Drug vial adapter assemblages including vented drug vial adapter and vented liquid vial adapter

10765604 ยท 2020-09-08

Assignee

Inventors

Cpc classification

International classification

Abstract

Dual vial adapter assemblage for use with a drug vial and a liquid vial and including a vented drug vial adapter and a vented liquid vial adapter such that simultaneous venting of the liquid vial and the drug vial assists gravitational flow of liquid contents from the liquid vial into the drug vial for forming liquid drug therein.

Claims

1. A dual vial adapter assemblage for use with a drug vial, a liquid vial and a needleless syringe, the drug vial having a drug vial bottle and a drug vial stopper sealing the drug vial bottle, the drug vial containing a medicament, the liquid vial having a liquid vial bottle and a liquid vial stopper sealing the liquid vial bottle, the liquid vial containing liquid contents for mixing with or reconstituting the medicament in the drug vial to form a liquid drug therein, the needleless syringe being empty, the dual vial adapter assemblage having a longitudinal dual vial adapter assemblage centerline and comprising: a vented drug vial adapter having a longitudinal drug vial adapter centerline and including a transverse drug vial adapter top wall with an upright drug vial adapter connector, an oppositely directed drug vial adapter skirt for telescopic mounting on the drug vial, and a dual lumen drug vial stopper puncturing cannula for puncturing the drug vial stopper on said telescopic mounting of said vented drug vial adapter on the drug vial, said dual lumen drug vial stopper puncturing cannula having i) a liquid lumen in flow communication with said drug vial adapter connector and ii) a vented air lumen openly vented to the ambient surroundings; and a vented liquid vial adapter having a longitudinal liquid vial adapter centerline and including a transverse liquid vial adapter top wall with an upright liquid vial adapter connector, an oppositely directed liquid vial adapter skirt for telescopic mounting on the liquid vial, and a dual lumen liquid vial stopper puncturing cannula for puncturing the liquid vial stopper on said telescopic mounting of said vented liquid vial adapter on the liquid vial, said dual lumen liquid vial stopper puncturing cannula having i) a liquid lumen in flow communication with said liquid vial adapter connector and ii) a vented air lumen openly vented to the ambient surroundings, the vented drug vial adapter and the vented liquid vial adapter being formed as discrete components, at least one of said dual lumen drug vial stopper puncturing cannula and said dual lumen liquid vial stopper puncturing cannula further comprising a tip located on the longitudinal drug vial adapter centerline or the longitudinal liquid vial adapter centerline, the arrangement being such that in a set-up position of the dual vial adapter assemblage in which said drug vial adapter connector is connected to, and in flow communication with said liquid vial adapter connector, on initial telescopic mounting of said vented liquid vial adapter on the liquid vial and said vented drug vial adapter on the drug vial, said liquid lumen of said vented drug vial adapter and said liquid lumen of said vented liquid vial adapter collectively define a nonrectilinear fluid flow path from said liquid vial to said drug vial, and subsequent disposing of the liquid vial above the drug vial leads to gravitational flow of liquid contents from the liquid vial to the drug vial for forming the liquid drug therein assisted by simultaneous venting of the liquid vial by drawing ambient air thereinto through said dual lumen liquid vial stopper puncturing cannula's vented air lumen and the drug vial by expelling air therefrom through said dual lumen drug vial stopper puncturing cannula's vented air lumen to the ambient surroundings, the drug vial adapter being detachable from the liquid vial adapter for providing access to the drug vial adapter connector for enabling connection of the empty needleless syringe thereto for aspiring a liquid drug dosage from the drug vial for administration to a patient.

2. The assemblage according to claim 1 wherein said liquid vial adapter connector is a male connector and said drug vial adapter connector is a female connector for direct sealed engagement with said male connector.

3. A dual vial adapter assemblage for use with a drug vial, a liquid vial and a needleless syringe, the drug vial having a drug vial bottle and a drug vial stopper sealing the drug vial bottle, the drug vial containing a medicament, the liquid vial having a liquid vial bottle and a liquid vial stopper sealing the liquid vial bottle, the liquid vial containing liquid contents for mixing with or reconstituting the medicament in the drug vial to form a liquid drug therein, the needleless syringe being empty, the dual vial adapter assemblage having a longitudinal dual vial adapter assemblage centerline and comprising: a vented drug vial adapter having a longitudinal drug vial adapter centerline and including a transverse drug vial adapter top wall with an upright drug vial adapter connector, an oppositely directed drug vial adapter skirt for telescopic mounting on the drug vial, and a dual lumen drug vial stopper puncturing cannula for puncturing the drug vial stopper on said telescopic mounting of said vented drug vial adapter on the drug vial, said dual lumen drug vial stopper puncturing cannula having i) a liquid lumen in flow communication with said drug vial adapter connector and ii) a vented air lumen openly vented to the ambient surroundings; and a vented liquid vial adapter having a longitudinal liquid vial adapter centerline and including a transverse liquid vial adapter top wall with an upright liquid vial adapter connector, an oppositely directed liquid vial adapter skirt for telescopic mounting on the liquid vial, and a dual lumen liquid vial stopper puncturing cannula for puncturing the liquid vial stopper on said telescopic mounting of said vented liquid vial adapter on the liquid vial, said dual lumen liquid vial stopper puncturing cannula having i) a liquid lumen in flow communication with said liquid vial adapter connector and ii) a vented air lumen openly vented to the ambient surroundings, the vented drug vial adapter and the vented liquid vial adapter being formed as discrete components, at least one of said dual lumen drug vial stopper puncturing cannula and said dual lumen liquid vial stopper puncturing cannula further comprising a tip located on the longitudinal drug vial adapter centerline or the longitudinal liquid vial adapter centerline, the arrangement being such that in a set-up position of the dual vial adapter assemblage in which said drug vial adapter connector is connected to, and in flow communication with said liquid vial adapter connector, on initial telescopic mounting of said vented liquid vial adapter on the liquid vial and said vented drug vial adapter on the drug vial, subsequent disposing of the liquid vial above the drug vial leads to gravitational flow of liquid contents from the liquid vial to the drug vial for forming the liquid drug therein assisted by simultaneous venting of the liquid vial by drawing ambient air thereinto through said dual lumen liquid vial stopper puncturing cannula's vented air lumen and the drug vial by expelling air therefrom through said dual lumen drug vial stopper puncturing cannula's vented air lumen to the ambient surroundings, the drug vial adapter being detachable from the liquid vial adapter for providing access to the drug vial adapter connector for enabling connection of the empty needleless syringe thereto for aspiring a liquid drug dosage from the drug vial for administration to a patient, wherein each of said liquid vial adapter connector and said drug vial adapter connector is a female connector and the dual vial adapter assemblage further comprises a dual ended liquid transfer coupler having a pair of opposite coupler ends in the form of male connectors for sealed engagement with said liquid vial adapter connector and said drug vial adapter connector in said set-up position.

4. A dual vial adapter assemblage for use with a drug vial, a liquid vial and a needleless syringe, the drug vial having a drug vial bottle and a drug vial stopper sealing the drug vial bottle, the drug vial containing a medicament, the liquid vial having a liquid vial bottle and a liquid vial stopper sealing the liquid vial bottle, the liquid vial containing liquid contents for mixing with or reconstituting the medicament in the drug vial to form a liquid drug therein, the needleless syringe being empty, the dual vial adapter assemblage having a longitudinal dual vial adapter assemblage centerline and comprising: a vented drug vial adapter having a longitudinal drug vial adapter centerline and including a transverse drug vial adapter top wall with an upright drug vial adapter connector, an oppositely directed drug vial adapter skirt for telescopic mounting on the drug vial, and a dual lumen drug vial stopper puncturing cannula for puncturing the drug vial stopper on said telescopic mounting of said vented drug vial adapter on the drug vial, said dual lumen drug vial stopper puncturing cannula having i) a liquid lumen in flow communication with said drug vial adapter connector and ii) a vented air lumen openly vented to the ambient surroundings; and a vented liquid vial adapter having a longitudinal liquid vial adapter centerline and including a transverse liquid vial adapter top wall with an upright liquid vial adapter connector, an oppositely directed liquid vial adapter skirt for telescopic mounting on the liquid vial, and a dual lumen liquid vial stopper puncturing cannula for puncturing the liquid vial stopper on said telescopic mounting of said vented liquid vial adapter on the liquid vial, said dual lumen liquid vial stopper puncturing cannula having i) a liquid lumen in flow communication with said liquid vial adapter connector and ii) a vented air lumen openly vented to the ambient surroundings, the vented drug vial adapter and the vented liquid vial adapter being formed as discrete components, at least one of said dual lumen drug vial stopper puncturing cannula and said dual lumen liquid vial stopper puncturing cannula further comprising a tip located on the longitudinal drug vial adapter centerline or the longitudinal liquid vial adapter centerline, the arrangement being such that in a set-up position of the dual vial adapter assemblage in which said drug vial adapter connector is connected to, and in flow communication with said liquid vial adapter connector, on initial telescopic mounting of said vented liquid vial adapter on the liquid vial and said vented drug vial adapter on the drug vial, subsequent disposing of the liquid vial above the drug vial leads to gravitational flow of liquid contents from the liquid vial to the drug vial for forming the liquid drug therein assisted by simultaneous venting of the liquid vial by drawing ambient air thereinto through said dual lumen liquid vial stopper puncturing cannula's vented air lumen and the drug vial by expelling air therefrom through said dual lumen drug vial stopper puncturing cannula's vented air lumen to the ambient surroundings, the drug vial adapter being detachable from the liquid vial adapter for providing access to the drug vial adapter connector for enabling connection of the empty needleless syringe thereto for aspiring a liquid drug dosage from the drug vial for administration to a patient, wherein each of said liquid vial adapter connector and said drug vial adapter connector is a male connector and the dual vial adapter assemblage further comprises a dual ended liquid transfer coupler having a pair of opposite coupler ends in the form of female connectors for sealed engagement with said liquid vial adapter connector and said drug vial adapter connector in said set-up position.

Description

BRIEF DESCRIPTION OF DRAWINGS

(1) 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:

(2) FIG. 1 is a pictorial view of an administration set including a needleless syringe, a drug vial, a liquid vial, an IV infusion set, and a dual vial adapter assemblage in accordance with a first preferred embodiment of the present invention;

(3) FIG. 2 is an exploded view of the FIG. 1 dual vial adapter assemblage;

(4) FIG. 3 is a longitudinal cross section of the FIG. 1 dual vial adapter assemblage along line A-A in FIG. 1;

(5) FIG. 4 is a longitudinal cross section of the FIG. 1 dual vial adapter assemblage along line A-A in FIG. 1 showing transfer of liquid contents from a liquid vial to a drug vial;

(6) FIG. 5A to FIG. 5F show the use of the administration set;

(7) FIG. 6 is a perspective view of a dual vial adapter assemblage in accordance with a second preferred embodiment of the present invention;

(8) FIG. 7 is an exploded view of the FIG. 6 dual vial adapter assemblage;

(9) FIG. 8 is a longitudinal cross section of the FIG. 6 dual vial adapter assemblage along line B-B in FIG. 6;

(10) FIG. 9 is a perspective view of a dual vial adapter assemblage in accordance with a third preferred embodiment of the present invention;

(11) FIG. 10 is an exploded view of the FIG. 9 dual vial adapter assemblage; and

(12) FIG. 11 is a longitudinal cross section of the FIG. 9 dual vial adapter assemblage along line C-C in FIG. 9.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

(13) FIG. 1 shows an administration set 5 including an initially empty needleless syringe 10, a drug vial 20, a liquid vial 30, an infusion set 40 (shown in a reduced scale) and a dual vial adapter assemblage 100. The needleless syringe 10 includes a barrel 11 with a plunger 12 and a male Luer lock connector 13. The syringe 10 can be formed with other types of male connectors. The drug vial 20 has a longitudinal drug vial axis 20A and includes an open topped drug vial bottle 21 having a drug vial crown 22 and a narrow diameter drug vial neck 23. The drug vial crown 22 is sealed by a drug vial stopper 24. The drug vial stopper 24 is sealed by an aluminum band 26. The drug vial 20 contains a medicament 27 in the form of a powder, solid or liquid. The liquid vial 30 has a longitudinal liquid vial axis 30A and includes an open topped liquid vial bottle 31 having a liquid vial crown 32 and a narrow diameter drug vial neck 33. The liquid vial crown 32 is sealed by a liquid vial stopper 34. The liquid vial stopper 34 is sealed by an aluminum band 36. The liquid vial 30 includes liquid contents 37 in the form of diluent only or an active component. The IV infusion set 40 includes an IV spike 41, first tubing 42, a clamp 43, a drip chamber 44, second tubing 46, a roller clamp 47, a male Luer connector 48, and a Luer shield 49. First tubing 42 typically have dimensions 4.1 mm200 mm and second tubing 46 typically have dimensions 4.1 mm and 500 mm.

(14) FIGS. 2 and 3 show the dual vial adapter assemblage 100 has a longitudinal dual vial adapter assemblage centerline 101 and includes a vented drug vial adapter 110 and a vented liquid vial adapter 120.

(15) The vented drug vial adapter 110 has a longitudinal drug vial adapter centerline 111 and includes a transverse drug vial adapter top wall 112. The drug vial adapter top wall 112 has an upright drug vial adapter connector 113 preferably constituted by a female Luer connector including an external screw thread for screw thread engagement by a male Luer lock connector. The drug vial adapter top wall 112 has an oppositely directed drug vial adapter skirt 114 for telescopic mounting on the drug vial 20. The drug vial adapter top wall 112 includes a dual lumen drug vial stopper puncturing cannula 116 for puncturing the drug vial stopper 24 on telescopic mounting the vented drug vial adapter 110 on the drug vial 20. The dual lumen drug vial stopper puncturing cannula 116 includes a liquid lumen 117 in flow communication with the drug vial adapter connector 113 and a vented air lumen 118 with throughgoing bores 119 formed in the drug vial adapter top wall 112. The liquid lumen 117 typically has a wider diameter than the vented air lumen 118.

(16) The vented liquid vial adapter 120 has a longitudinal liquid vial adapter centerline 121 and includes a transverse liquid vial adapter top wall 122. The liquid vial adapter top wall 122 has an upright liquid vial adapter connector 123 preferably constituted by a male Luer lock connector for screw thread engagement on the female Luer connector 113. The liquid vial adapter top wall 122 has an oppositely directed liquid vial adapter skirt 124 for telescopic mounting on the liquid vial 30. The liquid vial adapter top wall 122 includes a dual lumen liquid vial stopper puncturing cannula 126 for puncturing the liquid vial stopper 34 on telescopic mounting the vented liquid vial adapter 120 on the liquid vial 30. The dual lumen liquid vial stopper puncturing cannula 126 includes a liquid lumen 127 in flow communication with the liquid vial adapter connector 123 and a vented air lumen 128 with throughgoing bores 129 formed in the liquid vial adapter top wall 122. The liquid lumen 127 typically has a wider diameter than the vented air lumen 128. The liquid vial adapter 120 can optionally include an air filter for filtering incoming air.

(17) FIG. 4 shows gravitational flow of liquid contents from the liquid vial 30 to the drug vial 20 through the liquid lumen 127, the liquid vial adapter connector 123, the drug vial adapter connector 113 and the liquid lumen 117 as denoted by arrows A. FIG. 4 shows the gravitational flow is facilitated by air being drawn into the liquid vial 30 via the vented air lumen 128 denoted by arrows B and air being expelled from the drug vial 20 via the vented air lumen 118 denoted by the arrows C.

(18) FIG. 5A to FIG. 5F show the use of the administration set 5 for preparing a liquid drug in a drug vial 20 ready for administration to a patient. FIG. 5A shows telescopic mounting the vented liquid vial adapter 120 on the liquid vial 30 for puncturing same. FIG. 5B shows inverting the dual vial adapter assemblage 100 together with the attached liquid vial 30 and telescopically mounting the vented drug vial adapter 110 on the drug vial 20 for puncturing same thereby leading to gravitational flow of liquid contents from the liquid vial 30 to the drug vial 20 to form a liquid drug therein. FIG. 5C shows unscrewing the vented liquid vial adapter 120 from the vented drug vial adapter 110. FIG. 5D shows screwing the syringe 10 onto the vented drug vial adapter 110 for aspirating a liquid drug dosage from the drug vial 20 for administration to a patient. FIG. 5E shows removal of the vented drug vial adapter 110 from the drug vial 20. FIG. 5F shows connection of the IV infusion set 40 to the drug vial 20 for infusion of liquid drug to the patient.

(19) FIG. 6 to FIG. 8 show a dual vial adapter assemblage 200 similar in construction and operation as the dual vial adapter assemblage 100. The latter 200 differs from the former 100 insofar as the latter 200 has a triple component construction as opposed to a dual component construction. The latter 200 includes a vented vial adapter 130, a vented vial adapter 140 and a dual ended liquid transfer coupler 150 intermediate the vented vial adapter 130 and the vented vial adapter 140. Both the vented vial adapter 130 and the vented vial adapter 140 are identical to the vented drug vial adapter 110 and correspondingly include a female Luer connector 131 and a female Luer connector 141. The dual ended liquid transfer coupler 150 is formed with dual opposite male Luer lock connectors 151 and 152 for corresponding sealing inter-engagement with the female Luer connector 131 and the female Luer connector 141.

(20) The use of the dual vial adapter assemblage 200 is the same as the dual vial adapter assemblage 100 except that one of the vented vial adapter 130 and the vented vial adapter 140 can be initially telescopic mounted on a liquid vial 30 and the other available vial adapter of the vented vial adapter 130 and the vented vial adapter 140 subsequently telescopic mounted on a drug vial 20 to prepare a liquid drug therein. Thereafter, the dual ended liquid transfer coupler 150 and the vented vial adapter 130 or the vented vial adapter 140 telescopic mounted on the empty liquid vial 30 are removed for enabling use from FIG. 5C onwards.

(21) FIG. 9 to FIG. 11 show a dual vial adapter assemblage 300 similar in construction and operation as the dual vial adapter assemblage 200. The latter 300 differs from the former 200 insofar as the latter 300 include a vented vial adapter 160 and a vented vial adapter 170 identical to the vented liquid vial adapter 120 and correspondingly include a male Luer lock connector 161 and a male Luer lock connector 171. Correspondingly, the latter 300 includes a dual ended liquid transfer coupler 180 formed with dual opposite female Luer connectors 181 and 182 for corresponding sealing inter-engagement with the male Luer lock connector 161 and the male Luer lock connector 171.

(22) The use of the dual vial adapter assemblage 300 is the same as the dual vial adapter assemblage 200 except that the dual ended liquid transfer coupler 180 is left attached to either the vented vial adapter 160 or the vented vial adapter 170 telescopically mounted on a drug vial 20 containing a liquid drug ready for syringe aspiration and/or infusion.

(23) While particular embodiments of the present invention are illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention.