专利摘要:
Invention Patent: "DRUG CONTAINER COVER FOR ASSEMBLY IN DRUG CONTAINER OPENED TO THE TOP TO FORM DRUG RECONSTITUTION ASSEMBLY FOR USE WITH NEEDLE-FREE SYRINGE". The present invention relates to a drug container lid for mounting in a drug container opened at the top to form a ready-to-use drug reconstitution assembly with a needle-free syringe. The drug container cap includes a drug container stop for sealing the drug container and a fluid transfer member with a syringe connector without an integral needle and a puncture cannula. The fluid transfer member is manually arranged along a pair of diametric inverted L-shaped rails from an initial non-puncture position to a puncture position. The pair of inverted L-shaped rails includes one-way pressure members to prevent a user from returning the fluid transfer member to a more anterior position, and indicating progress of user activation.
公开号:BR112015025847B1
申请号:R112015025847-6
申请日:2014-04-03
公开日:2021-02-23
发明作者:Nimrod Lev;Mordechai Bukhman
申请人:Medimop Medical Projects Ltd;
IPC主号:
专利说明:

Field of the Invention
[0001] The present invention relates to drug container caps for mounting on drug containers opened at the top to form so-called ready-to-use drug reconstitution assemblies for use with needle-free syringes. The drug container caps include a drug container stop for sealing an open drug container at the top and a fluid transfer member with an integral needle-free syringe connector and puncture cannula. Background of the Invention
[0002] Ready-to-use drug reconstitution assemblies, including an open drug container on top and a drug container cap having a fluid transfer member with an integral needle-free syringe connector and puncture cannula, are known. in the prior art. The exemplary prior art includes, among others:
[0003] United States Patent No. 4,576,211 to Valentini et al. titled SAFETY DEVICE FOR CONNECTION OF A SYRINGE WITH THE MOUTH OR OPENING OF A BOTTLE CONTAINING A DRUG OR A SMALL TUBE FOR DRUG DELIVERY FROM THE SYRINGE
[0004] United States Patent No. 5,429,614 to Fowles et al. entitled DRUG DELIVERY SYSTEM;
[0005] United States Patent No. 5,776,116 to Lopez et al. entitled MEDICAL CONNECTOR;
[0006] United States Patent No. 5,902,280 to Powles et al. titled ASPIRATION NEEDLE APPARATUS INCORPORATING ITS OWN VACUUM AND METHOD AND ADAPTER FOR USE THEREWITH;
[0007] United States Patent No. 6,070,623 to Aneas untitled CONNECTING DEVICE IN PARTICULAR BETWEEN A RECEPTACLE WITH A STOPPER CAPABLE OF BEING PERFORATED AND A SYRINGE;
[0008] United States Patent No. 6,382,442 to Thibault et al. entitled PLASTIC CLOSURE FOR VIALS AND OTHER MEDICAL CONTAINERS;
[0009] United States Patent No. 6,478,788 to Aneas entitled DEVICE FOR CONNECTION BETWEEN A RECIPIENT AND A CONTAINER AND READY-TO-USE ASSEMBLY COMPRISING SUCH A DEVICE;
[00010] United States Patent No. 6,706,031 to Manera entitled NEEDLELESS ACCESS APPARATUS AND SYSTEM;
[00011] United States Patent No. 7,074,216 to Fowles et al. entitled SLIDING RECONSTITUTION DEVICE FOR A DILUENT CONTAINER;
[00012] United States Patent No. 7,195,623 to Burroughs et al. titled KIT INCLUDING SIDE FIRING SYRINGE NEEDLE FOR PREPARING A DRUG IN INJECTION PEN CARTRIDGE;
[00013] United States Patent No. 7,615,041 to Sullivan et al. entitled VIAL ADAPTER;
[00014] United States Patent No. 8,225,949 to Aneas entitled PLUG DEVICE FOR A CONTAINER AND CONTAINER PROVIDED WITH ONE SUCH DEVICE;
[00015] United States Patent No. 8,480,646 to Nord et al. entitled MEDICAL DEVICE CONNECTOR;
[00016] United States Patent No. 8,562,582 to Tuckwell et al. entitled RECONSTITUTION DEVICE;
[00017] United States Patent Application Publication No. 2012/0310203 entitled APPARATUS AND METHOD;
[00018] United States Patent Application Publication No. 2013/0053814 entitled DEVICE.
[00019] There is a need for improved ready-to-use drug reconstitution assemblies including an open drug container on top and a drug container lid mounted thereon. Summary of the Invention
[00020] The present invention is directed to drug container caps for mounting in a drug container opened at the top to form a so-called ready-to-use drug reconstitution assembly for use with a needle-free syringe.
[00021] Drug container lids include three major components as follows: a lid housing for mounting securely in a drug container open at the top, a drug container stop securely mounted in the lid housing for sealing the drug container , and a fluid transfer member slidably mounted in the cap housing. The fluid transfer member includes a needle-free syringe connector integrally formed with a puncture cannula for puncturing the drug container stop, and in flow communication with the needle-free syringe connector.
[00022] The cap housing preferably includes a pair of diametric inverted L-shaped rails to guide the downward displacement of the fluid transfer member from an initial non-puncture position to a final puncture position. Alternatively, the cover housings can be designed with a single inverted L-shaped rail, or three or more inverted L-shaped rails.
[00023] The inverted L-shaped rails are configured to require a user to perform two actions to guide a fluid transfer member from its initial non-puncture position to its final puncture position, as follows: An initial minor hourly rotation to start the drug reconstitution assembly ready for activation and a subsequent major activation shift for puncturing a stop of the drug container. Inverted L-shaped rails ensure a safe trajectory, avoiding inadvertent pre-puncture, and include one-way pressure members to prevent a user from returning the fluid transfer member to a more anterior position, thereby providing evidence of integrity. One-way pressure members also provide audible indications to the user to indicate to proceed to the user's next action.
[00024] Drug container lids may have lid housings with inverted, open or closed L-shaped rails. The first requires additional shielding to hermetically seal a dependent puncture cannula downwards. The latter requires an additional outer sleeve mounted on the cover housing to seal open rails, thereby avoiding the need for additional shielding.
[00025] The fluid transfer members can be provided in a ventilated version, or in an unventilated version. Needle-free syringe connectors can be formed as a female Luer connector. Needle-free syringe connectors can be formed as a self-sealing orifice that can be cleaned for multiple aspirations of liquid drug contents. Brief Description of Drawings
[00026] In order to understand the invention, and to see how it can be carried out in practice, preferred modalities will now be described, by means of non-limiting examples only, with reference to accompanying drawings in which similar parts are likewise numbered , and where:
[00027] Fig. 1 is a pictorial representation of a first embodiment of a drug reconstitution assembly according to the present invention in an initial non-puncture position for use with a needle-free syringe;
[00028] Fig. 2 is a front elevation view disassembled from the drug reconstitution assembly of Figure 1;
[00029] Fig. 3 is a top elevation view of the drug reconstitution assembly of Figure 1;
[00030] Fig. 4 is a longitudinal cross-section of the drug reconstitution assembly of Figure 1 along line A-A in Figure 3;
[00031] Fig. 5 is a longitudinal cross-section of the drug reconstitution assembly of Figure 1 along line B-B in Figure 3;
[00032] Fig. 6 is an exploded front elevation view of the drug reconstitution assembly of Figure 1;
[00033] Fig. 7 is a longitudinal cross-section of the drug reconstitution assembly of Figure 1 along line C-C in Figure 6;
[00034] Fig. 8 is a front elevation view of the fluid transfer member of Figure 6 with syringe connector without integral needle and puncture cannula;
[00035] Fig. 9 is a longitudinal cross-section of the fluid transfer member of Figure 8 along its line D-D;
[00036] Fig. 10 is a longitudinal cross-section of the lid housing of the drug container lid of Figure 1 and the stop of the drug container;
[00037] Fig. 11 is a longitudinal cross-section of the drug container lid of Figure 1 in an initial non-puncture position;
[00038] Fig. 12 is a longitudinal cross-section of the drug container lid of Figure 1 being pushed into a prepared position ready for activation;
[00039] Fig. 13 is a longitudinal cross-section of the drug container lid of Fig. 1 in a final puncture position;
[00040] Figs. 14A to 14C show the use of the drug reconstitution assembly of Figure 1;
[00041] Fig. 15 is a front elevation view of a second embodiment of a drug reconstitution assembly according to the present invention in an initial non-puncture position; and
[00042] Fig. 16 is a longitudinal cross-section of the drug reconstitution assembly of Figure 15 along the E-E line thereof. Detailed Description of Preferred Modalities of the Invention
[00043] Figure 1 shows a drug reconstitution assembly 100 ready for use for use with a needle-free syringe 10 that constitutes a source of physiological fluid. The drug reconstitution assembly 100 includes a top open drug container 20 consisting of a top open drug bottle and a drug container lid 30 securely mounted thereon. The drug container opened at the top 20 may alternatively consist of other medical containers and receptacles for storing powdered or liquid drugs.
[00044] Syringe 10 includes a barrel 11 with a plunger 12 and a male Luer lock connector 13. Syringe 10 can be formed with other types of male connectors. Syringe 10 is filled with a liquid component 14. The liquid component 14 can be diluent only. Alternatively, the liquid component 14 can include an active component.
[00045] Figure 2 shows that the drug bottle opened at the top 20 has a longitudinal axis 21 and includes a shoulder of the drug bottle 22, a rim of the drug bottle 23 and a neck of the intermediate narrow drug bottle 24. The drug bottle rim 23 defines an opening for drug bottle 26. Drug bottle 20 contains a powder drug or a liquid drug 27.
[00046] Figures 2 to 13 show that the drug container cap 30 includes a longitudinal centerline 31 and a cap housing 32 for secure fitting of the assembly to the drug bottle 20 and a drug container stop 33 for sealing from the opening of the drug vial 26. The cap housing 32 accommodates a fluid transfer member 34 which slidably moves from an initial non-puncture position to a final puncture position for puncturing the stop of the drug container 33. The fluid transfer 34 includes an integral needle-free syringe connector 36 and a puncture cannula 37 in flow communication with syringe connector 36. needle-free syringe connector 36 is formed as a female Luer connector that can be cleaned for assembly thread of a female connector 13 on it. The drug container cap 30 includes a closure cap 38 for sealing the needle-free syringe connector 36.
[00047] The cover housing 32 is made of suitable plastic material, and includes a pair of diametric inverted L-shaped rails 39 to guide the activation displacement of the fluid transfer member 34 from its initial non-puncture position to your final puncture position. The drug container lid 30 includes a sleeve 41 outside the lid housing 32 for sealing the pair of diametric inverted L-shaped rails 39 to ensure the sterility of the puncture cannula 37. The sleeve 41 includes locking members 42 for fitting on the rim of the drug bottle 23 in the downward depression of the drug container lid 30 on the drug bottle 20 during assembly of the ready-to-use drug reconstitution assembly 100.
[00048] The fluid transfer member 34 includes a circular base member 43 formed with the needle-free syringe connector 36 and the puncture cannula 37. The base member 43 includes a pair of diametric external directed pins 44 for displacement to the along the pair of diametric inverted L-shaped rails 39 for guided activation displacement of the fluid transfer member 34. The fluid transfer member 34 optionally includes a ventilation arrangement 46 as disclosed in International Publication WIPO No. WO 2011 / 104712 commonly assigned entitled LIQUID DRUG TRANSFER DEVICE WITH VENTED VIAL ADAPTER.
[00049] The lid housing 32 includes a cross member 47 having an upper side of the cross member 47A and a lower side of the cross member 47B, and formed with a central opening 48 for passage through it of the puncture cannula 37. The side bottom of the cross housing 47B is integrally formed with the stop of the drug container 33. The cross member 47 and the stop of the drug container 33 can be overmolded together. Alternatively, the cross member 47 can be mechanically attached to the stop of the drug container 33, riveted to it, adhered to it, and the like.
[00050] The inverted L-shaped rails 39 each include an open-ended vertical access leg 49 codirectional with the longitudinal centerline 31, a horizontal initiation leg 51 transverse to the longitudinal centerline 31, and an activation leg vertical 52 codirectional with the longitudinal centerline 31. The larger vertical activation leg 52 has a proximal activation leg end 52A and a distal activation leg end 54B correspondingly adjacent and distal to the initiation leg 51.
[00051] The inverted L-shaped rails 39 also each include three one-way pressure members, as follows:
[00052] A one-way retaining pressure member 53 at a junction 54 between the open vertical access leg 49 and the horizontal initiation leg 51. One-way retaining pressure member 53 retains the fluid transfer member 34 in the lid housing 32 before use.
[00053] A one-way pressure member 56 at a junction 57 between the horizontal initiation leg 51 and the proximal activation leg end 52A.
[00054] A one-way activated pressure member 58 at the distal activation leg end 52B.
[00055] Figure 11 shows the fluid transfer member 34 in its initial installation position before use. The pair of outwardly directed pins 44 is located along the pair of horizontal initiation legs 51 that go beyond the pair of one-way retaining pressure members 53 and before the pair of initiated one-way pressure members 56. The cannula puncture plate 36 is unfolded above the central opening 48 in position to puncture the stop of the drug container 33.
[00056] Figure 12 shows the fluid transfer member 34 being pushed past the pair of pressure members initiated from a track 56 to its position initiated at the pair of proximal activation leg ends 52A ready for activation. This position is enabled by a user screwing a needle-free syringe 10 into the drug reconstitution assembly 100, and turning the needle-free syringe 10 in a clockwise direction until the pair of pins pointing out 44 press the pair of one-way pressure member 56. The user hears a click as the pair of outwardly directed pins 44 press the one-way pressure member 56 to indicate that he can proceed with activation. The puncture cannula 36 remains unfolded above the central opening 48 in position to puncture the stop of the drug container 33. The one-way pressure pair 56 initiates the fluid transfer member 34 from being returned to the pair of legs horizontal initiation 51.
[00057] Figure 13 shows the fluid transfer member 34 in its activated position on the pair of distal activation leg ends 52B. This position is enabled by a user pressing the needle-less syringe 10 towards the drug vial 20 until the pair of outwardly directed pins 44 press the activated one way pair of pressure members 58. The user hears a custom click that the pair of outwardly directed pins 44 presses the pair of one-way activated pressure members 58, indicating that it can proceed with reconstitution and administration of the drug. The pair of one-way activated pressure members 58 prevents the fluid transfer member 34 from being returned to a more anterior position.
[00058] The use of the drug reconstitution assembly 100 is now described with reference to Figures 14A to 14C as follows:
[00059] Figure 14A shows the drug reconstitution assembly 100 in its assembly position prior to use as shown in Figure 11. A user removes the closure cap 38 from the drug reconstitution assembly 100 to expose the syringe connector without needle 36.
[00060] Figure 14B shows the user screwing the needle-free syringe 10 into the needle-free syringe connector 36 in a clockwise direction denoted by arrow A to initially seal the syringe 10 therein and subsequently urge the fluid transfer member 34 to stop at the pair of proximally activated activation leg ends 52A, as shown in Figure 12. The user hears a click as the fluid transfer member 34 exceeds the initiated pressure path pair 56 to indicate that the drug reconstitution assembly 100 is initiated for activation.
[00061] Figure 14C shows that the user pushes the fluid transfer member 34 down along the activation legs 52, as denoted by arrow B to stop at the end of the distal activation pair 52B, as shown in Figure 13. The displacement causes the puncture cannula 37 to puncture through the stop of the drug container 33. The user hears a click as the fluid transfer member 34 exceeds the activated pressure pair of one way 58 for indicate that he proceeds with the reconstitution and administration of the drug.
[00062] Figures 15 and 16 show a drug reconstitution assembly 200 ready for similar use in construction and operation according to the drug reconstitution assembly 100 ready for use, and therefore similar parts are likewise numbered. The last 200 differs from the first 100, since the last 200 does not have the sleeve 41 and, therefore, its cover housing 32 is formed with the locking members 42, and has a pair of inverted open L-shaped rails 39 The last 200 includes a shield 61 placed in the punching cannula 37 to ensure sterility. The shield 61 breaks, and is propelled upwards against the underside of the cross member 48B in the downward displacement of the fluid transfer member 34 to its final puncture position.
[00063] 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.
权利要求:
Claims (4)
[0001]
1. Drug container cap for mounting on an open drug container on top to form a ready-to-use drug reconstitution mount for use with a needle-free syringe, the open drug container on top having a drug container rim defining an opening of the drug container, the drug container lid having a longitudinal center line, and being characterized by the fact that it comprises: (a) a tubular lid housing for secure mounting in the rim of the drug container, said cover housing including at least one inverted L-shaped rail (39) having an open end vertical access leg (49), a horizontal initiation leg (51), and a vertical activation leg (52), said activation leg having a proximal activation leg end (52A) and a distal activation leg end (54B) correspondingly adjacent and distal to said initiation leg, each said L-shaped rail poured having: i) a one-way retaining pressure member (53) between said open-ended vertical access leg and said horizontal initiation leg (51), ii) a one-way pressure member (56) between said horizontal initiation leg (51) and said proximal activation leg end (52A), and iii) one-way activated pressure member (58) towards said distal activation leg end (54B); (b) a drug container stop (33) fixedly mounted on said lid housing for sealing the opening of the drug container on the secure mounting of said lid housing on the rim of the drug container; and (c) a fluid transfer member (34) having a syringe connector without integral needle (36) and a puncture cannula (37) in flow communication with these, said needle-free syringe connector for fixing the needle-free syringe thereto, said puncture cannula (37) for puncturing said drug container stop (33), said fluid transfer member (34) being initially disposed along each horizontal initiation leg (51 ) whereby, in the manual rotation of said fluid transfer member (34) relative to said longitudinal center line, said fluid transfer member (34) is driven to pass each said pressure member initiated from one path for each said proximal activation leg end (52A) before being manually driven to overtake said one-way activated pressure member for each said distal activation leg end (54B) for puncture said stop of the drug container (33) for flow communication with the drug container.
[0002]
2. Cap, according to claim 1, characterized by the fact that it additionally comprises a sleeve external to said cap housing for sealing each said inverted L-shaped rail to ensure sterility of said puncture cannula (37).
[0003]
3. Cap, according to claim 1, characterized by the fact that it additionally comprises a shield in said puncture cannula (37).
[0004]
4. Ready-to-use drug reconstitution assembly, characterized by the fact that it includes an open drug container at the top, and a drug container lid, as defined in any one of claims 1 to 3, mounted thereon.
类似技术:
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同族专利:
公开号 | 公开日
DK2986267T3|2017-09-11|
CN105120826A|2015-12-02|
EP2986267A1|2016-02-24|
WO2014170888A1|2014-10-23|
JP2016515439A|2016-05-30|
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法律状态:
2018-11-13| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
2019-12-24| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
2020-12-22| B09A| Decision: intention to grant|
2021-02-23| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 03/04/2014, OBSERVADAS AS CONDICOES LEGAIS. |
优先权:
申请号 | 申请日 | 专利标题
IL225734|2013-04-14|
IL22573413A|IL225734D0|2013-04-14|2013-04-14|Ready-to-use drug vial assemblages including drug vial and drug vial closure having fluid transfer member, and drug vial closure therefor|
PCT/IL2014/050327|WO2014170888A1|2013-04-14|2014-04-03|Drug container closure for mounting on open-topped drug container to form drug reconstitution assemblage for use with needleless syringe|
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