Surgery – Container for blood or body treating material – or means used... – Bag type
Reexamination Certificate
1999-04-09
2001-05-15
Ruhl, Dennis (Department: 3761)
Surgery
Container for blood or body treating material, or means used...
Bag type
Reexamination Certificate
active
06231559
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The object of the invention is a flexible plastic container for the spatially separated storage and, optionally, selective sterilization of the ingredients of preparations for parenteral or enteral use comprising tree compartments and the use of the container.
2. Description of the Related Art
EP-0 295 204 B1 describes a container for medical use, in particular a container for infusions consisting of an envelope made of a flexible, homogeneous, polymerized material which is divided into three compartments separated from each other by leaktight welds of the envelope material and each of said compartments is provided with a occluded passage which can be opened deliberately to enable the contents of the part of the interior space to flow into another one, wherein the container has two adjacent parts (3,4) of the interior space within the upper portion thereof and one part (5) of the interior space within the lower portion thereof and is intended for taking up and mixing subsequently lipids, amino acids, and sugars just before the use thereof, wherein each interior part is provided with one occluded opening in order to supply the compound through said opening or to discharge the contents thereof through said opening outwards, and wherein the material of the envelope is chemically and biologically inert against any envisaged compound and the mixtures thereof.
DE 94 01 288 U1 pertains a multichamber bag having at least two chambers being arranged one upon another during the mixing stage and being surrounded by an exterior boundary, said chambers being separated from one another by at least one bar and forming an upper chamber and a mixing chamber, said bag having at least one connecting device being arranged within the bar and being closed by a locking device which is to be opened, said connecting device providing a flow connection between the chambers after being opened, said bag having at least one hang up opening at the upper boundary region and a discharge device being arranged at the mixing chamber as well as a second discharge device being opposite to said former discharge device and being arranged in the circumferential region of the mixing chamber.
With said plastic containers according to prior art mixing of the separate components of the preparations for parenteral or enteral use is possible without time-consuming kneading of the bags by the hospital personnel after opening the ports. Upon opening the ports, the ingredients of the upper compartments being in working position flow without expenditure of mechanical energy due to gravitational force into the lower mixing chamber. However, the spatial arrangement of the ingredients, in particular according to EP 0 295 204 B1, results in a relatively long mixing time before the solution can be administered to the patient.
SUMMARY OF THE INVENTION
Consequently, the problem of the present invention is to provide an improved flexible plastic container for the spatially separated storage and, optionally, selective sterilization of the ingredients of preparations for parenteral or enteral use, said container providing a more rapid and still safer mixing of all components.
The aforementioned problem of the present invention is solved by a flexible plastic container
1
for the spatially separated storage and, optionally, selective sterilization of the ingredients of preparations for parenteral or enteral use, comprising
three compartments
3
,
4
, and
5
being separated from each other by means of leaktight welds of the envelope material, said compartments having one closable fill in opening
7
,
8
, and
9
, each;
connecting means
10
and
11
which can be opened sterilely from the outside, by which flow connections between compartments
3
,
4
, and
5
can be provided; wherein
the proportions by volume of compartments
3
,
4
, and
5
are selected such that in the working position as resulting from suspending by the hang up means
12
a rapid and complete mixture of all ingredients within compartment
5
is possible by opening the connecting means
10
and
11
and compartment
3
contains carbohydrates, compartment
4
lipids and compartment
5
amino acids.
By means of the present invention it is possible to fill in the ingredients of the preparations for parenteral or enteral use selectively into the separate compartments and to subject said ingredients to a specific, that is, in particular, stepwise sterilization. Moreover, it is therefore possible to mix ingredients adjusted to the patient with each other selectively in order to obtain homogeneous mixtures this way, if possible without additional expenditure spent by the hospital personnel.
REFERENCES:
patent: 4465488 (1984-08-01), Richmond et al.
patent: 4507114 (1985-03-01), Bohman et al.
patent: 4997083 (1991-03-01), Loretti et al.
patent: 5431496 (1995-07-01), Balteau et al.
patent: 5560403 (1996-10-01), Balteau et al.
patent: 6007529 (1999-12-01), Gustafsson
patent: 6039719 (2000-03-01), Wieslander et al.
patent: 6039720 (2000-03-01), Wieslander
patent: 3700713 (1987-01-01), None
patent: 9401288 (1994-01-01), None
patent: 196 05 357 (1996-02-01), None
patent: 0295204 (1988-05-01), None
patent: 0790051 (1997-02-01), None
patent: WO9705851 (1997-02-01), None
patent: WO9705852 (1997-02-01), None
B. Braun Melsungen AG
Brobeck Phleger & Harrison LLP
Mager Carie
Ruhl Dennis
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