Safety drug handling device

[0001] This application is related to and claims priority to the following patent application:

Provisional Patent Application No. 60 / 516.613.

FIELD OF THE INVENTION [0002] The present invention generally relates to drug mixing systems.

BACKGROUND OF THE INVENTION [0003] The following US patents and United States non-patent literature publications are believed to be the current state of the art:

6,221,041; 6,715,520; 6,409,708; PCT US02 / 40596; WO 9943282 WO 2004004806; WO 03086529; WO 9819724; WO 03/086530; WO 0035517 and WO 0211794.

SUMMARY OF THE INVENTION [0004] The present invention aims to provide an improved syringe adapter for a drug mixing system adapted for use with a hypodermic syringe equipped with a luer tip, which is particularly useful for use with toxic drugs such as anti-neoplastic drugs.

[0005] Thus, according to one embodiment of the invention, there is provided a medicament mixing system comprising at least one reservoir port adapter adapted to enter a liquid reservoir port, at least one vial adapter adapted to be connected to a drug containing vial and at least one syringe adapter adapted to attach to the syringe and to at least one of the at least one reservoir port adapter and at least one vial adapter, wherein the system is characterized in that at least one of the at least one reservoir port connector, at least one syringe connector and at least one vial connector is vented to the atmosphere in a manner that prevents the release of potentially harmful contents of the vial in liquid, solid form or gas.

[0006] Also according to another embodiment of the invention, there is provided a medicament mixing system comprising at least one reservoir port adapter adapted to enter a liquid reservoir port, at least one vial adapter adapted to be connected to a drug containing vial and at least one syringe adapter adapted for connection to a syringe and at least one of at least one reservoir port adapter and at least one vial adapter, wherein the system is characterized in that at least one vial adapter is vented to the atmosphere in a manner preventing release of potentially harmful vial contents into the atmosphere.

[0007] Preferably, the drug mixing system also includes a membrane vent to vent at least one of the at least one reservoir port connector, at least one syringe connector and at least one vial connector to the atmosphere. In addition, the membrane vent contains a filter. Additionally or alternatively, the membrane vent includes a hydrophobic membrane.

[0008] According to another embodiment of the invention, there is also provided a drug mixing system comprising at least one reservoir port adapter adapted to enter a liquid reservoir port, at least one vial adapter adapted to be connected to a drug containing vial and at least one syringe adapter adapted for connection to a syringe and at least one of at least one reservoir port adapter and at least one vial adapter, wherein the system is characterized in that at least one syringe connector is adapted to be coupled with the possibility of fluid flow and mechanically attached to at least one of the at least one port of the reservoir and to at least one vial connector in a single stage.

Preferably at least one of the at least one vial adapter, at least one reservoir port adapter and at least one syringe adapter are vented to the atmosphere without allowing potentially harmful vial contents to enter the atmosphere.

[0010] Preferably, the drug mixing system also includes a closing cock connected to at least one vial adapter and at least one reservoir port adapter.

[0011] Additionally, in accordance with yet another embodiment of the invention, there is provided a medicament mixing system comprising at least one reservoir port adapter adapted to enter a liquid reservoir port and at least one vial adapter adapted to be connected to a medicament containing vial and connected to at least one tank port connector, whereby this system is characterized by that at least one of the at least one reservoir port adapter and at least one vial adapter is vented to the atmosphere in a manner that prevents potentially harmful vial contents from being released into the atmosphere.

[0012] Additionally, in accordance with yet another embodiment of the present invention, there is provided a drug mixing system comprising at least one reservoir port adapter adapted to enter a liquid reservoir port and at least one vial adapter adapted to be connected to a medicament containing vial and connected to with at least one reservoir port adapter, wherein the at least one vial adapter has a ventilation and sealing element, allowing air to be delivered to the drug mixing system and adapted to prevent air from escaping from the drug mixing system.

[0013] Preferably the ventilation and sealing element comprises a hydrophobic membrane and a narrow opening.

[0014] Preferably, the narrow opening is irreversibly filled with liquid due to the flow of liquid from the liquid container to the vial, whereby air escapes.

[0015] Alternatively or additionally, the reservoir port connector comprises an elastomer coated needle and the reservoir port connector and the vial adapter are integrally formed. Alternatively, the reservoir port adapter includes an elastomer coated needle and reservoir port adapter, syringe adapter and vial adapter are integrally formed.

[0016] Preferably, the at least one vial adapter also includes a vial protective housing to prevent the potentially harmful content of the vial from being released into the atmosphere in the form of a liquid, solid or gas if the vial is damaged.

[0017] According to another embodiment, the liquid container comprises a spike port and at least one reservoir port connector comprises a spike port connector. Additionally or alternatively, the liquid reservoir includes a needle port and the at least one reservoir port connector includes a needle port connector. In addition, the needle port connector includes a needle, the needle being protected by a needle protector. Preferably, the needle protector includes a latex needle cover.

[0018] Preferably, the drug mixing system also includes a vial head adapter adapted to connect the vial adapter and vial.

[0019] According to another embodiment, the at least one reservoir port connector and reservoir with liquid are adapted to be connected to an intravenous cannula in a patient through an intravenous infusion set.

[0020] Preferably, the at least one syringe connector and syringe are adapted to be connected to an intravenous cannula in a patient by an intravenous infusion set using an intravenous infusion set connector. Additionally or alternatively, the syringe connector is covered with a syringe housing member.

[0021] According to another embodiment, a drug mixing system comprising at least one drug mixing element with an atmospheric venting function is further provided, characterized in that it prevents the release of a potentially harmful drug substance into the atmosphere due to this venting feature, this potentially harmful substance the drug comprises at least one of solid, liquid, gaseous and aerosol forms.

[0022] According to yet another embodiment, there is further provided a method of mixing a medicament comprising attaching a hypodermic syringe equipped with a luer tip, having a plunger with a syringe connector, inserting a reservoir port connector into the liquid reservoir port, attaching the syringe connector, with attached to it with a syringe, to the tank port connector, piston withdrawal, thereby at least partially filling the syringe with liquid withdrawn from the reservoir in a manner that ensures that this liquid remains sterile and that the user is not exposed to this liquid, connecting the syringe adapter with the syringe attached to it with the vial adapter assembly having the vial attached to it the medicine, pressing the plunger, whereby the liquid in the syringe is injected into the medicine vial, thereby producing a solution of the medicine in the vial, and withdrawing the plunger, so that at least a portion of the vial contents are withdrawn into the syringe, at least one reservoir port adapter, syringe adapter and vial adapter is vented to the atmosphere in a manner that prevents potentially harmful contents of the vial being released into the atmosphere in liquid, solid or gas.

[0023] According to yet another embodiment, a method of mixing the medicament further comprising attaching a hypodermic syringe equipped with a luer tip, having a plunger with a syringe connector, inserting a reservoir port connector into the liquid reservoir port, attaching a syringe connector, with a syringe attached thereto, is provided to the tank port connector, piston withdrawal, thereby at least partially filling the syringe with liquid withdrawn from the reservoir in a manner that ensures that this liquid remains sterile and that the user is not exposed to the liquid, connecting the syringe adapter with the syringe attached to it with the vial adapter assembly having the vial attached to it medicine, pressing the plunger, which injects the liquid contained in the syringe into the medicine vial, thereby producing a drug solution in the vial and withdrawing the plunger, so that at least a portion of the vial contents are withdrawn into the syringe, the syringe adapter being adapted to be coupled with the possibility of fluid flow and mechanically attached to at least one of at least one of the reservoir port connectors and to the vial adapter in a single step.

[0024] According to another embodiment, a method of mixing the medicament further comprising attaching a hypodermic syringe equipped with a luer tip having a plunger to a syringe connector, inserting a reservoir port connector into a port in a liquid reservoir, attaching a syringe connector with a syringe attached thereto is further provided to the vial adapter assembly having the drug vial attached to it, withdrawing the plunger, thanks to which the syringe is at least partially filled with liquid taken from the reservoir, connecting the syringe connector having the syringe attached to it to the reservoir port connector and pressing the piston, thanks to which at least part of the vial contents is injected into the reservoir, at least one reservoir port connector, the syringe adapter and vial adapter is vented to the atmofera in a manner that prevents the potentially harmful content of the vial from being released into the atmosphere in liquid, solid or gaseous form.

[0025] According to another embodiment, a method of mixing the medicament further comprising attaching a hypodermic syringe equipped with a luer tip, having a plunger to a syringe connector, inserting a reservoir port connector into the liquid reservoir port, attaching a syringe connector, with a syringe attached thereto, is further provided to the vial adapter assembly having the drug vial attached to it, withdrawing the plunger, thanks to which the syringe is at least partially filled with liquid taken from the reservoir, connecting the syringe adapter having the syringe attached to it, to the reservoir port connector and pressing the plunger, thanks to which at least part of the vial contents is injected into the reservoir, wherein the syringe adapter is adapted to be coupled with the possibility of fluid flow and mechanically attached to at least one of the at least one reservoir port connector and to the vial adapter in a single step.

[0026] According to another embodiment, there is further provided a method of mixing a medicament comprising attaching a hypodermic syringe equipped with a luer tip having a plunger to a syringe adapter, connecting a syringe adapter having a syringe attached thereto, to a vial adapter assembly having a drug vial attached thereto , pulling back the plunger, so that at least some of the vial contents are drawn into the syringe, and pressing the plunger, whereby at least part of the vial contents are injected into the infusion line, wherein at least one reservoir port adapter, syringe adapter and vial adapter is vented to the atmosphere in a manner that prevents potentially harmful contents of the vial being released into the atmosphere in liquid, solid or gas form.

[0027] According to another embodiment, there is still further provided a method of mixing a medicament comprising attaching a hypodermic syringe equipped with a luer tip having a plunger to a syringe adapter, connecting a syringe adapter having a syringe attached thereto to a vial adapter assembly having a vial attached thereto medicine, pulling the plunger, so that at least part of the contents of the vial are drawn into the syringe, and pressing the plunger, thereby, at least a portion of the vial contents are injected into the infusion tube, wherein the syringe adapter is adapted to be fluid-coupled and mechanically attached to at least one of the at least one reservoir port connector and to the vial adapter in a single stage.

[0028] Preferably, connecting the syringe connector also includes disconnecting the syringe connector from the reservoir connector prior to connection.

[0029] Preferably, connecting the syringe connector having a syringe attached thereto to the reservoir port connector also includes disconnecting the syringe connector from the vial connector prior to connection.

[0030] Additionally or alternatively, combining the syringe adapter includes connecting the drug-containing vial to the vial head adapter and connecting the drug-containing vial having a vial head adapter attached thereto, to the vial adapter assembly before connecting the syringe to the vial adapter assembly. Alternatively or additionally, the method of mixing the drug also includes attaching a syringe connector having a syringe attached thereto containing at least a portion of the drug solution to the reservoir port connector and injecting the contents of the syringe into the reservoir.

[0031] According to yet another embodiment, a method of mixing the medicament is further provided comprising inserting the reservoir port connector into the liquid reservoir port, connecting the medicament vial to the reservoir port connector, transferring at least a portion of the liquid from the reservoir to the medicament vial by why the drug solution is made in the vial and then the drug solution is transferred from the vial to the reservoir.

[0032] Preferably, combining the drug-containing vial includes combining the drug-containing vial with the vial head adapter before attaching the drug-containing vial. Additionally or alternatively, the reservoir port connector includes at least one spike port connector and a needle port connector.

[0033] According to another embodiment, there is further provided a vial adapter adapted to be connected to a drug containing vial and adapted to be connected to other components of the drug mixing system, the vial adapter comprising a spike adapted to penetrate the vial, a mechanical closure for attaching the vial adapter to vials, when the spike penetrates the vial and the venting device, the inside of the vial enters the atmosphere without allowing potentially harmful vial contents to enter the atmosphere.

[0034] Preferably, the vial adapter also includes a membrane vent venting the vial adapter to the atmosphere. In addition, the membrane vent contains a filter. Alternatively or additionally, the membrane vent comprises a hydrophobic membrane.

[0035] Preferably the vial adapter also includes a septum equipped with a syringe port. Additionally or alternatively, the vial adapter includes at least one blocking element irreversibly blocking the vial adapter on the vial. Preferably, the at least one locking element comprises at least one radially extending part and at least one transversely extending part.

[0036] According to yet another embodiment, there is further provided a vial adapter adapted to be coupled to a drug containing vial and adapted to be connected to other components of the drug mixing system, the vial adapter comprising at least one blocking element irreversibly blocking the vial adapter on the vial.

[0037] Preferably, the at least one locking element comprises at least one radially extending part and at least one transversely extending part.

[0038] According to yet another embodiment, there is further provided a vial adapter adapted to be connected to the drug-containing vial and adapted to be connected to a fluid transfer device, wherein the vial adapter is vented to the atmosphere in a manner preventing release of potentially harmful contents of the vial into the atmosphere. in liquid, solid or gas form.

[0039] Preferably the vial adapter also includes a membrane vent venting the vial adapter to the atmosphere. In addition, the membrane vent contains a filter. Alternatively or additionally, the membrane vent comprises a hydrophobic membrane.

[0040] According to a preferred embodiment, there is provided a syringe connector according to claim 1 adapted to be connected to a syringe and adapted to be connected to at least one other drug mixing system component, wherein the syringe connector comprises a septum housing, at least two septum are located in the septum housing defining a certain space between them and the needle, embracing the tip located in this space, when the syringe connector is not connected to at least one other element.

[0041] The septum housing is movable relative to the needle, whereby the tip is exposed. Additionally or alternatively, at least some of the needle is shielded by the needle protector. In addition, the needle protecting element comprises an elastomeric tubular element.

[0042] According to yet an additional embodiment, the vial head adapter is further provided for use in connecting a vial having a first head circumference to a vial adapter adapted for use with a vial having a second head circumference, wherein the second head circumference is larger than the first head circumference, wherein the vial head adapter includes at least one locking member.

[0043] Preferably, the at least one locking element comprises four locking elements generally arranged at right angles to each other. In addition, the at least one locking element comprises a locking tooth.

[0044] According to yet another embodiment, there is further provided a reservoir port connector for use in a drug mixing system comprising a housing, a needle disposed within the housing and adapted to enter a fluid reservoir port, a septum disposed within the housing, and a locking mechanism to secure the connector tank port to this port.

[0045] Preferably, the needle is secured by a needle protector. In addition, the needle protector includes a latex needle cover. Alternatively or additionally, the needle moves between the secured position and the puncturing position.

[0046] According to yet another embodiment, a vial protective enclosure is also provided for use with a medicament mixing system comprising a fluid flow channel adapted to connect a medicament containing vial to a medicament mixing system, the vial protective enclosure preventing the potentially harmful contents of the vial from being released into the atmosphere. liquid, solid or gaseous form if the vial is damaged.

BRIEF DESCRIPTION OF THE FIGURES [0047] The present invention will be more fully understood and appreciated by reading the following detailed description in connection with the drawing, in which:

Figures 1A, 1B, 1C, 1D, 1E, 1F, 1G, 1H, 1I, 1J, 1K, 1L and 1M are simplified illustrative illustrations of the various assembly steps and typical use of a drug mixing system constructed and operating in accordance with the embodiments of the present invention;

Fig. 2 is a simplified pictorial illustration of the vial head adapter being part of the drug mixing system of Figs. 1A-1M;

Fig. 3 is an illustration of the section along section line III-III of Fig. 2;

Fig. 4 is a simplified illustration of an exploded view of the vial adapter assembly that is part of the drug mixing system of Figs. 1A-1M;

Fig. 5 is a simplified assembled illustration of the vial adapter assembly of Fig. 4;

Figures 6A and 6B are sectional illustrations along respective section lines VIA - VIA and VIB - VIB in Fig. 5;

Fig. 7 is a simplified illustration of an exploded view of a syringe adapter member that is part of the drug mixing system of Figs. 1A-1M;

Fig. 8 is a simplified assembled illustration of the syringe connector element of Fig. 7;

Figures 9A and 9B are sectional illustrations along respective section lines IXA-IXA and IXB-IXB in Fig. 8;

Fig. 9C is a cross-sectional illustration of an alternative embodiment of the syringe connector element of Fig. 8 along section line IXA-IXA of Fig. 8.

Fig. 10 is a simplified illustrative illustration of a spike port connector element that forms part of the drug mixing system of Figs. 1A-1M;

Figures 11A and 11B are sectional illustrations along section line XI-XI of Fig. 10 of two different internal structures of the spike port connector element;

Figures 12A and 12B are simplified pictorial illustrations of a needle port connector element that forms part of the drug mixing system of Figures 1A-1M;

Figures 13A and 13B are sectional illustrations along respective section lines XIIIA - XIIIA and XIIIB - XIIIB in Fig. 12A;

Fig. 14 is a simplified pictorial illustration of the protective cover of a syringe that is part of the drug mixing system of Figs. 1A-1M;

Fig. 15 is a sectional illustration along section line XV-XV of Fig. 14;

Fig. 16 is a simplified illustrative illustration of an injection kit adapter member that forms part of the drug mixing system of Figs. 1A-1M;

Fig. 17 is a sectional illustration taken along the section line XVII - XVII in Fig. 16;

Figures 18A and 18B are, respectively, a simplified flat illustration and a simplified cross-sectional illustration of the drug mixing system of Fig. 1A when attaching the vial adapter, the section taken along the line XVIIIB - XVIIIB in Fig. 18A;

Figures 19A and 19B are respectively a simplified flat top view and a simplified cross-sectional illustration of the drug mixing system of Fig. 1C when attaching the syringe connector, the section taken along line XIXB-XIXB in Fig. 19A;

Figures 19C and 19D are respectively a simplified flat side view and a simplified cross-sectional illustration of the drug mixing system of Fig. 1C when attaching the syringe adapter, section taken along line XIXD-XIXD in Fig. 19C;

Fig. 20 is a partially pictorial, partly cross-sectional illustration of the drug mixing system of Fig. 1D when attaching the spike port connector element;

Fig. 21 is a partially pictorial, partly cross-sectional illustration of the drug mixing system of Fig. 1D when attaching the needle port connector element;

Fig. 22 is a partially pictorial, partly cross-sectional illustration of the drug mixing system of Figs. 1E and 20 before attaching the syringe;

Fig. 23 is a partially pictorial, partly cross-sectional illustration of the drug mixing system of Figs. 1E and 20 after attachment of the syringe;

Fig. 24 is a partially pictorial, partly cross-sectional illustration of the drug mixing system of Figs. 1E and 21 before attaching the syringe;

Fig. 25 is a partially pictorial, partly cross-sectional illustration of the drug mixing system of Figs. 1E and 21 after the syringe is attached;

Fig. 26 is an illustration of the cross sectional view of the drug mixing system of Fig. 1G before dilution of the drug;

Fig. 27 is an illustration of the cross sectional view of the drug mixing system of Fig. 1H after drug dilution;

Fig. 28 is an illustration of a cross sectional view of the drug mixing system of Figs 1K and 1L in a protected state, ready for delivery;

Fig. 29 is a partially pictorial, partly cross-sectional illustration of the drug mixing system of Figures 1M and 28 ready for injection;

Fig. 30 is a partially pictorial, partly cross-sectional illustration of the drug mixing system of Figures 1M and 20 ready for injection;

Figures 31A, 31B, 31C, 31D, 31E, 31F, 31G, 31H, 31I, 31J, 31K and 31L are simplified pictorial illustrations of the various stages of assembly and typical use of a drug mixing system constructed and operating in accordance with another embodiment;

Fig. 32 is a simplified pictorial illustration of a vial head adapter that forms part of the drug mixing system of Figs. 31A-31L;

Fig. 33 is an illustration of the section taken along section line XXXIII - XXXIII of Fig. 32;

Fig. 34 is a simplified illustrative illustration of a spike port connector element that is part of the drug mixing system of Figs. 31A-31L;

Fig. 35 is an illustration of the section along section line XXXV - XXXV of Fig. 34;

Fig. 36 is a simplified illustration of an exploded view of the connector assembly that is part of the drug mixing system of Figs. 31A-31L;

Fig. 37 is a simplified pictorial illustration of a closing cock member that is part of the connector assembly of Fig. 36;

Figures 38A and 38B are sectional illustrations along respective section lines XXXVIIIA XXXVIIIA and XXXVIIIB - XXXVIIIB in Fig. 37;

Fig. 39 is a simplified illustrative illustration of the tank connector subassembly that forms part of the connector assembly of Fig. 36;

Figures 40A and 40B are sectional illustrations along respective section lines XLA - XLA and XLB - XLB in Fig. 39;

Fig. 41 is a simplified illustrative illustration of the vial adapter assembly which is part of the adapter assembly of Fig. 36;

Figures 42A and 42B are sectional illustrations along respective section lines XLIIA - XLIIA and XLIIB - XLIIB in Fig. 41;

Figures 43A and 43B are simplified pictorial illustrations of a housing component that forms part of the connector assembly of Fig. 36 in the closed and open positions, respectively;

Fig. 44 is a simplified assembled illustration of the connector assembly of Fig. 36;

Figs. 45A and 45B are sectional illustrations along respective section lines XVA-XVA and XVB-XVB in Fig. 44;

Fig. 46 is an illustration of the cross section of the drug mixing system of Fig. 31C when attaching the syringe to the connector assembly of Figs. 44-45B;

Fig. 47 is an illustration of the cross sectional view of the drug mixing system of Fig. 31D when attaching the reservoir adapter member of Fig. 31B to the adapter assembly of Fig. 46;

Fig. 48 is an illustration of the cross sectional view of the drug mixing system of Fig. 31E when attaching the vial to the connector assembly of Fig. 47;

Fig. 49 is an illustration of a cross-sectional view of the drug mixing system of Figs. 31F and 48 when withdrawing liquid from a reservoir;

Fig. 50 is an illustration of the cross sectional view of the drug mixing system of Figs. 31G and 48 when injecting liquid into a vial;

Fig. 51 is an illustration of the cross sectional view of the drug mixing system of Figs. 31I and 48 when withdrawing liquid from the vial;

Fig. 52 is an illustration of the cross sectional view of the drug mixing system of Figs. 31J and 48 when injecting liquid into a reservoir;

Fig. 53 is an illustration of the cross section of the drug mixing system of Fig. 31L in storage ready condition;

Figures 54A, 54B, 54C, 54D, 54E, 54F, 54G and 54H are simplified pictorial illustrations of the various stages of assembly and typical use of a drug mixing system constructed and operating in accordance with another embodiment;

Fig. 55 is a simplified illustrative illustration of a vial head adapter element that is part of the drug mixing system of Figs. 54A-54H;

Fig. 56 is an illustration of the section along the section line LVI - LVI of Fig. 55;

Fig. 57 is a simplified illustrative illustration of a spike port connector element that is part of the drug mixing system of Figs. 54A-54H;

Fig. 58 is a sectional illustration along section line LVIII - LVIII of Fig. 57;

Fig. 59 is an exploded view of the connector assembly that is part of the drug mixing system of Figs. 54A-54H;

Fig. 60 is a simplified illustrative illustration of the vial adapter assembly which is part of the adapter assembly of Fig. 59;

Figures 61A and 61B are sectional illustrations along respective section lines LXIA - LXIA and LXIB - LXIB in Fig. 60;

Fig. 62 is a simplified illustrative illustration of the tank connector subassembly that forms part of the connector assembly of Fig. 59;

Figures 63A and 63B are sectional illustrations along respective section lines LXIIIA LXIIIA and LXIIIB - LXIIIB in Fig. 62;

Figs. 64A and 64B are simplified pictorial illustrations of a housing component that forms part of the connector assembly of Fig. 59 in the closed and open positions, respectively;

Fig. 65 is a simplified assembled illustration of the connector assembly of Fig. 59;

Figures 66A and 66B are sectional illustrations along respective section lines LXVIA LXVIA and LXVIB - LXVIB in Fig. 65;

Figures 67A and 67B are cross-sectional illustrations of the drug mixing system of Fig. 54C when attaching the vial to the connector assembly of Fig. 65;

Fig. 68 is an illustration of a cross sectional view of the drug mixing system of Figs. 54D-54G when attaching the reservoir port connector element of Fig. 54B to the connector assembly of Fig. 67;

Fig. 69 is an illustration of a cross sectional view of the drug mixing system of Figs. 54H and 68 when detaching the reservoir port connector element of Fig. 54B from the connector assembly of Fig. 67;

Fig. 70 is an exploded illustration of a drug mixing system that is constructed and operated in accordance with an additional embodiment;

Fig. 71 is a simplified illustrative illustration of the vial support that is part of the drug mixing system of Fig. 70;

Figs. 72A and 72B are illustrative sectional illustrations and pictorial illustrations of sectional views along section line LXXII-LXXII of Fig. 71, respectively;

Fig. 73 is a simplified illustrative illustration of the vial support of Fig. 71 while supporting the vial;

Fig. 74 is an illustration of the section along section line LXXIV - LXXIV of Fig. 73;

Figures 75A and 75B are simplified pictorial illustrations of a vial lancing cap member that is part of the vial adapter subassembly of Fig. 70;

Fig. 76 is an illustration of the section taken along the section line LXXVI - LXXVI of Fig. 75A;

Fig. 77 is a simplified assembled illustration of the vial adapter assembly of Fig. 70;

Fig. 78 is an illustration of the section along section line LXXVIII - LXXVIII of Fig. 77;

Fig. 79 is an illustrative illustration of the vial adapter assembly of Fig. 77 when assembled with the adapter assembly in accordance with one embodiment;

Fig. 80 is an illustration of the section along the section line LXXX - LXXX of Fig. 79;

Fig. 81 is an illustrative illustration of the vial adapter assembly and the adapter assembly of Fig. 79 when combined with the reservoir port adapter and reservoir in accordance with a preferred embodiment of the present invention;

Fig. 82 is a sectional illustration taken along the section line LXXXII - LXXXII in Fig. 81;

Fig. 83 is an exploded view illustration of a drug mixing system that is constructed and operates in accordance with yet an additional preferred embodiment of the present invention;

Fig. 84 is a simplified pictorial illustration of the reservoir connector housing assembly that is part of the drug mixing system of Fig. 83;

Figures 85A and 85B are sectional illustrations along section line LXXXVA - LXXXVA and LXXXVB - LXXXVB in Fig. 84;

Fig. 86 is a simplified illustrative illustration of a reservoir connector needle element that is part of the drug mixing system of Fig. 83;

Figures 87A and 87B are sectional illustrations along section line LXXXVIIA - LXXXVIIA and LXXXVIIB - LXXXVIIB in Fig. 86;

Fig. 88 is a simplified assembled illustration of the reservoir connector subassembly of Fig. 83;

Figures 89A and 89B are sectional illustrations along section line LXXXIXA - LXXXIXA and LXXXIXB - LXXXIXB in Fig. 88;

Fig. 90 is an illustrative illustration of the reservoir adapter subassembly of Fig. 88 after assembling with the vial adapter subassembly according to an embodiment before connecting the needle to the reservoir point element;

Fig. 91 is an illustration of the section along the XCI-XCI section line of Fig. 90;

Fig. 92 is an illustrative illustration of the reservoir adapter subassembly of Fig. 88 after assembly with the vial adapter subassembly after the needle has been attached to the reservoir port component; and

Fig. 93 is an illustration of the sectional view taken along the section line XCIII - XCIII in Fig. 92.

DETAILED DESCRIPTION [0048] Reference is now made to Figs. 1A, 1B, 1C, 1D, 1E, 1F, 1G, 1H, 1I, 1J, 1K, 1L and 1M, which provide simplified pictorial illustrations of various assembly steps and the typical use of a mixing system a drug constructed and operating in accordance with one embodiment.

[0049] As can be seen in Fig. 1A, a conventional vial 10, comprising an upper part 12 and a neck part 13, is pressed into engagement with the vial adapter assembly 30, which is described below with reference to Figs. 4 - 6B. The top portion 12 of the vial 10 preferably has a septum 31 sealed within it. Figs. 18A-18B show a cross-sectional view of the drug mixing system at this stage.

[0050] Alternatively, when using the small vial 32, the small vial 32 is pressed to engage with the vial head connector member 34, which is described below with reference to Fig. 2 3, as shown in Fig. 1B, and then pressed to obtain couplings with the vial adapter assembly 30. Vials 10 and 32 usually contain the drug in the form of a soluble powder, solution, or other suitable form.

[0051] As shown in Fig. 1C, a hypodermic syringe equipped with a luer tip 40 having a plunger 42 and a luer tip 44 is attached to the syringe connector element 50, which is described below with reference to Figs. 7-9B. Figures 19A-19D are flat views and sections of the drug mixing system at this stage.

[0052] Fig. 1D shows the spike port connector element 60, as described below with reference to Figs. 10-11, which is inserted into the spike port 61 in a liquid containing tank 62. Fig. 20 is a partially illustrative, partly cross-sectional view of the drug mixing system at this stage. Typically, reservoir 62 contains a pouch and the liquid contained therein is a sterile saline solution, water, or any other suitable sterile solution or pure liquid.

[0053] Alternatively, the needle port connector element 70, as described below with reference to Figs. 12A-13B, is inserted into the needle port 64 in the reservoir 62. Fig. 21 is a cross-sectional view of the drug mixing system at this stage.

[0054] Those skilled in the art will recognize that the assembly steps shown in Figs. 1B-1D can be carried out in any appropriate order.

[0055] As can be seen in Fig. 1E, the syringe connector element 50, having a syringe 40 attached thereto (Fig. 1C), is connected to the connecting port in one of the elements of the spike port connector 60 or the needle port connector 70 of Fig. 1D. Figures 22-23 and 24-25 respectively show partial views, partly cross-sectional views of two alternative positions of the drug mixing system at this stage.

[0056] Usually, the plunger 42 of the syringe 40 is fully depressed inside the syringe 40 before connecting the syringe connector element 50 to one of the spike port connector elements 60 and the needle port connector 70.

[0057] As seen in Fig. 1F, the user pulls the plunger 42 into one of the operating positions of Fig. 1E, thereby at least partially filling the syringe 40 with liquid taken from the reservoir 62. The liquid flows through the spike port connector element 60 or through the connector element needle port 70 directly to syringe 40. This liquid flow ensures that the liquid remains sterile and that the user is not exposed to the liquid. Subsequently, the syringe 40 and syringe connector element 50 are detached from the spike port connector element 60 or needle port connector element 70. The drug mixing system of the present invention also ensures that the user is not exposed to liquid during their disconnection, as described below.

[0058] The user then connects the syringe adapter member 50 that is attached to the syringe 40 to the vial adapter assembly 30 having the vial 10 attached thereto, as shown in Fig. 1G. Fig. 26 is a cross-sectional view of the drug mixing system at this stage.

[0059] When the syringe 40 and vial 10 are connected and liquid can flow between them, the user pushes the plunger 42 inwards, the vial being in an upright position, thereby injecting the liquid contained in the syringe 40 into the vial 10 and dissolving the vial her medicine. Fig. 27 shows a cross-sectional view of the drug mixing system at this stage.

[0060] As seen in Fig. 1H, the user then shakes the drug mixing system of Fig. 1G to ensure complete dissolution of the drug in the vial 10 and homogeneity of the resulting solution.

[0061] It should be noted that when the vial 10 contains the drug in pre-dissolved form, the steps described above with reference to Figures 1E-1H can be omitted.

[0062] As can be seen in Fig. 1I, the user turns the drug mixing system upside down and pulls off the plunger 42, thereby withdrawing at least a portion of the solution from the vial 10 into the syringe 40. Then the syringe 40 and syringe adapter part 50 are detached from the vial 10 and the vial adapter assembly 30 as shown in Fig. 1J. At this stage, if some of the drug solution remains in the vial 10, the vial 10 and vial adapter assembly 30 connected to it can be stored in a suitable facility for further use.

[0063] In the next step, the drug solution contained in the syringe 40 is prepared for delivery to the hospital ward for infusion to the patient. As shown in Fig. 1K, the syringe 40 containing the drug solution is connected to the spike port connector element 60 to transfer the drug to the reservoir 62. Alternatively, the syringe 40 can be connected to the needle port connector element 70.

[0064] As an additional alternative, the user may place the syringe protective cover 80, which is described below with reference to Figs. 14-15, on the syringe connector piece 50 which is attached to the syringe 40, before being delivered to the hospital ward.

[0065] As can be seen in Fig. 1L, the user pushes the piston 42 of the syringe 40 inwards, thereby injecting the drug solution into the reservoir 62 and further diluting it before infusing the patient. Alternatively, the syringe 40 may be covered by the syringe protective cover 80 and is ready for delivery to the appropriate hospital ward. Fig. 28 is a cross-sectional view of the drug mixing system at this stage.

[0066] As seen in Fig. 1M, reservoir 62 and spike port connector element 60 are connected by a standard infusion set 92 such as the BIAS model kit which is commercially available from Teva Medical Ltd. from Ashdod, Israel, with a cannula intravenous in a patient. The connection of the spike port connector element 60 is performed after removing the connector element that is located at the end of the spike port connector element 60. Fig. 30 shows a cross-sectional view of the drug mixing system at this stage.

[0067] Alternatively, the syringe 40 and syringe connector element 50 can be connected by means of the connector element of the infusion set 90, which is described below with reference to Figs. 16-17, to the infusion set 92 having port 93 and the intravenous cannula 94 which is placed at the injection site. Before the syringe connector element 50 is connected to the connector element of the infusion set 90, the syringe protective cover 80 is removed from the end of the syringe connector element 50. Fig. 29 is a partially pictorial, partly cross-sectional view of the drug mixing system at this stage.

[0068] The construction of the components of the drug mixing system of Figs. 1A-1M is described below with reference to Figs. 2-17.

[0069] Referring now to Fig. 2, which is a simplified pictorial illustration of a vial head adapter element 34 that is part of the drug mixing system of Figs. 1A-1M, and to Fig. 3, which is a cross-sectional illustration along section line III - III from Fig. 2.

[0070] As can be seen in Fig. 2, the vial head adapter 34 is preferably an integrally shaped lateral symmetrical component that is preferably injection-molded plastic.

[0071] The connector element of the vial head 20 preferably has a generally cylindrical portion of the main body 200 and has a central axis 201. The inner cylindrical surface 202 of the main body portion 200 preferably has four arms 204 extending therefrom, each of the arms 204 being located generally right angle to neighboring arms.

[0072] Each of the arms 204 terminates at its upper end, as shown in Fig. 1B, an inwardly directed, generally triangular tooth 206 having a forwardly inclined surface 208 and a downwardly facing coupling surface 210 extending generally perpendicular to the arm 204.

[0073] On the lower surface of the vial head connector element 34 there are four inwardly protruding surfaces 212, extending generally perpendicular to the inner surface 202 of the main body parts 200. Each of the adjacent surfaces 212 is preferably generally generally at right angles to the adjacent surfaces. surface 212. Surfaces 212 and arms 204 are pivotally offset relative to each other about axis 201.

[0074] Reference will now be made to Fig. 4, which is an exploded view of the preferred vial adapter assembly 30 that is part of the drug mixing system of Figs. 1A-1M, to Fig. 5, which is a simplified assembled illustration of the assembly vial adapter 30, and to Figs. 6A and 6B, which show cross-sectional illustrations along respective section lines VIA - VIA and VIB - VIB in Fig. 5.

[0075] As can be seen in Figs. 4-6B, the vial adapter assembly 30 has a main body element 302 disposed generally about axis 303. The main body element 302 is preferably integrally shaped and preferably injection-molded plastic.

[0076] The main body component 302 is preferably laterally symmetrical about axis 303 and preferably includes a rear portion 304 that is generally cylindrical and ends at front wall 306. Rear portion 304 includes a front base portion 308, at the rear of which four are preferably shaped tabs 310, each of which has a rectangular window 312. On the back of the rectangular windows 312 and on the inner surface 314 of each of the projections 310 there are preferably two radially shaped rearwardly extending projections 316, each having an inclined surface. The projections 316 preferably end at its front end, directed inward, transversely extending projection 318. At the rear of the projections 316, each of the projections 310 preferably has an outwardly facing conical portion 320.

[0077] The hollow puncture spike 322 of the vial extends backwards from the back surface 324 of the front wall 306 and is surrounded by the base portion 308 and by the tabs 310. The back surface 324 additionally has a circular cylindrical projection 325 surrounding the puncture spike 322. Two radially extending holes 326 and 327 extend in the spike pricking vials 322.

[0078] In front of the front wall 306 of the rear portion 304, an intermediate portion 328 is formed that is generally rectangular and includes an axially hollow tubular portion 330 that is fluid-coupled to the puncture spike opening 327 of the vial 322.

[0079] A support surface of the plastic membrane 332 is formed on the upper surface of the intermediate portion 328 and slightly depressed relative thereto, having a plurality of generally uniformly spaced spherical projections 334 formed thereon, which are adapted to support the hydrophobic membrane 336 and protect it from overfilling and before cracking. The membrane 336 is adapted to allow free flow of air to the main body element 302, but to prevent liquid and particles from the air, microorganisms and aerosol to pass through it. Preferably, the 336 membrane is a membrane of the Versapor R 0.2 Micron model, which is commercially available from Pall Corporation of New York, USA. The membrane 336 remains in fluid coupling with the lancing spike of the vials 322 through the opening 326 and through the cavity 337 formed in the intermediate portion 328.

[0080] The rim 338 surrounding the support surface 332 is adapted to support the optional carbon fabric filter 340 and holds it in a raised position and away from the membrane 336. The carbon fabric filter 340 is adapted to prevent harmful vapors from entering the main body element 302, thereby protects users. A preferred fabric carbon filter 340 is the Zorflex EMI model filter, which is commercially available from Charcoal Cloth International Ltd, from Houghton-le-Spring, England.

[0081] The intermediate portion 328 ends at its front end with a generally circular wall 342. A hollow neck portion 344 is formed at the front of the circular wall 342, which is fluid-coupled to the hollow tubular portion 330 and the hollow spike piercing vial 322. The hollow portion neck 344 ends at its front end with the surface of a generally circular wall 346.

[0082 ] In front of the neck portion 344 there is a shaped portion 348 facing forward which is adapted to seal a generally circular septum 350 of the socket 352 which is positioned at the front end of this portion 348. The forward portion 348 defines a central hole. 354, which connects pipe part 330 and partition 350.

[0083] The vial adapter assembly 30 preferably further comprises a covering member 360 that supports and covers the membrane 336 and a carbon filter 340. The covering member 360 is generally cylindrical, is generally side-symmetrical and is preferably formed with a central hole 362 at its front end, through which the front part 348 extends. [0084] Each of the pair of outer side surfaces 364 of the covering element 360 is formed with ribbed gripping areas 366. The inner upper surface 368 of the covering element 360 is preferably flat and is adapted to support the upper surfaces of the membrane 336 and the carbon filter 340 and to prevent it from being overfilled and cracking.

[0085] It should be noted that the functional features of membrane 336 and carbon fabric filter 340, consisting in allowing free flow of air into the drug mixing system while preventing liquid and airborne particles, microorganisms and aerosol from entering inside and preventing harmful penetration vapors from the drug mixing system can be obtained by using similar elements to any element of the syringe connector 50, spike port connector piece 60 and needle port connector piece 70.

[0086] Reference will now be made to Fig. 7, which is an exploded view of the syringe connector element 50 that is part of the drug mixing system of Figs. 1A-1M, to Fig. 8, which is a simplified assembled illustration of the connector element syringes 50, and to Figs. 9A, 9B and 9C, which show cross-sectional illustrations along respective section lines IXA-IXA and IXB-IXB in Fig. 8.

[0087] As can be seen particularly clearly in Fig. 7, the syringe connector element 50 includes a housing element 500 which is embedded therein, a front septum 502 and a rear septum 504. [0088] The housing element 500 is preferably an integrally shaped cylindrical hollow member made of plastic and is preferably laterally symmetrical, symmetrical up-down and front-back.

[0089] Preferably, the front portion 506 of the housing element 500 includes a seat 508 for the front partition 502 and the rear portion 510 of the housing element includes a seat 512 for the rear partition 504.

The intermediate portion 514 of the housing element 500 preferably includes on its upper and lower surfaces generally rectangular outwardly extending projections 516.

[0090] The partitions 502 and 504 are preferably shaped such that they have a generally circular portion 518 with a partially spherical projection 520 on one of their sides.

Around the housing element 500 is a shaped body 522 that defines a portion of the main body 523 that is generally cylindrical, preferably laterally symmetrical and up-down, and preferably plastic-shaped, and side surfaces 524. Extending from the front of each of the side surfaces 524, there is an outwardly extending arm 526, defining at its inwardly directed end a generally triangular tooth 527 having a transversely extending rearward surface 528 that is adapted to engage with forward with the surface of the intermediate part 514 of the housing element 500.

[0092] A generally rectangular gap 529 is formed at the back of each arm 526. A circumferential projection 532 is formed next to the rear portion 530 of the housing element 500, in front of which an additional circumferential projection 534 is formed, having a slightly larger outer circumference than projection 532.

[0093] The compression spring 536 is embedded within the housing element 500, on the arm 538 located between the intermediate part 514 and the rear portion 510 of the housing element 500.

[0094] Generally, a cylindrical rear sealing element 540 is disposed at the rear of the main body portion 523. The rear sealing element 540 is preferably laterally symmetrical and is usually formed of plastic.

[0095] The rear sealing element 540 preferably defines a front hood 542 ending at its rear end with a portion of the generally circular wall 544. Front hood 542 preferably has a circumferential recess 546 that is adapted to engage the peripheral projection 532 of the main body portion 523. The forward-facing surface 547 of the sealing member 540 is adapted to engage the rearward-facing surface of the additional circumferential projection 534 when the syringe connector element 500 is assembled. Part of wall 544 preferably defines a rear spring seat for compression spring 536.

[0096] The inner tapered portion 548 of the rear sealing member 540, which has a smaller circumference than the housing member 500, is preferably located with it on the rear portion thereof. Inner portion 548 is shaped at the front and immediately adjoins wall portion 544 and lies within compression spring 536. Radially extending hole 549 is preferably formed in inner portion 548 and the hollow needle 550 is sealed in it. The inner portion 548 is preferably surrounded by a cylindrical portion 552 which ends at its rear end with a portion of the wall 544 and which also has a circumference that is smaller than the circumference of the housing element 500.

[0097] The needle 550 preferably extends axially within the compression spring 536 and through the center of the housing element 500 and the rear septum 504. The sharpened tip of the needle 550 is preferably positioned between the front septum 502 and the rear septum 504, thereby keeping the needle inaccessible to the user and atmosphere.

[0098] The two generally concave symmetrical surfaces 554 forming an almost full cylinder may extend to the rear of the wall portion 544 and preferably surround the inner rear cylindrical portion 556 that is adapted to engage the luer tip of a syringe equipped with a luer tip 40, defining generally symmetrical, side-facing tabs 558 at their rear ends. The back portion of the needle 550 preferably extends axially within the inner cylindrical portion 556.

[0099] Referring specifically to Fig. 9C, which shows an alternative embodiment of the syringe connector element of Fig. 8, it can be seen that the needle protection element 560, preferably made of latex, at least partially covers the needle 550, thereby protecting it against the surrounding atmosphere.

[0100] Reference will now be made to Fig. 10, which provides a simplified pictorial illustration of the spike port connector element 60 that is part of the drug mixing system of Figs. 1A-1M, and to Figs. 11A and 11B, which show cross-sectional illustrations along the section line XI-XI of Fig. 10.

[0101] The spike port connector element 60 preferably includes a hollow flexible plastic tube 602 having a standard clamp 604 cooperating therewith, which is commercially available from various manufacturers such as Qosina from Italy.

[0102] At its front end, the tube 602 is placed in the hollow spike element 606, which is preferably laterally symmetrical and shaped from plastic. The spike element 606 is preferably formed from a portion of the main body 607, which preferably defines at its front end a spike 608 having holes formed therein communicating with the two axially extending holes 610 and 612. At the rear of spike 608, part of the main body 607 defines a generally semicircular flat projection 614 adapted to determine where the user holds the spike.

[0103] Alternatively, as can be seen particularly clearly in Fig. 11B, a portion of the main body 607 may have a single hole formed therein that communicates with a single, axially extending hole 615.

[0104] The interior of the tube 602 is in fluid communication with the opening 612. The opening 616 is formed in the neck portion 618, which preferably extends transversely from the portion of the main body 607 and communicates with the opening 610. The hollow neck portion 618 preferably it terminates in a forwardly directed cylindrical portion 620 that seals within it generally a circular septum 622 disposed on the seat 624 that communicates with the opening 616.

[0105] The sealing assembly 630 is preferably attached to the rear end of the tube 602. The sealing assembly 630 preferably includes at its rearmost end a selectively removable conical sealing portion 632, in front of which is a portion of the connecting tube 634 which is adapted to connect the sealing section. 632 with 602 tube. The sealing assembly 630 is adapted to seal the tube 602 when using the drug mixing device and can be removed from the tube 602 when the reservoir 62 is connected directly to the spike of the infusion set to infuse the fluid therein.

[0106] It should be noted that the spike connector assembly 630 of the spike port connector element 60 may optionally be replaced by a luer connector.

[0107] Reference will now be made to Figs. 12A and 12B, which are simplified pictorial illustrations of the needle port connector element 70 that is part of the drug mixing system of Figs. 1A 1M, and Figs. 13A and 13B, which are cross-sectional illustrations along respective section lines XIIIA - XIIIA and XIIIB - XIIIB in Fig. 12A.

[0108] The needle port connector element 70 preferably includes a main body element 700 located generally around axis 701. The main body element 700 is preferably integrally shaped and preferably injection-molded plastic.

[0109] The main body element 700 is preferably laterally symmetrical about axis 701 and preferably includes a rear portion 702, which is generally cylindrical, ending at the front of the wall 704 having a hole 706 extending through it. Each of the side surfaces 708 of the rear portion 702 preferably contains a ribbed portion of the coupling surface 710.

[0110] Four axially extending seats 712 extend along the rear portion 702, each seat 712 is positioned at generally right angles to the adjacent seats. Designated between seats 712 at the rearward end of back portion 702, there are four outwardly facing conical projections 714. Each protrusion 714 includes an inwardly directed triangular tooth 715 and ends at transversely extending portion 716. Rear portion 702 preferably surrounds a generally cylindrical portion 718 that extends backwards from the front wall portion 704.

[0111] A neck portion 720 defining a radially extending hole 722 is formed in front of the wall portion 704. A hollow needle 724 is coherently mounted in the hole 722 and extends backwards along axis 701.

[0112] In front of the neck portion 720, a forward-facing, cylindrical portion 726 is formed that tightly supports the generally circular partition 728 on the seat 730, which is located at the front end of the cylindrical portion 726. The hole 732 preferably extends axially through the forward-facing cylindrical portion 726. Bore 732 is preferably coupled, with the possibility of fluid flow, to the cavity of the hollow needle 724.

[0113] Generally, the conical cover element 740, which is generally laterally symmetrical and up-down around axis 701, preferably can be axially displaced relative to the main body element 700 to obtain a selective environment of the rear portion 702 of the main body element 700.

[0114] The rear portion 742 of the cover member 740 preferably tapers outwardly and ends at the transversely extending end surface 744. Four outwardly extending radially extending projections 746 lie along the outer surface of the cover element 740, each of the projections 746 being disposed. at generally right angles to adjacent projections.

[0115] The four outwardly directed, generally peripheral projections 748 are preferably formed on the outer surface 750 of the cover member 740 between the projections 746, thereby defining a handle area.

[0116] At its front end, the inner surface 751 of the cover member 740 includes an outwardly tapering portion 752 that is adapted to slide engagement with the ribbed portion of the coupling surface 710 of the back portion 702 of the main body member 700. Four generally rectangular outward projections 754 extend from section 752, each projection 754 is positioned at generally right angles to adjacent projections. The projections 754 are adapted to slide engagement with the slots 712 of the rear portion 702 of the main body component 700.

[0117] Reference will now be made to Fig. 14, which is a simplified pictorial illustration of the protective cover of a syringe 80 that is part of the drug mixing system of Figs. 1A-1M, and to Fig. 15, which is a cross-sectional illustration along section line XV-XV from Fig. 14.

[0118] The protective cover of the syringe 80 is preferably integrally shaped and is generally laterally symmetrical around axis 800. Generally, the circular locking element 802 is preferably formed at the lower end of the protective cover of the syringe 80.

[0119] The locking element 802 preferably includes a flat, generally circular base surface 804, preferably extending along a plane that is perpendicular to axis 800. The surface 804 is integrally formed with the generally cylindrical portion 806. The cylindrical portion 806 ends with a generally circular, radially extending outside part of wall 808 that lies on a plane parallel to that defined by surface 804. Part of wall 808 ends with a generally cylindrical portion 810 that generally surrounds the cylindrical portion 806. The elongated tab 812 extends from surface 804 along axis 800.

[0120] Reference will now be made to Fig. 16, which is a simplified pictorial illustration of an infusion set connector element 90 that is part of the drug mixing system of Figs. 1A-1M and to Fig. 17, which is a cross-sectional illustration along section line XVIII- XVII from Fig. 16.

[0121] As can be seen in Figs. 16 and 17, the infusion member of the infusion set 90 is preferably integrally shaped and is preferably laterally symmetrical along axis 901.

[0122] The connector element of the infusion set 90 preferably includes a forward-facing cylindrical portion 902 that is adapted to surround a generally circular septum 904 that is sealed to a seat 906 which is located at the front end of the cylindrical portion 902.

[0123] Generally, the cylindrical intermediate portion 908 is formed at the rear of the cylindrical portion 902, having an outer circumference slightly smaller than the cylindrical portion 902. At its rear end, the intermediate portion 908 tapers towards a cylindrical neck portion 910 that has an outer circumference smaller than the portion intermediate 908.

[0124] The axially extending opening 912 extends through the neck portion 910, intermediate portion 908 and cylindrical portion 902, allowing fluid to flow through the infusion member of the infusion set 90 when the septum 904 is properly pierced.

[0125] The assembled structure of the drug mixing system at various stages of its application is described below with reference to Figs. 18A-30.

[0126] Reference will now be made to Figs. 18A and 18B, which show, respectively, a simplified flat illustration and a simplified cross-sectional illustration of the drug mixing system of Fig. 1B when attaching the vial adapter 30, a cross-sectional illustration along the line XVIIIB-XVIIIB in Fig. 18A.

[0127] As can be seen particularly clearly in Fig. 18B, the lancing spike 322 of the vial adapter assembly 30 punctures the septum 31 located inside the top portion 12 of the vial 10, thereby allowing fluid to flow between the main body of the vial 10 and the forward portion 348 of the main body element 302 of the vial adapter assembly 30. Preferably, piercing the septum 31 releases any vacuum in the vial 10 by letting air into the vial 10 through carbon filter 340 (Fig. 4 and 6B) and membrane 336 (Figs. 4 and 6B).

[0128] The coupling between the vial adapter assembly 30 and the vial 10 is preferably maintained by snap engagement of the projections 316 and 318 of the rear portion 304 of the main body element 302 with the neck portion 13 of the vial 10. The coupling of the projections 316 and 318 with the neck portion 13 ensures that the assembly vial adapter 30 is latched onto vial 10 and cannot be removed from there. The projections 310 and, tapering outwardly, portions 320 generally surround the top portion 12 and the neck portion 13 of the vial 10.

[0129] Reference will now be made to Figs. 19A and 19B and to Figs. 19C and 19D, which show, respectively, a simplified flat top and side view illustration and a simplified cross-sectional illustration of the drug mixing system of Fig. 1C when attaching the syringe connector piece 50 to syringe 40, with cross-sections taken along lines XIXB-XIXB in Fig. 19A and XIXD-XIXD in Fig. 19C.

[0130] As can be seen in Figs. 19A-19D, the luer tip 44 of the hypodermic syringe equipped with the luer tip 40 preferably couples the inner rear cylindrical portion 556 of the sealing element 540 of the syringe coupling member 50 and the protrusions 558 formed thereon so that the needle 550 is engaged. with the possibility of liquid flow, with the hollow body of the syringe 40. [0131] At this stage, the pointed needle tip 550 is preferably positioned between the septum 502 and 504 and the compression spring 536 is released. Preferably, when the syringe 40 is connected to the syringe connector assembly 50, the plunger 42 of the syringe 40 is pushed completely inside the syringe.

[0132] Reference will now be made to Fig. 20, which is a partly pictorial, partly cross-sectional illustration of the drug mixing system of Fig. 1D when attaching spike port connector element 60.

[0133] As seen in Fig. 20, spike 608 of spike element 606 of spike port connector element 60 is preferably slid into spike port 61 of reservoir 62. At this stage, reservoir 62 and tube 602 are coupled with fluid flow. However, the clamp 604 is closed and prevents liquid from flowing out of the reservoir through the opening 612 into the tube 602. In addition, the opening 610 is in communication with the possibility of fluid flow with the cylindrical portion 620 through the opening 616 of the neck portion 618.

[0134] Reference will now be made to Fig. 21, which is a partially pictorial, cross-sectional illustration of the drug mixing system of Fig. 1D when attaching the needle port connector element 70.

[0135] As seen in Fig. 21, the needle 724 of the needle port connector element 70 is preferably inserted into the needle port 64 of the reservoir 62. Preferably the teeth 715 of the tabs 714 engage the port 64 when the needle 724 is inserted. In addition, after insertion of the needle 724, the cover member 740 is preferably offset relative to the main body member 700 along the ridged portion of the coupling surface 710 (Fig. 13B).

[0136] The axial displacement of the cover element 740 preferably seals and closes the connection between the main body element 700 and the port 64 by applying pressure to the tabs 714 and sliding them inward. The offset of the cover member 740 includes a corresponding axial offset of the projections 754 relative to the slots 712 of the rear portion 702 of the main body member 700. The axial offset ends when the sections 716 of the tabs 714 engage with the inner surface 751 of the cover member 740.

[0137] At this stage, the reservoir 62 is preferably coupled to fluid flow with the opening 732 of the cylindrical portion 726 through the intermediate portion 720 and the needle 724. However, the liquid does not flow out of the cylindrical portion 726 because the cylindrical portion is sealed by the septum 728.

[0138] Reference will now be made to Fig. 22, which is a partially pictorial, cross-sectional illustration of the drug mixing system of Figs. 1E and 20 prior to attaching the syringe 40 and syringe connector element 50 to the spike port connector element 60.

[0139] As can be seen in Fig. 22, the syringe connector element 50 and the associated syringe 40 are located near the cylindrical portion 620 of the spike port connector element 60. It should be noted that at this stage the compression spring 536 is released and the pointed needle tip 550 is preferably positioned between partitions 502 and 504. Preferably, surfaces 528 of teeth 527 of arms 526 engage with forwardly facing surfaces of each side of intermediate portion 514 of housing element 500.

[0140] Due to the coupling process, the septum 622 of the spike port connector element 60 and the septum 502 of the syringe connector element 50 are pushed with tactile feedback by the biasing force of the spring 536, thereby preventing exposure of the needle tip 550 to the environment.

[0141] Reference will now be made to Fig. 23, which is a partially pictorial, cross-sectional illustration of the drug mixing system of Figures 1E and 20 after attaching the syringe 40 and syringe connector element 50 to the spike port connector element 60.

[0142] As can be seen in Fig. 23, the syringe connector element 50 and the associated syringe 40 are pushed into engagement with the cylindrical portion 620 of the spike port connector element 60. [0143] Preferably, the surfaces 528 of the teeth 527 of the arms 526 snap to the portion wall 618, whereby secure coupling is provided between the syringe coupling member 50 and the cylindrical portion 620. At this stage, the spring 536 is in a compressed state and the housing element 500 is pushed backwards by the pressure of the cylindrical part 620.

[0144] The reverse movement of the housing element 500 causes the septum 502 and 622 to puncture through the pointed tip of the needle 550. As a result, the needle 550 partially extends through the hollow space in the cylindrical portion 620 and is coupled, with the possibility of fluid flow, to the reservoir 62 through an opening 610 of the spike 608 of the spike element 606 and through the opening 616 of the neck portion 618. Due to the fluid flow coupling between the syringe luer tip 44 of the syringe 40 and the needle 550 of the syringe connector element 50, the syringe 40 is now in fluid-conjugated engagement with the reservoir 62. It should be noted that using the syringe connector element described in with reference to Fig. 9C, the needle protector 560 at least partially falls, thereby exposing the needle 550.

[0145] To withdraw liquid from the reservoir 62 into the syringe 40 through spike 606, neck portion 616, cylindrical portion 620 and needle 550, the user pulls the plunger 42. To disengage the syringe coupling member 50 and the cylindrical portion 620, the user slightly pushes the arms 526 extending from the side surfaces 524 of the housing member 522, causing the teeth 527 to move outward and release the rearward surface of the cylindrical portion 620, thereby disengaging cylindrical part.

[0146] Throughout the retraction process, the septum 622 of the spike port connector element 60 and the septum 502 of the syringe connector element 50 are pushed with tactile feedback by the force of the spring 536, thereby preventing exposure of the tip of the needle 550 to the environment.

[0147] Reference will now be made to Fig. 24, which is a partially pictorial, cross-sectional illustration of the drug mixing system of Figs. 1E and 21 before attaching the syringe 40 and syringe adapter member 50 to the needle port connector member 70. As seen in Fig. 24 , the syringe connector element 50 and the syringe 40 connected thereto are positioned close to the cylindrical portion 726 of the needle port connector element 70. It should be noted that at this stage the compression spring 536 is released and the pointed needle tip 550 is preferably positioned between the septum 502 and 504. Preferably, the surfaces 528 of the teeth 527 of the arms 526 engage with the facing surfaces on each side of the intermediate portion 514 of the housing element 500.

[0148] Reference will now be made to Fig. 25, which is a partially pictorial, cross-sectional illustration of the drug mixing system of Figs. 1E and 21 after attaching the syringe 40 and syringe connector element 50 to the needle port connector element 70. As can be seen in Fig. 25 , the syringe connector member 50 and the syringe 40 connected thereto are pushed into engagement with the cylindrical portion 726 of the needle port connector member 70.

[0149] Preferably, the surfaces 528 of the teeth 527 of the arms 526 snap engage with the rearwardly facing portion of the wall of the cylindrical portion 726, thereby providing secure engagement between the syringe coupling member 50 and the cylindrical portion 726. At this stage, the spring 536 is in a compressed state and the member the housing 500 is pushed backwards by the pressure of the cylindrical part 726.

[0150] The reverse movement of the housing element 500 causes the septum 502 and 728 to be punctured through the pointed tip of the needle 550. As a result, the needle 550 partially extends through the opening 732 of the cylindrical portion 726 and is coupled to allow fluid to flow into the reservoir 62 through the rear needle 724. part 702, the neck part 720 of the main body member 700 and the opening 732 of the cylindrical part 726. Due to the fluid flow coupling between the syringe luer tip 44 of the syringe 40 and the needle 550 of the syringe connector element 50, the syringe 40 is now coupled to the fluid flow with the reservoir 62. It should be noted that using the syringe connector element described with reference to Fig. 9C, the needle protector 560 at least partially falls, exposing the 550 needle.

[0151] To withdraw liquid from the reservoir 62 into the syringe 40 through the needle 724, hole 732 and needle 550, the user pulls the plunger 42. To disengage the syringe coupling member 50 and the cylindrical portion 726, the user slightly pushes arms 526 extending from side surfaces 524 the housing element 522 causing the teeth 527 to move outward and release the rearwardly facing portion of the wall of the cylindrical portion 726, thereby disengaging the cylindrical portion 726.

[0152] During the coupling and uncoupling process, the septum 728 of the needle port connector element 70 and the septum 502 of the syringe connector element 50 are pushed with tactile feedback by the biasing force of the spring 536, thereby preventing the exposure of the needle tip 550 to the environment.

[0153] Reference will now be made to Fig. 26, which shows an illustration of a cross-sectional view of the drug mixing system of Fig. 1G prior to dilution of the drug.

[0154] As can be seen in Fig. 26, the syringe connector element 50 and the syringe 40 connected thereto are positioned close to the forward-facing portion 348 of the vial connector element 30. It should be noted that at this stage the compression spring 536 is released and the pointed needle tip 550 is preferably positioned between partitions 502 and 504. Preferably, surfaces 528 of teeth 527 of arms 526 engage with forwardly facing surfaces on each side of intermediate portion 514 of housing element 500.

[0155] At this stage, the syringe 40 is preferably filled with liquid taken from the reservoir 62 (Figs. 22-25), and therefore the piston 42 is at least partially drawn away.

[0156] Reference will now be made to Fig. 27, which illustrates a cross-sectional illustration of the drug mixing system of Fig. 1H after drug dilution.

[0157] As can be seen in Fig. 27, the syringe connector element 50 and the associated syringe 40 are pushed into engagement with the forward-facing portion 348 of the vial connector element 30.

[0158] Preferably, the surfaces 528 of the teeth 527 of the arms 526 snap-engage with the wall portion 346 of the forward-facing portion 348, thereby providing secure engagement between the syringe coupling member 50 and portion 348. At this stage, the spring 536 is in a compressed state and the member the housing 500 is pushed backwards by the pressure of the forward-facing portion 348.

[0159] Backward movement of the housing element 500 causes the pointed tip of the needle 550 to puncture septum 502 and 350. As a result, the needle 550 partially extends through the hollow section of part 348 and is coupled with the possibility of fluid flow, with the vial 10 through the opening 350 of the part neck 344 and a spike puncturing vial 322 of body member 302. Due to the fluid flow coupling between the syringe luer tip 44 of the syringe 40 and the needle 550 of the syringe connector element 50, the syringe 40 is now coupled to the fluid flow of the vial 10. It should be noted that when using the syringe connector element described with reference to Fig. 9C the needle protector 560 at least partially falls, thereby exposing the 550 needle.

[0160] At this stage, the user injects the liquid contained in the syringe 40 into the vial 10 through the neck opening 350 and the vial spike 322 by pushing the piston 42 of the syringe 40 inwards. An appropriate volume of air escapes from the vial 10 through membrane 336 and possibly carbon fabric filter 340. It should be noted that every aerosol containing drug is blocked by the membrane and any non-aerosolized drug vapors are absorbed by the carbon filter, thus protecting users and the environment from poisoning.

[0161] Preferably, the user ensures complete dissolution of the drug contained in the vial 10 and withdraws at least a portion of the drug solution contained in the vial 10 into the syringe 40 by turning the system upside down and pulling the plunger 42 (not shown). At this stage, an adequate volume of sterile air enters the vial 10 through the membrane 336 and optionally a carbon fabric filter 340.

[0162] To disengage the syringe coupling member 50 and forward portion 348, the user slightly pushes the arms 526 extending to the side surfaces 524 of the housing member 522, causing teeth 527 to move outward and releasing the wall portion 346 of the forward portion 346, thereby the forward-facing part decouples.

[0163] During the coupling and uncoupling process, the septum 350 of the vial adapter member 30 and the septum 502 of the syringe adapter member 50 are pushed to tactile feedback by the biasing force of the spring 536, thereby preventing exposure of the needle tip 550 to the environment.

[0164] Referring now to Fig. 28, which shows a cross-sectional illustration of the drug mixing system of Figs. 1K and 1L in a shielded state, ready to be delivered when the syringe connector element 50 is covered by the syringe protective cover 80.

[0165] As can be seen in Fig. 28, the syringe adapter member 50 is preferably covered at its front end by the protective cover of the syringe 80. At this stage, the plunger 42 is preferably at least partially drawn away from the syringe 40 and the syringe contains the drug solution withdrawn from the vial 10 ( Fig. 27).

[0166] The most forward circumference of the main body portion 523 is preferably embedded in a recess shaped by the wall portions 806 and 810 of the syringe protective cover 80 and the surface 804 of the syringe cover member 80 preferably engages the front surface of the septum 502.

[0167] It should be noted that at this stage the compression spring 536 is released and the pointed needle tip 550 is preferably positioned between the septum 502 and 504. Preferably, the surfaces 528 of the teeth 527 of the arms 526 engage the forward facing surfaces of each intermediate portion 514 of the housing element 500 .

[0168] Reference will now be made to Fig. 29, which shows a partially pictorial, partly cross-sectional illustration of the drug mixing system of Figures 1M and 28 in readiness for injection.

[0169] As can be seen in Fig. 29, the syringe protective cover 80 has been removed from the syringe connector element 50 and the syringe connector element 50 and the associated syringe 40 are pushed into engagement with the cylindrical portion 902 of the connector element of the infusion set 90, while the element The infusion set connector 90 is connected to the side port of the intravenous cannula located at the injection site.

[0170] Preferably, the surfaces 528 of the teeth 527 of the arms 526 snap-engage with the rearwardly facing portion of the cylindrical wall portion 902, thereby providing secure engagement between the syringe coupling member 50 and the cylindrical portion 902. At this stage, spring 536 is in a compressed state and the housing element 500 is pushed back by the pressure of the cylindrical portion 902.

[0171] Backward movement of the housing element 500 causes the septum 502 and 904 to puncture through the pointed tip of the needle 550. As a result, the needle 550 partially extends through the hole 912 of the connector element of the infusion set 90 and is therefore fluid-coupled with the place injection. Due to the fluid flow coupling between the syringe luer tip 44 of the syringe 40 and the needle 550 of the syringe coupling member 50, the syringe 40 is now coupled, fluid-permeable, to the injection site. It should be noted that when using the syringe connector element described with reference to Fig. 9C, the needle protector 560 at least partially falls and exposes the needle 550.

[0172] To disengage the syringe coupling member 50 and the cylindrical portion 902, the user slightly pushes the arms 526 extending from the side surfaces 524 of the housing member 522, causing teeth 527 to move outward and releasing the rearwardly directed portion of the wall of the cylindrical portion 902, thereby disengaging cylindrical part.

[0173] Reference will now be made to Fig. 30, which shows a partially pictorial illustration, a partial illustration of the cross section of the drug mixing system of Fig. 1M and 20 ready for injection. [0174] Preferably, the reservoir 62 is connected through the spike port connector element 60 to the infusion set 92. The infusion set is then connected to a standard intravenous cannula 94 such as a Venolit cannula commercially available from Teva Medical Ltd. from Ashdod, Israel, which is placed at the infusion site. Typically, prior to connecting the spike port connector element 60 to the infusion set 92, the sealing member 630 is removed and the infusion set 92 is connected directly to the tube 602.

[0175] Alternatively, the infusion set 92 may be combined with a new, drug-free reservoir, in which case the drug solution is injected directly into the infusion set. When choosing this option, a syringe connector 50 having a syringe 40 connected thereto (Fig. 28) is connected to port 93 after removal of the syringe protective cover 80 and the drug solution contained therein is injected into the infusion tube.

[0176] Preferably, the surfaces 528 of the teeth 527 of the arms 526 snap on to the rearwardly facing portion of the port 93 wall, thereby providing secure engagement between the syringe connector element 50 and port 93. At this stage, the spring 536 is in a pressure state and the housing element 500 is pushed backward by the pressure of port 93.

[0177] Backward movement of the housing member 500 causes the septum 502 to be punctured through the pointed tip of the needle 550 and the port sealer septum 93. As a result, the needle 550 partially extends into the infusion set 92 and is therefore coupled with the possibility of fluid flow to the injection site. Due to the fluid flow coupling between the luer tip 44 of the syringe 40 and the needle 550 of the syringe connector element 50, the syringe 40 is now coupled, with the possibility of fluid flow, to the injection site.

[0178] To disengage the syringe coupling member 50 and port 93, the user slightly pushes arms 526 extending from side surfaces 524 of housing member 522, causing teeth 527 to move outward and releasing the backward portion of port wall 93, thereby decoupling the port.

[0179] Reference will now be made to Figs. 31A, 31B, 31C, 31D, 31E, 31F, 31G, 31H, 31I, 31J and 31L, which provide simplified pictorial illustrations of the various stages of assembly and typical use of a drug mixing system constructed and operating in accordance with with another embodiment.

[0180] Fig. 31A shows the spike port connector element 1030, as described below with reference to Figs. 34-35, inserted into the spike port 1031 in the liquid container 1032. Preferably, the luer fitting of the spike port fitting 1030 is sealed by the luer fitting of cover 1034.

[0181] Typically, reservoir 1032 includes a bag and the liquid contained therein is a sterile saline solution, water, or any other suitable sterile solution or pure liquid.

[0182] As shown in Fig. 31B, a hypodermic syringe equipped with a luer tip 1040, having a piston 1042 and a luer tip 1044, connects to the syringe port of the entire connector assembly 1050, which is described below with reference to Figs. 36 and 44 - 45B. Preferably, the syringe port is defined by a closing cock 1052, which is described below with reference to Fig. 37 38B, and includes a removable protective cap 1054. Fig. 46 is a cross-sectional view of the drug mixing system at this stage.

[0183] Usually, the piston 1042 of the syringe 1040 is pushed completely inward before the syringe connects to the port of the closing cock 1052 syringe.

[0184] Fig. 31C shows the spike port connector element 1030 and the reservoir 1032 connected thereto connected to the reservoir connector subassembly 1055 of the connector assembly 1050. Subassembly 1056 is described below with reference to Figs. 39-40B. Preferably, the closing cock 1052 is in an operating position that allows fluid to flow between the reservoir connector subassembly 1056 and the syringe 1040. Fig. 47 is a cross-sectional view of the drug mixing system at this stage.

[0185] As seen in Fig. 31D, the vial 1060, including the top portion 1062 and the neck portion 1063, is pressed into engagement with the vial adapter subassembly 1058 of the adapter assembly 1050. The top portion 1062 of the vial 1060 preferably has a septum 1064 sealed therein. Assembly 1058 is described below with reference to Figs. 41-42B.

[0186] Alternatively, when using the small vial 1066, the small vial 1066 is pressed to engage with the vial head adapter 1068, which is described below with reference to Figs. 32-33, as shown in Fig. 31E, and then pushed to engage the 1058 vial adapter assembly. Vials 1060 and 1066 typically contain the drug in the form of a soluble powder, solution, or other suitable form. FIG. 48 is a cross-sectional view of the drug mixing system at this stage.

[0187] It will be appreciated that the closing cock 1052, reservoir adapter subassembly 1056 and vial adapter subassembly 1058 are preferably located inside the housing element 1070 of the adapter assembly 1050, which is described below with reference to Figs. 43A-43B.

[0188] It will be understood by those skilled in the art that the assembly steps depicted in Figs. 31C-31E can be carried out in any appropriate order.

[0189] As seen in Fig. 31F, the user pulls off the plunger 1042 while the reservoir 1032 is in an upright position and the vial 1060 is below it, thereby at least partially filling the syringe 1040 with liquid taken from the reservoir 1032. The operating position of closing cock 1052 allows this liquid to flow from reservoir 1032 to syringe 1040 through spike port connector element 1030, reservoir connector assembly 1056 and closure cock 1052 so that the liquid remains sterile and that the user is not exposed to it. Fig. 49 is a cross-sectional view of the drug mixing system at this stage. [0190] The user then rotates the closure tap handle 1052 to allow fluid to flow between the syringe 1040 and the vial adapter subassembly 1058 having the vial 1060 connected thereto, as shown in Fig. 31G.

[0191] When the syringe 1040 and the vial 1060 are coupled, with the possibility of fluid flow, the user pushes the piston 1042 inside, thereby injecting the liquid contained in the syringe

1040 into vial 1060 and dissolves the medicine contained in it. Fig. 50 is a cross-sectional view of the drug mixing system at this stage.

[0192] As seen in Fig. 31H, the user then shakes the drug mixing system of Fig. 31G to ensure complete dissolution of the drug in vial 1060 and uniformity of the resulting solution.

[0193] As can be seen in Fig. 31I, the user turns the system upside down so that the vial 1060 points upwards and then pulls the plunger 1042; thereby withdrawing at least a portion of the solution from vial 1060 into syringe 1040. Fig. 51 is a cross-sectional view of the drug mixing system at this stage.

[0194] Those skilled in the art will recognize that at this stage the drug mixing system of the present invention is preferably held in such a way that the vial 1060 is located above the syringe 1040 to allow fluid to flow smoothly from the vial 1060 to the syringe 1040 through vial adapter 1058 and stopper 1052.

[0195] As shown in Fig. 31J, the handle 1080 of the closing cock 1052 is positioned to allow fluid to flow between the syringe 1040 and the reservoir 1032. The user then pushes the piston 1042 of the syringe 1040 inward, thereby injecting the drug solution into the reservoir 1032 and in addition dilute it before infusing the patient. Fig. 52 is a cross-sectional view of the drug mixing system at this stage.

[0196] Next, the spike port connector element 1030, having a reservoir 1032 connected thereto, decouples from the connector assembly 1050, which remains connected to the vial 1060, as shown in Fig. 31K.

[0197] As can be seen in Fig. 31L, if some of the drug solution remains in the vial 1060, the vial 1060 and its coupler assembly 1050 can be stored in a suitable facility for further use. It should be noted that at this stage the syringe 1040 remains connected to the closure valve syringe port 1052 of the connector assembly 1050. Fig. 53 is a cross-sectional view of the drug mixing system at this stage.

[0198] The construction of the components of the drug mixing system of Figs. 31A-31L is described below with reference to Figs. 32-43B.

[0199] Reference will now be made to Fig. 32, which is a simplified pictorial illustration of a vial head connector element 1468 that is part of the drug mixing system of Figs. 31A-31L, and to Fig. 33, which is a cross-sectional illustration along section line XXXM - XXXIII from Fig. 32. [0200] As can be seen in Fig. 32, the vial head attachment member 1068 is preferably a laterally symmetrical integrally shaped member that is preferably injection molded from plastic.

[0201] The vial head connector element 1068 preferably includes a main body portion 1200 that is generally cylindrical and has a central axis 1201. The inner cylindrical surface 1202 of the main body portion 1200 preferably has four arms 1204 extending therefrom, each arm 1204 being disposed generally at right angles to the adjacent arms.

[0202] Each arm 1204 ends at its upper end, as shown in Fig. 31A, an inwardly directed, generally triangular tooth 1206 having an upwardly inclined surface 1208 and a downwardly facing coupling surface 1210 extending generally perpendicular to arm 1204.

[0203] At the bottom of the vial head connector element 1068 there are four inwardly projecting surfaces 1212, extending generally perpendicular to the inner surface 1202 of the main body portion 1200. Each of the adjacent surfaces 1212 is preferably generally generally at right angles to the adjacent surfaces 1212. Surfaces 1212 and arms 1204 are rotatably displaced with respect to each other around axis 1201.

[0204] Reference will now be made to Fig. 34, which is a simplified pictorial illustration of the spike port connector element 1030 that is part of the drug mixing system of Figs. 31A-31L, and to Fig. 35, which is a cross-sectional illustration along section line XXXV - XXXV in Fig. 34.

[0205] The stud port connector element 1030 preferably includes a hollow flexible plastic tube 1302 having a standard clamp 1304 cooperating therewith, which is commercially available from various manufacturers such as Quosina from Italy.

[0206] At its front end, the tube 1302 is connected to the tube port 1305 of the hollow spike element 1306, which is preferably formed from plastic. The spike element 1306 preferably includes a portion of the main body 1307 that defines at its front end a spike 1308 that has an opening communicating with the axially extending opening 1310, and an additional opening 1312 that extends partially through the portion of the main body 1307 and communicates with the portion upper hole 1310, making it easier to completely prime before injecting the drug.

[0207] At the back of the spike 1308, a portion of the main body 1307 defines a generally circular flat projection 1314 adapted to determine where the user holds the spike.

[0208] The interior of the tube 1302 is in fluid communication with the opening 1312 through the port of the tube 1305. The opening 1310 preferably ends with an opening located in the spike 1308 of the main body portion 1307 and extends completely through the body portion 1307.

[0209] A portion of the main body 1307 preferably ends with a connection port 1318 that is adapted to connect the spike port connector element 1030 to the reservoir connector subassembly 1056. The connection port 1318 preferably seals within a generally circular baffle 1320 on seat 1322. The baffle 1320 preferably engages with the rear end of the opening 1310, thereby sealing the rear end of the opening.

[0210] In front of the coupling port 1318, there is a circumferential projection 1324 formed on a portion of the main body 1307, in front of which an additional circumferential projection 1326 is shaped, having an outer circumference slightly larger than the projection 1324. The protrusions 1324 and 1326 are adapted to contain movement of the spike port connector element 1030 when it is connected to the reservoir connector component 1056.

[0211] The luer fitting 1330 is preferably attached to the rear end of the tube 1302. The luer fitting 1330 preferably has at its rearmost end a narrow hollow port section 1332, in front of which is a shaped connecting portion of the tube 1334 and a hollow neck portion 1336, which connects the port section 1330 to the tube 1302. Preferably, the luer fitting 1330 is sealed by the cover of the luer element 1034.

[0212] It should be noted that the spike port connector element 1030 may alternatively be the same as the spike port connector element 630 described above with reference to Figs. 10-11B.

[0213] Reference will now be made to Fig. 36, which is an exploded view of the connector assembly 1050, which is part of the drug mixing system of Figs. 31A-31L.

[0214] As can be seen particularly clearly in Fig. 36, the adapter assembly 1050 includes a vial adapter assembly 1058 on which a hydrophobic membrane 1402 is located over which a carbon fabric filter 1404 is optionally mounted. The vial adapter assembly 1058 is connected on its front with the vial port 1082 of the stopcock 1052, which further includes a 1084 syringe port adapted to engage with the luer tip 1044 of the 1040 syringe. The closing cock 1052 additionally includes a tank port 1086 that is adapted to connect to the rear connecting piece 1406 of the tank connector subassembly 1056.

[0215] Preferably, when the syringe 1040 is not connected to the closing valve syringe port 1052, the syringe port 1084 is sealed by the protective cap 1054.

[0216] The needle retainer 1408 is preferably embedded within the rear connector 1406 and supports the needle 1410. The front portion of the needle 1410 is preferably shielded by a flexible latex needle protector 1412. The reservoir connector assembly 1056 connects at its rear end to the rear connector 1406 , in which there is a needle retainer 1408, a needle 1410 and a needle guard 1412.

[0217] The front portion of the vial adapter subassembly 1058 as well as the closing cock 1052 and the rear portion of the reservoir adapter subassembly 1056 are located within the housing member 1070. However, the handle 1080 of the closing cock 1052 protrudes from the housing member 1070, thereby enabling the user to change the operating direction of the closing cock 1052 and thus switching the liquid flow path.

[0218] Reference will now be made to Fig. 37, which is a simplified pictorial illustration of a closing cock 1052, which is part of the connector assembly of Fig. 36, and to Figs. 38A and 38B, which show cross-sectional illustrations along respective section lines XXXVIIIA - XXXVIIIA and XXXVIIIB - XXXVIIIB in Fig. 37.

[0219] The closure cock 1052, as noted above, has a vial port 1082, a syringe port 1084 and a reservoir port 1086, all of which are in the housing portion 1090. The user's working handle 1080 is attached to the path defining element 1092, which marks a three-way trail, as seen especially in Fig. 38B. The selectable rotatable position of the handle 1080 allows each of the two ports 1082,1084 and 1086 to be placed in mutual communication with the possibility of fluid flow. Closing cock 1052 is commercially available from Elcam Ltd. of Baram, Israel.

[0220] Reference will now be made to Fig. 39, which is a simplified pictorial illustration of the tank connector subassembly 1056, which is part of the connector assembly of Fig. 36 and to Figs. 40A and 40B, which show cross-sectional illustrations along respective XLA-XLA section lines XLB - XLB in Fig. 39.

[0221] As can be seen in Figs. 39-40B, the tank connector subassembly 1056 includes a main body element 1600 that is generally positioned around axis 1601. The main body element 1600 is preferably integrally formed from plastic and is preferably laterally symmetrical about axis 1601. The main body member 1600 preferably includes a generally cylindrical base portion 1602 ending at the rear portion 1604.

[0222] The upper and lower generally concave wall portion 1606 are formed at the front end of the base portion 1502, each wall portion 1606 defining with its external outwardly oriented axially extending rib 1608 which extends from the foremost end of each portion walls 1606 and along part of the base 1602. [0223] The joining surface 1610 extending transversely from the side surfaces 1612 of the base portion 1602 connects the outwardly extending arm 1614 to each of the side surfaces 1612. Each arm 1614 preferably has a generally square rear portion 1616, shaped to the rear of the joining surface 1610, and has shaped on her, radially extended forward projection 1618. The projection 1618 preferably extends to the outer surface of the generally rectangular front portion 1620 of each of the arms 1614, which extends forward to the joining surface 1610.

[0224] The inwardly directed triangular tooth 1622 is shaped adjacent the upper end of each of the front portions 1620. Each tooth 1622 preferably has a forwardly inclined surface 1624 and a rearwardly facing engagement surface 1626.

[0225] The rear portion 1604 preferably has a transversely extending generally circular portion 1630 that forms the base of the ribs 1608 and which terminates at its rear end in an axially extending generally cylindrical wall portion 1632.

[0226] Part of the wall 1632 preferably defines on its upper and lower surface a small generally rectangular window 1634 and two forwardly facing slits 1636 that are shaped on both sides of window 1634. Two generally symmetrical sideways projections 1638 are shaped on the side surfaces 1640 wall portion 1632, each tab 1638 being formed in front of a generally rectangular forward facing slot 1642.

[0227] Rear connecting member 1406 preferably includes a front disk 1652 defining a central opening 1654. Disk 1652 preferably serves as the end wall of the forwardly directed cylindrical portion 1656, with the rear of disk 1652 preferably having a shaped rear portion 1658 having extending through it narrow opening 1660. The opening 1660 preferably expands towards the rear end of the rear portion 1658, thereby enabling the rear portion 1658 to be connected to the appropriate port. Preferably, the two generally symmetrical projections 1662 are formed on the upper and lower surfaces of the rear portion 1658. The cylindrical portion 1656 preferably has an outer perimeter that is slightly smaller than the perimeter of wall portion 1632 and is disposed therein.

[0228] The needle retainer 1408 preferably supports the needle 1410 on a generally circular disk portion 1672. Needle 1410 extends axially through the base portion 1602 of the main body member 1600 and through the opening 1660 of the rear connecting member 1650. Disk portion 1672 is preferably seated in the cylindrical portion 1656 and is locked in the cylindrical part 1656 by the part 1630.

[0229] Reference will now be made to Fig. 41, which is a simplified pictorial illustration of the vial adapter assembly 1058 which is part of the adapter assembly 1050 of Fig. 36, and to Figs. 42A and 42B, which show cross-sectional illustrations along respective section lines XLIIA - XLIIA and XLIIB - XLIIB in Fig. 41.

[0230] As seen in Figs. 41-42B, the vial adapter subassembly 1058 includes a main body component 1702 disposed generally about axis 1703. The main body component 1702 is preferably integrally shaped and preferably injection-molded plastic.

[0231] Main body element 1702 is preferably laterally symmetrical about axis 1703 and preferably includes a rear portion 1704, which is generally cylindrical and ends on front wall 1706. Rear portion 1704 includes a front base section 1708, preferably having four laterally extending from it outwardly extending 1709, each protrusion being generally at right angles to adjacent protrusions.

[0232] At the back of the base section 1708 there are four tabs 1710 each having a rectangular window 1712. At the back of the rectangular windows 1712 and on the inner surface 1714 of each tab 1710 there are preferably shaped two inwardly extending projections 1716 each having an inclined surface. The projections 1716 preferably terminate at its forward end inwardly extending the projection 1718. At the rear of the projections 1716, each tab 1710 preferably has an outwardly tapering portion 1720.

[0233] The hollow puncture spike 1722 of the vial extends backwards from the back surface 1724 of the front wall 1706 and is surrounded by base section 1708 and tabs 1710. The back surface 1724 additionally has a round cylindrical projection 1725 surrounding the puncture spike 1722. Two axially extending holes 1726 and 1727 extend through the spike puncturing vials 1722.

[0234] In front of the front wall 1706 of the rear portion 1704 there is a shaped intermediate portion that is shaped with two generally rectangular surfaces 1728 and which has an axial tubular portion 1730 having an opening 1731 extending therethrough, the opening 1731 being coupled, with the possibility of fluid flow, with the hole 1726 of the hollow piercing spike 1722 vial.

[0235] At the top of the rectangular surface 1728 and slightly depressed relative thereto there is a plastic-shaped support surface of the membrane 1732 having a plurality of generally uniformly spaced spherical projections 1734 formed thereon which are adapted to support the hydrophobic membrane 1402 and protect it from excessive filling and before cracking. The membrane 1402 is adapted to allow free flow of air to and from the main body element 1702, but to protect against the ingress of liquids and particles from the air, microorganisms and aerosol. A preferred 1402 membrane is the Versapor R 0.2 Micron membrane, which is commercially available from Pall Corporation of New York, Staby USA. The membrane 1402 is coupled, with the possibility of fluid flow, to the vial pricking spike through the opening 1727 and through the recess 1737 formed on top of the rectangular surface 1728.

[0236] The rim 1738 surrounding the support surface 1732 is adapted to support the carbon fabric filter 1404 and keep it raised and at a distance from the membrane 1402. The carbon filter 1404 is adapted to prevent the release of harmful fumes from the main body element 1702, thereby protecting users. Preferably, the 1404 carbon fabric filter is a Zorflex model filter

EMI, which is commercially available from Charcoal Cloth International Ltd. of Houghton-le-Spring, England.

[0237] The rectangular surfaces of the intermediate portion 1728 terminate at its front end with a forwardly directed cylindrical portion 1748 having an opening 1750 extending therethrough. Preferably, the opening 1750 is an extension of the tubular portion 1730 of the intermediate portion.

[0238] It should be noted that the functional characteristics of the membrane 1402 and the carbon fabric filter 1404, consisting in allowing free flow of air into the drug mixing system while preventing liquid and particles from air, microorganisms and aerosol from entering inside and preventing harmful penetration vapors from the drug mixing system can be obtained using similar components, to the spike port coupler 1030 or reservoir coupler 1056 subassembly.

[0239] Reference will now be made to Figs. 43A and 43B, which provide simplified pictorial illustrations of the housing element 1070 that forms part of the connector assembly 1050 of Fig. 36 in the closed and open positions, respectively.

[0240] As can be seen in Figs. 43A and 43B, the housing element 1070 is preferably integrally formed around axis 1800 and includes an upper housing portion 1801 and a lower housing portion 1802. Preferably, housing parts 1801 and 1802 are laterally symmetrical about axis 1800. Preferably, each of housing parts 1801 and 1802 include a half-cylindrical front portion 1804 and a semi-cylindrical rear portion 1806.

[0241] The upper housing portion 1801 has an inwardly recessed portion 1808 comprising a generally circular opening 1810 that extends forward to the elongated opening 1812. Behind the opening 1810 there is preferably a shaped elongated projection 1814. Preferably the openings 1810 and 1812 lie below handle 1080 closing cock 1052 when connector assembly 1050 is assembled.

[0242] The lower housing portion 1802 includes an inwardly recessed portion 1816 that is generally symmetrical with respect to the recessed portion 1808 of the upper housing portion 1801 and which includes a central generally circular opening 1818. Two elongated protrusions 1820 are shaped on both sides of the opening 1818 so that the rear projection 1820 was generally symmetrical with respect to projection 1814 of upper housing portion 1801. Preferably, the bottom portion of the path valve 1090 of the closing cock 1052 extends through the opening 1818 when the coupler assembly 1050 is assembled.

[0243] The upper part of the housing 1801 has at its front and rear ends outwardly extending fingers 1822 ending generally with triangular teeth 1824 which have sloping outwardly facing surfaces 1826 and coupling surfaces 1828. The lower housing portion 1802 preferably has at its front and rear ends two generally rectangular windows 1830 which are generally located below the fingers 1822 and are adapted to engage with the surfaces of the coupling 1825 of the fingers 1822 when the housing component 1070 is assembled.

[0244] The inner surface 1834 of the housing element 1070 preferably has at its front and rear ends a circumferential recess 1836 that is adapted to engage the projections 1709 of the rear portion 1704 of the vial adapter subassembly 1058. The outer surface of the housing element 1070, which is located above the recess 1836, preferably has an outward facing projection 1840 which projects from the cylindrical front portion 1804.

[0245] Preferably, the side surfaces of the upper housing portion 1801 and lower housing portion 1802 have generally parallel rectangular slots 1842 through which the syringe port 1084 of the closing cock 1052 extends when the connector assembly 1050 is assembled.

[0246] Reference will now be made to Fig. 44, which shows a simplified assembled illustration of the connector assembly of Fig. 36, and to Figs. 45A and 45B, which show cross-sectional illustrations along respective section lines XLVA - XLVA and XLVB - XLVB with Fig. 44.

[0247] As seen in Figs. 44-45B, the rear portion 1704 of the vial adapter subassembly 1058 extends from the rear of the housing component 1070. The vial lancing spike 1722 preferably extends out of the housing component 1070 and is available for connecting vials 1060 or vials 1066 (Fig. 31E).

[0248] Preferably, the peripheral recess 1836 of the inner surface 1834 of the housing member 1070 engages the protrusions 1709 of the back portion 1704 of the vial adapter subassembly 1058. Preferably, the forward cylindrical portion 1748 couples the vial port 1082 of the closing cock 1052. [0249] The front portion of the main body element 1600 of the reservoir connector subassembly 1056 preferably extends from the front portion of the housing element 1070 of the connector assembly 1050 and surrounds the needle 1410 disposed in the needle protector 1412. The main body element including the needle 1410 and the needle protective cover 1412 is preferably available for connecting the spike port connector element 1030 to it (Figs. 34-35).

[0250] Preferably, the rear portion 1658 of the rear connecting member 1406 engages the tank port 1086 of the closing cock 1052. The rear end of the needle 1410 at least partially extends through the opening 1660 so that the needle 1410 is in fluid communication with the tank port 1086.

[0251] The port of the syringe 1084 of the closing cock 1052 preferably extends from the housing member 1070 through slots 1842 formed on its lateral surfaces. Preferably, the track designation element 1092 extends from the openings 1810 and 1812 of the upper housing portion 1801 and the lower portion of the closing cock 1052 extends through the opening 1818 of the lower housing member.

[0252] The housing element 1070 is preferably assembled such that the upper housing portion 1801 and the lower housing portion 1802 are connected by coupling the engagement surface 1828 of teeth 1824 of the upper housing portion 1801 and windows 1830 of the lower housing portion 1802.

[0253] Reference will now be made to Fig. 46, which illustrates a cross-sectional illustration of the drug mixing system of Fig. 31B when attaching the syringe 1040 to the connector assembly 1050 of Figs. 44-45B.

[0254] As seen in Fig. 46, the luer tip 1044 of syringe 1040 is attached to the port of the syringe 1084 of the closing cock 1052. At this stage, the handle of the closing cock 1052 is positioned so that liquid can flow from the port of the reservoir 1086 to its syringe 1040. It should be noted that at this stage, the piston 1042 of the syringe 1040 is preferably completely pushed into the syringe.

[0255] Reference will now be made to Fig. 47, which illustrates a cross-sectional illustration of the drug mixing system of Fig. 31C when attaching the spike port connector element 1030 and reservoir 1032 of Fig. 31A to reservoir connector subassembly 1056 of the connector assembly 1050 of Fig. 46.

[0256] As seen in Fig. 47, the spike port connector element 1030 having a reservoir 1032 connected thereto is connected to the reservoir connector subassembly 1056 of the connector assembly 1050.

[0257] Spike 1308 is preferably previously introduced into the spike port 1031 of the tank 1032 so that the opening 1310 of the spike element 1306 engages with the liquid content of the tank 1032. The connecting port 1318 of the spike port connector element 1034 engages wall portion 1606 and base portion 1602 of the main body element 1600 tank connector subassembly 1056.

[0258] The coupling port 1318 is preferably locked in connection with the tank connector subassembly 1056 by coupling the coupling surface 1626 of the front portions 1620 of the arms 1614 (Fig. 40B) and the rearward portion of the port of the connecting port 1318.

[0259] Preferably, the needle 1410 protrudes from the needle protection cover 1412 and the septum 1320, which results in a change in the design of the needle protection cover. At this stage, the reservoir 1032 is in communication with the possibility of fluid flow, with the syringe 1040 through the spike opening 1310 1308 of the spike port connector element 1030, the needle 1410, the opening 1660 and the port of the reservoir, and the syringe port 1084 of the closing cock 1052.

[0260] Reference will now be made to Fig. 48, which illustrates a cross-sectional illustration of the drug mixing system of Fig. 31D when attaching the vial 1060 to the vial adapter subassembly 1058 of the adapter assembly 1050 of Fig. 47.

[0261] Vial 1066 and vial head adapter 10 connected thereto (Fig. 31E) or vial 1060 are preferably pushed into engagement with the lancing spike of vial 1722 of vial adapter 1058.

[0262] Typically, the lancing spike 1722 of the vial adapter 1058 punctures the septum 1064 located inside the top portion 1062 of the vial 1060, thereby allowing fluid to flow between the main body of the vial 1060 and the cylindrical portion 1748 of the main body component 1702 of the vial adapter 1058. Preferably, puncture 1064 releases vacuum in vial 1060 by introducing air into vial 1060 through carbon filter 1404 (Fig. 42B) and membrane 1402 (Fig. 42B).

[0263] The coupling between the vial adapter subassembly 1058 and vial 1060 is preferably maintained by snap engagement of projections 1716 and 1718 (Figs. 42A and 42B) of the rear portion 1704 of the main body component 1702 with the neck portion 1063 of the vial 1060. Coupling of the projections 1716 and 1718 with the portion neck 1063 ensures that the vial adapter subassembly 1058 snaps onto the 1060 vial and cannot be removed from it. Tabs 1710 and outwardly tapering portions 1720 generally surround the top portion 1062 and the neck portion 1063 of vial 1060.

[0264] At this stage, the main body of the vial 1060 is in fluid communication with the syringe port 1084 through the vial spike 1722, opening 1750 of the cylindrical portion 1748, and vial port 1082 of the closing cock 1052.

[0265] Reference will now be made to Fig. 49, which illustrates a cross-sectional illustration of the drug mixing system of Figs. 31F and 48 when withdrawing liquid from reservoir 1032 to syringe 1040. [0266] At this stage, piston 1042 of syringe 1040 is preferably withdrawn, thereby fluid is taken from reservoir 1032 to syringe 1040. The liquid taken from the reservoir 1032 reaches the syringe 1040 through the spike opening 1310 1308 of the spike port connector element 1030, needle 1410, opening 1660 of the reservoir connector subassembly 1056, reservoir port 1086, trail design element 1092, syringe port 1084 and luer tip 1044.

[0267] Reference will now be made to Fig. 50, which is an illustration of a cross-sectional view of the drug mixing system of Figs. 31G and 48 when injecting liquid from syringe 1040 into vial 1060.

[0268] Initially, the user rotates the handle 1080 of the closing cock 1052, thereby coupling the syringe port 1084 with the possibility of fluid flow to the vial port

1082.

[0269] Preferably, the user pushes the piston 1042 of the syringe 1040 inwards relative to the syringe 1040, which results in the injection of liquid from the syringe 1040 into the vial 1060, thereby dissolving the drug contained in the vial. Liquid injected from syringe 1040 flows into vial 1060 through luer tip 1044 of syringe 1040, syringe port 1084, pathway designator 1092, vial port 1082, hole 1750 of cylindrical part 1748 and spike of vial 1722.

[0270] The user preferably shakes the drug mixing system of Fig. 50 as shown in Fig. 31H to ensure complete dissolution of the drug contained in vial 1060 and uniformity of the drug solution.

[0271] Reference will now be made to Fig. 51, which illustrates a cross-sectional illustration of the drug mixing system of Figs. 31I and 48 when withdrawing liquid from vial 1060 into syringe 1040.

[0272] At this stage, the user places the system so that the vial 1060 is on top and preferably withdraws at least a portion of the drug solution contained in the vial 1060, by at least partially pulling back the plunger 1042 of the syringe 1040. The liquid withdrawn from the vial 1060 flows into the syringe 1040 through the lancing spike of the vials 1722, opening 1750 of the cylindrical portion 1748, vial port 1082, pathway designator 1092 and syringe port 1084, closing cock 1052, and luer tip 1044 of syringe 1040.

[0273] Reference will now be made to Fig. 52, which illustrates a cross-sectional illustration of the drug mixing system of Figs. 31J and 48 when injecting liquid from syringe 1040 into reservoir 1032. [0274] In a first step, the user rotates handle 1080 of closing cock 1052, as a result of which the 1084 syringe port is fluid coupled to the 1082 vial port. [0275] Next, the piston 1042 of the syringe 1040 is preferably pushed inward relative to the portion of the main body of the syringe. Sliding inwardly the piston 1042 injects liquid from the syringe 1040 into the reservoir 1032. The liquid withdrawn from syringe 1040 reaches reservoir 1032 through luer tip 1044, syringe port 1084, track designation 1092, reservoir port 1086 of closing cock 1052, opening 1660 of tank connector subassembly 1056, needle 1410 and opening 1310 of spike 1308 of spike port connector 1030.

[0276] Reference will now be made to Fig. 53, which shows an illustration of a cross-sectional view of the drug mixing system of Fig. 31L during its storage readiness.

[0277] As shown in Fig. 53, the spike port connector element 1030 (Figs. 34-35) and the reservoir 1032 connected thereto detach from the reservoir connector subassembly 1056 of the connector assembly 1050. Usually the spike port connector element 1030 disconnects from the connector subassembly tank 1056 by slightly pushing the arms 1614 extending from the side surfaces 1612 (Fig. 39 40B) of the base portion 1602, causing teeth 1620 to move outward and releasing the rearwardly facing portion of the connecting port wall 1318 (Figs. 34-35), thereby disengaging the connecting port. Usually, the needle 1410 is released from the coupling port 1318 and the protective cover of the needle 1412 is used and again completely contains the needle 1410, thereby preventing liquid spill and aerosol spray.

[0278] The connector assembly 1050, including the vial connector assembly 1058, the closing cock 1052, the reservoir connector assembly 1056, and the housing member 1070 are preferably stored in a suitable cooling facility. During its cooling, the connector assembly is preferably connected to a syringe 1040 having a plunger 1042 completely pushed inwards and a vial 1060 containing the drug solution. Typically, the pathway designation 1092 of the closing cock 1052 connects the port of the reservoir 1086 to the port of the syringe 1084 at this stage.

[0279] Reference will now be made to Figs. 54A, 54B, 54C, 54D, 54E, 54F, 54G and 54H, which provide simplified pictorial illustrations of the various assembly steps and typical use of a drug mixing system constructed and operating in accordance with yet another embodiment.

[0280] Fig. 54A shows the spike port connector element 2010, as described below with reference to Figs. 57-58, introduced into the spike port 2011 in a liquid reservoir 2012. Preferably, the luer fitting of the spike port connector 2014 is sealed by the cover of the luer element 2014.

[0281] Typically, the reservoir 2012 comprises a bag and the liquid contained therein is a sterile saline solution, water or any other suitable sterile solution or a clean liquid.

[0282] As seen in Fig. 54B, the vial 2020 having the top portion 2022 and the neck portion 2023 is pressed to engage the vial adapter subassembly 2044 of the adapter assembly 2040. The top portion 2022 of the vial 2020 preferably has a sealed septum 2024. Subassembly 2044 described below with reference to Figs. 60-61B.

[0283] Alternatively, when using the small vial 2026, the small vial 2026 is pressed into engagement with the vial head connector element 2030, which is described below with reference to Figs. 55-56 as shown in Fig. 54C, and then pushed coupling to the vial adapter 2044. Vials 2020 and 2026 typically contain the drug in the form of a soluble powder, solution, or other suitable form. FIG. 67A and 67B show a cross-sectional view of the drug mixing system at this stage.

[0284] Fig. 54D illustrates the spike port connector element 2010 and its associated reservoir 2012 connected to reservoir connector subassembly 2046 of the connector assembly 2040, which is described below with reference to Figs. 62-63B.

[0285] It will be appreciated that the reservoir adapter subassembly 2046 and the vial adapter subassembly 2044 are preferably located in the housing element 2050 of the adapter assembly 2040, which is described below with reference to Figs. 64A-64B.

[0286] As is well known to those skilled in the art, the assembly steps depicted in Fig. 54A54D can be carried out in any appropriate order.

[0287] As seen in Fig. 54E, the user holds the reservoir 2012 vertically and presses the reservoir, thereby at least partially filling the vial 2020 with liquid squeezed from the reservoir 2012. This liquid flow ensures that the liquid remains sterile and that the user is not exposed to it. Causes the.

[0288] As seen in Fig. 54F, the user then shakes the drug mixing system of Fig. 54E to ensure complete dissolution of the drug in the vial 2020 and the homogeneity of the resulting solution.

[0289] As can be seen in Fig. 54G, the user reverses the direction of the tank 2012 so that it is now facing downwards and then presses the tank. Pressing the reservoir 2012 draws the drug solution contained in the vial 2020 into the reservoir, thereby further diluting the solution. The user preferably repeats these steps until the vial is emptied 2020, thereby diluting the entire content of the vial in one container.

[0290] As shown in Fig. 54H, the reservoir connector spike element 2010 having its reservoir 2012 connected thereto detaches from the connector assembly 2040, which remains connected to the vial 2020. It should be noted that at this stage the connector assembly 2040 and the vial 2020 can be removed.

[0291] The construction of the components of the drug mixing system of Figs. 54A-54H is described below with reference to Figs. 55-64B.

[0292] Reference will now be made to Fig. 55, which is a simplified pictorial illustration of a vial head connector element 2030 that is part of the drug mixing system of Figs. 54A-54H, and to Fig. 56, which is a sectional illustration along section line LVI - LVI from Fig. 55.

[0293] As can be seen in Fig. 55, the vial head connector element 2030 is preferably a laterally symmetrical, integrally shaped element, which is preferably injection-molded plastic.

[0294] The connector of the vial head 2030 preferably has a main body portion 2200 that is generally cylindrical and has a central axis 2201. The inner cylindrical surface 2202 of the main body portion 2200 preferably has four arms 2204 extending therefrom, each arm 2204 being arranged at generally right angles to the adjacent arms.

[0295] Each arm 2204 ends at its upper end, as shown in Fig. 54C, an inwardly directed generally triangular tooth 2206 having an inclined forward surface 2208 and a downward facing coupling surface 2210 extending generally perpendicular to the arm 2204 .

[0296] On the bottom surface of the vial head connector element 2030 there are four inwardly protruding surfaces 2212 shaped, extending generally perpendicular to the inner surface 2202 of the main body portion 2200. Each of the adjacent surfaces 2212 is preferably positioned at a generally right angle to the adjacent surfaces 2212 Surfaces 2212 and arms 2204 are rotatably displaced about each other about axis 2201.

[0297] Reference will now be made to Fig. 57, which is a simplified pictorial illustration of the spike port connector element 2030 that is part of the drug mixing system of Figs. 54A-54H, and to Fig. 58, which is a sectional illustration along section line LVIII- LVIII from Fig. 57.

[0298] The spike port connector element 2010 preferably has a hollow plastic flexible pipe 2302 having a standard 2304 clamp cooperating therewith, which is commercially available from various manufacturers such as Qosina from Italy.

[0299] At its front end, the tube 2302 is connected to the tube port 2305 of the hollow spike element 2306, which is preferably formed from plastic. The spike element 2306 is preferably formed from a portion of the main body 2307 that preferably defines at its front end a spike 2308 having an opening formed therein communicating with the axially extending opening 2310, and an additional opening 2312 that extends partially through the portion of the main body 2307 and communicates with the top of hole 2310.

[0300] At the back of the spike 2308, a portion of the main body 2307 defines a generally circular flat projection 2314 adapted to determine the location where the user grips the spike.

[0301] The interior of the tube 2302 is in fluid communication with the opening 2312 through the port of the tube 2305. The opening 2310 preferably ends with an opening located in the spike 2308 of the main body portion 2307 and extends completely through the main body portion. [0302] A portion of the main body 2307 preferably ends with a connecting port 2318 that is adapted to connect the spike port connector element 2010 to the reservoir connector subassembly 2046. The connecting port 2318 preferably seals generally a circular septum 2320 in the seat 2322. The septum 2320 preferably engages the rear end of the opening 2310, thereby sealing the rear end of the opening.

[0303] In front of the connecting port 2318, there is a circumferential projection 2324 formed on a portion of the main body 2307, in front of which an additional circumferential projection 2326 is shaped, having an outer circumference slightly larger than the circumference of the projection 2324. The protrusions 2324 and 2326 are adapted to restricting movement of the spike port coupler 2010 member when it is connected to the reservoir coupler 2044 subassembly.

[0304] The luer fitting 2330 is preferably attached to the rear end of the tube 2302. The luer fitting 2330 preferably has at its rearmost end a narrow hollow portion of the port 2332, on the front of which is the shaped connecting portion of the tube 2334 and the hollow neck portion 2336 which it is adapted to connect the luer fitting 2330 to the pipe 2302. Preferably the luer fitting 2330 is sealed by a cover element of the luer fitting 2014.

[0305] It should be noted that the spike port connector element 2010 may alternatively be the same as the spike port connector element 630 described above with reference to Figs. 10-11B.

[0306] Reference will now be made to Fig. 59, which is an exploded view of the connector assembly 2040, which is part of the drug mixing system of Figs. 54A-54H.

[0307] As can be seen particularly clearly in Fig. 59, the adapter assembly 2040 has a vial adapter assembly 2044 on which a hydrophobic membrane 2402 is located, above which a carbon fabric filter 2404 is optionally mounted. The vial adapter assembly 2044 is connected on its front part to rear connecting piece 2406 of tank 2046 subassembly.

[0308] The needle retainer 2408 is preferably embedded within the rear connector 2406 and supports the needle 2410. The front portion of the needle 2410 is preferably shielded by a flexible latex needle protection element 2412. The reservoir connector assembly 2046 connects at its rear end to the rear connector 2406 , including needle retainer 2408 and needle protector 2412.

[0309] The front portion of the vial adapter 2044 as well as the rear portion of the reservoir adapter 2046 are located inside the housing component 2050.

[0310] Reference will now be made to Fig. 60, which provides a simplified illustrative illustration of the vial adapter assembly 2044 that is part of the adapter assembly 2040 of Fig. 59, and to Figs. 61A and 61B, which show cross-sectional illustrations along respective section lines LXIA - LXIA and LXIB - LXIB in Fig. 60.

[0311] As seen in Figs. 60-61B, the vial adapter subassembly 2044 has a main body component 2502 generally positioned around axis 2503. The main body component 2502 is preferably integrally shaped and preferably injection-molded plastic.

[0312] The main body element 2502 is preferably laterally symmetrical about axis 2503 and preferably has a rear portion 2504 that is generally cylindrical and ends at the front wall 2506. The rear portion 2504 includes a front base section 2508, preferably having four laterally extending therefrom inwardly projecting 2509, each projection being positioned at generally right angles to adjacent projections.

[0313] Behind the base section 2508 there are a plurality of shaped tabs 2510, each having a rectangular window 2512. On the back of the rectangular windows 2512 and on the inner surface 2514 of each tab 2510 there are preferably two shaped radially extending inward projections 2516, each having sloping surface. The projections 2516 preferably end at their front end in the inwardly extending projection 2518. At the back of the protrusions 2516, each tab 2510 preferably has an outwardly tapering portion 2520.

[0314] The hollow puncture spike 2522 of the vial extends backwards from the back surface 2524 of the front wall 2506 and is surrounded by the base section 2508 and by the tabs 2510. The back surface 2524 additionally has a circular cylindrical projection 2525 surrounding the puncture spike 2522. Two axially extending holes 2526 and 2527 extend through the pricking spike of vials 2522.

[0315] At the front of the front wall 2506 of the rear portion 2504 there is a shaped intermediate portion that forms two generally rectangular surfaces 2528 and has an axial tubular portion 2530 having a bore 2531 extending therein, the bore 2531 being coupled with the possibility of fluid flow with the bore 2526 hollow spike puncturing 2522 vials.

[0316] At the top of the rectangular surface 2528, and slightly recessed relative thereto, there is a plastic shaped support surface of the membrane 2532, having on it a plurality of generally uniformly spaced spherical projections 2534 formed thereon, which are adapted to support the hydrophobic membrane 2402 and prevent its excessive filled and broken. The 2402 membrane is adapted to allow free flow of air to and from the body's main element 2502, but to prevent liquids and particles from entering the air, germs, and aerosol from entering. Preferably, the 2402 membrane is a Versron R 0.2 Micron membrane that is commercially available from Pall Corporation of New York, USA.

[0317] Narrow orifice 2537 connects membrane 2402 to orifice 2531, thereby allowing pressure equalization of the emptied drug vial 2020 after connecting the vial 2020 to the vial adapter subassembly 2044. When liquid first travels through the system during drug dilution, orifice 2537 irreversibly fills with liquid so that no air escapes from the system.

[0318] Prevention of air escaping from the system is necessary for the reversible transfer of liquid from the 2012 reservoir to the vial 2020 and vice versa. The movement of air between the vial 2020 and the 2012 tank causes pressure changes in the vial, which pushes the liquid from the vial into the tank.

[0319] The rim 2538 surrounding the support surface 2532 is adapted to support the optionally used carbon fabric filter 2404 and to keep it raised and at a distance from the membrane 2402. The carbon filter 2404 is adapted to prevent the release of harmful fumes from the main body element 2502 , thus protecting users. A preferred carbon fabric filter 2404 is model No. Zorflex EMI filter, which is commercially available from Charcoal Cloth International Ltd. of Houghton-le-Spring, England.

[0320] The rectangular surfaces of the intermediate part 2528 terminate at the front end thereof with a forwardly directed cylindrical part 2548 having an opening 2550 extending through it. Preferably the opening 2550 is an extension of the tubular part 2530 of the intermediate part.

[0321] It should be noted that the functional features of membrane 2402 and carbon fabric filter 2404, consisting of allowing free flow of air into the drug mixing system while preventing the entry of liquid and particles from air, microorganisms and aerosol into its interior and preventing harmful penetration vapors from the drug mixing system, can be obtained by using similar components with any of the tank connector components 2046.

[0322] Reference will now be made to Fig. 62, which is a simplified pictorial illustration of the tank connector assembly 2046, which is part of the connector assembly 2040 of Fig. 59, and to Figs. 63A and 63B, which show cross-sectional illustrations along respective section lines LXIIIA LXIIIA and LXIIIB - LXIIIB in Fig. 62.

[0323] As can be seen in Figs. 62-63B, the tank connector subassembly 2046 has a main body element 2600 that is generally positioned around axis 2601. The main body element 2600 is preferably integrally formed from plastic and is preferably laterally symmetrical about axis 2601. The main body element 2600 preferably has a generally cylindrical base portion 2602 ending at the rear portion 2604.

[0324] The upper and lower, generally concave, wall portions 2606 are formed at the front end of the base portion 2602, each wall portion 2606 defines on its outer surface an outwardly extending rib 2608 that extends from the foremost end of each wall parts 2606 and along base parts 2602.

[0325] The joining surface 2610 extending laterally from the side surfaces 2612 of the base portion 2602 connects the outwardly extending arm 2614 to each side surface 2612. Each arm 2614 preferably has a generally square rear portion 2616 shaped at the rear of the joining surface 2610 and having a extending radially shaped outward projection 2618. The projection 2618 preferably extends to the outer surface of the generally rectangular front portion 2620 of each arm 2614 that extends forwardly the joint surface 2610.

[0326] The inwardly directed triangular tooth 2622 is shaped adjacent the upper end of each of the front portions 2620. Each tooth 2622 preferably includes a forwardly inclined surface 2624 and a rearwardly facing engagement surface 2626.

[0327] Rear portion 2604 preferably includes a transversely extending generally circular portion 2630 that forms the basis for ribs 2608 and which terminates at its rear end in an axially extending generally cylindrical portion of wall 2632.

[0328] Part of the wall 2632 preferably defines on its upper and lower surface a small, generally rectangular window 2634 and two forward facing slots 2636, which are shaped on both sides of the window 2634. Two generally symmetrical lateral projections 2638 are shaped on the lateral surfaces 2640 wall parts 2632, each tab 2638 being shaped forward of a generally rectangular forward facing slot 2642.

[0329] The rear connecting member 2406 preferably has a front disk 2652 defining a central opening 2654. The disk 2652 preferably serves as the end wall of the forwardly facing cylindrical portion 2656. On the back of disk 2652 there is preferably a shaped rear portion 2658 having a narrow, extending through it aperture 2660. The aperture 2660 preferably expands towards the rear end of rear portion 2658, thereby enabling the rear portion 2658 to be connected to the appropriate port. Preferably, the two generally symmetrical protrusions 2662 are formed on the upper and lower surfaces of the rear portion 2658. The cylindrical portion 2656 preferably has an outer periphery that is slightly smaller than the wall portions 2632 and is disposed therein.

[0330] The needle retainer 2408 preferably supports the needle 2410 on a generally circular disk portion 2672. Needle 2410 extends axially through the base portion 2602 of the main body member 2600 and through the aperture 2660 of the rear connecting member 2650. Disk portion 2672 is preferably seated in cylindrical portion 2656 and is locked in cylindrical part 2656 by part 2630.

[0331] Reference will now be made to Figs. 64A and 64B, which provide simplified pictorial illustrations of a housing element 2050 that forms part of the connector assembly 2040 of Fig. 59 in the open and closed positions, respectively.

[0332] As seen in Figs. 64A and 64B, housing member 2050 is preferably integrally formed around axis 2700 and includes upper housing portion 2701 and lower housing portion 2702. Preferably, housing portions 2701 and 2702 are laterally symmetrical about axis 2700. Preferably, each housing parts 2701 and 2702 include a semi-cylindrical front portion 2704 and a semi-cylindrical rear portion 2706.

[0333] Each upper and lower housing portion 2701 and 2702 includes an inwardly recessed portion 2708 including generally a central elongated projection 2710.

[0334] The upper housing portion 2701 includes at its front and rear ends outwardly facing fingers 2722 ending generally with triangular teeth 2724, which include outwardly sloping surfaces 2726 and engagement surfaces 2728. The lower housing portion 2702 preferably includes at its front and rear ends two generally rectangular windows 2730 that are generally located below the fingers 2722 and are adapted to engage the engagement surface 2728 of the fingers 2722 when the housing component 2050 is assembled.

[0335] The inner surface 2734 of the housing member 2050 preferably includes at its rear end a circumferential recess 2736 that is adapted to engage the protrusions 2509 of the rear portion 2504 of the vial adapter subassembly 2044. The outer surface of the housing member 2050 that is located above the recess 2736 preferably includes outward projection 2740 which protrudes outward from the cylindrical rear portion 2706.

[0336] Reference will now be made to Fig. 65, which shows a simplified assembled illustration of the connector assembly 2040 of Fig. 59, and to Figs. 66A and 66B, which show cross-sectional illustrations along respective section lines LXVIA - LXVIA and LXVIB - LXVIB of Fig. 65. [0337] As can be seen in Figs. 65-66B, the rear portion 2504 of the vial adapter 2044 extends from the rear of the housing component 2050. The vial lancing spike 2522 preferably extends out of the housing member 2050 and is available to connect vial 2020 or vial 2026 to it (Fig. 54B).

[0338] Preferably, the circumferential recess 2736 of the inner surface 2734 of the housing member 2050 engages the protrusions 2509 of the rear portion 2504 of the vial adapter subassembly 2044. Preferably the forward cylindrical portion 2548 couples the rear portion 2658 of the rear connecting member 2406. The rear end of the needle 2410 extends at least partially through aperture 2660 and through aperture 2550 so that aperture 2550 is in fluid communication with the needle 2410 of the reservoir connector subassembly 2046.

[0339] The front portion of the main body element 2600 of the reservoir connector subassembly 2046 preferably extends from the front portion of the housing element 2050 of the connector assembly 2040 and surrounds the needle 2410 located within the needle protector 2412. The main body element 2600 including the needle 2410 and the needle protective cover 2412 is preferably available for connecting the 2010 port spike connector element to it (Figs. 57-58).

[0340] Housing component 2050 is preferably mounted such that the upper housing portion 2701 and lower housing portion 2702 are connected by coupling the engagement surface 2728 of teeth 2724 of upper housing portion 2701 and windows 2730 of lower housing portion 2702.

[0341] Reference will now be made to Figs. 67A and 67B, which are cross-sectional illustrations of the drug mixing system of Fig. 54B when attaching the vial 2020 to the vial adapter subassembly 2044 of the adapter assembly 2040 of Fig. 65.

[0342] Vial 2026 and the vial head connector member 2030 (Fig. 54C) or vial 2020 connected thereto are preferably pushed into engagement with the lancing spike of the vials 2522 of the vial adapter 2044.

[0343] Typically, the vial lancing spike 2522 of the vial adapter 2044 punctures the septum 2024 located inside the top portion 2022 of the vial 2020, thereby allowing liquid to flow between the main body of the vial 2020 and the opening 2550 of the cylindrical portion 2548 of the main body component 2502 of the vial adapter 2044. Preferably, puncture of the septum 2024 releases the vacuum from the vial 2020 by passing air into the vial 2020 through the optionally used carbon fabric filter 2404 (Fig. 61A) and membrane 2402 (Fig. 61A).

[0344] The coupling between the vial adapter subassembly 2044 and the vial 2010 is preferably maintained by snap engagement of the protrusions 2516 and 2518 of the rear portion 2504 of the main body element 2600 with the neck portion 2023 of the vial 2020. The coupling of the protrusions 2516 and 2518 with the neck portion 2023 ensures that the adapter subassembly vial 2044 is snapped onto vial 2020 and cannot be removed from it. Tabs 2510 and outwardly tapering portions 2520 generally surround the top portion 2022 and the neck portion 2023 of the vial 2020.

[0345] At this stage, the main body of the vial 2020 is in communication with the possibility of fluid flow with the needle 2410 through the vial spike 2522, opening 2550 of cylindrical portion 2548 and opening 2660 of cylindrical portion 2658.

[0346] Reference will now be made to Fig. 68, which illustrates a cross-sectional illustration of the drug mixing system of Figs. 54D-54G when attaching reservoir port connector element 2010 and reservoir 2012 of Fig. 54A to reservoir connector subassembly 2046 of connector assembly 2040 of Fig. 67 having a vial attached to it 2020.

[0347] As can be seen in Fig. 68, the spike port connector element 2010 having a reservoir 2012 connected thereto is connected to reservoir connector subassembly 2046 of the connector assembly 2040.

[0348] Spike 2308 is preferably previously introduced into the spike port 2011 of the reservoir 2012 so that the opening 2310 of the spike element 2306 engages the liquid contained in the reservoir 2012. The connecting port 2318 of the spike port connector element 2010 couples wall portion 2606 and base portion 2602 of main body element 2600 tank connector subassembly 2046.

[0349] The coupling port 2318 is preferably locked in connection with the reservoir connector subassembly 2046 by coupling the coupling surface 2626 of the front portions 2620 of the arms 2614 and the rearward portion of the port of the connecting port 2318.

[0350] Preferably, the needle 2410 punctures the needle protection cover 2412 and the septum 2320, as a result of which the needle protection cover is partially lowered. At this stage, reservoir 2012 is in communication, with the possibility of liquid flow, with the main body of the vial 2020 through the spike opening 2310 2308 of the spike port connector element 2010, needle 2410, opening 2660, opening 2550 of cylindrical part 2548, opening 2531 of tubular part 2530 and piercing spike vials 2522.

[0351] Reference will now be made to Fig. 69, which illustrates a cross-sectional illustration of the drug mixing system of Figs. 54H and 68 when detaching spike port connector element 2010 and reservoir 2012 from reservoir connector subassembly 2046 of connector assembly 2040 of Fig. 67.

[0352] As shown in Fig. 69, the spike port connector element 2010 and associated reservoir 2012 detach from reservoir connector assembly 2046 of connector assembly 2040. Usually, the 2010 port spike connector element is disconnected from the reservoir connector subassembly 2046 by slightly pushing arms 2614 extending from side surfaces 2612 of base portion 2602, causing teeth 2620 to move outward and releasing the rearward facing portion of the connecting port wall 2318, thereby unhooking the port joining. Normally, the 2410 needle is released from the connection port 2318 and the protective cover of the 2412 needle is exposed and fully covers the 2410 needle again, thereby sealing it to prevent leakage.

[0353] Reference will now be made to Fig. 70, which is an exploded view of a drug mixing system constructed and operating in accordance with a further embodiment. The example shown in Fig. 70 is a modification of the examples shown in Figs. 31A 53 and 54A- 69. Accordingly, for the sake of brevity, it is described in a somewhat simplified way below with reference to Figs. 71-78.

[0354] According to this embodiment, the drug vial is in a protective housing during storage and dilution, thereby preventing spillage of its contents in case of damage.

[0355] As can be seen particularly clearly in Fig. 70, the drug mixing system includes a vial adapter subassembly 3000, which preferably includes an externally threaded vial support member 3010 on which the vial 3020 is placed.

[0356] The vial lancing cap assembly 3030 includes an internally threaded cover member 3032 that engages at its front end with an externally threaded portion of vial support 3010. At its upper end, cover member 3032 engages with vial spike member 3034 that supports the membrane hydrophobic 3036. [0357] The puncture cap assembly 3030 connects at its front end to the coupling port of the reservoir connector subassembly 3040 that is adapted to engage the reservoir spike port component 3050. The reservoir spike port port element 3050 is preferably inserted into reservoir port 3051 of reservoir 3052.

[0358] Alternatively, the puncture cap assembly 3030 may connect at its front end to the vial port 3080 of the closing cock 3082 and the port port connecting assembly of the reservoir port connector 3040 connects to the reservoir of the port 3084 of the closing cock 3082. When this option is used, the syringe port 3086 stopcock 3082 is preferably coupled to a syringe equipped with a luer tip.

[0359] It should be noted that vial 3020 may be the same as vials 2020 and 2026, and that tank 3052 may be the same as container 2012, described above with reference to Figs. 54A-54C. [0360] The tank connector subassembly 3040 may be the same as the tank connector subassembly 2046 described above with reference to Figs. 62-63B.

[0361] The spike port connector element 3050 may be the same as the spike port connector element 2010, described above with reference to Figs. 57-58.

[0362] Reference will now be made to Fig. 71, which is a simplified pictorial illustration of the vial support component 3010 that is part of the vial adapter subassembly 3000 of the drug mixing system of Fig. 70, and Figs. 72A and 72B, which show a cross-section, respectively and pictorial illustration along section line LXXII - LXXII of Fig. 71.

[0363] The vial support 3010 includes a generally cylindrical base member 3100 coupled generally around axis 3101. The body member 3100 is preferably integrally shaped and is preferably generally laterally symmetrical about axis 3101.

[0364] The body element 3100 preferably includes an upper portion 3102 that is externally threaded and is separated from the lower portion 3104 by an outwardly directed circumferential projection 3106. The axially extending outwardly extending projections 3108 are preferably formed on the lower portion 3104, wherein each projection 3108 is generally positioned at right angles to adjacent projections.

[0365] The body member 3100 preferably ends in a laterally extending wall base portion 3110 that includes a central spherical projection 3112 that is adapted to center the vial 3020 in the vial support 3010.

[0366] As can be seen particularly clearly in Fig. 72B, the inner surface 3114 of the body element 3100 may optionally include a plurality of axially extending inwardly oriented rectangular projections 3116 that operate to adapt the vial support 3010 to support the smaller vial. Various body components 3100 can be used, shaped with 3116 projections of different sizes, for different sizes of vials. Similarly, a portion of the wall base 3110 can optionally be shaped to achieve different heights relative to the bottom portion 3104, thereby allowing vials of different heights to be supported by different support elements of the vial 3010.

[0367] Reference will now be made to Fig. 73, which is a simplified pictorial illustration of the vial support member 3010 of Figs. 71-72B containing the vial 3020, and to Fig. 74, which is a sectional illustration along the section line LXXIV-LXXIV of Fig. 73 .

[0368] As seen in Figs. 73 and 74, the vial 3020 is placed inside the vial support 3010 so that the top portion 3022, the septum 3024 and at least a portion of the neck portion 3023 extend over the vial support and are accessible to the user.

[0369] The base of the vial 3020 is preferably mounted on a portion of the base of the wall 3110 and engages the spherical projection 3112.

[0370] Reference will now be made to Figs. 75A and 75B, which provide simplified pictorial illustrations of the vial lancing cap assembly 3030 that is part of the vial adapter subassembly 3000 of Fig. 70, and Fig. 76, which shows a cross-sectional illustration along section line LXXVI LXXVI of Fig. 75A.

[0371] The puncture cap assembly 3030 includes a cover member 3032 that includes a generally cylindrical portion of the main body 3202 generally positioned around axis 3203.

[0372] The base of the main body 3202 is preferably internally threaded and is adapted to engage the externally threaded top portion 3102 of the vial support member 3010. Four axially extending outwardly extending projections 3204 are preferably formed on the outer surface 3205 of the main body portion 3202, each projection 3204 is generally positioned at right angles to adjacent projections. The outwardly extending axially wall portion 3206 extends from the lower end of the main body portion 3202.

[0373] A portion of the main body 3202 ends with a portion of the wall 3208 that preferably extends transversely to the axis 3203 and generally includes a circular opening 3210. The inner surface 3212 of the portion of the wall 3208 preferably includes two semicircular tracks 3214.

[0374] The vial lancing spike member 3034 preferably has the vial lancing spike 3220 extending through the opening 3210 of wall portion 3208. The vial lancing spike 3220 preferably has two axial holes 3222 and 3224 extending therein.

[0375] Preferably, the membrane 3036 is coupled to fluid flow with the cover member 3032 through the prong opening 3224 of the vial 3220.

[0376] The spike 3220 preferably extends forward from the generally circular wall portion 3226 that engages the upper surface of the wall portion 3208. Four generally rectangular wall portions 3228 extend radially from the spike 3220, each wall portion 3228 generally positioned beneath right angle to neighboring wall parts.

[0377] Wall portions 3228 preferably define on their upper surfaces four spherical protrusions 3230 that engage the coupling paths 3214 and are adapted to block the vial lancing element 3034 relative to the covering element 3032.

[0378] Generally, the cylindrical portion 3232, including the axial opening 3234, preferably extends backwards from the wall portion 3226. The cylindrical portion 3232 is preferably adapted to engage the rear portion 3658 of the reservoir connector subassembly 3040.

[0379] The second generally cylindrical portion 3236 preferably extends backwards from the wall portion 3226 and the adjacent cylindrical portion 3232. The portion 3236 preferably defines a seat 3238 that is adapted to support the unidirectional breathing membrane 3036 and prevents it from over-filling and breaking. The membrane 3036 is adapted to allow free flow of air to the main body element 3032, but prevents liquid and particles from entering the air from it, microorganisms and aerosol. A preferred 3036 membrane is the Versapor R 0.2 Micron membrane, which is commercially available from Pall Corporation of New York, USA.

[0380] Reference will now be made to Fig. 77, which is a simplified assembled illustration of the vial adapter subassembly 3000 of Fig. 70, and to Fig. 78, which is a sectional illustration along the section line LXXVIII - LXXVIII of Fig. 77.

[0381] As can be seen in Figs. 77 and 78, the puncture cap assembly of the vial 3030 is threadedly coupled to the support of the vial 3010, thereby containing the vial 3020 inside.

[0382] Thread engagement between the vial support member 3010 and the puncturing cap member of the vial 3032 causes the puncture spike 3220 to be pushed into engagement with the vial 3020.

[0383] Typically, the vial lancing spike 3220 of the vial lid puncture element 3030 punctures the septum 3024 located inside the top portion 3022 of the vial 3020, thereby allowing liquid to flow between the main body of the vial 3020 and the opening 3234 of the cylindrical portion 3232 through the puncture spike opening 3222. Preferably, puncturing the septum 3024 releases the vacuum from the 3020 vial.

[0384] Reference will now be made to Fig. 79, which illustrates an illustrative illustration of the vial adapter subassembly 3000 of Fig. 77 when mounted to the reservoir adapter subassembly 3040, thereby forming the adapter assembly in accordance with one embodiment, and to Fig. 80, which shows a sectional illustration along section line LXXX - LXXX of Fig. 79.

[0385] As seen in Figs. 79 and 80, the cylindrical portion 3232 of the vial cover member 3030 engages with the rear portion 3658 of the reservoir connector subassembly 3040. The rear end of the needle 3410 extends at least partially through the opening 3660 and through the opening 3234 so that the opening 3234 remained in communication, with the possibility of liquid flow, with the needle 3410 of the 3040 tank connector subassembly. By communicating with the possibility of fluid flow between the opening 3234 and the main body of the 3020 vial, the needle 3410 remains in communication with the possibility of fluid flow with the 3020 vial.

[0386] The front portion of the main body element 3414 of the reservoir connector subassembly 3040 preferably surrounds the needle 3410 within the needle protector 3412. The main body element 3600 including the needle 3410 and the needle protective cover 3412 is preferably accessible for connecting the spike port connector element 3050 to it.

[0387] It should be noted that the cylindrical portion 3232 of the vial cover member 3030 may alternatively engage with a closure cock 3052, which further couples the reservoir adapter subassembly 3040 and the syringe as described above with reference to Figs. 31A-53. In this case, the method of application the system will be similar to that described in Figs. 31A-31L.

[0388] Reference will now be made to Fig. 81, which is a pictorial illustration of the vial adapter subassembly 3000 connected to the reservoir adapter subassembly 3040 of Fig. 79 when it is connected to the spike port connector component 3050 and reservoir 3052, and to Fig. 82, which shows an illustration of the section along section line LXXXII - LXXXII of Fig. 81.

[0389] As can be seen in Figs. 81 and 82, the spike port connector element 3050 having the reservoir 3052 connected thereto is connected to the reservoir connector subassembly 3040.

[0390] Spike 3308 is preferably previously introduced into spike port 3051 of tank 3052 so that opening 3310 of spike element 3306 engages liquid content in reservoir 3052. Connecting port 3318 of spike port connector element 3050 couples wall portion 3606 and base portion 3602 of body element 3414 3040 tank connector subassembly.

[0391] The coupling port 3318 is preferably locked when connected to the tank connector subassembly 3040 by coupling the coupling surface 3626 of the front portions 3620 of the arms 3614 and the rearward portion of the port of the connecting port 3318.

[0392] Preferably, the needle 3410 punctures the needle protection cover 3412 and the septum 3320, resulting in a partial lowering of the needle protection cover. At this stage, reservoir 3052 is in communication with fluid flow with the main body of the vial 3020 through the spike opening 3310 3308 of the spike port connector 3050, the needle 3410, the opening 3660, the opening 3234 of the cylindrical portion 3232 and the spike piercing 3220.

[0393] Reference will now be made to Fig. 83, which is an exploded view of a drug mixing system constructed and operating in accordance with yet another embodiment. The example shown in Fig. 83 is a modification of the embodiment shown in Figs. 54A-69. Accordingly, for the sake of brevity, it is described below in a form somewhat limited with reference to Figs. 84-92.

[0394] As can be seen particularly clearly in Fig. 83, the drug mixing system includes a tank connector subassembly 4000, which preferably includes a tank connector housing element 4010. The tank connector housing element 4010 preferably couples the tank connector needle assembly 4020. The tank connector assembly 4000 preferably couples some port such as tank port 4031 tank 4032.

[0395] The reservoir connector needle assembly 4020 connects at its rear end to the coupling port of the vial connector assembly 4040 that is adapted to engage the vial 4050.

[0396] It will be appreciated that the vial 4050 may be the same as any of the vials 2020 and 2026, and the reservoir 4032 may be the same as the reservoir 2032 described above with reference to Fig. 54A 54C.

[0397] The vial adapter subassembly 4040 may be the same as the vial adapter subassembly 2046 described above with reference to Figs. 60-61B.

[0398] Tank port 4031 may be the same as tank port 2031 described above. It should be noted that the reservoir connector subassembly 4000 may engage the spike port connector element, such as the spike port connector element 2030 described above with reference to Figs. 57-58.

[0399] Reference will now be made to Fig. 84, which shows a simplified pictorial illustration of the reservoir connector housing of the housing element 4010, which is part of the drug mixing system of Fig. 83, and to Figs. 85A and 85B, which show cross-sectional illustrations along the section line LXXXVA LXXXVA and LXXXVB - LXXXVB in Fig. 84.

[0400] The reservoir housing element 4010 includes a body element 4100 disposed generally about axis 4101. The body element 4100 comprises a tube with a generally rectangular cross section that is preferably integrally shaped and preferably is generally laterally symmetrical about axis 4101.

[0401] The body element 4100 preferably includes a rear portion 4102 that is shaped with ribbed gripping areas 4104 on the outer surface 4106. Two elongated windows 4108 are preferably formed on the upper and lower surfaces of the rear portion 4102.

[0402] The front portion 4110 of the body element 4100 has a slightly smaller outer circumference than the rear portion 4102 and generally includes a rectangular window 4112 on each of its surfaces. The front portion 4110 preferably seals inside a septum 4114 in a seat 4116.

[0403] Four axially extending tabs 4118 extend forward the front portion 4110, each tab 4118 being generally positioned at right angles to adjacent tabs. Each tab 4118 preferably includes an inward tooth 4120 and preferably ends with an outwardly tapering portion 4122.

[0404] Reference will now be made to Fig. 86, which is a simplified pictorial illustration of the needle connector reservoir assembly 4020 that forms part of the drug mixing system of Fig. 83, and Figs. 87A and 87B, which show cross-sectional illustrations along section line LXXXVIIA LXXXVIIA and LXXXVIIB - LXXXVIIB in Fig. 86.

[0405] The needle connector reservoir assembly 4020 includes a generally cylindrical body element 4200 disposed generally about axis 4201. The body element 4200 is preferably integrally shaped and is preferably generally laterally symmetrical about axis 4201.

[0406] The body element 4200 preferably includes a rear attachment port 4202 that is separated from the front portion 4204 by a circumferential outwardly extending projection 4206. The projection 4206 is adapted to limit the extent to which the needle connector reservoir reservoir assembly 4020 is inserted into the housing element tank connector 4010.

[0407] The front portion 4204 preferably ends at the front portion of the wall 4205, from which extends a cylindrical portion 4210 having an outer circumference that is slightly larger than the front portion 4204. The cylindrical portion 4210 preferably has four axially extending projections 4212 formed thereon, each projection 4212 is generally positioned at right angles to adjacent projections.

[0408] Two outwardly extending arms 4214 are formed at the front end of the cylindrical portion 4210, with each arm 4214 generally extending through a different arm. The projections 4212 and the arms 4214 are preferably pivoted relative to each other about the axis 4201. Each arm 4214 preferably defines at its farthest end a generally triangular tooth 4216 comprising a coupling surface 4218.

[0409] The hollow needle 4220 is preferably sealed in a cylindrical portion 4222 that is formed inside the cylindrical portion 4210 of the needle connector reservoir assembly 4020. [0410] Reference will now be made to Fig. 88, which provides a simplified assembled illustration of the reservoir connector assembly 4000 from Fig. 83 and to Figs. 89A and 89B, which show cross-sectional illustrations along section line LXXXIXA - LXXXIXA and LXXXIXB LXXXIXB in Fig. 88.

[0411] As seen in Figs. 88-89B, the cylindrical portion 4210 of the needle connector reservoir assembly 4020 preferably couples the rearmost portion of the rear portion 4102 of the reservoir connector housing element 4010. The teeth 4216 of the arms 4214 of the cylindrical portion 4210 preferably extend through windows 4108 and keep the 4020 needle connector reservoir assembly locked in the reservoir connector element of the 4010 housing.

[0412] It should be appreciated that the user may push the needle connector reservoir assembly 4020 inward relative to the reservoir connector element housing 4010. Such movement inwardly of the needle connector reservoir assembly 4020 is limited by projection 4206.

[0413] Referring now to Fig. 90, which shows a pictorial illustration of the reservoir adapter subassembly 4000 of Fig. 88 after assembled with the vial adapter subassembly 4040 and with tank port 4031, before inserting needle 4220 into tank port 4031 and to Fig. 91, which shows an illustration of the section along the section line XCI - XCI of Fig. 90.

[0414] The vial 4050 is preferably pushed to engage the lancing spike of the vials 4522 of the vial adapter subassembly 4040.

[0415] Typically, the lancing spike 4522 of the vial adapter subassembly punctures 4014 punctures the septum 4014 located inside the upper portion 4012 of the vial 4050, thereby allowing fluid to flow between the main body of the vial 4050 and the opening 4550 of the cylindrical portion 4548 of the main body component 4548 of the vial connector assembly 4050. Preferably Septum 4014 releases vacuum from the 4050 vial by air entering the 4050 vial through a 4404 carbon filter and 4402 membrane.

[0416] The coupling between the vial adapter subassembly 4040 and the vial 4050 is preferably maintained by snap engagement of the protrusions 4516 and 4518 of the rear portion 4504 of the main body component 4502 with the neck portion 4013 of the vial 4050. The coupling of the protrusions 4516 and 4518 with the neck portion 4013 ensures that the adapter subassembly 4040 vial is latched onto the 4050 vial and cannot be removed from it. Tabs 4510 and outwardly tapering portions 4520 generally surround the top portion 4012 and the neck portion 4013 of the vial 4050.

[0417] The cylindrical portion 4548 preferably couples the connecting port 4202 of the needle connector reservoir assembly 4020 so that the needle 4220 is in fluid communication with the vial 4050 through the front portion 4204, the opening 4550 of the cylindrical portion 4548 and the pricking spike of the vial 4522. Sharpened the needle tip 4220 preferably partially extends through the septum 4114.

[0418] The teeth 4120 of the arms 4118 preferably couple the tank port 4031 of the tank 4032 or may alternatively couple any other suitable port such as the spike port connector element 4030, as described above.

[0419] Reference will now be made to Fig. 92, which is a pictorial illustration of the reservoir connector subassembly 4000 of Fig. 88 after assembled with the vial connector assembly 4040 and reservoir port 4031, after insertion of needle 4220 into reservoir port 4031, and to Fig. 93 , which shows an illustration of the section along section line XCIII - XCIII of Fig. 92.

[0420] As can be seen in Figs. 92 and 93, the user preferably pushes the needle reservoir connector assembly 4020 inward so that the needle 4220 punctures and the septum 4114, resulting in communication with the possibility of fluid flow between the reservoir 4032 and the vial 4050.

[0421] It will be understood by those skilled in the art that the present invention is not limited to what is specifically illustrated and described above.

Teva Medical Ltd.

Proxy:

PL-PAT-2012-183

EP 2 463 201 B1