CLOSED SYSTEM FOR TRANSFERRING MEDICATION FROM A FLEXIBLE CONTAINER

Abstract

A closed transfer system for transferring metered dose of a beneficial agent from a flexible primary container to a second reservoir or to a patient. The system can be configured to transfer multiple doses.

Claims

1. A closed system transfer device (CSTD) arrangement for storing a beneficial agent and transferring the beneficial agent to a destination port, the CSTD arrangement comprising: a primary container comprising a package for storing the beneficial agent comprising at least one flexible wall such that pressure in the primary container is substantially equalized to ambient pressure; a metering pump; a delivery port for communicating the beneficial agent with the destination port; and a valve in selective fluid communication with the primary container, the metering pump, and the delivery port, the valve comprising a valve housing, wherein: the primary container extends from the valve housing, the metering pump is joined to the valve housing, the delivery port is an opening in the valve housing configured to accommodate the destination port, the valve is moveable from a first configuration where it is not engaged with the destination port, to a second configuration where it is engaged with the destination port, in the first configuration the primary container and the metering pump are in fluid communication and neither is in fluid communication with the delivery port, in the second configuration the metering pump is in fluid communication with the delivery port and neither is in fluid communication with the primary container, and the flexible wall collapses when the beneficial agent is transferred from the primary container to the metering pump.

2. The CSTD arrangement of claim 1, wherein the valve further comprises a needle and a forward septum configured to interface with the destination port, wherein: in the first configuration the needle does not penetrate through the forward septum and the forward septum blocks fluid communication between the valve and the destination port; and in the second configuration the needle penetrates through the forward septum and establishes fluid communication between the valve and the destination port.

3. The CSTD arrangement of claim 2, wherein the destination port is configured to manipulate the valve from the first configuration, in which the destination port is disengaged from the delivery port, to the second configuration, in which the destination port is engaged with the delivery port, and wherein the destination port comprises a septum which, in the first configuration, blocks fluid communication between the delivery port and the destination port and, in the second configuration, the needle penetrates through the septum to establish fluid communication between the delivery port and the destination port.

4. The CSTD arrangement of claim 3, wherein in the second configuration the forward septum and the septum establish a fluid-tight seal preventing the beneficial agent from leaking out of the CSTD arrangement.

5. The CSTD arrangement of claim 1, wherein the destination port is configured to manipulate the valve from the first configuration, in which the destination port is disengaged from the delivery port, to the second configuration, in which the destination port is engaged with the delivery port.

6. The CSTD arrangement of claim 1, wherein the flexible wall comprises at least one of a film, a foil, a molded component, a blow-molded component.

7. The CSTD arrangement of claim 1, wherein the package comprises at least a first compartment containing at least a first constituent of the beneficial agent.

8. The CSTD arrangement of claim 7, wherein the package further comprises at least a second compartment containing at least a second constituent of the beneficial agent, wherein the first compartment and the second compartment are separated by a frangible seal that, when opened, allows the first and the second constituents of the beneficial agent to aseptically merge.

9. The CSTD arrangement of claim 1, wherein the metering pump is a syringe.

10. The CSTD arrangement of claim 9, wherein the syringe is configured to be threaded onto the valve housing and thereafter the syringe is locked to the valve housing and cannot be removed.

11. The CSTD arrangement of claim 9, wherein the syringe comprises a graduation correlating to dosing options of the beneficial agent.

12. The CSTD arrangement of claim 1, wherein the destination port is configured to communicate with at least one of an intravenous delivery system, a catheter, a tube, a needle, or a combination thereof.

13. The C STD arrangement of claim 1, further comprising: a spring that biases the valve to the first configuration.

14. The CSTD arrangement of claim 13, further comprising: a forward septum and where the forward septum and the spring are combined into a single component.

15. The C STD arrangement of claim 1, further comprising: a receptacle in fluid communication with the valve such that in the first configuration the metering pump can only receive fluid from the primary container, and the metering pump can only push fluid to the receptacle.

16. The CSTD arrangement of claim 1, further comprising: a latch mechanism for holding the destination port joined to the delivery port such that the valve remains in the second configuration.

17. The CSTD arrangement of claim 1, wherein the primary container further comprises a semi-rigid backing for supporting the package and interfacing the primary container with the valve.

18. The CSTD arrangement of claim 17, wherein the valve comprises a stopcock moveable between the first configuration and the second configuration by rotating the semi-rigid backing, and wherein, in the first configuration, a long axis of the semi-rigid backing and a long axis of the metering pump are parallel, and the semi-rigid backing extends beyond the delivery port to interrupt access of the destination port for engagement with the delivery port.

19. The CSTD arrangement of claim 1, wherein the valve comprises a stopcock and a rotating actuation lever for operating the stopcock between the first configuration and the second configuration, wherein the rotating actuation lever comprises a protrusion that, in the first configuration, occludes the delivery port to prevent it from being connected to the destination port.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0035] FIG. 1 illustrates a general view of a CSTD arrangement;

[0036] FIGS. 2a-2c illustrate cross section view of operational states of a CSTD arrangement;

[0037] FIG. 3 illustrates a CSTD arrangement with a receptacle;

[0038] FIGS. 4a-4b illustrate a CSTD arrangement where the valve comprises a bellows;

[0039] FIG. 5 illustrates a CSTD arrangement where the backing of the primary container is oriented in parallel to the syringe and has a dosing scale graduation;

[0040] FIG. 6 illustrates a CSTD arrangement where the primary container backing, and the valve are combined, and the valve axis is perpendicular the backing plane;

[0041] FIG. 7 illustrates a CSTD arrangement where the primary container backing, and the valve are combined, and the valve axis is perpendicular the backing plane;

[0042] FIGS. 8a-8b illustrate a CSTD arrangement comprising a stopcock valve;

[0043] FIGS. 9a-9c illustrate a CSTD arrangement comprising a stopcock valve wherein the backing of the primary container is the handle of the stopcock valve.

DETAILED DESCRIPTION

[0044] While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that it is not intended to limit the invention to the particular form disclosed, but rather, the invention is to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the claims.

[0045] FIG. 1 illustrates a general view of a CSTD arrangement 100 according to the present disclosure. The CSTD arrangement 100 is configured to compound, transfer and administer a metered dose of a beneficial agent from a primary container to a reciprocal port of at least one of a second reservoir, an intravenous (IV) container, and IV line, directly to a patient (for instance through a needle a catheter, or a nozzle), or to another desired destination, together hereafter referred to as destinations.

[0046] In one embodiment, the CSTD arrangement 100 for storing a beneficial agent and transferring the beneficial agent to a destination port may include a primary container 140 comprising a package 141 for storing the beneficial agent comprising at least one flexible wall 148 such that pressure in the primary container 140 is substantially equalized to ambient air pressure; a metering pump 110; a delivery port 130 for communicating the beneficial agent with the destination port; a valve 120 in fluid communication with the primary container 140, the metering pump 110, and the delivery port 130, the valve 120 may include a valve housing, wherein the primary container 140 extends from the valve housing, the metering pump 110 may be joined to the valve housing, and the delivery port 130 may be an opening in the valve housing configured to accommodate the destination port. The valve 120 may be moveable from a first configuration where it is not engaged with the destination port, to a second configuration where it is engaged with the destination port. In the first configuration the primary container 140 and the metering pump 110 may be in fluid communication and neither may be in fluid communication with the delivery port 130. In the second configuration the metering pump 110 may be in fluid communication with the delivery port 130 and neither may be in fluid communication with the primary container 140. The flexible wall 148 collapses when the beneficial agent is transferred from the primary container 140 to the metering pump 110 (e.g., to equalize any pressure imbalance in the primary container 140 in response to the removal of the beneficial agent therefrom).

[0047] The metering pump 110 may be capable of removing a metered dose of a beneficial agent from the primary container 140 and pushing said dose through the delivery port 130 to a reciprocal destination port. In one embodiment the metering pump 110 is a syringe. In some embodiments the pump 110 comprises a graduation correlating to dosing options of the beneficial agent.

[0048] The flexible wall 148 of the package 141 presents a barrier between the beneficial agent and ambient air that allows for pressure equilibrium between the beneficial agent and ambient air pressure. The primary container wall 148 is capable of collapsing in, or bulging out (e.g., plastically or elastically deforming), to adjust the primary container 140 volume as the beneficial agent is moved into or out of the primary container 140. This inherent pressure equalizing capability eliminates the motive force for leakage from the CSTD arrangement 100. The flexible wall 148 of the package 141 comprises at least one of a film, a foil, or a thin molded or blow-molded component. The package 141 may comprise a pouch, a sachet, a flexible tube, and a molded container. The flexible wall 148 may be performed, and may be deformable, between a first preformed state in which it structurally defines a fillable cavity of the first compartment 142, configured to receive the beneficial agent, to a deformed state in which said volume of the primary container 140 is substantially depleted, the beneficial agent having been moved to the metering pump 110. The first compartment 142 may be defined by a peripheral seal 145 between a first wall 148 and a second wall 149 of the package 141, and wherein the compartment wall 148 is preformed in a perpendicular direction to this seal 145.

[0049] In some embodiments the package 141 may include two compartments: a first compartment 142 containing at least a first constituent of the beneficial agent, and a second compartment 143 containing at least a second constituent of the beneficial agent. The first compartment 142 and the second compartment 143 may be separated by a frangible seal 144 that, when opened, allows the first and the second constituents of the beneficial agent to aseptically merge. The package 141 may be supported by a rigid or semi-rigid backing 146. The backing 146 can facilitate digital manipulation of the package 141 for example for breaking the frangible seal 144 by depressing the first compartment 142 (e.g., by a finger of a user). The backing 146 may interface the primary container 140 and the valve 120 via connector 147. The CSTD arrangement 100 can be provided to the user when the primary container 140 and the metering pump 110 are pre-assembled, in which case the CSTD arrangement 100 would be considered a prefilled drug delivery system. In another arrangement of the CSTD 100, at least one of the metering pump 110 and the primary container 140 are assembled to the valve 120 post-manufacturing, e.g. by the user.

[0050] As will be further illustrated in FIG. 2, the delivery port 130 may comprise a leak-tight connector that may have a substantially similar configuration to the connector implemented in the Tevadaptor™ system described above. In one embodiment the CSTD arrangement 100 may include a latch mechanism for holding the destination port joined to the delivery port such that the valve remains in the second configuration. In this embodiment the wing-shaped cantilever arms 131 are operable to release a latched connection with a port of a destination. In one arrangement the connector 147 allows changing the position and orientation of the primary container 140 relative to the pump 110. In one arrangement a tube connects between the connector 147 and the valve 120.

[0051] FIGS. 2a to 2c illustrate cross-section cut out views of a CSTD arrangement 200, of a similar arrangement to CSTD 100 of FIG. 1, in three operational states. FIG. 2a illustrates the first operational state where the CSTD arrangement 200 and the destination are not in contact and the CSTD arrangement 200 is in the first configuration, also referred to as the metering state. FIG. 2b illustrates CSTD arrangement 200 in the second operational state where the CSTD arrangement 200 is in contact with the destination but remains in the first configuration or metering state. FIG. 2c illustrates the CSTD 200 in the third operational state where it is in fluid communication with the destination, and CSTD 200 is in the second configuration, also referred to as the delivery state.

[0052] The CSTD arrangement 200 comprises a primary container 240, a metering pump in a form of a syringe 210, a leak-tight delivery port 230, and a valve 220, communicating between said primary container 240, the syringe 210, and the delivery port 230 configured to communicate with a reciprocal port of a destination. Such a destination may be, but is not limited to, a container, an IV bag, and IV line, a vial, a delivery device, and a connector, an adapter, or a coupler to the former.

[0053] The primary container 240 is virtually outlined as a circle connected to the valve 220. The primary container 240 can be of any fashion known in the art for storing, compounding, handling, or transferring a beneficial agent, however, as will be taught in this disclosure, the primary container 240 preferably comprises at least one flexible wall capable of deforming to adjust its internal capacity to the beneficial agent volume. This flexible wall act as a barrier between ambient air and the beneficial agent, and ensures that the beneficial agent pressure in the primary container 240 and elsewhere in the CSTD 200 is near ambient air pressure.

[0054] FIG. 2a illustrates CSTD arrangement 200 when it is not connected to a destination port 250 (first configuration, or metering state), either before or after such a connection was made.

[0055] In one embodiment of the CSTD arrangement 200 the valve 220 further comprises a needle 225 and a forward septum 223 configured to interface with the destination port 250, wherein: in the first configuration the needle 225 does not penetrate through the forward septum 223 and the forward septum 223 blocks fluid communication between the valve 220 and the destination port 250; and in the second configuration the needle 225 penetrates through the forward septum 223 and establishes fluid communication between the valve 220 and the destination port 250. The needle 225 can be any of a metal needle, a tube, a molded part, integrated or attached to adjacent part, or of any other embodiment of an elongated hollow body that can penetrate through the forward septum 223 to establish fluid communication between the valve 220 and the destination port 250 through the hollow portion of the elongated body, and prevent fluid communication around the hollow body. The forward septum 223 (also referred to as a seal, stopper, or plunger) may be of various embodiments that provide a seal between the valve cavity 228 and the delivery port 230 and is openable by the needle 225. The forward septum 223 can be made of silicone or other elastic materials known in the art of a combination of a rigid and elastic materials.

[0056] In one embodiment the CSTD arrangement 200 the valve 220 comprises a valve carriage 229, comprising a tubular body 221, the forward septum 223 and a rear septum 224, forming a valve cavity 228 therebetween, in fluid communication with the primary container 240 via port 222. The carriage may be moveably disposed in the valve housing 231, between its current metering state to a delivery state, and is biased to its metering state by spring 226. Effectively, the spring 226 biases the valve 220 to the first configuration. The needle 225 forms fluid communication between the syringe 210 and the valve carriage 229 (or “carriage”). The rear septum 224 seals against the needle 225 and may be of various embodiments that prevent liquid from leaking out of the valve cavity 228 around the needle 225. The rear septum 224 can be made of silicone or other elastic materials known in the art of a combination of a rigid and elastic materials.

[0057] The distal end of the housing 231 is in a form of a female Luer connector 232, configured to communicate with the male connector of the syringe body 211. In one arrangement the syringe 210 is configured to be threaded onto the valve housing 231 and thereafter the syringe is locked to the valve housing 231 and cannot be removed. Fluid communication between the syringe 210 and the primary container 240 is interfaced through the valve cavity 228, whereby retracting the syringe's plunger 212 will move fluid from primary container 240 to the syringe 210, and advancing the syringe plunger 212 toward the tip of the syringe 210 will move fluid from the syringe 210 to the primary container 240. In this metering state the beneficial agent can be metered into the syringe 210 and any air present in the syringe can be pushed back into the primary container 240. Additionally, if the dose that was initially metered into the syringe 210 exceeded the desired amount, excess beneficial agent can be pushed back into the primary container 240 to reach the desired dose. In one arrangement, a first constituent of the beneficial agent in the primary container 240 needs to be mixed with a second constituent of the beneficial agent that is in the syringe 210, for example in the event that the first constituent is in a dry form (lyophilized or spray-dried), and the second constituent is the required diluent for solubilizing the first constituent for injection. In the valve's metering state, the second constituent can be pushed into the primary container 240. It can also be moved back and forth into and from the primary container 240 to facilitate homogenous mixing of the beneficial agent. The flexible wall of the primary container ensures that the beneficial agent and its constituents in the CSTD arrangement 200 remain at close to ambient pressure, reducing the risk of beneficial agent leakage from the CSTD arrangement 200, and of foreign material to be forced into the CSTD arrangement 200. In one arrangement, a check valve is disposed between the primary container 240 and the valve cavity 228 to allow beneficial agent to move from the primary container 240 to the syringe 210, and prevent flow from the syringe 210 into the primary container 240.

[0058] FIG. 2a additionally illustrates an embodiment of the CSTD arrangement 200 where the CSTD arrangement 200 further comprises the destination port 250 configured to manipulate the valve 220 from the first configuration wherein the destination port 250 is disengaged from the delivery port 230, to the second configuration wherein the destination port 250 is engaged with the delivery port 230. The destination port 250 comprises a body 251, comprising a fluid passageway, 253 between a distal end in a form of a Luer connector 254, and a proximal end which is sealed by septum 252. The septum 252 in the first configuration blocks fluid communication between the delivery port 230 and the destination port 250, and in the second configuration the needle 225 penetrates through the septum 252 to establish fluid communication between the delivery port 230 and the destination port 250.

[0059] The Luer connector 254 of the destination port 250 may be connected to a second destination. In some embodiments the destination port 250 is configured to communicate with at least one of an intravenous delivery system, a catheter, a tube, a needle, or a combination thereof.

[0060] FIG. 2b illustrates CSTD arrangement 200 when the delivery port 230 is brought in contact with the destination port 250. The spring 226 serves to establish a set force between the forward septum 223 and the septum 252 before the carriage 229 starts moving, thereby ensuring a strong seal between the delivery port 230 and the destination port 250 before the valve 220 is moved from the metering state to the delivery state. This seal ensures that the beneficial agent will not leak out of the CSTD arrangement 200 during transfer of material between the destination port 250 and the CSTD arrangement 200, and that foreign materials will not ingress the CSTD arrangement 200 to contaminate the beneficial agent.

[0061] FIG. 2c illustrates the CSTD arrangement 200 where the valve 220 is in the second configuration (delivery state). Pushing the destination port 250 into the delivery port 230 overcomes the spring 226 force and moves the carriage 229 backward, causing the tip of the needle 225 to move out of the valve cavity 228 and penetrate the septum 252 of the destination port 250, establishing fluid communication between the syringe 210 and the destination port 250, and allowing transfer of the metered dose of the beneficial agent to the destination port 250. Note that in this state fluid can also be drawn from the destination port 250 into the syringe 210, but where this is not desired, a check valve can be implemented in passageway to block the flow from to the destination port 250 to CSTD arrangement 200.

[0062] In the second configuration the forward septum 223 and the septum 252 establish a fluid-tight seal preventing the beneficial agent from leaking out of the CSTD arrangement 200. The septum 252 can be made of silicone or other elastic materials known in the art of a combination of a rigid and elastic materials. The seals that are formed between contact surfaces of the needle 225 and the rear septum 224, and the needle 225 and the forward septum 223 isolate the primary container 240 from both the destination port 250 and the syringe 210, ensuring that no beneficial agent can be moved from the primary container 240 to the destination port 250, and that no additional dose of beneficial agent can be metered into the syringe 210 without first disconnecting the CSTD arrangement 200 from the destination port 250.

[0063] In one embodiment, a check valve is disposed between the primary container 240 and the valve cavity 228 to allow beneficial agent to move from the primary container 240 to the syringe 210, and to prevent flow from the syringe 210 into the primary container 240. When the destination port 250 is removed from the delivery port 230 the spring 226 moves the valve carriage 229 back to the forward position and the valve 220 returns to the first configuration (metering state). While the seal of the forward septum 223 has been compromised from the piercing of the needle 225 at the delivery state, the pressure in the valve cavity 228 remains balanced with the ambient pressure therefore no leak will occur through the pierced region of the forward septum 223.

[0064] The connection between the primary container 240 and the valve 220 can be of various types known in the industry including: a) a fixed, permanent connection from during the manufacturing process of the CSTD arrangement 200, b) a removable connection such as a Luer connection, and c) a leak tight connection similar to the leak-tight delivery port 230 or other leak-tight connector types known in the art.

[0065] FIG. 3 illustrates another arrangement of CSTD 300, similar to the CSTD arrangement 200 of FIGS. 2a-2c and further comprising a receptacle 370 in fluid communication with the valve 220 such that in the first configuration a metering pump (e.g., syringe 210) can only receive fluid from the primary container 360, and the syringe 210 can only push fluid to the receptacle 370. The valve carriage 329 communicates with the primary container 360 via a port 362 in the carriage body 321, and it also communicates with the receptacle 370 via a second port 372 in the carriage body 321. A first check valve 361 is disposed in the fluid passageway between the primary container 360 and the syringe 210, enabling a unidirectional flow from the primary container 360 to the syringe 210. The first check valve 361 may be located in the primary container 360 or the carriage 329. A second check valve 371 is disposed in the fluid passageway between the syringe 210 and the second receptacle 370, permitting a unidirectional flow from the syringe 210 to the receptacle 370. The second check valve 371 may be located in the receptacle 370 or in the carriage 329. The receptacle 370 may comprise at least one wall made from a flexible material, capable of adjusting the internal capacity of the receptacle 370 to the volume of fluid that it contains, while maintaining pressure equilibrium with ambient air pressure. This CSTD arrangement 300 is particularly advantageous where it is desired not to permit fluids that have been outside the primary container 360 to move into the primary container 360, such as air from the syringe 210 or excess beneficial agent. Possible reasons for that requirement are concerns of contamination or foaming of the beneficial agent in the primary container 360. In one arrangement of the CSTD 300 the primary container 360 and the second receptacle 370 are compartments of the same package.

[0066] FIGS. 4a and 4b illustrate another arrangement of a CSTD 400, similar to the CSTD arrangement 200 of FIGS. 2a-2c except for some of the components of the valve 420. In this arrangement the forward septum and the spring are combined into a single component. The valve 420 comprises a rigid tubular body 421, axially moveable within the valve housing 431. At its forward end, the moveable body 421 accommodates the forward septum 423 comprising a bellows 424 that extends rearward and forms a cavity 428 between the valve housing 431 and the forward septum 423. The bellows 424 acts as a spring that biases the moveable body 421 to the metering state. In one arrangement a spring is added in the space 433 in the housing 431, and external to the bellows 424. This spring would bias the moveable body 421 to the metering state of the valve 420.

[0067] FIG. 4a illustrates the CSTD arrangement 400 when the valve 420 is in the first configuration (metering state), where fluid communication is established between a metering pump (e.g., syringe 210) and the primary container 440 via needle 425, cavity 428, passageway 429 between the needle 425 and the valve housing 431, and the primary container connection 432. Fluid can be moved from the primary container 440 into the syringe 210 and vice versa.

[0068] FIG. 4b illustrates the CSTD arrangement 400 when the delivery port 430 is engaged with a destination port 450, moving the valve 420 to the second configuration (delivery state). The tip of the needle 425 is outside of the cavity 428 preventing fluid communication between a metering pump (e.g., syringe 210) and the primary container 440. The tip of the needle 425 is penetrating through the forward septum 423 and the septum 452 of the destination port 450, and establishes fluid communication between the syringe 210 and the destination port 450.

[0069] FIG. 5 illustrates an arrangement of a CSTD 500, similar to the CSTD 200 of FIG. 2, but where the backing 546 is arranged in parallel and along the long axis of the metering pump 510. Advantageously, in this arrangement information can be presented on the backing 546 in a graphic or text form to facilitate the use of the device. While the metering pump 510 may be marked with the typical milliliter graduation scale, the backing 546 is marked with graduation 549 that may provide supplemental or alternative information that is specific to the beneficial agent application. In one arrangement of the CSTD 500 the graduation 549 on the backing 546 is of the weight of active pharmaceutical ingredient (API) of the dose, typically provided in units (e.g. milligrams/deciliter) or weight (typically in milligrams). In many instances a prescription of a drug is provided in units that are different from the regular volumetric graduation of a syringe, e.g. in milligrams or units. When a regular syringe is used to meter the dose, the healthcare practitioner (e.g. pharmacist, nurse) is required to convert the prescription to the units of the syringe's graduation, which might be a source for dosing errors. By providing alternative or supplemental information on the backing 546 the unit conversion process may be verified or avoided altogether. The backing 546 may also be printed with all the beneficial agent's labeling required by the relevant regulations.

[0070] FIG. 6 illustrates another arrangement of a CSTD 600, similar to the CSTD 200 of FIG. 2 but where the valve housing 631 is integrated with the backing 641 of the primary container 640. The axis of the delivery port 630 is oriented in perpendicular to the backing 641. At least a portion of the valve housing 631 and the backing 641 can be made of the same manufactured part.

[0071] FIG. 7 illustrates another arrangement of a CSTD 700, similar to the CSTD 200 of FIG. 2 but where the valve housing 731 is integrated with the backing 741 of the primary container 740. The axis of the delivery port 730 is in parallel to the backing 741. At least a portion of the valve housing 731 and the backing 741 can be made of the same manufactured part.

[0072] FIGS. 8a and 8b illustrate a CSTD arrangement 800 similar to the CSTD 200 of FIG. 2 but where the valve is in a form of a stopcock valve operable by a lever which also functions to occlude the delivery port in the metering state thus preventing user from connecting the CSTD arrangement 800 to a destination. CSTD arrangement 800 comprises a metering pump in a form of a syringe 810, a delivery port 830, a primary container 840 comprising a backing 846, and a valve 870 communicating with said primary container 840, the syringe 810, and the delivery port 830. The valve 870 comprises a stopcock, moveable between the first configuration (metering state), where communication is established between the primary container 840 and the syringe 810 and the primary container 840, and the second configuration (delivery state) where fluid communication is established between the syringe 810 and the delivery port 830. The valve 870 comprises a rotating actuation lever 871 which operates the stopcock. The rotating actuation lever 871 comprises a protrusion 872 that, in the metering state, prevents the delivery port 830 from being connected to a destination port.

[0073] FIG. 8a illustrates the CSTD 800 in the first configuration (metering state) wherein the rotating actuation lever 871 is generally oriented in line with the syringe's 810 long axis, and the valve 870 is in the first configuration. The protrusion 872 occludes the delivery port 830, preventing user from connecting the delivery port 830 to a destination.

[0074] FIG. 8b illustrates the CSTD 800 in the second configuration (delivery state) wherein the rotating actuation lever 871 is generally oriented in perpendicular to the syringe's 810 long axis. The protrusion 872 does not occlude the delivery port 830, allowing user to connect the delivery port 830 to a destination.

[0075] FIGS. 9a and 9b illustrate a CSTD arrangement 900, comprising a metering pump in a form of a syringe 910, a delivery port 930, a primary container 940 comprising a semi-rigid backing 946, and a valve 970 communicating with said primary container 940, syringe 910, and the delivery port 930. The valve 970 comprises a stopcock, moveable between the first configuration (metering state), where communication is established between the primary container 940 and the syringe 910, and the second configuration (delivery state) where fluid communication is established between the syringe 910 and the delivery port 930. The primary container 940 communicates with the valve 970 through the center of the rotating core of the stopcock valve 970. The backing 946 is connected with the core of the stopcock of the valve 970 and serves as the rotating lever of the stopcock, operable between the metering state and the delivery state of the valve 970.

[0076] FIG. 9a illustrates the CSTD 900 in the first configuration wherein the long axis of the backing 946 and the long axis of the syringe 910 are parallel and the backing 946 extends beyond the delivery port 930 to interrupt access of a destination for engagement with the delivery port 930, and wherein the valve 970 is in the metering state.

[0077] FIG. 9b illustrates the CSTD 900 in the second configuration wherein the backing 946 is turned in a perpendicular direction to the syringe 910, enabling access of a destination for engagement with the delivery port 930, and wherein the valve 970 is in the delivery state.

[0078] FIG. 9c is a partial cross section view of the CSTD 900 illustrating the valve 970 in the metering state. The valve 970 interfaces three fluid passageways connecting with the primary container 940, syringe 910 and the delivery port 930. The rotating core 973 of the stopcock valve 970 is a cylindrical protrusion of the backing 946. The core 973 establishes fluid communication between the syringe 910 and the primary container 940, while isolating the fluid passageway that leads to the delivery port 930.

[0079] While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description is to be considered as exemplary and not restrictive in character. For example, certain embodiments described hereinabove may be combinable with other described embodiments and/or arranged in other ways (e.g., process elements may be performed in other sequences). Accordingly, it should be understood that only the preferred embodiment and variants thereof have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.