This application is a Section 371 of International Application No. PCT/IL2012/000164, filed Apr. 17, 2012, which was published in the English language on Oct. 26, 2012, under International Publication No. WO 2012/143921 A1 and the disclosure of which is incorporated herein by reference.
1. Field of the Invention
The invention relates to liquid drug transfer assemblies for liquid drug reconstitution and administration purposes.
2. Background of the Invention
Dual ended dual lumen linear transfer spikes are typically employed for gravitational liquid transfer from a liquid vial containing a liquid component to a drug vial containing a drug component for forming liquid drug contents in the drug vial for administration purposes and simultaneous air transfer from the drug vial to the liquid vial for pressure equalization. The transfer spikes have exposed drug vial stopper and liquid vial stopper puncturing members with sharp vial stopper puncturing tips which pose a danger to users in general and home users in particular. Moreover, it is difficult to accurately center and correctly insert a transfer spike on a vial stopper to ensure that the transfer spike correctly punctures same for flow communication with a vial interior. Furthermore, a user has to manually remove the transfer spike and use other means, for example, a needle, to withdraw the liquid drug contents which can be cumbersome action and lead to a needle stick injury and contamination of the liquid drug contents.
The invention relates to liquid drug transfer assemblies for use with a drug vial including a drug vial bottle containing a drug component and having a drug vial opening stopped by a drug vial stopper. The drug component is typically a powdered drug component but can equally be a liquid drug component of different viscosities. The liquid drug transfer assemblies include a drug vial stopper puncturing member and a drug vial adapter having a substantially cylindrical drug vial adapter skirt with a drug vial adapter top surface, a drug vial adapter body portion for telescopically slidingly receiving a drug vial opening therein and a drug vial adapter skirt margin. The drug vial adapter top surface is formed with an upright drug vial adapter port and a downward depending drug vial adapter sleeve opposite the drug vial adapter port and in flow communication therewith. The drug vial adapter skirt can be optionally formed from a multitude of at least two drug vial adapter flex members. The drug vial adapter skirt can optionally include inwardly directed protrusions for snap fitting onto a drug vial opening. The drug vial adapter skirt margin can be optionally outwardly flared with respect to the drug vial adapter body portion for assisting in guidance of the drug vial adapter on a drug vial. The drug vial adapter is slidingly disposed on the drug vial stopper puncturing member such that its drug vial stopper puncturing member protrudes beyond the drug vial adapter sleeve in a set-up position of the liquid drug transfer assembly.
The liquid drug transfer assembly is mounted on a drug vial such that the drug vial stopper puncturing member punctures the drug vial stopper to form a throughgoing puncture bore and the drug vial adapter sleeve lines the puncture bore through the drug vial stopper. The drug vial adapter sleeve stops the drug vial stopper from sealing itself on withdrawal of the drug vial stopper puncturing member therefrom, thereby maintaining continuous flow communication between the drug vial bottle and the drug vial adapter port. The drug vial adapter sleeve also prevents remnants of the drug vial stopper contaminating liquid drug contents in a drug vial. Suitable medical devices can be readily mounted on the drug vial adapter port for flow communication with the drug vial bottle. Suitable medical devices include inter alia a needleless syringe, an administration line, and the like.
The drug vial stopper puncturing member can be configured as one end of a dual ended dual lumen linear transfer spike including an opposite liquid vial stopper puncturing member for puncturing a liquid vial stopper of a liquid vial containing a liquid component. The liquid component is typically a diluent but can equally contain an active drug component. Such a dual ended dual lumen linear transfer spike enables simultaneous gravitational liquid transfer from a liquid vial to a drug vial for forming liquid drug contents in a drug vial for administration purposes and air transfer from the drug vial to the liquid vial for pressure equalization purposes.
The dual ended dual lumen linear transfer spike can be integrally formed with a liquid vial adapter for mounting onto a liquid vial. Alternatively, the dual ended dual lumen linear transfer spike can be integrally formed with a liquid drug transfer device for use with a discrete liquid vial adapter for mounting onto a liquid vial thereby forming a triple component liquid drug transfer assembly including the drug vial adapter. The liquid drug transfer device includes a transverse directed spacing collar midway along the dual ended dual lumen linear transfer spike, at least two longitudinal directed drug vial legs and at least two longitudinal directed liquid vial legs oppositely directed to the at least two longitudinal directed drug vial legs. The drug vial legs and the liquid vial legs are employed for centering purposes of their corresponding drug vial stopper puncturing tip and liquid vial stopper puncturing tip with respect to their respective vial stoppers.
The foregoing summary, as well as the following detailed description of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.
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:
In the drawings:
The drug vial adapter 120 has a longitudinal drug vial adapter axis 121 and includes a drug vial adapter skirt 122 having a transversely directed drug vial adapter top surface 123 formed with an upright drug vial adapter port 124 and a multitude of six downward depending drug vial adapter flex members 126. The drug vial adapter flex members 126 are provided with internal directed protrusions 127 for snap fitting under the drug vial opening 23 and define a drug vial adapter body portion 128 for snugly receiving the drug vial opening 23. The drug vial adapter flex members 126 define a drug vial adapter skirt margin 129 outwardly flared with respect to the drug vial adapter body portion 128 for assisting in guidance of the drug vial adapter 120 on the drug vial 20. The drug vial adapter port 124 is preferably implemented as a female Luer connector for screw thread engagement of the needleless syringe 10 thereon. Alternatively, the drug vial adapter port 124 can be formed with a wide diameter, for example, for enabling gravitational flow of viscous liquid drug contents from a drug vial 20.
The drug vial adapter 120 also includes a downward depending drug vial adapter sleeve 131 opposite the drug vial adapter port 124 and in flow communication therewith. The drug vial adapter 120 including the drug vial adapter port 124 and the drug vial adapter sleeve 131 can be formed as a single injection plastic molded unit from the same suitable plastic material, for example, polycarbonate, and the like. The drug vial adapter sleeve 131 stops short of the drug vial stopper puncturing tip 112 in an initial set-up position of the liquid drug transfer assembly 100A such that the drug vial stopper puncturing tip 112 protrudes therebeyond. Thus, the drug vial stopper puncturing tip 112 contacts a drug vial stopper 24 before the drug vial adapter sleeve 131 on mounting the liquid drug transfer assembly 100A on the drug vial 20.
The liquid vial adapter 140 also includes a dual ended dual lumen linear transfer spike 151 having a drug vial stopper puncturing member 152 for puncturing the drug vial stopper 24 and an opposite liquid vial stopper puncturing member 153 for puncturing the liquid vial stopper 34. The drug vial stopper puncturing member 152 extends from the liquid vial adapter top surface 143 away from the liquid vial adapter skirt 142. The drug vial stopper puncturing member 152 terminates at a drug vial stopper puncturing tip 154 which extends beyond the drug vial adapter sleeve 131 on mounting the liquid drug vial adapter 140 on the drug vial adapter 120. The liquid vial stopper puncturing member 153 extends from the liquid vial adapter top surface 143 into the liquid vial adapter skirt 142. The liquid vial stopper puncturing member 153 terminates at a liquid vial stopper puncturing tip 156. The dual ended dual lumen linear transfer spike 151 includes a liquid transfer lumen 157 for liquid transfer from the liquid vial 30 to the drug vial 20 and an air transfer lumen 158 for air transfer from the drug vial 20 to the liquid vial 30 for pressure equalization purposes.
The drug vial adapter 160 has the same construction as the drug vial adapter 120 and therefore similar parts are likewise numbered. The drug vial adapter 160 differs from the drug vial adapter 120 insofar as the former 160 includes an opposite pair of drug vial adapter flex members 161 formed with throughgoing drug vial leg tip apertures 162 in the region of the drug vial adapter body portion 128. Also, the drug vial adapter flex members 161 have smooth external surfaces 163 in the region of the drug vial adapter skirt margin 129 as opposed to the ridged surfaces of the drug vial adapter flex members 126.
The liquid vial adapter 170 has the same construction as the liquid vial adapter 140 and therefore similar parts are likewise numbered. The liquid vial adapter 170 differs from the liquid vial adapter 140 insofar as the former 170 includes an opposite pair of liquid vial adapter flex members 171 formed with throughgoing liquid vial leg tip apertures 172 in the region of the liquid vial adapter body portion 147. Also, the liquid vial adapter flex members 171 have smooth external surfaces 173 in the region of the liquid vial adapter skirt margin 148 as opposed to the ridged surfaces of the liquid drug vial adapter flex members 144.
And additionally, the liquid vial adapter 170 is formed without the dual ended dual lumen linear transfer spike 151 and instead has an upright tubular member 174 extending from the liquid vial adapter top surface 143 away from the liquid vial adapter skirt 142. The tubular member 174 includes a transversely directed flange 176.
The liquid drug transfer device 180 has a similar construction to the dual ended dual lumen linear transfer spike 151 and therefore similar parts are likewise numbered. The liquid drug transfer device 180 includes a drug vial stopper puncturing member 152 terminating at a drug vial stopper puncturing tip 154 and an opposite liquid vial stopper puncturing member 153 terminating at a liquid vial stopper puncturing tip 156. The liquid drug transfer device 180 includes a liquid transfer lumen 157 and an air transfer lumen 158. The liquid transfer lumen 157 has a larger lumen cross section area than the air transfer lumen 158. The liquid transfer lumen 157 has a generally crescent transverse cross section which partially wraps around the air transfer lumen 158 thereby reducing the overall transfer spike cross sectional area for facilitating puncturing of the drug and liquid vial stoppers 24 and 34.
The liquid drug transfer device 180 is additionally formed with a transverse directed spacing collar 182 rigidly mounted midway therealong, a pair of longitudinal directed drug vial legs 183 hinged on the spacing collar 182 and extending co-directional with and spaced apart from the drug vial stopper puncturing member 152 and a pair of longitudinal directed liquid vial legs 184 hinged on the spacing collar 182 and extending co-directional with and spaced apart from the liquid vial stopper puncturing member 153. The drug vial legs 183 terminate at drug vial leg tips 186 co-extensive with and inwardly protruding toward the drug vial stopper puncturing tip 154. The drug vial leg tips 186 are intended to be initially inserted into the throughgoing apertures 162. The liquid vial legs 184 terminate at liquid vial leg tips 187 co-extensive with and inwardly protruding toward the liquid vial stopper puncturing tip 156. The liquid vial leg tips 187 are intended to be initially inserted into the throughgoing apertures 172.
The liquid vial legs 184 are preferably each formed with a pair of outwardly directed liquid vial leg protrusions 188 for bearing against the blister pack 101C's internal surface 102 for assisting in the snap fitting of the liquid drug transfer assembly 100C on the drug vial 20.
The liquid drug transfer assembly 100C includes a snap fit arrangement 190 for mechanically attaching the liquid vial adapter 140 to the spacing collar 182 on snap fitting the liquid vial adapter 140 on the liquid vial 30. The snap fit arrangement 190 is constituted by the tubular member 174 and the spacing collar 182 having a pair of snap members 191 for snap fitting on the transversely directed flange 176.
The liquid drug transfer assembly 100C snap fits onto the liquid vial 30 in a similar manner as it snap fits onto the drug vial 20. The liquid drug transfer device 180 additionally snap fits on the liquid vial adapter 140 for enabling convenient removal of the two components and the empty liquid vial 30 after forming the liquid drug contents in the drug vial 20.
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.
It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.
Number | Date | Country | Kind |
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212420 | Apr 2011 | IL | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/IL2012/000164 | 4/17/2012 | WO | 00 | 9/17/2013 |
Publishing Document | Publishing Date | Country | Kind |
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WO2012/143921 | 10/26/2012 | WO | A |
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Number | Date | Country | |
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20140020793 A1 | Jan 2014 | US |