Two-compartment syringe assembly and a method of producing a two

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

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604 87, 604 89, A61M 3700

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054296030

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to a two-compartment syringe assembly for storing a liquid and a material, and for preparing a dilution of said material within said liquid prior to dispensing said liquid, and further to a method of producing a two-compartment syringe assembly for storing a liquid and a material and for preparing a dilution of said material within said liquid prior to dispensing said liquid.
From published European Patent Application, Publication No. 0397589, an apparatus for preparing a mixture of a solid, particulate or powdered component, and a liquid component, so as to provide a paste-like material therefrom is known, particularly for preparing acrylate bone cement. U.S. Pat. No. 4,910,259 describes an acrylate bone cement which is preferably used in the apparatus known from the published European patent application.
The technique of storing two components such as a liquid or solvent and a material, such as a medicament constituting a solid or liquid component within separate containers or barrels of a so-called two-compartment syringe prior to preparing a dilution of the material within the liquid is also well-known within the art. Reference is to be made to CH 622752, GB 1313339, GB 1413734, DE 2838222, WO 85/04567, WO 86/06618, FR 1164351, SE 378064, SE 464797, U.S. Pat. No. 3,108,591, U.S. Pat. No. 3,570,486, U.S. Pat. No. 3,685,514, U.S. Pat. No. 4,254,768, U.S. Pat. No. 4,306,554, U.S. Pat. No. 4,464,174, U.S. Pat. No. 4,546,767, U.S. Pat. No. 4,693,706, U.S. Pat. No. 4,768,568, and U.S. Pat. No. 4,886,495, and the above-listed U.S. patents are further incorporated in the present specification by reference.
A representative example of the prior art two-compartment syringe assembly is disclosed in U.S. Pat. No. 3,685,514 which two-compartment syringe assembly is basically composed of two separate, conventional syringes, one of which constitutes an inner syringe comprising an inner barrel and a plunger, which inner barrel contains the liquid or solvent. The inner barrel and plunger together constitute a plunger assembly of an outer syringe which further comprises an outer barrel containing the medicament. Among the above-listed references, elaborated structures comprising sealed capsules to be perforated and elaborated vents are disclosed.
Common to the two-compartment syringe assemblies known within the art is the fact that the active material, i.e. the medicament or an active liquid component which is to be diluted within the liquid prior to dispensing from the two-compartment syringe assembly is contained within the outer barrel.
A serious drawback of the two-compartment syringe assembly is due to the lack of providing a controllable venting of the two-compartment syringe assembly when the dilution is prepared, as some materials or medicaments when diluted in a liquid or in a solvent create aerosols and gases which have to be vented, however, have to be vented through filtering means in order to eliminate to any substantial extent the risk that the person, such as a doctor, a nurse, or a pharmacist, operating the two-compartment syringe assembly is exposed to hazardous, such as toxic or carcinogenic aerosols and gases.
Particularly when preparing cytostatics, serious problems have arisen, since hazardous, such as toxic or carcinogenic aerosols and gases are developed. Hitherto, attempts have been made as to solving these serious problems by prescribing that the person operating the two-compartment syringe assembly should use gloves, masks, specialized semi-closed mixing devices and carry out the mixing or preparation procedure in a fume cupboard with forced ventilation.
A further drawback of the two-compartment syringe assembly originates from the fact that the two-compartment syringe assembly in case it is exposed to shocks or blows or dropped on a floor may leak, causing an extremely hazardous situation in case the two-compartment syringe assembly is dropped, e.g. in a hospital.
An object of the present invention is to provide a two-compartment syringe assembly for storing a liq

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Copy of database search in the name of Kabi Pharmac identifying patent applications and patents filed in the name of Kabi Pharmacia AB which is a Swedish Company.

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