Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-06-14
2001-04-24
Yasko, John D. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S086000, C604S905000
Reexamination Certificate
active
06221041
ABSTRACT:
The present invention concerns a fluid transfer device connecting a medicinal vessel and an intravenous (IV) bag in dosed system. More specifically, the invention relates to a device provided with a three-way valve, allowing to transfer two pharmaceutical products, respectively from a rigid container such as a bottle or a vial and from a bag-type container, by means of a syringe. The device is used to obtain the mixture of the two products by transfer from one container to the other, without removing any one of the three elements (i.e., vessel, bag and syringe) from the assembly until the end of the operation.
As it is known, many medicinal products for intravenous administration are diluted before use in suitably proportioned amounts of injectable or perfusional solutions, in order to be injected or infused to the patient by the intravenous route, i.e. in the phleboclysis form. In some cases these medicaments are placed on the market in the liquid form, e.g. as solutions or as stable suspensions, while in other cases they are in the dry powder form. Active ingredients in the dry powder form must be reconstituted before use by the addition of a measured amount of liquid. The transfer and the dilution or the reconstitution of the said medicinal products before use are conventionally carried out by means of a syringe provided with needle.
When a medicament to be reconstituted is used, a predetermined amount of injectable diluent solution or of perfusional solution is taken by means of a syringe from the relevant container, and is introduced in the bottle or vial of medicament. The latter is normally provided with a pierceable rubber stopper. Once it has been diluted, the drug is taken up from its bottle with the syringe and is administered to the patient intravenously, or it is transferred, wholly or in part, in the container of the perfusional solution, so as to obtain the desired dosage of active ingredient to be infused.
It is evident that the operations referred to above unavoidably involve the production of splashes and aerosols that diffuse through the air from the syringe, for instance when air is expelled from the syringe during the dosing operation, or when the needle is extracted from the bottle of medicament. In the particularly important case where the medicament is an anticancer drug, the medical personnel coming into contact with the drug, or breathing it, during the preparation of the intravenous infusion set is exposed to a non negligible risk. The prolonged and repeated exposure to doses even extremely reduced of such substances may result in long term effects of the same kind as those borne by the patients. For some antineoplastic drugs, such as, e.g., cyclophosphamide, a carcinogenic activity has already been ascertained, while other drugs are still under evaluation in this respect.
Another case where the formation of drug-containing aerosols is particularly harmful is the case of antibiotics. In this case the active ingredient released in the environment may cause the development of resistance by the bacterial strains present therein. The foregoing may easily result in the development of infections difficult to overcome, specially in the hospital environment.
A further problem involved by the conventional operations of transfer and reconstitution of drugs by means of a syringe is the impossibility of maintaining a complete sterility in the manipulation. The micro-organisms present in the environment or on the operator's hands may come into contact with the needle, and from here they may be carried into the solution to be infused or injected to the patient. Since the said solution is injected directly in the patient's bloodstream, the foregoing involves a remarkable risk of infections, specially in view of the weakened conditions of the patient receiving such therapies.
In order to reduce to some extent the occurrence of the first one of the problems cited above, that is the formation of splashes and aerosols, some devices known as “vented spike” are already available on the market. Such devices are spikes provided with a hydrophobic filter that are placed between the syringe (without needle) and the container of medicinal product, serving as a port for the inlet and the outlet of air during the movements of the syringe plunger and, if desired, as a filter for the liquid transferred. The vented spike devices consist of a hollow spike suitable to perforate the stopper of a pharmaceutical container in the same way as a syringe, of an aperture for the passage of air, provided with a hydrophobic filter of a porosity suitable to prevent both the passage of aerosol toward the exterior and the passage of micro-organisms towards the interior, optionally of a filter placed on the liquid path and of a connector for a syringe.
Although they actually reduce the production of aerosols, the vented ;spike devices do not constitute systems completely isolated from the exterior, as they do not connect both vessels at the same time, and require that the device be removed from the first vessel in order to transfer the liquid to the second vessel. Therefore, the risk of contamination of the medicament still exists, and the risk that the operator comes into contact with the drug is still not totally avoided.
The PCT application publ. No. 96/29113, in the name of Medimop Medical Projects Ltd. et al., discloses a transfer device for medicinal fluids having at least three ports, one of which is connected with a syringe (also in this case, without needle). The device is provided with a plug cock, that may be rotated to establish fluid communication between two of the three ports, in turn. At least one of the three ports is provided with an adaptor for connection with the upper part of a bottle, said adaptor having a hollow spike.
In some of its embodiments, the said transfer device is designed to connect a syringe, previously filled in with diluting solution, a vial of medicament to be reconstituted and, on the third port, directly the patient to be treated. Other embodiments concern the connection of two medicinal containers (through the syringe), in order to obtain a closed system that allows the blending of two different liquid products through the syringe, without removing any one of the three elements up to the completion of the operation. Such device, according to the disclosure of the document, is designed so as to allow an antiseptic administration of the drug, as it prevents any contact of the latter and of the injectable or perfusional solution with the external environment for the whole blending and dosing operation, up to the administration to the patient.
In the embodiments providing the connection of two vessels, the device at issue is endowed with two opposedly placed housings for the head of two vials or bottles, each housing being provided with a hollow spike. Between the said two housings there is provided a valve assembly consisting of a three-way plug cock with the third port connected to a housing for the syringe tip After connecting the two vessels and the syringe to the device, the cock is positioned so as to put the syringe in communication with the bottle containing the perfusional solution or with the vial containing the injectable solution, and the solution is sucked into the syringe. Then the cock is rotated so as to connect the syringe with the bottle of medicament to be reconstituted, and the liquid is injected from the syringe in the bottle. Once diluted, the medicament is sucked from its bottle and, in the case of preparation of products to be administered by infusion, the cock is rotated so as to connect again the syringe with the bottle of perfusional solution and the diluted medicament is transferred from the syringe to the bottle of solution, to give the product ready for infusion.
The last one of the 29 figures accompanying the above PCT application shows an embodiment which takes into account (at least in part) that this series of operations, carried out in a closed system, requires the presence of some apertures for the passage of air.
Eurospital S.p.A.
Nixon & Vanderhye
Yasko John D.
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