Source: http://www.google.ca/patents/US8684994
Timestamp: 2017-10-17 06:01:56
Document Index: 743441737

Matched Legal Cases: ['Application No. 2012', 'Application No. 2012', 'Application No. 2012', 'Application No. 2008', 'Application No. 2007', 'Application No. 2008', 'Application No. 2008801108283', 'Application No. 2007', 'Application No. 2', 'Application No. 218730', 'Application No. 2008', 'Application No. 2008']

Patent US8684994 - Fluid transfer assembly with venting arrangement - Google Patents
A fluid transfer assembly including a vented female vial adapter and male vial adapter for use with a pair of vials including a vial with contents under negative pressure for liquid drug reconstitution and administration purposes. The vented female vial adapter includes a venting arrangement and the...http://www.google.ca/patents/US8684994?utm_source=gb-gplus-sharePatent US8684994 - Fluid transfer assembly with venting arrangement
Publication number US8684994 B2
Application number US 13/522,410
PCT number PCT/IL2011/000186
Also published as CN102711712A, CN102711712B, EP2512399A1, EP2512399B1, US20120323210, WO2011104711A1
Publication number 13522410, 522410, PCT/2011/186, PCT/IL/11/000186, PCT/IL/11/00186, PCT/IL/2011/000186, PCT/IL/2011/00186, PCT/IL11/000186, PCT/IL11/00186, PCT/IL11000186, PCT/IL1100186, PCT/IL2011/000186, PCT/IL2011/00186, PCT/IL2011000186, PCT/IL201100186, US 8684994 B2, US 8684994B2, US-B2-8684994, US8684994 B2, US8684994B2
Inventors Nimrod Lev, Niv Ben Shalom, Amir Lev
Patent Citations (676), Non-Patent Citations (104), Referenced by (22), Classifications (12), Legal Events (1)
US 8684994 B2
(a) a female vial adapter having a top wall, a skirt with flex members for snap fitting onto the second vial, a pointed cannula for puncturing the second vial's vial stopper on snap fitting said female vial adapter on the second vial, said pointed cannula including a liquid transfer lumen for establishing flow communication with the second vial's vial interior, and a female connector in flow communication with said liquid transfer lumen; and
(b) a male vial adapter having a top wall, a skirt with flex members for snap fitting onto the first vial, a pointed cannula for puncturing the first vial's vial stopper on snap fitting said male vial adapter on the first vial, said pointed cannula including a liquid transfer lumen for establishing flow communication with the first vial's vial interior, and a male connector in flow communication with said liquid transfer lumen and for sealing said female connector on assembling said male vial adapter on said female vial adapter for reconstitution of the liquid drug contents, wherein said female vial adapter having a venting arrangement including i) an air filter underlying said top wall, ii) at least one vent port formed in said top wall and iii) a venting lumen formed in said pointed cannula for establishing flow communication between said at least one vent port and the second vial's vial interior on snap fitting said female vial adapter on the second vial, and
said male vial adapter having a sealing arrangement for sealing said at least one vent port during reconstitution of the liquid drug contents,
2. The assembly according to claim 1, wherein said sealing arrangement includes at least one axial directed port sealing member for sealing said at least one vent port during reconstitution of the liquid drug contents.
3. The assembly according to claim 2, wherein said at least one axial directed port sealing member includes an annular port sealing member for simultaneously sealing at least one vent port of said at least one vent port during reconstitution of the liquid drug contents.
4. The assembly according to claim 1, wherein said fluid transfer assembly is pre-assembled in an initial ready for reconstitution state including said male vial adapter assembled on said female vial adapter, said male connector sealing said female connector and said sealing arrangement sealing said at least one vent port.
5. The assembly according to claim 1, wherein said fluid transfer assembly is pre-assembled in an initial non ready for reconstitution state including said male vial adapter assembled on said female vial adapter and said sealing arrangement axially displaced from said at least one vent port thereby not sealing said venting arrangement,
6. The assembly according to claim 5, wherein said sealing arrangement includes at least one inward directed engagement member for engaging said female connector in said initial non ready for reconstitution state for assembling said male vial adapter on said female vial adapter.
7. The assembly according to claim 5, wherein said male vial adapter includes at least two axial directed grip members lateral to said male connector and having inward directed projections for engaging said female connector's free end on said axial displacement of said male vial adapter towards said female vial adapter.
8. The assembly according to claim 1, wherein said female connector includes an internal annular seal for sealing engagement with said male connector during reconstitution of liquid drug contents and an IV spike during liquid drug administration.
9. The assembly according to claim 1, wherein said female connector includes a manually placed cap for sealing said female connector subsequent to said complete mechanical detachment of said male vial adapter from said female vial adapter.
10. The assembly according to claim 1, wherein said venting arrangement includes at least one hooded vent port having a vent aperture facing radial outward with respect to said longitudinal axis.
This application is a Section 371 of International Application No. PCT/IL2011/000186, filed Feb. 23, 2011, which was published in the English language on Sep. 1, 2011, under International Publication No. WO 2011/104711 A1, and the disclosure of which is incorporated herein by reference.
Commonly owned U.S. Pat. No. 6,558,365 to Zinger et al. illustrates and describes a fluid transfer assembly including a pair of initially inter-engaged vial adapters for use with a pair of vials for liquid drug reconstitution and administration purposes. Such fluid transfer assemblies are commercially available under the registered trademark MIX2VIAL® from the present Applicant Medimop Medical Projects Ltd., Ra'anana, Israel. The pair of vial adapters includes a vial adapter including a female connector referred to hereinafter as a “female vial adapter” and another vial adapter including a male connector referred to hereinafter as a “male vial adapter”. The male and female connectors are Luer connectors and preferably Luer lock connectors. The vials typically include one vial containing diluent and another vial containing a powdered drug medicament under vacuum. Typical vial sizes include 13 mm neck diameter and 20 mm neck diameter.
The present invention is directed toward fluid transfer assemblies similar in construction and operation as the hitherto described fluid transfer assemblies and additionally provisioned for precluding undesirable drawing of potentially septic air into a vial connected to a female vial adapter on detaching a male vial adapter therefrom thereby maintaining the sterility of a reconstituted liquid drug. This is achieved by replacing a hitherto employed non-vented female vial adapter by a vented female vial adapter including a venting arrangement having an air filter and one or more vent ports and providing an otherwise conventional male vial adapter with a sealing arrangement having one or more port sealing members for sealing the vent ports.
The fluid transfer assemblies of the present invention are preferably blister packed with their male vial adapters pre-assembled on their female vial adapters thereby expediting their use for reconstitution and administration purposes. Alternatively, a male vial adapter and a female vial adapter can be supplied as discrete components requiring a user to assembly the male vial adapter on the female vial adapter prior to reconstitution and administration purposes. Fluid transfer assemblies can be pre-assembled in a ready for reconstitution state, namely, their male connectors seal their female connectors and their sealing arrangements seal their venting arrangements. Alternatively, fluid transfer assemblies can be pre-assembled in a non ready for reconstitution state with their sealing arrangements axially displaced from their vent ports and therefore not sealing their venting arrangements. Such fluid transfer assemblies require axial displacement of their male vial adapter toward their female vial adapter for urging their male connectors to seal their female connectors and their sealing arrangements to seal their venting arrangements thereby priming the fluid transfer assemblies from their non ready for reconstitution state to their ready for reconstitution state. Such axial displacement preferable automatically occurs during the snap fit of a fluid transfer assembly on its vials for reconstitution purposes. The latter non ready for reconstitution state is envisaged to afford a longer shelf life than the former ready for reconstitution state by virtue of the sealing arrangement only sealing the venting arrangement as required for reconstitution purposes and thereby precluding inadvertent adhesion therebetween.
The present invention can be readily implemented for use with a wide range of vials including inter alia 13 mm neck diameter vials, 20 mm neck diameter vials and so-called large diameter vials with typically 28 mm, 32 mm and larger neck diameter. The one or more port sealing members are preferably designed to additionally stabilize a male vial adapter on a vented female vial adapter as well as sealing the latter's one or more vent ports. Fluid transfer assemblies intended for use with large diameter large vials preferably include a vented female vial adapter having a female connector adapted to receive an IV spike. Fluid transfer assemblies can include alternative inter-engagement arrangements to a screw threading arrangement including inter alia friction fit arrangements, and the like.
FIG. 2 is a top perspective cutaway view of FIG. 1's vented female vial adapter along line A-A in FIG. 1;
FIG. 3 is a bottom perspective cutaway view of FIG. 1's vented female vial adapter;
FIG. 4 is a longitudinal cross section of FIG. 1's male vial adapter;
FIG. 5 is a bottom perspective cutaway view of FIG. 1's vented female vial adapter;
FIG. 6 is a front perspective view of an assemblage of FIG. 1's fluid transfer assembly and two connected vials for reconstitution of liquid drug contents;
FIG. 7 is a longitudinal cross section of a FIG. 6's assemblage along line B-B therein;
FIG. 8 is a longitudinal cross section of a FIG. 6's assemblage along line B-B therein subsequent to initial axial displacement of the male vial adapter from the vented female vial adapter;
FIG. 9 is a front perspective view of FIG. 6's assemblage subsequent to complete mechanical detachment of the male vial adapter from the vented female vial adapter;
FIG. 11 is a pictorial representation of FIG. 10's vented female vial adapter and male vial adapter;
FIG. 13 is a pictorial representation of FIG. 12's vented female vial adapter and male vial adapter;
FIG. 14 is a pictorial representation of a fluid transfer assembly in accordance with a fourth embodiment of the present invention for use with large diameter vials and an IV spike;
FIG. 15 is a longitudinal cross section of FIG. 14's vented female vial connector along line C-C therein;
FIG. 16 is a longitudinal cross section of FIG. 14's vented female vial connector with an IV spike for liquid drug administration;
FIG. 17 is a pictorial representation of FIG. 1's vented female vial adapter including a manually placed cap for sealing its female connector;
FIG. 18 is a top perspective cutaway view of FIG. 1's vented female vial adapter along line A-A in FIG. 1 including a pre-split septum for sealing its female connector;
FIG. 20 is a pictorial representation of FIG. 19's male vial adapter; and
FIG. 21 is a pictorial representation of FIG. 19's fluid transfer assembly in a ready for reconstitution state.
FIG. 1 shows a fluid transfer assembly 100 in an initial ready for reconstitution state for use with an empty syringe 10 and a pair of vials 20A and 20B constituting medicinal vessels. The fluid transfer assembly 100 has a longitudinal axis 101 and includes a vented female vial adapter 110 having a venting arrangement 110A and initially screw threaded on a male vial adapter 130 having a sealing arrangement 130A for selectively sealing the venting, arrangement 110A. The syringe 10 includes a barrel 11 with a plunger 12 and a male Luer lock connector 13. The syringe 10 can be formed with other types of male connectors. The vials 20 include an open topped bottle 21 sealed by a vial stopper 22 capped by a metal band 23. The vial 20A has a vial interior 24 containing either a powder or liquid medicament 26 under negative pressure. The vial 20B has a vial interior 24 containing a liquid medicament 27 for reconstituting the vial contents 26 to form reconstituted liquid drug contents 28. The liquid medicament 27 can be diluent or containing an active drug component.
FIGS. 2 and 3 show the vented female vial adapter 110 includes a transverse top wall 111, a downward depending skirt 112 with flexing members 113 for snap fitting onto the vial 20A, and a downward depending pointed cannula 114 having a liquid transfer lumen 116 for puncturing the vial 20A's vial stopper 22, and an oppositely directed female connector 117 in flow communication with the liquid transfer lumen 116. The female connector 117 is preferably a female Luer connector including an external screw thread 117A at its free end.
The venting arrangement 110A includes an annular air filter 118 disposed beneath the top wall 111, four equi-spaced circular vent ports 119 formed in the top wall 111 and a venting lumen 121 formed in the pointed cannula 114 for establishing flow communication between the vent ports 119 and the vial 20A's vial interior on snap fitting the female vial adapter 110 on the vial 20A. The vent ports 119 are flush with the top wall 111 and each include a vent aperture 122 and an annular elastomer rim 123 disposed on the top wall 111 for sealing same on application of an axial force thereon.
FIGS. 4 and 5 show the male vial adapter 130 includes a transverse top wall 131, a downward depending skirt 132 with flexing members 133 for snap fitting onto the vial 20B, a downward depending pointed cannula 134 with a liquid transfer lumen 136 for puncturing the vial 20B's vial stopper 22 and an oppositely directed male connector 137 in flow communication with the liquid transfer lumen 136. The male, connector 137 is preferably a male Luer lock connector for screw threading engagement with the female Luer connector 117.
FIGS. 6 to 9 show use of the fluid transfer assembly 100 for reconstitution and administration purposes.
FIGS. 6 and 7 show an assemblage 140 of the fluid transfer assembly 100 snap fitted on the two vials 20A and 20B on following the aforesaid steps (a) to (d) to form reconstituted liquid drug contents 28 in the vial 20A. The assemblage 140 includes the female connector 117 in sealed engagement with the male connector 137 and the sealing arrangement 130A sealing the vent ports 119 prior to snap fitting the fluid transfer assembly 100 on the vials 20A and 20B. The axial separation between the opposite top walls 111 and 131 is denoted by the height H1. The arrow P denotes drawing of the liquid medicament 27 from the vial 20B into the vial 20A to form the reconstituted liquid drug contents 28.
FIG. 8 shows an initial axial displacement of the male vial adapter 130 from the vented female vial adapter 110 by initial unscrewing the male Luer lock connector 137 from the female Luer connector 117 denoted by arrow Q. The initial axial displacement is denoted by the axial separation H2 where H2 is slightly greater than H1 and is designed to enable the sealing arrangement 130A to open the vent ports 119 before the male Luer lock connector 137 unseals the female Luer connector 117. The initial axial displacement is typically in the order of the pitch of the Luer lock inter-engagement between the male Luer lock connector 137 and the female lock connector 117. The opening of the venting arrangement 110A draws filtered air through the air filter 118 into the vial 20A as denoted by arrows R to equalize its residual negative pressure with ambient pressure.
FIG. 9 shows continued axial displacement of the male vial adapter 130 from the vented female vial adapter 110 by continuing unscrewing the male Luer lock connector 137 from the female Luer connector 117 until complete mechanical detachment thereby exposing the female Luer connector 117 for attachment of the syringe 10 for administration of reconstituted liquid drug contents 27.
FIGS. 10 and 11 show a fluid transfer assembly 150 similar in construction and operation as the fluid transfer assembly 100 and therefore similar parts are likewise numbered. The former 150 includes a vented female vial adapter 110 with a venting arrangement 151 modified with respect to the venting arrangement 110A. The venting arrangement 151 includes open topped vent ports 119 raised with respect to the top wall 111 and each having a vent aperture 122 inclined towards the longitudinal axis 101. The vent ports 119 are provided with annular elastomer rims 123 for sealing same on depression by an annular port sealing member 139 in an initial ready for reconstitution state of the fluid transfer assembly 150.
FIGS. 12 and 13 show a fluid transfer assembly 160 similar in construction and operation as the fluid transfer assembly 100 and therefore similar parts are likewise numbered. The former 160 includes a vented female vial adapter 110 with a venting arrangement 161 modified with respect to the venting arrangement 110A. The venting arrangement 161 includes quarter sphere shaped vent ports 119 raised with respect to the top wall 111 and each having a vent aperture 122 facing radial outward with respect to the longitudinal axis 101 and fitted with a semi-circular elastomer rim 123. The male vial adapter 130 has three elongated port sealing members 139 for sealing the vent ports 119 in an initial ready for reconstitution state of the fluid transfer assembly 160.
FIG. 14 shows a fluid transfer assembly 170 for use with a pair of large diameter vials, for example 32 mm neck diameter, and an IV device 30 including an IV spike 31, a chamber 32, and IV tubing 33. The fluid transfer assembly 170 has a similar construction to the fluid transfer assembly 100 and therefore similar parts are likewise numbered. The fluid transfer assembly 170 includes a vented female vial adapter 171 including a venting arrangement 110A and a male vial adapter 172 including a sealing arrangement 130A. The fluid transfer assembly 170 has an initial ready for reconstitution state with the male vial adapter 172 screw thread engaged on the female vial adapter 171.
The vented female vial adapter 171 differs from the vented female vial adapter 110 insofar its female connector 117 is fashioned for receiving the IV spike 31. The female vial adapter 171 includes a female connector 117 which is taller with respect to its top wall 111 than the female vial adapter 110's female connector 117 to sealingly accommodate the IV spike 31. The male vial adapter 172 includes a port sealing member 139 which is taller with respect to its top wall 131 than the male vial adapter 130's port sealing member 139 to compensate for the female vial adapter 171's female connector 117. FIGS. 15 and 16 show the female connector 117 includes an annular seal 173 for sealing a male connector 137 in an initial ready for reconstitution state of the fluid transfer assembly 170 and an IV spike 31 during liquid drug administration.
FIG. 17 shows FIG. 1's vented female vial adapter 110 including a manually placed cap 124 for sealing its female connector 117 subsequent to reconstitution of liquid drug contents for maintaining sterile conditions while the female vial adapter 110 is left standing for subsequent use. Alternatively, FIG. 18 shows FIG. 1's vented female vial adapter 110 with a pre-split septum 126 for the same purpose.
FIG. 19 shows a fluid transfer assembly 180 similar in construction to the fluid transfer assembly 100 but differing therefrom insofar it has an initial non ready for reconstitution state as opposed to an initial ready for reconstitution state. The fluid transfer assembly 180 includes a female vial adapter 181 having a venting arrangement 110A and a female connector 117 and a male vial adapter 182 having a sealing arrangement 130A and a male connector 137. The female vial adapter 181 can be constituted by either a female vial adapter 110 for use with syringes 10 for administration purposes or a female vial adapter 171 for use with IV devices 30 for administration purposes. The male vial adapter 182 correspondingly includes a suitably shaped and dimensioned male connector 137. The difference between the non ready for reconstitution state and the ready for reconstitution state is that in the former state the male vial adapter 182 is axially displaced from the female vial adapter 181 such that the male connector 137 does not seal the female connector 117 and the sealing arrangement 130A does not seal the venting arrangement 110A.
FIG. 20 shows the male vial adapter 182 is similar to the male vial adapter 130 but differs therefrom in two respects as follows: The sealing arrangement 130A additionally includes a pair of opposite inward directed engagement members 183 for engaging a female connector 117 in the initial non ready for reconstitution state for assembling the male vial adapter 182 on the female vial adapter 181. Also, the male vial adapter 182 includes three equispaced axial directed grip members 184 lateral to the male connector 137 and having inward directed projections 186 for engaging the female connector's external screw thread 117A on axial displacement of the male vial adapter towards the female vial adapter.
FIG. 21 shows the fluid transfer assembly 180 pursuant to snap fitting the male vial adapter 182 on a vial 20B containing a liquid medicament 27. A user applies a downward force F on the female vial adapter 181 causing the female vial adapter 181 to axially move towards the male vial adapter 182. The axial displacement causes the sealing arrangement 130A to seal the vent ports 119A and the male connector 137 to seal the female connector 117 thereby effectively priming the fluid transfer assembly 180 into its ready for reconstitution state. The inward directed projections 186 engage the external screw thread 117A in a similar manner to a male Luer lock connector such that a user unscrews the male vial adapter 182 from the female vial adapter 181 for the initial opening of the venting arrangement 110A to enable drawing in of filtered air and the subsequent complete mechanical detachment of the male vial adapter 182 from the female vial adapter 181.
EP882441A2 Title not available
1 Article with picture of West Pharmaceutical Services' Vial2Bag Needleless System, [on-line]; ISIPS Newsletter, Oct. 26, 2007]; retrieved from Internet Feb. 16, 2010]; URL: (7 pages. see pp. 5-6).
2 Article with picture of West Pharmaceutical Services' Vial2Bag Needleless System, [on-line]; ISIPS Newsletter, Oct. 26, 2007]; retrieved from Internet Feb. 16, 2010]; URL:<http://www.isips.org/reports/ISIPS—Newsletter—October—26—2007. html.> (7 pages. see pp. 5-6).
4 Drug Adminsitration Systems product information sheets; http://www.westpharma.com/eu/en/products/Pages/Vial2Bag.aspx; pp. 1-3 (admitted prior art).
5 English translation of an Office Action issued Jul. 26, 2013 in JP Application No. 2012-538464.
6 English translation of an Office Action issued Jun. 19, 2013 in JP Application No. 2012-531551.
7 English translation of an Office Action issued Sep. 10, 2013 in JP Application No. 2012-554468.
8 Grifols Vial Adapter Product Literature, 2 pages, Jan. 2002.
9 http://www.knovel.com/web/portal/browse/display?-EXT-KNOVEL-DISPLAY-bookid=1023&VerticalID=0 [retrieved on Feb. 9, 2011].
10 http://www.knovel.com/web/portal/browse/display?—EXT—KNOVEL—DISPLAY—bookid=1023&VerticalID=0 [retrieved on Feb. 9, 2011].
11 International Search Report Issued Jan. 23, 2007 in Int'l Application No. PCT/IL/2006/001228.
12 Int'l Preliminary Report on Patenability Issued Oct. 20, 2009 in Int'l Application No. PCT/IL2008/000517.
13 Int'l Preliminary Report on Patentability issued Aug. 28, 2012 in Int'l Application No. PCT/IL2011/000186.
14 Int'l Preliminary Report on Patentability Issued Dec. 4, 2007 in Int'l Application No. PCT/IL2006/000912.
15 Int'l Preliminary Report on Patentability Issued Jun. 19, 2006 in Int'l Application No. PCT/IL2005/000376.
16 Int'l Preliminary Report on Patentability Issued Jun. 19, 2008 in Int'l Application No. PCT/IL2007/000343.
17 Int'l Preliminary Report on Patentability issued May 6, 2008 in Int'l Application No. PCT/IL2006/001228.
18 Int'l Search Report & Written Opinion issued on Mar. 7, 2012 in Int'l Application No. PCT/IL2011/000829.
19 Int'l Search Report and Written Opinion issued Mar. 6, 2012 in Int'l Application No. PCT/IL2011/000834.
20 Int'l Search Report dated Nov. 20, 2006 in Int'l Application No. PCT/IL2006/000881.
21 Int'l Search Report issued Aug. 16, 2012 in Int'l Application No. PCT/IL2012/000164.
22 Int'l Search Report Issued Aug. 25, 2008 in Int'l Application No. PCT/IL2008/000517.
23 Int'l Search Report Issued Dec. 6, 2006 in Int'l Application No. PCT/IL2006/000912.
24 Int'l Search Report issued Feb. 3, 2011 in Int'l Application No. PCT/IL2010/000777; Written Opinion.
25 Int'l Search Report issued Jan. 22, 2013 in Int'l Application No. PCT/IL2012/000354.
26 Int'l Search Report issued Jul. 1, 2013 in Int'l Application No. PCT/IL2013/050180.
27 Int'l Search Report issued Jul. 12, 2011 in Int'l Application No. PCT/IL2011/000186.
28 Int'l Search Report issued Jul. 12, 2011 in Int'l Application No. PCT/IL2011/000187.
29 Int'l Search Report issued Jul. 26, 2013 in Int'l Application No. PCT/IL2013/050316.
30 Int'l Search Report Issued Jul. 27, 2007 in Int'l Application No. PCT/IL2007/000343.
31 Int'l Search Report issued Jul. 31, 2103 in Int'l Application No. PCT/IL2013/050313.
32 Int'l Search Report issued Jun. 19, 2013 in Int'l Application No. PCT/IL201/050167.
33 Int'l Search Report issued Jun. 19, 2013 in Int'l Application No. PCT/IL2013/050167.
34 Int'l Search Report issued Jun. 5, 2013 in Int'l Application No. PCT/IL2012/050407.
35 Int'l Search Report Issued Mar. 12, 2009 in Int'l Application No. PCT/IL2008/001278.
36 Int'l Search Report issued Mar. 17, 2011 in Int'l Application No. PCT/IL2010/000854; Written Opinion.
37 Int'l Search Report issued Mar. 17, 2011 in Int'l Application No. PCT/IL2010/000915; Written Opinion.
38 Int'l Search Report issued Mar. 18, 2013 in Int'l Application No. PCT/IL2012/050516.
39 Int'l Search Report Issued Mar. 27, 2009 in Int'l Application No. PCT/US2008/070024.
40 Int'l Search Report issued Mar. 6, 2012 in Int'l Application No. PCT/IL2011/000834; Written Opinion.
41 Int'l Search Report issued Mar. 7, 2012 in Int'l Application No. PCT/IL2011/000829; Written Opinion.
42 Int'l Search Report issued Nov. 25, 2010 in Int'l Application No. PCT/IL2010/000530.
43 Int'l Search Report Issued Oct. 17, 2005 in Int'l Application No. PCT/IL2005/000376.
44 Int'l Search Report issued Oct. 7, 2011 in Int'l Application No. PCT/IL2011/000511.
45 Int'l Search Report issued on Mar. 17, 2011 in Int'l Application No. PCT/IL2010/000854.
46 Int'l Search Report issued on Mar. 17, 2011 in Int'l Application No. PCT/IL2010/00915.
47 IV disposables sets catalogue, Cardinal Health, Alaris® products, SmartSite® access devices and accessories product No. 10013365, SmartSite add-on bag access device with spike adapter and needle-free valve bag access port, pp. 1-5, Fall edition (2007).
48 Non-Vented Vial Access Pin with ULTRASITE.RTM. Valve, B. Braun Medical, Inc. website and product description, 3 pages, Feb. 2006.
49 Novel Transfer, Mixing and Drug Delivery Systems, MOP Medimop Medical Projects Ltd. Catalog, 4 pages, Rev. 4, 2004.
50 Office Action issued Apr. 2, 2013 in U.S. Appl. No. 13/505,790.
51 Office Action Issued Apr. 20, 2010 in U.S. Appl. No. 11/997,569.
52 Office Action issued Aug. 20, 2013 in U.S. Appl. No. 13/576,461 by Lev.
53 Office Action issued Aug. 3, 2011 in JP Application No. 2008-525719.
54 Office Action issued Dec. 13, 2010 in U.S. Appl. No. 12/293,122.
55 Office Action issued Dec. 20, 2010 in U.S. Appl. No. 12/063,176.
56 Office Action issued Dec. 23, 2010 in U.S. Appl. No. 29/334,696.
57 Office Action Issued Feb. 20, 2009 in U.S. Appl. No. 11/694,297.
58 Office Action Issued Feb. 22, 2005 in U.S. Appl. No. 10/062,796.
59 Office Action issued Feb. 7, 2011 in U.S. Appl. No. 12/783,194.
60 Office Action issued Jan. 2, 2014 in U.S. Appl. No. 13/505,881 by Lev.
61 Office Action Issued Jan. 20, 2010 in JP Application No. 2007-510229.
62 Office Action issued Jan. 23, 2013 in U.S. Appl. No. 12/112,490 by Zinger.
63 Office Action issued Jul. 11, 2011 in U.S. Appl. No. 12/293,122.
64 Office Action issued Jul. 13, 2012 in U.S. Appl. No. 12/112,490 by Zinger.
65 Office Action issued Jun. 1, 2010 in U.S. Appl. No. 11/568,421.
66 Office Action issued Jun. 14, 2012 in U.S. Appl. No. 29/376,980.
67 Office Action issued Jun. 15, 2011 in JP Application No. 2008-538492.
68 Office Action issued Jun. 15, 2012 in U.S. Appl. No. 29/413,170.
69 Office Action issued Jun. 21, 2012 in U.S. Appl. No. 12/596,167.
70 Office Action Issued Jun. 8, 2010 in U.S. Appl. No. 12/112,490 by Zinger.
71 Office Action issued Mar. 1, 2012 in CN Application No. 2008801108283.4.
72 Office Action issued Mar. 1, 2012 in JP Application No. 2007-510229.
73 Office Action issued Mar. 13, 2012 in CA Application No. 2,563,643.
74 Office Action issued Mar. 6, 2012 in U.S. Appl. No. 12/678,928.
75 Office Action Issued May 12, 2011 in U.S. Appl. No. 12/063,176.
76 Office Action Issued May 27, 2010 in U.S. Appl. No. 11/559,152.
77 Office Action issued May 31, 2013 in U.S. Appl. No. 13/505,790.
78 Office Action issued Nov. 11, 2013 in IL Application No. 218730.
79 Office Action issued Nov. 12, 2010 in U.S. Appl. No. 29/334,697.
80 Office Action issued Nov. 29, 2010 in U.S. Appl. No. 11/568,421.
81 Office Action Issued Oct. 5, 2005 in U.S. Appl. No. 10/062,796.
82 Office Action Issued Oct. 6, 2003 in U.S. Appl. No. 10/062,796.
83 Office Action issued Sep. 28, 2010 in U.S. Appl. No. 12/112,490 by Zinger.
84 Photographs of Alaris Medical Systems SmartSite.RTM. device, 5 pages, 2002.
85 Publication date of Israeli Patent Application 186290 [on-line]. [Retrieved from Internet May 24, 2010]. URL:. (1 page).
86 Publication date of Israeli Patent Application 186290 [on-line]. [Retrieved from Internet May 24, 2010]. URL:<http://www.ilpatsearch.justrice.gov.il/UI/RequestsList.aspx>. (1 page).
87 Smart Site.RTM. Alaris Medical Systems Product Brochure, 4 pages, Issue 1, Oct. 1999.
88 Smart Site.RTM. Needle-Free Systems, Alaris Medical Systems Webpage, 4 pages, Feb. 2006.
89 The MixJect transfer system, as shown in the article, "Advanced Delivery Devices," Drug Delivery Technology Jul./Aug. 2007 vol. 7 No. 7 [on-line]. [Retrieved from Internet May 14, 2010.] URL: . (3 pages).
90 The MixJect transfer system, as shown in the article, "Advanced Delivery Devices," Drug Delivery Technology Jul./Aug. 2007 vol. 7 No. 7 [on-line]. [Retrieved from Internet May 14, 2010.] URL: <http://www.drugdeiverytech-online.com/drugdelivery/200707/?pg=28pg28>. (3 pages).
91 Translation of Office Action issued Apr. 15, 2013 in JP Application No. 2008-538492.
92 Translation of Office Action issued Jun. 18, 2012 in JP Application No. 2008-538492.
93 U.S. Appl. No. 13/505,790 by Lev, filed May 3, 2012.
94 U.S. Appl. No. 13/505,881 by Lev, filed May 3, 2012.
95 U.S. Appl. No. 13/576,461 by Lev, filed Aug. 1, 2012.
96 U.S. Appl. No. 13/883,289 by Lev, filed May 3, 2013.
97 U.S. Appl. No. 13/884,981 by Denenburg, filed May 13, 2013.
98 U.S. Appl. No. 14/005,751 by Denenburg, filed Sep. 17, 2013.
99 U.S. Appl. No. 29/438,134 by Lev, filed Nov. 27, 2012.
100 U.S. Appl. No. 29/438,141 by Gilboa, filed Nov. 27, 2012.
101 U.S. Appl. No. 29/478,723 by Lev, filed Jan. 8, 2014.
102 U.S. Appl. No. 29/478,726 by Lev, filed Jan. 8, 2014.
103 Written Opinion of the Int'l Searching Authority Issued Oct. 27, 2008 in Int'l Application No. PCT/US2008/070024.
104 Written Opinion of the ISR Issued Oct. 17, 2009 in Int'l Application No. PCT/IL08/00517.
US20140257204 * 5 Mar 2013 11 Sep 2014 Stuart Robert Lessin Apparatus for reconstituting and dispensing drugs for topical application
US20150274331 * 12 Jun 2015 1 Oct 2015 Parker Laboratories, Inc. Adaptor for connecting a fluid package to a dispenser bottle
US20170100305 * 20 Dec 2016 13 Apr 2017 Roche Diagnostics International Ag Adapter and drug cartridge alignment device
U.S. Classification 604/415, 604/416, 604/405
Cooperative Classification A61J1/201, A61J1/2013, A61J1/2068, A61J1/2079, A61J1/2055, A61J1/2065, A61J1/2096, A61J1/2089
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:LEV, NIMROD;BEN SHALOM, NIV;LEV, AMIR;REEL/FRAME:028557/0672