Surgery – Container for blood or body treating material – or means used... – Having hollow needle or spike for piercing container or...
Patent
1996-03-07
1998-10-27
Coggins, Wynn Wood
Surgery
Container for blood or body treating material, or means used...
Having hollow needle or spike for piercing container or...
604 82, 604 86, 604 87, 604 88, A61B 1900
Patent
active
058272623
DESCRIPTION:
BRIEF SUMMARY
The subject of the present invention is a syringe device making it possible to mix two compounds and inject the mixture thus obtained.
More precisely, the invention relates to a device allowing storage in separate form of two compounds which are to be mixed before they are injected.
It is known that there are, especially in the medical field, products which are to be stored separately and which must not be mixed until the time at which they are injected into a patient, for example subcutaneously, intravenously or intramuscularly. This is, in particular, the case of medicinal products which are prepared in freeze-dried form or in powder form, and which must be mixed with a solvent, for example physiological saline solution in order to allow them to be administered to the patient.
In other cases, the two compounds to be mixed may be liquids, it not being possible for these liquids to be preserved for a long time in mixed form.
The solution most frequently used consists in storing the powder in a separate container which is closed by a leaktight membrane which can be perforated using a needle. Furthermore, using a syringe, a certain quantity of solvent is withdrawn from a second container and injected into the first container through the membrane. The whole is then mixed in the first container and the mixture is sucked out using the same syringe. The syringe is then ready for carrying out the injection of the medication using, in most cases, a change of needle.
The solution described hereinabove has numerous drawbacks: on the one hand, it requires the use of the container closed by the perforable membrane, of the syringe and of the second container containing the solvent, which are separate articles. Furthermore, the handling operations required are relatively complex. On the other hand, it is not always easy to adhere to aseptic conditions during the various handling operations of the two components.
It is also necessary to consider the fact that freeze-drying installations preferably receive glass containers of standard form with a flat external bottom. It is therefore advantageous for the part of the syringe device intended to receive the product to be freeze-dried to have this form. In addition, most current medications are already in this form and any alteration of the packaging would require a new authorization to market, with long and expensive stability studies.
Furthermore, it is essential to ensure confinement of the needle throughout the storage period and preferably, during the handling operations corresponding to mixing the products.
One object of the present invention is to provide a syringe device making it possible to store the two compounds in separate enclosures, to mix these compounds and to inject them into a patient while preferably allowing freeze-drying of one of the two compounds in a first compartment independently of the sterilization of the solvent in a second compartment under conditions which are as close as possible to those which are encountered during freeze-drying of a product in a standard vial, the syringe device being in the overall form of a single assembly which is easy to handle and ensures, throughout its period of storage, maintenance of perfect asepsis of the various parts of the device which can come into contact with the patient or the product to be injected, and making it possible to carry out the handling operations for mixing the two products while keeping the needle under rigorous aseptic conditions.
In order to achieve this object, the syringe device making it possible to mix two compounds, at least the first of which is liquid, comprising a syringe provided with an injection end, the syringe containing the said first compound, is characterized in that it furthermore comprises: between a first withdrawn so-called storage position and a second inserted so-called active position, the said guide means including a first end emerging opposite the perforable zone of a stopper capable of closing in leaktight manner the opening of a vial intended to contain one of the
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Copy of the International Search Report for PCT/FR94/01053, filed Sep. 4, 1994.
Bouvier Bernard
Neftel Frederic
Coggins Wynn Wood
Debiotech S.A.
Gring N. Kent
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