FLUID TRANSFSER DEVICE
A fluid ducting assembly for enabling flow communication between a syringe and either one of a vessel and a dispenser for dispensing a fluid contained, a priori in the syringe or in the vessel. The fluid ducting assembly includes a base having a first member, a second member, and a third member for connection to and providing flow communication with the syringe, the vessel and the dispenser, respectively. The fluid ducting assembly further includes a flow controller within the base enabling any one of a flow path between the first member and the second member and a flow path between the first member and the third member. The flow controller has either a first operative position in which the flow path between the first member and the second member is enabled or a second operative position in which the flow path between the first member and the third member is enabled. The flow controller being readily switchable from its first operative position to its second operative position but not readily switchable from its second operative position to its first operative position.
This is a Continuation-In-Part Application of co-pending U.S. Ser. No. 09/633,056 filed Aug. 8, 2000 which is a Divisional Application of U.S. Ser. No. 08/913,342 now U.S. Pat. No. 6,238,372B1.
BACKGROUND OF THE INVENTION1. Field of the Invention
2. Discussion of the Prior Art
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. No. Des. 271,421, U.S. Pat. Nos. 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 INVENTIONThe 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 he 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.
BRIEF DESCRIPTION OF THE DRAWINGSFor a better understanding of the present invention and to show how the same may be carried out in practice, and solely by way of non-limiting examples, reference will now be made to the accompanying
drawings, in which:
As shown in
The fluid control device 10 further includes an integrally formed adaptor and flow control member, generally designated 20, for insertion into the bore 17 in which it is restrained therein by means of a peripherally formed groove 22 designed for receiving the flange 18 therein. The flow control member 20′ is formed with two flow ducts as follows: A first flow duct 23 (see
In addition, the flow control member 20′ is provided with a minor peripheral abutment wall portion 26′ protruding radially outward relative to its major peripheral wall portion 26″ (see
The adaptor 20″ is shown to be adapted for the attachment thereto of a vial 28 (not drawn to size) provided with a rubber stopper 29. As such, the fluid conduit member 24 is fashioned as a puncturing tool 30 for penetrating a rubber stopper 29 on attachment of a vial 28 to its adaptor 20″. Alternatively, the adaptor 20″ can be adapted for the attachment thereto of an ampoule 31 (not drawn to size), the difference. being that such an adaptor will preferably have relatively long springy grips.
Each stage of the two stage operation of the fluid control device 10 for the administration of a drug provided in powder form for dilution with a physiological solution provided in a pre-filled syringe is now described with reference to
As shown in
In this arrangement, a pre-filled syringe 32 is inserted into the port 12 and the vial 28 is attached to the adaptor 20″ by means of which action, the puncturing tool 30 punctures the vial's rubber stopper 29, thereby enabling flow communication with its interior via the fluid conduit member 24. Typically, the syringe 32 requires actuation for expressing its contents into the vial 28 while in some cases, if the contents of the vial 28 are under vacuum, then the physiological solution of the syringe 32 can be sucked into the vial without user intervention. Thereafter, the contents of the vial 28 are shaken so as to reconstitute the powdered drug. The fluid control device 10 together with the vial 28 are then preferably inverted and the syringe 32 is aspirated so as to draw the reconstituted liquid drug thereinto.
Turning now to
It can be readily appreciated that the advantage. of this design over the design of the fluid control device 34 while retaining all the advantages of the latter resides in the fact that the former is reusable after sterilization while the latter can only be used once due to the destruction of the adaptor cum flow control member 35.
A further difference between the fluid control devices 40 and 10 resides in the fact the former includes a dispensing port 13 provided with a needle 47.
The main difference between the two fluid control devices 48 and 41 resides in the fact that the former includes a flow control member 49 which is required to be rotated through a 180° turn between its first flow control position (see
Turning now to
The main difference between the two fluid control devices 64 and 41 resides in the fact that the former is adapted to be fitted with two medicinal vessels and, as such, its base member 11 is provided with a port 12, a dispensing port 13 and two bores 17A and 17B which are interconnected by a channel 65. As shown, the medicinal vessels are vials 28A and 29B where the vial 28A contains the powdered drug and the vial 28B contains the physiological solution for diluting the powdered drug. As explained in greater detail hereinbelow for the case when the vial 28A has its contents under high vacuum, the sequence and order of the attachment of the vials 28A and 28B to the adapters 41A and 41B is not arbitrary.
In this case, the flow control member 42A has a first flow control position in which its L-shaped flow duct 23A registers in flow communication with the channel 65 and a medicinal vessel attached to its adaptor 41A (see
The operation of the fluid control device 64 for the administration of a powder drug provided in the pressurized vial 28A after reconstitution with a physiological solution provided in the vial 28B is now described. First, as shown in
The base member 68 includes two adapters 78 and 79 which are adapted for the attachment thereto of medicinal vessels. In this case, the adapters 78 and 79 are adapted for the attachment thereto of vials and, as such, they include respective co-axial fluid conduit members 78′ and 79′ fashioned as piercing tools for puncturing the vials' rubber stoppers. The fluid conduit members 78′ and 79′ have respective internal apertures 78″ and 79″.
The flow control member 72 is rotatably mounted for enabling either, in a first flow control position, a flow path between vials attached to the adapters 78 and 79 or, in a second flow control position, a flow path between a syringe and one of the vials. As such, in a similar manner to the flow control member 20′ (see
The operation of the fluid control device 67 is now described with reference to the steps depicted in
The fluid control device 67 is typically provided in a hermetically sealed package with its flow control member 72 set so as to enable the flow path between flow conduit members 78′ and 79′ by means of the ends 80′ and 80″ of its semi-circular groove 80 registering with their interior openings 78″ and 79″ (
The syringe 74 is inserted into the port 73 (
The difference between the flow control member 85 and 72 being that a fluid control device 67 fitted with the former can be employed with medicinal vessels in which their contents are under a low vacuum or no vacuum, thereby requiring user intervention to perform the mixing of the powder drug with the physiological solution. In particular, the flow control member 85 is suitable for use with a fluid control device 67 having an adaptor suitable for connection to an IV bag such that on setting the flow control member 85 in its first operative position, the syringe 74 is aspirated so as to introduce a predetermined volume of diluent solution thereinto. Thereafter, on setting the flow control member 85 into its second operative position, the syringe 74 is actuated so as to introduce the diluent solution into a second medicinal vessel containing the drug to be reconstituted. After mixing of the drug with the diluent solution, the syringe 74 is aspirated a second time so as to introduce the medicinal liquid thereinto at which time the syringe 74 is removed for administration of the drug to a patient. In this fashion, such a fluid control device can be used a number of times with one or more medicinal vessels.
Referring next to
The skirt 106 of the adapter component is of a unique configuration and includes a generally cylindrical body portion 106a, an angularly outwardly extending marginal portion 106b and an angularly inwardly extending intermediate portion 106c that is disposed between body portion 106a and marginal portion 106b. This important intermediate portion 106c comprises a circumferentially extending protuberance 106d that functions to releasably grip the neck portion of bottle 28. As in the earlier described adapter constructions, the adapter of the present form of the invention is provided with a plurality of circumferentially spaced slits 110 that permit the skirt portion to flex sufficiently to enable it to be expediciously snapped over the neck portion of the bottle.
Adapter 100 also includes a connector portion 112 that is connected to top wall 102 and extends outwardly therefrom in the manner shown in
Referring particularly to
Referring to
As in the earlier described embodiments, this later form of adapter component is constructed of plastic and includes a skirt 128 that extends from top wall 122. Skirt 128 has a generally cylindrically shaped portion 128a and an outwardly extending marginal portion 128b. Skirt 128 also has an intermediate portion 128c that includes a circumferentially extending protuberance 128d that functions in the manner previously described to releasably grip the neck portion of the vial or drug bottle.
As indicated in the drawings, filter 126 is mounted within a chamber 130 formed in top wall 122 of the adapter. With this construction, during the vial filling step, displaced air can flow from the interior of the bottle through lumen 120b in the direction of the arrow 132 toward a disk filter 134, around lumen 120a, through a passageway 136 in the direction of arrow 138 (
Having now described the invention in detail in accordance with the requirements of the patent statutes, those skilled in this art will have no difficulty in making changes and modifications in the individual parts or their relative assembly in order to meet specific requirements or conditions. Such changes and modifications may be made without departing from the scope and spirit of the invention, as set forth in the following claims.
Claims
1. A fluid control device for use with a vial having a container portion; an upper, generally cylindrically shaped portion; and an intermediate neck portion, for delivering the contents of the vial to a patient, the fluid control device including an adapter for interconnection with the vial, said adapter comprising:
- (a) a top wall; and
- (b) a resiliently deformable skirt connected to said wall and extending therefrom for telescopically receiving the upper portion of the vial, said skirt having: (i) a generally cylindrical body portion; (ii) an angularly outwardly extending marginal portion; and (iii) an angularly inwardly extending intermediate portion disposed between said body portion and said outwardly extending intermediate portion for releasably gripping the vial.
2. The device as defined in claim 1 in which said adapter further includes a cannula connected to said top wall and extending into said skirt.
3. The device as defined in claim 1 in which said skirt is provided with a plurality of circumferentially spaced slits.
4. The device as defined in claim 1 in which said intermediate portion comprises a circumferentially extending protuberance formed intermediate said body portion and said angularly outwardly extending marginal portion.
5. The device as defined in claim 1 in which said adapter further includes a connector portion connected to said top wall and filter means for filtering the fluid within the vial, said filter means being carried by said connector portion.
6. The device as defined in claim 1 in which said adapter further includes venting means for providing an air passageway between the interior of the vial and atmosphere.
7. A fluid control device for use with a vial having a container portion; an upper, generally cylindrically shaped portion; and an intermediate neck portion, for delivering the contents of the vial to a patient, the fluid control device including an adapter for interconnection with the vial, said adapter comprising:
- (a) a top wall; and
- (b) a resiliently deformable skirt connected to said wall and extending therefrom for telescopically receiving the upper portion of the vial, said skirt having: (i) a generally cylindrical body portion; (ii) an angularly outwardly extending marginal portion; and (iii) an angularly inwardly extending intermediate portion disposed between said body portion and said outwardly extending intermediate portion for releasably gripping the vial;
- (c) a cannula connected to said top wall and extending into said skirt; and
- (d) a connector portion connected to said top wall and extending therefrom for connecting tubing to said adapter.
8. The device as defined in claim 7 in which said adapter portion includes a tapered bore having a cavity formed therein and further includes a filter disposed within said cavity.
9. The device as defined in claim 7 in which said cannula includes first and second spaced apart lumens, said second lumen defining a venting passageway for permitting the flow of air between the interior of the vial and the exterior thereof.
10. The device as defined in claim 9 further including filter means carried by said top wall for filtering air flowing toward the exterior of the vial.
11. The device as defined in claim 9 in which said filter means comprises a filter that permits the flow of liquid therethrough, but prevents the flow of air therethrough.
12. The device as defined in claim 9 in which said skirt is provided with a plurality of circumferentially spaced slits.
13. A fluid control device for use with a vial containing a lypholized drug for mixing the lypholized drug with a diluent, the vial having a generally cylindrically shaped top portion, a body portion and an intermediate neck portion, said fluid control device comprising an adapter receivable over the top portion of the vial, said adapter comprising:
- (a) a top;
- (b) a resiliently deformable skirt integrally formed with said top and extending therefrom, said skirt including: (i) a body portion (ii) an outwardly extending marginal portion; (iii) an inwardly extending intermediate portion located between said body portion and said marginal portion for releasably gripping the vial; and
- (c) a hollow cannula connected to said top wall and extending into said skirt.
14. The device as defined in claim 13 in which said skirt portion of said adapter is provided with at least two circumferentially spaced slits.
15. The device as defined in claim 16 in which said adapter is molded in a single piece from a moldable plastic.
16. The device as defined in claim 13 in which said adapter further includes a connector portion connected to said top wall and extending therefrom.
17. The device as defined in claim 16 in which said connector portion includes a tapered bore having an upper portion having an inwardly tapering wall and a lower portion having an outwardly tapering wall.
18. The device as defined in claim 17 further including filter means disposed within said lower portion of said tapered bore for filtering fluid flowing through said tapered bore.
19. The device as defined in claim 16 in which said cannula includes first and second spaced apart lumens, said second lumen defining a venting passageway for permitting the flow of air between the interior of the vial and the exterior thereof.
20. The device as defined in claim 19 further including filter means carried by said top wall for filtering air flowing toward the exerior of the vial.
Type: Application
Filed: Jan 31, 2002
Publication Date: Nov 22, 2007
Patent Grant number: 7326194
Inventors: Freddy Zinger (Ra'anana), Igor Denenburg (Rehovot)
Application Number: 10/062,796
International Classification: A61M 25/00 (20060101);