JP4579486B2 - 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]
Drugs that are difficult to maintain pharmaceutical and medicinal stability when mixed are conventionally stored separately in ampoules or vials and stored, and mixed using a syringe or transfusion needle at the time of use. It is prepared and used.
For example, in the case of a lyophilized preparation contained in a vial, the solution contained in the vial or ampoule is sucked into a syringe (or a solution injection needle is attached to a so-called prefilled syringe containing a solution in advance) The injection needle is pierced through the rubber stopper of the vial, the solution is injected from the syringe into the vial, the freeze-dried preparation is mixed with the solution to prepare a drug solution, and after the drug solution preparation operation is completed, the drug solution is transferred from the vial to the syringe. Aspirated and used.
[0003]
In addition, a so-called prefilled syringe has been proposed and put into practical use, in which a plurality of drugs are stored separately in the same syringe and mixed for use. The prefilled syringe currently marketed is generally a two-component mixed type as shown in FIG. That is, when the barrel 60 is divided into two spaces by the first gasket 61 and the second gasket 62 and the bypass groove 63 is formed in the inner wall of the central portion of the barrel 60 and the plunger 64 is pushed in, the rear space 65 A solution 66 (for example, physiological saline or glucose) enters the front space 67 through the bypass groove 63 and is mixed with a freeze-dried preparation 68 (for example, freeze-dried antibiotic).
[0004]
[Problems to be solved by the invention]
However, the above prior art has the following problems.
In the conventional method using a syringe, a metal needle is required for the preparation of the chemical solution, so there is a risk that the operator may be injured by the injection needle. There is a possibility that foreign matter such as coring generated when puncturing is mixed into the chemical solution. Moreover, since the operation is complicated, the preparation takes time.
[0005]
On the other hand, in the prefilled syringe, the first gasket 61 is moved to the bypass groove 63 and the entire amount of the lysate 66 in the rear space 65 enters the front space 67, and then the lyophilized preparation 68 and the lysate 66 are sufficiently mixed. A large space is required to do this.
However, even if the plunger 64 is pulled after the first gasket 61 moves to the bypass groove 63, the liquid moves to the rear space 65 through the bypass groove 63, and the first gasket 61 and the second gasket 62 are separated separately. Since the first gasket 61 slides, the first gasket 61 cannot move in the direction of the proximal end 60a of the barrel 60 from the bypass groove 63, and a space necessary for mixing both drugs cannot be created in the barrel 60. Therefore, the volume of the front space 67 needs to be increased in advance, and there is a problem that the size of the syringe increases with respect to the medicine volume.
Even if it is necessary to add another chemical after mixing the two components, the first gasket 61 does not move in conjunction with the plunger 64 even if the plunger 64 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.
[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 includes a syringe comprising a barrel having an injection needle connecting portion at the tip, a gasket that is liquid-tightly and slidably inserted in the barrel, and an extendable and retractable device having a discharge port at the tip. It consists of a bottom cylindrical bellows container, and the injection needle connecting portion and the discharge port can be connected in a liquid-tight manner.
[0008]
The distal end opening of the injection needle connecting portion and the opening at the distal end of the discharge port are preferably sealed in a liquid-tight manner, and the discharge port is weakly welded so that the seal member can be peeled inside thereof, It can also be sealed liquid-tight.
[0009]
Further, the prefilled syringe kit of the present invention includes a syringe having a barrel having an injection needle connecting portion at the tip, a gasket that is liquid-tightly and slidably inserted in the barrel, and an extendable and retractable having a discharge port at the tip. Consists of a bottomed cylindrical bellows container, the injection needle connecting part and the discharge port are connected in a liquid-tight manner, and the discharge port is made liquid-tight by weakly welding the seal member inside thereof in a peelable manner. It may be sealed.
[0010]
The shape of the injection needle connection portion is preferably a male luer taper, and the shape of the discharge port is preferably a female luer taper that fits into the injection needle connection portion.
[0011]
Further, it is preferable that the first medicine is contained in the barrel and the second medicine is contained in the bellows container.
[0012]
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 present invention, in which a sealing means for a discharge port opening is a cap member. FIG. 2 is a longitudinal sectional view showing another embodiment of the present invention, in which the sealing means for the discharge port opening is a seal member. FIG. 3 is a partially enlarged longitudinal sectional view of the discharge port of the bellows container according to the embodiment of the present invention. FIG. 4 is a partial cross-sectional view showing another embodiment of the bellows container of the present invention, which has a structure in which the remaining liquid is discharged as much as possible and the contracted state of the bellows is maintained.
FIG. 5 is a longitudinal sectional view showing another embodiment of the present invention, in which a syringe and a bellows container are connected in advance. FIG. 6 and FIG. 7 are diagrams for explaining the usage status of the prefilled syringe kit of the present invention.
[0013]
As shown in FIG. 1, the prefilled syringe kit 1 of the present invention includes a barrel 12 having an injection needle connecting portion 11 at the tip, and a gasket 13 inserted into the barrel 12 so as to be liquid-tight and slidable. And an expandable bottomed cylindrical bellows container 20 having a discharge port 21 at the tip, and the injection needle connecting portion 11 and the discharge port 21 can be connected in a liquid-tight manner.
[0014]
Here, as the syringe 10, a barrel 12 having a proximal end 12 a having an injection needle connecting portion 11 at the distal end is opened, and the barrel 12 is inserted from the proximal end 12 a of the barrel 12 into the barrel 12 so as to be liquid-tight and slidable. A syringe comprising the gasket 13 is preferably employed. The barrel 12 of the syringe 10 is a cylindrical member usually formed of glass, polypropylene, or polyethylene, and a flange 14 for finger hooking is provided on the base end 12a.
The gasket 13 is formed of butyl rubber, thermoplastic elastomer, or the like, and a coupling means such as a female screw 15 is provided at the base end so that a plunger 30 provided with a male screw 31 at the tip can be coupled. It has become.
The injection needle connecting portion 11 has a male luer taper shape and can be fitted to a female luer taper-shaped discharge port 21 of the bellows container 20 described later. The male-type luer taper and the female-type luer taper mentioned here refer to a standard that can be connected to connectors of medical instruments such as three-way stopcocks, infusion tubes, and catheters that are generally distributed. Furthermore, a cap member 16 formed of butyl rubber, thermoplastic elastomer or the like is liquid-tightly attached to the injection needle connection portion 11, but if the injection needle connection portion 11 is liquid-tightly sealed, The material and the sealing method are not particularly limited. For example, a sealing member (not shown) may be welded to the tip of the injection needle connecting portion 11 and sealed.
Further, the barrel 12 may be provided with a bypass groove 17 so that freeze-drying can be performed with the gasket 13 half-plugged at the base end 12a during manufacture.
[0015]
The bellows container 20 is a bottomed cylindrical container having a top surface 22 provided with a discharge port 21 and an expandable / contractible bellows-like body portion 23, and is usually formed from polypropylene, polyethylene or the like, but is allowed as a medical device. As long as it is a flexible material, the material is not particularly limited. The bellows-like body portion 23 is formed into a corrugated shape so that it can expand and contract. By folding the bellows-like copper portion 23 in a twisted manner, the volume of the bellows container 20 is reduced, and the contents are discharged from the discharge port 21. be able to.
The discharge port 21 has a female luer taper shape, and can be fitted to the male luer taper-shaped injection needle connecting portion 11 described above. The female-type luer taper and the male-type luer taper mentioned here refer to a standard that can be connected to connectors of medical instruments such as three-way stopcocks, infusion tubes, and catheters that are generally distributed.
A cap member 24 made of butyl rubber, thermoplastic elastomer or the like is liquid-tightly attached to the discharge port 21. However, if the discharge port 21 is liquid-tightly sealed, the material and the sealing method are as follows. There is no particular limitation, and as shown in FIG. 2, a flange 42 may be provided at the tip of the discharge port 41, and a seal member 43 may be welded and sealed to the tip surface of the flange 42. As the seal member 43, sterilized paper can be suitably employed, but synthetic resin can also be employed.
Further, as shown in FIG. 3, the drug passage 25 inside the discharge port 21 is reduced in diameter by a shoulder portion 26, and the seal member 27 is weakly welded to the shoulder portion 26 so as to be peeled off. May be hermetically sealed. The material of the seal member 27 is not particularly limited as long as the material is incompatible with the forming material of the bellows container 20. For example, when the bellows container 20 is made of polypropylene, the seal member is preferably a mixture of polypropylene and polyethylene. The seal member may be peeled off when the injection needle connecting portion inserted into the discharge port pushes the seal member.
On the side surface of the bellows container 20, a peripheral surface 28 that is not bellows-like is provided near the tip. By mechanically holding the peripheral surface 28 at the time of manufacture, the filling operation and the capping operation can be advantageously and efficiently performed without being affected by the expansion and contraction of the bellows, and also when the syringe 10 and the bellows container 20 are connected. If the peripheral surface 28 is held, there is no possibility of discharging the contents. The circumferential surface 28 may be provided with a groove or a step in the radial direction so that it can be easily held.
Furthermore, as shown in FIG. 4, when the bellows container 50 is contracted, a concave portion 52 in which a part of the bellows container 50 is indented toward the inside so that the drug remaining inside the container is reduced as much as possible. May be provided.
[0016]
As shown in FIG. 5, the prefilled syringe 3 of the present invention may have a configuration in which the bellows container 20 having the discharge port 21 sealed by the seal member 27 and the syringe 10 are fitted in advance. Thereby, a means for sealing the injection needle connecting portion 11 and the discharge port 21 becomes unnecessary, the manufacturing cost is reduced, and the waste during use is reduced. Furthermore, there is no possibility of contamination by airborne bacteria when connecting the bellows container and the syringe.
[0017]
Next, the use of the prefilled syringe kit of the present invention will be described with reference to FIGS.
First, as shown in (1) in FIG. 6, a prefilled syringe kit 1, which is a preferred embodiment of the present invention, includes a syringe 10 containing a lyophilized preparation D and a bellows container 20 containing a solution S. The cap member 11 that seals the injection needle connecting portion 11 of the syringe 10 and the cap member 24 that seals the discharge port 21 of the bellows container 20 as shown in (2) of FIG. The injection needle connection part 11 and the discharge port 21 are connected by detachment.
Next, as shown in (1) in FIG. 7, when the bottom surface 29 of the bellows container 20 is pushed in the direction of arrow A, the seal member 27 that has been weakly welded to the inside of the discharge port is peeled off by that pressure, and the bellows container 20 The dissolved solution S flows into the syringe 10. Thereafter, the entire prefilled syringe 1 is shaken, and the lyophilized preparation D is completely dissolved in the dissolving solution S to prepare a drug solution LD.
Finally, as shown in (2) in FIG. 7, if the bellows container 20 is removed, the injection needle 70 is connected to the injection needle connecting portion 11 of the syringe 10, and the plunger 30 is connected to the gasket 13, the patient's vein For example, the liquid medicine LD can be injected.
[0018]
【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, in which a sealing means for a discharge port opening is a cap member.
FIG. 2 is a longitudinal sectional view showing another embodiment of the present invention, in which the sealing means for the discharge port opening is a seal member.
FIG. 3 is a partially enlarged longitudinal sectional view of a discharge port of the bellows container according to the embodiment of the present invention.
FIG. 4 is a partial cross-sectional view showing another embodiment of the bellows container of the present invention, wherein the remaining liquid is drained as much as possible to keep the bellows in a contracted state.
FIG. 5 is a longitudinal sectional view showing another embodiment of the present invention, in which a syringe and a bellows container are connected in advance.
FIG. 6 is a diagram for explaining a use situation of the prefilled syringe kit of the present invention.
FIG. 7 is a diagram for explaining a use situation of the prefilled syringe kit of the present invention.
FIG. 8 is a longitudinal sectional view of a conventional two-component mixed prefilled syringe.
[Explanation of symbols]
1, 3 Pre-filled syringe kit 10 Syringe 11 Injection needle connection part 12, 60 Barrel 12a, 60a Base end 13 Gasket 14 Flange 15 Female thread 16, 24 Cap member 17, 63 Bypass groove 20, 50 Bellows container 21, 41 Discharge port 22 Top surface 23 Bellows-shaped body portion 25 Drug passage 26 Shoulder portion 28 Peripheral surface 30, 64 Plunger 31 Male screw 42 Flange 27, 43 Seal members 29, 51 Bottom surface 52 Recess 61 First gasket 62 Second gasket 65 Rear space 67 Front Space 70 Injection needle D, 68 Lyophilized preparation S, 66 Dissolved solution LD Chemical solution

Claims (1)

Syringe containing a freeze-dried preparation comprising a barrel having an injection needle connecting portion sealed in a liquid-tight manner at the tip, and a gasket that is liquid-tight and slidably inserted in the barrel, and a seal inside the tip. It consists of an expandable and bottomed cylindrical bellows container having a discharge port sealed liquid-tightly by releasably welding the member, and the tip opening of the injection needle connecting portion and the discharge port A prefilled syringe kit in which a distal end opening is liquid-tightly sealed, and the injection needle connecting portion and the discharge port are connectable in a liquid-tight manner.

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