Receptacles – Container attachment or adjunct – Expanding or contracting portion or component
Reexamination Certificate
1999-11-10
2001-05-01
Moy, Joseph M. (Department: 3727)
Receptacles
Container attachment or adjunct
Expanding or contracting portion or component
C222S386500
Reexamination Certificate
active
06223933
ABSTRACT:
The invention relates to a pressure compensation device for a two-part container which consists of a rigid outer container and a collapsible inner container. The inner container contains a fluid.
The aim of the invention is to disclose a device which is suitable for the compensation of pressure between the ambient air and the gaseous space between the inner container and the outer container, and which can be produced economically and which is protected from blockages.
The keeping of fluids, possibly containing a medicine, in a flexible inner container disposed inside a rigid outer container prior to use is known. When fluid is removed from the inner container by means of a metering pump, the inner container collapses. If the outer container does not contain an opening, a reduced pressure builds up in the closed intermediate space between the two containers. When a metering pump is used, which can only produce a small intake pressure, removal of fluid becomes difficult as soon as the reduced pressure between the two containers has become approximately equal to the intake pressure. It is then necessary to produce pressure compensation in the intermediate space between the two containers.
DE-41 39 555 describes a container which consists of a rigid outer container and an easily deformable inner bag. The container is produced in a co-extrusion-blowing process from two thermoplastics synthetic materials which merge together without a join. The outer container has a closed bottom and contains at least one opening for the compensation of pressure between the surroundings and the space between the outer container and the inner bag. The shoulder section of the outer container has at least one unwelded seam between two oppositely disposed wall sections of the outer container which are not welded together. Preferably, two unwelded seams are provided in the shoulder region of the outer container. The inner bag is sealingly closed in this region by weld seams. By virtue of the unwelded seam sections in the shoulder region of the outer container air is able to enter the intermediate space between the outer container and the inner bag. The edges which are not welded together at the open seam in the shoulder region of the outer container tend to rest against each other when reduced pressure prevails. Therefore, a further proposal has been made to provide preferably a plurality of holes in the upper region of the wall of the outer container to act as ventilation openings which may be produced by ultrasound or mechanically by perforating the outer container, for example. All openings in the wall of the outer container in the shoulder region and upper wall region are covered by means of the housing of the pump which is placed on the container.
The two-part containers according to the prior art contain open seams or holes in the outer container. The outer container consists, without exception, of a thermoplastics synthetic material.
Should the flexible inner container not be completely impenetrable to diffusion and the fluid in the inner container be volatile or contain volatile components, then fluid is lost from the inner container by diffusion, or the composition of the fluid is changed in a way which is perhaps inadmissible. This effect is promoted by air no longer flowing into the intermediate space between the outer container and the inner container over a long period of time after pressure compensation has ended, and by the pressure compensation openings in the outer container having a cross-section like the known two-part containers.
Therefore the problem is posed of disclosing a device for a two-part container which is suitable for the compensation of pressure between the ambient air and the gas space between the inner container and the outer container, even if the inner container contains a fluid which is volatile or which contains a volatile component with respect to which the inner container is impenetrable to diffusion to a limited extent. Even when the filled two-part container is in storage for many years and when the two-part container undergoes prescriptive use for many months, the quantity of fluid in the inner container or the concentration of fluid components should only change to an extent which is s substantially less than when the known two-part container is used.
This problem is solved according to the invention by way of a pressure compensation device for a two-part container which consists of an outer container and an inner container. The inner container contains an, at least partially volatile, fluid. The two-part container is disposed in gas-filled surroundings. The pressure-compensation device is characterised by the following features:
The inner container is impenetrable to diffusion to a limited extent vis-à-vis the at least partially volatile fluid, and is collapsible. The outer container is impenetrable to diffusion and rigid.
The outer container is sealingly connected to the inner container.
A gas-filled intermediate space is present between the two containers.
At least one channel communicates the as-filled intermediate space between the outer container and the inner container with the surroundings of the two-part container.
The, at least one, channel has a cross-sectional surface area with an equivalent diameter of between 10 &mgr;m and 500 &mgr;m.
The, at least one, channel is between five thousand times and one tenth of a time as long as the equivalent diameter of the, at least one, channel.
The equivalent diameter of the, at least one channel, is the diameter of a circle, the surface area of which is equal to the cross-sectional surface area of the, at least one, channel. The, at least one, channel can preferably be between one hundred times and one tenth of a time, particularly preferably between ten times and once, as long as the equivalent diameter of the, at least one, channel.
The cross-section of the channel is preferably as wide as tall, that is to say is preferably a round or approximately square cross-section or triangular cross-section. Furthermore, the cross-section of the channel can be rectangular, trapezoidal, semi-circular, slot-like, or of irregular shape. The ratio of the length of the sides of a slot-like channel can be up to 50:1. A plurality of channels can be arranged uniformly, e.g. at the points of intersection of a grid, or non-uniformly, e.g. statistically distributed. The cross-sectional surface area of the channel is less than 1 mm
2
and can extend into the range of a few thousand square micrometers.
The channel can be straight or curved, or be shaped in the form of a meander, spiral or screw. The channel can be arranged, preferably in the form of a bore, in the wall of the outer container. Furthermore, the channel can be arranged in an insert which preferably consists of plastics material, the insert being sealingly arranged on the wall of the outer container, preferably in an inwardly inverted recess in the bottom of the outer container. In this case, the end of the channel which faces the intermediate space communicates with an opening in the wall of the outer container. That opening is of greater cross-section than the channel.
A gas-permeable filter, e.g. a fibre fleece or a body of open-pore sintered material, can be arranged to act as a dust protector at the one end of the channel, preferably at the end facing the surroundings.
The end of the channel facing the surroundings can be closed by means of a sealing foil whilst the two-part container filled with a fluid is being stored, the sealing foil being torn partially or completely away from the inner container, or being pierced, when fluid is removed for the first time.
The wall of the, at least one, channel, can be smooth or rough.
The, at least one, channel can be produced in the form of a micro-bore in a plate, e.g. by means of a laser beam. A meander-like or spiral channel can be produced by selective cauterization of a silicium surface, for example; a channel of this kind can be of triangular or trapezoidal cross-section. Furthermore, a channel of triangular cross-sec
Eicher Joachim
Essing Martin
Hausmann Matthias
Hochrainer Dieter
Kladders Heinrich
Boehringer Ingelheim International GmbH
Devlin M. E. M.
Moy Joseph M.
Raymond R. P.
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