Note: Descriptions are shown in the official language in which they were submitted.
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WO 95/13972 PCT/LJS94/12537
1
SINGLE-USE CLOSURE, PARTICULARLY FOR ANAESTHETIC-AGENT CONTAINER.
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 forr,~~ 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
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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
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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
WO 95/13972 ~ ~ 7 4 6 51 pCT~S94/12537
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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
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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.
A container closure, particularly for anaesthetic
containers is described in Italian Patent No. IT 1266646,
filed by the same applicant on October 29,
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1993. Whilst such closure has been found to solve the
above mentioned problems, it has also been found to be
susceptible to improvement.
In particular, it is desirable to provide an
improved anaesthetic container closure, attached to a
container which cannot be reused with another container
upon being removed therefrom.
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, the invention seeks 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.
The invention also seeks 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.
Further the invention seeks to provide a closure for
anaesthetic agent containers which is selectively
perforatable by piercing means within the closure adaptor
of an anaesthetic transfer system.
Still further the invention seeks to provide a
closure for anaesthetic agent containers which can safely
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retain a closure adaptor of an anaesthetic transfer
device in operative engagement therewith.
Still further the invention seeks 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 anaesthetic container, such as the ABBOTT ~~Security
Lock" filling system.
Still further the invention seeks to provide a
closure for anaesthetic containers, which, upon being
attached to one container, cannot be detached therefrom
and reused with a different container.
In accordance with the invention there is provided a
container containing an anaesthetic agent and comprising
a closure with a locking ring connected to a collar at a
frangible annular portion and means for preventing reuse
of said closure upon being detached from said container,
wherein said closure further comprises means fixed to and
extending outwardly from said collar for selectively and
detachably connecting said closure to a user device.
There is also provided a closure particularly for
anaesthetic agent containers comprising a locking ring
connected to a collar at a frangible annular portion,
characterized in that it further comprises means fixed to
said collar for selectively connecting said closure to a
user device adaptor, and means for preventing reuse of a
container upon said closure being detached from a
container.
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7a
Further features and advantages of the invention
will become apparent from the following detailed
description thereof, and the following drawing wherein:
Fig. 1 is a cross sectional view of the container
closure according to the invention, attached to the
threaded neck of an anaesthetic container.
With reference to the above described drawing
figure, the closure according to the invention is
generally
WO 95/13972 ~ ~ ? 4 6 51 pCT~S94/12537
indicated by the reference numeral 100. The closure is shown
in screw-thread engagement with the neck 102 of an
anaesthetic container 103 which, in the illustrated
example, is constituted by a standard threaded neck glass
bottle 103. The neck 102 defines an upper edge 104 and
an externally protruding annular rib 105. Screw threads 106
are formed on the outer surface of the neck 102 and extend
axially between the annular rib 105 and the upper edge
104.
The closure 100 has a locking ring 107 which engages
the externally protruding annular rib 105 of the container
103 and is connected to a collar 108. The collar 108 is
connected to the ring 107 at a frangible annular band 110,
and preferably has knurled or ribbed annular band 111 formed
thereon for facilitating gripping by a user when applying a
torque force for separating the collar 108 from the ring 107
by breaking the frangible annular band 110.
Above the portion of the collar 108 defining the
knurled band 111, the collar has an annular flange 112
defining, in cross section, a first flange portion 113
connected to the annular band 111 and extending
substantially perpendicularly with respect to the
longitudinal axis 116 of the closure 100; a second flange
portion 114 connected to the first flange portion 113 and
extending on a plane which is inclined with respect to the
longitudinal axis 116 of the closure 100; and a third
flange portion 115 connected to the second flange portion
114 and extending parallel to the longitudinal axis 116 of
the closure 100.
The closure 100 further comprises a stopper member 120
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defining a bottom flange 121 having an external surface
engaged by the annular flange 112 of the collar
108, and an internal surface in sealing engagement with the
upper face of an annular sealing member or gasket 122. The
.
gasket 122 is interposed between the bottom flange 121 and
the upper edge 104 of the container 103. Engagement of the
locking ring 107 with the externally protruding annular rib
105 of the container 103 maintains a compressive force,
which is exerted through the collar 108 and flange 112, on
the bottom flange 121 and on the gasket 122. Thus, the upper
face of gasket 122 is in sealing abutment engagement with
the lower internal surface of the bottom flange 121, while
the lower face of the gasket 121 is in sealing abutment
engagement with the upper edge 104 of the container 103.
A discharge passage 123 and a venting passage 124
extend through the stopper member 120, parallel to the
longitudinal axis 116 of the closure 100. The discharge
passage 123 defines a discharge opening 125 at the upper end
126 of the stopper member, and is occluded by a first
pierceable membrane 127, located within the discharge
passage 123, preferably at a location inwardly spaced from
the discharge opening 125. Similarly, the venting passage
124 defines a venting opening 128 and is occluded by a
second pierceable membrane 129, located within the venting
passage 124, preferably at a location inwardly spaced from
the venting opening 128. A one way check valve 130 can be
press-fitted within the venting passage 124 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.
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Advantageously, the locking means comprise an outwardly
projecting wedge 140, for engagement with a recessed edge
formed on a transfer device.
The closure described so far is substantially
identical to the closure described in Italian Patent No. IT
1266646, filed by the same applicant on October 29, 1993.
According to the present invention, the closure also
comprises means for preventing reuse of the closure upon
being detached from a container. Advantageously, the means
for preventing reuse of the container comprise a planar face
109, defined on the internal face of the collar 108 facing
the screw threads 106 formed on the neck 102 of the
container 103. Thus there is no engagement between the
collar 108 and the screw threads 106.
The closure 100 is securely and safely retained in a
correct position of the container 103 by the engagement of
the locking ring 107 with the protruding rib 105 of the
container 103. The contents of the container may be
transferred to a vaporizer either by connecting the
discharge and venting passages 123, 124 to an anaesthetic
transfer device, or by rupturing the frangible annular band
110 in order to completely remove the closure 100 from the
container 103 and permit the contents to be poured directly
into a vaporizer, as fully described in the above-mentioned
Italian Patent No. IT 1266646.
Upon removal of the closure 100 from the container
103 by rupturing the frangible annular band 110, the planar
face 109 prevents the closure from being reused with another
container by preventing engagement with the threaded neck of
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537
such container. Reuse of the closure according to the
invention on successive container is thus prevented.
The closure member 100 may be applied to containers
containing a specific type of anaesthetic, and the stopper
member may be provided with a configuration for matching a
transfer device for a vaporizer intended for use with such
specific anaesthetic. BY providing the planar face 109, the
closure 100 cannot be removed from one agent-specific
container, and used on a different type of container.
Thereby, it becomes impossible to transfer a specific type
of anaesthetic to the wrong vaporizer.
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.
