Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-09-17
2001-05-29
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S027000, C604S032000, C604S411000
Reexamination Certificate
active
06238372
ABSTRACT:
This is a CIP of U.S. Application 08/499,213 filed Jul. 7, 1995, now abandoned, which is a CIP of 08/407,287 filed Mar. 20, 1995, now abandoned.
FIELD OF THE INVENTION
The invention relates to fluid control devices in general and in particular to fluid control devices adapted for facilitating the aseptic administration of drugs to patients.
BACKGROUND OF THE INVENTION
Drugs intended for parenteral administration are typically stored in a medicinal vessel either as a dry powder or as a solution. The solution can be ready for immediate use or in the form of a liquid concentrate which requires reconstitution with a physiological solution prior to administration in a similar manner to a dry powder drug. The physiological solution can be provided in a pre-filled syringe or a medicinal vessel.
Medicinal vessels typically fall into one of three categories. The first type is a vial or a glass bottle closed by a rubber stopper which can be penetrated by a puncturing tool, for example, a needle, and which is self-closing upon withdrawal of the puncturing tool. Such a vial or glass bottle can contain a single dose or a multiple dose of a drug. The drug contained in a vial can be under a high vacuum. The second type is an ampoule whose top portion is broken off enabling access to its contents. The third type is an IV bag provided with a sample port for enabling access to its contents. The sample port can be of the pre-slit septum type.
Regardless of the manner in which a drug is stored, there is a need to transfer fluid under sterile conditions before its administration to a patient by a dispensing tool be it a needle, a pre-slit septum, or the like. When a prior dilution of a drug is required, the process requires at least two fluid transfers. The problem of ensuring proper fluid transfer under aseptic conditions is especially acute in the case of self-administration of drugs by patients in their homes.
Assemblies which have hitherto been proposed for the aseptic administration of drugs are described in U.S. Pat. Nos: Des. 271,421, 3,618,637, 3,757,981, 3,826,261, 3,957,052, 3,977,555, 3,993,063, 4,051,852, 4,564,054, 4,604,093, 4,721,133, 4,758,235, 4,967,797, 4,997,430, 5,201,705, 5,269,768, 5,279,576, 5,288,290, 5,334,163, and 5,466,220, and European Publication Nos: 0 258 913 A2, 0 195 018 B1, 0 192 661 B1, and 0 416 454 B1.
In particular, EP 0 521 460 B1 describes a fluid control device for use with a syringe and a pair of medicinal vessels. The fluid control device includes a housing with a Luer-connector port for receiving the syringe and second and third ports each comprising an adaptor having a fluid conduit member extending into the interior of a medicinal vessel when attached thereto. In the housing, a flow control member is slidingly displaceable from a first flow control position enabling a flow path between the two medicinal vessels when connected and a second flow control position enabling a flow path between one of the medicinal vessels and the syringe.
SUMMARY OF THE INVENTION
The object of the invention is to provide fluid control devices enabling the aseptic administration of drugs.
In accordance with the invention, there is provided a fluid control device for use with a syringe and at least one medicinal vessel, the fluid control device comprising:
(a) a first port;
(b) a second port for receiving the syringe;
(c) a third port comprising an adaptor having a fluid conduit member extending into the interior of the medicinal vessel when attached thereto; and
(d) a flow control member selectively disposable from a first flow control position enabling a flow path between a first pair of two ports and a second flow control position enabling a flow path between a second pair of two ports, said flow control member being coupled to one of said ports for manipulation between said flow control positions.
In accordance with the teachings of the present invention, there is provided a family of fluid control devices which are adapted for the aseptic administration of drugs either directly or indirectly to a patient. The selection of the most suitable fluid control device depends on the type of drug to be administered to a patient, the manner in which it is packaged, the manner in which it is to be administered to a patient and by whom apart from other factors. Some of the devices are designed to enable the reconstitution of a drug provided in a powder form or as a liquid concentrate. Some of the devices are suited for vials or ampoules containing a single dose of a drug whilst others are suited for vials or IV bags containing multiple doses.
In a preferred embodiment of a fluid control device, the flow control member is rotatably mounted in a body member so as to be selectively rotatable between its first flow control position and its second flow control position.
In a preferred embodiment of a fluid control device, the first port is adapted for dispensing a drug directly or indirectly to a patient and, as such, it can be provided with a needle, it can be fashioned as a male Luer connector on which a needle can be mounted or it can be fashioned as a plastic cannula for insertion into a pre-slit septum. In such an embodiment, the adaptor is preferably coupled to a flow control member adapted for rotation in a body member having the port adapted for receiving a syringe and the dispensing port.
The adaptor can be integrally formed with the flow control member and designed so as to readily broken off therefrom after rotation of the flow control member from its first flow control position to its second flow control position. Alternatively, the adaptor can be detachably engaged to the flow control member by means of an interengaging means enabling axial detachment of the adaptor from the body member on a relative rotation therebetween to a position which urges the flow control member from its first flow control position to its second flow control position.
In a preferred embodiment of a fluid control device suitable for use with drugs which require reconstitution, the fluid control device includes a fourth port in the form of an adaptor for enabling the attachment of a second medicinal vessel to the body member..
In a preferred embodiment of a fluid control device, the first port is also provided with an adaptor adapted for attachment thereto of a medicinal vessel and, in this case, the port adapted for receiving the syringe is rotatably coupled to the flow control member.
In each case, the adaptor can be adapted for attachment thereto of a vial, an ampoule or an IV bag, the former requiring that the fluid conduit member be formed as a puncturing tool for piercing the vial's rubber stopper on its attachment thereto. In the case of attachment of an ampoule, because the ampoule cannot be inverted, the fluid conduit member is required to be provided as a long straw to enable all or nearly all of its contents to be aspirated therefrom.
The adaptor can also include a conduit for venting the vessel when attached thereto. The conduit can include a filter for filtering the air traversing therethrough. The filter can be deployed within a lateral cavity provided within the adaptor or, alternately, the filter can be provided as a discrete element exterior to the fluid control device.
REFERENCES:
patent: 4253501 (1981-03-01), Ogle
patent: 4638975 (1987-01-01), Iuchi et al.
patent: 4997430 (1991-03-01), Van Der Heiden et al.
patent: 5104387 (1992-04-01), Pokorney et al.
patent: 5288290 (1994-02-01), Brody
patent: 5334163 (1994-08-01), Sinnett
patent: 0521460 (1993-01-01), None
Denenburg Igor
Zinger Fredy
Kennedy Sharon
Ladas & Parry
Maynard Jennifer
Medimop Medical Projects Ltd.
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