MEDICAL DEVICE WITH COLLAR ABUTMENT ARRANGEMENT

Field of the Invention

The invention pertains to medical devices for use with syringes for liquid drug administration purposes.

Background of the Invention

Commonly owned US Patent No. 6,238,372 to Zinger et al., the contents of which are incorporated herein by reference, illustrates and describes fluid control devices for liquid drug administration purposes. US '372 Figures 1 to 19 illustrate fluid control devices including a housing with a syringe port for receiving a syringe, a vial adapter port with a vial adapter for snap fit receiving a vial, and a drug administration port for administering a reconstituted liquid drug. The syringe ports and the preferred syringes are preferably of the Luer lock type as opposed to the Luer slip type for enabling screw threaded attachment to prevent possible detachment between a fluid control device and a syringe during handling for initial liquid drug reconstitution and subsequent liquid drug administration. Fluid control devices based on commonly owned US '372's Figures 11 to 15 are commercially available under the registered trademark MIXJECT ^® from Medimop Medical Projects Ltd., Ra'anana, Israel. MIXJECT ^® product information is available online at httpV/www.westpharma.com/products/medimop/Information/mixjec t.pdf.

International Standard ISO 594-2 entitled Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings specifies two types of syringes: Figure 1 shows a syringe with a male 6% (Luer) conical lock fitting with a permanently connected internal threaded collar. Figure 2 illustrates a syringe with a male 6% (Luer) conical lock fitting and a rotatable internal threaded collar. The rotatable collars have an internal diameter smaller than the external diameter of the male Luer connector at an annular shoulder for preventing collar detachment. In the case of syringes with

permanently connected collars, screw threading a syringe onto a syringe port causes the syringe to advance into the syringe port until the syringe's male Luer connector sealingly fits into the syringe port's female Luer connector before the syringe's collar has reached the end of the syringe port's thread. However, in the case of syringes with rotatable collars, a user may continue screw threading a syringe's collar onto a syringe port's thread even after the syringe's male Luer connector has sealingly fitted into the syringe port's female Luer connector. Such continued screw threading or over tightening causes the syringe's collar to initially ride over the male Luer connector's annular shoulder and possibly advance so far along the tapering male Luer connector that the collar is no longer in frictional contact therewith. Thus, in certain circumstances, the preferred Luer lock arrangement is effectively reduced to a Luer slip arrangement with its inherent undesirable possible detachment.

Summary of the Invention The present invention is directed toward medical devices for use with syringes including inter alia syringes having rotatable internal threaded collars susceptible inadvertent over tightening leading to undesirable collar detachment. The medical devices include a syringe port having an external screw thread, a distal free end surface, and a collar abutment arrangement for stopping screw thread advancement of a syringe's rotatable internal threaded collar along the syringe port's screw thread subsequent to secure screw thread engagement and preventing over tightening of the collar thereby precluding collar detachment. It should be noted, however, that due to manufacturing tolerances and collars being made from semi-rigid materials, collar abutment arrangements can stop undesirable collar advancement for most but not all commercially available syringes with rotatable internal threaded collars. Collar abutment arrangements can be implemented by wing-like stoppers, an annual spacer placed at the front of a syringe port's original distal end surface, and the like.

The present invention can be readily applied to a wide range of medical devices including a syringe port including inter alia fluid control devices having a similar construction and operation as aforesaid US '372 Figures 11 to 15's fluid control devices. In the latter case, the collar abutment arrangements are designed not to interfere with rotation of a vial adapter to dispose of a spent vial subsequent to liquid drug reconstitution and prior to liquid drug administration.

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 pictorial representation of a syringe, a vial, and a conventional fluid control device according to US Patent No. 6,238,372's Figures 11 to 15;

Fig. 2 is an exploded view of Figure 1 's fluid control device; Fig. 3 is a longitudinal cross section of Figure 1 's fluid control device along line A-A in Figure 1 in a reconstitution flow control position;

Fig. 4 is a longitudinal cross section of Figure 1 's fluid control device along line A-A in Figure 1 in an administration flow control position subsequent to vial adapter detachment; Fig. 5 is an enlarged longitudinal cross section of a syringe with a rotatable internal threaded collar;

Fig. 6 is a top perspective view of a fluid control device with a syringe port having a first preferred embodiment of a collar abutment arrangement in accordance with the present invention; Fig. 7 is a top view of Figure 6's fluid control device;

Fig. 8 is a top view of Figure 6's fluid control device with a syringe having a rotatable internal threaded collar inserted into its syringe port and having its collar abutting against the syringe port's collar abutment arrangement; Fig. 9 is a cross section of Figure 8 along line B-B in Figure 8; and

Fig. 10 is a top perspective view of a fluid control device with a syringe port having a second preferred embodiment of a collar abutment arrangement in accordance with the present invention.

Detailed Description of Preferred Embodiments of the Present Invention Figure 1 shows a syringe 10, a vial 20, and a fluid control device 30 for liquid drug reconstitution and administration purposes. The syringe 10 includes a barrel 11 with a plunger 12, a male Luer connector 13 and either a permanently mounted or rotatable internal threaded collar 14. The hitherto mentioned International Standard ISO 594-2 does not specify collar lengths which is discretionary according to syringe manufacturers. The vial 20 includes an opened topped bottle 21 sealed by a rubber stopper 22 capped by a metal band 23.

Figures 2 to 4 show the fluid control device 30 includes a housing 31 having a longitudinal axis 32, a syringe port 33 and a drug administration port 34 co-directional with the longitudinal 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 a lumen 37 in flow communication with the vial adapter port 36 and slidingly receives a syringe 10. The syringe port 33 ends in a female Luer lock connector 33A including an external screw thread 33B and a distal free end surface 33C. The hitherto mentioned International Standard ISO 594-2 does specify female Luer lock connector dimensions. The drug administration port 34 includes a lumen 38 in flow communication with the vial adapter port 36 and intended for administrating a liquid drug.

The vial adapter port 36 has an outer cylindrical surface 39 with a lowermost portion 41 having a pair of opposite quarter turn screw threads 42. The vial adapter port 36 supports a flow control member 43 rotatable about an axis of rotation 44 generally perpendicular to the longitudinal axis 32. The flow control member 43 has an L-shaped reconstitution flow channel 46 including a radial section 47 for registration with the syringe port's lumen 37 in a

reconstitution flow control position and an axial section 48 terminating in a diametrical slot 49. The flow control member 43 has a peripheral semi-circular administration flow channel 51 for registration with the syringe port's lumen 37 and the drug administration port's lumen 38 in an administration flow control position subsequent to a quarter turn with respect to its reconstitution flow control position.

The fluid control device 30 includes a vial adapter 53 with a skirt 54 for telescopically receiving a vial 20. The skirt 54 has a top surface 56 with a pair of opposite screw thread members 57 for screw thread engaging the screw threads 42 thereby coupling the vial adapter 53 to the housing 31, and six downward depending flex members 58 for snap fitting onto a vial 20. The vial adapter 53 includes an upright tapered hollow male connector 59 for sealing insertion into the flow control member's axial section 48 and a pair of keys 61 for insertion into the flow control member's slot 49 for coupling the vial adapter 53 to the flow control member 43. The vial adapter 53 includes a downward depending hollow cannula 62 for puncturing a vial's rubber stopper 22 and extending into a vial bottle 21 's interior. The male connector 59 and the cannula 62 are in flow communication.

Figure 5 shows the syringe's male Luer connector 13 with a rotatable internal threaded collar 14 with an annular base surface 15. The male Luer connector 13 has an end surface 16 and an annular shoulder 17 for preventing collar detachment except in cases of forced riding over same due to over tightening onto a female Luer lock connector 33A. The collar 14 has an end surface 18, an internal length Ll and an internal diameter D. Internal lengths Ll are in the range of about 7.5 ± 0.5 mm.

Figures 6 and 7 show a fluid control device 70 similar in construction to the fluid control device 30 and therefore similar parts are likewise numbered. The fluid control device 70 includes a syringe port 33 having a collar abutment arrangement 71 adjacent the screw thread 33B on the opposite side to the distal free end surface 33 C such that the screw thread 33B is intermediate the collar

abutment arrangement 71 and the distal free end surface 33C. The collar abutment arrangement 71 includes at least one stopper 72 for stopping screw thread advancement of a syringe's rotatable internal threaded collar along the screw thread 33B subsequent to secure screw thread engagement and preventing over tightening.

The at least one stopper 72 is distanced from the distal free end surface 33C by a length L2 where the lengths Ll and L2 necessarily satisfy the condition that L1>L2 to ensure abutment of a syringe's collar 14 thereagainst on screw thread advancement of the collar 14 along the screw thread 33B and prevent over tightening. Additionally, the length L2 must not be too short to prevent secure screw thread engagement between a collar 14 and the screw thread 33B. The length L2 is typically within the range of about 5.5+0.5 mm and has a minimum length of about 3mm to ensure secure screw thread engagement with the syringe 10 sealingly inserted in the syringe port 33. The minimum length L2 is in the range of about 3±0.3 mm and preferably 3 mm. The one or more stoppers 72 are designed not to interfere with rotation of the vial adapter 53 for removal of same together with a spent vial after liquid drug reconstitution.

The collar abutment arrangement 71 preferably includes a pair of wing- like stoppers 72 on opposite sides of the syringe port 33. The wing-like stoppers 72 each have a lateral side surface 73 extending from the vial adapter port 36 co- directional with the longitudinal axis 32 toward the female Luer lock connector 33 A and a trailing generally straight abutment surface 74 toward the distal free end surface 33C. The wing-like stoppers 72 can assume different wing shapes but necessarily require an external width W where W>D for ensuring collar abutment thereagainst. The one or more stoppers 72 also afford convenient gripping surfaces for assisting user assembly and operation of the fluid control device 70.

Figures 6 and 7 show a preferred collar abutment arrangement 71 in which the wing-like stoppers 72 have a delta-wing like configuration defining an imaginary plane 76 passing through the longitudinal axis 32 and perpendicular to

the axis of rotation 44. Alternatively, the wing-like stoppers 72 can be slightly inclined such that their lateral side surfaces 73 lie beneath the imaginary plane 76 toward the vial adapter port's lowermost portion 41.

Figures 8 and 9 show the screw thread mounting a syringe 10 onto the fluid control device 70's syringe port 33 proceeds until the collar's end surface

18 abuts against the abutment surfaces 74 to ensure a sealing connection between the syringe 10 and the syringe port 33 but preventing inadvertent over tightening.

The collar's base surface 15 is spaced apart from the distal free end surface 33C.

Figure 10 shows a fluid control device 80 similar in construction and operation as the fluid control device 70 but differing therefrom insofar the former includes a collar abutment arrangement 81 constituted by a non-threaded section 82 between the screw thread 33B and the distal free end surface 33C. The non- threaded section 82 has a length in the range of about 2.2±0.7 mm. The fluid control device 80 preferably includes a discrete annular spacer 83 mounted on an original distal free end surface 84, for example, by gluing, ultrasound welding, and the like. Alternatively, fluid control devices 80 can be manufactured with their screw threads 33B spaced apart from their distal free end surfaces 33C. In this embodiment, the collar's base surface 15 abuts against the distal free end surface 33 C to prevent inadvertent over tightening.

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.