Fluent material handling – with receiver or receiver coacting mea – Inserted or external form or protector
Reexamination Certificate
1999-08-26
2001-05-29
Huson, Gregory L. (Department: 3751)
Fluent material handling, with receiver or receiver coacting mea
Inserted or external form or protector
C141S114000, C220S495050
Reexamination Certificate
active
06237655
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an apparatus for holding a deformable fluid container (commonly called a “bag” in medical parlance) that is made of a gas-tight flexible material.
2. Description of the Prior Art
U.S. Pat. No. 4,734,184, discloses the use of a bag having a multiple layer of plastic containing a metal layer, and filled with gas-equilibrated electrolyte solutions, in particular electrolyte solutions that are pre-tonometered. The metal layer, for example an aluminum foil, forms a gas barrier that makes the bag particularly gas-tight. In contrast to, for example, a glass bottle, the flexibility of the bag resulting from the flexibility of the multiple layer also prevents an exchange of gases during the removal of the solution, since, in contrast to a glass bottle, the bag can collapse during the removal of the solution, and need not be vented.
SUMMARY OF THE INVENTION
An object of the present invention is to provide a bag that is made of a gas-tight flexible material and which is to be filled with fluid, wherein the gas-tightness can be ensured even if there is a risk of the occurrence of a gas leak of the bag, given a bending, buckling, crimping and/or folding of this material.
This object is achieved in any apparatus according to the invention having a hollow space that is limited by a concavely cylindrically curved fixed side wall surface that allows a flat application of the unfilled flat bag, and two fixed front wall surfaces of the bag that face one another and are each convexly curved, causing an inward bending of the edge sides, these convex surfaces being positioned opposite one another, and lying flat against the side wall surface.
The invention is based on the observation that a bag having a multiple layer of plastic that contains a metal layer tend toward a breakage of the metal layer when the multiple layer is bent, in particular when a critical angle is exceeded, or due to multiple bending during manufacture, filling, shipping, and in particular handling by the end user. The gas-tightness is no longer guaranteed in case of breaks in the metal layer.
In addition, the invention is based on the finding that this problem is due in particular to the geometries of the empty and filled bag. The bag conventionally has two multiple layers between which there is located the hollow space in the bag, to be filled with the fluid. Before the bag is filled, the hollow space thereof is evacuated in a suitable manner. When the bag has been evacuated, the two multiple layers lie flat against one another, in close contact, so that the bag has a two-dimensional flat shape. After filling the bag with fluid, its geometry has changed into a three-dimensional shape that exhibits folds that can cause breaks in the metal layer.
The inventive apparatus forms a protective apparatus for such a bag, this protective apparatus taking into account the differing geometries of the empty (in particular evacuated) bag and the filled bag. The specially shaped hollow space of this apparatus serves to hold the empty (in particular evacuated) bag before filling, and to fix the geometry of the filled bag. The shape of the hollow space is selected such that the empty bag held therein advantageously undergoes only minimal folding during the filling, and the filled bag exhibits a minimum of folds, so that buckling, crimping, folding or other excessive bending of the material of the bag, in particular the metal layer in a multiple layer of plastic, is prevented.
In further embodiments the inventive apparatus can have one or more of the following features. The front wall surfaces can be curved in mirror-symmetrical fashion to one another. An additional side wall surface, enclosing the apparatus hollow space, can be arranged opposite the side wall surface. The additional side wall surface can be curved in concavely cylindrical fashion, mirror-symmetrically to the one side wall surface. The one side wall surface and additional side wall surfaces can be constructed so as to be capable of being removed from one another. A front wall surface and a side wall surface can be pivoted relative to one another around a common axis of rotation. The axis of rotation common to a front wall surface and the side wall surface can be arranged at a vertex of curvature of a side wall surface.
In order to enable the empty bag held in the hollow space of the apparatus to be filled with fluid, if necessary an opening can be formed in at least one wall surface of this hollow space, through which opening a bag projection, that protrudes from the bag fits, this projection containing a filling opening, connected with the hollow space of the bag, for filling the bag with fluid. This opening is sealed in gas-tight fashion after filling. Such an opening is required at least when the hollow space of the apparatus holding the bag is closed on all sides during filling of the bag.
In a bag having a multiple layer made of plastic, in particular a multiple layer containing a metal layer, the problem is known to arise that a filling opening for filling the bag with fluid must be made of a material that can be fused with an inner layer of the multiple layer. If, for example, the inner layer of the multiple layer is a plastic, e.g. polypropylene, the material of the filling opening, which material is in contact with the inner layer, must also be made of the same plastic or similar as this layer.
The gas permeability of plastic materials is much greater than that of a metal foil, so that openings made of plastic reduce the storage life of gas-equilibrated solutions, and are not suitable as gas-tight seals.
The problem of the gas-tight sealing of the filling opening for filling the bag can be solved by sealing this opening by means of heat fusion after filling the bag with the fluid, so that the presence of gas-permeable material next to or lateral to the inner layer of the multiple layer is avoided.
An opening for removing the fluid from the filled bag must be sealed in gas-tight fashion preceding the opening. Preferably, a special opening for removing the fluid is entirely omitted in the inventive bag apparatus. In order to enable connection to the bag for removal of the fluid, the bag is perforated with the tip of a hollow needle, however, such a procedure tends to damage the wall of the bag.
In order to enable perforation, with the tip of a hollow needle, of the bag filled with fluid and held in the hollow space of the inventive apparatus, this apparatus has an opening in a wall surface for the introduction of the tip of a hollow needle into the hollow space from the outside.
The risk of damaging the wall of the bag is avoided, or at least reduced, in an embodiment wherein the bag held in the hollow space is fastened to the wall surface having the opening for the introduction of the tip of the hollow needle, by means of an adhesive layer located opposite this opening. In addition, for the protection of the wall of the bag it is advantageous for the opening for the introduction of the tip of the hollow needle to be sealed by a covering layer made of elastic material, which covering layer is pierced by the tip of the hollow needle. A diameter of the opening for the introduction of the tip of the hollow needle is advantageously selected to be substantially equal to a cross-sectional diameter of the hollow needle. Each of these three measures contributes to the prevention of a perforation of any other part of the bag during the perforation of the covering layer and the wall of the bag with the tip of a hollow needle.
According to the above, in the inventive apparatus a bag, in a pre-fastened state, is filled with fluid, and the fluid is stored with a maximum integrity against leakage with the gas-tightness of the bag maintained, and the fluid can be removed by perforation of the bag material, while protecting the bag. The inventive apparatus provides an inexpensive manufacturing process and reliable and simple handling by the end user.
In particular, the inventive apparatus is suitabl
deVore Peter
Huson Gregory L.
Schiff & Hardin & Waite
Siemens Aktiengesellschaft
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