WO2002072175A1

WO2002072175A1 - Chemical liquid injection port, and chemical liquid container having the same

Info

Publication number: WO2002072175A1
Application number: PCT/JP2002/002003
Authority: WO
Inventors: Nobuo Takagi; Takamitsu Ohkawara; Koji Munechika; Norihide Kishi; Tadaaki Inoue
Original assignee: Nipro Corporation; Mitsubishi Pharma Corporation
Priority date: 2001-03-05
Filing date: 2002-03-05
Publication date: 2002-09-19
Also published as: JP4408338B2; CN1254280C; KR100816974B1; JPWO2002072175A1; KR20030088450A; CN1501819A; JP2009178584A

Abstract

A chemical liquid injection port comprising a cylindrical body formed at one end with a chemical liquid injection port section adapted to have a syringe connected thereto and at the other end with a chemical liquid discharge port adapted to have a chemical liquid container connected thereto and having a passageway extending from the chemical liquid injection port section to the chemical liquid discharge port, a microorganism separation filter installed in the passageway, and a closing means installed between the microorganism separation filter and the chemical liquid discharge port for closing the passageway and adapted to open the passageway when the chemical liquid is injected into the passageway through the chemical liquid injection port section; and a chemical liquid container having the same.

Description

Specification

Chemical liquid injection port and chemical liquid container provided therewith

Technical field

The present invention relates to a medicinal solution injection port for aseptically and easily performing co-injection of medicinal solutions, specifically, co-injection of another medicinal solution into an injection solution such as an infusion solution, and a medicinal solution provided with the medicinal solution injection port. For containers.

Background art

In clinical settings, it is common to simultaneously administer multiple drug solutions to patients. For example, when it is desired to inject a vitamine into a vein, the vitamine is likely to be degraded by heat, so it should be stored in a drug container such as an infusion bag and subjected to high-pressure steam sterilization beforehand. Can not. For this reason, it is necessary to inject and mix the errands and other chemicals into the chemical container in which they are stored in advance (this is called mixed injection) and mix them in the chemical container.

Conventionally, when the above-mentioned drug solution is mixed into a drug solution container, a method has been adopted in which a syringe needle is inserted into the rubber stopper of the drug solution discharge port of the drug solution container to mix and inject the drug solution. It was difficult to secure the quality. If microorganisms (microorganisms) are mixed in from the outside during the co-injection operation, microbes will propagate in the co-injection solution while the co-injection solution is being administered to the patient. In particular, when the injection is an infusion intended for nutritional supplementation, such as a high-calorie infusion, there is a risk that microorganisms will proliferate during the administration period even with a small amount of contaminants. In such cases, large amounts of microorganisms may be injected into the patient at the same time as the infusion at a later stage of administration. Patients receiving such mixed injections cause severe side effects such as sepsis and endotoxin shock. Therefore, it is necessary to ensure the sterility of the co-injection operation in consideration of patient safety. Japanese Patent Application Laid-Open No. 9-184080 discloses a medical container for aseptically performing a co-injection operation. This medical container comprises a cylindrical mouth member which is attached to the plastic container body in a liquid-tight manner, A rubber stopper that tightly seals, a housing that is communicated with a piercing portion that can pierce the rubber stopper, or that is integrally formed with the piercing portion; a sterilization filter that is supported by the housing; A co-injection port (chemical solution injection port) is provided, which houses the puncture portion, the housing, and the sterilization filter in a sterilized state, and includes a storage cover attached to the mouth member.

However, in such a medical container, there is a problem that a coring is generated by piercing a rubber stopper, and a foreign substance is mixed in the chemical solution in the container. In addition, the structure in which the needle part is moved to pierce the rubber stopper makes the drug solution injection port relatively large, and the number of parts increases the cost. is there.

ADVANTAGE OF THE INVENTION This invention can inject a chemical | medical solution aseptically, without generating coring, and has a small number of parts, a chemical | medical solution injection port of a small-sized and simplified structure compared with the conventional, and this chemical liquid injection port is provided. The purpose is to provide a drug solution container.

Disclosure of the invention

The present inventors have conducted intensive studies to solve the above-mentioned problems, and as a result, completed the present invention. That is, the present invention is as follows.

[1] At one end, there is formed a liquid inlet that can be connected to a syringe, and at the other end, a liquid outlet that can be connected to a liquid container is formed. A tubular body having a passage extending from the inlet to the drug solution outlet; a disinfecting filter provided in the passage;

Closing means provided between the sterilization filter and the chemical solution discharge port so as to close the passage and to open the passage when a chemical solution is injected into the passage from the chemical liquid inlet; A chemical solution input port characterized by this.

[2] The cylindrical body has an annular projecting portion projecting toward the passage, and the closing means is a film welded to the chemical solution outlet side of the 潆 -shaped projecting portion. The liquid injection port according to [1] above. [3] The cylindrical body is composed of a first cylindrical member having a chemical liquid inlet, and a second cylindrical member having a chemical liquid outlet and an annular protrusion, and the first cylindrical member and the second cylindrical member. The liquid injection port according to the above [1] or [2], wherein the shape member is fitted to each other while holding the sterilization filter therebetween.

[4] The liquid injection port according to any one of [1] to [3] above, wherein the liquid injection port is aseptically shielded by a sealing means that can be opened before use. G.

[5] The shielding means is a rubber cap fitted into the chemical inlet. The rubber cap has an opening in a top surface thereof communicating with the passage, and the hole is formed by a gas filter. The drug solution injection port according to the above [4], wherein the port is closed so as to allow ventilation.

[6] A drug solution container provided with the drug solution injection port according to any one of [1] to [5].

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a front view, partially cut away, showing a drug solution container provided with a drug solution injection port as a preferred example of the present invention.

FIG. 2 is an enlarged cross-sectional view showing a chemical injection port of the example of FIG. FIG. 3 is a cross-sectional view schematically showing another preferred example of the liquid injection port of the present invention.

FIG. 4 is a cross-sectional view showing a simplified still another example of a liquid injection port according to the present invention.

Detailed description of the invention

Hereinafter, the present invention will be described in detail.

FIG. 1 is a partially cutaway front view of a chemical container 1 having a preferable example of a chemical injection port 2 of the present invention, and FIG. 2 is a schematic view of the chemical injection port 2 of the example of FIG. It is sectional drawing which expands and shows. FIG. 2 is a cross-section including the axis of the chemical injection port 2. The liquid injection port 2 of the present invention is a cylindrical body. 3, a disinfection filter 4 and a closing means 5 are basically provided.

The cylindrical body 3 is a substantially cylindrical, preferably cylindrical member, and a chemical solution that can be connected to a syringe at one end (hereinafter, sometimes referred to as “one axial side A1 side”). An injection port 6 is formed, and a chemical solution discharge port 7 that can be connected to a chemical solution container is formed at an end of the other side (hereinafter, sometimes referred to as “the other axial direction A2 side”). Further, the cylinder 3 has a passage 9 extending from the chemical liquid inlet 6 to the chemical liquid outlet 7. The chemical liquid inlet 6 may be any structure that can connect a syringe containing a chemical liquid to be co-injected. In the example shown in FIG. 2, the passage 9 is formed through the passage (a through hole 18 described later) from the middle. It is formed in a gently tapered shape such that the diameter gradually increases toward one side A1 in the axial direction, so that the luer tip portion of the luer tip type syringe can be fitted and connected. The chemical solution outlet 7 may be any structure that can be connected to the chemical solution container, and in the example shown in FIG. 2, it is formed so as to expand outward at the end on the other side A2 in the axial direction, for example. Moreover, it is realized to have the flange portion 8 formed of a material that can be welded to the chemical solution container.

The sanitizing filter 4 is provided in the cylindrical body 3 in the middle of the passage 9. Such a disinfecting filter 4 is not particularly limited, but is generally used in the art, such as a membrane type, a screen type, a depth type, and an anisotropic type. Each type of filter can be suitably used. Among them, it is particularly preferable to use a membrane filter. If the sterilizing filter 4 is a membrane-type real soul, its pore size (coarseness) is selected to be 0.01 im to l.O / im, which is a size that can prevent the passage of gentle bacteria. It is more preferable to select from 0.1 μπι to 0.5 m. Materials for forming the sterilizing filter 4 include cellulose acetate, regenerated cenorellose, cellulose ester / ester, nylon, polytetrafluoroethylene, polystyrene, polycarbonate, acryl-based resin, and the like. Examples include, but are not limited to, polyolefin, polyvinylidene difluoride, and polyether sulfone.

The closing means 5 is provided so as to close the passage 9 between the sterilizing filter 4 and the chemical solution outlet 7. The closing means 5 is not particularly limited as long as it closes the passage 9 so that the passage 9 can be opened when a chemical is injected into the passage 9 from the chemical inlet 6. Such closing means 5 may be realized by a film welded to a cylindrical body as described later, or may be realized by a check valve.

The chemical liquid injection port 2 of the present invention having the above-described structure allows the chemical liquid injected from the chemical liquid inlet 6 to reach the closing means 5 when mounted on the chemical liquid container as shown in FIG. Since the closing means 5 is opened only for the first time, the chemical solution contained in the chemical solution container can be prevented from flowing out to the chemical solution injection port side at least before use (before the co-injection operation). In addition, since the liquid injection port 2 does not allow the closing means 5 to communicate the portion of the passage 9 closer to the liquid injection port 6 than the closing means 5 of the passage 9 with the internal space of the liquid medicine container, the liquid injection port 2 is not used. The chemical solution contained in the chemical solution container can be aseptically maintained before use, with G2 attached.

At the time of co-injection operation, a syringe (not shown) containing another medicinal solution to be co-injected into the medicinal solution in the medicinal solution container (hereinafter, sometimes referred to as “co-injection solution”) is connected to the medicinal solution inlet 6. Then, the mixed injection liquid is injected into the passage 9 from the chemical liquid inlet 6. As described above, the disinfecting filter 4 is provided in the middle of the passage 9, so that the mixed injection liquid after passing through the disinfecting filter 4 is sterilized. Reaching the closing means 5 provided between 4 and the chemical solution discharge port 7, the closing means 5 is opened. After the closing means 5 is released, the mixed injection liquid is discharged from the chemical liquid outlet 7 and flows into the chemical liquid container, and mixes with the chemical liquid in the chemical liquid container. As described above, since the chemical liquid injection port 2 of the present invention is configured such that the passage 9 and the internal space of the chemical liquid container are communicated only after the mixed liquid is injected, the aseptic mixed injection operation can be reliably performed. With Wear. Therefore, it is not necessary to sterilize the mixed drug solution in the drug solution container 1 after the co-injection, and even the one that is likely to be deteriorated by the sterilization process can be used for the co-injection operation.

In the present invention, a chemical solution injection port capable of performing the aseptic co-injection operation as described above is sealed in a liquid-tight manner at an opening as disclosed in a conventional Japanese Patent Application Laid-Open No. 9-148080, for example. The present invention can be realized without using a rubber stopper and a piercing portion capable of piercing the rubber stopper. Therefore, unlike the conventional case, coring does not occur when a rubber stopper is pierced, and foreign matter such as rubber chips does not enter the chemical solution container. In addition, compared to a chemical injection port that has a rubber stopper and a puncture part, the chemical injection port is small and has a simple structure with a small number of parts, so the manufacturing cost is significantly reduced. can do.

There is no particular limitation on the co-infusion solution to be co-injected into the medicinal solution in the medicinal solution container using such a medicinal solution injecting port 2 of the present invention, but one that is likely to be altered by sterilization. Particularly, those which are extremely unstable, and those which are susceptible to a change in the composition due to sterilization treatment, are exemplified as particularly preferable.

In the present invention, the cylindrical body 3 has a projecting portion of a ring projecting toward the passage 9, and the closing means 5 is realized by a film welded to the side of the annular projecting portion on the side of the chemical solution outlet 7. Preferably. In FIG. 2, the cylindrical body 3 has a substantially cylindrical peripheral wall 10, and an annular protrusion 11 protruding from the peripheral wall 10 toward the passage 9. The annular projection 11 is welded to the chemical outlet 7 side, and more specifically, is welded to the annular rib 12 formed on the chemical outlet 7 side of the annular projection 11. An example is shown. However, for the purpose of the present invention, the film must be weakly welded so that the film easily peels off from the annular rib 12 due to the weight of the chemical when the chemical passes through the passage 9. Until the chemical reaches the closing means 5 and the welding is maintained to such an extent that the welding is maintained. It must be welded to the ribs 12.

In the above-described structure, when the co-injection liquid is injected into the passage 9 from the chemical injection port 6, the film as the closing means 5 is peeled off from the annular rib 12 by the injection pressure caused by the injection of the chemical. Closing means 5 is opened. In the example shown in FIG. 2, since the film is provided on the side of the chemical discharge port 7 of the annular protrusion 11, the film is easily peeled off by the pressure from the side of the chemical liquid inlet 6, and the liquid is discharged. It has the advantage that it does not easily peel off under pressure from the outlet 7 side. As a result, for example, when the chemical solution container 1 is erroneously pressed before use, pressure is applied to the film from the chemical solution discharge port 7 side, the film is peeled off, and the closing means is undesirably opened. It is possible to reliably maintain the sterility of the drug solution in the drug solution container before use.

Further, as shown in FIG. 2, the cylindrical body 3 according to the present invention includes a first cylindrical member 13 having the chemical liquid inlet 6 and a second cylindrical member having the chemical liquid outlet 7 and the annular protrusion 11. It is preferable that the first tubular member 13 and the second tubular member 14 are realized by being fitted to each other while holding the sterilization filter 4 therebetween.

With such a structure of the cylindrical body 3, the first cylindrical member 13 and the second cylindrical member 14 are fitted to each other while sandwiching the sterilizing quilter 4, so that the first cylindrical member 13 and the second cylindrical member 14 are provided in the middle of the passage 9. A chemical solution injection port provided with the sterilization filter 4 can be easily manufactured.

In the example shown in FIG. 2, the human first cylindrical member 13 has a support part 15, a fitting part 16, and a peripheral wall part 17, in addition to the chemical liquid inlet 6. The support part 15 is a disc-shaped part and has a concentric through hole 18. The chemical liquid inlet 6 is formed so as to rise from the periphery of the through hole 18 of the support portion 15 toward the one axial direction A1 side and coaxially. The chemical liquid inlet 6 in the example shown in FIG. 2 is formed in a gently tapered shape such that the diameter gradually increases from the through hole 18 toward one side A 1 in the axial direction as described above. You. The opening of the chemical liquid inlet 6 and the through hole 18 in the support 15 form a part of the passage 9 described above. The fitting portion 16 is formed so as to be fitted to a fitting portion 19 of a second cylindrical member 14 described later. In the example of FIG. 2, the fitting portion 16 is formed as a concave portion that gradually becomes deeper in a so-called skirt shape toward the center axis, for example, on the other axial side A 2 of the support portion 15. . Further, the peripheral wall portion 17 is a cylindrical portion formed on the outer periphery of the support portion 15, and the peripheral wall portion 17 forms a part of the peripheral wall 10 of the above-described cylindrical body 3. FIG. 2 shows an example in which the liquid injection port 6 is formed so as to rise from the force supporter 15 toward the one axial side A 1 in the axial direction by the same distance as the peripheral wall 17. .

Examples of a material for forming such a first cylindrical member 13 include synthetic resins having chemical resistance such as polyethylene, polypropylene, polyvinyl chloride, polyester, and polycarbonate.

In addition, in the example shown in FIG. 2, the second cylindrical member 14 has a fitting portion 19 and a peripheral wall portion 20 in addition to the chemical solution outlet 7 and the annular projecting portion 11. The fitted portion 19 is formed so as to be fitted with the fitted portion 16 of the first cylindrical member 13 described above. In the example of FIG. 2, the fitted portion 19 is a convex portion having a stepwise height corresponding to the shape of the fitted portion 16 on the other axial side A 2 of the support portion 15. It is formed. The peripheral wall portion 20 is a substantially cylindrical portion, and the first cylindrical member 13 and the second cylindrical member 14 are fitted together as shown in FIG. Together with the peripheral wall portion 17 of the cylindrical member 13, the peripheral wall 10 of the cylindrical body 3 is formed. The annular protrusion 11 protrudes from the peripheral wall 20 toward the passage 9.

Examples of the material forming the second cylindrical member 14 include the same materials as those of the first cylindrical member 13 described above, such as polyethylene, polypropylene, polyvinyl chloride, polyester, and polycarbonate. Synthetic resin having the above chemical resistance. The first tubular member 13 and the second tubular member 14 are formed of the same material if selected from the above synthetic resin materials. They may be formed of different materials, but are preferably formed of the same material. In addition, when the chemical liquid injection port is connected to the chemical liquid container by welding as described later, a material that can be welded is selected from the above-described resin materials according to the material of the mating member to be welded. Further, the second cylindrical member and the flange portion may be formed separately, and if the second cylindrical member and the flange portion are connected to the container body by welding in this manner, at least the flange portion is formed of a material that can be welded. It should be done.

In the example of FIG. 2, the closing means 5 is realized by a film welded to the annular rib 12 as described above. The material for forming the film is not particularly limited as long as it has chemical resistance and can be welded to the annular rib 12. The material for forming the second cylindrical member 14 described above is not particularly limited. (Material for forming the annular ribs 12) is appropriately selected. As an example of the film forming material, there is a case where the second cylindrical member 14 is formed of a polymer blend of a material for forming the second cylindrical member 14 and a resin having no compatibility with the material. For example, when the second cylindrical member 14 is formed of polyethylene, a polymer blend of polyethylene and polypropylene is preferably used as a film forming material serving as the closing means 5. In this case, the mixing ratio of polyethylene and polypropylene in the film is preferably 3: 7 to 7: 3.

The annular ribs 12 and the film may both be formed of polyethylene, and more preferably both, of high-density polyethylene. Even with such a combination of forming materials, the film can be welded to the annular rib 12 as described above.

The welding of the film to the annular projecting portion 11 may be performed by heating, ultrasonic induction, or high-frequency, induction heat generation as in the case of the conventionally known welding. Since it is intended to be peeled off by injecting a chemical solution from the inlet section 6, in the example of Fig. 2, welding is performed on the annular rib 12 having a semicircular cross section, in other words, the area of welding is reduced. it can The above-mentioned weak welding has been realized by reducing the number of welds. In the present invention, the above-mentioned weak welding is realized by adjusting the welding conditions, not the area to be welded, for example, by lowering the heating temperature or shortening the heating time. Is also good.

In addition, it is preferable that the drug solution injection port 2 of the present invention is realized such that the drug solution inlet port 6 is aseptically shielded by a sealable means that can be opened before use. The shielding means may be any one that can aseptically shield the chemical solution inlet 6 until the chemical solution injection port is used, in other words, a material that can substantially hermetically seal the chemical solution inlet 6. There is no particular limitation. Thus, the sterilized state of the passage 9 before use can be maintained.

FIG. 2 shows a sealing seal attached to the cylindrical body 3 as a shielding means so as to cover the entire opening of the chemical solution inlet 6 over the entire surface (indicated by a two-dot chain line 2 in the figure). 2) is used. The hermetic seal 22 is realized by a film such as a sterilized paper, an aluminum film, for example, a film made of aluminum alone, a plastic film, a laminated film of an anore film and another plastic, or an aluminum film. If you want to co-inject the chemical at the chemical injection port 2, peel off the sealing seal 22 before use.

In the example of FIG. 2, the chemical solution inlet 6 is formed so as to rise from the support portion 15 toward the one axial side A 1 by the same distance as the peripheral wall portion 17. If a sealing seal 22 is adhered to one end portion 1, 7 a of the peripheral wall portion 17 on one axial side, the opening of the chemical solution inlet 6 can be entirely covered with the sealing seal 22. By forming the peripheral wall portion 17 on the first cylindrical member 13 in this manner, the sticking and peeling of the hermetic seal 22 are easier than in the case where the peripheral wall portion is not formed. There are advantages. Note that the chemical liquid inlet may be formed so as to rise from the support portion toward one side in the axial direction by a distance smaller than the peripheral wall portion, and the above-described advantage can be obtained by such an embodiment. Such a liquid injection port 2 can be suitably used as a liquid injection port for a liquid container as shown in FIG. The chemical container is not particularly limited as long as it can be used for medical purposes. The chemical solution container 1 in the example shown in FIG. 1 includes a container body 25 and a chemical solution discharge port 26 in addition to the chemical solution injection port 2.

The container body 25 is a container formed by laminating two sheets made of a flexible synthetic resin and welding the periphery thereof. Materials for forming this container include polyethylene, polypropylene, soft polyester, vinyl chloride, ethylene-vinyl acetate copolymer, etc., especially low-density polyethylene, which has excellent chemical resistance, and Chain low-density polyethylene, polypropylene, etc. are preferably used. The container body 25 contains a liquid such as an amino acid solution, a glucose solution, a solution containing an electrolyte, or a physiological saline solution.

The container body is not limited to the one having only one chamber as in the present example shown in FIG. 1, but may be one having two or more chambers separated by a partition wall. Further, in addition to the shape in which the sheets are overlapped, a tube-shaped member or the like can be used.

The chemical solution discharge port 26 is composed of a discharge port member 27 made of a synthetic resin molded article such as polyethylene or polypropylene, and a connection member formed of the same material as the discharge port member 27. 28, and a rubber stopper 29 supported by the discharge port member 27 and hermetically sealing the opening thereof in a liquid-tight manner. The rubber stopper 29 and the inside of the container body 25 communicate with each other via a connecting member 28, and a bottle needle of an infusion set is pierced through the rubber stopper 29, and the medicinal solution contained inside the human body is removed. Will be administered.

The rubber stopper 29 may be made of any material that does not leak chemicals during infusion, and a rubber-like elastic body such as a thermoplastic elastomer may be used. In addition, the medical solution discharge port is not limited to a shape in which a bottle needle of an infusion set is pierced through a rubber-like elastic body such as a rubber stopper 29 or the like. It may be shaped so that they are connected together.

The chemical solution and injection port 2 is a port for aseptically injecting the chemical solution into the container body 25 described above, a first cylindrical member having a chemical solution injection port 6 connectable to a syringe, and a closing means. The sterilization filter 4 is sandwiched between the second cylindrical member 5 and the second cylindrical member, and the second cylindrical member is fixed to the connection port 30.

FIG. 3 is a cross-sectional view schematically showing a chemical injection port 46 of another preferred example of the present invention. Portions having the same configuration as the above-described liquid injection port 2 are denoted by the same reference numerals as those in FIG. 2, and description thereof will be omitted. The chemical liquid injection port 46 of the embodiment shown in FIG. 3 has a shape corresponding to a luer-lock type (with a lock screw) syringe, for example, a female luer single-port structure. It is formed in such a shape. As a result, compared to the tapered liquid inlet 6 shown in FIG. 2, the liquid inlet 47 that can be connected to the syringe more stably and stably can be realized. To perform a co-injection operation.

In addition, depending on the sterilization method, the chemical injection port of the present invention may be replaced with the hermetic seal 22 described above, and the rubber cap 48 may be replaced with the chemical injection port 47 as shown in FIG. It can be used as a shield to keep the sterile condition before use by fitting it into the opening. In the example of FIG. 3, unlike the case of FIG. 2, the first tubular member 51 does not have a peripheral wall portion, and only the peripheral wall portion 20 of the second tubular member 14 has a cylindrical body 50. This is realized so as to form the peripheral wall 10. Of course, such a rubber cap 48 is removed during the co-injection operation, but after the co-infusion operation, it can be fitted into the opening of the chemical liquid inlet 47 to prevent the mixed chemical solution from flowing back.

The chemical injection port 46 shown in FIG. 3 may be assembled in a sterile space from the fitting of the first tubular member 51 and the second tubular member 14 to the fitting of the rubber cap 48. Usually, after the rubber cap 48 is fitted into the opening of the drug solution inlet 47, the assembly is performed by γ-ray sterilization. FIG. 4 is a simplified cross-sectional view showing a chemical solution injection port 56 of still another preferred embodiment of the present invention. Portions having the same configuration as the above-described liquid injection port 2 are denoted by the same reference numerals as in FIG. 2 and description thereof is omitted. As shown in FIG. 4, the chemical solution injection port 56 of the present invention has a shielding means whose top surface (in the rubber cap 57, the side fitted to the opening of the chemical solution inlet 47) This is realized by fitting a rubber cap (elastomer cap) 57 with a hole 58 formed with an opening 59 in 5a into the opening of the chemical inlet 47. Is also good.

The material for forming the rubber cap 57 is not particularly limited as long as it has rubber-like elasticity, and examples thereof include elastomers, ordinary natural rubber, butyl rubber, and polystyrene resins. However, considering the weldability of the gas filter 60 and the waterproof sheet 61 described later, for example, * styrene-ethylene-butylene-styrene block copolymer (SEBS), styrene-butylene-styrene block Styrene-based thermoplastic elastomers such as copolymers (SBS) and styrene-isoprene-styrene block copolymers (SIS), and olefin-based polymers such as ethylene-propylene copolymer copolymers Thermoplastic elastomer can be preferably used.

The hole 58 in the rubber cap 57 has an opening 59 in the top surface 57a of the rubber cap 57, as described above, and the rubber cap 57, as shown in FIG. It is formed so as to communicate with the passage 9 of the chemical liquid injection port 56 and the external space in a state of being fitted into the opening of the injection port portion 47. The diameter of the hole 58 is not particularly limited as long as it is smaller than the outer diameter of the liquid inlet 47, but usually, the diameter is 1 mm! A diameter of ~ 5 mm is adopted.

The hole 58 formed in the rubber cap 57 is closed by a gas filter (bactericidal filter) 60 so as to allow ventilation. In FIG. 4, for example, the hole 58 is closed by a gas filter 60 provided so as to cover the opening 59 from the outside (above the top surface 57 a). An example Is shown. The gas filter 60 is provided, for example, by being thermally welded to the top surface 57 a of the rubber cap 57. The gas filter 60 has the same disinfection performance as the disinfection filter 4 described above, and has a pore size (high-temperature steam sterilization or ethylene oxide gas sterilization (EOG sterilization) described later) capable of sterilization. It is preferable that the material has a (roughness). The pore size of the gas filter 60 is, for example, 0.011 to 1.0 μm, more preferably 0.01 // // η to 0.5 / zm. The material for forming such a gas filter 60 is not particularly limited, and includes, for example, the same material as for the sterilization filter 4 provided in the passage 9. When the gas finoleta 60 is heat-welded to the top surface 57a so as to cover the opening 59 as described above, for example, polytetrafluoroethylene, polyvinylidene funoleoleide, tetranoroleo, etc. A filter formed by laminating a material having good heat adhesion such as, for example, polyethylene or polypropylene as a material having poor heat adhesion such as an ethylene-hexafluoropropylene copolymer can be preferably used.

In addition, the gas filter 60 may be provided in the middle of the hole 58 so as to block the hole 58 so as to allow ventilation.

According to the rubber cap 57 shown in FIG. 4, gas can pass through the gas filter 60, so that it is not limited to the γ-ray sterilization that was used when the rubber cap 48 shown in FIG. 3 was used. Sterilization methods such as high-pressure steam sterilization and EOG sterilization can be adopted.

The above-mentioned drug solution injection port 56 is fixed to the connection port 30 of the drug solution container filled with the drug solution, and then subjected to high-pressure steam sterilization again. In this high-pressure steam sterilization, if a drying step is not provided after the sterilization, water droplets will remain in the passage 9. At the chemical injection port 56, a waterproof sheet (a portion 61 enclosed by a two-dot chain line in FIG. 4) is attached to the outside of the gas filter 60 by heat welding or the like to prevent this. The waterproof sheet 61 is preferably made of a material such as polyethylene or polypropylene. Plastics, such as laminates and plastics made of aluminum and plastic, are used.

The liquid injection port 56 of the embodiment shown in FIG. 4 is different from the embodiments shown in FIGS. 2 and 3 in that the cylindrical body 62 has a first rectangular member 63 having a liquid injection port 47. A second cylindrical member 64 having a chemical solution discharge port 7 and an annular protrusion 11; and a third cylindrical member 65 having a flange portion 8. The first cylindrical member 63 And the second tubular member 64 are fitted to each other via the third tubular member 65 with the sterilization filter 4 held therebetween. In the chemical liquid injection port 56 of the example shown in FIG. 4, the first cylindrical member 63 and the second cylindrical member 64 both have no peripheral wall, and the peripheral wall 6 of the third cylindrical member 65 does not have a peripheral wall. 6 alone forms the peripheral wall of the cylindrical body 62.

Further, in the example shown in FIG. 1, the chemical solution discharge port member of the chemical solution container of the present invention is formed so as to have a peripheral wall and a rubber stopper fitted into the peripheral wall. Although the configuration was such that the drug solution in the drug solution container was discharged by penetrating a bottle needle or the like, the present invention is not limited to this, and for example, a shape in which a drug solution discharge port member is connected by a connector. You may.

Example

EXAMPLES The present invention will be described in more detail with reference to Examples, but the present invention is not limited thereto.

Example 1

A drug solution injection port 46 of the present invention having the embodiment shown in FIG. 3 was produced. As the disinfecting filter 4, a nylon filter having a hole diameter of 0.2 // m was used. As a material for forming the first tubular member 51 and the second tubular member 14, high-density polyethylene was used. As the closing means 5, a polymer film of polyethylene and polypropylene was used.

The opening of the chemical solution inlet 47 is made of a styrene-based thermoplastic elastomer, SEBS (styrene-ethylene ■ butylene-styrene block coke). After fitting a rubber cap made of polymer, 7-line sterilization was performed. Example 2

A drug solution injection port 56 of the present invention having the embodiment shown in FIG. 4 was produced. A filter made of polyvinylidene fluoride having a pore size of 0.2 μm was used as the sterilization filter 4 provided in the passage 9. A rubber cap 57 made of SEBS and having a hole 58 with a diameter of 2 mni was fitted into the opening of the medicine inlet 47. The top surface 57 a of the rubber cap 57 is laminated with polytetrafluoroethylene having a hole diameter of 0.2 m and high-density polyethylene so as to cover the opening 59 of the hole 58. A gas filter 60 was thermally welded. As a material for forming the first tubular member 63, the second tubular member 64, and the third tubular member 65, high-density polyethylene was used. As the closing means 5, a polymer blend fi / rem of polyethylene and polypropylene was used.

After the rubber cap 57 to which the gas finoleta 60 is heat-welded is sterilized with ethylene oxide gas, the gas filter 60 is covered using a polyethylene seal as the waterproof sheet 61, and the top surface 57 After heat-sealing and affixing to a, the whole was subjected to high-pressure steam sterilization.

Industrial applicability

As is clear from the above description, according to the present invention, a chemical solution can be aseptically injected without the occurrence of coring, the number of parts is small, and the chemical solution injection port has a smaller and simplified structure than the conventional one. And a drug solution container provided with the drug solution injection port. This application is based on the patent application No. 201-0.604 368 and Japanese patent application No. 200-230 530 filed in the S book, the contents of which are incorporated herein by reference. All are to be included.

Claims

The scope of the claims

1. At one end, there is formed a liquid inlet for connecting a syringe, and at the other end, a liquid outlet which can be connected to a liquid container is formed. At the other end, liquid is discharged from the liquid inlet. A tubular body having a passage communicating with the outlet portion,

A disinfection filter provided in the passage;

Closing means is provided between the sterilizing filter and the drug solution outlet so as to close the passage and open the passage when the drug solution enters the passage from the drug solution inlet. A liquid injection port.

2. The cylindrical body has an annular projecting portion projecting toward a passage, and the closing means is a film welded to the side of the annular projecting portion on the side of the chemical solution discharge port. The chemical solution injection port according to range 1.

3. The cylindrical body is composed of a first cylindrical member having a chemical liquid inlet, and a second cylindrical member having a chemical liquid outlet and an annular protrusion, and the first cylindrical member and the second cylindrical member. 3. The drug solution injection port _{c according} to claim 1 or 2, wherein the drug solution injection port _{c is} fitted to each other while sandwiching a sterilization filter.

4. A chemical solution according to any one of claims 1 to 3, characterized in that the mouth is aseptically shielded by an openable shielding means before use. Injection port.

5. The shielding means is a rubber cap fitted into the chemical liquid inlet, wherein the rubber cap has an opening of a hole communicating with the passage on a top surface thereof, and the hole is made permeable by a gas filter. The liquid injection port according to Item 4, which is closed.

6. A drug solution container with a drug solution injection port, comprising the drug solution injection port according to any one of claims 1 to 5.