Surgery – Container for blood or body treating material – or means used... – Materials mixed within container
Patent
1991-06-05
1993-11-02
Hafer, Robert A.
Surgery
Container for blood or body treating material, or means used...
Materials mixed within container
604403, 604411, A61B 1900
Patent
active
052579867
DESCRIPTION:
BRIEF SUMMARY
This invention relates to a container for the separate sterile storage of at least two substances and for mixing said substances, the container including a first chamber as well as a second chamber which communicates with said first chamber and consists especially of a bag made of a thermoplastic material.
The present invention also relates to a sterile, medical mixing assembly comprising at least one first chamber which is closed on all sides and contains a first substance, and a second chamber, in particular a plastic bag containing a second substance, in particular an aqueous solution, said chambers being adapted to be brought into flow communication for mixing purposes, and to a method for the manufacture thereof.
Medical storage bags are inter alia used for storing infusion solutions and must therefore be heat-sterilizable above 100.degree. C. to satisfy the normal hygienic demands. Bags of this type are e.g. known from German patent specification 32 00 264 or German patent specification 33 05 365.
However, these known bags made of a plastic foil only comprise one chamber, so that they are merely suited for storing infusion solutions that do not lose their potency or strength when stored over a long period of time.
For special therapies, however, there are infusion solutions which can only be prepared shortly before infusion on account of their extremely low storage stability, with two different substances being intermixed as a rule.
These two substances may be liquid components which are mixed prior to infusion, or powdery medicaments, such as antibiotics or cytostatic agents which are dissolved in a carrier solution, such as an aqueous saline solution.
Bags which are made on the basis of the above-mentioned storage bags are known to be used for storing and subsequently mixing a liquid active substance and a carrier fluid. These bags are welded in the center to form two chambers, a tubular member and a break-off part closing the tubular member being arranged in the weld as a connection between the two chambers. Prior to infusion the break-off part is broken off and subsequently falls into the interior of the one chamber. The liquid may then flow from the one chamber into the second one, with the necessary sterility being ensured.
Such an infusion bag which consists of two chambers is also known from German utility model 77 19 528. Several infusion solutions can be stored separately in this infusion bag and applied. The two chambers are separated from each other by welds having arranged therein a breakable tube which can be opened easily and is divided into several parts.
There are however several reasons why these known bags cannot be used for storing a powdery component and a liquid component and for subsequently mixing the same. On the one hand, it is a lot more expensive and difficult to fill a bag with a powder than with a liquid. On the other hand, it is not possible to pass the powder from the one bag chamber into the other one without any remainders being left.
Although there is the possibility of passing the liquid into the respectively other chamber containing the powder, this is not advantageous for all substances.
Another problem resides in the fact that, on account of the necessary sterilization of the plastic bag, water vapour cannot be prevented from passing through the bag wall into the interior of the bag. Moreover, the inner sides of most bags inseparably stick to one another during sterilization without any filling. Since the powder which may e.g. be an antibiotic or cytostatic agent and can only be filled into the container after heat sterilization must be stored in the container in a dry state, it would be necessary in another production step to remove the diffused water again, which would entail corresponding costs.
For this reason powdery medicaments have so far been stored in gas bottles and introduced into the liquid stored in a bag prior to infusion. However, since this operation must be carried out under sterile conditions, special precautionary measures must again be taken.
REFERENCES:
patent: 4484920 (1984-11-01), Kaufman et al.
patent: 4515586 (1985-05-01), Mendenhall et al.
patent: 4548606 (1985-10-01), Larkin
patent: 4550825 (1985-11-01), Sutryn et al.
patent: 4589879 (1986-05-01), Pearson
patent: 4781679 (1988-11-01), Larkin
patent: 4871354 (1989-10-01), Conn et al.
patent: 4927013 (1990-05-01), Van Brunt et al.
Herbert Reinhold
Sommermeyer Klaus
Fresenius AG
Hafer Robert A.
Rimell Sam
Schuman Jack
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