TW202224663A - Plastic adapter and closed drug transfer system which covers a plastic cap and can be safely used in a closed drug transfer system - Google Patents

Abstract

The present invention provides a plastic adapter that covers a plastic cap and can be safely used in a closed drug transfer system. The plastic adapter provided by the present invention is installed on a drug container mounted with the plastic cap. The plastic adapter comprises a top surface part having a chimeric part at the center thereof, and a cylindrical side edge part suspended from the outer periphery of the top surface part and having an open lower end. The chimeric part has a lip and a middle cylinder suspended from the lip. The chimeric part is fitted with a medical instrument used in the closed drug transfer system.

Description

Plastic fittings and closed medication handling systems

The present invention relates to a plastic-made adapter and a closed drug transfer system (Closed System Drug Transfer Device: CSTD). More specifically, it relates to a plastic-made fitting that covers a plastic-made cap and can be safely used in a closed drug delivery system, and a closed drug delivery system using the aforementioned fitting.

Conventionally, as containers for storing various medicines such as medicines, medicine containers such as vials are widely used. In the above-mentioned pharmaceutical container, after the medicine is contained, the mouth of the medicine container is sealed with a rubber stopper, and the inside of the medicine container is used in a sealed state. For the transfer of the drug contained in the drug container, for example, the liquid drug transfer device described in Patent Document 1 or the telescoping master bottle adapter described in Patent Document 2 are used by medical practitioners. wait for the user. In order to prevent exposure to the aforementioned user due to leakage of aerosol, vapor, or liquid from the inside of the drug container, the drug contained in the drug container must generally be handled by a closed drug delivery system. Transfer of an agent, especially where the aforementioned agent is a tumor suppressor. [Prior Art Literature] [Patent Literature]

[Patent Document 1] Japanese Patent Publication No. 2009-504230. [Patent Document 2] Japanese Patent Publication No. 2015-528368.

[The problem to be solved by the invention]

If the above-mentioned medicine transfer device or the like is not aligned with the medicine container, it becomes difficult to pierce the rubber stopper etc. of the medicine container to make a hole, and depending on the situation, there may be an accident that the medicine leaks from the medicine container of doubts.

In addition, in the aforementioned telescopic female vial mating connector, the lower part of the mating connector is aligned relative to the vial for the drug supply bottle mating connector. For engagement with a needleless syringe, the upper portion of the aforementioned adapter has an upstanding female connector. Therefore, not only the vial side of the lower part of the fitting, but also the upper part of the fitting must be fitted with a medical device used in a closed drug delivery system, and there is a problem that a plurality of connecting fittings are required.

Moreover, all the medicine vials described in Patent Document 1 and Patent Document 2 are equipped with an aluminum lid called a band at the opening of the vial. Here, although aluminum caps have been the mainstream in the past, in recent years, the use of plastic caps with different shapes and sizes from various manufacturers has also increased, and there is also a shortage of medicine bottles that can cover the plastic caps. Problems with the via adapter.

Therefore, the present invention provides a plastic fitting, which can prevent drug leakage by being safely used in a closed drug delivery system, does not require a plurality of connecting fittings, and can cover a plastic cover , for card connection. [means to solve the problem]

That is, the present invention first provides a plastic fitting (E), which is mounted on a medicine container (A) with a plastic lid; the fitting (E) has: a top surface (E1) , which has a fitting portion (E11) in the center; and a cylindrical skirt portion (E2), which is suspended from the outer periphery of the top surface portion (E1) and has an open lower end; the fitting portion (E11) The system has: a lip (E112); and a middle cylinder (E113), which is suspended from the lip (E112); the fitting part (E11) is connected with a medical device (F) for a closed drug delivery system Do chimera. In addition, the plastic fitting system of the present invention may further include a piercing portion (E3) in the interior of the side edge portion (E2), suspended from the center of the lower surface of the top surface portion (E1), and connected to the medical The interior of the product container (A) communicates. In the present invention, the lip (E112) is composed of an upper surface (E115), a rubber plug (E111) and a lower surface (E114), and the plastic fitting is attached to the upper surface (E115) or the lower surface At least one of (E114) is in surface contact with the aforementioned medical device (F). In the present invention, at least one or more engaging claws (E21) may be formed on the inner surface of the lower end of the side edge portion (E2) to engage under the lip (A2) of the pharmaceutical container (A). . In this invention, at least one or more notch part (E22) may be provided in the height direction on the outer peripheral surface of the said side edge part (E2). In this invention, the cover (D) which can be detached with a finger may be provided on the upper surface of the said fitting part (E11).

In addition, the present invention also provides a closed medicine delivery system, which uses a plastic cover (C) and a plastic fitting (E); the plastic cover (C) is mounted on a medicine container (C). A), and has: a top surface portion (C1), which has an opening portion (C10) in the center; a cylindrical side edge portion (C2), which is suspended from the outer periphery of the aforementioned top surface portion (C1) and has an opening at its lower end; and An inner cover (C3) is located inside the side edge portion; the coefficient of friction between the inner cover (C3) and the rubber plug (B) is higher than that between the inner cover (C3) and the cover (C) The friction coefficient between them is also high; the plastic fitting (E) is mounted on the plastic cover (C), and has: a top surface (E1), and a fitting part (E11) in the center; and The cylindrical side edge portion (E2) is suspended from the outer periphery of the top surface portion (E1) and has an open lower end; the fitting portion (E11) is provided with: a lip (E112); and a middle cylinder (E113), which is Suspended from the lip (E112); the fitting portion (E11) is fitted with a medical device (F) for a closed drug delivery system. [Inventive effect]

According to the present invention, a plastic fitting can be provided, which can cover the plastic cover and can be safely used in a closed drug delivery system. In addition, the effect described here is not limited to the above-mentioned effect, and may be any effect described in this specification.

Preferred embodiments for carrying out the present invention will be described below. The embodiment described below is an embodiment showing an example of a typical embodiment of the present invention, and is not intended to limit and interpret the scope of the present invention.

<1. Plastic fitting E> FIG. 1 is a diagram illustrating an example of an embodiment of the mating connector E of the present invention. The plastic fitting E of the present invention covers a rubber stopper B that seals the opening A1 of the pharmaceutical container A, and is fitted to the pharmaceutical via, for example, a plastic cap C, which will be described later, or a general vial fitting, etc. It is used as a product container A, and it is a fitting that can be used in a closed drug delivery system. Here, the definition of a closed drug delivery system will be described. There are two cases of closed drug delivery system, which means closed connection device (not shown) and closed administration route, but in the description of this case, it mainly refers to the former closed connection device.

The mating head E is composed of a top surface E1 having a fitting portion E11 in the center, and a cylindrical side edge portion E2 suspended from the outer periphery of the top surface E1 and having a lower end open. Moreover, the said fitting part E11 has a lip E112; and a middle cylinder E113 is suspended from the said lip E112; The said fitting part E11 is fitted with the medical instrument F which is an airtight connector. Preferably, the outer diameter of the side edge portion E2 is larger than the diameter of the middle cylinder E113. In addition, as the aforementioned medical device F, for example, it refers to a vial adapter having a general needle. Since the fitting E of the present invention has the above-mentioned configuration, when the plastic cap C and the fitting E of the present invention are used, the leakage of aerosol, vapor, and liquid from the inside of the medicine container A can be prevented. It can be safely used in a closed drug delivery system by maintaining the sterility of the inside of the drug container A and maintaining the internal sterility of the drug container A.

As shown in FIG. 1 and FIG. 2 , in a preferred embodiment of the present invention, the mating head E mounted so as to cover the plastic cover C further has a piercing portion E3 inside the side edge portion E2. , which is suspended from the center of the lower surface of the top surface E1, and communicates with the inside of the medicine container A. By having the piercing portion E3, the rubber stopper B can be pierced without using a piercing tool or the like separately, and the troublesomeness in use can be avoided.

As shown in FIGS. 1 and 3 , the fitting E of the present invention has: a top surface E1, which has a substantially T-shaped fitting part E11 in the center; and a cylindrical side edge E2, which is attached from the top The outer periphery of the face portion E1 is suspended and the lower end is open; the fitting portion E11 is composed of a lip E112 and a middle cylinder E113 suspended from the lip E112. The lip E112 has an upper surface E115 and a lower surface E114, and a disc-shaped rubber plug E111 is provided inside the lip E112 to prevent exposure of the medicine.

As shown in FIG. 2 , in the fitting portion E11 of the mating connector E of the present invention, the height t1 constituting the lip E112 can take into account the depth (length) of the inner surface on the side where the needle is installed on the side of the medical instrument F (not shown). And/or the thickness of the rubber plug E111, wherein the medical instrument F is a hermetic connector for fitting, and the rubber plug E111 is provided inside the fitting portion E11.

In addition, on the inner surface of the lower end of the side edge portion E2, at least one or more engaging claws E21 are formed to engage with the plastic cover C from the outside.

Next, how the fitting portion E11 of the fitting E of the present invention is fitted will be described with reference to FIG. 5 . In addition, there are cases where the fitting portion E11 of the fitting E of the present invention is fitted, the case where the vial fitting of the medical instrument F has a housing, and the case where the vial fitting of the medical instrument F does not have a housing. In the case of the case, the case with the case in the former is illustrated in FIG. 5 .

In the case where the vial fitting of the medical instrument F has a cover, the vial fitting of the medical instrument F provided with the lancet F1 is fitted with the fitting portion E11 of the fitting E from the upper surface, and the fitting portion E11 of the fitting E is fitted from the upper surface. The upper surface E115 and the lower surface E114 are surface-contacted and fitted inside the sleeve, wherein the upper surface E115 and the lower surface E114 constitute the outer edge portion of the lip E112. Thereby, the medical instrument F and the fitting E of the present invention can be firmly fixed.

In the case where the vial adapter of the medical device F does not have a cover, the tang portion (not shown) constituting the base of the puncture needle F1 is in surface contact with the upper surface E115 of the lip E112 at at least one place. In this case, since the puncturing needle F1 can be pierced into the medicine through the disk-shaped rubber stopper E111 provided in the lip E112, exposure due to leakage of liquid etc. Used in closed drug handling systems.

As shown in FIG. 1 and FIG. 2 , in a preferred form of the present invention, at least one or more engaging claws E21 are formed on the inner side of the lower end of the side edge portion E2 of the fitting E. The outside covers the cover C made of plastic for engaging. The number of the engaging claws E21 is not particularly limited, but it is preferable to form a plurality of them. In addition, although the shape of the engaging claw E21 can be made into a J shape, it can also make into the convex shape extended horizontally in an inner diameter direction, for example. Thereby, even if an upward force is applied to the mating head E, it is possible to prevent the mating head E from falling off easily. In addition, when fitting with the cap C, which will be described later, the cutout portion E22 of the gap provided near the engaging claw E21 and perpendicular to the side edge portion E2 can also be used as a position where the pharmaceutical container A can be fitted. Visually confirm the positioning mechanism to use.

As shown in FIG. 3 , in one preferred embodiment of the present invention, at least one or more notch portions E22 are provided in the height direction on the outer peripheral surface of the side edge portion E2. Although the number of objects of the notch part E22 is not specifically limited, It is preferable to form a plurality of objects. Thereby, the flexibility of the side edge portion E2 can be improved, and the occurrence of damage such as cracking can be prevented when the aforementioned fitting E is fitted.

In the present invention, as the rubber stopper B shown in FIG. 1 , from the viewpoint of slipperiness, or in order to prevent the rubber stoppers from sticking to each other (sticking docking), a rubber stopper B is laminated on the leg portion B2 of the rubber stopper B. Plastic-made film. Furthermore, in order to ensure higher sealing performance than the rubber stopper B shown in FIG. 1 , it is preferable that the lower part of the top part B1 is a bare surface of rubber, and further, the root part of the leg part B2 of the rubber stopper B is also Rubber bare face. Further, it is preferable that the top surface of the top portion B1 of the rubber stopper B is a top surface that is not coated with a lubricant such as polysilicone, like the aforementioned leg portion B2 of the rubber stopper B. This is because if a lubricant such as polysiloxane is applied, protein aggregation will occur. In the case where the top surface of the cover portion B1 of the rubber plug B needs to be slippery, it is sufficient to laminate a plastic film. As the plastic film used for the rubber stopper B, general plastic films such as polyethylene, polypropylene, and fluorine-based resins can be used.

As a material for forming the mating joint E of the present invention, for example, it is only necessary to be a resin excellent in heat resistance, slipperiness, antibacterial and bactericidal properties, and strength. Although there are thermoplastic resins, thermoplastic elastomers (TPE: thermoplastic elastomer), A polyolefin (polyolefin) system is not limited to this, It can select suitably and freely. Specifically, for example, fluorine-based resins, polyethylene-based resins, and polypropylene-based resins (PP, also include copolymers (copolymers) obtained by copolymerizing ethylidene groups, butenyl groups, etc. in addition to homopolymers. )), polyester resin (PET), polyamide resin (PSF), methylpentene resin (PMP), polyacrylate resin (PAR), polyamide resin (PA), Modified polyphenylene oxide resin (m-PPE), cyclic olefin (olefin) compound or cross-linked polycyclic hydrocarbon as polymer component resin, polycarbonate resin (PC), Resins modified (grafted) of olefin-based resins with polar groups, polyacetal (POM) excellent in abrasion resistance, etc., are not limited to these as long as they are materials that can withstand, for example, The high-pressure steam sterilization conditions of 121°C for 20 minutes have no problems with the strength of heat resistance, deterioration, rupture, etc., and can be sterilized by radiation sterilization or the like. By forming the mating connector E of the present invention with plastic, even if it rubs against or collides with the medical device F, which is a hermetic connection device, particles and the like will not be generated. In addition, since the fitting E system can be manufactured by, for example, injection molding, the degree of freedom of the shape and structure is high.

As shown in FIGS. 1 and 2 , in the fitting E of the present invention, a cover D that can be detached with fingers may be integrally provided on the upper surface of the fitting portion E11 . That is, it is preferable that the fitting E and the cover D are formed by, for example, the above-mentioned resins, respectively, formed by molding and welding. Of course, the mating head E and the cover D can be integrally formed by various methods. Although the said cover D is not essential in this invention, it is preferable to provide in order to prevent contamination of the upper surface of the fitting part E11. Preferably, the cover D is formed with: one or a plurality of finger hooks D1, which are formed over the entire circumference or partially. The user can easily remove the cover D by placing his finger on the finger hook D1 as required.

In addition, as another embodiment of the cover D, molding with a gas-impermeable film that does not pass gas, water vapor, bacteria, etc., or molding with a gas-permeable film that allows gas, water vapor, etc. to pass, etc. can be mentioned. . In the present invention, as long as it is a method that can prevent the contamination of the rubber plug E111 provided inside the fitting portion E11, for example, a method that can cover the upper surface E115 of the fitting portion E11 of the fitting E of the present invention and A peelable seal or the like forms the cover D.

A method of using the mating connector E of the present invention described above will be described with reference to FIG. 1 . First, after the medicine container A is filled with a desired medicine, a rubber stopper B of an appropriate size is inserted into the opening A1 of the medicine container A, and the medicine container A is sealed. The medicine container A containing the medicine is used for CSTD by users such as medical practitioners, but at this time, in order to prevent exposure due to the leakage of aerosol, vapor, and liquid from the inside of the medicine container A, the rubber is used. In the medicine container A in the state sealed by the stopper B, the fitting E is fitted through the plastic cover C which will be described later. In this way, along with the descending of the fitting E, the J-shaped engaging claws E21 provided on the inner surface of the fitting E are elastically deformed and descend while contacting the outer peripheral surface of the side edge portion C2 of the cover C. When the front end of the engaging claw E21 exceeds the outer peripheral surface of the side edge portion C2 of the cover C, the engaging claw E21 returns to the original state, and the fitting E is fixed. Next, the user fits the medical device F for CSTD and the fitting E from the upper cover side of the fitting part E11, and transfers the medicine.

In addition, in the above-mentioned example, although the rubber stopper B is inserted into the opening A1 of the medicine container A, the fitting E is inserted through the plastic cover C to be described later after the medicine container A is sealed. , but the present invention is not limited to this.

<2. Closed drug delivery system> The present invention also provides a closed drug delivery system using the plastic cover C described later and the mating connector E of the present invention described above. As mentioned above, the adapter E series can be applied to the CSTD through the cover C. Since the fitting E is the same as the above, the description is omitted here.

As shown in FIG. 1 , the plastic cap C is a cap for preventing the rubber stopper B that seals the opening A1 of the pharmaceutical container A from being detached. The cover C is composed of the following: a top surface C1, which has an opening C10 in the center; a cylindrical side edge part C2, which is suspended from the outer periphery of the top surface C1 and has a lower end opening; and an inner cover C3, which is inside the side edge portion. In addition, the coefficient of friction between the inner cover C3 and the rubber stopper B is higher than the coefficient of friction between the inner cover C3 and the cover C. Therefore, when the cap C is applied to the capped rubber stopper B for insertion, even if a force is applied to the cap C in the lateral direction, the cap C is only idling and the rubber stopper B does not rotate. Therefore, the airtightness of the rubber plug B can be maintained.

As shown in FIG. 1 , in a preferred embodiment of the present invention, the cover C has at least one slit C21 on the side edge portion C2. Preferably, a plurality of slit portions C21 are formed, for example, it is preferably formed at three places. The aforementioned slit portion C21 can be used as a positioning mechanism when the cover C and the mating joint E of the present invention are fitted. Moreover, as a positioning mechanism of the fitting E, the method of providing a convex shape member (not shown) on the inner wall of the side edge part C2, etc. are mentioned, for example.

The top surface C1 of the cover C is disc-shaped, and an opening C10 is formed in the center of the top surface C1. However, the size of the opening C10 is not particularly limited as long as the effect of the present invention can be achieved. In the closed drug delivery system of the present invention, the piercing part E3 is inserted into the center of the opening part C10, and pierces the rubber plug B held inside the cover C. As shown in FIG.

A method of using the closed drug delivery system of the present invention described above will be described with reference to FIG. 1 . First, after the medicine container A is filled with a desired medicine, a rubber stopper B of an appropriate size is inserted into the opening A1 of the medicine container A, and the medicine container A is sealed. Next, when the cap C is fitted into the pharmaceutical container A in the state sealed by the rubber stopper B, ideally, when the cap C is fitted with a capper, the rubber stopper B and the cap C are fixed. The medicine container A containing the medicine is used by a user such as a medical practitioner in the CSTD, and the fitting E is inserted so as to cover the cap C while positioning by the slit C21. The cap C and the fitting E are be fixed. Next, the user pierces the rubber stopper E111 from the upper surface E115 side with the medical instrument F used for CSTD, and transfers the medicine.

In addition, in the above-mentioned example, although the rubber stopper B is inserted into the opening A1 of the medicine container A, and the medicine container A is sealed, the cap C is inserted into the rubber stopper B, and the medicine container A is further sealed. The connector E is embedded in the cover C, but the present invention is not limited to this.

Since the mating joint E of the present invention can wrap the plastic cover C in the side edge portion E2 and can be clamped by the engaging claws E21 provided on the side edge portion E2, it can be safely used in closed medicine transportation The system can prevent the leakage of the medicine. In addition, in the fitting portion E11 of the fitting E of the present invention, the height t1 constituting the lip E112 can take into account the depth (length) of the inner surface and/or the rubber on the side where the needle is installed on the side of the medical instrument F (not shown) The thickness of the plug E111 can be freely changed as appropriate, wherein the medical device F is a hermetic connection device for fitting, and the rubber plug E111 is provided inside the fitting portion E11; therefore, the fitting E11 can be used alone. In all kinds of hermetic connection equipment, multiple connection fittings are not required. [Industrial Availability]

As is clear from the above, according to the present invention, it is possible to provide a plastic fitting capable of maintaining the sterility of the inside of the medicinal product container while preventing exposure due to leakage of aerosol, vapor, or liquid from the inside of the medicinal product container. , can be safely used in a closed drug delivery system, furthermore, it does not need a plurality of connection and fitting joints, and can wrap a plastic cover and be clamped.

A: Medicine container A1, C10: Opening A2, E112: Lips B, E111: Rubber plug B1: Kasabe B2: Feet C: cover C1, E1: top face C2, E2: side edge C3: inner cover E21: clamping claw C21: Gap D: cover D1: Finger hook E: mating connector E3: Piercing E11: Fitting part E22: Cutout E113: Medium tube E114: Lower surface E115: Upper surface F: Medical Devices F1: Needle t1: height

Fig. 1 is a diagram illustrating an example of an embodiment of the mating connector E of the present invention. 2] It is a figure explaining the state which applied the example of embodiment of the fitting E of this invention to the medicine container A. [FIG. [ Fig. 3 ] is a perspective view of an example of the embodiment of the mating connector E of the present invention viewed from above. [ Fig. 4] Fig. 4 is a perspective view of an example of the embodiment of the mating connector E of the present invention viewed from below. [ Fig. 5] Fig. 5 is a diagram illustrating an example of an embodiment of the mating connector E of the present invention.

A: Medicine container

A1, C10: Opening

A2, E112: Lips

B, E111: Rubber plug

B1: Kasabe

B2: Feet

C: cover

C1, E1: top face

C2, E2: side edge

C3: inner cover

E21: clamping claw

C21: Gap

D: cover

D1: Finger hook

E: mating connector

E3: Piercing

E11: Fitting part

E22: Cutout

E113: Medium tube

E114: Lower surface

E115: Upper surface

Claims (7)

A plastic fitting (E), which is mounted on a pharmaceutical container (A) with a plastic lid; The aforementioned mating head (E) has: a top face portion (E1), tied in the center with a fitting portion (E11); and The cylindrical side edge portion (E2) is suspended from the outer periphery of the top surface portion (E1) and has an open lower end; The aforementioned fitting part (E11) has: lips (E112); and The middle cylinder (E113), suspended from the aforementioned lip (E112); The aforementioned fitting portion (E11) is fitted with a medical device (F) for a closed drug delivery system. The plastic fitting according to claim 1, further comprising a piercing portion (E3) suspended from the center of the lower surface of the top surface portion (E1) inside the side edge portion (E2), and It communicates with the inside of the aforementioned medicine container (A). The plastic fitting as claimed in claim 1 or 2, wherein the lip (E112) is composed of an upper surface (E115), a rubber plug (E111) and a lower surface (E114); The aforementioned plastic fitting is in surface contact with the aforementioned medical device (F) at at least one of the aforementioned upper surface (E115) or the aforementioned lower surface (E114). The plastic fitting according to claim 1 or 2, wherein at least one or more engaging claws (E21) are formed on the inner surface of the lower end of the side edge portion (E2), which are connected to the medicine container (E2). The lower part of the lip (A2) of A) is engaged. The plastic fitting according to claim 1 or 2, wherein at least one or more notch portions (E22) are provided in the height direction on the outer peripheral surface of the side edge portion (E2). The plastic fitting according to claim 1 or 2, wherein a cover (D) that can be detached with fingers is provided on the upper surface of the fitting portion (E11). A closed drug delivery system, which uses a plastic cover (C) and a plastic fitting (E); The aforementioned plastic lid (C) is mounted on the pharmaceutical container (A) and has: a top surface (C1) with an opening (C10) at the center; A cylindrical side edge portion (C2) suspended from the outer periphery of the top surface portion (C1) and having an open lower end; and an inner cover (C3), located inside the aforementioned side edge portion; The coefficient of friction between the inner cover (C3) and the rubber plug (B) is higher than the coefficient of friction between the inner cover (C3) and the cover (C); The plastic fitting (E) is mounted on the plastic cover (C) and has: a top face portion (E1), tied in the center with a fitting portion (E11); and The cylindrical side edge portion (E2) is suspended from the outer periphery of the top surface portion (E1) and has an open lower end; The aforementioned fitting part (E11) has: lips (E112); and The middle cylinder (E113), suspended from the aforementioned lip (E112); The aforementioned fitting portion (E11) is fitted with a medical device (F) for a closed drug delivery system.

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