Surgery – Container for blood or body treating material – or means used...
Reexamination Certificate
1999-02-26
2004-02-03
Hayes, Michael J. (Department: 3763)
Surgery
Container for blood or body treating material, or means used...
C604S408000, C604S415000, C222S095000, C222S105000
Reexamination Certificate
active
06685691
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a container for a medicinal liquid, more particularly to a container for a medicinal liquid, wherein the container is gas-tight and liquid-tight.
2. Related Art
EP-0 182 094 A2 sets forth a bottle-shaped pack comprising an outer container which is stiff in respect of shape and an inner container which is disposed in the outer container and which is in the form of an easily deformable bag for containing the filling material. The preform is produced by co-extrusion of two coaxial tubular portions. The two portions comprise two thermoplastic materials which are not joined together. The preform is expanded in a blow molding mold. A welded seam is provided at the flat bottom of the inner container. The flat bottom which is formed on the outer container has an opening in the form of a slot. The outer container and the inner container are connected together in a positively locking relationship in the region of the discharge opening. That pack is produced substantially in one working operation.
The filling material is discharged from the container by means of a pump which is disposed in the discharge opening. The pump causes the inner container to deform as its volume decreases. Air passes into the space between the outer container and the deformed inner container, through the open slot in the flat bottom of the outer container, thereby preventing the occurrence of a reduced pressure in that intermediate space. The inner container does not involve a fixed contact with respect to the outer container, except in the region of the discharge opening. The pack can be provided with a dip tube which extends almost as far as the flat bottom and which holds the inner container in the extended condition. That pack can be satisfactorily used and completely emptied, only when it is in a given position in space.
A tubular bag of composite foil is described in EP-0 620 165 A1. The composite foil comprises at least an outwardly disposed plastic foil and an inwardly disposed metal foil. The tubular bag is closed at both ends in a sack-like configuration. The bag is provided with a desired-rupture location, by means of which it can be reliably opened at that point. A tubular bag of that kind serves to store a hardenable material which is expelled from the tubular bag by means of an expelling device.
EP-0 068 653 A1 describes a flexible and collapsible container which is intended for one-trip use and which is made from a foil and which is used in a suction or feeding bottle which can be used a plurality of times. The one end of the container is open while the other end is closed by means of a welded seam and provided with a tongue portion. The tongue portion is clamped in a gap provided at the bottom of the suction or feeding bottle. That provides that the bag-like container is constantly held in an extended condition in the suction or feeding bottle.
SUMMARY OF THE INVENTION
The invention aims to make the production of a container which is intended for one-trip use more economical without adversely affecting its usefulness, and to simplify handling thereof.
The object of the present invention is to provide a container for a medicinal liquid, which is gas-tight and liquid-tight, and which has a filling volume that is suited to the intended purpose of use. The container plastically and irreversibly collapses under a slightly reduced pressure in a predetermined manner such that it can be substantially emptied.
The container of the present invention includes a foil bag which is closed at both ends. At a differential pressure between the interior of the container and its surroundings below 300 hPa (300 mbar), the foil bag is deformable by the external pressure and collapses. The container further includes a flange which is stable in respect of shape and which is sealingly mounted to the foil bag. The flange is a releasable connecting element for fitting the container on to a discharge connection member.
The foil bag is closed at least one end with at least one welded seam which extends substantially transversely with respect to the axis of the bag. The flange has a sealing location which is stable in respect of shape. A discharge location for the liquid in the region of the flange is also provided, the discharge location being is stable in respect of shape.
The container of the present invention has several advantages over conventional containers. For example, the container of the present invention is economical to produce, is suitable for one-trip use and requires only a small amount of material usage.
Further, the container of the present invention can be produced in a sterile condition and filled and sealed in a sterile condition. It can also be used for medicaments intended for inhalation, which are typically provided as solutions in ethanol, water, or an ethanol and water mixture.
The liquid is discharged from the container of the present invention under sterile conditions, such that no air is sucked into the container upon discharge. As such, the liquid does not come into contact with air, oxygen or carbon dioxide.
Further, the container of the present invention permits gas and bubble-free discharge of the medicinal liquid.
The container of the present invention is sealed so that diffusion of liquids and gases is minimized. The container can be filled and then stored over several years, depending on the particular medicament involved, and still satisfy the requirements of all official pharmacopoeiae.
The container is easily deformable at a slightly reduced pressure. Further, in the collapsed condition the container of the present invention remains flat and stretched out, such that it retains its initial length after emptying.
Further, the container of the present invention does not require a valve for pressure equalization after a portion of the liquid has been discharged, and the container can be substantially emptied, even in a fluctuating position and when it is upside down.
The foil bag of the present invention is connected only to the flange which is stable in respect of shape and is not fixed to any casing, if such is provided.
The filling volume of the container can be easily adjusted to a predetermined value within a certain range by changing the length and/or the diameter of the foil bag. Further, the container can be filled prior to closure, before the single or the second welded seam is produced. As such, there is no need for a separate closure means.
The container can be used with or without a casing. If the container is disposed in a casing, it is protected from external damage.
The liquid is stored in the container of the present invention such that it is protected from the effect of light by an opaque foil bag or by an opaque casing which is closed all around.
Further, the container of the present invention can be fitted into and removed from a discharge device in a simple fashion and without rotary movement.
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Eicher Joachim
Essing Martin
Freund Bernhard
Geser Johannes
Hochrainer Dieter
Boehringer Ingelheim GmbH
Hayes Michael J.
Serke Catherine
Sterne Kessler Goldstein & Fox P.L.L.C.
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