Surgery – Container for blood or body treating material – or means used... – Having hollow needle or spike for piercing container or...
Patent
1993-10-21
1994-10-25
Hafer, Robert A.
Surgery
Container for blood or body treating material, or means used...
Having hollow needle or spike for piercing container or...
604415, 604412, 604411, 604403, A61B 1900
Patent
active
053585011
DESCRIPTION:
BRIEF SUMMARY
The present invention concerns a storage bottle containing a component of a medicinal substance and a transfer device for transferring said substance either directly, or after mixing it with another substance, into a container for final use, said bottle comprising a narrow open neck and the transfer device comprising a sealing means at least partially engaged in said neck, at least during storage.
Medicinal substances, whether usable directly or comprising the components of a mixture, are usually stored in receptacles which may be either flame sealed glass ampoules or bottles sealed with a sealing means. In the case where the substance is obtained by dissolving a powder or a lyophilisate using a liquid solvent, this liquid must be introduced into the storage bottle to come into contact with the solid or pulverized component and dissolve it. To do this, the sealing means must be punctured for the liquid to flow through, or pushed back completely inside the bottle so as to free the neck, or even partially pushed back so as to free a lateral opening allowing the liquid to pass through.
A first problem posed by bottles known in the art is that which arises when the sealing means is punctured to pour the solvent inside the bottle. Puncturing it may break off some elastomeric material from the plug usually used as a sealing means, and the broken particles may in some cases be injected into the organism and cause serious problems.
The present invention remedies the disadvantages of known prior art systems and eliminates all the risks connected with puncturing the plug.
A second problem posed by bottles known in the art is that of the sealing barrier and the aseptic barrier. The sealing means must fulfill several functions and must respond to several requirements at the same time during storage and during use.
During storage, it must constitute both a tight barrier and an aseptic barrier especially for preventing any bacteria from entering the bottle. During the phase of use, the sealing means must maintain, particularly in the initial phase of activation, an aseptic barrier to protect the bottle contents and to allow access inside the bottle for the solvent to penetrate it.
The present invention is designed to resolve this problem by structuring the sealing means in such a way that it can fulfill all the functions described above.
A third problem posed by bottles known in the art is due to the fact that when the component is dissolved by the solvent, large quantities of gas may be discharged, particularly anhydrous carbon, which causes considerable pressure in the bottle or in the container for use. In the case where the container for use has a large capacity or when it is rigid and its walls resist pressure, the gas may be transferred into this container. On the other hand, when the container is a flexible pouch and when too great a pressure would risk causing it to burst, it is imperative that this gas be at least partially evacuated.
The present invention also overcomes this problem by providing means for evacuating the pressurized gas inside the storage bottle at the time the solvent dissolves the pulverized solid substance.
These various objectives are attained either separately or in combination by virtue of the bottle according to the invention.
To this end, the bottle is characterized in that the sealing means consists of two elements: a first element consisting of a solid elastomeric plug with a diameter essentially equal to that of the bottle neck and which is engaged in the neck to seal it tightly during storage, and a second element consisting of an elastomeric toric connection with an outside diameter essentially equal to that of the bottle neck and which engages in the neck, and in that the transfer device further comprises at least one inside opening emptying into the space formed between said first element and said second element.
According to an advantageous embodiment, the transfer device comprises a capsule adapted above the bottle neck, movable between a storage position in which it is partial
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Becton Dickinson France S.A.
Hafer Robert A.
Rimell Sam
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