JP4144026B2 - Two-component prefilled syringe - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a two-component mixed prefilled syringe. The two-component mixed prefilled syringe of the present invention can mix two components aseptically and then inhale and mix 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 (Japanese Patent Laid-Open No. 10-337321). . 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]
[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. It aims at providing a mold prefilled syringe at a reasonable price.
[0006]
[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 provides a first barrel having a distal tip at the distal end and a flange at the proximal end, and a liquid-tight and slidably inserted into the lumen of the first barrel. A first gasket that defines a chamber; a double-ended needle that is slidably inserted into the lumen of the first barrel adjacent to the first gasket; and an inner portion of the first barrel adjacent to the double-ended needle. A plunger-like container slidably inserted into the cavity, the plunger-like container having a second barrel having a mouth at the tip and a mouth of the second barrel. A second gasket that seals and defines a lumen of the first barrel and is slidable in the lumen; and a fluid-tight and slidably inserted into the lumen of the second barrel; A drug chamber is defined on the distal end side of the first end, and a plunger coupling means is provided on the proximal end. When the plunger-like container is advanced, the first gasket and the second gasket are pierced by the double-ended needle, respectively, so that the solution chamber and the drug chamber are in fluid communication. The present invention relates to a two-component mixed prefilled syringe.
Here, in order to facilitate the piercing with the double-ended needle, it is preferable that the first gasket and the second gasket each have a thin portion formed by the double-ended needle. Also, a stopper is provided on the outer periphery of the proximal end of the second barrel so that the plunger-like container does not move backward when the third gasket is retracted, and the stopper and the first barrel are located at a position where the advancement of the plunger-like container is stopped. You may make it engage. Further, in order to maintain sterility in the second barrel, the opening at the base end of the second barrel may be closed with sterilized paper.
[0007]
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 two-component mixed 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 includes a first barrel 1 having a distal tip 11 and a flange 12 at a distal end and a proximal end, and a dissolution chamber 13 inserted into the first barrel 1. A first gasket 2 to be provided, a double-ended needle 3 inserted into the first barrel 1 and a plunger-like container P are included. The plunger-like container P includes a second barrel 4 having a mouth portion 41 at the tip, a second gasket 5 that is attached to the mouth portion 41 of the second barrel 4, and a medicine chamber that is inserted into the second barrel 4. And a third gasket 6 defining 42. When the plunger-like container P is advanced, the first gasket 1 and the second gasket 5 are pierced by the double-ended needle 3, respectively, so that the solution chamber 13 and the drug chamber 42 are in fluid communication.
[0008]
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 first gasket 2, a double-ended needle 3, and a plunger-like container P are inserted into the lumen of the first barrel 1 from the open end in this order. A solution chamber 13 is provided.
[0009]
The first gasket 2 is generally formed of a rubber elastic material such as natural rubber or synthetic rubber such as butyl rubber, isoprene rubber, or elastomer, and is inserted into the lumen of the first barrel 1 in a liquid-tight and slidable manner. Has been. And it is liquid-tightly divided by this 1st gasket 2, The front end side of the lumen | bore of the 1st barrel 1 becomes the solution chamber 13, and this solution chamber 13 was filled with the solution inside. Thereafter, the tip chip 11 is sealed by covering a sealing means such as a rubber cap 9 or the like.
The front end side of the first gasket 2 is generally formed in a conical shape, and is preferably laminated with a fluororesin such as polytetrafluoroethylene. The first gasket 2 includes a portion (piercing portion) that can be easily pierced by the tip side puncture needle 31 of the double-ended needle 3. In order to facilitate the piercing, for example, as shown in FIG. It is thin. Although not shown in the figure, the piercing portion 21 may be one in which a through hole is provided on the shaft of the first gasket 2 and the through hole is sealed with a film such as polyethylene. The piercing portion 21 is preferably provided on the distal end side where the liquid contact surface is laminated with a fluororesin, and therefore, the portion opposite to the piercing portion 21 of the first gasket 2 (in this case, the proximal end portion). Is a recess 22 as shown in FIG. The recess 22 is formed so that the distal puncture needle 31 of the double-ended needle 3 can be inserted, but may be formed so as to hold the inserted distal puncture needle 31.
[0010]
A double-ended needle 3 is slidably inserted into the lumen of the first barrel 1 adjacent to the first gasket 2. The double-ended needle 3 has a cutting edge, that is, a distal end side puncture needle 31 and a proximal end side puncture needle 33 on both sides with an intermediate hub 32 as a boundary so that it can slide along the lumen of the first barrel 1. The hub 32 is formed in a disk shape having a slide surface 321 at its end edge, for example.
[0011]
A plunger-like container P is further slidably inserted into the lumen of the first barrel 1 adjacent to the double-ended needle 3. The plunger-like container P is composed of a second barrel 4, a second gasket 5 that is crowned at the tip of the second barrel 4, and a third gasket 6 that is inserted into the lumen of the second barrel 4. ing. The second barrel 4 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 41, and its proximal end is open. The second gasket 5 is attached to the mouth portion 41 of the second barrel 4 so as to seal the mouth portion 41, and defines a lumen of the first barrel 1. It is slidable. The portion on the distal end side of the second gasket 5 includes a portion (piercing portion) that can be easily pierced by the proximal puncture needle 33 of the double-ended needle 3, and as shown in FIG. Is formed thin. When the plunger-like container P is advanced, it is necessary to release air between the first gasket 2 and the second gasket 5. There is no problem if the lumen of the first barrel 1 is not hermetically sealed by the second gasket 5, but if the compartment is hermetically sealed, for example, the air vent groove in the lumen of the first gasket 2 may be used. May be provided. 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.
[0012]
The third gasket 6 is inserted in the lumen of the second barrel 4 so as to be liquid-tight and slidable. Then, the second gasket 4 is partitioned liquid-tightly by the third gasket 6, and the distal end side of the lumen of the second barrel 4 is a drug chamber 42. The drug chamber 42 is opened after the drug is stored therein. The part 41 is sealed with the second gasket 5. The third gasket 6 is formed of the same material as that of the first gasket 2, and the tip side thereof is formed in a flat shape in FIG. 1 according to the shape of the tip side of the second barrel 4, for example, at the base end. Plunger coupling means 61 is provided. In FIG. 1, the plunger coupling means 61 is a recess having an internal thread formed on its inner wall.
A short cylindrical stopper 7 as shown in FIG. 1 is provided on the outer periphery of the base end of the second barrel 4 so that the plunger-like container P does not move backward when the third gasket 6 is moved backward. The stopper and the first barrel may be engaged with each other at a position where the forward movement of the container P is stopped (see FIG. 2c). In FIG. 1, the annular rib 71 of the stopper 7 is engaged with the annular groove 14 at the base end of the first barrel 1. In order to maintain sterility in the second barrel 4, the opening at the base end of the second barrel 4 may be closed with sterilized paper 8.
In the prefilled syringe configured as described above, when the plunger-like container P is advanced, the first gasket 2 and the second gasket 5 are pierced by the double-ended needle 3, respectively, and the solution chamber 13 and the drug chamber 42 are formed. Liquid communication.
[0013]
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 2 and the second gasket 5 are pierced by the double-ended needle 3, the distal puncture needle 31 protrudes into the solution chamber 13, and the proximal puncture needle 33 protrudes into the drug chamber 42. The solution chamber 13 and the drug chamber 42 communicate with each other through the passage 34 (FIG. 2b). When the plunger-like container P is further moved forward in this state, the solution in the solution-solution chamber 13 moves to the drug chamber 42 and the third gasket 6 of the plunger-like container P moves backward. The forward movement of the plunger-like container P is stopped at a position where the first gasket 2 hits the tip constriction of the first barrel 1 and the forward movement is prevented. At this time, the annular rib 71 of the stopper 7 at the rear end of the second barrel 4 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 of 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 8 is peeled off, and a plunger (not shown) is coupled to the plunger coupling means 61 of the third gasket 6 (see FIG. 2c), the rubber cap 9 may be removed from the tip 11 and an injection needle (not shown) may be connected.
[0014]
【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 third gasket forward and backward, the two components are mixed aseptically, and then other components are inhaled and mixed if necessary. 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 First gasket 21 Puncture 22 Engaging recess 3 Double-ended needle 31 Tip puncture needle 32 Hub 321 Slide surface 33 Base end puncture needle 4 Second Barrel 41 Mouth portion 42 Drug chamber 5 Second gasket 51 Puncture portion 6 Third gasket 61 Plunger coupling means 7 Stopper 71 Annular rib 8 Sterilized paper 9 Rubber cap P Plunger container

Claims (3)

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 double-ended needle slidably inserted into the lumen of the first barrel adjacent to the first gasket, and slidable into the lumen of the first barrel adjacent to the double-ended needle comprise becomes the inserted are plunger-like container, said plunger-like containers, have a mouth portion at the distal end, and a second barrel stopper is provided at the base end outer circumference, the crown into the mouth end of the second barrel A second gasket that seals the mouth portion and seals the lumen of the first barrel and is slidable in the lumen; and is fluid-tight and slidable in the lumen of the second barrel. A third portion that is inserted and defines a drug chamber on the distal end side of the lumen, and is provided with a plunger coupling means at the proximal end; Comprises a gasket, when advancing the plunger-like container, the double-ended needle the first gasket and second gasket is pierced respectively by the solution chamber and drug chamber is adapted to fluid communication A two-component mixed prefilled syringe in which the first barrel and the stopper are engaged at a position where the advance of the plunger-like container is stopped . 2. The prefilled syringe according to claim 1, wherein the first gasket and the second gasket each have a thin portion formed by being pierced by a double-ended needle. The prefilled syringe according to claim 1 or 2 , wherein the opening at the proximal end of the second barrel is closed with sterilized paper.

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