巴西专利BR112014008551B1 VALVE SET FOR USE WITH CONTAINER OF LIQUID AND MEDICINE BOTTLE AND LIQUID MEDICINE TRANSFER UNIT

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专利摘要:
Invention Patent: "VALVE SET FOR USE WITH LIQUID CONTAINER AND MEDICINAL BOTTLE". The present invention relates to valve assemblies for use with a liquid container and a medicine bottle to allow an initial transfer of liquid contents from the liquid container to the medicine bottle, for the purpose of forming liquid medicine and subsequent transfer of liquid medicine contents from the medicine bottle to the liquid container for administration purposes. Liquid drug transfer units may include a valve assembly fixed to a liquid container. Alternatively, liquid drug transfer units may include a set of valves packaged in sterile blister packs, ready to be attached to a liquid container prior to use.
公开号:BR112014008551B1
申请号:R112014008551-0
申请日:2012-10-10
公开日:2021-02-23
发明作者:Nimrod Lev；Niv Ben Shalom
申请人:Medimop Medical Projects Ltd；
IPC主号:

专利说明:

Field of the Invention
[001] The present invention relates to valve assemblies for use with liquid containers and medicine bottles. Fundamentals of the Invention
[002] US Patent No. 4,607,671 to Aalto et al. illustrates and describes a reconstitution device for constituting a drug in a standard drug bottle, with a liquid in a second container, such as a parenteral solution container. The reconstitution device includes a casing and a hollow double-tipped needle mounted inside the casing. The housing includes a sheath having a substantially circular base and a skirt hanging from the base. The skirt includes a free end, a substantially cylindrical inner surface and an outer surface. A plurality of protrusions protruding inwardly are spaced intermittently on the inner surface. The projections are arranged at a substantially equal distance from the base, the distance being substantially equal to the width of the malleable band.
[003] US Patent No. 5,304,163 to Bonnici et al. illustrates and describes an integral reconstitution device including a flexible container having an administration port and a flexible tube extending therefrom. The delivery port includes an access membrane through which a crimped cannula can be inserted to gain access to the interior of the flexible container. The flexible tube contains a frangible or rupture valve in it. Permanently attached to the end of the flexible tube is a housing having a substantially circular base and an open skirt, which includes an internal surface depending on the base. The skirt includes a plurality of inwardly protruding projections, intermittently spaced around the inner surface to seal a standard medicine bottle in a sealed manner. A sharp cannula is mounted inside the skirt to pierce the stopper of the standard medicine bottle to establish fluid communication between the cannula and the inside of the medicine bottle. A detachable closure is provided covering the opening of the skirt before being used to maintain a sterile condition of the device. A lumen is provided in the housing to establish fluid communication between the cannula and the frangible or rupture valve.
[004] US Patent No. 8,025,653 to Capitaine et al., Illustrates and describes a Luer connector, a medical connector for a container that has a piercable stopper and a transfer unit, including such a Luer connector. This Luer connector comprises an internal conduit for a fluid to pass, connecting elements to a second Luer connector having a perforator, these connecting elements being placed at one of its ends. This term also includes a continuous ring forming a projection in the conduit, in order to provide a seal on it, when the perforator is inserted into the conduit, in order to couple these connectors. A breakable membrane is also placed in the conduit, in order to be separated, when the second Luer connector is coupled to this Luer connector. Summary of the Invention
[005] The present invention is directed to valve assemblies for use with a liquid container and a medicine bottle containing medicine to allow an initial transfer of the liquid contents of the liquid container to the medicine bottle for purposes of forming liquid medicine. and a further transfer of the liquid medicine content from the medicine bottle to the liquid container for administration purposes. The liquid container can be a bottle, an IV bag, and the like. The liquid container usually includes double access doors. The liquid contents can reconstitute a powdered medicine or dilute a liquid medicine contained in the medicine bottle.
[006] Valve assemblies include a conventional medicine bottle adapter with a cannula and a male connector and an access port adapter having an access port connector for insertion sealing on one of the double access ports and a connector female to the watertight support on the male connector. The medicine bottle adapter is manually reciprocal with the access door adapter between a closed position to prevent fluid communication between a liquid container and a medicine bottle and an open position to allow fluid communication between a liquid container and a bottle of medicine.
[007] Manual reciprocal arrangements may include inter-thread and screw arrangements, push and pull arrangements, and so on. The reciprocal arrangements allow the valve assembly to be sealed after transferring the liquid contents of a medicine bottle to a liquid container to prevent drainage or leakage of the liquid container into the medicine bottle. The reciprocal arrangements also prevent the rupture of a seal thus ensuring that no fragments or sealing particles are mixed with the contents of the medicine bottle in the transfer of liquid contents.
[008] The male connector is preferably a male Luer lock connector. Suitable drug bottle adapters with male Luer lock connectors are commercially available from West Pharmaceutical Services, Inc. Lionville, PA 19341, USA www.westpharma.com. Medicine bottle adapters can be implemented in non-ventilated and ventilated versions. The valve assemblies are preferably prefixed with a liquid container to form a liquid medicine transfer unit with a removable sealing element mounted on its cannula to ensure sterile condition until use. Alternatively, liquid drug transfer units may include a set of valves packaged in sterile blister packs ready for attachment to a liquid container prior to use. Brief Description of Drawings
[009] In order to understand the invention and see how it can be carried out in practice, the preferred modalities will now be described, by way of non-limiting examples only, with reference to the accompanying drawings, in which similar parts are numbered in the same way, and where:
[0010] Figure 1 is an illustrative view of a liquid medicine transfer unit that includes a first preferred embodiment of a valve assembly of the present invention, fixed to an IV bag, for use with a medicine bottle;
[0011] Figure 2 is an exploded view of the valve assembly that includes a medicine bottle adapter, an access port adapter and a sealing member;
[0012] Figure 3 is a section in longitudinal section of the valve assembly along line B-B in Figure 2, which shows the medicine bottle adapter fitted to the medicine bottle;
[0013] Figure 4 is a section in longitudinal section of the access door adapter along line C-C in Figure 2;
[0014] Figure 5 is a cross-section of the access door adapter along line D-D in Figure 2;
[0015] Figure 6A is a section in longitudinal section of the valve assembly in its closed position, along line A-A in Figure 1;
[0016] Figure 6B is a section in longitudinal section of the valve set in its open position, along line A-A in Figure 1;
[0017] Figures 7A to 7F are illustrative views showing the use of the liquid medicine transfer unit of Figure 1;
[0018] Figure 8 is an illustrative view of a second preferred embodiment of a set of valves of the present invention, for attachment to an IV bag, prior to use;
[0019] Figure 9 is an illustrative view of a third preferred embodiment of a set of valves of the present invention, for attachment to an IV bag, prior to use;
[0020] Figure 10 is a section in longitudinal section of the valve set of Figure 9, along the E-E line of Figure 9;
[0021] Figure 11A is an illustrative view of a fourth preferred embodiment of a set of valves of the present invention for connection to a liquid container that has two access ports, and
[0022] Figure 11B is a top plan view of the liquid container of Figure 11A. Detailed Description of the Preferred Modalities of the Invention
[0023] Figure 1 shows a liquid medicine transfer unit 100 for use with a medicine bottle 10. The liquid medicine transfer unit 100 includes a liquid container 20, consisting of an IV bag and a set of valves 30A prefixed to bag IV 20. The medicine bottle 10 has a longitudinal axis of the medicine bottle 10A and includes a body of the medicine bottle 11 with a rim of the medicine bottle 12 and a narrow diameter neck 13 intermediating the body of the medicine bottle medicine 11 and the rim of the medicine bottle 12. The rim of the medicine bottle 12 defines an opening of the medicine bottle 14 tightly closed by a stopper of the medicine bottle 16, and covered by a band 17. The body of the medicine bottle 11 defines an interior of the medicine bottle 18 containing liquid or powdered medicine contents 19. The bag IV 20 includes a first access door 21, a second access door 22 and contains liquid items 23. Access doors 21 and 22 are in the form of a plastic tube. An access port 21 is typically fitted with a self-sealing plug 24 (shown removed) intended for injecting the syringe contents into the IV bag 20. The access port 22 is normally twisted off the cap 26 to insertion of an IV peak for administration purposes.
[0024] Figures 2 to 6 show the valve assembly 30A that includes a medicine bottle adapter 40, an access port adapter 60 pre-fixed to the first access opening 21, and a sealing element 90. The bottle adapter of medication 40 is manually rotatable with respect to the access door adapter 60 between a closed position (see Figure 6A) and an open position (see Figure 6B). Valve assembly 30A is provided in the closed position to prevent liquid contents 23 from draining from IV bag 20. Valve assembly 30A is temporarily open to allow an initial transfer of liquid contents from IV bag 20 to medicine bottle 10 and subsequent transfer of the liquid medicine content from the medicine bottle 10 to the IV bag 20, before being closed again. The empty medicine bottle 10 preferably remains installed in the medicine bottle adapter 40 during the administration of the liquid medicine content through the administration port 22 to the patient, but can be optionally isolated from them.
[0025] The medicine bottle adapter 40 has a longitudinal axis of the medicine bottle adapter 40A and includes a body of the medicine bottle adapter 41 with an upper wall 42 transverse to the longitudinal axis of the medicine bottle 40A, an enlarged skirt pendant 43 with a multitude of flexible elements 44 to fit the medicine bottle 10, a pointed tubular cannula 46 with a tip of the cannula 47 to pierce the stopper of the medicine bottle 16, and a fluid communication lumen 48 in fluid communication with the cannula 46. Fluid communication lumen 48 ends in a vertical male connector 49 mounted on the top wall 42 opposite cannula 46. Male connector 49 has a ring rim of male connector 51. Male connector 49 is formed with a locking collar 52 having an internal thread 53 and a pair of opposite peripheral grooves 54. The peripheral grooves 54 each have a sector angle between about 45 ° and about 90 ° to delimit tar the rotation between the medicine bottle adapter 40 and the access port adapter 60.
[0026] The access port adapter 60 has a longitudinal axis of the access port adapter 60A intended to be co-directional with the longitudinal axis of the 40A medicine bottle adapter and, preferably, coaxial with it. The access port adapter 60 includes a main tubular body 61 which has a lumen 62, an access port connector 63 to seal the insert within the access port 21 and a female connector 64 for watertight support over the male connector 49. The female connector 64 has a distal end 64A with an external screw thread 66 for engagement with the internal screw thread 53. The lumen 62 includes a cross member 67 halfway between the access port connector 63 and the female connector 64 The beam 67 has an upper side of the beam 67A facing the connector of the access port 63 and a lower side of the beam 67B facing the female connector 64. The beam 67 includes four longitudinal holes that continuously cross equidistant 68 peripherally disposed adjacent to the main body 61. The bottom side of the beam 67B is formed with a sealing projection 69 for the insertion of a selective seal in the fluid communication lumen 48 in the male connector 49.
[0027] The access door adapter 60 includes a pair of longitudinally directed legs 71 each having an inwardly directed projection 72, facing the external thread screw 66 for insertion in the peripheral grooves 54. The access door adapter 60 includes a pair of directed radial opposite wings 73 to assist manual rotation of the medicine bottle adapter 40 relative to the access port adapter 60. The wings 73 have uppermost wing surfaces 73A. The pair of directed longitudinal legs 71 of the female connector 64 with their corresponding projections directed inward 72 is rotatable in the pair of peripheral grooves 54 of the locking collar 52 between a corresponding first extreme position with a closed position 52 of the valve assembly 30A ( see Figure 6A) and a second opposite extreme position corresponding to an open position of the valve assembly 30A (see Figure 6B).
[0028] In the closed position, the ring ring of the male connector 51 rests against the underside of the beam 67B to seal the peripheral holes that continuously cross 68, to seal the lumen 62 to prevent fluid communication between the IV bag 20 and the medicine bottle 10. The sealing projection 69 is tightly inserted into the fluid communication lumen 48 in the male connector 49 in the closed position, to ensure that there is no leakage of liquid through the lumen 62. The upper wing surface 73A defines a height H1 in relation to a reference surface S in the closed position. The manual loosening rotation of the medicine bottle adapter 40 relative to the access port adapter 60 bounded by the movement of the inwardly directed projections 72 inside the peripheral grooves 54 displaces the ring rim of the male connector 51 on the underside of the beam 67B , to deflect the peripheral holes that continuously cross 68 to deflate the lumen 62 in the open position to allow fluid communication between the connector of the access port 63 and the female connector 64 (see Figure 6B). The uppermost surfaces of the wing 73A define a height H2 in relation to the reference surface S in the open position where H2> H1. The height difference H2 - H1 is typically in the region of about 1 mm and depends on the pitch of the screw screw of the medicine bottle adapter 40 and the access port adapter 60 and the angle of the peripheral groove sector 54.
[0029] The sealing member 90 includes a fastener 91 which extends through the skirt 43 and a sleeve 92 mounted vertically on the fastener 91 for watertight support over the cannula 46. The fastener 91 includes slots 93 for fitting the distal ends opposite the flexible elements. The sealing component 90 includes a tamper-proof sheet 94 to indicate the integrity of the valve assembly 30A before use.
[0030] Figures 7A to 7F show the use of the liquid medicine transfer unit 100 as follows:
[0031] Figure 7A shows the valve assembly 30A in its closed position and fitted with its sealing element 90 mounted on the medicine bottle adapter 40. Figure 7A also shows the removal of the sealing element 90, as indicated by arrow A, to expose the cannula 46 before the insertion of the medicine bottle 10 into the medicine bottle adapter 40, as indicated by the arrow C (see Figure 7B). Removal of the sealing member 90 separates the evidence sheet 94 from the medication bottle adapter 40, as indicated by arrow B.
[0032] Figure 7C shows the manual loosening rotation of the medicine bottle adapter 40 together with the medicine bottle installed 10 in relation to the access port adapter 60, as indicated by arrow D, to propel the valve assembly 30A from its closed position to its open position, to allow fluid communication from the IV bag 20 to the medicine bottle 10 for transferring liquid contents from the first to the last.
[0033] Figure 7D shows the contraction of the IV bag 20 to transfer the liquid content inside the medicine bottle 10, as indicated by arrow E before shaking the liquid medicine transfer unit 100 defined to form the liquid medicine in the medicine bottle. medicine 10.
[0034] Figure 7E shows the inversion of the liquid medicine transfer unit 100 to transfer the liquid medicine content from the medicine bottle 10 to the IV bag 20 as indicated by the arrow F before the manual tightening rotation of the bottle adapter. medicine 40 and its medicine bottle installed in relation to the access port adapter 60 to close the valve assembly 30A, as indicated by arrow G.
[0035] Figure 7F shows the inversion of the liquid drug transfer unit 100 and the insertion of an infusion unit for the second access port 22 after opening the twist off the lid 26 to administer the liquid drug content to a patient.
[0036] Figures 8 to 11 show three similar sets of valves 30B, 30C and 30D in construction and operation according to the valve support 30A and, therefore, similar parts are numbered in the same way.
[0037] Valve sets 30B and 30C are shown in use with an IV bag 20 having a first access port 21 fitted with a self-sealing plug 24 and a second access port 22 fitted outside the screw cap 26. The assemblies of valves 30B, 30C and 30D are intended to be supplied as a discrete item in a sterile blister pack 31, therefore excluding the need for the sealing element 90.
[0038] Figure 8 shows a valve assembly 30B that includes a shroud 32 for firmly sliding into the access port 21 and a needle 33 for penetration through the self-sealing cap 24. Shroud 32 is shown in partial section to show needle 33.
[0039] Figures 9 and 10 show a set of valves 30C, including a reciprocal pull-and-push arrangement to allow the manual linear reciprocal of the medicine bottle adapter 40 with respect to the access port adapter 60 for draining the set of 30C valves between a closed position and an open position. Valve set 30C includes a dual component access port adapter 80 having a main component of the access port adapter 81 with the access port connector 63 for sealing insertion in an access port and a tracking component of the access port adapter 82 having the female connector 64 to seal the bracket on the male connector 49. The access port adapter tracking component 82 is integrally formed with the medicine bottle adapter 40. Suitable connection means to fully support the access port adapter tracking component 82 on the medicine bottle adapter 40 includes, inter alia, bonding, ultrasound, and the like.
[0040] The main component of the access door adapter 81 includes a pair of lateral longitudinal lumens 83 for a sealing projection 84. The tracking component of the access door adapter 82 includes a longitudinal lumen 86 in fluid communication with the lumen 62 In the closed position of the 30C valve assembly, the sealing projection 84 seals the lumen 86 to prevent fluid communication between an IV bag and a medicine bottle. In the open position of the valve assembly 30C, the sealing projection 84 is arranged above the lumen 86, to allow fluid communication between the lumens 83 and the lumen 86 and, therefore, between an IV bag and the medicine bottle.
[0041] Figures 11A and 11B show a set of valves 30D in use with a container of liquid 20 consisting of a bottle and double access ports 21 and 22. Valve set 30D is similar to valve set 30A, but includes a peak of the access door 34 for the insertion of the seal slide in one of the doors 21 and 22.
[0042] Although the invention has been described in relation 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 (9)
[0001]
1. Valve set (30A) for use with a liquid container (20) and a medicine bottle (10), the liquid container (20) including double access ports and containing liquid contents, and the medicine bottle ( 10) having a medicine bottle stopper and an inside of the medicine bottle containing a medicine, the valve assembly (30A) comprising: (a) a medicine bottle adapter (40) having a longitudinal axis of a medicine bottle adapter medicines (40A) and including a medicine bottle adapter body (41) with an upper wall (42) transverse to said longitudinal axis of the medicine bottle adapter (40A), a pointed tubular cannula (46) with a tip of the cannula (47) for piercing the stopper of the medicine bottle (16) for establishing fluid communication with the inside of the medicine bottle in the holder of said medicine bottle adapter (40) in the medicine bottle (10), and a connect r male vertically (49) mounted on said upper wall opposite to said cannula (46), and in fluid communication with it, said male connector (49) having an annular ring of the male connector on the upper part (51), and (b) an access port adapter (60) having a longitudinal axis of the access port adapter (60A) codirectional with said longitudinal axis of the medicine bottle adapter (40A) and including an access port connector ( 63) to seal the insert inside one of the access doors and a female connector (64) for the support in a watertight manner in said male connector (49), characterized by the fact that: said medicine bottle adapter (40) is manually mounted reciprocally on said access door adapter (60), so as to be manually reciprocal with respect to it along said longitudinal axis of the medicine bottle adapter (40A) between a closed position to prevent the communication flows between the liquid container (20) and the medicine bottle (10), and an open position to allow fluid communication between the liquid container (20) and the medicine bottle (10), said adapter of the medicine bottle medicament (40) being arranged in the direction of said access door adapter (60) in the displacement of said open position to said closed position, and away from said access door adapter (60) in the displacement of said closed position for said open position.
[0002]
2. Assembly according to claim 1, characterized in that said medicine bottle adapter (40) includes a locking collar (52) peripheral to said male connector (49), said locking collar (52 ) having at least two peripheral grooves (54), said access door adapter (60) includes a corresponding number of longitudinally directed legs (71) each having an inwardly directed projection (72), for insertion into said at least two peripheral grooves (54) so that said medicine bottle adapter (40) is rotatable manually with respect to said access door adapter (60) between said closed position and said open position, said access port adapter (60) further includes a lumen (62) for fluid communication between said access port connector (60) and said female connector (64), said lumen (62) having a transverse beam ersal (67), with at least one peripheral orifice that continuously crosses (68) to allow said fluid communication between said access port connector (63) and said female connector (64), said medicine bottle adapter (40) pressing said ring ring of the male connector (51) against said crosspiece (67) to seal said at least one peripheral hole that continuously crosses (68) to seal said lumen (62) in said closed position, and moving said ring ring from the male connector (51) of said crosspiece (67) to deflect said at least one peripheral hole that continuously traverses (68) in said open position.
[0003]
3. Assembly according to claim 2, characterized in that said access door adapter (60) includes a sealing projection to seal the insertion within said fluid communication lumen in said male connector in said closed position .
[0004]
4. Assembly according to claim 2, characterized by the fact that said access door adapter (60) includes at least one radial wing directed to assist said manual rotation of said medicine bottle adapter (40) in with respect to said access port adapter.
[0005]
5. Assembly according to claim 1, characterized in that said access port adapter (60) has a double component construction, including a main access port adapter component (81) which has said connector of the access port (63) and a tracking component of the access port adapter (82) having said female connector (64) to seal the holder over said male connector (49), said tracking component of the adapter of the access door (82) being integrally formed with said medicine bottle adapter (40), said medicine bottle adapter (40) being reciprocal, linearly manual to said main component of the access door adapter (81) to along said longitudinal axis of the medicine bottle adapter (40A) between said closed position to prevent fluid communication between said male connector (49) and said access port connector (63), and said open position to allow fluid communication between the liquid container (20) and the medicine bottle (10).
[0006]
6. Assembly according to any one of claims 1 to 5, characterized by the fact that it is for prefixing to the liquid container (20), and also comprises a sealing element (90) for removable support on said cannula ( 46).
[0007]
7. Assembly according to claim 6, characterized in that the body of the medicine bottle adapter (41) includes an extended downward-hanging skirt (43) with a plurality of flexible elements (44) to fit the bottle of medicine (10) and said sealing element (90) includes a fixing element (91) which extends through said skirt (43) and a sleeve (92) mounted vertically on said fixing element (91) for sealing support on said cannula (46).
[0008]
8. Assembly according to claim 6, characterized in that said sealing element (90) includes a tamper-proof information sheet (94) that extends between said sealing element (90) and the said medicine bottle adapter (40) to indicate the removal of said sealing element (90) from said medicine bottle adapter (40).
[0009]
9. Liquid drug transfer unit characterized by the fact that it comprises a liquid container (20) with a prefixed valve assembly as defined in any one of claims 1 to 8.

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法律状态:
2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

2020-03-31| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|

2020-08-18| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application according art. 36 industrial patent law|

2020-12-01| B09A| Decision: intention to grant|

2021-02-23| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/10/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

IL21569911A|IL215699D0|2011-10-11|2011-10-11|Liquid drug reconstitution assemblage for use with iv bag and drug vial|

IL215699|2011-10-11|

PCT/IL2012/000354|WO2013054323A1|2011-10-11|2012-10-10|Valve assembly for use with liquid container and drug vial|

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