Prefilled syringe for storing and for transfer of liquid and ste

Details Prefilled syringe for storing and for transfer of liquid and ste Prefilled syringe for storing and for transfer of liquid and ste

1994-10-12

1995-12-26

Yasko, John D.

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

604218, 604232, A61M 500

Patent

active

054783240

DESCRIPTION:

BRIEF SUMMARY
This application is a 371 of PCT/IB94/00016 filed Feb. 18, 1994.
The present invention relates to a prefilled syringe for storing and for transfer of a liquid and sterile medicinal substances, having a rigid reservoir made of glass, with a closed bottom and closed at its opposite open end by means of a stopper--piston--valve, which is axially slidable, the reservoir being axially movable within a cylindrical body and has a shaft connected to the stopper--piston--valve and is provided with an axial conduit adapted to communicate with a needle fixed to the end of the body, opposite to the reservoir.
There are a variety of devices of this type, which have as object to contain a liquid and sterile substance intended to be transferred by direct injection to a patient or to another receiving instrument.
The prefilled syringe described in U.S. Pat. No. 2,574,339 comprises a central double needle, the end of which perforates a piston closing off a container. This syringe has the advantage of permitting the transfer of a liquid contained in the container by exerting pressure on the container without having to apply other manipulations in order to activate the syringe. This pressure effect perforates the piston by the central needle in order to permit the flow of the solution along this needle. The main disadvantage of this syringe is that it is impossible to use it for withdrawing a patient's blood into the container, from the time of direct injection in order to obtain a "vein" test or a mixture obtained after transfusion to a different device. Added to this disadvantage, are the costly manufacture of a double needle having bevellings at both ends, the perforation by this needle of the central part of the piston, which generates undesirable particles which are impossible to eliminate, and finally the fact that the injection needle is irreversibly attached to the body of the syringe, and cannot be withdrawn away into the body of the syringe after use.
The syringe has to be closed off as before in order to protect it after use, which fact at present represents a major risk of accidental contamination to a person due to being pricked by a soiled needle. The Food and Drug Administration (FDA) as well as the American Society of Hospital Pharmacists (ASHP) encourage the design of systems provided with a needle for the preparation of injectionable solutions for injecting a solution to a patient and the retraction of such a needle into the needle device after use (Vol. 49, Aug. 1992 Am. Hosp. Pharm. 1851; Letter dated Oct. 26, 1992 of Suzan A. Coutrell, Director, ASHP Home Care and Management Department to Edmund M. Fry, PDA Executive Vice President). Furthermore, this needle does not provide means to prevent its re-use. This applies both to the proximal part as well as to the distal part, due to the fact that means for fixing the container to the body is not provided. This syringe also is not provided with means to permit the maintainance of sterility of the piston surface before being perforated by the needle and of the needle itself.
Patent WO-A-92/18178 describes a syringe of which the stopper is perforated by a needle, which causes a considerable risk of injecting solid particles into a patient's blood stream.
U.S. Pat. No. A 3,841,329 describes a needle in which the stopper serves both as piston as well as a valve and is pierced. The piercing is, however, by way of a membrane of significant thickness, so that the slit made must open under pressure exerted by the liquid contained in the reservoir. For this reason this system results in a lack of tightness, which in turn implies that the stopper-- piston--valve of necessity must be connected to the shaft for transferring prior to its hermetical positioning in the reservoir and that it is impossible to achieve suction, particularly for effecting the "vein" test. The lack of tightness is the most serious consequence, namely the loss of sterility to the charge in the needle.
The syringe described in U.S. Pat. No. 1,159,663 similarly provides a double needle. It has a scr

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Vol. 49, Aug. 1992, Am. Hosp. Pharm. 1851; letter dated Oct. 26, 1992 of Suzan A. Coutrell, Director, ASHP Home Care and Management Department of Edmund M. Fry, PDA Executive Vice President.

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