JP4092994B2 - Prefilled syringe kit - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a prefilled syringe kit. More specifically, the present invention relates to a prefilled syringe kit including a syringe containing a powder preparation or a solution and a syringe containing a solution.
[0002]
[Prior art]
Liquid chemicals, that is, chemicals, are stored in chemical containers such as ampoules and vials sealed with rubber stoppers. And when injecting these ampoules and liquids contained in vials, in the case of ampoules, after cutting the ampule, in the case of vials, pierced the rubber stopper with the injection needle attached to the syringe, A syringe needle is newly attached to the syringe, which is different from the needle used for puncturing the rubber stopper and inserted into the syringe, and the patient is injected.
[0003]
In addition, a so-called multi-component mixed type prefilled syringe, in which a plurality of drugs are stored separately in the same syringe and mixed at the time of use, has been put into practical use. The multi-component mixed prefilled syringe currently marketed is generally a two-component mixed type as shown in FIG. That is, when the barrel 190 is divided into two spaces by the first gasket 270 and the second gasket 200 and the bypass groove 210 is recessed in the inner wall of the central portion of the barrel 190 and the plunger 220 is pushed in, the rear space 230 The lysate 240 (for example, physiological saline or glucose) enters the front space 250 through the bypass groove 210 and is mixed with the lyophilized preparation 260 (for example, lyophilized antibiotic).
[0004]
In addition, as a conventional example of a two-component mixed prefilled syringe, there has also been proposed one in which two container-use syringes made of a cartridge that contains a medicine in advance are connected on the same axis so that the tube tips face each other (for example, , See Patent Document 1). According to this, both ends of the cartridge of each container-use syringe are sealed by the first rubber topper and the second rubber topper to which the plunger rod can be connected, and the opening sealed by the first rubber topper Is provided with a bypass chamber capable of accommodating the first rubber topper. And the bypass wall is provided in the inner wall surface of this bypass chamber, and in use, the pressure inside the cartridge is increased by pushing the plunger rod, and the first rubber stopper is pushed into the bypass chamber by this pressure, The bypass groove and the inside of the cartridge are opened.
[0005]
[Patent Document 1]
Japanese Unexamined Patent Publication No. 2000-70366 (page 7, FIG. 1)
[0006]
[Problems to be solved by the invention]
However, the method using an ampoule or vial requires a metal needle to connect the drug container and the syringe, so the operator may be injured by the injection needle. There is a possibility that foreign matters such as rubber pieces generated when the rubber stopper of the vial is punctured are mixed in the chemical solution. Furthermore, since the operation is complicated, it takes time for injection, and an accurate amount cannot be aspirated. Further, in the case of a high-viscosity chemical solution such as sodium hyaluronate, a great amount of time and suction force are required to suck the chemical solution from the chemical solution container into the syringe. In addition, when a chemical solution in a vial is aspirated, the inside of the vial is depressurized as it is aspirated. Therefore, a force is gradually required for a suction operation, and a smooth suction cannot be performed.
[0007]
On the other hand, in the two-component mixed prefilled syringe shown in FIG. 7, the first gasket 270 is moved to the bypass groove 210, and the entire amount of the lysis solution 240 in the rear space 230 enters the front space 250. A large space is required to sufficiently mix the solution 240 and the solution 240. However, even if the plunger 220 is pulled backward after the first gasket 270 has moved to the bypass groove 210, the liquid flows back to the rear space 230 through the bypass groove 210 or the first gasket 270 and the second gasket 200. The first gasket 270 cannot move in the direction of the proximal end 190a of the barrel 190 from the bypass groove 210, and creates a space necessary for mixing the two drugs in the barrel 190. I can't. Therefore, the volume of the front space 250 needs to be increased in advance, and there is a problem that the size of the syringe increases with respect to the volume of the medicine.
In addition, even if it is necessary to add another chemical after mixing the two components, the first gasket 270 does not move in conjunction with the plunger 220 even if the plunger 220 is pulled. It is difficult to aspirate quantitatively. Furthermore, additives such as sulfur and vulcanization accelerators contained in the gasket may be eluted into the solution during storage. Furthermore, since two kinds of medicines are contained in the same barrel, they cannot be sterilized separately at the time of manufacture.
[0008]
On the other hand, in the conventional example shown in Patent Document 1, after opening the bypass groove of one of the container and syringe, the bypass groove of one of the container and syringe must be further opened, which may take time for preparation. In addition, after sealing both ends of the two container / use syringes with a rubber topper, a bypass chamber must be provided on one side, which may increase the number of parts and increase the manufacturing cost.
[0009]
The present invention has been made in view of the above circumstances, and two or more kinds of medicines can be sterilized separately, and there is no risk of operator injury or foreign matter contamination during the preparation of the medicine. An object of the present invention is to provide a prefilled syringe kit that can be operated.
[0010]
[Means for Solving the Problems]
The inventors of the present invention have arrived at the present invention as a result of intensive studies in order to solve the above problems. That is, the prefilled syringe kit of the present invention can be coupled with a first barrel having a male luer taper needle connection at the tip, and a plunger that is liquid-tightly and slidably inserted into the first barrel. A second syringe having a first syringe containing a first medicine therein, a female luer taper discharge port capable of being fluid-tightly connected to the injection needle connection portion, and the second barrel A second gasket which is inserted into the barrel in a liquid-tight and slidable manner and which can be coupled with a plunger; and a second syringe containing a second medicine therein. The outlet is connected in a liquid-tight manner, and the peripheral edge of the base end of the discharge port is reduced in diameter to form a flat surface, and the seal member is weakly welded to the flat surface so as to be liquid-tight. Sealed structure It becomes more.
Further, a part of the seal member may be strongly welded so as not to be peeled off as compared with the weakly welded portion, and the tip of the discharge port is peeled off by a relative rotation operation of the first syringe and the second syringe. It may be weakly welded to the shoulder portion of the first syringe via a possible weak portion.
Further, a male screw may be provided at a proximal end of the injection needle connecting portion, a female screw that is screwed with the male screw may be provided at a distal end of the discharge port, and a shoulder at the distal end of the first syringe may be provided. A skirt portion having a female screw on the inner wall surrounding the injection needle connecting portion concentrically may be provided, and a flange threadedly engaged with the female screw may be provided at the tip of the discharge port.
In addition, the plunger may be pre-coupled to the first gasket, and it is preferable that the first drug is a solid preparation and the second drug is a liquid.
[0011]
DETAILED DESCRIPTION OF THE INVENTION
Next, embodiments of the present invention will be described with reference to the drawings.
FIG. 1 is a diagram showing an embodiment of the present invention. (A) is a longitudinal cross-sectional view, (b) is the A'-A 'sectional view taken on the line in (a). As shown in FIG. 1, a prefilled syringe kit 10 of the present invention has a first barrel 21 having a male luer taper injection needle connecting portion 22 at the tip, and is fluid-tight and slidable in the first barrel 21. The inserted first gasket 40 that can be coupled to the plunger 60, the first syringe 20 containing the first medicine D1 therein, and the female luer that can be fluid-tightly connected to the injection needle connecting portion 22 The second medicine D2 includes a second barrel 31 having a tapered discharge port 32 and a second gasket 50 which is inserted into the second barrel 31 in a liquid-tight and slidable manner and which can be coupled with a plunger. Fragile portion 8 that can be peeled off by relative rotation between the first syringe 20 and the second syringe 30. In addition, the peripheral edge of the base end of the discharge port 32 is reduced in diameter to form a flat surface 33, and the sealing member 70 is weakly welded to the flat surface 33 so as to be peeled off. Thus, the discharge port 32 is liquid-tightly sealed.
As described above, by adopting a configuration in which the first syringe 20 and the second syringe 30 are connected in advance, the seal that seals the injection needle connecting portion 22 of the first syringe 20 and the discharge port 32 of the second syringe 30, respectively. Since the stopping means is not required, the manufacturing cost is reduced and the number of wastes in use is reduced. Furthermore, when the first syringe and the second syringe are sealed by separate sealing means, there is no risk of contamination by airborne bacteria when connecting the two.
[0012]
Here, the injection needle connecting portion 22 is a male luer taper, and the discharge port 32 is a female luer taper that fits with the male luer taper. The male luer taper and female luer taper referred to here are those of ISO standards, and refer to 6% male luer taper and 6% female luer taper that are generally used in medical instruments that are commercially available. By adopting such a general-purpose luer taper for the connecting portion, the first syringe 20 and the second syringe 30 are separately connected to general medical instruments such as a three-way stopcock and an infusion tube, as necessary. Can do.
[0013]
Here, as the first syringe 20, the first barrel 21 having the proximal end 21 a having the injection needle connecting portion 22 at the distal end is opened, and the first barrel 21 is liquid-tight from the proximal end 21 a of the first barrel 21 to the first barrel 21. A syringe comprising the first gasket 40 inserted slidably is suitably employed, and the first drug D1 is accommodated in the front space of the first gasket 40 in the first barrel 21. The first drug D1 may be either a solid preparation or a liquid preparation, but is preferably a solid preparation, more preferably a lyophilized preparation. A finger hooking flange 23 is provided at the base end 21 a of the first barrel 21. The first barrel 21 is usually made of glass or a plastic material such as polyethylene, polypropylene, or a mixture of polyethylene and polypropylene, but the plastic material has transparency that is accepted as a medical material. For example, the material is not particularly limited.
[0014]
The first gasket 40 is formed of butyl rubber, thermoplastic elastomer, or the like, and a coupling means such as a female screw 41 is provided at the base end so that a plunger 60 provided with a male screw 61 at the tip can be coupled. It has become.
In addition, when accommodating the freeze-dried preparation in the first syringe 20, after filling the medicine to be freeze-dried in the first barrel 21, the first gasket 40 was half-plugged at the base end 21 a of the first barrel 21. In the state, after freeze-drying by evaporating moisture from the bypass groove 24 provided in the first barrel 21, the first gasket 40 is vacuum-plugged to a predetermined position in the first barrel 21. At this time, the space in front of the first gasket 40 in the first barrel 21 is filled with the freeze-dried preparation, and there are almost no voids. Accordingly, since the first gasket 40 can be positioned in the distal direction of the first barrel 21, even if the plunger 60 is coupled to the first gasket 40 and stored, the total length of the prefilled syringe kit becomes too long. There is no.
[0015]
Here, as the second syringe 30, a second barrel 31 having a base end 31 a having a discharge port 32 at the front end and an open base end 31 a of the second barrel 31 is liquid-tight and slid into the second barrel 31. A syringe composed of the second gasket 50 movably inserted is suitably employed, and the second medicine D2 is accommodated in the front space of the second gasket 50 in the second barrel 31. Here, it is preferable that the 2nd chemical | medical agent D2 is a liquid agent. Unlike the first syringe 20, the base end 31 a may be provided with a finger hooking flange 34, but is not essential. Because the second gasket 50 is slidable by suction from the first syringe 20, it is not always necessary to connect the plunger to the second gasket 50 and press it. This is because it is rare to use the second syringe 30 as an injection syringe because the injection needle 300 as shown in FIG. 6D is connected to the injection needle connection portion 22 and used as an injection syringe. As described above, since the plunger may not be connected to the second gasket 50, it is not always necessary to provide the female screw 51 for connecting the plunger at the base end of the second gasket 50. However, when the second drug D <b> 2 is a liquid with a high viscosity, it may be difficult to move the liquid from the second barrel 31 to the first barrel 21 with only the suction force from the first syringe 20. In such a case, a plunger can be connected to the second gasket 50 and the liquid agent can be moved to the first barrel 21 by pressing. As the plunger connected to the second gasket 50, it is preferable to use a plunger 60 that is coupled to the first gasket 40. This eliminates the need to attach a new plunger for the second gasket 50, and also reduces the manufacturing cost. Lowers the number of waste and reduces the size of the prefilled syringe kit.
The second barrel 31 is usually formed of glass or a plastic material such as polyethylene, polypropylene, or a mixture of polyethylene and polypropylene. However, the plastic material may have transparency that is recognized as a medical material. For example, the material is not particularly limited.
[0016]
Here, the discharge port 32 has a flat peripheral surface 33 formed by reducing the diameter of the peripheral edge of the base end, and is liquid-tightly sealed by weakly welding the seal member 70 to the flat surface 33 in a peelable manner. Has been. The material of the seal member 70 is not particularly limited as long as the material is incompatible with the material forming the second barrel 31. For example, when the second barrel 31 is made of polypropylene, the material of the seal member 70 is Is preferably a mixture of polypropylene and polyethylene. Then, the seal member 70 is peeled toward the distal end direction of the discharge port 32, that is, toward the outer side due to the pressure increase inside the second barrel 31 caused by pushing the second gasket 50 toward the distal end direction. Further, when the seal member 70 is peeled off from the second barrel 31, it may be strongly welded that it is difficult to peel off a part of the welded surface so that the weak welded portion does not peel off at all.
[0017]
Here, the discharge port 32 is fluid-tightly fitted with the injection needle connecting portion 22, and the distal end portion of the discharge port 32 is connected to the shoulder portion 25 of the first barrel 21 with the first syringe 20 and the second syringe 30. Are welded via a weakened portion 80 that can be peeled off by a relative rotation operation. The fragile portion 80 is usually formed of a material having poor compatibility with the forming material of the first barrel 21. For example, when the first barrel 21 is formed mainly of polypropylene, the fragile portion 80 is formed. 80 is formed of a material mainly composed of a mixture of polypropylene and polyethylene, a copolymer or grafted product of polyethylene, and the first syringe 20 and the second syringe 30 are welded so as to be peelable through the fragile portion 80. .
Although not shown, when the first syringe is formed with polypropylene as a main component, the second syringe is formed with a mixture of polyethylene and polypropylene, a polyethylene copolymer or a grafted product as a main component, and a discharge port. You may weakly weld directly the front-end | tip part to the shoulder part of a 1st barrel so that it can peel by the relative rotation operation of a 1st syringe and a 2nd syringe.
Thus, since the 1st syringe 20 and the 2nd syringe 30 are adhere | attached not only by fitting but by welding, a chemical | medical agent leaks at the time of transportation or storage, or the 1st syringe 20 and the 2nd syringe 30. There is no such thing as inadvertent separation.
Further, the first syringe 20 and the second syringe 30 have the shoulder portion 25 of the first barrel 21 and the distal end portion of the discharge port 32 weakly welded via the fragile portion 80. Is away from the distal end opening of the injection needle connector 22. Therefore, even if a foreign material piece is generated when the fragile portion 80 is peeled off, there is no possibility that the foreign material piece enters the first barrel 21 from the distal end opening of the injection needle connecting portion 22.
[0018]
Next, another embodiment of the present invention will be described.
FIG. 2 is a cross-sectional view of a main part of another embodiment of the present invention, in which an engaging portion that engages with the fragile portion is provided on the side surface of the distal end of the discharge port.
The configuration of each part of the prefilled syringe kit of this embodiment shown in FIG. 2 is substantially the same as that of the prefilled syringe kit of the embodiment shown in FIG. The difference is that the engaging portion 92 is provided at several locations or all around the tip side surface of the discharge port 91 so that the weakened portion 180 and the second barrel 93 are difficult to physically separate from each other. Even when the compatibility with the fragile portion 180 is poor, the fragile portion 180 and the second barrel 93 are always integrated and peeled from the first syringe 100. Thus, after the second syringe 90 is peeled from the first syringe 100, there is no possibility that the weakened portion 180 remains on the shoulder 111 of the first syringe 100, and the injection of the injection needle 300 as shown in FIG. The injection needle connecting portion 112 can be fitted to the back of the needle base.
[0019]
Furthermore, another embodiment of the present invention will be described.
FIG. 3 is a cross-sectional view of an essential part of another embodiment of the present invention, in which a female screw screwed with a male screw provided at a proximal end of an injection needle connecting portion of a first syringe is a distal end of a discharge port of a second syringe. Is provided.
The configuration of each part of the prefilled syringe kit of this embodiment shown in FIG. 3 is substantially the same as that of the prefilled syringe kit of the embodiment shown in FIG. The difference is that a male screw 122 is provided at the proximal end of the injection needle connecting portion 121 of the first syringe 120, and a female screw 132 to be screwed with the male screw 122 is provided at the distal end of the discharge port 131 of the second syringe 130. It is in the point provided.
Thus, since the injection needle connecting portion 121 and the discharge port 131 are coupled not only by fitting with the luer taper but also by screwing the male screw 122 and the female screw 132, the drug leaks during transportation or storage. Or the first syringe 120 and the second syringe 130 may be inadvertently separated.
[0020]
Furthermore, another embodiment of the present invention will be described.
FIG. 4 is a cross-sectional view of a main part of another embodiment of the present invention, in which a flange portion screwed with a female screw provided on an inner wall of a skirt portion formed on the shoulder portion of the first barrel is a discharge port of the second syringe. It is provided at the tip of the outlet.
The configuration of each part of the prefilled syringe kit of this embodiment shown in FIG. 4 is substantially the same as that of the prefilled syringe kit of the embodiment shown in FIG. The difference is that a flange portion 152 that engages with a female screw 144 provided on an inner wall of a skirt portion 143 that surrounds the injection needle connecting portion 142 formed on the shoulder portion 141 of the first barrel 145 of the first syringe 140 is the first one. It exists in the point provided in the front-end | tip of the discharge outlet 151 of 2 syringe 150. FIG.
As described above, the first syringe 140 and the second syringe 150 are coupled by screwing the flange portion 152 and the female screw 144 in addition to the fitting by the luer taper between the injection needle connecting portion 142 and the discharge port 151. Therefore, there is no possibility that the medicine leaks during transportation or storage, or the first syringe 140 and the second syringe 150 are inadvertently separated.
[0021]
Furthermore, another embodiment of the present invention will be described.
FIG. 5 is a longitudinal sectional view showing another embodiment of the present invention, which is characterized in that the second barrel is thick and short.
The configuration of each part of the prefilled syringe kit of this embodiment shown in FIG. 5 is substantially the same as that of the prefilled syringe kit of the embodiment shown in FIG. The difference is that the second syringe 160 of the present embodiment is larger in diameter and shorter in length than the second syringe shown in FIGS.
Thus, by shortening the length of the second syringe 160, the total length of the prefilled syringe kit 170 can be shortened. Note that the diameter naturally increases as the total length of the second syringe is shortened, but since the ratio of increasing the diameter is smaller than the ratio of decreasing the total length, the merit of shortening the total length is higher. For reference, for example, when the total length of the second syringe containing about 15 mL of the drug solution is about 80 mm and the diameter is about 20 mm, the diameter is about 10 mm even if the length is about 30 mm shorter. Stays expanded.
[0022]
Next, the use of the prefilled syringe kit of the present invention will be described with reference to FIG.
First, as shown to (a) of FIG. 6, the 1st syringe 20 which accommodated the freeze-dried formulation D, and the 2nd syringe 30 which accommodated the solution L are the 1st syringe 20 and the 2nd syringe 30. A prefilled syringe kit 10, which is a preferred embodiment of the present invention, is connected in a liquid-tight manner through a fragile portion 80 that can be peeled off by a relative rotational operation, as shown in FIG. 6 (b). When the plunger 60 connected to the first gasket 40 is connected to the second gasket 50 and the plunger 60 is pushed in the direction of the arrow A, as shown in FIG. The seal member 70 that has been weakly welded to the base end portion of the discharge port peels off toward the distal end direction of the discharge port 32, that is, the outer side, leaving the strong weld portion, and the solution L in the second barrel 31 is removed from the first barrel. 21 flows into. Thereafter, the entire prefilled syringe 10 is shaken, and the lyophilized preparation D is completely dissolved in the solution L to prepare an injection LD.
Finally, as shown in FIG. 6 (d), the second syringe 30 is removed, the injection needle 300 is connected to the injection needle connecting portion 22 of the first syringe 20, and the plunger 60 is coupled to the first gasket 40 again. Then, the injection drug LD can be injected into a patient's vein or the like.
[0023]
【The invention's effect】
As is apparent from the above description, according to the present invention, two or more kinds of medicines can be sterilized separately, and there is no risk of operator injury or foreign matter contamination during preparation of the medicine, and the medicine can be conveniently and quickly. A prefilled syringe kit capable of a preparation operation can be provided.
[Brief description of the drawings]
FIG. 1 is a diagram showing an embodiment of the present invention. (A) is a longitudinal cross-sectional view, (b) is the A'-A 'sectional view taken on the line in (a).
FIG. 2 is a longitudinal sectional view of an essential part showing an embodiment of the present invention.
FIG. 3 is a longitudinal sectional view of an essential part showing an embodiment of the present invention.
FIG. 4 is a longitudinal sectional view of an essential part showing an embodiment of the present invention.
FIG. 5 is a longitudinal sectional view showing an embodiment of the present invention.
FIG. 6 is a diagram for explaining a use situation of the present invention.
FIG. 7 is a longitudinal sectional view showing a conventional technique.
[Explanation of symbols]
10 Prefilled syringe kit 20, 100, 120, 140 First syringe 21, 145 First barrel 22, 112, 121, 142 Injection needle connection portion 25, 111, 141 Shoulder portion 30, 90, 130, 150, 160 Second syringe 31, 93 Second barrel 32, 91, 131, 151 Discharge port 33 Flat surface 40 First gasket 50 Second gasket 60 Plunger 70 Seal member 80, 180 Fragile portion 122 Male screw 132, 144 Female screw 143 Skirt portion 152 Flange D1 First 1 drug D2 2nd drug

Claims (4)

A first barrel having a male luer taper needle connection at the tip, and a first gasket which is inserted into the first barrel so as to be fluid-tight and slidable and to which a plunger can be coupled. A first barrel containing one medicine, a second barrel having a discharge port of a female luer taper that can be liquid-tightly connected to the injection needle connecting portion, and liquid-tight and slidable in the second barrel It is composed of a second syringe that is inserted and is composed of a second gasket that can be coupled with a plunger, and in which a second medicine is accommodated, and the injection needle connecting portion and the discharge port are connected in a liquid-tight manner. In addition, the peripheral edge of the base end of the discharge port is reduced in diameter to form a flat surface, and the discharge port is liquid-tightly sealed by weakly welding the seal member to the flat surface in a peelable manner , The tip of the discharge port is the first syringe The second through the peelable weak portion by the relative rotation operation of the syringe, prefilled syringe kit formed by weakly welded to the shoulder portion of the first syringe. The prefilled syringe kit according to claim 1, wherein a part of the seal member is strongly welded so as not to be peeled off as compared with the weak welded part. The prefilled syringe kit according to claim 1 or 2 , wherein the plunger is pre-coupled to the first gasket. The prefilled syringe kit according to any one of claims 1 to 3 , wherein the first drug is a solid preparation and the second drug is a liquid.

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