JP2003504120A - Closure device for medical containers - Google Patents

Abstract

SUMMARY A closure device is designed to hold and attach a first substance to a neck (1) of a separate container (2), preferably of glass material. The closure device defines a passageway (10) extending between a first opening and a second opening (11, 13) at opposite ends of the closure device. The sealing means (30) is arranged to close the first opening (11) and confine the second substance in the passage (10). A piercing means (33) is incorporated in the device and operable to pierce the sealing means (30) so that fluid communication is established between the passage (10) and the container (2). . In the method of mixing the first and second substances, the physician introduces the end of the syringe directly into the second opening (13) by removing the cap (8) which cannot be resealed. By engaging, the penetrating means (33) is operated to penetrate the sealing means (30), thereby exposing the second opening (13). By operating the syringe, the physician can transfer the first and second substances to the syringe and mix them in the process with minimal need for sterilization.

Description

Detailed Description of the Invention

The present invention generally relates to holding an injectable agent and transferring the injectable agent to a syringe,
Regarding containers such as vials and ampoules. More particularly, the invention relates to closure devices for such containers.

Injectable solutions are generally held in sterile vials or ampoules which are closed by suitable seals, such as rubber stoppers or aluminum foil. Such a solution is injected into the patient by a syringe. There are many different forms of syringes currently available to medical personnel. One particular design difference between the various syringes is the technique of molding the open end of the syringe to accommodate a hypodermic needle. The two most common forms of needle attachment are the friction fit attachment (such as the Luer Slip attachment) and
A combination of screw and friction engagement fittings (such as Luer Lock fittings). When the solution is to be injected into the patient, the wide channeled needle is attached to the open end fitting of the syringe. This needle can be used to penetrate the sealant and thus transfer the solution in the vial to the syringe. After transfer, the wide channeled needle is removed from the syringe and replaced with a narrower channeled needle suitable for injecting the solution into the patient. It will be appreciated that this procedure is costly and complicated as it requires the use of several separate components. Furthermore, in order to transfer the solution when injecting into the human body, it is necessary to thoroughly sterilize the constituent elements, and therefore, in this implementation method, it is necessary to take measures to separately sterilize each step.

[0003] These problems are due to the closure members attached to the stoppers that are fitted to the prior art devices known from WO 97/39720 and WO 98/13006, ie the neck of the container holding the solution. The device provides at least a partial solution. The closure member includes an axial passage extending between the first opening and the second opening, the second opening adapted to receive the end of the syringe. A piercing member is disposed within the passageway and the piercing tip in the first opening is adjacent the bung. The piercing member is arranged to be displaced to penetrate the stopper when the end of the syringe is received in the second opening. After penetrating the bung, the solution can be transferred to the syringe through a channel defined in the piercing member, which itself does not require any needle with a wide channel formed.

In some cases, however, an injectable preparation is prepared by mixing a first substance, liquid or solid, and a second liquid substance in a given ratio before administering the injectable drug to a patient. It is necessary. Generally, such mixing is a complex procedure, requiring the use of several separate components. Thus, this method of implementation carries with it the risk of increased contamination, and it is therefore necessary to take measures to carry out sterilization separately at each step. Moreover, in many cases the substances must be mixed in precise proportions just prior to administration to the patient, which can be difficult to achieve.

The prior art also includes US-A-5 740 654, for the solution and suspension of a solid active product encapsulated in a container sealed with a stopper fitted on the neck of the container. Disclosed is an assembly intended for extemporaneous preparation. The bung has an axial channel covered with a thin lid secured to the outer surface of the bung. To prepare the solution, first attach a separate connecting member to the neck, then open the compressible flask that holds the liquid product and has a pointed tip and screw it into the connecting member. Allow the tip of the to penetrate the lid to establish fluid communication between the flask and the container. By compressing the flask the liquid enters the container where it is mixed with the active product.
The flask can then be repeatedly compressed to transfer the liquid into its original container, from which it can be transferred by syringe as discussed in the introduction. This known device contains several components and is shown to increase the risk of contamination. When using this device, several separate steps are required before the solution can be injected into the patient. At each step, individual sterilization measures must be taken.

The object of the present invention is to solve at least some of the problems mentioned above, or to some extent. This object is achieved by a closure device, a container and a method of preparing a solution by mixing two substances, as set forth in claims 1, 28 and 29 respectively of the above claims.

The passageway is formed so that the substance is confined within it, so that two different substances can be separately enclosed in one and the same package and mixed with each other just prior to injection. With the closure device attached to the container of the present invention, the physician can access the contents of the container and introduce and preferably engage the syringe into the second opening of the closure device. Since both substances enter the syringe through the passage of the closure device, these substances are automatically mixed in the syringe and / or in the chamber defined in the passage connecting the first and second openings. To be done. Thus, the closure device of the present invention minimizes the need for sterilization and eliminates the need for two different needles. Further, the closure device of the present invention is of a cost effective construction with minimal components.

The container may contain a unit dose of the first substance. When enclosing another unit dose of the second substance in the passage of the closure device, the present invention provides the further advantage that the first and second substances are automatically mixed in a known precise ratio. .

The closure device is preferably of unitary or one-piece construction. In one variation, the closure device is configured to replace commonly used seals, such as rubber stoppers or aluminum foil, that fit into the neck of the container. In another variation, the closure device holding the second substance is attached to an existing conventional sealant, such as a rubber stopper or foil of a container holding the first substance. Modification 1 of the latter
One advantage is that the container, sealed with respect to the liquid substance contained therein, can be of conventional design. This will facilitate and shorten the procedure for obtaining approval from the competent authority for closure devices and containers having such closure devices.

In conventional closure devices mounted on rubber plugs, the penetrating means preferably comprises a hollow needle to facilitate penetration of the plug. The second portion is preferably provided with a cap that cannot be resealed in order to seal the second opening. This allows the physician to access the contents of the container simply by removing the cap and exposing the second opening. The second end preferably includes a Luer fitting near the second opening, the fitting adapted to be in direct fluid tight engagement with the open end of the syringe.

According to a first aspect of the invention, a penetrating means is provided in the passage so that when the syringe end is inserted into the second opening, the penetrating means is in the first opening. Displaced towards and through the sealing means closing the first opening of the device. Thus, the penetrating means is enclosed in a sterile closed space, minimizing the need for additional sterilization steps during use of the closure device of the present invention. In one simple construction for penetrating a thin foil closing the first opening, the penetrating means comprises a bow-shaped cutting element extending over a range of more than 180 ° and less than 360 °.
Such a cutting element minimizes the risk of a clean, not completely cut piece of the foil being produced in the foil and the cut foil falling into the container. The cutting element is connected to a mandrel extending to the second opening for engagement with the end of the syringe, the perimeter of which is one or more longitudinal directions defining a flow path within the passageway of the closure device. It is preferable that the groove is provided.

According to a second aspect of the invention, the closure device itself is such that fluid communication is established between the passage holding the second substance and the container holding the first substance. It is possible to displace towards the container. The penetrating means comprises a first end with a cutting element adapted to break the sealing means and a second end sealingly mounted in the first opening, the first and the second end thereof. And two internal channels in fluid communication with the two ends. Therefore, when the closure device is mounted on the neck portion of the container, the closure device can be displaced towards the container so that the cutting element breaks the sealing means, whereby fluid communication between the passageway and the container is established. Established, permitting intimate mixing of the first and second substances. The sealing means is preferably attached to the first end of the penetrating means so as to close the internal channel and thus indirectly close the first opening. A second aspect provides a device of simple construction with no moving parts that can be attached to the neck of a container, for example by means of a removable snap fit engagement.

The present invention will now be described in more detail with reference to the preferred embodiments of the present invention shown in the accompanying drawings. 1a-1d, and in particular with reference to FIG. 1a, there is shown a first embodiment of a closure device of the present invention according to a first aspect. The closure device is attached to the neck 1 of the container 2 so that the injection is enclosed inside the container. The container 2, or at least its neck 1, is generally made of a non-decaying material, such as glass. The closure device of the first embodiment has a body 3 including an engagement portion 4 adapted to engage in conformity with the inner circumference of the neck portion 1. The engagement portion 4 is joined to the shell portion 5. The spigot 6 extends from the shell portion 5 to the distal end 7. A flat grip 8 is connected to the distal end 7 via a weakened portion 9 having a thickness smaller than that of the distal end 7. A passageway 10 is formed in the body 3 from a proximal opening 11 defined in the cross section 12 of the engagement portion 4 to a distal opening 1 defined in the distal end 7.
A passage 10 extending to 3 is formed, which passage 10 is closed by a grip 8. The spigot 6 defines a fitting for engaging the open end (not shown) of the syringe, in this case a Luer Slip fitting, the interior of the spigot 6 corresponding to the outer circumference of the syringe end. It is adapted to frictionally engage the outer circumference, which allows temporary fluid tight engagement with the outer circumference of the syringe end.

Attached to the body 3 of the closure device is a foil 30, preferably a foil of aluminum or an aluminum laminate, in the cross section 12 of the body 3 the passage 1
0 is closed. The closed passage 10 holds the liquid substance, which is mixed with the injectable solution in the container 2 as described below. The passage 10 comprises a smaller diameter conduit 31 defined within the spigot 6 and a larger diameter chamber 32 defined within the engagement portion 4 and within the shell portion 5. The chamber 32 has a cross section 1
It is open at 2 and defines an opening 11 therein.

A pusher 33, shown in more detail in FIGS. 1b-1d, is slidably disposed in the passage 10. The pusher 33 is preferably a one-piece construction of a material compatible with the fluid in the container and passage. The pusher 33 includes an elongated shaft 34,
It includes a plate 35 at its first end. An elongated recess 37 extends between the ends of the shaft 34. The outer periphery of the plate 35 is shaped so as to be perfectly received in the chamber 32. The plate 35 is provided with through holes 39 connecting both sides of the plate. An arcuate cutting edge 40 extending substantially parallel to the periphery of the plate 35 is held on the surface of the plate 35 on the side not facing the shaft 34. For the following reasons, the cutting edge 40 preferably forms an arc extending over a range of more than 180 ° and less than 360 °. The cutting edge 40 is a foil 3
It includes an axial protrusion 41 that facilitates zero penetration.

As shown in FIG. 1 a, the pusher 33 is arranged such that the cutting edge 40 is adjacent to the foil 30 that seals the opening 11. The shaft 34 passes through the chamber 32 and into the conduit 31 so that the second end of the shaft 34 is located near the opening 13. Once penetrated, the arcuate cutting edge 40 forms a corresponding arcuate cut in the foil 30. This cut-out will define a tongue that can be automatically folded into the container 2 without causing loosening, thereby minimizing the risk of the cut-out foil portion falling into the container 2. Can be suppressed to.

To access the contents of the container 2, the user grasps a flat grip 8 and tears it off at the weakened part 9, whereby the distal opening 13 of the distal end 7 is broken.
Expose. The end of the syringe (not shown) is then introduced into the distal opening 13 and engaged tangentially to the pusher 33. When the end of the syringe comes into fluid-tight engagement with the Luer fitting formed in the spigot 6, the cutting edge 40 of the pusher 33 automatically passes through the foil 30 and between the syringe and the container 2. Fluid communication is established via passageway 10. Thus, when the user manipulates the syringe to transfer the injectable agent from the container 2 to the syringe, the injectable agent will flow through the through hole 39 and into the container 32, where it will at least partially enter the interior thereof. Mixed with the contained liquid substance,
The chamber 32 is then left through the channel defined by the recess 37 and the wall of the conduit 31. Thus, the first embodiment allows two different substances to be separately packaged in the same package and mixed with each other just prior to injection. Since both of these substances enter the syringe through opening 13, they will be automatically mixed in the syringe and / or in chamber 32. After such transfer and mixing, a hypodermic needle can be attached to the end of the syringe to inject the injection into the patient. Alternatively, the end of the syringe can be directly engaged with an intravenous cannula or the like.

The body 3 of the embodiment closure device shown in FIG. 1a is formed in one piece, preferably by injection molding, of a plastic material, preferably of a soft material such as polyethylene or polypropylene. At the time of assembly, first, the pusher 33 is inserted into the main body 3 through the opening 11 of the main body 3. Liquid material is then filled into the passageway 10 through the opening 11. Finally, the foil 30 is attached to the body 3 to provide a single closure device that can be attached to the filled container 2 in a subsequent step. Conventionally, in the container 2 sealed with a rubber stopper, when a closure device is used in place of the rubber stopper, only a slight change needs to be made to the sealing device. In addition, standard filling equipment can be used.

In this and the following embodiments, the container can be filled with any drug solution suitable for injection, but with propofol and other conditions used under demanding conditions for easy handling and sterilization. It is particularly advantageous when used with sterile anesthetics or anesthetics, such as drugs. The closure device of the present invention is most suitable for use with substances to be mixed shortly before injection into a patient, for example, without compromising efficacy.

An example of an injection is propofol, which is commonly used as an anesthetic and as a sedative. Injection of propofol is often painful when given intravenously. This pain can be reduced by adding pH-lowering substances such as HCl or local anesthetics such as lidocaine and ropivacaine.
Thus, by encapsulating propofol in container 2 and by enclosing a pH-lowering substance or local anesthetic in the closure device attached to container 2, these substances can be administered together. .

A second embodiment of the closure device according to the first aspect of the present invention, in its operative position, is shown in FIG. Similar elements are provided with similar reference numbers as compared to FIG. 1 and a detailed description of such elements is not repeated.

Similar to the first embodiment, the closure device of the second embodiment has an engagement portion 4,
It has a shell part 5 and a body 3 containing a spigot 6, the mutual relationships of which are shown in FIG.
As mentioned earlier in relation to. A stopper 20 preferably made of an elastic material such as rubber is fitted into the neck portion 1 of the container 2 to enclose the substance therein. Although not shown in FIG. 2, it is preferable to form a recess portion on the upper surface of the plug 20 to facilitate its penetration. A closure means in the form of a thin foil 30 is attached to the body 3 of the closure device to close the proximal opening 11 and thus the passage 10. The distal opening 13 is sealed with a suitable cap (not shown) that cannot be resealed, such as a foil or a grip of the type shown in Figure 1a. As in the first embodiment, a pusher 33 'is arranged in the passage 10 of the closure device of the second embodiment. One end 35 'of the pusher 33' has the shape of a needle with a wide channel formed, i.e. a hollow needle with a central channel 39 '. Sharp tip 40 at one end of needle 35 '
′ Is arranged adjacent to the stopper 20. The opposite end of the needle 35 'has a shaft 34' of similar construction to the shaft 34 of the first embodiment (see FIGS. 1b and 1c).
(Not shown in detail). This provides a flow path for the injectable solution from the container 2 through the chamber 32 to the distal opening 13. In the operative position shown in FIG. 2, the end of the syringe 5 is engaged with the distal opening 13, whereby the needle 3
The 5'is pierced through the foil 30 and the stopper 20 to establish fluid communication between the syringe S and the container 2 via the chamber 32.

One of ordinary skill in the art will appreciate that there are numerous alternative structures that accomplish this function. In one embodiment (not shown), pusher 33 'is a needle having a long, wide channel formed therein and extending into conduit 31 to channel 39' and chamber 3 '.
2 has a hole for connecting 2 on the side surface. The needle can be connected to an annular gasket slidably disposed within the conduit 31 so as to seal the space defined between the needle and the wall of the conduit 31. Gasket is conduit 3
The needle can be guided to 1 and can provide a surface for engaging the end of the syringe S. As another alternative, two separate flow paths could instead be provided in the closure device, one flow path for the injection liquid from the container to the distal opening 13 and the other flow path. Is for the liquid substance from the chamber 32 to the distal opening 13 and the mixing takes place in the syringe.

It is also conceivable that the plug 20 is fixedly attached to the body 3 by means such as glue, whereby the proximal opening 11 is closed and the neck 1 of the container 2 is closed.
A unit is formed which can be fitted directly into the. In this case, the foil 30 can be omitted.

During operation and manufacture, the second embodiment is essentially the same as the first embodiment, and the description thereof will not be repeated. Essentially the second embodiment provides the same advantages as the first embodiment.

3a-3 of an embodiment of the second aspect of the closure device of the present invention.
This will be described with reference to b. Similar elements are provided with similar reference numerals as compared to FIGS. 1 and 2 and a detailed description of such elements is not repeated.

Similar to the embodiment described above, the closure device of FIGS. 3a-3b has an engagement part 4, a shell part 5 and a body 3 containing a spigot 6, the interrelationship of which is related to FIG. And then mentioned earlier. As with the embodiment of FIGS. 1 and 2, the passageway 10 consists of a smaller diameter conduit 31 defined within the spigot 6 and a larger diameter chamber 32 defined within the shell portion 5. The chamber 32 is open at the cross section 12 and defines the proximal opening 11 therein. A hollow needle 35 'with an internal channel 39' is attached to seal the opening 11 and has a sharp tip 40 '.
It extends to ′. A sheath 30 'of elastic material, such as rubber, slides over the surface of the needle, thereby forming a bonnet that seals the open tip 40' of the needle 35 '. Thus, the sheath 30 ′ indirectly closes the opening 11 and confines the liquid substance within the passage 10. The distal opening 13 is closed by the foil 8. The engagement portion 4 of the closure device comprises two parallel extensions 4 for retaining an injectable agent and snap-fittingly engaging a neck portion of a container which is closed by a conventional sealing material such as a stopper or foil.
'including. For this reason, the closure device of Figures 3a-b is designed for a removable attachment on a container with a sharp tip 40 'located adjacent the seal.

The body 3 of the closure device shown in Figures 3a to 3b is a two piece construction which is preferably formed by injection molding of a plastic material, preferably a soft material such as polyethylene or polypropylene. More specifically, the body 3 is formed by joining a lid portion including a spigot 6 and a peripheral flange at one end thereof and a sleeve portion including a shell portion 5 and an engaging portion 4. The lid portion engages the sleeve portion at its open end, thereby forming a non-removable peripheral snap-fit joint 60. The two piece construction reduces manufacturing costs, i.e. the lid portion can be produced with a smaller tolerance depending on what the Luer fitting requires, while the sleeve portion can be produced with a larger tolerance. be able to. Obviously, snap fit joint 60 can be incorporated into any one of the embodiments of the present invention.

In assembly, the sheath 30 ′ is slid over the surface of the needle 35 ′, thereby filling the passageway 10 with the liquid substance through the spigot 6. The foil 8 is then attached to seal the distal opening 7, thereby providing a single closure device that can be attached to the filled container in a subsequent step.

To access the contents of the container, the user pushes the closure device towards the container and pierces the tip 40 'of the needle 35' through the container seal. In this process, extension 4'aligns needle 35 'so that it is perpendicular to the seal to provide controlled penetration of the seal. The tip 40 'penetrates the sealant while simultaneously penetrating the sheath 30' to establish fluid communication between the passage 10 and the container. The user then grasps the grip portion 8'and removes the foil 8, thereby exposing the distal opening 13. The end of the syringe (not shown) is then introduced into the distal opening 13 resulting in fluid tight engagement with the Luer fitting formed in the spigot 6. When the user then manipulates the syringe to transfer the solution from the container to the syringe, the solution flows into chamber 32 where it is at least partially mixed with the liquid substance contained therein and thereafter conduit 31 To leave chamber 32.

It is understood that various modifications, variations and / or additions may be introduced to the previously described structures and parts without departing from the spirit or scope of the invention as defined in the claims below. See. In one possible alternative, the closure device is integrally formed with the container.

[Brief description of drawings]

Figure 1a   FIG. 3 is a cross-sectional view of the closure device according to the first aspect of the present invention.

Figure 1b   FIG. 1b is a perspective view of the penetrating means of FIG. 1a.

[Fig. 1c]   FIG. 1b is a side view of the penetrating means of FIG. 1a.

[Fig. 1d]   FIG. 2a is a bottom view of the penetrating means of FIG. 1a.

[Fig. 2]   It is sectional drawing which shows the modification of the closure apparatus of FIGS.

FIG. 3a   FIG. 6 is a perspective view of a closure device according to a second aspect of the present invention.

FIG. 3b   FIG. 6 is a cross-sectional view of the closure device according to the second aspect of the present invention.

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Claims (30)

[Claims] 1. A closure device for attaching to a neck (1) of a container (2) holding a first substance, the closure device comprising a first end (4) and a second end (6). Including a first opening (11) defined at a first end (4), a second opening (13) defined at a second end (6), and a passageway (10) defined at the first end (4). Opening and second opening (11,
A closure device (30) extending within the closure device for fluid communication between them (13) closing the first opening (11) to confine the second substance within the passage (10). 30 ') and penetrating means (33; 33'; operable to penetrate the sealing means (30; 30 ') so that fluid communication is established between the passageway (10) and the container (2). 35 ') and a closure device. 2. A second opening (13) is provided with a second end (13) for receiving the end of the syringe (S) for fluid communication between the passage (10) and the syringe (S). 6. The closure device according to claim 1, defined in 6). 3. The first end (4) has a neck (1) directly or indirectly.
A closure device according to claim 1 or 2 adapted to engage with. 4. When the end of the syringe (S) is received in the second opening (13), the penetrating means (33; 33 ') is displaced towards the first opening (11) and seals. A penetrating means (33; 33 ') is provided for passage (10) so as to penetrate the means (30; 30').
The closure device according to any one of claims 1 to 3, which is provided inside. 5. Penetrating means (33; 33 ') are slidably arranged in the passage (10) such that the cutting element (40; 40') breaks the sealing means (30; 30 '). A closure device according to claim 4, having a first end adapted and a second end adapted to cooperate directly or indirectly with the end of the syringe (S). 6. Closure device according to claim 5, wherein the cutting element (40; 40 ') is arranged adjacent to the sealing means (30; 30'). 7. Sealing means, preferably comprising a frangible foil (30) of an aluminum material or an aluminum laminate, arranged to close the first opening (11). The closure device according to any one of claims. 8. Closure device according to any one of the preceding claims, adapted to be mounted directly in the opening defined by the neck (1) of the container (2). 9. A cutting element (40) is connected to one side of the holder member (35),
7. A closure device according to claim 5 or 6, projecting from said one side in an essentially arcuate shape, said bow extending over a range of more than 180 ° and preferably less than 360 °. 10. Closure device according to claim 9, wherein the part of the bow forms the leading part (41) for the initial penetration of the sealing means (30). 11. A closure device according to claim 9 or 10, wherein the holder member (35) is tightly received in the passage (10) and comprises at least one through hole (39). 12. An internal channel (39 ') adapted to be placed on a stopper (20), preferably of rubber material, fitted into the neck (1) of the container (2), the internal channel (39') being a penetrating means (33 '). ) Extending from its first end through the sealing means (30) and the stopper (20) and then through the channel (39 ') to the container (2) and the passage (1).
Closure device according to any one of claims 5 to 7, wherein the penetrating means (33 ') are arranged such that a fluid communication is established between them. 13. A passage (10) comprising a conduit (31) extending from the second opening (13) and a chamber (32) communicating with the conduit (31) and the first opening (11), the penetrating means. The (33; 33 ') is guided in the conduit (31) and extends into the chamber (32) wider than the conduit (31) and containing the second substance. The closure device according to any one of claims. 14. Penetrating means (33; 33 ') are provided with cutting elements (40; 40').
Extending into the conduit (31) including the mandrel (34; 34 ') connected to the mandrel (34; 34') and the wall of the conduit (31) on the outer periphery of the mandrel (34; 34 '). 14. The closure device according to claim 13, wherein at least one longitudinal groove (37) defining at least one channel is provided therebetween. 15. A first end with a penetrating means (35 ') comprising a cutting element (40') adapted to break the sealing means (30 ') and a first opening (11). Has a second end sealedly attached to the container, and an internal channel (39 ') in fluid communication with the first and second ends thereof, the neck (1) of the container (2). The container (2) so that the cutting element (40 ') breaks the sealing means (30') when mounted on it.
) Towards the passage (10) and the container (2).
4. A closure device according to any one of claims 1 to 3 in which fluid communication is provided between. 16. Sealing means (30 '), preferably in the form of an elastic bonnet.
Attached to the first end of the penetrating means (35 ') to provide an internal channel (39').
16. The closure device according to claim 15, wherein the closure is closed and thus the first opening (11) is closed. 17. Closure device according to claim 15 or 16, wherein the penetrating means comprises a hollow needle (35 ') attached to and projecting from the first opening (11). 18. The first end (4) engages the neck (1),
And having at least two parallel extensions (4 ') adapted to allow said displacement during alignment of the penetrating means (35') with the container (2).
The closure device according to any one of 5 to 17. 19. A container according to any one of claims 15 to 18, adapted to be placed on a stopper (20), preferably of rubber material, fitted in the neck (1) of the container (2). Closure device. 20. The passage (10) comprises a sleeve element (4,5) and a second opening (10).
A lid element (6) including a lid element (6) and a lid element (6) attached to the open ends of the sleeve elements (4, 5) to define a passageway (10). 20. A closure device according to any one of claims 1-19. 21. Luer Sl at the second opening (13) at the second end (6).
21. A closure device according to any one of claims 1 to 20 including Luer fittings such as ip fittings and Luer Lock fittings. 22. A closure device according to any one of the preceding claims, which is of unitary construction and adapted for attachment to the neck (1) of the container (2). 23. A non-resealable cap (8) is provided at the second end (6) so as to seal the second opening (13). The closure device according to any one of claims. 24. A closure device according to claim 23, wherein a cap (8) is attached to the second end (6) along its frangible section (9). 25. A foil () comprising a cap attached to the second opening (6).
8) The closure device according to claim 23 which is 8). 26. The closure device according to claim 1, wherein the second substance is a pH-lowering substance such as HCl or a local anesthetic such as lidocaine or ropivacaine. 27. The closure device according to any one of claims 1 to 26, wherein the first substance in the container (2) is a pharmaceutically active agent, preferably propofol. 28. A container having a separate closure device according to any one of claims 1-27 attached thereto. 29. A method for preparing a solution by mixing two substances using the container according to claim 28, wherein the end of the syringe (S) is provided with a second opening (13).
), Activating the penetrating means (33; 33 ';35') to penetrate the sealing means (30; 30 '), and operating the syringe (S) for the first and second Of the substance of claim 1 into the syringe (S). 30. The method of claim 29, wherein the transferring step comprises transferring the first substance to the passageway (10) and mixing with the second substance trapped therein.