Field of the Invention

The invention pertains to medical apparatus for liquid drug reconstitution and administration purposes.

Background of the Invention

Fluid transfer devices including a vial adapter with a pointed cannula for mounting on a medicinal vessel hermetically sealed by a vial stopper and containing a liquid or powder medicament are now commonly employed for liquid drug reconstitution and administration purposes. Many such fluid transfer devices are also commonly employed with a syringe requiring connection to a syringe port of the fluid transfer device. One type of syringe connection is a so-called slip connection requiring a linear displacement of a syringe towards a syringe port. A syringe connector can be formed with a male connector and a syringe port can be formed with a matching female connector or vice versa. Another type of syringe connection is a so-called lock connection requiring a simultaneous combined motion of rotation of a syringe towards a syringe port and its linear displacement theretoward. A syringe port can be formed with an external screw thread and a syringe connector can be formed with a matching internal screw thread or vice versa. The matching screw threads can require either a clockwise or counterclockwise rotation of a syringe relative to its direction of injection for tightening onto a syringe port. However, a slip connection requires considerable dexterity for alignment purposes and is time consuming and burdensome. Moreover, a lock connection requires even greater dexterity. Summary of the Invention

The present invention is directed , towards syringe connection modules for connecting a syringe to a syringe port of a fluid transfer device mounted on a medicinal vial and hereinafter referred to as a vial assemblage for liquid drug reconstitution and administration purposes. The syringe connection modules are equally suitable for use with both hitherto described slip and lock syringe connections.

The syringe connection modules include a housing having a longitudinal housing axis and a vial assemblage retaining arrangement for fixedly retaining a vial assemblage with its syringe port co-directional with the housing axis. The syringe connection modules also include a motorized syringe drive unit having a syringe support mechanism for supporting a syringe co-directional with the housing axis and its syringe connector co-axial with a syringe port and at least one motor unit for effecting a simultaneous combined motion of rotation of the syringe relative to the housing axis and linear displacement of the syringe towards the vial assemblage for connecting the syringe connector to the syringe port.

Motorized syringe drive units can be implemented by either a single motor for effecting both rotation and linear displacement or two separate motors for effecting the two motions. Some vial assemblages have an inline configuration with their syringe port co-axial with a vial axis in which case a vial assemblage retaining arrangement retains a vial co-directional with a housing axis. Other vial assemblages have a transverse configuration with their syringe port transverse to a vial axis in which case a vial assemblage retaining arrangement retains a vial transverse to a housing axis.

The syringe connection module can be provided as a standalone unit suitable for home users, for example, requiring assembly of a preparatory assemblage including a syringe, a vial and a fluid transfer device. The fluid transfer device may be as illustrated and described in commonly owned US Patent No. 6,238,372's Figures 1 1 to 15 and commercially available under the

®

registered trademark MIXJECT for preparing a liquid drug assemblage for self administration purposes. Alternatively, the syringe connection module can be incorporated in an automatic liquid drug preparation apparatus for use with an aforesaid preparatory assemblage for preparing an aforesaid liquid drug assemblage as illustrated and described in commonly owned PCT International Application No. PCT/IL2008/000606 entitled Automatic Liquid Drug Preparation Apparatus for the Preparation of a Predetermined Dosage of Liquid Drug and published under PCT International Publication No. WO 2008/135989, thereby reducing a preparatory step prior to operation of the aforesaid WO 2008/13598 apparatus.

Brief Description of 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 shows a combined pictorial representation and block diagram of a syringe connection module for connecting a syringe to a syringe port for use with a syringe, a vial, and a fluid transfer device including a syringe port and a needle;

Fig. 2 is a perspective view showing a preferred embodiment of Figure l 's syringe connection module including a housing having a motorized syringe drive unit with a pair of driven rollers for supporting a syringe and a vial assemblage retaining arrangement for retaining a vial transverse to the housing's longitudinal axis, and a syringe and a vial assemblage including a vial and a fluid transfer device;

Fig. 3 is a top view of Figure 2's syringe connection module showing the motorized syringe drive unit supporting the syringe and the vial assemblage retaining arrangement retaining the vial assemblage; Fig. 4 is a longitudinal cross section of Figure 2's syringe connection module along line A- A in Figure 1;

Fig. 5 is a front perspective view of Figure 2's motorized syringe drive unit supporting the syringe, and the vial assemblage;

Fig. 6 is a rear perspective view of Figure 2's motorized syringe drive unit supporting the syringe, and the vial assemblage;

Figs. 7A - 7C are longitudinal cross sections showing operation of Figure 2's syringe connection module for connecting a syringe to a syringe port;

Fig. 8 is a longitudinal cross-sectional view of an alternative embodiment of Figure l 's syringe connection module along line A- A therein, the syringe connection module including a housing having a motorized syringe drive unit with a pair of driven rollers for supporting a syringe and a vial assemblage retaining arrangement for retaining a vial co-directional with the housing's longitudinal axis;

Fig. 9 is a longitudinal cross-sectional view of yet another alternative embodiment of Figure l 's syringe connection module along line A- A therein, the syringe connection module including a housing having a motorized syringe drive unit with a motorized syringe retainer for rotating a syringe on non-driven rollers and a vial assemblage retaining arrangement for retaining a vial transverse to the housing's longitudinal axis; and

Fig. 10 shows a schematic representation of still another alternative embodiment of Figure l 's syringe connection module including a single motorized roller for effecting simultaneous combined motion of rotation and linear displacement of a syringe.

Detailed Description of Preferred Embodiments of the Invention

Figure 1 shows a syringe connection module 100 for use with a syringe 10, a vial 20 and a fluid transfer device 30. The syringe 10 has a longitudinal syringe axis 11 and a direction of injection DOI. The syringe 10 includes a syringe barrel 12, a syringe plunger 13, and a syringe connector 14. The syringe connector 14 is typically implemented as a male connector tip 16 and a collar 17 with an internal screw thread 18. The internal screw thread 18 can be either a clockwise or counterclockwise thread. One suitable implementation of the syringe connector 14 is a male Luer lock connector. The vial 20 has a longitudinal vial axis 21 and includes an opened topped bottle 22 sealed by a vial stopper 23 capped by a metal band 24. The vial 20 has a vial interior 26 containing powder or liquid medicament 27. The syringe 10 is pre-filled with a diluent for mixing with the vial medicament 27.

The fluid transfer device 30 includes a body member 31 having a longitudinal device axis 32, a syringe port 33 and a drug administration port 34 co-directional with the device axis 32, and a tubular vial adapter port 36 intermediate the syringe port 33 and the drug administration port 34. The syringe port 33 has an external screw thread 33A for screw thread engagement with the syringe connector 14. One suitable implementation of the syringe port 33 is a female Luer connector. The fluid transfer device 30 also includes a vial adapter 37 rotatably mounted on the body member 31 and including a pointed cannula 38 (see Figure 4) for puncturing the vial stopper 23. The vial adapter 37 rotates a flow control member (not shown) from an initial first flow control position for establishing flow communication between the syringe port 33 and the cannula 38 for liquid drug reconstitution purposes to a subsequent second flow control position for establishing flow communication between the syringe port 33 and the drug administration port 34 for liquid drug administration purposes on its simultaneous detachment from the body member 31. The drug administration port 34 is fitted with a needle 41 protected by a needle shield 42.

The fluid transfer device 30 is intended to be mounted on the vial 20 for establishing flow communication between the syringe port 33 and the vial interior 26. The fluid transfer device 30 mounted on the vial 20 is hereinafter referred to as a vial assemblage 50. The vial assemblage 50 has a transverse configuration in the sense that its syringe port 33 is transverse to the vial axis 21.

The syringe connection module 100 includes a housing 101 having a longitudinal housing axis 102, a base 103, and a cover 104. The cover 104 is maintained closed while the syringe connection module 100 is in operation, and may include a safety switch for preventing operation when open. The cover 104 is transparent, or alternatively may have a window, for enabling a user to view the operation of the syringe connection module 100. The syringe connection module 100 includes a vial assemblage retaining arrangement 106 for fixedly retaining the vial assemblage 50 with its syringe port 33 co- directional with the housing axis 102.

The syringe connection module 100 also includes a power unit 107 for supplying AC and/or DC power, a motorized syringe drive unit 108 and a controller 109 for controlling operation. The power supply 107, the motorized syringe drive unit 108, and the controller 109 are all preferably accommodated inside the housing 101. The motorized syringe drive unit 108 includes a syringe support mechanism 111 for supporting the syringe 10 co-directional with the housing axis 102 and its syringe connector 14 co-axial with the syringe port 33.

The motorized syringe drive unit 108 effects a simultaneous combined motion of rotation of the syringe 10 relative to the housing axis 102 and a linear displacement of the syringe 10 towards the syringe port 33. The direction of rotation of the syringe 10 relative to the housing axis 102 can be either clockwise or counterclockwise relative to the syringe's direction of injection DOI in the case either one or both of the syringe connector 14 and the syringe port 33 do not have a screw thread. In the case that the syringe connector 14 and the syringe port 33 have matching screw threads, the motorized syringe motor unit 108 rotates the syringe 10 in a suitable direction relative to its direction of injection DOI to screw thread engage the syringe connector 14 onto the syringe port 33. This operation is maintained until the syringe 10 is adequately sealingly connected to the syringe port 33, at which time operation of the motorized syringe drive unit 108 is interrupted by the controller 109. Detection of adequate sealing connection may include the use of methods known in the art, including using a limit switch which the motorized syringe drive unit 108 contacts during linear motion, or torque sensing during syringe 10 rotational motion.

The syringe connection module 100 includes a START pushbutton 112 for initiating operation, a green LED 113 for indicating the syringe connection module 100 is in operation, and a red LED 114 for indicating termination of operation. The LED 113 and LED 114 may also be used to indicate correct and incorrect operation of the syringe connection module 100, respectively.

Figures 2 to 6 shows a syringe connection module 100A for use with a vial assemblage 50 retained with its vial axis 21 transverse to the housing axis 102. The housing 101 includes a vial assemblage retaining assembly 106 in the form of an upright open topped tubular vial support 116 attached to the base 103 for retaining the vial assemblage 50. The vial support 116 may include a shape, for example, keyed, for accommodating the vial assemblage 50 such that the syringe port 33 is oriented in the direction of the syringe connector 14, and/or may include markings (not shown) which may serve to guide a user for properly orienting the vial assemblage 50.

The housing 101 includes a motorized syringe drive unit 108 having a single motor unit 122, a threaded shaft 123, a carriage 124 screw threaded on the threaded shaft 123 and reciprocal therealong under the control of the motor unit 122. The carriage 124 includes a unidirectional bearing 126 and a drive wheel 127 for driving a pair of driven rollers 128 and 129 constituting the syringe support mechanism 111. The driven rollers 128 and 129 correspondingly have gears wheel 128A and 129A which interact with the drive wheel 127 for turning one of the rollers 128 and 129 in a clockwise direction relative to the syringe's direction of injection DOI and the other roller of the rollers 128 and 129 in a counterclockwise direction. A syringe retainer 131 forming part of the syringe support mechanism 111 and attached to the cover 104 bears on the syringe barrel 12 for urging same on the rollers 128 and 129 for preventing slippage of the syringe barrel 12 thereon during their rotation.

The housing 101 includes an upright support 132 rigidly attached to the base 103, and to which the threaded shaft 123 is rigidly affixed. Clockwise rotation of the motor unit 122 drives the carriage 124 in a forward direction along the threaded shaft 123 in the direction of the support 132 and simultaneously rotates the rollers 128 and 129 for rotating the syringe 10 in a predetermined direction for connecting its syringe connector 14 to the syringe port 33 and screw threading thereon in the case of a so-called lock connection. The unidirectional bearing 126 enables the carriage 124 to be displaced rearward relative to the vial assemblage 50 without unscrewing the syringe 10 from the syringe port 33. The housing 101 additionally includes a sliding surface 133 attached to the base 103 on which the motorized syringe driving unit 108 reciprocates forward and rearward.

The use of syringe connection module 100A for connecting the syringe

10 on the vial assemblage 50 is shown in Figs. 7A - 7C. In an exemplary operation, a user attaches the fluid transfer device 30 to the vial 20 for forming the vial assemblage 50 and places the vial assemblage 50 in the vial assemblage retaining arrangement 106. The user places the syringe 10 on the rollers 128 and 129 so that the syringe connector 14 is facing the syringe port 33. A position of the syringe 10 on the rollers 128 and 129 may be fixed for all types of syringes, or may vary according to the syringe. The user closes the cover 104 and presses the START pushbutton 112 for activating the motorized syringe drive unit 108. In Fig. 7A, the motorized syringe drive unit 108 is shown in its initial position, the syringe 10 on the rollers 128 and 129, and the vial assemblage 50 positioned in the vial assemblage retaining arrangement 106. The syringe connector 14 is coaxial with the syringe port 33. The carriage 124 is at an initial separation denoted SI from the support 132.

In Fig. 7B, the motorized syringe drive unit 108 is shown in an intermediate position, prior to connecting the syringe connector 14 to the syringe port 33. The motorized syringe drive unit 108 has advanced towards the support 132 as the carriage 124 is rotated by the motor unit 122 and advances along the fixed threaded shaft 123 as indicated by an intermediate separation denoted S2 where S2<S1. The rotation of the carriage 124 causes the rollers 128 and 129 to rotate for rotating the syringe 10.

In Fig. 7C, the motorized syringe drive unit 108 is shown in its final position following sealing connection of the syringe connector 14 to the syringe port 33 as indicated by a final separation denoted S3 where S3<S2. The controller 109 has interrupted operation of the motor unit 122 for preventing over tightening the syringe connector 14 on the syringe port 33.

The user removes the syringe 10 and the vial assemblage 50 now connected together and switches off the syringe connection module 100A. Switching off the syringe connection module 100A operates the motorized syringe drive unit 108 to return the carriage 124 to its initial separation SI in preparation for the next operation of the syringe connection module 100A.

Figure 8 shows a syringe connection module 100B similar to the syringe connection module 100A and differing therefrom insofar it is designed for use with a vial assemblage 51 having an inline configuration as opposed to the vial assemblage 50's transverse configuration. The vial assemblage 51 is formed by a fluid transfer device 60 mounted on a vial 20. The fluid transfer device 60 includes a cap-like member 61, a downward depending skirt 62 for fitting onto the vial 20, and a syringe port 63 in direct flow communication with a pointed cannula 64.

The housing 101 includes a vial assemblage retaining arrangement 106 intended to retain the vial 20 such that its vial axis 21 is co-directional with the housing axis 102. The vial assemblage retaining arrangement 106 is in the form of an upright vial support 117 mounted on the base 103 and having a rounded top surface 118 for supporting the vial 20 placed lengthwise thereon and a vial retainer 119 attached to the cover 104 for bearing against the vial bottle 22 for preventing rotation of the vial assemblage 51 as the syringe connector 14 is connected to the syringe port 63.

Figure 9 shows a syringe connection module lOOC similar to the syringe connection module 100A and differing therefrom insofar that its motorized syringe drive unit 108 does not drive the rollers 128 and 129 but instead includes a motor unit 134 for driving a driven syringe retainer 135 for directly contacting the syringe barrel 12 for rotating the syringe 10 in a predetermined direction while preventing slippage on the supporting rollers 128 and 129.

Figure 10 shows a syringe connection module 100D similar to the syringe connection module 100A insofar that its motorized syringe drive unit 108 includes a single motor unit 136 for simultaneous combined clockwise motion of rotation of the syringe 10 relative to the housing axis 102 and linear displacement of the syringe 10 toward a vial assemblage (not shown). The motor unit 136 differs from the motor unit 122 insofar that the former 136 includes a motor 137 having a drive shaft 138 with an axis of rotation 139 angled with respect to the syringe barrel 12 and a driven syringe retainer 141 for directly contacting the syringe barrel 12 such that rotation of the syringe retainer 141 causes the simultaneous combined motion of rotation and linear displacement of the syringe barrel 12, due to friction between syringe retainer 141 and the syringe barrel 12 for connecting a syringe connector 14 to a syringe port (not shown). The syringe support mechanism 111 includes a pair of opposite and parallel supports 142 having ball bearings 143 for enabling the combined simultaneous motion of rotation and linear displacement of the syringe 10.

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.