巴西专利BR112014024530B1 fluid transfer device for use with a cartridge and drug vial

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专利摘要:
FLUID TRANSFER DEVICES THAT HAVE A CARTRIDGE PORT WITH CARTRIDGE EJECTION ARRANGEMENT. The present invention relates to a fluid transfer device for use in a procedure for manually loading a cartridge with a dose of liquid drug from a liquid drug vial. Fluid transfer devices include a main body with two ends, having a longitudinal axis, a drug vial for telescopically receiving a drug vial, and a cartridge port for slidingly receiving the front end of the cartridge. The cartridge port includes a cartridge fixing arrangement for reliably securing the front end of the cartridge and a cartridge ejection arrangement for at least partially ejecting the cartridge from it, to assist in manual sliding ejection of a loaded cartridge. The cartridge port may include either a combined cartridge clamping / ejection arrangement or a discrete cartridge clamping arrangement and discrete cartridge ejection arrangement.
公开号:BR112014024530B1
申请号:R112014024530-4
申请日:2013-04-07
公开日:2020-11-24
发明作者:Nimrod Lev；Niv Ben Shalom
申请人:Medimop Medical Projects Ltd.；
IPC主号:

专利说明:

[0001] [001] The present invention relates to a liquid transfer device for loading a cartridge with a dose of liquid drug. Background of the Invention
[0002] [002] Auto-injectors for self-administration of liquid drugs, so-called tubes or cartridges including a tube with an open end, hermetically sealed by a rubber septum at one front end of the cartridge, and a sliding seal at the rear end of the opposite cartridge. Cartridges can contain one or multiple doses of liquid drug. The user at home is typically served by cartridges pre-loaded with a dose of liquid drug, but can also be served with empty cartridges, which require a manual refill procedure to load them with a dose of liquid drug. The procedure for loading the cartridge manually includes the steps: preparing a syringe with a dose of liquid drug; mount a needle on the syringe; perforate the rubber septum of the cartridge; and inject the dose of liquid drug into the cartridge. The user may still need to take an additional step to reconstitute the liquid drug dose from a powdered drug.
[0003] [003] PCT International Patent Application commonly owned No. PCT / IL 2007/000343 "Fluid Transfer Devices for Use with Cartridges" and published as PCT International Publication No. WO 2007/105221, describes fluid transfer devices that will be discussed for use with syringes and needleless cartridges to help provide a procedure for manually loading a cartridge.
[0004] [004] International PCT Patent Application Commonly Owned In PCT / IL 2010/000530 "Fluid Transfer Devices for Filling a Cartridge with Liquid Drug Dosage" and published as International Publication WO 2011/004360 describes the fluid transfer device discussed here for use with cartridges and bottles to assist in the procedure of manually loading a cartridge. WO 2011/004360 describes how to provide conventional cartridges differently including a sliding seal with a releasable connection arrangement and a manual plunger for releasable connection to the sliding seal to allow manual displacement for injection and aspiration purposes. Suitable releasable connection arrangements include inter alia a threaded arrangement and the like.
[0005] [005] There is a need for liquid transfer devices that facilitate the procedure for loading cartridges with a dose of liquid drug and providing a manual sliding ejection of the loaded cartridge, for subsequent installation in an auto-injector. Summary of the Invention
[0006] [006] The present invention is directed to fluid transfer devices for use in manual cartridge filling procedures to load cartridges with doses of liquid drug from vials containing drug. Fluid transfer devices include a double-ended main body having a longitudinal axis, a vial port for telescopically receiving a drug vial, and a cartridge port for slidingly receiving a front end of the cartridge. The cartridge ports include a cartridge attachment arrangement for reliably attaching a front end of the cartridge to a cartridge port and a cartridge ejection arrangement for ejecting, at least partially, a loaded cartridge from it, to assist its ejection complete slider. Fluid transfer devices preferably include a pair of fingers, arranged transversely outward, to allow the user to use them in a manner similar to a syringe.
[0007] [007] Cartridge ports may include a combined cartridge attachment and ejection arrangement including one or more lever members, to attach a cartridge to a cartridge port and transmit a lever action to eject at least one cartridge loaded from it. Alternatively, the cartridge ports may include a discrete cartridge attachment arrangement and a discrete cartridge ejection arrangement. Such a discrete cartridge ejection arrangement may include one or more cartridge ejection members pressed into a first state upon insertion by manually sliding a cartridge into a position fixed on a cartridge door. Upon manual release of the cartridge attachment arrangement, the one or more cartridge ejection members invert to their unpressed state to eject, at least partially, a loaded cartridge from the cartridge port. Brief Description of Drawings
[0008] [008] In order to understand the present invention and appreciate how it can be carried out in practice, preferred configurations will now be described by means of non-limiting examples, referring to the attached drawings, in which similar parts receive the same numbers, in which: Figure 1 corresponds to the aforementioned Patent Application Publication WO 2007/105221 of Figure 2; Figure 2 corresponds to the mentioned Patent Application Publication WO 2007/105221 of Figure 5; Figure 3 corresponds to the aforementioned Patent Application Publication WO 2007/105221 of Figure 2; Figure 4 corresponds to the mentioned Patent Application Publication WO 2007/105221 of Figure 6; Figure 5 is a pictorial representation of a kit including a preloaded cartridge, plunger, drug vial, and fluid transfer device having a combined cartridge attachment / ejection arrangement, according to a preferred first configuration of the the present invention; Figure 6 is an exploded view of the fluid transfer device of Figure 5; Figure 7 is a front elevation view of the fluid transfer device of Figure 5 with its combined cartridge attachment / ejection arrangement in an initial cartridge insertion position; Figure 8A is a longitudinal cross section of the fluid transfer device of Figure 5 along line AA in Figure 7; Figure 8B is an enlarged view of the area circled in Figure 8A showing an end of the front lever member of the combined fixing / ejection arrangement; Figure 9 is a front elevation view of the fluid transfer device of Figure 5, with its combined cartridge attachment / ejection arrangement in the final ejection position; Figure 10 is a longitudinal cross-section of the fluid transfer device of Figure 5 along the BB line of Figure 9; Figure 11A is a longitudinal cross section of the fluid transfer device of Figure 5, showing a cartridge attached to its combined fixation / ejection arrangement; Figure 11B is an enlarged view of the area circled in Figure 11A, showing the attachment of the front end of the cartridge; Figure 12 is a longitudinal cross section of the fluid transfer device of Figure 5, showing partial ejection of the cartridge from the cartridge door; Figures 13A to 13H show the use of the fluid transfer device of Figure 5 to load a cartridge with a dose of reconstituted liquid drug; Figure 14 is a front perspective view of a fluid transfer device, including a combined cartridge attachment / ejection arrangement, according to a second preferred configuration of the present invention; Figure 15A is a longitudinal cross section of the fluid transfer device of Figure 14 along the line CC of Figure 14 in the sliding insert of the cartridge in its cartridge port; Figure 15B is a longitudinal cross section of the fluid transfer device of Figure 14 along the CC line in Figure 14, in manual operation of its fixation / ejection arrangement to eject, at least partially, the cartridge from the cartridge door; Figure 16 is a front perspective view of a fluid transfer device including a discrete cartridge attachment arrangement and a discrete cartridge ejection arrangement, according to a third preferred embodiment of the present invention; Figure 17 is a longitudinal cross section of the fluid transfer device of Figure 16 along the DD line of Figure 16; Figure 18 is a longitudinal cross section of the transfer device of Figure 16 along the DD line in Figure 16 when sliding a cartridge into its fluid port, to provide the cartridge ejection arrangement. Detailed Description of Preferred Invention Configurations
[0009] [009] Figure 1 corresponds to the mentioned Patent Application Publication WO 2007/105221 of Figure 2, showing a fluid transfer device 30 including a main body with two ends 31, longitudinal axis 32, a syringe port 33 for receiving a needleless syringe, and a cartridge port 34 for receiving a cartridge telescopically.
[0010] [0010] Figure 2 corresponds to Patent Application Publication WO 2007/105221 of Figure 5, showing a fluid transfer device 50 of construction and operation similar to fluid transfer device 30, including rotationally detachable vial adapters , as described in US Patent commonly owned No. 6,238,372 to Zinger et al, in Figures 11 to 15.
[0011] [0011] Figure 3 corresponds to Patent Application Publication WO 2007/105221 of Figure 2 showing a fluid transfer device 40 including a main body with two ends 42 having a cartridge door 43 for slidingly receiving the front end of the cartridge , and a vial port 44 to provide a sealed connection to a vial.
[0012] [0012] Figure 4 corresponds to Patent Application Publication WO 2007/105221 of Figure 6 showing a fluid transfer device 60 including a male connector 61, a cartridge holder with two ends 62 for slidingly receiving a cartridge, and a sealed finger operated cartridge connection arrangement 63 to initially engage the cartridge in its sliding insert in the cartridge holder 62, and to allow the cartridge to slide freely into the cartridge holder 62.
[0013] [0013] Figure 5 shows a kit 100 including a preloaded cartridge 110, a plunger 124 having a threaded front end 126, a drug vial 130, and a fluid transfer device 140 to provide a manual cartridge loading procedure to load cartridge 110 with a dose of liquid drug.
[0014] [0014] Figures 6 to 12 show cartridge 110 including an open end tube 111 having a longitudinal axis 112, small diameter front cartridge end 113, intermediate neck 114, and a large diameter rear cartridge end 116. A front end of cartridge 113 is hermetically sealed with a rubber cartridge septum 117 covered with a metal band 118. front end of cartridge 113 has a cartridge end surface 119 including a circular rubber surface 119A with a diameter of 2 to 3 mm. The rear end 116 is hermetically sealed with a sliding seal 121. The sliding seal 121 has an exposed rear surface 122 formed with a threaded blind hole 123 to provide a threaded connection with the threaded front end of the plunger 126. The cartridge 110 is pre- loaded with a liquid content 127. The liquid content 127 is typically a diluent to reconstitute a powdered drug. Alternatively, the liquid content 127 may contain an active component.
[0015] [0015] Drug vial 130 includes an open vial bottle 131, hermetically sealed, having the longitudinal axis 132, including a vial stopper 133 capped with a metal band 134. Vial 130 may contain a liquid drug content or powder 136. The powdered drug content 136 is typically stored under negative pressure, and needs to be reconstituted prior to administration. Alternatively, drug vial 130 may contain a liquid drug, suitable for transferring directly to an empty cartridge.
[0016] [0016] The fluid transfer device 140 has a longitudinal axis 141 and includes a main body with two ends 142, having a vial port 143 to telescopically receive a vial of drug 130, and a cartridge port 144, to receive slidable the front end of cartridge 113.
[0017] [0017] Vial port 143 includes a grooved edge 146, with a plurality of flexible members 147, having inwardly directed ribs 148 that are fitted to drug vial 130, and a piercing cannula 149, coaxial with longitudinal axis 141 of the fluid transfer device, to pierce the vial plug 133 when inserting the drug vial 130.
[0018] [0018] The cartridge port 144 includes a base surface 151, formed with a pair of cartridge supports 152 disposed opposite, to provide an axial support for the front end of the cartridge 113, slidably inserted therein. Cartridge port 144 also includes a piercing member 152 for piercing cartridge septum 117 when sliding insertion of the front end of cartridge 113. Piercing member 153 preferably consists of a metal needle with an outside diameter, for example , about 0.5 mm. The drilling member 153 is also coaxial with the longitudinal axis of the fluid transfer device, in fluid communication with the drilling cannula 149, to allow direct fluid communication between the cartridge 110 and the drug vial 130, when assembling the fluid transfer device 140, cartridge 110 and drug vial 130. The pair of cartridge holders 152 include teeth 154 (see Figure 10).
[0019] [0019] Cartridge port 144 is additionally provided with a combined cartridge attachment / ejection arrangement 160 to reliably attach the front end of cartridge 113 and to at least partially eject cartridge 110 loaded with a dose of drug net. The combined cartridge attachment / ejection arrangement 160 includes a pair of opposed elongated lever members 161A and 161B. The lever members 161 extend beyond the cartridge holders 152 and are co-directional with the longitudinal axis 141 in the initial position of the insert, to help guide the slide insert of the cartridge 110 into the cartridge port 144 (see Figures 5, 7, and 8A).
[0020] [0020] Lever members 161A and 161B respectively have front lever member ends 162A and 162B, adjacent to vial door 143 and rear lever member ends 163A and 163B, remote from vial door 143. The pair of members lever 161 pivot on the main body 142 at the ends of the front lever member 162, when manually levered from the initial cartridge insertion position, to tilt from longitudinal axis 141 to the final cartridge ejection position (see Figures 9, 10, 12).
[0021] [0021] The front ends of the lever members 162A and 166A have the respective edges 162A and 154B, rear edges 166A and 166B, and intermediate sections 167A and 167B. The front edges 164 have lower upper surfaces 168, 169, respectively, facing opposite directions, towards the vial port 143. The front edges 164 are formed including teeth 171, to couple pins 172 formed in the opposite cartridge holders 152, to allow a pivotal action of the pair of lever members 161. In the initial position of inserting the cartridge, the front edges 164 overlap the base surface 151, and define the separation between them, which must be less than the diameter of the front end of the cartridge 113.
[0022] [0022] Lever members 161 are dimensioned extending half extension along cartridge 110 when fully inserted into cartridge port 144, and at the rear lever member ends 163A and 163B are formed with finger holders directed transversely to out 173A and 173B with respect to longitudinal axis 141, to provide for the use of fluid transfer device 140 in a manner similar to a syringe.
[0023] [0023] The pair of lever members 161 is formed including shoulders 174 to engage the teeth 154 of the pair of cartridge holders 152, and secure the pair of lever members 161 in their initial co-directional position when sliding insertion of the cartridge 110 on cartridge port 144.
[0024] [0024] Figures 11A and 11B show the front surface of cartridge 119 topping the upper surfaces 168 of the front edges 164, when the front end of cartridge 113 is completely inserted into cartridge port 144, to be separated from the base surface 151. The Figures 11A and 11B also show intermediate sections 167 sized so that the rear edges engage the front end of cartridge 113 for fixing purposes.
[0025] [0025] Figure 12 shows the leverage of the pair of lever members 161, which makes the pair of lever members 161 pivot at their ends 162, so that their front edges 164 act against the front surface of cartridge 119, to eject, at least partially, the cartridge from the cartridge port 144, to help manually provide a complete sliding ejection of the cartridge therefrom.
[0026] [0026] Figures 13A to 13H show how to use kit 100 to reconstitute a dose of liquid drug, and aspirate the dose into the cartridge, as described below.
[0027] [0027] Figure 13A shows the user inserting a pre-loaded cartridge with thinner in the cartridge port, as represented by arrow A.
[0028] [0028] Figure 13B shows the user screwing a plunger into the preloaded cartridge, as represented by arrow B.
[0029] [0029] Figure 13C shows the user fitting the vial port onto the drug vial, as represented by the arrow C.
[0030] [0030] Figure 13D shows the user injecting the contents of the cartridge into the vial, for the purpose of reconstitution, as represented by the arrow D, to reconstitute a powdered drug in the drug vial, to form a reconstituted liquid drug LD (LD of Liquid Drug).
[0031] [0031] Figure 13E shows a drug vial loaded with the liquid drug LD.
[0032] [0032] Figure 13F shows the user inverting the fluid transfer device, drug vial, and cartridge assembly, and aspirating the LD liquid drug into the cartridge, as represented by the arrow E.
[0033] [0033] Figure 13G shows the user inverting the set.
[0034] [0034] Figure 13H shows the user manually levering outward on the pair of lever members in relation to the longitudinal axis, as represented by the arrow F, to partially eject the loaded cartridge from the cartridge port. The loaded cartridge can be readily ejected completely from the cartridge port.
[0035] [0035] Figures 14 and 15 show a fluid transfer device 180 of construction and operation similar to fluid transfer device 140. The first device 180 differs from the second device 140 with respect to the fact that the first device 180 includes an elongated door of cartridge 181 extending about half an extension along the cartridge 110, upon its complete insertion in it, and be integrally formed with a pair of finger supports directed transversely outward 182, to allow the use of fluid transfer device 180 similarly to a syringe. The fluid transfer device 180 includes a combined cartridge attachment / ejection arrangement 183 with a lever member 184 for attachment / ejection purposes. Lever member 184 at least partially ejects a loaded cartridge 110 by pressing on a front end of its open-ended tube 11 disposed opposite the front cartridge surface 110 in the case of the fluid transfer device 140.
[0036] [0036] Figures 16 to 18 show a fluid transfer device 190 of construction and operation similar to fluid transfer device 140. The first device 190 differs from the second device 140 with respect to the fact that the first device 190 includes a port elongated cartridge holder 101 including opposing cartridge holders 192 terminating at an annular cartridge holder base 193 constituted with a pair of outwardly directed finger holders 194 to allow use of the fluid transfer device 190 in a similar manner to a syringe. The elongated cartridge port 191 is formed with a discrete cartridge attachment arrangement 196 to secure the cartridge 110 to the cartridge port 191. The cartridge attachment arrangement 196 is similar to the finger-operated cartridge attachment arrangement of WO 2011 / 004360 of Figure 6 (see Figure 4), and includes a pair of opposing flexible members 197 which are resiliently flexibly mounted at the base of the cartridge door 193. Flexible members 197 have a finger operated member directed outwards 198 and end in a inward rib 199 to allow insertion by snapping into an intermediate neck of cartridge 114 upon sliding insertion of cartridge 110 into cartridge port 191. The depression of the pair of finger-operated members 198 against each other, as indicated by the arrow G presses out the ribs directed inward 19, thus releasing the cartridge 110.
[0037] [0037] The fluid transfer device 190 also includes a discrete cartridge ejection arrangement 201 to selectively eject, at least partially, cartridge 110 from cartridge port 191 to help manually eject a cartridge loaded therefrom. The discrete cartridge ejection arrangement 201 includes at least one cartridge ejection member 202 pressed in the insertion state when manually sliding insertion of a cartridge front end 113 into the cartridge port 191 in a position secured by a discrete arrangement of cartridge clamp 196. Cartridge ejection members 202 may consist of spring beam members, springs, etc. The cartridge ejection arrangement 201 includes a pair of spring beam members 202. When manually releasing the spring arrangement cartridge attachment 195 under the depression of the finger-operated member 198, the ejection members 202 extended outwardly force the front cartridge end 113 of the cartridge port 190 to help manually eject the loaded cartridge completely slidably.
[0038] [0038] While the present invention has been described with reference to a limited number of configurations, it should be appreciated that many variations, modifications, and other applications of the invention may be made within the scope of the appended claims.

权利要求:
Claims (7)
[0001]
Fluid transfer device (140; 180; 190), for use with a cartridge (110) and drug bottle (130), for loading a cartridge containing a dose of liquid drug, the cartridge including a tube with an open end (111 ) having a cartridge front end (113) and a cartridge rear end (116), the cartridge front end being sealed with a cartridge septum (117) and the rear cartridge end sealed with a sliding seal (121), the front end of the cartridge having the front surface of the cartridge (119), the drug vial including a drug vial bottle (131) containing the drug component (136), and having a drug vial opening sealed with a plug of drug vial (133), the fluid transfer device (140; 180; 190) comprising: a main body with two ends (142), having a longitudinal axis (141) and including a vial port (143) for telescopically receiving the drug vial (130) and having a perforation cannula (149) for perforating the drug vial (133) to provide fluid communication with the drug vial bottle (131), and a cartridge port (144; 181; 191) having: (i) a piercing needle (151) to pierce the cartridge septum (117), to provide fluid communication with the open end tube (111), when manually inserting the cartridge towards said bottle port (143 ), said cannula (149) providing fluid communication with said piercing needle (153) to provide the procedure for manually loading a cartridge with a dose of liquid drug; (ii) a cartridge fixing arrangement (160; 183; 184; 196) for releasably securing the cartridge (110) to said cartridge door (144; 181; 191), upon said manual sliding insertion therein; and characterized by the fact that the cartridge port further comprises: (iii) a cartridge ejection arrangement (160; 183; 184; 201) to eject, at least partially, the loaded cartridge from the cartridge port, to help complete the sliding ejection of the cartridge loaded therefrom.
[0002]
Device according to claim 1, characterized in that said cartridge port (144; 181) includes a combination of cartridge fixation and ejection arrangement (160; 183; 184) having at least one lever member (161 A; 161B; 184) with a front end of the lever member (162A; 162B) and a rear end of the lever member (163A; 163B) corresponding remote and adjacent from said bottle port (143), each of said at least one lever member being (161 A; 161B; 184) pivotable on said main body (142) on its said front lever member (162A; 162B), to be manually levered from a position of cartridge insertion, co-directional with the longitudinal axis (141), to allow said manual sliding insertion in said cartridge port (144; 181) to the cartridge eject position, to at least partially eject the cartridge loaded from the cartridge door.
[0003]
Device according to claim 2, characterized in that the aforementioned combined cartridge fixing / ejection arrangement (160) includes a pair of opposite elongated lever members (161 A; 161B), co-directional with the longitudinal axis ( 141), and sized to guide said manual sliding insertion of the cartridge (110) into said cartridge port (144).
[0004]
Device according to claim 3, characterized in that the aforementioned pair of opposed elongated lever members (161 A; 161B) are arranged to extend, in use, half extension along the cartridge (110) in the said initial cartridge insertion position, and each of said rear lever member end (163A; 163B) of said opposed lever member pair includes a finger holder directed transversely outward to allow the use of a device transfer fluid (140) in a manner similar to a syringe.
[0005]
Device, according to claim 2, characterized by the fact that the aforementioned cartridge door (181) is elongated and dimensioned to extend, in use, half extension along the cartridge (180), when said manual sliding insertion in the same , and formed with a pair of opposing transverse outwardly directed finger holders (182), to allow the use of a fluid transfer device (180) in a manner similar to a syringe.
[0006]
Device according to claim 1, characterized in that said cartridge ejection arrangement (201) includes at least one cartridge ejection member (202) pressed to the state inserted in said cartridge fixation (110) in said cartridge door (191), whereby, when manually releasing said cartridge attachment arrangement (196), said at least one cartridge ejection member (202) ejects, at least partially, the cartridge from said door cartridge.
[0007]
Device according to claim 6, characterized in that the aforementioned cartridge door (191) is elongated and dimensioned to extend, in use, half an extension along the cartridge (110), when said manual sliding insertion in the same , and formed with a pair of finger holders, transversely opposed (194), to provide the use of the fluid transfer device (190) in a similar manner to a syringe.

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法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

2019-10-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|

2020-08-04| B09A| Decision: intention to grant|

2020-11-24| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 07/04/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

IL219065|2012-04-05|

IL21906512A|IL219065D0|2012-04-05|2012-04-05|Fluid transfer device with manual operated cartridge release arrangement|

PCT/IL2013/050313|WO2013150538A1|2012-04-05|2013-04-07|Fluid transfer devices having cartridge port with cartridge ejection arrangement|

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