JP2004073296A - Prefilled syringe kit - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a prefilled syringe kit with which two or more kinds of medicines can separately be sterilized, the fear of elution from rubber and leakage of the medicines never occur, the fear of injury of an operator, foreign matter inclusion and contamination with air floating bacteria is eliminated in the case of medicine preparation , waste is reduced and the medicine preparation operation is performed simply and speedily to improve handleability. <P>SOLUTION: This prefilled syringe kit consists of a syringe 20 consisting of a barrel 22 having the syringe needle connection part 21 of male-type Luer taper at a tip and a gasket 50 inserted slidably into the barrel 22; and a bellows container 30 having at its tip a discharging port 31 and a nozzle 33 which surrounds the port 31 and whose inner side functions as the medical liquid path 32 of a female-type Luer taper . The nozzle 33 is connected water-tightly with the connection part 21. At the tip side periphery part 31a of the port 31, a seal member 40 is sealed water-tightly by weakly welding the seal member 40 separably. <P>COPYRIGHT: (C)2004,JPO

Description

[0001]
TECHNICAL FIELD 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 formulation or a solution, and a bellows container containing a solution.
[0002]
[Prior art]
A liquid drug, that is, a drug solution, is contained in a drug solution container such as an ampule and a vial sealed with a rubber stopper. When injecting the medicinal solution contained in these ampoules or vials, cut the ampule in the case of an ampoule, pierce a rubber stopper with a syringe needle attached to a syringe in the case of a vial, and then inject the medicinal solution into the syringe. A syringe needle different from the syringe needle used for piercing the rubber stopper is newly attached to the syringe, and the patient is injected.
[0003]
Also, a so-called multi-component mixed-type prefilled syringe in which a plurality of drugs are separated and stored in the same syringe, and mixed at the time of use, has been put to practical use. A multi-component prefilled syringe currently commercially available is generally a two-component mixed type as shown in FIG. That is, the first gasket 220 and the second gasket 230 divide the inside of the barrel 210 into two spaces and form a bypass groove 240 in the center inner wall of the barrel 210 so that when the plunger 250 is pushed in, the rear space 260 A lysing solution 270 (eg, saline or glucose) enters the front space 280 through the bypass channel 240 and is mixed with the lyophilized formulation 290 (eg, a lyophilized antibiotic).
[0004]
[Problems to be solved by the invention]
However, in the method using an ampoule or vial, a metal needle is required to connect the drug solution container and the syringe, so that the operator may be injured by the injection needle, and a glass piece or the like generated at the time of ampule cutting may be used. In addition, foreign substances such as rubber pieces generated when the rubber stopper of the vial is punctured may be mixed into the chemical solution. Furthermore, since the operation is complicated, it takes a considerable amount of time for injection, and an accurate amount cannot be aspirated. In addition, in the case of a highly viscous chemical such as sodium hyaluronate, a great deal of time and suction force are required to suck the chemical from the chemical container into the syringe. Further, when sucking the chemical solution in the vial, the pressure in the vial is reduced as the suction is performed, so that the suction operation gradually requires force, and smooth suction cannot be performed.
[0005]
On the other hand, in the prefilled syringe, the first gasket 220 is moved to the bypass groove 240 and the entire amount of the lysis solution 270 in the rear space 260 is made to enter the front space 280, and then the lyophilized preparation 290 and the lysis solution 260 are sufficiently mixed. Requires a large space. However, even if the plunger 250 is pulled backward after the first gasket 220 moves to the bypass groove 240, the liquid moves to the rear space 260 through the bypass groove 240, or the first gasket 220 and the second gasket 230 The first gasket 220 cannot move in the direction of the base end 210a of the barrel 210 from the bypass groove 240 due to the sliding of the gaskets separately, so that a space necessary for mixing both drugs is created in the barrel 210. Can not. Therefore, it is necessary to increase the volume of the front space 280 in advance, and there is a problem that the size of the syringe becomes large for the capacity of the medicine.
Further, even if it is necessary to mix another chemical after mixing the two components, even if the plunger 250 is pulled, the first gasket 220 does not move in conjunction therewith, so that a new chemical is added to the barrel 210. It is difficult to aspirate quantitatively. Further, additives contained in the gasket, such as sulfur and vulcanization accelerator, may elute into the solution during storage. Further, since two types of drugs are contained in the same barrel, they cannot be sterilized separately during manufacture.
[0006]
The present invention has been made in view of the above circumstances, and can sterilize two or more types of drugs separately, does not cause elution from rubber during storage, does not leak drug solutions, and operates during drug preparation. It is an object of the present invention to provide a prefilled syringe kit which is free from injuries, contamination of foreign substances, and contamination by airborne bacteria, has little waste, can be easily and quickly prepared, and is excellent in handling.
[0007]
[Means for Solving the Problems]
The present inventors have intensively studied to solve the above-mentioned problems, and as a result, have arrived at the present invention. That is, the prefilled syringe kit of the present invention comprises a barrel having a male luer tapered syringe needle connection at the tip, a syringe consisting of a gasket that is slidably and slidably inserted into the barrel, a discharge port, A bellows container having a top surface provided with a nozzle surrounding the discharge port, the inside of which is a female luer taper chemical liquid passage, wherein the nozzle is liquid-tight to the injection needle connection portion. In addition to the connection, the sealing member is liquid-tightly sealed by peelably weakly welding a sealing member to a peripheral edge portion on the distal end side of the discharge port.
[0008]
Here, the nozzle may be welded to the top surface of the outer edge of the seal member, and a part of the seal member that is weakly welded to the outer peripheral edge portion of the discharge port is hardly peeled off compared to the weakly welded portion and is strongly welded. May be. Also, the tip of the nozzle may be welded to the shoulder of the syringe via a weak part that can be peeled off by the relative rotation operation of the bellows container and the syringe, or the base end of the injection needle connection part A male screw may be provided, and a female screw to be screwed with the male screw may be provided at the distal end of the drug solution passage, or a shoulder at the distal end of the syringe may concentrically surround the injection needle connection part, A skirt portion having a female screw may be provided, and a tip of the nozzle may be provided with a flange screwed with the female screw.
Further, it is preferable that the first medicine is accommodated in a space in front of the gasket in the barrel, and the medicine is accommodated in the bellows container.
[0009]
BEST MODE FOR CARRYING OUT 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. The tip of a nozzle is weakly welded to a shoulder of a syringe so as to be peelable via a fragile portion. (A) is a longitudinal sectional view, and (B) is a sectional view taken along line AA in (A). FIG. 2 is a longitudinal sectional view showing another embodiment of the bellows container of the present invention, and a flange for finger hanging is provided on the top surface of the bellows container. FIG. 3 is a view showing another embodiment of the bellows container of the present invention, in which a convex portion is provided on the bottom surface of the bellows container. (A) is a longitudinal sectional view, and (B) is a longitudinal sectional view showing a state where the bellows container has contracted. FIG. 4 is a longitudinal sectional view of a main part showing another embodiment of the present invention, in which an engaging means for engaging with a fragile portion is provided at the tip of the nozzle.
[0010]
As shown in FIG. 1, the prefilled syringe kit 10 of the present invention has a barrel 22 having a male luer tapered injection needle connecting portion 21 at the tip and a liquid-tight and slidably inserted into the barrel 22. A syringe 20 comprising a gasket 50, a discharge port 31, and a bellows container 30 having a nozzle 33 at its tip which surrounds the discharge port 31 and has a female liquid passage 32 with a female luer taper at the inside. The nozzle 33 is liquid-tightly connected to the injection needle connection portion 21, and is liquid-tightly sealed to the distal end side peripheral portion 31 a of the discharge port 31 by detachably welding the seal member 40 to be peelable. Have been.
As described above, by adopting a configuration in which the syringe 20 and the bellows container 30 are connected in advance, the means for sealing the injection needle connecting portion 21 of the syringe 20 and the chemical solution passage 32 of the bellows container 30 becomes unnecessary, so that the manufacturing Costs are reduced and waste during use is reduced. Further, there is no risk of contamination by airborne bacteria when connecting the bellows container and the syringe.
[0011]
The male luer taper and female luer taper referred to herein are those of the ISO standard, and are 6% male luer taper and 6% female luer taper which are generally used for the syringe needle connection part of a commercially available syringe. Refers to a taper. By adopting such a general-purpose luer taper as the connection portion, each of the syringe and the bellows container can be connected to a general medical device such as a three-way cock or an infusion tube as needed.
[0012]
Here, as the syringe 20, a barrel 22 having an open proximal end 22a having an injection needle connecting portion 21 at the distal end, and a liquid-tight and slidably inserted into the barrel 22 from the proximal end 22a of the barrel 22. A syringe made of the gasket 50 is preferably used. The barrel 22 is a tubular member usually formed of glass, polypropylene or polyethylene, and has a flange 23 for finger hooking at a base end 22a.
The gasket 50 is formed of butyl rubber, thermoplastic elastomer, or the like, and is provided with a coupling means such as a female screw 51 at the base end, so that a plunger 60 having a male screw 61 at the distal end can be connected. I have.
Further, a bypass groove 24 may be formed in the base end 22a of the barrel 22 so that freeze drying can be performed in a state where the gasket 50 is half-plugged on the base end 22a during manufacturing.
The first medicine is accommodated in the space in front of the gasket 50 in the barrel 22. The first drug may be a solid preparation or a liquid preparation, but is preferably a solid preparation, more preferably a lyophilized preparation.
[0013]
The bellows container 30 is a bottomed cylindrical container having a discharge port 31, a top surface 34 provided with a nozzle 33 surrounding the discharge port 31, and a bellows-shaped body 35 that can expand and contract, and contains a chemical solution therein. ing. The bellows container 30 is usually formed from polyethylene, polypropylene, a mixture of polyethylene and polypropylene, and the like, but the material is not particularly limited as long as it is a flexible material that is acceptable as a medical device. The bellows-like body 35 is formed into a corrugated shape so as to be able to expand and contract, and the bellows-like body 35 is folded in an inconsistent manner to reduce the volume of the bellows container 30 and discharge the chemical solution from the discharge port 31. Can be.
The discharge port 31 is liquid-tightly sealed by weakly welding the seal member 40 to the distal end side peripheral portion 31a in a peelable manner. The seal member 40 is usually formed of a material having poor compatibility with the material forming the bellows container 30. For example, when the bellows container 30 is formed mainly of polypropylene, the seal member 40 is formed of a material mainly containing a mixture of polypropylene and polyethylene, or a copolymer or grafted product of polyethylene.
[0014]
Further, as shown in FIG. 2, a flange 72 for finger hanging may be formed on the peripheral portion 71 a of the top surface 71 of the bellows container 70. By placing the middle finger and the index finger on the finger-holding flange 72 and pressing the bottom surface 73 with the thumb, it is possible to apply a force for efficiently shrinking the bellows-shaped body 74 in the axial direction.
[0015]
As shown in FIG. 3A, a convex portion 82 may be formed on the bottom surface 81 of the bellows container 80 so that a part of the bottom surface 81 projects substantially in a cylindrical shape toward the inside of the container. By forming the convex portion 82, when the bellows-shaped body portion 83 is completely contracted, the bellows container 80 has a shape as shown in FIG. 3B, and the amount of the chemical solution remaining in the container is almost completely reduced. At the same time, since the amount of the chemical solution moved into the syringe can be accurately grasped, it is not necessary to adjust the amount of the chemical solution after suction. The outer diameter and height of the projection 82 do not interfere with the inside 83a of the bellows-shaped body 83 and the back side 84a of the top surface 84 of the bellows container 80 when the bellows-shaped body 83 is completely contracted. It can be set arbitrarily within the range. When the convex portion 82 is formed, an opening formed in the bottom surface 81 of the bellows container 80 by the cap 90 including the skirt portion 91 that contacts the inside 82 a of the convex portion 82 and the bottom surface 93 having the flange 92. It is desirable to block 85. By providing the cap 90, the bottom surface 81 of the bellows container 80 can be pressed by a finger without any trouble even if the recess 85 is formed. Examples of a method of attaching the cap 90 to the bottom surface 81 of the bellows container 80 include fitting, welding, and adhesion. Further, a through hole 94 may be provided in the bottom surface 93 of the cap 90 so as to penetrate the bottom surface 93, and air may escape from the through hole 94 when the cap 90 is attached to the bottom surface 81 of the bellows container 80. Although not shown, a male screw may be provided on the skirt portion of the cap, and a female screw may be provided on the inside of the convex portion, and the cap and the bottom surface of the bellows container may be connected by screwing. As the material of the cap, those generally used for medical instruments, such as polyethylene, polypropylene, polystyrene, polycarbonate, polyurethane, polyvinyl chloride, and ABS resin, can be adopted. If the height of the skirt portion is very small and it is merely a positioning means, the cap can be attached to the bellows container by welding or bonding the flange of the cap and the bottom surface of the bellows container.
[0016]
The nozzle 33 fits the injection needle connection portion 21 in a liquid-tight manner, and the tip of the nozzle 33 can be broken at the shoulder 25 of the barrel 22 by the relative rotation operation of the syringe 20 and the bellows container 30. It is welded through the fragile part 300. The fragile portion 300 is usually formed of a material having poor compatibility with the material for forming the syringe 20. For example, when the syringe 20 is mainly formed of polypropylene, the fragile portion 300 is made of polypropylene. The syringe 20 and the bellows container 30 are detachably welded to each other through the fragile portion 300. The syringe 20 is made of a material mainly containing a mixture of polyethylene, a copolymer of polyethylene, or a grafted product.
Here, as shown in FIG. 4, an engagement portion 102 is provided on the nozzle 101 of the bellows container 100 so that the weak portion 110 and the bellows container 100 are hardly physically separated. It may be so arranged that they are always integrated and peeled off from the syringe 20.
Although not shown, when the syringe is formed mainly of polypropylene, the bellows container is formed mainly of a mixture of polyethylene and polypropylene, a copolymer of polyethylene or a grafted product, and the tip of the nozzle is formed. It may be weakly welded directly to the shoulder of the syringe so that the syringe and the bellows container can be peeled off by a relative rotation operation.
As described above, since the syringe 20 and the bellows container 30 are bonded not only by fitting but also by welding, the medicine leaks during transportation or storage, or the syringe 20 and the bellows container 30 are inadvertently separated. Nothing to do.
Further, since the syringe 20 and the bellows container 30 are weakly welded via the fragile portion 300 at the shoulder 25 and the distal end of the nozzle 33, the position of the fragile portion 300 is determined by opening the distal end of the injection needle connection portion 21. Away from the department. Therefore, even if foreign matter pieces are generated when the fragile portion 300 is peeled off, there is no possibility that the foreign matter pieces will enter the inside of the barrel 22 from the distal end opening of the injection needle connection part 21.
[0017]
Next, another embodiment of the present invention will be described.
FIG. 5 is a longitudinal sectional view of another embodiment of the present invention, in which a nozzle is a separate member, and the nozzle is attached by welding to the top surface of the bellows container.
As shown in FIG. 5, the configuration of each part of the prefilled syringe kit of this embodiment is substantially the same as that of the prefilled syringe kit of the embodiment shown in FIG. The difference is that the nozzle 120 formed of a separate member is attached to the top surface 131 of the bellows container 130 by welding. That is, the nozzle 120 according to the present embodiment is generally formed of polyethylene, polypropylene, or a mixture of polyethylene and polypropylene, and the base end 120a of the nozzle 120 is weakly welded to the distal side peripheral portion 132a of the discharge port 132. The sealing member 40 is welded to the top surface 131a of the outer edge. By using the nozzle 120 as a separate member in this manner, the inner diameter of the base end of the chemical liquid passage 121 whose distal end is a female luer taper conforming to the ISO standard can be arbitrarily enlarged, and the discharge port 132 The distance from the tip side peripheral portion 132a to the wall of the chemical solution passage 121 can be increased. Accordingly, the width of the surface on which the seal member 40 and the distal end side peripheral portion 132a of the discharge port 132 are weakly welded can be widened, so that leakage of the chemical solution due to weak welding failure can be prevented. In addition, since the sealing member 40 can be weakly welded in a state where the nozzle 120 is not provided, the weak welding step is facilitated. Further, since the diameter of the discharge port 132 can be increased, the waste liquid property is improved.
In the blow molding, which is usually adopted as a method for molding a bellows container, as in the present embodiment, the diameter of the chemical liquid passage of the female luer taper whose diameter decreases toward the base end is enlarged from the middle, and further reduced. It is difficult to form a discharge port by providing a flat surface.
[0018]
Another embodiment of the present invention will be described.
FIG. 6 is a longitudinal sectional view of another embodiment of the present invention, in which a male screw provided at the base end of the injection needle connection portion is screwed with a female screw provided at the tip of the nozzle of the bellows container. As shown in FIG. 6, the configuration of each part of the prefilled syringe kit of the present embodiment is substantially the same as that of the prefilled syringe kit of the embodiment shown in FIG. The difference lies in the method of connecting the injection needle connection part 141 of the syringe 140 and the nozzle 151 of the bellows container 150. That is, the distal end of the injection needle connecting portion 141 of the syringe 140 according to the present embodiment has a male luer taper, and the proximal end has a male screw 142. The inside of the tip of the nozzle 151 of the bellows container 150 is a female screw 152 screwed into the male screw 142 in a liquid-tight manner, and the chemical liquid passage 153 inside the nozzle is fitted in a liquid-tight manner with the male luer taper. Female luer taper.
As described above, since the injection needle connecting portion 141 and the nozzle 151 are also connected by screwing in addition to fitting by the luer taper, the medicine leaks during transportation or storage, or the syringe 140 and the bellows container 150 However, there is no such thing as inadvertent separation.
[0019]
Another embodiment of the present invention will be described.
FIG. 7 is a longitudinal sectional view of another embodiment of the present invention, in which a female screw of a skirt provided at the tip of the barrel is screwed with a flange provided at the tip of the nozzle of the bellows container.
As shown in FIG. 7, the configuration of each part of the prefilled syringe kit of this embodiment is substantially the same as that of the prefilled syringe kit of the embodiment shown in FIG. The difference lies in the method of connecting the injection needle connection portion 181 of the syringe 180 and the nozzle 191 of the bellows container 190. That is, the distal end of the barrel 184 of the syringe 180 according to the present embodiment has a skirt portion 182 that concentrically surrounds the male luer taper injection needle connection portion 181, and the inside of the skirt portion 182 has a female screw 183. It has become. The tip of the nozzle 191 of the bellows container 190 is a flange 192 which is screwed into the female screw 183 in a liquid-tight manner. The chemical liquid passage 193 inside the nozzle 191 is fitted in a liquid-tight manner with the male luer taper. It has a female luer taper.
As described above, since the injection needle connecting portion 181 and the nozzle 191 are connected by screwing in addition to fitting by the luer taper, the medicine leaks during transportation or storage, or the syringe 180 and the bellows container There is no possibility that the image 190 and the image 190 are inadvertently separated.
[0020]
Next, the use of the prefilled syringe kit of the present invention will be described with reference to FIG.
First, as shown in FIG. 8A, a syringe 20 containing a first drug D (for example, a freeze-dried preparation) and a bellows container 30 containing a drug solution L (for example, a dissolution solution) are composed of the syringe 20 and the bellows. A prefilled syringe kit 10 according to a preferred embodiment of the present invention, which is liquid-tightly connected via a fragile portion 300 that can be peeled off by a relative rotation operation with respect to the container 30, is prepared, and FIG. When the bottom surface 36 of the bellows container 30 is pushed in the direction of arrow A, the sealing member 40 that has been weakly welded inside the discharge port is peeled off at that pressure, leaving a strongly welded portion, as shown in FIG. The liquid medicine L flows into the barrel 22 of the syringe 20. Thereafter, the entire prefilled syringe 10 is shaken, and the first drug D is completely dissolved in the drug solution L to prepare an injection drug LD.
Finally, as shown in FIG. 8C, the bellows container 30 is removed, the injection needle 200 is connected to the injection needle connection part 21 of the syringe 20, and the plunger 60 is connected to the gasket 50. For example, the injection LD can be injected.
[0021]
【The invention's effect】
As is apparent from the above description, according to the present invention, two or more types of drugs can be separately sterilized, and during storage, there is no risk of elution from rubber, and there is no leakage of the drug solution, and during drug preparation, It is possible to provide a pre-filled syringe kit that is easy to handle and can be easily and quickly prepared without any risk of operator injuries, contamination of foreign substances, or contamination by airborne bacteria, and that can be easily and quickly performed.
[Brief description of the drawings]
FIG. 1 is a diagram showing an embodiment of the present invention. (A) is a longitudinal sectional view, and (B) is a sectional view taken along line AA in (A).
FIG. 2 is a longitudinal sectional view showing another embodiment of the bellows container of the present invention.
FIG. 3 is a view showing another embodiment of the bellows container of the present invention. (A) is a longitudinal sectional view, (B) is a longitudinal sectional view showing a state where the bellows container is contracted.
FIG. 4 is a longitudinal sectional view of a main part showing another embodiment of the present invention.
FIG. 5 is a vertical sectional view of a main part showing another embodiment of the present invention.
FIG. 6 is a vertical sectional view of a main part showing another embodiment of the present invention.
FIG. 7 is a longitudinal sectional view of a main part showing another embodiment of the present invention.
FIG. 8 is a diagram for explaining a use situation of the present invention.
FIG. 9 is a longitudinal sectional view showing a conventional technique.
[Explanation of symbols]
10 Prefilled Syringe Kit 20, 140, 180 Syringe 21, 141, 181 Injection Needle Connection 25 Shoulder 22, 184, 210 Barrel 30, 70, 80, 100, 130, 150, 190 Bellows Container 31, 132 Discharge Port 31a, 132a Tip side peripheral portion 32, 121, 153, 193 Chemical passage 33, 101, 120, 151, 191 Nozzle 34, 71, 84, 131 Top surface 40 Seal member 50 Gasket 110, 300 Fragile portion 142 Male screw 152, 183 Female screw 182 Skirt part 192 Flange

Claims (7)

A barrel having a male luer taper injection needle connection at the tip and a syringe consisting of a gasket inserted in the barrel in a liquid-tight and slidable manner, a discharge port, and the inside surrounding the discharge port. A bellows container having a top surface provided with a nozzle serving as a chemical liquid passage of a female luer taper, wherein the nozzle is liquid-tightly connected to the injection needle connection portion and a tip of the discharge port. A prefilled syringe kit which is liquid-tightly sealed by weakly welding a seal member to a side peripheral portion so as to be peelable. The prefilled syringe kit according to claim 1, wherein the nozzle is attached by welding to a top surface of an outer edge of the seal member. The prefilled syringe kit according to claim 1 or 2, wherein a part of the seal member that is weakly welded to the peripheral portion on the distal end side of the discharge port is hardly peeled off compared to the weakly welded part and is strongly welded. The prefilled syringe kit according to any one of claims 1 to 3, wherein a tip of the nozzle is welded to a shoulder of the syringe via a weak portion that can be peeled off by a relative rotation operation of the bellows container and the syringe. The prefilled syringe kit according to any one of claims 1 to 3, wherein a male screw is provided at a base end of the injection needle connection portion, and a female screw to be screwed with the male screw is provided at a distal end of the drug solution passage. The shoulder at the distal end of the syringe is provided with a skirt portion having a female screw inside, which concentrically surrounds the injection needle connection portion, and the distal end of the nozzle is provided with a flange screwed with the female screw. 4. The prefilled syringe kit according to any one of 1 to 3. The prefilled syringe kit according to any one of claims 1 to 6, wherein the first medicine is housed in a space in front of the gasket in the barrel, and the medicine is housed inside the bellows container.

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