巴西专利BR112015005157B1 telescopic female drug bottle adapter

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专利摘要:
TELESCOPIC FEMALE PHARMACEUTICAL BOTTLE ADAPTER. A telescopic female drug bottle adapter including a tip component telescopically mounted on a skirt component to snap-fit and pierce a drug bottle in an actuated position. The telescopic female drug bottle adapter is particularly suitable for implementation in a ventilated version to prevent moistening of your air filter while aspirating liquid contents from a drug bottle.
公开号:BR112015005157B1
申请号:R112015005157-0
申请日:2012-10-17
公开日:2020-12-08
发明作者:Nimrod Lev；Igor Denenburg；Mordechai Bukhman
申请人:Medimop Medical Projects Ltd；
IPC主号:

专利说明:

FIELD OF THE INVENTION
[0001] The invention relates to general drug vial adapters and female drug vial adapters in particular. BACKGROUND OF THE INVENTION
[0002] Commonly Owned PCT International Application No. PCT / IL2006 / 000912 entitled “Liquid Drug Transfer Devices for Failsafe Correct Snap Fitting onto Medicinal Vials” and published under PCT International Publication No. WO 2007/017868 illustrates and describes liquid drug transfer devices including a drug vial adapter designed for guided alignment with the drug vial prior to pressure fitting and perforating it to ensure flow communication with the vial interior of drug. Figure 4 of WO 2007/017868 illustrates a ventilated female drug vial adapter for use with a needleless syringe.
[0003] A WO 2007/017868 drug vial adapter includes an upper wall with a perforating element hanging down and an opposite upright access hole in flow communication with the perforating element. The upper wall is also formed with a generally cylindrical skirt surrounding the perforation element. The generally cylindrical skirt includes at least four flexible axially directed elements, longer than the piercing element, to prevent the piercing element from contacting a drug bottle cap of the drug bottle before aligning the medicine bottle adapter and of the drug bottle. Axially directed flexible elements include two non-adjacent flexible drug vial retaining elements for snapping onto a drug vial opening for drug vial retention purposes and at least two non-adjacent flexible vial guide elements longer than their counterparts of flexible drug vial retaining elements to guide the drug vial adapter with respect to a drug vial prior to pressure fitting therein.
[0004] A ventilated female drug vial adapter from WO2007 / 017868 includes a double lumen piercing element having a liquid transfer lumen and a ventilation lumen. The liquid transfer lumen is in flow communication with a female connector for sealingly receiving a needle-free syringe. The ventilation lumen is in flow communication with a generally circular air filter formed on the upper wall. The inversion of the ventilated female drug vial adapter for aspiration of its liquid medicine contents leads to the undesirable entry of the liquid medicine contents into the ventilation lumen and moistening of the air filter, therefore decreasing its ability to allow filtered air to pass through of the same for pressure equalization purposes during aspiration.
[0005] There is a need for female drug vial adapters for guided alignment with respect to a drug vial for mounting and drilling, but with a longer piercing element. SUMMARY OF THE INVENTION
[0006] The present invention is directed to female drug fragrance adapters including a double component construction having a tip component telescopically mounted on a skirt component for manual displacement from a configuration position to an actuated position for tight fitting and perforation. a vial of drug. Manual displacement of the tip component to the skirt component provides initial guided alignment of the drug vial adapter with respect to a drug vial prior to fitting it tightly and puncturing it.
[0007] The present invention is particularly advantageous for ventilated female drug vial adapters that can be provided with a long piercing element having a ventilation lumen with a ventilation lumen opening at its piercing tip. Ventilated female drug vial adapters are intended for use with needle-free syringes filled with a predetermined volume of liquid contents so that, when reversing a ventilated female drug vial adapter shown in a drug vial with drug contents liquid for aspiration purposes, the opening of the ventilation lumen is above the liquid level of the liquid drug contents in a manner similar to a swimming snorkel. Due to this provision, liquid drug contents are prevented from entering the ventilation lumen and moistening the air filter. BRIEF DESCRIPTION OF THE DRAWINGS
[0008] In order to understand the invention and see how it can be carried out in practice, a preferred embodiment will now be described, by way of a non-limiting example only, with reference to the attached drawings in which similar parts are equally numbered, and in which: Figure 1 is a pictorial representation of a syringe, a drug vial including a longitudinal cross section, and a ventilated telescopic female vial adapter having a longitudinal drug vial adapter shaft in a preparation position; figure 2 is an exploded view of the ventilated telescopic female drug vial adapter; Figure 3 is a top plan view of the telescopic female drug vial adapter along the longitudinal drug vial adapter axis; figure 4 is a longitudinal cross section of the telescopic female drug vial adapter along line A-A in figure 3 in a preparation position; figure 5 is a longitudinal cross section of the ventilated telescopic female drug vial adapter along line BB in figure 3 in its preparation position; figure 6 is a longitudinal cross section of the ventilated telescopic female drug vial adapter along line A-A in figure 3 in an actuated position; Figure 7 is a longitudinal cross-section of the ventilated telescopic female drug vial adapter along line BB in Figure 3 in an actuated position; figure 8A is a longitudinal cross section of the telescopic female drug bottle adapter and the drug bottle along line A-A in figure 3 prior to use; figure 8B is a longitudinal cross section of the ventilated telescopic female drug vial adapter and the drug vial along line A-A in figure 3 according to an initial downward depression from the first to the last; Figure 8C is a longitudinal cross-section of the ventilated telescopic female drug vial adapter and drug vial along line A-A in Figure 3 according to a continuous downward depression from the first to the last; figure 8D is a longitudinal cross-section of the ventilated telescopic female drug vial adapter completely mounted on and perforating the drug vial along line A-A in figure 3; figure 8E is a longitudinal cross section of the ventilated telescopic female drug vial adapter completely mounted on and perforating the drug vial along line B-B in figure 3; figure 8F is a longitudinal cross section of the ventilated telescopic female drug vial adapter and the drug vial along line A-A in figure 3 on a screw threading a needle-free syringe on the first for injection purposes; and figure 8G is a longitudinal cross section of the ventilated telescopic female drug vial adapter and the drug vial along line A-A in figure 3 after inversion for aspiration purposes. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION
[0009] Figure 1 shows a syringe 10 that constitutes a source of physiological fluid, a vial of medicinal drug 20 and a ventilated telescopic female vial adapter 30 for use with syringe 10 and vial of drug 20. 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.
[00010] Drug vial 20 has a longitudinal drug vial axis 20A and includes a drug vial bottle 21 having a drug vial 22, a drug vial ring 23 and a narrow drug vial neck intermediate 24. Drug vial ring 23 defines a vial opening 26 sealed by a drug vial cap 27 capped with a band 28. Drug vial 20 contains a powdered drug 29 under negative pressure or a liquid drug 29 .
[00011] Figures 1 to 7 show the ventilated telescopic female drug vial adapter 30 having a longitudinal drug vial adapter shaft 31 and includes a ventilated tip member 32, a skirt member 33, and a fixing arrangement. 34 to secure the point member 32 to the skirt member 33 in a position actuated as shown in figures 6 and 7.
[00012] The ventilated tip component 32 includes a cross-directed tip component upper wall 36 having a circular air filter 37 and a pair of ventilation openings 38. The ventilated tip component 32 preferably includes protective covers 38, such as illustrated and described in PCT Commonly Owned International Application No. PCT / 2011/000187 entitled “Liquid DrugTransfer Device with Vented Vial Adapter” and published under PCT International Publication No. WO 2011/104712.
[00013] The upper wall of the tip component 36 includes a double lumen piercing element descending 39 with a piercing tip 41 for piercing a drug bottle cap and an opposite upright female connector 42. The female connector 42 is preferably a female Luer connector with an external screw thread 43. The double lumen piercing element 39 includes a liquid transfer lumen 44 in flow communication with the opposite upright female connector 42, the double lumen piercing element 39 includes a ventilation lumen 46 having a ventilation lumen opening 47 adjacent to the drilling tip 41 and in flow communication with the pair of ventilation openings 38.
[00014] The top wall of the tip component 36 includes a top wall surface of the top tip component 36A facing the upright female connector 42 and a top wall surface of the bottom tip component 36B facing the drilling element double lumen 39. The piercing element 39 has a length L1 defined between the upper wall surface of the lowest point component 36B and the drilling point 41.
[00015] The tip component top wall 36 also includes a pair of tip component legs hanging downwardly spaced opposite 48 to the drilling element 39. The tip component legs 48 end at leg tips 49 projecting internally into the direction of the drill tip 41.
[00016] The skirt component 33 includes a transverse directed skirt component upper wall 51 having a central opening 52 and a substantially cylindrical skirt hanging downwardly 53. The skirt 53 includes several flexible drug vial elements 54 defining a rim cavity drug vial 56 to properly receive drug vial rim 23 therein and a skirt component rim 57 away from the top skirt component wall 51. The flexible drug vial elements 54 preferably include directed projections inward 58 to press fit into the drug vial ring 23.
[00017] The upper skirt component wall 51 includes a upper upper skirt component wall surface 51A facing the tip component 32 and a lower lower skirt component wall surface 51B facing the skirt 53. The skirt 53 has a length L2 defined between the upper wall surface of the upper skirt component 51A and the edge of the skirt component 57.
[00018] Two opposing flexible drug vial elements 54A have leg tip openings 59 to initially receive leg tips 49 to initially space the tip component top wall 36 from the skirt component top wall 51 with the perforation 39 projecting through the central opening 52 in a position for preparing the telescopic female drug bottle adapter 30. The flexible drug bottle elements 54A are preferably formed with smooth outer surfaces 61 below the leg openings 59 for allow smooth sliding movement from leg tips 49 to skirt edge 57.
[00019] In the preparation position, the upper wall surface of the lower tip component 36B and the upper wall surface of the upper skirt component 51A are separated by a length L3. In the preparation position, L1 <L2 + L3 so that the piercing tip 41 does not protrude beyond the skirt component margin 57 that would lead the piercing tip 41 to contact a drug vial cap 27 before correct alignment of the ventilated telescopic female drug vial adapter 30 with a vial of drug 20. The piercing element 39 and the skirt 53 are preferably dimensioned so that L1> L2 so that the vent tip 47 protrudes beyond the margin skirt member 57 in the actuated position where the nose member 32 completely contacts skirt member 33.
[00020] Fixing arrangement 34 includes a pair of opposite snap-fit clips 62 orthogonal to the pair of opposite pointed component legs 48.
[00021] Figures 8A to 8G show the use of the needle-less syringe 10, the drug bottle 20 and the ventilated telescopic female drug bottle adapter 30. The needle-free syringe 10 is filled with a predetermined volume of liquid contents 29 for ensure a snorkel effect so that the liquid contents do not wet the circular filter 37 as described here below with respect to figure 8G.
[00022] Figure 8A shows the female drug vial adapter 30 in its preparation position and in coaxial alignment with the drug vial 20 ready to press fit and puncture it.
[00023] Figure 8B shows an initial downward depression from the female drug vial adapter 30 to the drug vial 20 as indicated by the arrow A. the leg tips 49 impart a downward force to the skirt component 33. The flexible elements 54 ensure that the peak component 32 is aligned with the skirt component 33 in the event of misalignment before the piercing tip 41 begins to pierce the drug vial cap 27.
[00024] Figure 8C shows that the continuous downward depression of the drug vial adapter 30 towards the drug vial 20 as indicated by the arrow B causes the piercing element 39 to pierce the drug vial cap 27. The drug vial 20 pushes the leg tips 49 radially outward from the leg tip openings 59. In the case of negative pressure drug vial 20, air enters the drug vial 20 via the liquid transfer lumen 44 and the ventilation lumen 46.
[00025] Figures 8D and 8E show the complete downward depression of the drug vial adapter 30 towards the drug vial 20 until the first 30 snaps and punctures the drug vial cap 27 as indicated by the arrow C. The tip component 32 stops against the skirt component 33. The leg tips 49 slide along the smooth outer surfaces 61 towards the skirt component margin 57. The fastening arrangement 34 is engaged to secure the vial adapter. drug 30 and drug vial 20.
[00026] Figure 8F shows the syringe 10 ready for screw thread mounting on the female drug vial adapter 30 for injection of its liquid contents 29. The assembly of the syringe 10, the vial 20 and the vial adapter female drug 30 is gently agitated to ensure complete reconstitution of powder contents. In injection of the liquid contents, the air exits the drug vial 20 through the ventilation lumen 46 and the ventilation openings 38.
[00027] Figure 8G shows the inversion of the assembly of figure 8F for aspiration of the liquid drug contents from the drug vial 20 in the syringe 10 as indicated by the arrow D for administration purposes. The vent lumen opening 47 is above the liquid level of the liquid drug contents to resemble a swimming snorkel so that the air filter 37 is not wet. Air is sucked into the drug vial 20 through ventilation openings 38, air filter 37 and ventilation lumen 46.
[00028] 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 (5)
[0001]
1. Telescopic female drug bottle adapter (30) for use with a drug bottle (20) including a drug bottle bottle (21) containing a drug (29), and a drug bottle ring (23) defining a drug vial opening (26) capped by a drug vial cap (27), the drug vial adapter (20) having a longitudinal drug vial adapter shaft (31) and comprising: (a) a tip component (32) including a top wall of tip component (36) transversely directed having: i) a downward pending piercing element (39) with a piercing tip (41) for piercing the drug vial cap ( 27) and an opposite upright female connector (42) in flow communication with said drilling element (39), and ii) at least two downwardly spaced pointed component legs (48) lateral to said drilling element ( 39); and (b) a skirt component (33) including an upper wall of skirt component (51) transversely directed having a central opening (52), a substantially cylindrical skirt hanging downward (53) from various flexible drug vial elements (54) and a skirt component margin (57) away from said skirt component upper wall (51), said various flexible drug bottle elements (54) defining a drug bottle rim cavity (56) to justly receive the drug bottle rim (23) therein, characterized by the fact that the two at least two legs of the tip component ending at the leg ends (49) are projected inwardly towards said tip of perforation (41), at least two of said flexible drug bottle elements having leg tip openings (59) to initially receive said leg tips (49) in a preparation position of the telescopic female drug bottle adapter ( 30) for initially spacing said upper wall of the tip component (36) from said upper wall of skirt component (51) with said piercing element (39) projecting through said central opening (52), and the arrangement being such that by pushing the drug vial adapter (30) towards a drug vial (20) positioned below said drug vial adapter (30) and manual sliding displacement of said tip component (32) towards said component with skirt (33) to stop against it in an actuated position of the telescopic female drug bottle adapter (30), said flexible drug bottle elements (54) justly receive the drug bottle rim (23) in said drug bottle rim cavity (56), said piercing element (39) pierces the drug bottle cap (27) and said leg tips (49) are propelled radially outward from their openings matching leg tips (59) to slide p down along its flexible drug vial elements (54) corresponding to said skirt component margin (57).
[0002]
2. Adapter according to claim 1, characterized by the fact that it still comprises a fixing arrangement (34) for securing said tip component (32) on said skirt component (33) in said actuated position.
[0003]
Adapter according to claim 2, characterized in that said tip component (32) includes a pair of opposing tip component legs (48) and said fixing arrangement (34) includes a pair of opposite snap-fit tabs (62) orthogonal to said pair of opposite pointed component legs (48).
[0004]
4. Adapter according to any one of claims 1 to 3, characterized in that said piercing element (39) projects beyond said skirt component margin (57) in said actuated position.
[0005]
Adapter according to any one of claims 1 to 4, characterized in that said tip component (32) is ventilated, said tip component upper wall (36) includes a circular air filter (37 ) and at least one ventilation opening (38), and said piercing element (39) includes a liquid transfer lumen (44) in flow communication with said opposite upright female connector (42) and a ventilation lumen (46) in flow communication with said air filter (37), and said ventilation lumen includes an opening of ventilation lumen (47) adjacent to said drilling tip (41).

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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|

2020-04-22| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|

2020-09-01| B09A| Decision: intention to grant|

2020-12-08| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 17/10/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

IL22192012|2012-09-13|

IL221920|2012-09-13|

PCT/IL2012/050407|WO2014041529A1|2012-09-13|2012-10-17|Telescopic female drug vial adapter|

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