Liquid drug delivery devices for use with syringes with widened distal tips

Liquid drug delivery devices for use with syringes with widened distal tips

5 Field of the Invention

The invention relates to liquid drug delivery devices for use with syringes with widened distal tips to avoid having to slide a conventional needle with a female Lauer connector.

Background of the invention

International PCT application commonly owned No. PCT / IL2005 / 000376, entitled "Liquid drug delivery devices and needle shield removal device" and published under International Publication No. 15 PCT WO 2005/105014 illustrates and describes a liquid drug transfer device that includes an elastomer tube vial adapter to prepare a syringe having a distal tip widened with a reconstituted liquid drug for immediate administration to a subject (see WO 2005/015014, figures 8 to 11). The widened distal tip is sized to prevent a conventional needle from having to be slidably disposed therein. The free end of the elastomeric tube is intended to be hermetically stretched over a widened distal tip to effect fluid communication between a syringe and a medical vial containing a medication that needs to be reconstituted. Reconstitution normally requires agitation of the liquid drug transfer device assembly, a vial and a syringe, which can lead to accidental disconnection of the syringe and loss of content.

25 Summary of the invention

The present invention provides a liquid drug delivery device as claimed in claim 1.

The present invention is directed to liquid drug delivery devices for safely and reliably preparing a syringe having a distal tip widened with a reconstituted liquid drug for immediate administration to a subject. The present invention is based on fluid control devices with rotatable removable vial adapters, as illustrated and described in US Pat. Commonly assigned No. 6,238,372 (corresponding to WO 96 / 29113A) by Zingler et al., Figures 11 a

35 15, and includes two modifications as follows: first, the liquid drug delivery devices of the present invention include a syringe hole with a widened distal tip and a single-use locking mechanism to secure it and prevent accidental disconnection of the syringe under normal use that includes agitation for reconstitution purposes. And secondly, the liquid drug delivery devices of the present invention include an orifice for the administration of drugs with a widened distal tip preferably similar to a widened distal tip of a syringe for the same purposes to avoid having to dispose of Sliding form on them the conventional needles with a female Luer connector.

The orifices of the syringes include any hermetic arrangement suitable for effecting the hermetic communication of fluids with a widened distal tip of the syringe. The appropriate hermetic provisions

Four. Five they include, inter alia, an elastomeric tube that is tightly stretched over a widened distal tip of the syringe similar to the liquid drug transfer device of WO 2005/105014, an elastomeric seal against which a widened distal tip of the syringe is forced Hermetically, and the like. Single-use locking mechanisms preferably prevent accidental disconnection of the syringe by providing one or more stopping members to cut underneath a widened distal tip of a syringe to surround its syringe tip. The single-use locking mechanisms are operated automatically by sliding a syringe into a hole in the syringe. Alternatively, single-use locking mechanisms may require user action.

Brief description of the drawings

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

Figure 1A corresponds to Figure 8 of WO 2005/105014 commonly possessed, mentioned above, showing a liquid drug transfer device that includes a vial adapter with an elastomer tube for preparing a syringe with a reconstituted liquid drug for a immediate administration to a subject;

65 Figure 1B corresponds to Figure 9 of WO 2005/105014 commonly possessed, mentioned above, showing a longitudinal cross-section of the liquid drug transfer device to

along the line AA in Figure 1A;

Figure 2 is a drawn representation of a syringe, a vial and a fluid control device according to Figures 11 to 15 of US Pat. commonly owned, previously mentioned, no. 6,238,372; Figure 3 is an exploded view of the fluid control device of Figure 2;

Figure 4 is a longitudinal cross-section of the fluid control device of Figure 2 along the line BB in Figure 2 in a reconstitution fluid control position;

Figure 5 is a longitudinal cross section of the fluid control device of Figure 2 along the line BB in the flow management control position after disconnection of the vial adapter;

Figure 6 is a side view of a first preferred embodiment of a drug delivery device

fifteen liquids including a syringe hole with an elastomer tube and a single-use automatic locking mechanism in accordance with the present invention, for use with a syringe having a widened distal tip to safely and reliably prepare the syringe with a reconstituted liquid drug;

Figure 7 is an unfolded view of the syringe hole of Figure 6;

Figure 8 is an assembled side view of the liquid drug delivery device of Figure 6 and a syringe with a widened distal tip;

Figure 9 is a perspective view of the liquid drug delivery device of Figure 6 with a gasket 25 instead of the elastomer tube;

Figure 10 is an assembled side view of the liquid drug delivery device of Figure 9 and a syringe with a widened distal tip;

Figure 11 is a perspective view of a second preferred embodiment of a liquid drug delivery device that includes a syringe hole with an elastomer tube and a single-use manual locking mechanism in accordance with the present invention;

Figure 12 is a perspective view showing the manual actuation of the single use manual locking mechanism 35 of Figure 11; and

Figure 13 is a perspective view of a third preferred embodiment of a liquid drug delivery device that includes a syringe hole with an elastomer tube and an alternative single-use automatic locking mechanism in accordance with the present invention.

Detailed description of preferred embodiments of the present invention

Figure 1A shows a syringe 10, a vial 16 and a liquid drug transfer device 20 for reconstitution of liquid drugs. Syringe 10 includes a reservoir 11 with a plunger 12 and a tip

Four. Five 13 of the syringe ending in a widened distal tip 14 to prevent the sliding arrangement of a conventional needle with a female Luer connector therein. The distal tip 14 has an external diameter D1, a length L1 and an annular drag surface 15. The syringe 10 normally includes a diluent for reconstituting a powdered drug or mixing with a liquid drug contained in the vial 16. The vial 16 includes a canister 17 with top opening by means of a rubber stopper 18 topped by a metal band 19.

Figures 1A and 1B show that the liquid drug transfer device 20 includes a vial adapter 21 with an upper wall 22, a shoulder 23 with flexibly deformable notch for a snap fit on the vial 16 and a hollow puncture member 24 for pierce the rubber stopper 18 of the vial and an elastomer tube 26 in fluid communication with the piercing member 24. The tube 26 has a distal end 27 for a tight fit

55 on the distal tip 14 to enable fluid communication between the syringe 10 and the vial 16. The tube 26 has an internal diameter D2 in which D2 <D1 and a free length L2 from its point of attachment with the vial adapter 21 in that L2> L1 to be tightly stretched over preferably the entire distal tip 134 without tearing, cutting, etc. The tube 26 is preferably formed from one of the following substances: PVC, silicone, rubber and the like.

Figures 2 to 5 show a conventional fluid control device 30 for use with a conventional syringe 28 with a male Luer lock connector 29 and a vial 16 for reconstitution of liquid drugs and for administration purposes. The fluid control device 30 includes a housing 31 having a longitudinal axis 32, a hole 33 of the syringe and a hole 34 for the administration of co-directional drugs with the longitudinal axis 32 and a hole 36 for vial adapters Tubular between the hole 33 of the syringe and the hole 34 for drug delivery. The orifice 33 of the syringe includes a cavity 37 in

fluid communication with the orifice 36 for vial adapters and slidably receives the syringe 28. The orifice 34 for drug delivery includes a cavity 38 in fluid communication with the orifice 36 for vial adapters and intended to administer a liquid drug.

5 The hole 36 for vial adapters has an outer cylindrical surface 39 with a lower portion 41 having a pair of screw threads 42 of four opposite. The orifice 36 for vial adapters holds a flow control member 43 that rotates about a rotation axis 44 generally perpendicular to the longitudinal axis 32. The flow control member 43 has an L-shaped mixing flow channel 46 that includes a radial section 47 to be registered with the cavity 37 of the syringe hole in a flow control position and an axial section 48 ending in a diametral groove 49. The flow control member 43 has a flow channel 51 of peripheral semicircular administration to be registered with the cavity 37 of the syringe hole and the cavity 38 of the drug delivery hole in a post flow administration control position at a quarter turn with respect to its flow mix control position.

fifteen The fluid control device 30 includes a vial adapter 53 with a flange 54 for telescopically receiving a vial. The flange 54 has an upper surface 56 with a pair of members 57 of opposite screw threads for threading the threads 42, thereby coupling the vial adapter 53 to the housing 31, and six flexible members 58 for pressure adjustment in the vial 16. The vial adapter 53 includes a hollow male connector 59 of decreasing outward section for a tight insertion in the axial section 48 of the flow control member and a pair of projections 61 to be inserted into the slots 49 of the flow control member to couple the vial adapter 53 to the flow control member 43. The vial adapter 53 includes a hollow cannula 62 to pierce the rubber stopper 18 of the vial and extend it downwardly to pierce the rubber stopper 18 of the vial and extend it inside the vial canister. Male connector 59 and cannula 62 are in fluid communication.

25 Figures 4 and 5 show the operation of the fluid control device 30:

Figure 4 shows the fluid control device 30 with the vial adapter 53 coupled thereto and the flow control member 43 in its initial mixed-loose control position that makes fluid communication between a syringe inserted into the hole 33 for syringes and a vial inserted in the vial adapter 53. The diluent is injected into the vial to be mixed with its contents before aspiration of the liquid drug into the syringe, ready for administration.

Figure 5 shows the fluid control device 30 after a quarter turn rotation of the

35 vial adapter 53 relative to housing 31 to disconnect vial adapter 53 with an exhausted vial thereof and simultaneously rotate the flow control member 43 from its initial flow mixing control position to its rear control position. administration of flow to enable fluid communication between the orifice 33 for syringes and the orifice 34 for drug administration.

Figures 6 to 8 show a liquid drug delivery device 70A for use with a syringe 10 and a vial 16. The liquid drug delivery device 70A is similar in construction to the fluid control device 30 and therefore , similar parts are equally numbered. The two main differences between device 70A and device 30 are as follows: device 70A includes a syringe hole 71 designed to effect fluid tight communication with a syringe 10 instead of a syringe 28. And in

Four. Five Secondly, the device 70A includes an opening 72 for drug administration having a widened distal tip 73 to prevent conventional needles with a female Luer connector being slidably disposed therein in a manner similar to the syringe 10.

The syringe hole 71 includes an inlet port 74 provided with an elastomeric tubular member 76 constituted by an elastomeric tube 77 which has a free end 78 and is coaxial with the longitudinal axis

32 The tube 77 is preferably formed by PVC, silicon, rubber and the like. The tube 77 has an internal diameter D3 and a length L3 beyond its point of attachment with the inlet port 74 where D3 <D1 and L3> L1 to tightly receive the distal tip 114 of the syringe by forced sliding insert into the same. The inlet port 74 supports an automatic single-use locking mechanism 79 to prevent accidental disconnection of the syringe. The locking mechanism 79 includes a solid coaxial tubular guide member 81 with the longitudinal axis 32 to help the user align the syringe 10 along the longitudinal axis 32 to insert it into the syringe hole but with a slightly larger internal diameter D4 than D1, so that the distal tip 14 can freely pass through it. The guide member 81 has four elastically flexible and equidistant detention members 82 that converge internally to the hole 36 of vial adapters and terminate at the tips 82A of the detention members that shortly stop the free end 78 by means of a gap S1 and they define an opening having a diameter smaller than the diameter D1 such that the distal tip 14 of the syringe forces radially outwardly the members 82 of stop, which are snapped behind it to encompass the tip 13 of the syringe in the sliding insert forced therethrough. An accidental disconnection of the syringe 10 of the device 70A of

65 Liquid drug delivery is avoided by the drag surface 15 which stops against the tips 82A of the detention members. The gap S1 is smaller than the length L1 to ensure that the distal tip 14 remains inside the tube 77 when the drag surface 15 protrudes from the tips 82A of the stopping members in the most posterior position of the syringe 10 with respect to the 70A device.

The use of the liquid drug delivery device 70A to safely and reliably prepare a syringe 5 10 with a reconstituted liquid drug for immediate administration to the subject is similar to the use of the fluid control device 30.

The steps for using the liquid drug delivery device 70A are as follows: a user attaches a vial to the device vial adapter. The user aligns a syringe along the longitudinal axis of the device and subsequently inserts the syringe into its syringe hole. The guide member holds the syringe as its widened distal tip radially forces the stopping members outwardly before stretching the book end of the elastomer tube. The user continues to slide the syringe until the tips of the stopping member snap fit behind the distal tip of the syringe to secure the syringe thereon and prevent displacement of the syringe outwards. The syringe is sufficiently

fifteen inserted into the end free of elastomer tube and ensures a fluid tight communication with it. The user injects the syringe diluent into the vial and shakes the assembly to reconstitute the medication from the vial. The user inverts the assembly and aspirates the reconstituted liquid drug into the syringe. The user rotates the vial a quarter turn to detach it. The device is now ready for immediate administration of the reconstituted liquid drug to a subject.

twenty FIGS. 9 and 10 show a liquid drug delivery device 70B analogous to the liquid drug delivery device 70A with the exception that the tubular elastomeric tubular member 76 is constituted by an annular gasket 83 instead of the tube 77. The gasket 83 has an exposed front surface 83A and an axial transit hole 84 of internal diameter D5 in which D5 <D1. The tips 82A of the detention member are

25 they stop near the front surface 83A of the gasket in a gap shorter than the length L1, so that the tips 82A of the stopping member continuously force the drag surface 15 towards the hole 36 for vial adapters, whereby the distal tip 14 lightly and continuously compresses the seal 83 to effect fluid tight communication after the forced insertion of the syringe 10 into the hole 71 of the syringe to effect fluid tight communication.

30 Figures 11 and 12 show a liquid drug delivery device 70C analogous to the liquid drug delivery device 70A, with the exception that the inlet port 74 includes a single-use manual locking mechanism 86 instead of the 79 mechanism single use automatic lock. The single-use manual locking mechanism 86 includes swiveling male and female block members 87A and 87B

35 for a snap closure on a syringe tip 13 behind its widened distal tip 14 after application of a manual compression force F directed toward the longitudinal axis 32.

Figure 13 shows an alternative liquid drug delivery device 70D analogous to the liquid drug delivery device 70A, but its inlet port 74 includes a single-use automatic locking mechanism 88. The locking mechanism 88 includes a tubular guide member 89 with a coaxial pin ring with the longitudinal axis 32 and which includes elements of opposite guide members 89A and 89B elastically flexible connected to the inlet hole 74. The guide member 89 has a pair of opposing stop members 91 that converge inward toward the hole 36 for vial adapters and terminate at the tips 91A of the stop member near the free end 78 and define an opening having a diameter smaller than diameter D1 of distal tip 14, so that the distal tip 14 of the syringe elastically forces out the stopping members 91 that are snapped behind it to encompass the tip 13 of the syringe after a forced insertion therethrough. Accidental detachment of the syringe 10 from the liquid drug delivery device 70D is prevented by the drag surface 15 that stops against the tips 91A of the stopping member. Distal tip 14 remains in tube 77 when the

fifty Drag surface 15 protrudes from the tips 91A of the stop members in the most posterior position of the syringe 10 with respect to the device 70D.

Although 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.