WO1995011717A1

WO1995011717A1 - A container closure, particularly for anaesthetic agent containers

Info

Publication number: WO1995011717A1
Application number: PCT/US1994/011606
Authority: WO
Inventors: Rodolfo Genga
Original assignee: Abbott Laboratories
Priority date: 1993-10-29
Filing date: 1994-10-12
Publication date: 1995-05-04
Also published as: IT1266646B1; ITMI932316A0; EP0725663A1; CA2174755A1; AU8076694A; ITMI932316A1

Abstract

The closure has a locking ring (7) connected to an internally threaded collar (8) at a frangible annular portion (10), which can be ruptured to gain immediate access to the contents of a container. A stopper member (20) is fixed to the threaded collar (8) for selectively connecting the closure (1) to an anaesthetic transfer device. A discharge passage (23) and a venting passage (24) extend through the stopper member (20) for communication with a container (3) engaged by the threaded collar (8). A first pierceable diaphragm (25) is located within and occludes the discharge passage (23), and second pierceable diaphragm (29) is located within and occludes the venting passage (24).

Description

A CONTAINER CLOSURE, PARTICULARLY FOR ANAESTHETIC AGENT CONTAINERS

The present invention relates to a container closure, particularly for anaesthetic agent containers, which permits transfer of anaesthetic agent from a storage container to an administration system by means of one of a plurality of transfer methods which can be selected according to requirements.

Inhalable anaesthetics are typically volatile substances with relatively low boiling points and high vapor pressures. They can be flammable and explosive substances in both their liquid and vapor states. Such anaesthetics are typically dispensed in liquid form to an apparatus such as an anaesthetic vaporizer, which mixes the anaesthetic with carrier gases, normally oxygen and nitrous oxide. The mixture is supplied in gaseous form to the patient for inhalation. Since inhalation of the vapour by health care personnel using them can cause drowsiness, such anaesthetics must be safely stored in the hospital pharmacy and safely handled in operating rooms in order to minimize the risk of inhalation by health care personnel, as well as to minimize the risk of fire or explosion. Therefore, the anaesthetic agent should be stored and used in a way that will ensure that there is no contamination of the atmosphere at all stages of handling during normal storage and surgical procedures.

Different types of closures have been developed for safely sealing anaesthetic agent containers. The type of closure used depends upon the method or device used for transferring the anaesthetic agent from the container to the vaporizer. Some closures do not permit such transfer of anaesthetic in a closed system that eliminates the escape of anaesthetic gases to the atmosphere. Typically, during set¬ up procedures, a supply container of anaesthetic is opened in the operating room and either poured directly into a vaporizer or attached to a feed line leading to a vaporizer. One such closure is constituted by a threaded aluminium cap incorporating a frangible sealing ring, known as a "Rolled On Pilfer Proof Cap" or R.O.P.P. cap. Such closures are widely used and are advantageous in that by unscrewing the cap in an opening direction, the frangible ring is broken and the cap easily and quickly unscrewed to give easy and rapid access to the contents of the container. R.O.P.P. caps are used for sealing some anaesthetic agent containers. Anaesthetic agents may be transferred from such containers by using a standard reusable I.S.O. filling device or by pouring the anaesthetic directly into the vaporizer reservoir. This permits very rapid charging of the vaporizer as may be necessary e.g., in the instance of an unscheduled emergency surgical intervention, but results in a period of time during which the open container of anaesthetic is exposed to the atmosphere. Accordingly, in order to avoid the risks of inhalation by health care personnel, fire or explosion, suitable precautions such as ensuring adequate ventilation, must be adopted when transferring anaesthetic agent from such containers sealed with R.O.P.P. caps to a vaporizer.

Closures have been required for use with devices which have been developed to permit the transfer of an anaesthetic agent from a container to a vaporizer. Some of these devices do not permit anaesthetic to be transferred from a container to a vaporizer in a closed system. U.S. Patent 5,144,991 discloses a filling device for an anaesthetic vaporizer with a temperature sensitive switching member. U.S. Patent 4,867,212 discloses a safety arrangement for filling and emptying an anaesthetic vaporizer. However, when using these devices, the supply container remains open to the atmosphere for a period of time while being connected to the vaporizer, therefore allowing anaesthetic to escape to the atmosphere.

Further devices were developed which eliminated the escape of anaesthetic gas to the atmosphere. Such devices have a vaporizer adaptor that engages with an anaesthetic vaporizer, and a closure adaptor which engages with a closure on the anaesthetic container. The closure is preferably connected to the supply container prior to use in the operating room. The container closure has a frangible seal adapted to be perforated by piercing means within the closure adaptor as the adaptor is engaged with the closure. Following perforation of the frangible seal of the closure by the piercing means of the adaptor, the closure adaptor and the closure remain held together in a snap fit, thereby permitting transport of anaesthetic from the supply container to the vaporizer in a system which remains closed to the atmosphere throughout assembly or disassembly procedures. One such system is known as the ABBOTT Security

Lock Filling System, and is available from Abbott Laboratories, Abbott Park, Illinois 60064-3500, U.S.A.

Furthermore, the shape of the closure adaptor is frequently chosen to mate with a corresponding shape of closure. In this way, containers of anaesthetic may have closures of different shapes to avoid accidents whereby the container is hooked up to an incorrect vaporizer.

Although these developments have improved the safe handling of anaesthetic agents, other problems have arisen regarding manufacture and use of the available anaesthetic container closures.

Storage and inventory problems have arisen since containers having different types of closure but containing the same type of anaesthetic have to be stored in order to be able to take full advantage of the different methods of filling vaporizer reservoirs, according to requirements.

Thus, for example, a hospital would typically store an anaesthetic agent in sealed containers having frangible aluminium R.O.P.P. caps, for pouring directly into a vaporizer reservoir or for use with standard reusable I.S.O. agent-specific filling devices. The same anaesthetic agent would typically also be manufactured and stored in a hospital pharmacy in sealed containers having closures comprising a frangible seal adapted to be perforated by piercing means within the closure adaptor of an anaesthetic transfer system, such as the above mentioned ABBOTT

Security Lock Filling System.

Since the shapes of the closure adaptor of the various transfer devices in use are frequently chosen to mate with a corresponding shape of closure, the same anaesthetic may also have to be stored in containers of anaesthetic having closures of different shapes to mate with the different adaptors of the transfer devices in use in the hospital. This avoids accidents by preventing the container from being hooked up to an incorrect vaporizer, but complicates storage and inventory. In fact, the number of anaesthetic agents being stored at any one time is multiplied by the number of different types of container also required for use with the various anaesthetic transfer systems and adaptors in use with a number of different vaporizers.

Furthermore, in unscheduled emergency surgery, in a life-saving situation where immediacy of anaesthetic administration is of prime priority, valuable time can be lost while seeking the correct anaesthetic in the correct container for use with a specific vaporizer in what may be the only available operating room. The possible consequences of every second wasted in such an emergency situation are obvious.

Problems are also created for manufacturers of sealed containers filled with anaesthetic agents, since various production lines have to be set up for containers having different types of closure for each anaesthetic agent. Specifically, threaded neck glass bottles coupled to screw caps have to be provided for transferring anaesthetic agent to a vaporizer via direct pouring or via I.S.O. agent specific filling devices, such as the devices commonly known as standard Vapofill with "Safety Pin" vaporizer connector. On the other hand however, standard flanged mouth glass bottles have to be used with anaesthetic transfer devices such as the ABBOTT "Security Lock" filling system.

Accordingly, an aim of the invention is to provide a closure particularly for anaesthetic agent containers which overcomes the problems encountered in the known anaesthetic agent containers.

Within this aim, an object of the invention is to provide a closure particularly for anaesthetic agent containers which permits an anaesthetic to be either poured directly into a vaporizer reservoir or selectively used with either a standard reusable I.S.O. agent-specific filling device, or with a container-to-vaporizer transfer device such as the currently used ABBOTT "Security Lock"

Filling System.

Another object of the invention is to provide a closure for anaesthetic agent containers which permits the anaesthetic to be selectively accessed as easily and as rapidly as could be achieved by using frangible aluminium "Rolled On Pilfer Proof" (R.O.P.P.) caps.

Another object of the invention is to provide a closure for anaesthetic agent containers which is selectively perforatable by piercing means within the closure adaptor of an anaesthetic transfer system.

A further object of the invention is to provide a closure for anaesthetic agent containers which can safely retain a closure adaptor of an anasthetic transfer device in operative engagement therewith.

A still further object of the invention is to provide a closure which permits a single type of bottle to be employed for direct pouring or for use with I.S.O. agent specific filling devices or with a container-to-vaporizer transfer device of the type having a vaporizer adaptor and a closure adaptor that engages with the closure on the anasthetic container, such as the ABBOTT "Security Lock" filling system. With these and other objects in view, there is provided a closure particularly for anasthetic agent containers comprising a locking ring connected to an internally threaded collar at a frangible annular portion, characterized in that it further comprises means fixed to said threaded collar for selectively connecting said closure to a user device adaptor.

More particularly, the invention provides a container closure, wherein said means fixed to said threaded collar for connecting said closure to a user device adaptor comprise a stopper member sealingly connected to said threaded collar, a discharge passage and a venting passage extending through said stopper member for communication with a container engaged by said threaded collar, first pierceable diaphragm means located within and occluding said discharge passage, and second pierceable diaphragm means located within and occluding said venting passage.

Further features and advantages of the invention will become apparent from the following detailed description thereof, and the following drawings wherein: fig. 1 is a cross sectional view of the container closure according to the invention, attached to the threaded neck of an anasthetic container; fig. 2 is a cross sectional view of the closure of fig.

1, wherein the frangible annular portion has been broken to permit separation of the threaded sleeve from the sealing ring, and; fig. 3 is a cross sectional view of the closure of fig.

1, illustrating the use of the closure with an anaesthetic transfer device. With reference to the above described drawing figures, and in particular with reference to Fig. 1, the closure according to the invention is generally indicated by the reference numeral 1. The closure is shown in screw-thread engagement with the neck 2 of an anaesthetic container 3 which, in the illustrated example, is constituted by a standard threaded neck glass bottle 3. The neck 2 defines an upper edge 4 and an externally protruding annular rib 5.

Screw threads 6 are formed on the outer surface of the neck 2 and extend axially between the annular rib 5 and the upper edge 4.

The closure 1 has a locking ring 7 which engages the externally protruding annular rib 5 of the container 3 and is connected to a collar 8. The collar 8 has threads 9 formed on its internal surface which engage the external screw threads 6 formed on the outer surface of the neck 2 of the container 3. The collar 8 is connected to the ring 7 at a frangible annular band 10, and preferably has knurled or ribbed annular band 11 formed thereon for facilitating gripping by a user when applying a torque force for separating the collar 8 from the ring 7 by breaking the frangible annular band 10.

Above the portion of the collar 8 defining the internal threads 9 and the knurled band 11, the collar has an annular flange 12 defining, in cross section, a first flange portion 13 connected to the annular band 11 and extending substantially perpendicularly with respect to the longitudinal axis 16 of the closure 1; a second flange portion 14 connected to the first flange portion 13 and extending on a plane which is inclined with respect to the longitudinal axis 16 of the closure 1; and a third flange portion 15 connected to the second flange portion 14 and extending parallel to the longitudinal axis 16 of the closure 1.

The closure 1 further comprises a stopper member 20 defining a bottom flange 21 having an external surface engaged by the annular flange 12 of the threaded collar 8, and an internal surface in sealing engagement with the upper face of an annular sealing member or gasket 22. The gasket

22 is interposed between the bottom flange 21 and the upper edge 4 of the container 1. Engagement of the locking ring 7 with the externally protruding annular rib 5 of the container 3 maintains a compressive force, which is exerted through the collar 8 and flange 12, on the bottom flange 21 and on the gasket 22. Thus, the upper face of gasket 22 is in sealing abutment engagement with the lower internal surface of the bottom flange 21, while the lower face of the gasket 21 is in sealing abutment engagement with the upper edge 4 of the container 3.

A discharge passage 23 and a venting passage 24 extend through the stopper member 20, parallel to the longitudinal axis 16 of the closure 1. The discharge passage

23 defines a discharge opening 25 at the upper end 26 of the stopper member, and is occluded by a first pierceable membrane 27, located within the discharge passage 23, preferably at a location inwardly spaced from the discharge opening 25. Similarly, the venting passage 24 defines a venting opening 28 and is occluded by a second pierceable membrane 29, located within the venting passage 24, preferably at a location inwardly spaced from the venting opening 28. A one way check valve 30 can be press-fitted within the venting passage 24 if desired to ensure that no liquid can flow through it.

A locking means for connecting the closure to an anaesthetic transfer device may also be provided. Advantageously, the locking means comprise an outwardly projecting wedge 40, for engagement with a recessed edge formed on a transfer device, in a manner which will be described hereinafter.

The use of the closure according to the invention is illustrated in Fig. 2 and 3. Specifically, Fig. 2, illustrates a closure identical to the closure of Fig. 1, wherein the frangible annular band 10 has been broken by gripping the knurled or ribbed annular band 11 and applying a torque force for separating the collar 8 from the ring 7. by breaking the frangible annular band 10. In this condition, the closure according to the invention can be used for direct pouring of the anaesthetic into a vaporizer, or for permitting use of the closure with I.S.O. agent specific filling devices.

Fig. 3 illustrates the use of the closure according to the invention with the closure adaptor of a device for transferring anaesthetic from a container to a vaporizer. In the illustrated example the transfer device has a vaporizer adaptor (not illustrated) for connection to an anaesthetic vaporizer, and a closure adaptor 50, such as the one used in the said widely used ABBOTT Security Lock Filling System. Such adaptors 50 have a filling channel 51 which communicates with a first piercing member 52 and a venting channel 53 which communicates with a second piercing member 54. A sleeve 55 protrudes from a terminal abutment portion

56 of the adaptor 50, and surrounds the piercing members

52, 54. Advantageously, a recessed edge 57 is formed on the sleeve 55.

When it is desired to use the closure 1 with a closure adaptor 50, the collar 8 is not separated from the ring 7, but contrary to what is illustrated in figure 2, the frangible annular band 10 is retained intact.

In use, the sleeve 55 of the adaptor 50 is slid onto the stopper member 20 of the closure 1, with the discharge channel 51 and the venting channel 53 of the adaptor 50 in respective alignment with the discharge passage 23, and the venting passage 24 of the closure. Once the sleeve 55 has been partially slid onto the stopper member 20, the piercing members 52 and 54 contact the diaphragms 27, 29, located respectively in the discharge passage 23 and the venting passage 24. A slight pressure exerted in the direction of the arrow 58 causes the piercing members 52, 54 to penetrate the diaphragms 27, 29, and the sleeve 55 can be further slid onto the stopper member 20 until the upper end 26 of the stopper member 20 engages the terminal abutment portion 56 of the adaptor.

Means may be provided for locking an adaptor such as the adaptor 50 onto the closure 1 and may comprise, as mentioned heretofore, an outwardly projecting wedge 40 formed on the stopper member 20, and a recessed edge 57 on the sleeve 55 of the adaptor 50. Thus, when engaging the adaptor 50 and closure 1 together, the projecting wedge 40 snaps into engagement with the recessed edge 57, simultaneously with abutment engagement occurring between the upper end 26 ot the stopper member 20 and the terminal abutment portion 56 of the adaptor. Obviously, other engagement means may be provided, such as screw thread means.

The closure according to the invention thus permits an anaesthetic to be either poured directly into a vaporizer reservoir or selectively used with either a standard reusable I.S.O. agent-specific filling device, or with a container-to-vaporizer transfer device such as the currently used ABBOTT "Security Lock" Filling System.

Where technical features mentioned in any claim are followed by reference signs, those reference signs have been included for the sole purpose of increasing the intelligibility of the claims and accordingly, such reference signs do not have any limiting effect on the scope of each element identified by way of example by such reference signs.

Claims

CLAIMS .

1. A closure particularly for anaesthetic agent containers comprising a locking ring (7) connected to an internally threaded collar (8) at a frangible annular portion (10), characterized in that it further comprises means (20-29) fixed to said threaded collar (8) for selectively connecting said closure (1) to a user device.

2. A closure according to claim 1, wherein said means (20-29) fixed to said threaded collar (8) for connecting said closure (1) to a user device comprise a stopper member (20) sealingly connected to said threaded collar (8), a discharge passage (23) and a venting passage (24) extending through said stopper member (20) for communication with a container (3) engaged by said threaded collar (8).

3. A closure according to claim 2, characterized in that it further comprises first pierceable diaphragm means (25) located within and occluding said discharge passage (23), and second pierceable diaphragm means (29) located within and occluding said venting passage (24) .

4. A closure according to claim 1, characterized in that said threaded collar (8) defines an annular flange (12) at a portion thereof opposite said locking ring (7).

5. A closure according to claims 1 and 4, characterized in that it further comprises a bottom flange (21) defined by said stopper member (20), and an annular sealing member (22) for abutment with an upper edge (4) of a container (3) , said bottom flange (21) being located between said annular sealing member (22) and said annular flange (12).

6. A closure according to claims 2 and 3, characterized in that said discharge passage (23) defines a discharge opening (25) at an upper end (26) of said stopper member (20), and in that said venting passage defines a venting opening (28) at said upper end (26) of said stopper member (20) .

7. A closure according to claim 6, characterized in that said first diaphragm means (27) comprise a first pierceable membrane (27) located within said discharge passage (23) at a location spaced inwardly from said discharge opening (25), and in that said second diaphragm means (29) comprise a second pierceable membrane (29) located within said venting passage (24) at a location spaced inwardly from said venting opening (28).

8. A closure according to claim 2, characterized in that it further comprises a one-way valve (30) connected to said venting passage (24).

9. A closure according to claim 4, characterized in that said annular flange (12) comprises a first flange portion (13) connected to said threaded collar (8) and extending substantially perpendicularly with respect to the longitudinal axis (16) of said closure (1), a second flange portion (14) connected to said first flange portion

(13) and extending on a plane which is inclined with respect to said longitudinal axis (16), and a third flange portion (15) connected to said second flange portion (14) and extending parallel to said longitudinal axis (16).

10. A closure according to claim 1, characterized in that it further comprises locking means (40) for connecting said closure (1) to an anasthetic transfer device.