JP4114197B2 - 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 comprising a syringe containing a powder preparation or a solution and a bellows container containing a solution.
[0002]
[Prior art]
A liquid medicine, that is, a liquid medicine is accommodated in a liquid medicine container such as an ampoule and a vial sealed with a rubber stopper. 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, so-called prefilled syringes in which a plurality of drugs are separated from each other and stored in the same syringe and mixed before use are put into practical use. The prefilled syringe currently on the market is generally a two-component mixed type as shown in FIG. That is, when the barrel 160 is divided into two spaces by the first gasket 161 and the second gasket 162, the bypass groove 163 is recessed in the inner wall of the central portion of the barrel 160 and the plunger 164 is pushed in, the rear space 165 The lysing solution 170 (for example, physiological saline or glucose) enters the front space 166 through the bypass groove 163 and is mixed with the lyophilized preparation 180 (for example, lyophilized antibiotic).
[0004]
[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.
[0005]
On the other hand, in the prefilled syringe, the first gasket 161 is moved to the bypass groove 163, and after the entire amount of the lysis solution 170 in the rear space 165 has entered the front space 166, the lyophilized preparation 180 and the lysis solution 170 are sufficiently mixed. A large space is required to do this. However, even if the plunger 164 is pulled backward after the first gasket 161 has moved to the bypass groove 163, the liquid moves through the bypass groove 163 to the rear space 165, or the first gasket 161 and the second gasket 162. The first gasket 161 cannot move in the direction of the proximal end 160a of the barrel 160 from the bypass groove 163, and creates a space necessary for mixing the two drugs in the barrel 160. I can't. Accordingly, the volume of the front space 166 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 161 does not move in conjunction with pulling the plunger 164. 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.
[0006]
The present invention has been made in view of the above circumstances, and two or more kinds of drugs can be sterilized separately. There is a risk of elution from rubber during storage, operator injuries during the preparation of drugs, or contamination of foreign substances. An object of the present invention is to provide a compact prefilled syringe kit which is easy to handle and can be easily prepared in a short period of time and which is excellent in handling.
[0007]
[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 comprises a barrel having a male luer tapered injection needle connecting portion at the tip, and a gasket that is liquid-tightly and slidably inserted into the barrel, and contains a drug inside. A syringe and a bellows container having a female-type luer taper at the tip and containing a chemical solution therein, and the injection needle connecting portion and the discharge port are connected in a liquid-tight manner by a sealing means. It will be.
Here, the sealing means includes a distal end provided with a male luer taper sealing portion fitted to the discharge port, and a female luer tapered sealing portion fitted to the injection needle connecting portion. It is desirable that the sealing means has a skirt portion concentrically surrounding the discharge port fitted to the sealing portion of the male luer taper. You may do it.
[0008]
DETAILED DESCRIPTION OF THE INVENTION
Next, embodiments of the present invention will be described with reference to the drawings.
As shown in FIG. 1, the prefilled syringe kit 10 of the present invention includes a barrel 22 having an injection needle connecting portion 21 at the tip and a gasket 23 inserted into the barrel 22 in a liquid-tight and slidable manner. A syringe 20 containing a medicine in a space in front of the internal gasket 23, and a telescopic bottomed bellows container 30 having a discharge port 31 at the tip and containing a medicine inside, a syringe needle connecting portion 21 and the discharge port 31 are liquid-tightly connected by the sealing means 40.
[0009]
Here, the injection needle connecting portion 21 is a male luer taper, and the inner surface 31a of the discharge port 31 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 are generally used as 6% male luer taper and 6% female luer for syringe needle connection parts on commercially available syringes. Refers to taper. By adopting such a general-purpose luer taper as the shape of the connecting portion, the syringe and the bellows container can be separately connected to a general medical instrument such as a three-way stopcock and an infusion tube as necessary.
[0010]
Here, as the syringe 20, a barrel 22 having a proximal end 22 a having an injection needle connecting portion 21 at the distal end and an opened barrel 22 from the proximal end 22 a of the barrel 22 into the barrel 22 are slidably inserted. A syringe composed of a gasket 23 is preferably employed, and a medicine is accommodated in the front space of the gasket 23 in the barrel 22. The drug may be either a solid preparation or a liquid preparation, but is preferably a solid preparation, more preferably a lyophilized preparation. The barrel 22 of the syringe 20 is usually formed of glass, polyethylene, polypropylene, a mixture of polyethylene and polypropylene, and a finger-hanging flange 24 is provided at the base end 22a.
[0011]
The gasket 23 is formed of butyl rubber, thermoplastic elastomer, or the like, and a coupling means such as a female screw 25 is provided at the base end so that a plunger 50 provided with a male screw 51 at the tip can be coupled. Yes.
[0012]
Here, the bellows container 30 is a bottomed cylindrical container having a tip provided with a discharge port 31 and a bellows-like body part 32 that can be expanded and contracted and containing a chemical solution therein, and is usually made of polypropylene or polyethylene. Although it is formed, the material is not particularly limited as long as it is a flexible material acceptable as a medical device material. The bellows-like body part 32 is formed in a corrugated shape so that it can be expanded and contracted. When the bellows-like body part 32 is folded in a fold, the volume of the bellows container 30 is reduced, and the chemical solution can be discharged from the discharge port 31. it can.
[0013]
In addition, as shown in FIG. 2, a finger hooking flange 62 can be provided at the distal end peripheral edge 61 a of the bellows-like body 61 of the bellows container 60.
[0014]
Further, as shown in FIG. 3, the bellows container 70 is liquid-tightly sealed by weakly welding the seal member 80 to the inner surface 71a of the discharge port 71 so as to block communication between the inside and the outside of the container. May be. That is, the inner surface 71a of the discharge port 71 is reduced in diameter at the base end 71b to form a shoulder 72, and the seal member 80 is weakly welded to the distal end side of the shoulder 72 so as to be peeled off. Is hermetically sealed. The material of the seal member 80 is not particularly limited as long as it is a material that is incompatible with the forming material of the bellows container 70. For example, when the bellows container 70 is made of polypropylene, the seal member 80 is preferably a mixture of polypropylene and polyethylene. Thus, by closing the chemical solution passage inside the discharge port with the seal member, the stored chemical solution is not accidentally leaked when the chemical solution container according to the present invention is attached to the syringe.
[0015]
Here, the sealing means 40 shown in FIG. 1 is a substantially cylindrical member having a distal end provided with a convex portion 41 of a male luer taper and a proximal end provided with a concave portion 42 of a female luer taper. Usually formed from an elastic material such as butyl rubber or thermoplastic elastomer. The convex part 41 of the male luer taper at the distal end fits into the inner surface 31a of the discharge port 31 of the bellows container 30, and the concave part 42 of the female luer taper at the proximal end fits into the injection needle connecting part 21 of the syringe 20 in a liquid-tight manner. To do. Thus, since both the injection needle connection part 21 of the syringe 20 and the discharge port 31 of the bellows container 30 are sealed by the single sealing means 40, separate sealing means for the syringe 20 and the bellows container 30 are provided. There is no need to provide. Therefore, the manufacturing cost is reduced and the number of wastes is reduced.
[0016]
Here, the bellows container 30 falls off from the sealing means 40 in a state where the convex portion 41 of the male luer taper at the tip of the sealing means 40 is merely fitted to the inner surface 31 a of the discharge port 31 of the bellows container 30. There is a fear. In order to prevent such dropout, as shown in FIG. 4, the sealing means 90 is provided with a skirt portion 91 extending in the distal direction, and the outer surface of the convex portion 92 of the male luer taper and the inner surface of the skirt portion 91 are provided. The discharge port 31 of the bellows container 30 may be liquid-tightly sealed so as to narrow.
[0017]
Further, as shown in FIG. 5, the sealing means 100 is made of an elastic member 110 having a distal end provided with a convex portion 111 having a male luer taper and a proximal end provided with a concave portion 112 having a female luer taper. It is good also as a structure inserted in the outer cylinder 120 which consists of synthetic resins. By inserting the elastic member 110 into the outer cylinder 120, it is possible to suppress the expansion of the elastic member 110 in the radial direction, so that it is elastic when compared with the sealing means 40 of FIG. The thickness of the member 110 in the radial direction can be reduced, and the manufacturing cost of the elastic member can be suppressed. The outer cylinder 120 is usually formed of hard synthetic resin such as polypropylene, polystyrene, high density polyethylene, polycarbonate, polyurethane, polyvinyl chloride, ABS resin.
[0018]
As shown in FIG. 6, the sealing means 130 includes a protruding portion 131 of a male luer taper at the tip, and a skirt portion surrounding the discharge port 31 of the bellows container 30 fitted on the protruding portion 131 of the male luer taper. 132, and a distal end 132a of the skirt portion 132, which is the distal end of the sealing means, is connected to the shoulder portion 33 of the bellows container 30 and the sealing portion. The distal end 133a of the concave part 133 of the female luer taper that is the base end of the means is welded to the shoulder part 26 of the syringe 20 via the weak parts 140 and 150 that can be peeled off by the rotation operation of the sealing means 130, respectively. There may be. By using a flexible material such as plastic instead of a costly elastic material such as butyl rubber or thermoplastic elastomer as the material of the sealing means 130, the manufacturing cost can be reduced. The sealing means 130 shown in FIG. 6 is usually formed of polyethylene or polypropylene, or a mixture of polyethylene and polypropylene, and the weakened portions 140 and 150 are usually made of a material that is poorly compatible with the syringe 20 and the bellows container 30. It is formed. For example, when the syringe 20 and the bellows container 30 are formed with polypropylene as a main component, it is preferable that the weakened portions 140 and 150 have a mixture of polyethylene and polypropylene, a copolymer of polyethylene or a grafted product as a main component. When the syringe 20 and the bellows container 30 are formed with polypropylene as a main component, the sealing means 130 is formed with a mixture of polyethylene and polypropylene, a polyethylene copolymer or a grafted product as a main component, and the syringe 20 It may be weakly welded directly to the shoulder portion 26 and the shoulder portion 33 of the bellows container 30 so as to be peeled off by rotating the sealing means 130.
[0019]
Subsequently, the manufacturing method of the prefilled syringe kit which concerns on this invention is demonstrated. The prefilled syringe kit of the present invention is usually filled with a chemical solution in a bellows container, and the discharge port is sealed with a sealing means, followed by high-pressure steam sterilization, and a gasket is inserted into a syringe barrel to a predetermined position. And the drug is freeze-dried, and then the syringe needle connecting portion is aseptically attached to one end of the sealing means sealing the discharge port of the sterilized bellows container.
Also, when sealing the discharge port of the bellows container by welding a sealing member therein, the inside of the discharge port is sealed with a seal member, and the bellows container filled with a chemical is sterilized by high-pressure steam, After filling the barrel into which the injection needle connecting part is sealed with a sealing means, the drug is freeze-dried with the gasket half-plugged at the base end of the barrel, and after lyophilization, the gasket is moved to a predetermined position. The moving and sterilized bellows container outlet is aseptically attached to one end of the sealing means.
[0020]
【The invention's effect】
As is apparent from the above description, according to the present invention, two or more kinds of drugs can be sterilized separately, there is a risk of elution from rubber during storage, operator injuries or foreign matter contamination during drug preparation Therefore, it is possible to provide a compact prefilled syringe kit that is easy to handle and can be used for drug preparation in a short time and is excellent in handling.
[Brief description of the drawings]
FIG. 1 is a longitudinal sectional view showing an embodiment of the present invention.
FIG. 2 is a partial longitudinal sectional view showing another embodiment of the bellows container of the present invention.
FIG. 3 is a partial longitudinal sectional view showing another embodiment of the bellows container of the present invention.
FIG. 4 is a longitudinal sectional view showing another embodiment of the present invention.
FIG. 5 is a longitudinal sectional view showing another embodiment of the present invention.
FIG. 6 is a longitudinal sectional view showing another embodiment of the present invention.
FIG. 7 is a longitudinal sectional view showing a conventional technique.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 10 Prefilled syringe 20 Syringe 21 Injection needle connection part 22, 160 Barrel 23 Gasket 24, 62 Finger hook flange 25 Female screw 26, 33, 72 Shoulder part 30, 60, 70 Bellows container 31, 71 Discharge port 31a, 71a Inner surface 32, 61 Bellows-shaped body portions 40, 90, 100, 130 Sealing means 62a Tip peripheral edge portion 71b Base end 80 Seal member 91, 132 Skirt portions 92, 111, 131 Convex portion 110 of male luer taper Elastic member 112, 133 Female lure Tapered recess 120 Outer cylinder 132a, 133a Terminal 140, 150 Fragile portion 161 First gasket 162 Second gasket 163 Bypass groove 164 Plunger 165 Rear space 166 Front space 170 Dissolved solution 180 Lyophilized preparation

Claims (1)

A syringe having a male luer tapered injection needle connecting portion at the tip, a syringe that is liquid-tight and slidably inserted into the barrel, and containing a medicine inside, and a female luer taper at the tip The injection needle connecting portion and the discharge port are concentrically formed with a male luer taper that fits into the discharge port and the discharge port. A sealing means having a distal end provided with a sealing portion of the surrounding skirt portion and a proximal end provided with a sealing portion of a female luer taper fitted to the injection needle connecting portion is liquid-tightly connected and sealed. The distal end of the skirt, which is the tip of the stopper, is peeled off by the rotation of the sealing means, and the shoulder of the bellows container, and the distal end of the recess of the female luer taper, which is the proximal end of the sealing means, is peeled off by rotating the sealing means Possible It is welded through a weak part prefilled syringe kit comprising.

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