• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    fluid transfer device with sealing arrangement the present invention relates to fluid transfer devices including a vial adapter having an upper wall and a cannula with a cannula tip and a sealing element like an el-ring sticking the cannula with sealing and initially arranged towards the cannula tip and separated from the upper wall, the sealing element being brought into initial contact with the vial stopper subsequent to the cannula port, contact the vial stopper at a puncture site and then being propelled by sliding to the top wall and continuously sealing the puncture site during the assembly by pressing the bottle adapter into the bottle.
    公开号:BR112012011419B1
    申请号:R112012011419-0
    申请日:2010-10-19
    公开日:2020-01-07
    发明作者:Nimrod Lev；Niv Ben Shalom
    申请人:Medimop Medical Projects Ltd.；
    IPC主号:
    专利说明:

    Invention Patent Specification Report for FLUID TRANSFER DEVICE FOR USE WITH A
    MEDICINAL BOTTLE HAVING A LONGITUDINAL GEOMETRIC AXIS OF THE BOTTLE.
    Field of the invention [001] The present invention relates to fluid transfer devices for use with medicinal containers hermetically sealed by an elastic bottle stopper and containing a liquid or powdered medicine.
    Background of the invention [002] Fluid transfer devices including a vial adapter with a pointed cannula for snapping a medical container or vial mentioned above are now generally used for reconstitution and liquid drug delivery purposes. Such devices include, but are not limited to, female bottle adapters, male bottle adapters, the applicant's MIXJECT® fluid transfer device, the applicant's MIX2VIAL® fluid transfer assembly, and so on. Tears can be formed in a stopper of the bottle during fitting by pressing a fluid transfer device into it leading to leaks of the liquid contents during injection into and aspiration of the bottle. The tears also complicate the reconstitution of the liquid drug in the fluid transfer assemblies, for example, the aforementioned MIX2VIAL® fluid transfer assembly, aided by a negative pressure from a vial containing powder.
    [003] Tears often result from an initial inaccurate alignment between a fluid transfer device and a vial due to the latter centering the first when it presses into it, such that the fluid transfer device is mounted with concentrically press fit in the bottle. The alignment
    Petition 870190081960, of 08/22/2019, p. 9/24
    2/10 initial inaccuracy can be in the form of an inclined alignment between a fluid transfer device and a vial or an eccentric alignment between them particularly in the case of a vial adapter with a tapered skirt to help guide a vial adapter in a bottle. But tears can still occur even in the case of an initial concentric alignment between a fluid transfer device and a bottle due to the constitution of an elastic bottle stopper.
    [004] US Publication No. 2004/0236305 entitled Fluid Transfer Device illustrates and describes a fluid transfer device for mounting in a medical container. The fluid transfer device includes a receiving cap and a penetrating mandrel to pierce an elastic stopper. Regarding its direction of penetration, the penetrating mandrel has a penetrating front portion and a rear sealing portion that is larger in diameter to seal the tear in a stopper. An alternative embodiment includes providing a rear sealing portion with an elastic O-ring fixedly mounted to provide additional sealing capability.
    [005] US Patent No. 5,374,264 entitled Universal Fitting for
    Inoculation Receptacles illustrates and describes a fluid transfer device for mounting in a medical container. The fluid transfer device includes a vial adapter with an upper wall, a skirt and a pointed cannula provided with a liner to fold like an accordion when it is compressed between the upper wall and the elastic stopper of the medical container. Summary of the invention [006] The present invention is directed to fluid transfer devices with a sealing arrangement to prevent leakage of medicinal containers or vials containing medicament. Fluid transfer devices include an adapter
    Petition 870190081960, of 08/22/2019, p. 10/24
    3/10 vial pain having an upper wall, a descending drooping skirt with flexible members to snap into a vial having a vial stopper, a pointed tubular cannula to penetrate the vial stopper while snapping the vial adapter into the vial flask and a flow channel in flow communication with the cannula to enable the communication of the external flow with the inside of the flask. The bottle adapter can have a general cylindrical shaped skirt or a so-called tapered skirt to aid orientation in a bottle.
    [007] Each of the fluid transfer devices includes a sealing element such as an elastic O-ring arranged along a cannula and surrounding it with a seal. A sealing element is designed to seal the immediate proximity surrounding a puncture site of your cannula when the sealing element contacts a stopper of the bottle and to be propelled by sliding along a cannula to the top wall when a transfer device is used. fluid presses into a bottle to maintain a continuous sealing contact with a puncture site, thereby sealing any tears resulting from mounting the pressure fitting despite the reason for its formation. The sealing element is typically compressed axially between the upper wall of the fluid transfer device and the bottle stopper in the full pressure fitting assembly of the first in the latter, with which the sealing element extends radially outward to cover a greater area on the uppermost surface of the cork.
    [008] The initial location of a sealing element along a cannula depends on whether a sealing element is designed to prevent leakage of negative pressure or leakage of liquid. In the first case, a sealing element is necessarily arranged along a cannula towards its tip of the cannula, such that it
    Petition 870190081960, of 08/22/2019, p. 11/24
    4/10 contact the bottle stopper before the bottle is perforated. In the latter case, a sealing member can be disposed further from a tip of the cannula. Fluid transfer devices with proportionally sized sealing elements can be designed for use with different standard bottle sizes, for example, 13 mm, 20 mm and larger. The present invention can be readily applied to conventional fluid transfer devices including a vial adapter with a pointed cannula.
    Brief description of the drawings [009] 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 the accompanying drawings in which similar parts are numbered the same and in which:
    [0010] Figure 1 shows an illustrated representation of a syringe, a bottle having a bottle stopper and a conventional bottle adapter, [0011] Figure 2 is a bottom perspective view of the bottle adapter of figure 1, [0012 ] Figures 3A to 3E show the process of assembling the pressure fitting of the bottle adapter of figure 1 in a bottle and the process of tearing in its bottle stopper due to an initial eccentric misalignment between the bottle adapter and the bottle, [0013] Figure 4 is a front perspective view of a bottle adapter including a sealing element according to the present invention, [0014] Figure 5 is a bottom perspective view of the bottle adapter of figure 4 , [0015] Figure 6 is a longitudinal section of the bottle adapter from
    Petition 870190081960, of 08/22/2019, p. 12/24
    5/10 figure 4 along line AA showing its sealing element in its initial position, [0016] Figure 7 is a close perspective view of the sealing element of the bottle adapter of figure 4, [0017] figures 8A to 8E show the pressure fitting assembly process of the bottle adapter of figure 4 in a bottle and its sealing element sealing any tears, [0018] Figure 9 shows an illustrated representation of a MIXJECT fluid transfer device ® of the applicant including a bottle adapter mounted with pressure fitting on a bottle and [0019] Figure 10 is a longitudinal section of the applicant's MIX2VIAL® fluid transfer assembly including a male bottle adapter and a female bottle adapter, each adapted with a sealing element.
    Detailed description of the preferred embodiments of the invention [0020] Figure 1 shows a syringe 10 constituting a source of physiological fluid, a vial 20 constituting a medical container and a fluid transfer device 30 constituting a female adapter of the vial for use with the syringe 10 and vial 20, all known in the art. Syringe 10 includes a tube 11 with a plunger 12 and a Luer lock connector 13. Syringe 10 can be formed with other types of male connectors. The flask 20 has a longitudinal geometric axis of the flask 20A and includes a flask body 21 with a flask edge 22 and a narrow diameter neck 23 intermediate the flask body 21 and the flask edge 22. The flask edge 22 defines an opening of the bottle 24 hermetically sealed by an elastic stopper of the bottle 26, and capped by a metal strip 27. The stopper of the bottle 26 has a stopper thickness T adjacent to the geometric axis of the bottle 20A. The body of the bottle 21 defines an interior of the
    Petition 870190081960, of 08/22/2019, p. 13/24
    6/10 vial 28 containing contents of vial 29 in powder or liquid form. The stopper of the bottle 26 has a more upper surface of the stopper 26A. The syringe typically contains diluents to reconstitute the contents of the bottle 29.
    [0021] The fluid transfer device 30 consists of a female adapter of the bottle 31 having a longitudinal geometric axis of the adapter 31A and including an upper wall 32, a tapering downward sloping skirt 33 with several flexible members 34 for snap fit in the vial 20, a pointed tubular cannula 36 with a cannula tip 37 to pierce the stopper of vial 26, and a flow communication lumen 38 in flow communication with cannula 36. The female adapter of vial 31 includes a communication lumen flow 38 terminating at a Luer lock 39 female connector to seal the syringe 10 thread assembly on it. The flexible members 34 have a first portion 34A near the upper wall 32 including an inwardly directed protuberance 41 for snapping under the rim of the bottle 22 and a second portion 34B distal to the upper wall 32. The second portions 34B subtend an obtuse angle exterior relative to its first portions 34A. The conical skirt 33 aids in the assembly of the fluid transfer device 30 in the bottle 20, but can lead to relative large eccentric misalignments when compared to skirts in generally cylindrical shape.
    [0022] Figures 3A to 3E show the pressure fitting assembly process of the fluid transfer device 30 in the bottle 20 with reference to a horizontal surface S and the tear formation process in the bottle stopper 26.
    [0023] Figure 3A shows an initial stage of fitting with pressure fitting of the fluid transfer device 30 in the vial 20 starting from an initial eccentric misalignment represented
    Petition 870190081960, of 08/22/2019, p. 14/24
    7/10 by an initial misalignment distance MD1 between the geometric axis of the bottle 20A and the geometric axis of the adapter 31A. The tip of the cannula 37 contacts the stopper of vial 26 at a PS puncture site.
    [0024] Figure 3B shows a second stage of pressure-fitting assembly of the fluid transfer device 30 in vial 20. The depression of the vial adapter 31 to vial 20 represented by arrow A causes its tip of the cannula 37 begin to penetrate the stopper of the vial 26 at the puncture site PS and the slight flexion out of the flexible member 34 on the left. The MD offset distance remains unchanged.
    [0025] Figure 3C shows a third stage of the press-fit assembly of the fluid transfer device 30 in the bottle 20. The additional depression of the fluid transfer device 30 in the bottle 20 as represented by the arrow B causes the skirt 33 align the fluid transfer device 30 with the vial 20 to reduce the misalignment distance to a reduced distance MD2 where MD2 <MD1. Such alignment pushes the cannula 36 towards the geometric axis of the vial 20A, which in turn causes the tip of the cannula 37 to start a tear 42 on the uppermost surface of the stopper 26A.
    [0026] Figure 3D shows a fourth stage of pressure-fitting assembly of the fluid transfer device 30 in vial 20, in which the first 30 is fully concentric with the last 20 and the tip of the cannula 37 has fully penetrated through the stopper of the flask 26 to establish flow communication with the interior of the flask 28, but before the fluid transfer device 30 engages by pressure in the flask 20. The slot 42 can extend through the stopper of the flask 26, thereby creating a leakage trajectory. The final MD misalignment distance is zero.
    [0027] Figure 3E shows the last stage of the assembly with en
    Petition 870190081960, of 08/22/2019, p. 15/24
    8/10 pressure vessel of the fluid transfer device 30 in the bottle
    20, in which the flexible members 34 engage by pressure on the rim of the bottle 22.
    [0028] Figures 4 to 7 show a fluid transfer device 50 consisting of the female adapter of the bottle 31 and, therefore, the same reference numbers are used. The fluid transfer device 50 additionally includes a sealing element such as elastic O-ring 51. Sealing element 51 is formed of relatively soft elastic material, for example, silicon, or other elastomeric material, which is considerably softer than than the bottle stopper 26. O-rings are generally considered to have a hardness rating of 60-90 in the Shore A range with 70 Shore A being the standard. The sealing element 51 is formed of a relatively soft elastic material, preferably less than 50 Shore A and in the range of 5 - 35 Shore A. The manual application of an axial compressive force F to the sealing element 51 makes the sealing element seal expand outward in a radial direction E across the axial compression force F to assume a flattened toroidal shape (see figure 8E).
    [0029] The sealing element has a tubular main body 52 and a converging tubular front section 53 having a front surface 54. The sealing element 51 is adapted with sliding in the cannula 36 and arranged along it towards the upper wall 32 for away from the tip of the cannula 37 to leave an exposed length of the cannula L between the front surface 54 and the tip of the cannula 37. The exposed length of the cannula L is shorter than the thickness T of the stopper, such that the sealing element 51 contact the stopper of vial 26 before cannula 36 penetrates through it. The sealing element 51 seals the cannula 36 to form an airtight seal that is continuously maintained by sliding the
    Petition 870190081960, of 08/22/2019, p. 16/24
    9/10 sealing element 51 for the upper wall 32 as opposed to its bearing for it as can occur with a Shore assessment
    The toughest.
    [0030] Figures 8A to 8E show the same steps as figures 3A to 3E for the press fit assembly of the fluid transfer device 50 in the vial 20 to seal the slot 42. Figure 8A shows the tip of the cannula 37 contacting the surface of the cork 26A at the puncture site PS and the sealing element 51 initially arranged above the surface of the cork 26A. Figure 8B shows the sealing element 51 approaching the surface of the stopper 26A when the tip of the cannula 37 begins to tear the stopper of the bottle 26 starting from the puncture site PS. Figure 8C shows the fluid transfer device 50 starting to press fit into the vial 20 and the sealing element 51 sealing the puncture site PS and therefore the slot 42. Figure 8D shows the sealing element 51 being pushed with sliding to the upper wall 32 when the fluid transfer device 50 is lowered further into the bottle 20. The sealing element 51 continuously maintains a sealing wrap of the cannula 36 and seals the puncture site PS. Figure 8E shows the sealing element 51 being axially compressed between the upper wall 32 and the surface of the stopper 26A in the complete pressure fitting assembly of the fluid transfer device 50 in the bottle 20. The sealing element 51 is deformed for its compressed toroidal shape and continues to seal the slot 42.
    [0031] Figure 9 shows an illustrated representation of a MIXJECT® 60 fluid transfer control device including a vial adapter 61 snapped onto a vial 20. Vial adapter 61 can be attached with a sealing member 51 Figure 18 shows a longitudinal section of a MIX2VIAL® 70 fluid transfer assembly including a ma adapter
    Petition 870190081960, of 08/22/2019, p. 17/24
    10/10 vial choke 71 and a vial female adapter 72 similar to the vial female adapter 31. Vial adapters 71 and 72 can each be fitted with a sealing member 51.
    [0032] Although the invention has been described with respect to a limited number of modalities, it will be found 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 (6)
    [1]
    1. Fluid transfer device (50) for use with a medical vial (20) having a longitudinal axis of the vial (20A) and including a vial body (21) having a vial interior (28) for storing a medication , an edge of the bottle (22) defining an opening of the bottle (24), a narrow neck (23) intermediate the body of the bottle and the edge of the bottle, a stopper of the bottle (26) sealing the opening of the bottle and having a thickness Stopper T near the geometric axis of the bottle, the bottle stopper having a more upper surface of the stopper (26A), the fluid transfer device characterized by the fact that it comprises:
    a) a bottle adapter (31) having a longitudinal geometric axis of the adapter (31A) and including an upper wall (32) transverse to said geometric axis of the adapter, a descending pendant skirt (33) with flexible members (34) to fit by pressing on the rim of the bottle for concentric assembly of said bottle adapter in the bottle, a tubular cannula (36) having a pointed tip (37) to initially contact the bottle stopper (26) at a puncture site and drilling through it to establishing flow communication with the interior of the bottle in said pressure-fitting assembly, and a flow communication channel (38) in flow communication with said cannula (36); and
    b) a sealing element such as an elastic O-ring (51) sealing said cannula, said sealing element being initially disposed along said cannula and separated from said upper wall (32) and said cannula tip ( 37) to leave an exposed length L of the cannula between said sealing element and said cannula tip, said sealing element arranged with respect to the cannula so that, in use, during the assembly of the vial adapter
    Petition 870190081960, of 08/22/2019, p. 19/24
    [2]
    2/2 (31) in the vial, the sealing element is placed in initial contact with the vial stopper (26) subsequent to said tip of the cannula (37) contacting the vial stopper at said puncture site and then it is pushed with sliding to said upper wall, to continuously seal said puncture site during said fitting by pressing said bottle adapter into the bottle.
    2. Device according to claim 1, characterized in that said sealing element (51) includes a tubular main body (52) and a converging tubular front section (53) facing said cannula tip (37) ).
    [3]
    Device according to claim 1 or 2, characterized by the fact that, when in use with a medical bottle, (20) said exposed length L of the cannula is shorter than said stopper thickness T, such that said sealing element (51) contacts the stopper of the bottle before said cannula (36) punctures through it.
    [4]
    Device according to any one of claims 1 to 3, characterized in that said sealing element (51) deforms in a radial direction when compressed axially between said upper wall (32) and the uppermost surface of the stopper (26A).
    [5]
    Device according to any one of claims 1 to 4, characterized in that said sealing element (51) has a hardness rating of less than 50 Shore A.
    [6]
    6. Device according to any one of claims 1 to 5, characterized in that said sealing element (51) has a hardness rating in the range of 5 to 35 Shore A.
    类似技术:
    公开号 | 公开日 | 专利标题
    BR112012011419B1|2020-01-07|FLUID TRANSFER DEVICE FOR USE WITH A MEDICINAL BOTTLE HAVING A LONGITUDINAL GEOMETRIC AXIS OF THE BOTTLE
    US4201208A|1980-05-06|Sterile connecting device
    US6019751A|2000-02-01|Universal connector and a medical container
    EP1267794B1|2010-05-12|Housing capable of connecting a container to a medical device
    US6692478B1|2004-02-17|Swabbable needleless vial access
    EP1029526B1|2004-09-15|Medicament container stopper with integral spike access means
    US6186997B1|2001-02-13|Multiple use universal connector
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    AU2004200879A1|2004-09-23|Transfer device
    US20060253103A1|2006-11-09|Removable cap needle access site
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    US4592092A|1986-05-27|Medical solution container and port construction therefor
    JPH11321916A|1999-11-24|Repeatedly versatile plug
    BR102016019801A2|2017-05-23|sterile coupling system between a sterile inner chamber of a vial for containing medical or nutritional active substances and a tube for extracting said active substances and mixing them with a sterile liquid diluent solution in a container
    US20220040042A1|2022-02-10|Liquid transfer devices for use with intravenous | bottles
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    同族专利:
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    IL219570A|2017-02-28|
    BR112012011419A2|2016-05-03|
    IN2012DN03351A|2015-10-23|
    DK2490647T3|2014-03-10|
    WO2011058545A1|2011-05-19|
    JP5507700B2|2014-05-28|
    US20120220978A1|2012-08-30|
    CN102985047B|2015-07-01|
    EP2490647A1|2012-08-29|
    IL219570D0|2012-06-28|
    EP2490647B1|2013-12-18|
    JP2013510633A|2013-03-28|
    US8608723B2|2013-12-17|
    ES2446972T3|2014-03-11|
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    法律状态:
    2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-07-23| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2019-11-19| B09A| Decision: intention to grant|
    2020-01-07| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 19/10/2010, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    IL20206909A|IL202069D0|2009-11-12|2009-11-12|Fluid transfer device with sealing arrangement|
    IL202069|2009-11-12|
    PCT/IL2010/000854|WO2011058545A1|2009-11-12|2010-10-19|Fluid transfer devices with sealing arrangement|
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