shown in FIG. The tip side is a puncture portion 222. The puncture needle 22 is provided with a chemical liquid passage 221 that communicates with the through hole 23 from the puncture portion 222 through the base end portion 224, and this chemical liquid passage 221 is closed by a rubber shaft 24 that covers the puncture portion 222. . As a material for forming the rubber shaft 24, isoprene rubber, natural rubber, elastomer, or the like can be used.
[0011]
The gasket member 2 is inserted into the lumen of the first barrel 1 in a liquid-tight and slidable manner, and the distal end side of the lumen of the first barrel 1 is partitioned liquid-tight by the gasket member 2 to be dissolved. It is chamber 13. The solution chamber 13 is sealed by covering the tip chip 11 with a sealing means such as a rubber cap 8 after the solution is filled therein.
The front end side of the gasket portion 21 is generally formed in a conical shape, and preferably polytetrafluoroethylene or the like in order to prevent elution of the rubber component into a solution (not shown) accommodated in the solution chamber 13. Laminated with fluororesin.
[0012]
A plunger-like container P is further slidably inserted in the lumen of the first barrel 1 in the vicinity of the puncture needle 22 of the gasket member 2. The plunger-like container P includes a second barrel 3, a first gasket 4 that is attached to the tip of the second barrel 3, and a second gasket 5 that is inserted into the lumen of the second barrel 3. ing. The second barrel 3 is a cylindrical member formed of the same material as that of the first barrel 1, and has a distal end reduced in diameter and formed in the mouth portion 31, and a base end thereof is open. The first gasket 4 is attached to the mouth portion 31 of the second barrel 3 to seal the mouth portion 31, and defines a lumen of the first barrel 1. It is slidable. Note that there is no problem if the lumen of the first barrel 1 by the first gasket 4 is not airtight. However, if the compartment is airtight, when the plunger-like container P is advanced, the gasket member 2 is moved forward. It is necessary to release air between the first gasket 4 and the first gasket 4. For this purpose, for example, an air vent groove may be provided in the inner cavity of the gasket portion 21. Further, it may be lightly adhered to the inner cavity of the first barrel 1 so that the airtightness is lost when the first barrel 1 is slid.
[0013]
The second gasket 5 is inserted into the lumen of the second barrel 3 so as to be liquid-tight and slidable. The second gasket 5 is liquid-tightly partitioned, and the distal end side of the lumen of the second barrel 3 is a drug chamber 32. The drug chamber 32 is opened after the drug is stored therein. The portion 31 is sealed with the first gasket 4. The first gasket 4 and the second gasket 5 are formed of the same material as the gasket portion 21 of the gasket member 2. The distal end side of the second gasket 5 is formed flat, for example, in FIG. 1 according to the shape of the distal end side of the second barrel 3, and a plunger coupling means 51 is provided at the proximal end thereof. In FIG. 1, the plunger coupling means 51 is a recess having an internal thread formed on its inner wall.
A short cylinder is provided on the outer periphery of the base end of the second barrel 3 so that the kickback by the rubber shaft 24 does not occur and the plunger-like container P does not move backward when the second gasket 5 is moved backward. A stopper 6 is provided, and the stopper 6 and the first barrel 1 are engaged at a position where the advance of the plunger-like container P is stopped. For example, in FIG. 1, the annular rib 61 provided on the outer wall of the stopper 6 and the annular groove 13 provided on the proximal inner wall of the first barrel 1 are engaged. Although not shown, an annular groove may be provided on the inner wall of the stopper 6 and an annular rib may be provided on the proximal inner wall of the first barrel 1 so that the annular groove and the annular rib engage with each other. In order to maintain sterility in the second barrel 3, the opening at the base end of the second barrel 3 may be closed with the sterilized paper 7.
In the configuration as described above, when the plunger-like container P is advanced, the first gasket 4 is pierced by the puncture needle 22 so that the solution chamber 13 and the drug chamber 32 are in fluid communication with each other. The stopper 6 and the first barrel are engaged at a position where the forward movement is stopped.
[0014]
Next, the use of the prefilled syringe of the present invention will be described with reference to FIG. First, a prefilled syringe as shown in FIG. 1 is prepared (FIG. 2a), and the plunger-like container P is advanced. Then, the first gasket 4 is pierced by the puncture needle 22 of the gasket member 2 so that the puncture needle 22 protrudes into the drug chamber 32, and the solution chamber 13 and the drug chamber 32 through the drug solution passage 221 and the through hole 23. In fluid communication (FIG. 2b). When the plunger-like container P is further advanced in this state, the solution in the solution-solution chamber 13 moves to the drug chamber 32 and the second gasket 5 of the plunger-like container P moves backward. The forward movement of the plunger-like container P is stopped at a position where the gasket member 2 abuts against the narrowed end of the first barrel 1 to prevent the forward movement. At this time, the annular rib 61 of the stopper 6 at the rear end of the second barrel 3 and the annular groove 14 at the rear end of the first barrel 1 are engaged, and the plunger-like container P is fixed to the first barrel 1, and the state shown in FIG. become. Next, in this state, the prefilled syringe is sufficiently shaken to mix the solution and the chemical solution, and then the sterilized paper 7 is peeled off, and the plunger 9 is coupled to the plunger coupling means 51 of the second gasket 5 (see FIG. 2c). The rubber cap 8 may be removed from the chip 11 and an injection needle (not shown) may be connected.
[0015]
【The invention's effect】
As is apparent from the above description, by employing the present invention, a two-component mixed prefilled syringe with good operability can be provided. In addition, since the chemical solution can be poured out and inhaled by moving the second gasket forward and backward, the two components are mixed aseptically, and if necessary, other components are inhaled and mixed. It is possible.
[Brief description of the drawings]
FIG. 1 is a longitudinal sectional view showing one embodiment of a two-component mixed prefilled syringe of the present invention.
FIG. 2 is an explanatory diagram of a usage situation of the prefilled syringe shown in FIG. 1;
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 1st barrel 11 Tip tip 12 Flange 13 Dissolving liquid chamber 14 Annular groove 2 Gasket member 21 Gasket part 22 Puncture needle 221 Chemical liquid passage 222 Puncture part 223 Hub 224 Base end side part 23 Through hole 24 Rubber shaft 3 Second barrel 31 Mouth 32 Drug chamber 4 First gasket 5 Second gasket 51 Plunger coupling means 6 Stopper 61 Annular rib 7 Sterilized paper 8 Rubber cap 9 Plunger P Plunger-like container

Claims (2)

A first barrel having a tip at the tip and a flange at the base, and a fluid-tight and slidably inserted into the lumen of the first barrel, and a solution chamber is defined at the tip of the lumen And a plunger-like container slidably inserted into the lumen of the first barrel adjacent to the gasket member, the gasket member penetrating through the gasket member on a shaft. A puncture needle inserted into the through hole at the base end thereof, the puncture needle having a chemical liquid passage communicating with the through hole, the chemical liquid passage being attached to the puncture needle was being closed by a rubber shaft, said plunger-like container, have a mouth portion at the distal end, and a second barrel stopper is provided at the base end outer circumference, is capped at the mouth end of the second barrel the Sealing the mouth and the lumen of the first barrel A first gasket that is slidable and slidable within the lumen, and a liquid chamber that is slidably and slidably inserted into the lumen of the second barrel, and a drug chamber is defined on a distal end side of the lumen. A second gasket provided with a plunger coupling means at its end, and when the plunger-like container is advanced, the first gasket is pierced by a puncture needle of the gasket member, and the solution chamber and the medicine A two-component mixed type prefilled syringe in which the chamber is in fluid communication and the first barrel and the stopper are engaged at a position where the advance of the plunger-like container is stopped. The prefilled syringe according to claim 1, wherein the opening at the proximal end of the second barrel is closed with sterilized paper.

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