Source: https://patents.google.com/patent/JP4427965B2/en
Timestamp: 2019-12-07 21:52:10
Document Index: 204694967

Matched Legal Cases: ['art. 5', 'art 23', 'art 23', 'art 11', 'art 23', 'art 50', 'art 13', 'art 11', 'art 23', 'arts 50', 'art 323', 'art 350', 'art 311', 'art 350', 'art 311', 'art 350', 'art 311', 'art 421', 'art 423', 'art 550', 'art 550', 'art 20', 'art 22', 'art 50', 'art 13', 'art 12']

JP4427965B2 - Chemical container with communication means - Google Patents
Chemical container with communication means Download PDF
JP4427965B2
JP4427965B2 JP2003099935A JP2003099935A JP4427965B2 JP 4427965 B2 JP4427965 B2 JP 4427965B2 JP 2003099935 A JP2003099935 A JP 2003099935A JP 2003099935 A JP2003099935 A JP 2003099935A JP 4427965 B2 JP4427965 B2 JP 4427965B2
JP2003099935A
JP2004081819A5 (en
JP2004081819A (en
悟 五十嵐
壽和 平山
慶久 村井
2003-04-03 Application filed by ニプロ株式会社 filed Critical ニプロ株式会社
2004-03-18 Publication of JP2004081819A publication Critical patent/JP2004081819A/en
2006-01-19 Publication of JP2004081819A5 publication Critical patent/JP2004081819A5/ja
2010-03-10 Publication of JP4427965B2 publication Critical patent/JP4427965B2/en
The present invention relates to a chemical solution container with communication means in which a chemical solution is filled in advance. More specifically, the present invention relates to a chemical solution container with communication means in which a communication means including a puncture needle that punctures a sealing member at a vial mouth and a vial guide is releasably connected and is filled with a chemical solution in advance.
Drugs that are difficult to maintain pharmaceutical and medicinal stability when used as liquids have been stored in vials as solid preparations, powder preparations, and lyophilized preparations. It is used by mixing with the solution and preparing it as a liquid.
For example, in the case of a solid 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 pre-filled with a solution) for injection. The needle is pierced through the rubber stopper of the vial, the solution is injected from the syringe into the vial, the solid preparation is mixed with the solution to prepare the drug solution, and after the drug solution preparation operation is completed, the drug solution is re-aspirated from the vial into the syringe. It was.
However, since this method using a syringe requires a metal needle for the preparation of the chemical solution, the coring of the rubber stopper is necessary when the operator is injured by the injection needle or when the needle is inserted into the rubber stopper of the vial at an angle. May occur. Moreover, since the operation was complicated above all, it took time to prepare.
Therefore, in order to solve the above-described problem, as shown in FIG. 10, the cartridge 750 of the container-use syringe main body 740 that is liquid-tightly sealed by the two front and rear rubber stoppers 700 and 710 and contains the drug solution 720 inside. There is an invention in which a mounting portion 771 of a puncture needle member 770 is fitted to a nozzle 761 of a tube tip member 760 provided at a front end portion. According to the present invention, a liquid agent such as a solution can be easily and reliably injected from a syringe serving as a container into a vial filled with a powder preparation or the like, and a general injection needle is not used. There is no risk of injecting a drug solution containing the substance into a patient's body (see Patent Document 1).
Japanese Patent Laid-Open No. 2002-78798
However, in the invention described in Patent Document 1, since the puncture member 770 and the injection needle connecting portion 761 of the tube tip member 760 are connected only by screwing of the mounting portion 771, the inside of the cartridge 750 is not used without using the front rubber stopper 700. In the case where the chemical solution 720 is accommodated and high-pressure steam sterilization is performed, the chemical solution inside may leak from the connection portion. In order to prevent this problem, the chemical solution 720 inside the cartridge 750 is sealed by the front rubber stopper 700. However, a cylinder tip member 760 that forms a chemical fluid passage 762 on the outer wall surface of the front rubber stopper 700 is also required when in use. The manufacturing process becomes complicated. Moreover, since the rubber member used as the material of the rubber stoppers 700 and 710 is expensive, the manufacturing cost is also increased. Further, since the vial guide is not provided, it is difficult to puncture the sealing member of the vial mouth portion, and when puncturing obliquely with respect to the rubber stopper, coring is likely to occur, and the tip 772 of the puncture member 770 There is a risk of contact with fingers and the like.
Thus, the present inventors have intensively studied to solve the above-mentioned problems, and have arrived at the present invention. That is, the present invention
(1) A medical container having a syringe needle connecting portion at the tip, and a hollow communication means provided at the tip of the chemical liquid container, the communication means having a bottom with a slidably inserted mouth of the vial A cylindrical guide portion, and a hollow puncture member provided at the center of the bottom surface of the guide portion so as to penetrate the bottom surface. The puncture member includes a puncture needle on the distal side from the bottom surface and a proximal side from the bottom surface. A chemical container with communication means, comprising a connecting portion, wherein the connecting portion is connected to the injection needle connecting portion;
(2) While the connection part of the puncture member is fitted on the injection needle connection part, the connection part of the puncture member and the injection needle connection part are bonded to each other through a fragile part so as to be easily peelable. The chemical container according to (1) above;
(3) The chemical solution container according to (2), wherein the fragile portion is formed between a distal end of a connection portion of the puncture member and a shoulder portion of the chemical solution container;
(4) The drug solution container according to (2), wherein the fragile portion is formed between the inside of the connection portion of the puncture member and the outside of the injection needle connection portion;
(5) The chemical solution container according to any one of (2) to (4), wherein the fragile portion is formed of a mixed material of at least a forming material of the chemical solution container and a forming material of the puncture member;
(6) The chemical solution container according to any one of (2) to (4), wherein the fragile portion is formed of at least one material selected from thermoplastic elastomer, silicon elastomer, and butyl rubber;
(7) In any one of (2) to (6), the fragile portion is peeled off by relatively rotating the communication means and the chemical solution container, and the communication means can be easily detached from the chemical solution container. The chemical container as described;
(8) The drug solution container according to (1), wherein the connection portion of the puncture member is connected to the injection needle connection portion by screwing;
(9) The drug solution container is a syringe comprising a barrel having an injection needle connecting portion at the distal end and an open base barrel, and a gasket that is liquid-tightly and slidably inserted into the barrel from the base end of the barrel. The chemical solution container according to any one of (1) to (8),
(10) The chemical solution container according to any one of (1) to (8), wherein the chemical solution container is a bottle that can be easily deformed by pressing having an injection needle connecting portion at a tip;
(11) The chemical solution container according to any one of (1) to (10), in which a chemical solution is filled in advance.
FIG. 1 is a longitudinal sectional view showing an embodiment of the present invention, in which a fragile portion is formed by a mixture of forming materials for a connecting portion between a drug solution container and a puncture member.
FIG. 2 is a longitudinal sectional view showing another embodiment of the present invention, in which a fragile portion is formed by a mixture of materials for forming a connecting portion between a chemical solution container and a puncture member, and a bottle is adopted as the chemical solution container. .
FIG. 3 is a partial longitudinal sectional view showing still another embodiment of the present invention, in which a fragile portion is formed by a mixture of materials for forming a connection portion between a chemical solution container and a puncture member, and the fragile portion is formed in the connection portion. Is provided.
FIG. 4 is a diagram showing still another embodiment of the present invention. A fragile portion made of at least one material selected from thermoplastic elastomer, silicon elastomer, and butyl rubber is provided inside the connecting portion of the puncture member. 4A is a longitudinal sectional view, and FIG. 4B is a sectional view taken along line AA.
FIG. 5 is a partial longitudinal sectional view showing still another embodiment of the present invention, wherein all of the connecting portions of the communication means are formed of at least one material selected from thermoplastic elastomer, silicon elastomer, and butyl rubber. The anchor hangs down from the back side of the bottom surface of the guide part in the connection part. 5A is a partial longitudinal sectional view, and FIG. 5B is a sectional view taken along the line BB.
FIG. 6 is a partial longitudinal cross-sectional view showing still another embodiment of the present invention, in the form of a square ring made of at least one material selected from thermoplastic elastomer, silicon elastomer and butyl rubber at the base end of the communicating means. The vulnerable part is installed. 6A is a partial longitudinal sectional view, and FIG. 6B is a sectional view taken along the line CC.
FIG. 7 is a partial longitudinal sectional view showing still another embodiment of the present invention, in which the communication means and the chemical solution container are connected by screwing.
8 and 9 are diagrams for explaining the usage of the chemical container with communication means of the present invention.
In this specification, blocking refers to a phenomenon in which thermoplastic elastomer, silicon elastomer, butyl rubber, and polyolefin resin are in close contact with each other and are difficult to peel off.
As shown in FIG. 1, the chemical solution container with communication means of the present invention includes a chemical solution container 10 having an injection needle connecting portion 11 at the tip and a hollow communication means 20 provided at the tip of the chemical solution container 10, The communicating means 20 includes a bottomed cylindrical guide portion 21 into which a vial mouth portion can be slidably inserted, and a hollow puncture provided at the center of the bottom surface 22 of the guide portion 21 through the bottom surface 22. The member 23 is included. The puncture member 23 has a puncture needle 23a on the distal end side from the bottom surface 22 and a connection portion 23b on the proximal end side from the bottom surface 22, and the connection portion 23 is liquid-tightly connected to the injection needle connection portion 11. Yes.
Here, as the chemical solution container 10, a barrel 12 having a proximal end having an injection needle connecting portion 11 at the distal end and a barrel 12 opened from the proximal end of the barrel 12 are inserted into the barrel 12 in a liquid-tight and slidable manner. A syringe-type chemical solution container including the gasket 30 is preferably employed. The barrel 12 is a cylindrical member usually formed of a polyolefin resin such as polypropylene or polyethylene, and a shoulder portion 13 is formed from the proximal end of the injection needle connecting portion 11 to the outer peripheral edge of the barrel distal end surface. At the base end of the barrel 12, a flange 14 for finger hooking is provided. The gasket 30 is formed of butyl rubber, a thermoplastic elastomer, or the like, and is inserted from the base end of the barrel 12 so as to be liquid-tight and slidable. Engaging means such as a female screw 31 is provided at the base end of the gasket 30 so that a male screw 41 provided at the distal end of the plunger 40 can be coupled.
Moreover, as shown in FIG. 2, the chemical | medical solution container 110 may be the bottle 112 formed of flexible materials, such as polyethylene and a polypropylene, and can be easily deformed by pressing.
The communication means 20 shown in FIG. 1 is usually made of polypropylene, ABS resin, polyethylene, a mixture of polypropylene and polyethylene, and the like, and has a bottomed cylindrical guide portion 21 into which a vial mouth portion can be slidably inserted. The guide portion 21 includes a hollow puncture member 23 provided at the center of the bottom surface 22 so as to penetrate the bottom surface 22. The puncture member 23 includes a puncture needle 23 a on the distal end side from the bottom surface 22 and a proximal side from the bottom surface. Connection part 23b. And this connection part 23b has a luer taper inside, and is externally fitted to the injection needle connection part 11 of the drug solution container 10, and the tip of the connection part 23b is a fragile part 50 on the shoulder part 13 of the drug solution container 10. It can be easily peeled and bonded. Thereby, when the chemical | medical solution container with a communication means which concerns on this invention is sterilized by high pressure steam, the penetration | invasion of the water | moisture content from the fitting part of the injection needle connection part 11 and the connection part 23b to the inside of a container can be prevented. Here, it is preferable that the fragile portion 50 can be easily peeled by applying a relative rotation to the chemical solution container 10 to the communication means 20.
The fragile portion 50 is usually incompatible with the forming material of the drug solution container 10, for example, and has a good compatibility with the forming material of the puncture member 23, for example, the forming material of the drug solution container 10 and the puncture member 23. It is formed of a mixed material of forming materials. More specifically, when the drug solution container 10 is mainly composed of polypropylene and the puncture member 23 is formed mainly of polyethylene, the fragile portion 50 is made of a material mainly composed of a mixture of polypropylene and polyethylene. The medicinal solution container 10 and the puncture member 23 are weakly welded so as to be peeled through the fragile portion 50. When the communication means 20 is rotated relative to the chemical liquid container 10, the fragile portion 50 formed in this way is peeled off from the chemical liquid container 10 together with the communication means 20. In addition, when the fragile portion 50 is formed of a material that is poorly compatible with the forming material of the puncture member 23 and the adhesive force between the two is weak, the connecting portion of the puncture member 223 as shown in FIG. An engaging portion 223c may be provided on 223b so that the weakened portion 250 and the communication means 220 are difficult to physically separate.
In addition, these weak parts 50 and 250 may be formed by insert molding, or may be formed by two-color molding.
A fragile portion 350 made of at least one material selected from an elastic member such as a thermoplastic elastomer, a silicone elastomer, or butyl rubber is formed inside the connection portion 323b of the puncture member 323 of the communication means 320 shown in FIG. The drug solution container 310 and the communication means 320 are connected in a liquid-tight and detachable manner by blocking the injection needle connecting portion 310 and the fragile portion 350. The fragile portion 350 may be formed by insert molding, may be formed by two-color molding, or may be formed separately in advance and then fitted inside the connection portion 323b.
Next, a connection method by blocking the weakened portion 350 of the embodiment shown in FIG. 4 to the injection needle connecting portion 311 will be described. The connection part 323b of the puncture member 323 provided with the weak part 350 formed of thermoplastic elastomer, silicon elastomer, butyl rubber or the like is inserted into the injection needle connection part 311 of the drug solution container 310, and the weak part 350 and the injection needle connection part 311 are inserted. And the whole is subjected to high-pressure steam sterilization under conditions generally employed in the manufacture of chemicals, such as 115 ° C. × 30 minutes or 121 ° C. × 20 minutes, for example. Plastic elastomer, silicon elastomer, butyl rubber or the like causes blocking with the injection needle connecting portion 311 made of polyolefin resin, and the communication means 320 and the chemical solution container 310 are connected in a liquid-tight manner. And the weak part 350 peels from the injection needle connection part 311 by rotating the communication means 320 and the chemical | medical solution container 310 relatively, As a result, the communication means 320 and the chemical | medical solution container 310 can be removed.
In the communication means 420 shown in FIG. 5, the entire connection portion 423b of the puncture member 423 is formed of thermoplastic elastomer, silicon elastomer, butyl rubber, or the like. The inside of this connection portion 423b, the outside of the injection needle connection portion 411, and the shoulder Blocking is performed at the portion 413, and the liquid-tight and peelable connection is made. An anchor 424 hangs from the back side of the bottom surface 422 of the guide part 421 into the connection part 423. By providing the anchor 424, when the communication means 420 and the drug solution container 410 are relatively rotated, the communication means 420 leaves only the connection portion 423b blocking the injection needle connection portion 411 in the drug solution container 410. It can be prevented from coming off. The anchor 424 shown in FIG. 5 is composed of two partial cylinders each having an arc portion. However, the communication means other than the connection part of the communication means are connected to the chemical solution by the relative rotation operation of the communication means and the chemical solution container. An anchor having an arbitrary shape can be adopted as long as the bottom side of the guide portion and the connection portion are locked so as not to be removed from the container.
The communication means 520 shown in FIG. 6 has a rectangular ring-shaped fragile portion 550 made of at least one material selected from thermoplastic elastomer, silicon elastomer, and butyl rubber at the tip of the connecting portion 523b and the shoulder portion 513 between the chemical solution containers 510. The communication means 520 and the chemical solution container 510 are connected in a liquid-tight and peelable manner by blocking between the fragile portion 550 and the shoulder portion 513. Further, when the communication means 520 and the chemical solution container 510 are relatively rotated at the time of use, the communication means 520 and the weak part 550 are rotated by a rotational force so that the weak part 550 rotates integrally with the communication means 520. It is desirable to provide a protrusion 523d for preventing peeling at the base end of the connection portion 523b. In addition, although a square ring is employ | adopted as a weak part in a present Example, it will not be limited to a square ring if it is a ring which connects a communicating means and a syringe liquid-tightly and detachably by blocking. Moreover, the said protrusion can also be provided in a shoulder part.
Further, as described above, thermoplastic elastomer, silicon elastomer, and butyl rubber are preferable as the material of the weakened portion 350 in FIG. 4, the connecting portion 423b of the puncture member in FIG. 5, and the rectangular ring-shaped weakened portion 550 in FIG. As long as the injection needle connecting portions 311, 411, and 511 can be sealed in a liquid-tight and peelable manner, the material is not particularly limited.
A preferred embodiment of the chemical solution container with communication means of the present invention is a so-called prefilled syringe P in which a chemical solution is filled in advance in a syringe type chemical solution container as shown in FIG. In this case, the puncture needle of the communication means is hermetically or airtightly sealed with a cap 60 formed of butyl rubber or thermoplastic elastomer as shown in FIG.
Next, the use of the chemical container of the present invention will be described with reference to FIGS. The chemical container shown in FIG. 7 is substantially the same as that shown in FIG.
First, the chemical solution D1 (in this case, a solution) is housed, which has communication means 20 connected in a liquid-tight and peelable manner via the fragile portion 50, which is a preferred embodiment of the chemical solution container of the present invention. A prefilled syringe P and a vial V containing the medicine D2 therein are prepared, and a plunger 40 is coupled to the gasket 30 of the prefilled syringe P as shown in (1) of FIG. Next, the prefilled syringe P is moved in the direction of the arrow (A), the mouth V1 of the vial V is slid along the guide portion 21 of the communication means 20, and the puncture needle as shown in (2) in FIG. The rubber stopper V2 of the vial V is pierced with 23a. At this time, when the plunger 40 is pushed in the direction of the arrow (b), the drug solution D1 accommodated in the prefilled syringe P is injected into the vial V. In this state, the prefilled syringe P and the vial V are shaken well to mix the drug solution D1 and the drug D2 to obtain the drug solution MD, and then the positions of the prefilled syringe P and the vial V are turned upside down as shown in (3) in FIG. When the plunger 40 is pulled in the direction of the arrow (C), the drug solution MD in the vial V is sucked into the prefilled syringe P. Next, as shown in (4) in FIG. 8, when the communication means 20 is turned in the direction of the arrow (d), the communication means 20 is integrated with the fragile portion 50 as shown in (5) in FIG. Peel from prefilled syringe P. Finally, as shown in (6) in FIG. 8, if the injection needle 70 is connected to the injection needle connecting portion 11 at the tip of the prefilled syringe P, the drug solution MD can be injected into the patient's vein or the like.
As is apparent from the above description, according to the present invention, the communication means and the chemical container can be connected in a liquid-tight and peelable manner by a normal sterilization process, so that the operator can be injured or coring the coring. The chemical preparation can be easily performed in a short time without generating. Further, since no metal needle is used, labor for separating the metal needle and the plastic member can be saved.
FIG. 7 is a diagram showing a use situation of the present invention.
FIG. 8 is a diagram showing a use situation of the present invention.
FIG. 9 is a diagram showing a conventional technique.
10, 110, 310, 410, 510 Drug solution container 11, 311, 411 Injection needle connecting part 20, 220, 320, 420, 520 Communication means 21, 421 Guide part 22, 422 Bottom face 23, 223, 323, 423, 523 Puncture Member 23a, 223a, 323a, 423a, 523a Puncture needle 23b, 223b, 323b, 423b, 523b Connection part 50, 250, 350, 550 Fragile part 13, 413, 513 Shoulder part 12 Barrel 30 Gasket 112 Bottle D1 Chemical solution
A drug container having an injection needle connection portion at the tip, and a hollow communication means provided at the tip of the drug solution container, the communication means having a bottomed cylindrical shape that can be slidably inserted into the mouth of the vial. A guide portion, and a hollow puncture member provided at the center of the bottom surface of the guide portion so as to penetrate the bottom surface. The puncture member includes a puncture needle on the distal end side from the bottom surface and a connection portion on the proximal end side from the bottom surface. The connecting portion is connected to the injection needle connecting portion, and the connecting portion of the puncture member is externally fitted to the injection needle connecting portion, and the connecting portion of the puncture member and the injection needle connecting portion Is a chemical solution container with communication means, which is easily detachably bonded via a fragile portion, and the fragile portion is formed between the tip of the connecting portion of the puncture member and the shoulder portion of the chemical solution container.
The chemical solution container according to claim 1, wherein the fragile portion is formed of a mixed material of at least a forming material of the chemical solution container and a forming material of the puncture member.
The chemical solution container according to claim 1, wherein the fragile portion is formed of at least one material selected from a thermoplastic elastomer, a silicone elastomer, and butyl rubber.
The chemical solution container according to any one of claims 1 to 3 , wherein the weakened portion is peeled off by relatively rotating the communication means and the chemical solution container, and the communication means can be easily detached from the chemical solution container.
The syringe is a syringe comprising a barrel having a proximal end having an injection needle connecting portion at a distal end and a gasket that is liquid-tightly and slidably inserted into the barrel from the proximal end of the barrel. The chemical | medical solution container in any one of 1-4 .
The chemical solution container according to any one of claims 1 to 5 , wherein the chemical solution container is a bottle that can be easily deformed by pressing having an injection needle connecting portion at a tip.
The chemical solution container according to any one of claims 1 to 6 , wherein the chemical solution is previously filled therein.
JP2003099935A 2002-07-02 2003-04-03 Chemical container with communication means Expired - Fee Related JP4427965B2 (en)
CA 2433769 CA2433769C (en) 2002-07-02 2003-06-27 Drug solution container with a connector for communicating
US10/608,547 US6901975B2 (en) 2002-07-02 2003-06-30 Drug solution container with a connector for communicating
DE2003606851 DE60306851T2 (en) 2002-07-02 2003-07-01 Drug solution container with a communication connector
EP20030014955 EP1378223B1 (en) 2002-07-02 2003-07-01 Drug solution container with a connector for communicating
JP2004081819A JP2004081819A (en) 2004-03-18
JP2004081819A5 JP2004081819A5 (en) 2006-01-19
JP4427965B2 true JP4427965B2 (en) 2010-03-10
JP2003099935A Expired - Fee Related JP4427965B2 (en) 2002-07-02 2003-04-03 Chemical container with communication means
BR112015006659A2 (en) * 2012-09-26 2017-07-04 Transcoject Gmbh filled syringe
DE60306851T2 (en) 2006-11-30
Ref document number: 4427965