Field of the Invention

The invention pertains to fluid control devices. Background of the Invention

Commonly owned US Patent No. 6,379,340 entitled Fluid Control Device to Zinger et al. discloses fluid control devices for use with a pair of medicinal vials and a needleless syringe for preparation of a liquid drug for aspiration to the needleless syringe for administration purposes (see Figures 23 to 28). The fluid control devices have a rigid T-shaped housing including an inline configuration of two opposite vial adapters for telescopic mounting on a pair of medicinal vials and a syringe port perpendicular thereto for receiving a needleless syringe. The vial adapters are formed with puncturing cannulas for puncturing a vial stopper on telescopic mounting on a medicinal vial. The syringe port is integrally formed with a flow control member manually rotatable between two operative positions for controlling flow communication between the two opposite vial adapters and the syringe port.

US Patent No. 6,379,340 Figures 23 to 25 disclose a fluid control device particularly suitable for use with medicinal vials containing a powdered drug under negative pressure. The fluid control device includes a flow control member having a semi- circular peripheral groove for enabling direct flow communication between its two opposite vial adapters for enabling negative pressure drawing of liquid contents from a medicinal vial containing liquid contents to a medicinal vial containing powdered drug contents under negative pressure for forming a liquid drug in the latter medicinal vial. The liquid contents can include diluent only or alternatively may include an active component. The flow control member also includes an L- shaped lumen for enabling operation of the needleless syringe to aspirate the liquid drug to the needleless syringe.

US Patent No. 6,379,340 Figures 26 and 27 disclose a fluid control device similar to the former fluid control device except without the semi-circular peripheral groove. The latter fluid control device requires additional steps of aspirating the liquid contents from the medicinal vial containing liquid contents to the needleless syringe and injecting the liquid contents to the medicinal vial containing powdered drug contents for forming a liquid drug ready for aspiration to the needleless syringe. The latter fluid control device is typically employed for medicinal vials containing liquid drug contents or powdered drug contents not under negative pressure.

In the case of US Patent No. 6,379,340 Figures 23 to 25 fluid control device, there may be insufficient negative pressure in a powdered drug medicinal vial to transfer the entire liquid contents from a liquid vial to the drug vial thereby leaving some liquid contents in the liquid vial. In the case of a liquid vial containing diluent only, this may lead to incorrect reconstitution of a powdered drug. In the case of a liquid vial containing liquid contents with an active component, this may lead to incorrect administration of a medication.

US Patent No. 6,379,340 Figures 23 to 28 fluid control devices are formed with integrally formed vial adapters suitable for use with either 13mm vials or 20 mm vials. Accordingly, fluid control devices with different size vial adapters are required to be commercially available. And furthermore, US Patent No. 6,379,340 Figures 23 to 28 fluid control devices require a user to hold a fluid control device in one hand and a needleless syringe in his other hand and operate the needleless syringe in a transverse direction to the fluid control device. Some professional users and particularly non-professional users may find such handling inconvenient and unintuitive. There is a need for a universal three way fluid control device to overcome the aforementioned disadvantages to replace the hitherto described fluid control devices and for use in other clinical applications. Summary of the Invention

The present invention is directed toward a universal three way fluid control device including a rigid L- shaped housing defining an imaginary plane and integrally formed with a first port and a syringe port for receiving a needleless syringe, a flow control member rotatable in the rigid-L- shaped housing about a rotation axis perpendicular to the imaginary plane, and a second port manually rotatable about the rotation axis in the imaginary plane for urging the flow control member to one of three operative positions including a first operative position for inline flow communication between the first port and the second port, a second operative position for inline flow communication between the syringe port and the second port and a third operative position between the first operative position and the second operative position for flow communication between the first port and the syringe port. In accordance with one preferred embodiment of the present invention, one port is preferably formed with a male connector and the other port is preferably formed with a female connector to discriminate between the ports for clinical applications in which order of connection to the ports is important. Alternatively, the first and second ports can be differently colored, marked, and the like. In accordance with another preferred embodiment of the present invention, the ports are configured as integrally formed vial adapters for telescopic mounting on vials for flow communication therewith.

Brief Description of the Drawings

In order to understand the invention and to see how it can be carried out in practice, preferred embodiments will now be described, by way of non-limiting examples only, with reference to the accompanying drawings, in which similar parts are likewise numbered, and in which:

Fig. 1 is a perspective view of a first preferred embodiment of a universal three way fluid control device;

Fig. 2 A is an exploded view of the fluid control device;

Fig. 2B is another exploded view of the fluid control device;

Fig. 2C is a front view of a flow control member of the fluid control device;

Fig. 3 is a front perspective view of the fluid control device in a first operative position for inline flow communication between the first port and the second port;

Fig. 4 is a longitudinal cross section of the fluid control device along line A- A in Figure 3;

Fig. 5 is a front perspective view of the fluid control device in a second operative position for inline flow communication between the second port and the syringe port;

Fig. 6 is a longitudinal cross section of the fluid control device along line B-B in Figure 5;

Fig. 7 is a front perspective view of the fluid control device in a third operative position for flow communication between the first port and the syringe port;

Fig. 8 is a longitudinal cross section of the fluid control device along line C-C in Figure 7;

Figure 9 is a pictorial view of a kit including the universal three way fluid control device, a drug vial adapter, a liquid vial adapter, a drug vial, a liquid vial, and a needleless syringe for preparing the needleless syringe with a liquid drug ready for administration purposes;

Figs. 10A to 10J show the use of the Figure 9 kit for preparing the needleless syringe with a liquid drug for administration purposes; Fig. 11 is a side view of a second preferred embodiment of a universal three way fluid control device in its third operative position and connected with a drug vial, a liquid vial and a needleless syringe; and

Fig. 12 is a side view of a third preferred embodiment of a universal three way fluid control device in its third operative position and connected with a drug vial, a liquid vial and a needleless syringe.

Detailed Description of the Drawings

Figures 1 to 8 show a universal three way fluid control device 100 including a rigid L-shaped housing 101 defining an imaginary plane. The L- shaped housing 101 includes a tubular manifold 102 with a longitudinal manifold axis 102A perpendicular to the L-shaped housing's imaginary plane. The manifold 102 includes a peripheral manifold wall 103 and opposite manifold end faces 104 A and 104B. The manifold 102 is integrally formed with a first port 106 and a syringe port 107 for receiving a needleless syringe. The first port 106 is preferably formed with a female connector 108 for sealingly receiving a male connector. The syringe port 107 is preferably formed with a female connector 109 for sealingly receiving a male connector. The female connectors 108 and 109 are preferably formed as female Luer connectors.

The manifold wall 103 is formed with a generally quarter turn throughgoing slot 111 at the opposite side to the first port 106 and the syringe port 107. The throughgoing slot 111 has a first slot end 111 A opposite the first port 106 and a second slot end 11 IB opposite the syringe port 107. The manifold wall 103 is formed with a first throughgoing bore 112 opposite the first slot end 111 A and in flow communication with the first port 106. The manifold wall 103 is formed with a second throughgoing bore 113 opposite the second slot end 11 IB and in flow communication with the syringe port 107.

The manifold end faces 104 A and 104B are each formed with a first indent 114 in line with the first throughgoing bore 112. The manifold end faces 104 A and 104B are each formed with a second indent 116 in line with the second throughgoing bore 113. The manifold end faces 104 A and 104B are each formed with a third indent 117 intermediate their first indent 114 and second indent 116.

The fluid control device 100 includes a solid flow control member 118 rotatable in the L-shaped housing 101 about a rotation axis 119 co-axial with longitudinal manifold axis 102 A. The flow control member 118 has a peripheral surface 121 and includes a diametrical lumen 122 defining a transverse plane to the rotation axis 119. The lumen 122 has a stepped diameter includes a major wide diameter section 122 A and a minor small diameter section 122B. The flow control member 121 includes a curved channel 123 formed in the peripheral surface 121. The channel 123 has a first channel end 123 A and a second channel end 123B in the same transverse plane as the lumen 122. The channel ends 123 A and 123B are equi-distanced from the minor small diameter section 122B and are separated by a quarter turn.

The fluid control device 100 includes a second port 124 preferably formed with a male connector 126 for sealing insertion in a female connector. The male connector 126 is preferably formed as a male Luer lock connector. The second port 124 includes a tubular extension 127 extending through the throughgoing slot 111 into the major wide diameter section 122 A. The second port 124 is formed with a pair of downward depending supports 128 generally co-extensive with the extension 127. The supports 128 are each formed with an inward directed projection 129 for click fit insertion into indent pairs 114, 116 and 117.

The second port 124 is rotatable about the rotation axis 119 in the L- shaped housing 101 's imaginary plane for urging the flow control member 118 into one of three operative positions as follows:

Figures 3 and 4 show a first operative position for inline flow communication between the first port 106 and the second port 124. In this operative position, the projection pair 129 is disposed at the indent pair 114, the extension 127 is disposed at the first slot end 111 A and the lumen 122 is in flow communication with the bore 112.

Figures 5 and 6 show a second operative position for inline flow communication between the syringe port 107 and the second port 124. In this operative position, the projection pair 129 is disposed at the indent pair 116, the extension 123 is disposed at the second slot end 11 IB and the lumen 122 is in flow communication with the bore 113.

Figures 7 and 8 show a third operative position between the first operative position and the second operative position for flow communication between the first port 106 and the syringe port 107. In this operative position, the projection pair 129 is disposed at the indent pair 117, and the channel end 123 A is disposed at the bore 112 and the channel end 123B is disposed at the bore 113.

Figure 9 shows a kit 200 including the universal three way fluid control device 100, a drug vial 210, a liquid vial 220, a needleless syringe 230, a male vial adapter 240 and a female vial adapter 250 for preparing the needleless syringe 230 with a liquid drug for administration purposes similar to aforementioned US Patent No. 6,379,340 Figures 23 to 28 fluid control devices.

The drug vial 210 has a longitudinal drug vial axis 21 OA and includes a drug vial bottle 211 having a drug vial opening 212 sealed by a drug vial stopper 213. The drug vial 210 contains a drug component 214 under negative pressure. The liquid vial 220 has a longitudinal drug vial axis 220A and includes a liquid vial bottle 221 having a liquid vial opening 222 sealed by a liquid vial stopper 223. The liquid vial 220 is filled with a liquid component 224. The liquid component 224 can be diluent only. Alternatively, the liquid component 224 can include an active component. The syringe 230 includes a barrel 231 with a plunger 232 and a male connector 233. The male connector 233 is preferably a male Luer lock connector.

The male vial adapter 240 includes a male connector 241 in flow communication with a puncturing cannula 242 for puncturing the liquid vial stopper 223 on telescopic mounting on the liquid vial 220. The male connector 241 is intended to sealingly mount on the first port 106. The male connector 241 is preferably a male Luer lock connector.

The female vial adapter 250 includes a female connector 251 in flow communication with a puncturing cannula 252 for puncturing the drug vial stopper 213 on telescopic mounting on the drug vial 210. The female connector 251 is intended to sealingly mount on the second port 124. The female connector 251 is preferably a female Luer connector.

The drug vial 210 and the female vial adapter 250 are preferably colored in one color and the liquid vial 220 and the male vial adapter 240 are preferably colored in a different color to assist a user to use the kit 200.

The use of the kit 200 is now described with reference to Figures 10A to 10J as follows:

Figure 10A shows the fluid control device 100 assembled with male vial adapter 240 mounted on the first port 106 and the female vial adapter mounted on the second port 124. The fluid control device 100 is in its first operative position disposed above a liquid vial 220 prior to its male vial adapter 240 being telescopically mounted on the liquid vial 220 as denoted by arrow A.

Figure 10B shows the male vial adapter 240 telescopically mounted on the liquid vial 220.

Figure IOC shows the fluid control device 100 inverted with respect to Figure 10B and disposed above a drug vial 210 prior to its female vial adapter 250 being telescopically mounted on the drug vial 210 as denoted by arrow B.

Figure 10D shows the most but not all the liquid contents of the liquid vial 220 drawn into the drug vial 210 for mixing with the drug component to form a liquid drug LD in the drug vial 210.

Figure 10E shows a 45° clockwise rotation of the second port 124 relative to Figure 10D as denoted by arrow C to urge the fluid control device 100 into its third operative position for flow communication between the first port 106 and the syringe port 107. The plunger 232 is retracted before screw threading the needleless syringe 230 on the syringe port 107.

Figure 10F shows injection of air from the syringe 230 into the liquid vial 220 as denoted by arrow D to pressurize the liquid vial 220.

Figure 10G shows aspiration of the liquid contents remaining in the liquid vial 220 into the syringe 230 as denoted by arrow E.

Figure 10H shows a further 45° clockwise rotation of the second port 124 relative to Figure 10G as denoted by arrow E to urge the fluid control device 100 into its second operative position for flow communication between the syringe port 107 and the second port 124. The liquid contents in the syringe 230 are injected into the drug vial 210 as denoted by arrow F such that the drug vial 210 contains the entire liquid contents of the liquid vial 220.

Figure 101 shows inversion of the assemblage to enable inline aspiration of the liquid drug LD from the drug vial 210 to the syringe 230 ready for aspiration purposes as denoted by arrow G in Figure 10J.

Figure 11 shows a universal three way fluid control device 300 similar in construction and operation as the fluid control device 100. The former 300 differs from the latter 100 insofar as the former 300 includes integrally formed puncturing cannulas 301 and 302 correspondingly for use with a drug vial 210 and a liquid vial 220 for flow communication therewith. The fluid control device 300 is shown in its third operative position for flow communication between the syringe 230 and the liquid vial 220.

Figure 12 shows a universal three way fluid control device 400 similar in construction and operation as the fluid control device 100. The former 400 differs from the latter 100 insofar as the former 400 includes integrally formed vial adapters 401 and 402 correspondingly for use with a drug vial 210 and a liquid vial 220 for flow communication therewith. The fluid control device 400 is shown in its third operative position for flow communication between the syringe 230 and the liquid vial 220. While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications, and other applications of the invention can be made within the scope of the appended claims.