JP2002177388A - Pharmaceutical and medical pre-filled syringe - Google Patents

Abstract

PROBLEM TO BE SOLVED: To prevent the loosening of a nozzle cap. SOLUTION: In a pharmaceutical and medical multi-chamber type pre-filled syringe being a pharmaceutical and medical syringe and having two or more chambers 2 capable of preserving a drug, a medical fluid or a dissolving liquid in a hermetically sealed state, a protective cap preventing the loosening of a nozzle cap is provided. The protective cap is fixed in a freely detachable manner by locking a screw means formed to the outside of a lure chip or lure lock and the screw means formed to the inside of the protective cap.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a pre-filled medical / medical syringe, and more particularly to a pre-filled medical / medical syringe having an improved structure for sealing the opening of the tip of an injection cylinder.

[0002]

2. Description of the Related Art A multi-chamber syringe is capable of stably transporting a drug solution which is unstable in a solution state in the same container as a drug (powder) and a solution (liquid) in a single container. Since these can be mixed and dissolved in particular, they are superior in safety and workability as compared with the case where the medicine, the dissolving solution, and the syringe are individually transported. Further, if they are individually transported, human errors such as a wrong combination of the drug and the solution may be induced. For these reasons, in recent years, multi-chamber syringes such as two-chamber syringes have been widely used.

Conventionally, in a disposable type syringe or a multi-chamber type pre-filled type syringe, a rubber stopper is attached to a tip end opening portion of a syringe tube in order to seal and hold a drug solution in the syringe tube. Further, some rubber stoppers are held by aluminum caps to prevent the rubber stopper from coming off. For example, in the syringe disclosed in Japanese Utility Model Publication No. 52-19432, a rubber stopper is provided at the tip of the syringe, and a sealing structure is employed in which the peripheral edge of the rubber stopper is held by a cap. . This syringe has a structure in which a needle support for supporting a needle is supported by a distal end of a syringe barrel, and a rubber stopper is disposed in a hollow portion formed in the needle support.

Further, Japanese Patent Application Laid-Open No. 8-52213 discloses that
In order to maintain the sterility at the distal end opening of the syringe barrel with a simple structure, the distal end opening of the syringe barrel is sealed with a rubber stopper, and is hermetically covered with an opening covering member together with the rubber stopper. In such a syringe, there has been proposed a syringe in which a support portion for supporting an injection needle is provided on the opening covering member. However, in this case, there is a disadvantage that the configuration of the opening covering member is complicated and a general-purpose injection needle cannot be used. On the other hand, in Japanese Patent Application Laid-Open No. 10-309306, as a sealing means for hermetically sealing the opening formed at the distal end opening of the drug solution injector, a male screw is attached to the inner peripheral surface of the base end of the cap body. It has been proposed to form a female screw that fits and to attach the cap body to the vicinity of the mouth by engaging the female screw and the male screw. However, this configuration is not intended to overcome the problems inherent in multi-chamber, pre-filled syringes.

[0005]

However, usually,
When mixing a drug and a solution with a multi-chamber syringe, high pressure is applied to the syringe barrel, and even if the nozzle cap is held down by hand so that it does not fly, the nozzle cap may pop out or float and the drug solution may leak However, there is no proposal for specific means for solving this problem in the above-mentioned conventional technology. The present invention has been made to solve such problems, and a multi-chamber syringe,
In particular, when mixing a drug and a solution using a commonly used two-chamber syringe, the nozzle cap is prevented from popping out and floating without being pressed by hand with a simple configuration, thereby achieving an efficient drug solution dispensing. It is an object of the present invention to provide a syringe which can be used.

[0006]

The above objects can be achieved by the inventions and embodiments summarized below. (1) A pharmaceutical / medical syringe, which is a pre-filled syringe having two or more chambers capable of sealingly storing a drug, a drug solution, and a solution, and having a protective cap for preventing a nozzle cap from being loosened. Prefilled medical multi-chamber syringe. (2) The protective cap according to (1), wherein the protective cap is detachably fixed by engaging a screw means formed outside the luer tip or the luer lock with a screw means formed inside the protective cap. Multi-chamber pre-filled syringe for medical and medical use.

(3) The above-mentioned (1) or (1), wherein a fragile portion is provided in a part of the protective cap, and when the package is opened, the fragile portion is broken and opened, so that the presence or absence of the opening can be confirmed at a glance. 2. The multi-chamber pre-filled syringe for medicine and medical treatment according to 2). (4) The multi-chamber medical / medical prefilled syringe according to any one of (1) to (3), wherein the protective cap and the nozzle cap are integrally formed. (5) The above (1) in which a backstop mechanism is provided.
The multi-chamber prefilled syringe for medicine and medical treatment according to any one of (1) to (4).

(6) The multi-chamber medical / medical system according to any one of (1) to (5), wherein the chamber is partitioned by an elastic body laminated by a synthetic resin film. Pre-filled syringe. (7) The synthetic resin film is a resin containing a fluororesin, an ultrahigh molecular weight polyethylene resin, a polypropylene resin, a polyester resin, a polysulfone resin and a cyclic olefin compound or a crosslinked polycyclic hydrocarbon compound as a polymer component. The pharmaceutical / medical multi-chamber prefilled syringe according to the above (6), which is one or more selected from the group consisting of:

[0009]

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a pre-filled syringe for medical and medical use according to the present invention.

FIG. 1 is a longitudinal sectional view showing an embodiment of the syringe of the present invention. The syringe is separated into a main body 1 and a needle portion 2 before use. The main body 1 is made of an injection cylinder 3 made of glass or resin. The injection cylinder 3 has a cylindrical body 4 which is open at both ends and has a cylindrical shape with a constant inner diameter. A flange 5 is provided on the periphery of the opening, and a nozzle cap 7 and a protection cap (tamper-proof cap) 8 are provided on an end 6 on the other end side.
Is installed. Here, the nozzle cap and the protection cap may be integrally formed.

A first rubber gasket 9 is provided in the cylinder 4.
Is arranged close to the inner wall in the center, and the second
Rubber gasket 10 is closely arranged near the inner wall of the flange 5. A plunger rod 11 is attached to the gasket 10 by screw fitting.
Further, in the cylindrical body 4, the bypass groove 4 a as shown in FIG.
4a are formed parallel to each other along the center axis direction of the cylindrical body 4. These bypass grooves 4a are provided at positions facing each other, and are formed longer than the thickness of the first gasket 9. The bypass groove 4a may be provided so as to be located only on one side.

In the present invention, the end 6 is formed within a predetermined length range from the opening, and the opening forms the distal end opening of the syringe barrel 3 and is sealed by a rubber nozzle cap 7. Here, a protective cap 8 is provided to prevent the nozzle cap from loosening such as popping out or floating. Details of the protective cap will be described below.

FIG. 2 shows a case in which the end of the syringe barrel 3 is of a luer tip type, and FIG.
In any case, the outer wall of the top surface of the nozzle cap 7 and the inner wall of the top surface of the protection cap 8 are almost in close contact with each other.
A female screw 13 is formed on the inner peripheral surface of the hole to engage with a male screw 12 provided on the outer peripheral surface of the end of the cylindrical body 4.
The protective cap 8 is attached to the outer peripheral surface of the end portion 6 by the engagement between the and the female screw 13. The pitch of the luer lock type external screw is the same as the pitch of the screw in the luer lock, and the rotation direction is the same when the outer screw and the inner screw of the luer lock are tightened. As described above, since the nozzle cap 7 is firmly pressed and fixed by the protective cap 8, when the plunger rod 11 is pushed in the direction of the arrow shown in FIG. In addition, it is possible to prevent the nozzle cap from jumping out without holding down the nozzle cap 7 by hand. In the case of the luer lock type shown in FIG. 3, the chemical liquid preparation operation can be performed by fixing the nozzle cap 7 with the protective cap 8 in substantially the same manner.

A tampering prevention mechanism 14 can be provided at the base of the end 6 of the cylinder 4. Falsification prevention mechanism 1
Examples of 4 include a shrink film, a tamper seal, a tear ring type (a part provided with a fragile part in a cap, and the fragile part breaks when the cap is opened so that the presence or absence of opening of the cap can be known). Can be applied. That is, a fragile portion is provided on a part of the protective cap 8, and when the fragile portion is opened, the fragile portion is broken by the tamper-proof mechanism 14, so that the presence or absence of the opening can be checked at a glance. Also, a backstop mechanism 15 for the second gasket can be provided. In this case, it is preferable that the back stop mechanism 15 be of a mounting flange type as shown in FIG.
The back-stop mechanism of the piston prevents the piston from jumping out of the syringe when the pressure in the syringe rises during sterilization processing, air transportation, or the like, and leakage of the drug solution occurs. This is achieved by inserting a jig after inserting the piston into the syringe so that the insertion end of the syringe is smaller than the outer diameter of the piston. In general,
In order to increase the joint strength between the syringe and the back stopper, it is desirable to have a structure in which the syringe flange and the back stopper are engaged, and a type in which the syringe flange is sandwiched and engaged from the vertical direction of the syringe shaft. Is generally mounted in a horizontal direction (on the flange side) and is engaged with a flange of the syringe with a claw or the like.

FIG. 4 is a schematic diagram for explaining the steps (I) to (IV) of preparing a drug solution in the two-chamber prefilled syringe of the present invention. As shown in FIG. 4 (I), in the main body 1, a powdered medicine A is sealed in a first chamber 20, which is sealed and formed by a first gasket 9 and a nozzle cap 7 in a cylindrical body 4. On the other hand, a second gasket formed by being hermetically sealed by the first gasket 9 and the second gasket 10.
The chamber 21 is filled with a solution B for dissolving the medicine A.

Next, as shown in FIG.
When pushed in the direction of the arrow I), the liquid pressure in the second chamber 21 increases, and the first gasket 9 is also pushed out in the direction of the arrow. When the gasket 9 reaches the bypass groove 4a and connects the first and second chambers 20 and 21, the solution B in the second chamber 21 passes through the passage formed by the bypass groove 4a and the outer peripheral wall of the first gasket 9. Through the first chamber 20. During that time, the nozzle cap is held by the protective cap and does not need to be pressed by hand. When all of the solution B flows into the first chamber 20 in this manner [FIG. 4 (III)], the gaskets 9 and 10 are brought into close contact with each other, and the drug A is dissolved in the solution B in the first chamber 20. It becomes a chemical solution. FIG. 4 (I
V) shows a state in which the gasket is pushed back by the internal pressure thereafter.

At the time of administration of the chemical solution, the needle tube member 2 shown schematically in FIG. 1 is removed from the nozzle cap 7 and the protective cap 8, and then engaged with the end 6 of the cylinder 1, and the plunger rod 9 is further pushed in. As a result, the drug solution is injected outside through the needle tube.

Next, the material of the gasket used in the syringe of the present invention will be described. The elastic body constituting the inside (body) of the gasket of the present invention includes natural rubber (NR), polyisoprene (IR), polybutadiene (BR), styrene-butadiene copolymer rubber (SB)
R), styrene-isoprene copolymer rubber (abbreviated as SIR), ethylene-propylene-nonconjugated copolymer rubber (abbreviated as EPDM), isobutylene-isoprene copolymer rubber (abbreviated as IIR), IIR chlorinated rubber (abbreviated as CIIR), IIR brominated rubber (abbreviated as BIIR), butadiene-acrylonitrile copolymer rubber (abbreviated as NBR), hydrogenated rubber of NBR, SBS, SEBS, An SEBS composition or the like can be used as a raw material.

In either case, the gasket body of the present invention can be made into a composition by blending the above-mentioned raw material elastomers with various compounding agents to form a composition comprising sulfur, a sulfur-containing crosslinking agent, an organic peroxide, It is preferable to crosslink with an electron beam or the like to obtain a highly elastic body. As an index of high elasticity,
An elastic material whose JIS K6301 has a permanent compression set under heating of 100 ° C. and a distortion amount of 40% or less is exemplified. As the hardness of the elastic body, the rubber hardness (H
Preferably, s) is from 35 to 75. Accordingly, examples of the crosslinking operation for obtaining the elastic body according to the present invention include a method of laminating a resin film simultaneously with heating and pressing in a mold, and a method of dynamic crosslinking performed in an extruder or a kneader. Further, at the same time, a material obtained by mixing various synthetic resins into an alloy or a composition can be used as a material.

In the present invention, the synthetic resin film laminated on the surface of the gasket has high sanitary properties, and passes the standard value when tested in accordance with the “49. Use a synthetic resin. Examples of the synthetic resin having such properties include a fluorine-based resin, a polyethylene-based resin, a polypropylene-based resin (including a copolymer obtained by copolymerizing an ethylene group, a butylene group, etc. in addition to PP and a homopolymer), and a polyester-based resin. (PET), polysulfone resin (PS
F), a methylpentene resin (PMP), a polyacrylate resin (PAR), a polyamide resin (PA), a modified phenylene oxide resin (PPE), a cyclic olefin compound or a crosslinked polycyclic hydrocarbon compound as a polymer component Resin, a polycarbonate resin (PC), a resin obtained by modifying (grafting) an olefin resin with a polar group, and the like. Preferred are a fluorine resin, an ultrahigh molecular weight polyethylene resin, a polypropylene resin, a polyester resin, and polysulfone. Resins containing a polymer resin, a cyclic olefin compound or a crosslinked polycyclic hydrocarbon compound as a polymer component. The thickness of the synthetic resin film to be laminated on the surface of the gasket of the present invention is preferably about 0.01 to 0.3 mm.
The film of the same standard may be used for the and the inner surface of the push rod fitting, or a film of a different standard may be used.

As for the parts other than the gasket of the syringe according to the present invention, those conventionally known in this technical field can be used. Glasses and plastics such as polymethylpentene resin, polypropylene resin, propylene-ethylene copolymer resin, polyester resin, polyethersulfone resin, polysulfone resin, cyclic olefin resin or crosslinked polycyclic hydrocarbon resin or the above-mentioned resin as an injection cylinder material It is preferable to use a laminate obtained by laminating two or more layers of a resin and a resin selected from a polyamide resin, a polyvinyl alcohol resin, and a saponified product of ethylene-vinyl acetate. The above-mentioned cyclic resin is excellent in chemical resistance, transparency, heat resistance and the like, and has properties suitable for a material of a syringe.

[0021]

According to the present invention, it is possible to prevent the nozzle cap from jumping out and rising without mixing the drug and the solution by the extremely simple tip structure of the injection cylinder without manually pressing the nozzle cap. Further, the presence or absence of opening can be confirmed at a glance by the tamper-proof mechanism.

[Brief description of the drawings]

FIG. 1 is a vertical cross-sectional view taken along a central axis of a syringe showing a configuration of a syringe according to an embodiment of the present invention.

FIGS. 2 (I) and (II) are half sectional views showing a structure of a tip part (luer tip type) and a structure of a nozzle cap and a protective cap for sealing an end part in the syringe shown in FIG.

FIGS. 3 (I) and (II) are half sectional views showing the structure of a tip part (luer lock type) and the structure of a nozzle cap and a protective cap for sealing the end part in the syringe shown in FIG.

FIGS. 4 (I) to (IV) are explanatory views showing steps of preparing an injection using a pre-filled syringe of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Syringe 2 Needle tube 3, 4 Injection cylinder 5 Flange part 6 End part 7 Nozzle cap 8 Protection cap 9 First gasket 10 Second gasket

──────────────────────────────────────────────────続 き Continued on the front page (51) Int.Cl. ⁷ Identification symbol FI theme coat ゛ (Reference) A61M 5/34 A61J 3/00 314C

Claims (7)

[Claims] Claims: 1. A pre-filled syringe having two or more chambers capable of sealingly storing a medicine, a drug solution, and a solution, which is provided with a protective cap for preventing a nozzle cap from being loosened. Medicine
Pre-filled syringe for medical use. 2. The protective cap according to claim 1, wherein the protective cap is detachably fixed by engaging a screw means formed outside the luer tip or the luer lock with a screw means formed inside the protective cap. Pre-filled syringe for medicine and medical use. 3. The method according to claim 1, wherein a fragile portion is provided in a part of the protective cap, and when the package is opened, the fragile portion is opened together with the rupture so that the presence or absence of the opening can be confirmed at a glance. Pre-filled syringe for medical and medical use. 4. The pre-filled medical / medical syringe according to claim 1, wherein the protective cap and the nozzle cap are integrally formed. 5. The pre-filled medical / medical syringe according to claim 1, further comprising a backstop mechanism. 6. The medicine according to claim 1, wherein the chamber is partitioned by an elastic body laminated by a synthetic resin film.
Pre-filled syringe for medical use. 7. The synthetic resin film is a fluororesin,
It is at least one selected from the group consisting of ultrahigh molecular weight polyethylene resin, polypropylene resin, polyester resin, polysulfone resin, and resin containing cycloolefin compound or crosslinked polycyclic hydrocarbon compound as a polymer component. The pharmaceutical container and syringe according to claim 6.