![]() fluid transfer set for use with a first vial and a second vial for reconstitution and liquid drug de
专利摘要:
fluid transfer set with ventilation arrangement. the present invention relates to a fluid transfer set including a vented female vial adapter and a male vial adapter for use with a pair of vials including a vial with negative pressure contents for reconstitution and liquid drug delivery . the vented female vial adapter includes a vent arrangement and the male vial adapter includes a sealing arrangement to selectively seal the vent arrangement. the fluid transfer set is designed so that only filtered air is drawn into the bottle under negative pressure, subsequent to the reconstitution of liquid medicine contents to ensure sterile conditions. 公开号:BR112012021134B1 申请号:R112012021134 申请日:2011-02-23 公开日:2020-01-21 发明作者:Lev Amir;Lev Nimrod;Niv Ben Shalon 申请人:Medimop Medical Projects Ltd; IPC主号:
专利说明:
Invention Patent Specification Report for FLUID TRANSFER ASSEMBLY FOR USE WITH A FIRST BOTTLE AND A SECOND BOTTLE FOR PURPOSE OF RECONSTITUTION AND LIQUID DRUG ADMINISTRATION. Field of the Invention [0001] The present invention relates to fluid transfer assemblies for reconstitution and liquid drug delivery. Background of the Invention [0002] The United States patent, commonly owned, No. 6,558,365, by Zinger and colleagues illustrates and describes a fluid transfer set including a pair of bottle adapters initially interlocked for use with a pair of bottles for reconstitution and liquid drug administration. These fluid transfer sets are commercially available under the registered trademark and industry name MIX2VIAL® of the present applicant Medimop Medical Projects Ltd., Ra'anana, Israel. The pair of bottle adapters includes a bottle adapter including a female connector hereinafter referred to as a female bottle adapter and another bottle adapter including a male connector hereinafter referred to as a male bottle adapter The male and female connectors are Luer connectors and, preferably, blocking Luer connectors. The vials typically include a vial containing diluent and another vial containing a powdered medicine under vacuum. Typical bottle sizes include 13 mm neck diameter and 20 mm neck diameter. [0003] The reconstitution and administration of liquid medication starting from an initial assembled configuration of a fluid transfer set includes the steps of: (a) maintaining the diluent containment bottle in Petition 870190095733, of 09/25/2019, p. 5/29 2/15 a flat surface and press down on the male bottle adapter on it; (b) reversing the fluid transfer set to hold the fluid transfer set upright with the male bottle adapter and its diluent containment bottle connected above the female bottle adapter; (c) keeping the medicine container on a flat surface and pressing down on the adapter with pressure on it, as a result of the vacuum prevailing in the medicine container, quickly pulls the diluent from the medicine container. diluent to form a reconstituted liquid drug and leave a residual vacuum in the sealed assembly of the fluid transfer assembly and the two connected vials; (d) gentle agitation of the sealed assembly of the fluid transfer assembly and the two connected vials to completely reconstitute the liquid drug in the vial connected to the female vial adapter; (e) separating the male bottle adapter from the female bottle adapter by unscrewing the male locking Luer connector from the female Luer connector; (f) screwing a syringe with a male locking Luer connector to the female vial adapter; (g) inversion of the female bottle adapter and its connected bottle for aspiration of the reconstituted liquid drug in the syringe; and (h) unscrewing the syringe from the female vial adapter, attaching a needle and administering the reconstituted liquid drug. [0004] Steps (a) to (d) are performed under sterile conditions, but step (e) draws ambient air to the bottle connected to the female bottle adapter via its female connector to equalize the presPetition 870190095733, of 25/09 / 2019, p. 6/29 3/15 are negative in the same. Ambient air, particularly in outpatient clinics, hospitals and the like, can be septic and therefore contaminate the contents of the reconstituted liquid drug. In addition, in some circumstances, female vial adapters are prepared prior to immediate use and left to rest for subsequent use, thereby leaving their contents of the reconstituted liquid drug exposed to ambient air. Summary of the Invention [0005] The present invention is directed to similar fluid transfer assemblies in construction and operation as the fluid transfer assemblies described so far and, additionally, provided to prevent the undesirable entrainment of potentially septic air into a connected vial to a female vial adapter in separating a male vial adapter from it, thus maintaining the sterility of a reconstituted liquid drug. This is achieved by replacing an unventilated female bottle adapter used so far with a ventilated female bottle adapter including a sealing arrangement having an air filter and one or more ventilation holes and providing a male bottle adapter from another conventional form with a sealing arrangement having one or more orifice sealing elements to seal the ventilation holes. [0006] The present invention is designed so that the step (e) mentioned above of separating the male bottle adapter from the female bottle adapter is effectively divided into a two-step process indiscernible to a user, as follows: first , the initial axial displacement causes the sealing arrangement to open ventilation holes in the female vial adapter to extract ambient air into its connected vial containing a reconstituted liquid drug through its air filter to equalize its residual vacuum. Petition 870190095733, of 09/25/2019, p. 7/29 4/15 al at room pressure before the male connector stops sealing the female connector. The air filter prevents septic air from being drawn into a container containing reconstituted liquid drugs, thus maintaining the sterility of its contents. And, second, the continued axial displacement to complete the mechanical separation of the male bottle adapter from the female bottle adapter. [0007] The fluid transfer sets of the present invention are preferably packaged as an ampoule with their male bottle adapters pre-assembled in their female bottle adapters, thus streamlining their use for reconstitution and administration purposes. Alternatively, a male vial adapter and a female vial adapter can be provided as separate components, requiring the user to mount the male vial adapter to the female vial adapter first, for reconstitution and administration. Fluid transfer assemblies can be pre-assembled in a ready to reconstitution state, namely, their male connectors seal their female connectors and their sealing arrangements seal their ventilation arrangements. Alternatively, fluid transfer assemblies can be pre-assembled in a state of not ready for reconstitution with their sealing arrangements displaced axially from their ventilation holes and therefore not sealing their ventilation arrangements. These fluid transfer assemblies require axial displacement of your male vial adapter towards your female vial adapter to urge your male connectors to seal your female connectors and their sealing arrangements to seal your ventilation arrangements, thus passing the assemblies of transferring fluid from its state of not ready for reconstitution to its state of ready for reconstitution. This axial displacement, preferably, occurs automatically during the Petition 870190095733, of 09/25/2019, p. 8/29 5/15 pressurized fitting of a fluid transfer set in its flasks for reconstitution purposes. The last state of not ready for reconstitution is considered to provide a longer service life than the first state of ready for reconstitution by virtue of the sealing device only sealing the ventilation arrangement, as required for reconstitution purposes and thus preventing inadvertent adhesion between them. [0008] The present invention can be readily implemented for use as a wide range of flasks, including, inter alia, flasks with a 13 mm diameter neck, flasks with a 20 mm diameter neck and so-called large diameter flasks, typically, neck with diameter of 28 mm, 32 mm and larger. One or more orifice sealing elements are preferably designed to further stabilize a male bottle adapter on a ventilated female bottle adapter as well as the seal of the one or more ventilation holes of the latter. Fluid transfer sets intended for use with large, large diameter bottles preferably include a vented female bottle adapter, having a female connector adapted to receive an IV tip. Fluid transfer assemblies can include alternative interlocking arrangements for a screwing arrangement, including, inter alia, friction fitting arrangements and the like. [0009] The female vial adapter can optionally be provided with a closure to seal its female connector to maintain a sterile environment for its contents of reconstituted liquid drug, following the mechanical separation of the male vial adapter from the vial adapter female. The closure may be in the form of a manually placed cap, a pre-division septum and the like. Brief Description of Drawings Petition 870190095733, of 09/25/2019, p. 9/29 6/15 [00010] In order to understand the invention and see how it can be carried out in practice, preferred modalities will now be described, by way of non-limiting examples only, with reference to the attached drawings in which similar parts are equally numbered and in what: [00011] Figure 1 is a pictorial representation of a fluid transfer set in an initial state of ready for reconstitution according to a first embodiment of the present invention, a syringe and a pair of vials, the fluid transfer set including a vented female bottle adapter and a male bottle adapter; figure 2 is a top perspective view of the vented female bottle adapter of figure 1 along line A-A in figure 1; Figure 3 is a cut-away perspective view of the vented female bottle adapter of Figure 1. figure 4 is a longitudinal cross-section of the male bottle adapter of figure 1; figure 5 is a cut-away perspective view of the vented female bottle adapter of figure 1; figure 6 is a front perspective view of an assembly of the fluid transfer assembly of figure 1 and two connected vials for reconstitution of liquid drug contents; figure 7 is a longitudinal cross-section of an assembly of figure 6 along line B-B; figure 8 is a longitudinal cross-section of an assembly of figure 6 along line B-B subsequent to the initial axial displacement of the male bottle adapter from the vented female bottle adapter; figure 9 is a front perspective view of the assembly Petition 870190095733, of 09/25/2019, p. 10/29 7/15 of figure 6 subsequent to the complete mechanical separation of the male bottle adapter from the ventilated female bottle adapter; figure 10 is a pictorial representation of a fluid transfer set in a ready for reconstitution state according to a second embodiment of the present invention; Figure 11 is a pictorial representation of the vented female bottle adapter and the male bottle adapter; figure 12 is a pictorial representation of a fluid transfer set in an initial state of ready for reconstitution according to a third embodiment of the present invention; figure 13 is a pictorial representation of the vented female bottle adapter and the male bottle adapter of figure 12; figure 14 is a pictorial representation of a fluid transfer set according to a fourth embodiment of the present invention for use with large diameter flasks and an IV tip; figure 15 is a longitudinal cross-section of the vented female bottle connector of figure 14 along line C-C; figure 16 is a longitudinal cross-section of the vented female bottle connector of figure 14 with an IV tip for liquid drug delivery; figure 17 is a pictorial representation of the vented female bottle adapter of figure 1, including a cap placed manually to seal its female connector; figure 18 is a cut-away perspective view of the vented female bottle adapter of figure 1, along line A-A in figure 1, including a pre-divided septum for sealing its female connector; figure 19 is a pictorial representation of a fluid transfer set in an initial state of not ready for recons Petition 870190095733, of 09/25/2019, p. 11/29 8/15 titution. The fluid transfer set, including a vented female bottle adapter and a male bottle adapter; figure 20 is a pictorial representation of the male bottle adapter of figure 19; figure 21 is a pictorial representation of the fluid transfer set of figure 19 in a ready for reconstitution state. Detailed Description of Preferred Modalities of the Invention [00012] Figure 1 shows a fluid transfer set 100 in an initial state ready for reconstitution for use with an empty syringe 10 and a pair of vials 20A and 20B that constitute medical vessels. The fluid transfer assembly 100 has a longitudinal axis 101 and includes a vented female bottle adapter 110 having a vent arrangement 110A and initially threaded on a male bottle adapter 130 having a sealing arrangement 130A for selectively sealing the arrangement ventilation fan 110A. Syringe 10 includes a cylinder 11 with a plunger 12 and a male locking Luer connector 13. Syringe 10 can be formed with other types of male connectors. Vials 20 include an open top bottle 21 sealed by a vial stopper 22 capped by a metal strip 23. Vial 20A has a vial interior 24 containing a powder or liquid medication 26 under negative pressure. Vial 20B has a vial interior 24 containing a liquid drug 27 for reconstituting the contents of vial 26 to form contents 28 of reconstituted liquid drug. The liquid drug 27 can be diluent or contain an active drug component. [00013] Figures 2 and 3 show the ventilated female bottle adapter 110 including a transverse top wall 11, a skirt hanging down 112 with bending elements 113 for fitting under Petition 870190095733, of 09/25/2019, p. 12/29 9/15 pressure in the vial 20A and a pointed downward cannula 114 having a liquid transfer lumen 116 for perforating the vial stopper 22 of the vial 20A and an oppositely directed female connector 117 in flow communication with the transfer lumen. liquid 116. Female connector 117 is preferably a female Luer connector, including an external thread 117A at its free end; [00014] The ventilation arrangement 110A includes an annular air filter 118 disposed below the top wall 111, four evenly spaced circular ventilation holes 119 formed in the top wall 111 and a ventilation lumen 121 formed in the pointed cannula 114 for establishment of flow communication between the ventilation holes 119 and the vial interior of the vial 20A, by pressing the female vial adapter 110 into the vial 20A under pressure. The ventilation holes 119 are flush with the top wall 111 and each includes a ventilation opening 122 and an elastomeric annular ring 123 disposed in the top wall 111 for sealing it in the application of an axial force. [00015] Figures 4 and 5 show the male bottle adapter 130 including a transverse top wall 131, a skirt hanging down 132 with flexing elements 133 for snapping onto the bottle 20B, a pointed cannula hanging down 134 with a liquid transfer lumen 136 for perforating the vial stopper 22 of the vial 20B and an oppositely directed male connector 137 in flow communication with the liquid transfer lumen 136. The male connector 137 is preferably a Luer connector male lock for screwing in with female 117 Luer connector. [00016] Sealing arrangement 130A includes a pair of opposing orifice sealing elements, axially directed, 138 to their Petition 870190095733, of 09/25/2019, p. 13/29 10/15 carrying an annular orifice sealing element 139 for applying an axial force over the elastomeric rings 123 for sealing the ventilation holes 119a in the initial state of ready for reconstitution of the fluid transfer set 100. The sealing arrangement 130A it also stabilizes the male vial adapter 130 on the vented female vial adapter 110 in the initial state of ready for reconstitution of the fluid transfer assembly 100. [00017] Figures 6 to 9 show the use of fluid transfer set 100 for reconstitution and administration purposes. [00018] Figures 6 and 7 show an assembly 140 of the fluid transfer assembly 100 fitted under pressure in the two vials 20A and 20B following steps (a) to (d) mentioned above, to form reconstituted liquid drug contents 28 in bottle 20A. Assembly 140 includes a female connector 117 in a sealed fitting with the male connector 137 and the sealing arrangement 130A sealing the ventilation holes 119 before pressurizing the fluid transfer assembly 100 in the vials 20A and 20B. The axial separation between the opposing top walls 111 and 131 is denoted by the height H1. The arrow P denotes the dragging of liquid drug 27 from bottle 20B to bottle 20A in order to form the reconstituted liquid drug contents 28. [00019] Figure 8 shows an initial axial displacement of the male bottle adapter 130 from the ventilated female bottle adapter 110 by the initial unscrewing of the male locking Luer connector 137 of the female Luer connector 117 denoted by the arrow Q. The initial axial displacement is denoted by the axial separation H2, where H2 is slightly larger than H1 and is designed to allow the sealing arrangement 130A to open the ventilation holes 119 before the male locking Luer connector 137 stops sealing the female Luer connector 117. The initial axial displacement is typically of the order Petition 870190095733, of 09/25/2019, p. 14/29 11/15 of the step of the locking Luer interlock between the male locking Luer connector 137 and the female locking connector 117. The opening of the ventilation arrangement 110A draws filtered air through the air filter 118 into the bottle 20A, as denoted by the arrows R to equalize your residual negative pressure with ambient pressure. [00020] Figure 9 shows continued axial displacement of the male bottle adapter 130 from the ventilated female bottle adapter 110 through continuous unscrewing of the male locking Luer connector 137 from the female Luer connector 117 until complete mechanical separation, thereby exposing the female Luer connector 117 for fixing the syringe 10 for administration of reconstituted liquid drug contents 27. [00021] Figures 10 and 11 show a fluid transfer set 150 similar in construction and operation to fluid transfer set 100 and, therefore, similar parts are numbered equally. The first 150 includes a vented female bottle adapter 110 with a ventilation arrangement 151 modified with respect to the ventilation arrangement 110A. Ventilation arrangement 151 includes open top ventilation holes 119 elevated relative to top wall 111 and each having a ventilation opening 122 inclined towards the longitudinal axis 101. Ventilation holes 119 are provided with elastomeric annular rings 123 for sealing them in the cavity by an annular orifice sealing element 139 in an initial state of ready for reconstitution of the fluid transfer assembly 150. [00022] Figures 12 and 13 show a fluid transfer set 160 similar in construction and operation to fluid transfer set 100 and, therefore, similar parts are numbered equally. The first 160 includes a ventilated female bottle adapter 110 with a modified ventilation arrangement 161 with respect to Petition 870190095733, of 09/25/2019, p. 15/29 12/15 tion to the 110A ventilation arrangement. Ventilation arrangement 161 includes ball-shaped ventilation holes 119 elevated from the top wall 111 and each having a ventilation opening 122 radially outwardly relative to the longitudinal axis 101 and fitted with a semicircular elastomeric rim 123, I The male bottle adapter 130 has three elongated orifice sealing elements 139 for sealing the ventilation orifices 119 in an initial state of ready for reconstitution of the fluid transfer assembly 160. [00023] Figure 14 shows a fluid transfer set 170 for use with a pair of large diameter flasks, for example, 32mm neck diameter and an IV 30 device including an IV 31 tip, chamber 32 and IV tubing 33. The fluid transfer set 170 is similar in construction to the fluid transfer set 100 and therefore similar parts are numbered equally. The fluid transfer set 170 includes a vented female vial adapter 171 including a vent arrangement 110A and a male vial adapter 172, including a sealing arrangement 130A. The fluid transfer set 170 has an initial state of ready for reconstitution with the male bottle adapter 127 with the screw thread fitted on the female bottle adapter 171. [00024] The female vented bottle adapter 171 differs from the female vented bottle adapter 110 in that its female connector 117 is shaped to receive the IV tip 31. Female bottle adapter 171 includes a female connector 117 which is taller with respect to its top wall 111 than the female bottle adapter of the female connector 117 of the female bottle adapter to sealably accommodate the IV tip 31. The male bottle adapter 172 includes an orifice sealing element 139 which is taller with Petition 870190095733, of 09/25/2019, p. 16/29 13/15 relative to its top wall 131 than the orifice sealing element 139 of the male bottle adapter 130 to compensate for the female connector 117 of the female bottle adapter 171. Figures 15 and 16 show the female connector 117 including a annular seal 173 for sealing a male connector 137 in an initial state of ready for reconstitution of the fluid transfer assembly 170 and an IV tip 31 during liquid drug administration. [00025] Figure 17 shows the vented female bottle adapter 110 of figure 1, including a manually placed cap 124 for sealing its female connector 117 following the reconstitution of liquid drug contents to maintain sterile conditions while the female bottle adapter 110 is left to rest for subsequent use. Alternatively, figure 18 shows the vented female bottle adapter 110 of figure 1 with a pre-divided septum 126 for the same purpose. [00026] Figure 19 shows a fluid transfer set 180 similar in construction to the fluid transfer set 100, but differing from it in that it has an initial state of not ready for reconstitution as opposed to the initial state of ready for reconstitution . The fluid transfer set 180 includes a female bottle adapter 181 having a vent arrangement 110A and a female connector 117 and a male bottle adapter 182, having a sealing arrangement 130A and a male connector 137. The female bottle adapter 181 may consist of a female vial adapter 110 for use with syringes 10 for administration purposes or a female vial adapter 171 for use with IV 30 devices for administration purposes. The male bottle adapter 182 correspondingly includes a properly shaped and dimensioned male connector 137. The difference between the state of not ready for reconstitution and the state of ready for reconstitution is that Petition 870190095733, of 09/25/2019, p. 17/29 14/15 in the first state the male bottle adapter 182 is axially displaced from the female bottle adapter 181, so that the male connector 137 does not seal the female connector 117 and the sealing arrangement 130A does not seal the ventilation arrangement 110A. [00027] Figure 20 shows the male bottle adapter 182 which is similar to the male bottle adapter 130, but differs from it in two aspects, as follows: The ventilation arrangement 130A additionally includes a pair of opposing fitting elements directed inwards 183 to fit a female connector 117 in the initial state of not ready for reconstitution for mounting the male bottle adapter 182 in the female bottle adapter 181. Also, the male bottle adapter 182 includes three equispaced clamping elements, directed axially, 184, laterally to the male connector 137 and having projections directed inwardly 186 to fit the screw thread 117A of the female connector, in axial displacement of the male bottle adapter towards the female bottle adapter. [00028] Figure 21 shows the fluid transfer set 180 according to fit under pressure of the male bottle adapter 182 in a bottle 20B containing a liquid medicine 27. A user applies a downward force F on the female bottle adapter 181 , causing the female bottle adapter 181 to move axially towards the male bottle adapter 182. The axial displacement causes the sealing arrangement 130A to seal the ventilation holes 119A and the male connector 137 to seal the female connector 117, thus, allowing the fluid transfer set 180 to enter its ready for reconstitution state. Inward directed projections 186 fit the external screw thread 117A similarly to a male locking Luer connector so that a user unscrews the male bottle adapter 182 from the female bottle adapter 181 for the initial opening of the vent arrangement 110aA Petition 870190095733, of 09/25/2019, p. 18/29 15/15 to allow aspiration of filtered air and the subsequent complete mechanical separation of the male bottle adapter 182 from the female bottle adapter 181. [00029] 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.
权利要求:
Claims (10) [1] 1. Fluid transfer set (100, 150, 160, 170, 180) for use with a first vial (20B) and a second vial (20A) for reconstitution and liquid drug delivery, the first vial (20B) having a vial opening and a vial stopper (22) sealing the vial opening and a vial inside (24) containing a liquid medication (27), the second vial having a vial opening and a vial stopper (22 ) sealing the opening of the bottle and the inside of a bottle (24) containing a medicine (27) under negative pressure, the liquid medicine (27) intended to reconstitute the medicine from the second bottle (26) to form reconstituted liquid drug contents (28 ), the fluid transfer assembly having a longitudinal axis (101) and comprising: (a) a female bottle adapter (110, 171, 181) having a top wall (111), a skirt (112) with flexing elements (113) for snapping onto the second bottle (20A), a pointed cannula (114) for piercing the bottle stopper of the second bottle under pressure fitting of said female bottle adapter in the second bottle, said pointed cannula including a liquid transfer lumen (116) for establishing flow communication with the interior of second bottle vial and a female connector (117) in flow communication with said liquid transfer lumen; and (b) a male bottle adapter (130, 172, 182) having a top wall (131), a skirt (132) with flexing elements (133) for snapping onto the first bottle (20B), a cannula pointed (134) for piercing the bottle stopper of the first vial under pressure of said male bottle adapter in the first vial, said pointed cannula including a liquid transfer lumen (136) for establishing communication Petition 870190095733, of 09/25/2019, p. 20/29 [2] 2/5 flow with the bottle interior of the first bottle and a male connector (137) in flow communication with said liquid transfer lumen; and for sealing said female connector in the assembly of said male bottle adapter in said female bottle adapter for reconstitution of liquid drug contents, characterized by the fact that said female bottle adapter having a ventilation arrangement (110A, 151, 161) including (i) an air filter (118) underlying said top wall (111); ii) at least one ventilation hole (119) formed in said top wall; and iii) a ventilation lumen (121) formed in said pointed cannula (114) for establishing flow communication between said at least one ventilation orifice and the vial interior of the second vial under pressure of said vial adapter female in the second bottle; and said male bottle adapter having a sealing arrangement (130A) for sealing said at least one vent hole during reconstitution of the liquid drug contents, the arrangement being as per the second fitting under initial pressure of i) o said male bottle adapter in the first bottle (20B) and then ii) said female bottle adapter in the second bottle (20A), the negative pressure of the second bottle drags the liquid medicine from the first bottle for reconstitution with your medicine to reconstitute the reconstituted liquid drug contents, the subsequent axial displacement of said male vial adapter from said female vial adapter initially displaces said sealing arrangement (130A) from said at least one vent hole (119) to open said sealing arrangement, while said male connector seals Petition 870190095733, of 09/25/2019, p. 21/29 [3] 3/5 the said female connector, so that the second bottle draws filtered air only to it to equalize its negative pressure and then complete the mechanical separation of said male bottle adapter from said female bottle adapter to allow for administration of the reconstituted liquid drug contents (28). 2. Assembly according to claim 1, characterized in that said sealing arrangement (130A) includes at least one axially directed orifice sealing element (138) for sealing said at least one ventilation hole (119) ) during the reconstitution of liquid drug contents. 3. Assembly according to claim 2, characterized in that said at least one axially directed orifice sealing element (138) includes an annular orifice sealing element (139) for simultaneously sealing at least one ventilation hole during the reconstitution of liquid drug contents. [4] 4. Assembly according to any one of claims 1 to 3, characterized in that said fluid transfer assembly is pre-assembled in an initial state of ready for reconstitution, including said male bottle adapter mounted on said female bottle adapter, said male connector (137) sealing said female connector (117) and said sealing arrangement (130A) sealing said at least one ventilation hole (119). [5] Assembly according to any one of claims 1 to 3, characterized in that said fluid transfer assembly is pre-assembled in an initial state of not ready for reconstitution, including said assembled male bottle adapter in said female bottle adapter and said sealing arrangement (130A) displaced axially from said at least one ventilation hole (119), thereby not sealing the Petition 870190095733, of 09/25/2019, p. 22/29 4/5 said ventilation arrangement, said fluid transfer assembly requiring axial displacement of said male bottle adapter towards said female bottle adapter to urge said male connector (137) to seal said female connector (117) and said sealing arrangement for sealing said at least one vent hole, thereby allowing said fluid transfer set from said initial state of not ready for reconstitution to a state of ready for reconstitution. [6] 6. Assembly according to claim 5, characterized in that said sealing arrangement (130A) includes at least one locking element directed inwards (183) to fit said female connector (117) in said initial state from not ready for reconstitution for mounting said male bottle adapter to said female bottle adapter. [7] 7. Assembly according to claim 5, characterized in that said male bottle adapter includes at least two clamping elements (184) directed axially, laterally to said male connector (137) and having projections (186 ) directed inwardly to engage the free end of said female connector in said axial displacement of said male bottle adapter towards said female bottle adapter. [8] An assembly according to any one of claims 1 to 7, characterized in that said female connector (117) includes an internal annular seal (173) for sealing fit with said male connector (137) during reconstitution of the liquid drug contents and an IV tip (31) during liquid drug administration. [9] 9. Assembly according to any one of claims 1 to 8, characterized by the fact that said female connector Petition 870190095733, of 09/25/2019, p. 23/29 5/5 (117) includes a manually placed cap (124) for sealing said female connector subsequent to said complete mechanical separation of said male bottle adapter from said female bottle adapter. [10] 10. Assembly according to any one of claims 1 to 9, characterized in that said ventilation arrangement (161) includes at least one covered ventilation hole (119) having a ventilation opening (122) facing radially out with respect to said longitudinal axis (101).
类似技术:
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同族专利:
公开号 | 公开日 WO2011104711A1|2011-09-01| US8684994B2|2014-04-01| IL219792A|2015-01-29| EP2512399B1|2015-04-08| IL219792D0|2012-07-31| US20120323210A1|2012-12-20| DK2512399T3|2015-06-22| CN102711712B|2014-08-13| CN102711712A|2012-10-03| JP2013520272A|2013-06-06| BR112012021134A2|2016-05-17| EP2512399A1|2012-10-24| JP5416848B2|2014-02-12|
引用文献:
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法律状态:
2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]| 2019-08-06| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]| 2019-12-10| B09A| Decision: intention to grant [chapter 9.1 patent gazette]| 2020-01-21| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 23/02/2011, OBSERVADAS AS CONDICOES LEGAIS. |
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申请号 | 申请日 | 专利标题 IL20414110|2010-02-24| PCT/IL2011/000186|WO2011104711A1|2010-02-24|2011-02-23|Fluid transfer assembly with venting arrangement| 相关专利
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