Patent Description:
Certain active agents, such as medications and nutrients, which may be unstable in liquid form, are stored in dry form. For example, active agents may be unstable at the pH of the IV fluid, susceptible to damage via light, or have other instability, thus requiring dry form storage. Dry form active agents may be stored in glass vials, sealed with rubber stoppers, or be stored in other containers such as plastic containers, ampoules, or in small bags that may be closed with standard screw caps. Prior to being administered to a patient, the dry form active agents are reconstituted. Reconstitution typically includes the removal of a protective cover to expose the rubber stopper, wiping the stopper with an antiseptic wipe, adding a diluent to the vial by inserting a needle of a syringe through the rubber stopper and depositing the contents of the syringe, such as the diluent, into the vial, and shaking the vial to fully dissolve or suspend the active agents. Subsequently, the resulting reconstituted solution or suspension is withdrawn from the vial by inserting a needle of a syringe through the rubber stopper, aspirating the solution or suspension into the syringe, and injecting the contents of the syringe into the flexible container via the medication port.

The above procedure is cumbersome and prone to spillage. An improved system and method for using a reconstitution device to administer medications via IV bags, is needed accordingly.

<CIT> discloses a reconstitution assembly that includes a housing including a lower sleeve and an upper sleeve, including a first container and a second container disposed vertically opposite the first container. A transfer set assembly is disposed within the housing between the first container and the second container. The transfer set assembly includes an upper spike housing and a lower spike housing, with a flow path defined through the upper spike housing and the lower spike housing. The transfer set assembly is configured to access contents of the first container and then upon the activation of a triggering mechanism, create a fluid pathway between the first container and the second container. The triggering mechanism includes trigger fingers which ensure the transfer set assembly sequentially accesses the contents of the first container before accessing the contents of the second container. The disposition of the first container activates the triggering mechanism.

<CIT> discloses a fluid valve and connection device comprising a housing with a receiving chamber with a second internal connection element and a second external connection element, a first movable valve element which is arranged in the receiving chamber, and an actuation element which has a first internal connection element and a first external connection element. The first internal connection element interacts with the second internal connection element and the valve element in order to establish or prevent a fluid connection between the first and second external connection element. The actuation element has a collar on which movable holding means are provided which hold a storage vessel that can be placed thereon.

<CIT> discloses a reconstitution device for the reconstitution of a drug which may be stored in a drug vial with a diluent stored in a flexible medical solution container. The reconstitution device includes a vial adapter and bag adapter which permit the permanent coupling of the vial and liquid container.

To improve the administration of medications via IV bags, a patient medication delivery paradigm is provided herein. To implement an improved way of medication administration, a reconstitution device, system, and method is disclosed. More specifically, a reconstitution device is provided to establish a fluid pathway between a source (e.g., a drug vial) and a location (e.g., an intravenous ("IV") bag), which includes a vent conduit to improve reconstitution, especially with respect to multi-chamber bags.

According to a first aspect of the present invention, there is provided a reconstitution device according to claim <NUM>.

In a first embodiment of the reconstitution device of the first aspect of the present invention, the cap is formed integrally with the collar.

In a second embodiment of the reconstitution device of the first aspect of the present invention, which may also be combined with the first embodiment, the collar is cylindrical and is configured to concentrically engage the vial.

In the second embodiment of the reconstitution device of the first aspect of the present invention, the collar engages the vial, such that the second piercing member extends into the vial, and such that the second piercing member is placed in fluid communication with the vial.

In a third embodiment of the reconstitution device of the first aspect of the present invention, which may also be combined with any other embodiment listed above, the first piercing member is configured to pierce an intravenous ("IV") bag port, such that the first piercing member is placed in fluid communication with the IV bag port.

According to the invention the second fluid pathway forms a vent conduit.

According to a second aspect of the present invention, there is provided a reconstitution system according to claim <NUM>.

In a first embodiment of the reconstitution system of the second aspect of the present invention, the first piercing member extends into the fluid container, and the collar engages the drug vial such that the second piercing member extends into the drug vial, and such that the fluid container is placed in fluid communication with the drug vial via the first fluid pathway.

In a second embodiment of the reconstitution system of the second aspect of the present invention, which may also be combined with any other embodiment listed above, the drug vial contains one of a pharmaceutical agent or a nutritional supplement.

In a fourth embodiment of the reconstitution system of the second aspect of the present invention, which may also be combined with any other embodiment listed above, the drug vial is formed of an ultraviolet ("UV") light blocking material.

In a fifth embodiment of the reconstitution system of the second aspect of the present invention, which may also be combined with any other embodiment listed above, the reconstitution system further includes an intravenous ("IV") line positioned and arranged to deliver a fluid from the fluid container to a patient.

In a sixth embodiment of the reconstitution system of the second aspect of the present invention, which may be combined with the fifth embodiment, the reconstitution system further includes an infusion pump in operable communication with the IV line.

According to a third aspect of the present invention, there is provided a drug reconstitution method according to claim <NUM>.

It is an advantage of the present disclosure to provide a reconstitution system that ensures complete reconstitution and subsequent infusion of a drug from a drug vial directly into a flexible container.

It is another advantage of the present disclosure to provide a reconstitution system that reduces drug degradation by reconstituting the drug and immediately delivering it to the flexible container. The particular system may be further configured to limit environmental degradation by avoiding solution-interaction with outside factors, such as light or air.

It is a further advantage of the present disclosure to provide a reconstitution system that ensures the contents of the vial, such as the reconstituted drug, are diluted prior to being administrated to the patient to prevent any medical or efficacy risks based on osmolarity.

It is yet another advantage of the present disclosure to provide a ready-to-use reconstitution system configured to accept vials directly.

It is yet a further advantage of the present disclosure to provide a reconstitution system avoiding tedious preparation steps involved with typical dried drug reconstitution by accepting vials directly.

It is still another advantage of the present disclosure to pre-plug the vial to ensure that drug prescriptions and deliveries are not inadvertently missed by medical professionals.

In yet another advantage of the present disclosure, each discrete component of the reconstitution system may be processed, sterilized, and handled separately on a component-by-component basis.

In yet a further advantage of the present disclosure, the reconstitution device may be particularly applicable for use with multi-chamber IV bags.

Moreover, an advantage of the present disclosure is to provide a reconstitution system ensuring that microbiological contamination risk is minimized by accepting pre-plugged vials in a sterile manner.

Additional features and advantages of the disclosed devices, systems, and methods are described in, and will be apparent from, the following Detailed Description and the Figures. Also, any particular embodiment does not have to have all of the advantages listed herein. Moreover, it should be noted that the language used in the specification has been selected for readability and instructional purposes, and not to limit the scope of the inventive subject matter.

Understanding that figures depict only typical embodiments of the invention and are not to be considered to be limiting the scope of the present disclosure, the present disclosure is described and explained with additional specificity and detail through the use of the accompanying figures.

Certain embodiments described herein relate generally to the field of intravenous ("IV") administration of an active agent. More particularly, some embodiments described herein relate to the reconstitution of an active agent in a vial, delivery to a flexible container, and subsequent IV administration of the active agent using the flexible container and an IV administration set.

As discussed herein, adding a dried drug to an IV bag typically includes several tedious steps. For example, a medical professional may be required to remove a protective cover from a vial, wipe a stopper of the vial, add diluent to the vial, and shake the vial. The drug then has to be withdrawn from the vial and injected into, for example, an IV bag.

Typical commercially available vial reconstitution systems (e.g., the Baxter Vial-Mate™ system) are configured such that the drug contained in the vial is added into a single chamber IV bag directly, via a port. In such systems, the drug from the vial is mixed with fluid within the entire single chamber IV bag, such as saline, prior to being administered to the patient. For example, the drug is delivered into the single chamber IV bag, via a medication port, mixes with the fluid of the single chamber IV bag, and is then administered to the patient via an administration port (e.g., by an IV set connected to the single chamber IV bag at the administration port). In this delivery paradigm, once the vial is connected to the IV bag, pressure is applied onto the IV bag to "push" liquid from the IV bag into the vial, for reconstituting the drug. The system is then flipped upside down, and pressure is applied to the bag to "push" headspace gas from the IV bag into the vial. The headspace gas consequently forces the reconstituted drug back into the IV bag.

The above delivery paradigm is particularly problematic with multi-chamber IV bags, which typically have frangible seals that open when pressure is applied to the bag. Further, multi-chamber IV bags are typically underfilled, thus making it difficult if not impossible to apply pressure to "push" headspace gas into the vial.

The reconstitution devices, systems, and methods disclosed herein are configured so that the vial containing the drug is connected directly with the multi-chamber IV bag. The connection allows for both an initial reconstitution in the vial, permitting fluid to flow from the multi-chamber IV bag to the vial, and a secondary reconstitution as the reconstituted drug travels directly into the multi-chamber IV bag from the vial. Implementation of an integrated vent conduit ensures that reconstituted solution can travel back into the IV bag, without requiring the application of pressure at the IV bag for "pushing" headspace gases. Thus, the devices, systems, and methods disclosed herein are particularly applicable in circumstances concerning underfilled bags, such as multi-chamber IV bags. The present configuration enhances the efficacy by which a drug is reconstituted in the vial and delivered subsequently to a patient. Further, the vial may initially be sealed and placed under a vacuum, thus eliminating the need to "push" liquid from the IV bag into the vial. When initially reconstituted, the vacuum may further enhance the efficacy by which a drug is reconstituted in a vial.

Referring now to the drawings and in particular to <FIG>, one embodiment of the reconstitution device and multi-chamber bag of the present disclosure is illustrated. Multi-chamber bag <NUM> includes several discrete chambers separated by frangible barriers, including first chamber <NUM>, second chamber <NUM>, third chamber <NUM>, and fourth chamber <NUM>. It should be appreciated that multi-chamber bag <NUM> could include more, or less, than four chambers. In an embodiment, first chamber <NUM> holds lipids in liquid form, second chamber <NUM> holds amino acids in liquid form, third chamber <NUM> holds trace elements in liquid form, and fourth chamber <NUM> holds glucose in liquid form. Each of the chambers <NUM>, <NUM>, <NUM>, <NUM> includes a respective administration port <NUM>, <NUM>, <NUM>, <NUM>. Multi-chamber bag <NUM> may be constructed of any suitable plastic or rubber material, such as polyvinyl chloride ("PVC"), non-DEHP PVC, Krayton polypropylene mixture, or other similar materials.

As illustrated, reconstitution device <NUM> engages with administration port <NUM> (associated with first chamber <NUM>). It should be appreciated that reconstitution device <NUM> could engage with any of the administration ports and/or chambers mentioned above. Reconstitution device <NUM> also engages with a vial <NUM>, discussed in greater detail herein. Any of the device engagements discussed herein may be via a luer connector, tube connector, snap fit, interference fit, or any other related means for connection. Via the vial engagement, a dried drug from vial <NUM> is reconstituted with fluid from the first chamber <NUM>, or alternatively several chambers if their seals have been broken, and the reconstituted drug is subsequently delivered into multi-chamber bag <NUM>, for further reconstitution with the entire multi-chamber bag <NUM> and future delivery to a patient. For example, multi-chamber bag <NUM> may further include a port or connection for engagement with an IV delivery tube, connected to a patient. Multi-chamber bag <NUM> may further include a loop <NUM>, for hanging the bag on a stand, as discussed in greater detail herein.

<FIG> is a sectioned view of the reconstitution device <NUM> and multi-chamber bag <NUM> of <FIG>, according to an example embodiment of the present disclosure. As illustrated, multi-chamber bag <NUM> initially includes a membrane <NUM> at administration port <NUM>.

Reconstitution device <NUM> includes a piercing end <NUM>, a body <NUM>, and a retaining end <NUM>. Reconstitution device <NUM> may be constructed of any suitable plastic or rubber material, such as polyvinyl chloride ("PVC"), non-DEHP PVC, Krayton polypropylene mixture, or other similar materials.

Retaining end <NUM> is configured to engage vial <NUM> (e.g., via concentric engagement). Vial <NUM> may be fitted with a stopper <NUM>, which may be a rubber stopper, a plastic stopper, and/or include a foil cover, or be any other similar structure for sealing vial <NUM>. Stopper <NUM> may protect the contents of vial <NUM> from environmental factors, such as ambient air. In an embodiment, the contents of vial <NUM> include a dried drug <NUM>. In an embodiment, vial <NUM> is formed of an ultraviolet ("UV") light blocking material, which may further protect the contents of vial <NUM> from environmental factors, such as light.

Specifically, regarding the concentric engagement of device <NUM> to vial <NUM>, retaining end <NUM> of reconstitution device <NUM> includes a cap <NUM>. Retaining end <NUM> further includes a cylindrical collar <NUM>. Cap <NUM> may be formed integrally with collar <NUM>, or be attached to retaining end <NUM>. In alternative embodiments, collar <NUM> may have differently shaped cross-sections (e.g., hexagonal, square, triangular, or other suitable geometric shape). Cylindrical collar <NUM> is configured to engage vial <NUM> (e.g., via concentric engagement).

In the illustrated embodiment, the stopper-side of vial <NUM> may be received within cylindrical collar <NUM> of device <NUM>, such that the cylindrical collar <NUM> is disposed around the outside of the stopper-side of vial <NUM>. Vial <NUM> typically contains an active agent such as a pharmaceutical agent or a nutritional supplement. The active agent may be present as a dried drug <NUM>, such as a powder obtained by lyophilization. Alternatively, the active agent is present in an aqueous solution or suspension, or other typical liquid form. The inner surface of collar <NUM> may include a plurality of ridges <NUM> that are configured to engage, e.g., via a spring-like deformation, to press-fit or snap-fit over the stopper-side of vial <NUM>, such that the stopper-side of vial <NUM> is retained inside the plurality of ridges <NUM> of the collar <NUM>.

Reconstitution device <NUM> further includes a first piercing member <NUM> and a second piercing member <NUM>. First piercing member <NUM> and second piercing member <NUM> may be made of metal (e.g., stainless steel), medical grade plastic, or other suitable material. A first fluid pathway <NUM> extends between first piercing member <NUM> and second piercing member <NUM>. Specifically, cap <NUM> extends from collar <NUM> and holds second piercing member <NUM>. Second piercing member <NUM> is disposed within collar <NUM>. As configured, first piercing member <NUM> is configured to engage with administration port <NUM> of multi-chamber bag <NUM>; likewise, second piercing member <NUM> is configured to engage with vial <NUM>. In an embodiment, at least one of the first piercing member <NUM> or the second piercing member <NUM> may include or form a syringe needle or a plastic spike.

Reconstitution device <NUM> further includes a plug <NUM>, disposed along a portion of body <NUM> between piercing end <NUM> and retaining end <NUM>. Specifically, plug <NUM> may be removably attached to a receptacle <NUM> along body <NUM>. Generally, plug <NUM> is configured to form a hermetic seal with receptacle <NUM> when engaged. In various embodiments, plug <NUM> engages with receptacle <NUM> via a threaded fit, snap fit, or other suitable fit. In an embodiment, plug <NUM> further includes an o-ring or other gasket. A second fluid pathway <NUM> extends between receptacle <NUM> and second piercing member <NUM>.

<FIG> is a section view of the reconstitution device <NUM> of <FIG>, further illustrating the engagement with multi-chamber bag <NUM>, according to an example embodiment of the present disclosure. As previously illustrated with respect to <FIG>, <FIG> also shows administration port <NUM> of multi-chamber bag <NUM> includes membrane <NUM> (e.g., a removable membrane or a pierceable membrane). Membrane <NUM> may initially prevent premature flow from multi-chamber bag <NUM>. Membrane <NUM> may further ensure that a vacuum exists within the various fluid pathways communicating with vial <NUM> during reconstitution, to advantageously generate pressurized fluid streams for reconstitution, as described in greater detail below. Membrane <NUM> may also reduce or eliminate leakage from multi-chamber bag <NUM>.

First piercing member <NUM> is, in the illustrated embodiment, configured to pierce an administration port (e.g., an IV bag port) at membrane <NUM>, so that the first piercing member <NUM> is in fluid communication with administration port <NUM> and thus with multi-chamber bag <NUM>. Administration port <NUM> may be connected to multi-chamber bag <NUM> or may be formed integrally with multi-chamber bag <NUM>.

As illustrated in <FIG>, vial <NUM> is engaged within collar <NUM> such that second piercing member <NUM> pierces stopper <NUM> of vial <NUM>. The user pushes vial <NUM> onto cap <NUM> to secure engagement between the vial <NUM> and the collar <NUM> and the second piercing member <NUM> pierces through the stopper <NUM> (e.g., a rubber stopper) of vial <NUM> and extends into vial <NUM>. Engagement between the collar <NUM> and the vial <NUM> may further include rotation or twisting of the vial <NUM>. For example, the collar <NUM> may include inner threads, and the vial <NUM> may include outer threads, such that a threaded engagement between the vial <NUM> and the collar <NUM> is implemented for secure engagement between the components.

Once engaged, multi-chamber bag <NUM> is in fluid communication with the vial <NUM> via first fluid pathway <NUM> that extends from first piercing member <NUM> to second piercing member <NUM>. The vial <NUM> is initially sealed and under a vacuum, prior to engagement with collar <NUM> (e.g., a low pressure such as <NUM> mbar, which is less than ambient air pressure).

It should be appreciated that the piercing described above for first piercing member <NUM> and second piercing member <NUM> may happen nearly simultaneously. For example, once first piercing member <NUM> pierces the administration port <NUM> (e.g., an IV bag port) at membrane <NUM>, first piercing member <NUM> is in fluid communication with administration port <NUM>; thus, liquid may flow from administration port <NUM> into the reconstitution device <NUM> via the first fluid pathway <NUM>. To ensure that liquid does not inadvertently spill out of the second piercing member <NUM> (e.g., via first fluid pathway <NUM>), the second piercing member <NUM> pierces stopper <NUM> of vial <NUM> immediately after the first piercing member <NUM> pierces the administration port <NUM> (e.g., nearly simultaneously). In this way, inadvertent spilling is prevented.

After the piercing of members <NUM> and <NUM>, fluid in multi-chamber bag <NUM> may flow directly from the first piercing member <NUM> to the second piercing member <NUM> via the first fluid pathway <NUM>, and consequently into vial <NUM>. Flow into vial <NUM> via first fluid pathway <NUM> can be characterized as a pressurized fluid stream (e.g., jet stream). Because vial <NUM> was initially sealed and under a vacuum prior to engagement with collar <NUM>, engagement causes fluid from multi-chamber bag <NUM> to be rapidly drawn into vial <NUM> by the negative pressure. The initial draw of fluid may generate a pressurized fluid stream from the second piercing member <NUM> (e.g., a jet stream) into vial <NUM>. The pressurized fluid stream may be advantageous for mixing and reconstituting a dried drug within vial <NUM>. The magnitude of the vacuum in vial <NUM> may be adjusted, to obtain an optimal mixing effect and/or to obtain the desired filling volume. The vacuum also aids in reducing or eliminating problems in removing air compared to vial <NUM> instead being under atmospheric pressure. As fluid from multi-chamber bag <NUM> flows into vial <NUM>, dried drug <NUM> is reconstituted. Dried drug <NUM> illustrated in <FIG> is no longer shown in <FIG> because the drug has been reconstituted with fluid from multi-chamber bag <NUM>.

The reconstituted drug within vial <NUM> next needs to be sent back into multi-chamber bag <NUM>. Reconstitution device <NUM> is capable of performing this operation via second fluid pathway <NUM>, also referred to herein as a vent or vented conduit. The process of flowing the reconstituted drug back into bag <NUM> is performed in connection with <FIG>, which illustrate engagement of reconstitution device <NUM> to multi-chamber bag <NUM>.

As illustrated in <FIG>, reconstitution device <NUM> and related vial <NUM> are rotated vertically to an upside-down configuration. Plug <NUM> is then removed from receptacle <NUM>, as illustrated by <FIG>. Alternatively, instead of physically removing plug <NUM>, the user merely moves plug <NUM> from a closed state to an opened state. By removing plug <NUM> from receptacle <NUM> (or opening plug <NUM>), vial <NUM> is placed in fluid communication with an external environment, such as a medical preparation room, via second fluid pathway <NUM>. In an embodiment, reconstitution device <NUM> further includes an air filter, such as a <NUM> air filter, disposed along receptacle <NUM> between plug <NUM> and second fluid pathway <NUM>. In a different embodiment, the air filter is disposed along second fluid pathway <NUM>.

As previously noted, vial <NUM> is initially sealed and under a vacuum. Likewise, the contents of multi-chamber bag <NUM> are sealed at a lower pressure. Thus, the entire system, prior to removal of plug <NUM>, is at a sub-atmospheric pressure. For this reason, removal of plug <NUM> causes atmospheric air from the external environment to flow into vial <NUM> via second fluid pathway <NUM>, and subsequently push the reconstituted material from the vial <NUM> to multi-chamber bag <NUM> via first fluid pathway <NUM>. Once reconstituted material flows into multi-chamber bag <NUM>, plug <NUM> is then re-attached to receptacle <NUM> (or closed), as illustrated by <FIG>.

The reconstitution device <NUM> may alternatively include a valve to replace plug <NUM>, although this is outside the scope of the present invention. For example, a user-operated valve may be implemented, such that the user may selectively open and close receptacle <NUM> via the valve, thereby controlling when second fluid pathway <NUM> communicates with the external environment. User -operated valve may further provide the user with the ability to selectively open and close first fluid pathway <NUM>. It should be appreciated that the user-operated valve may be positioned at any location along reconstitution device <NUM> and/or there could be multiple valves (e.g., one valve for each of first fluid pathway <NUM> and second fluid pathway <NUM>). The user-operated valve may be a ball valve, a gate valve, a globe valve, a check valve, or other related valves.

In an alternate embodiment, reconstitution device <NUM> may be implemented with an IV bag that is initially empty and under a vacuum or partial vacuum. For example, the reconstitution device <NUM> with vial <NUM> is connected to an empty IV bag (e.g., via administration port <NUM>). The empty IV bag may then be subsequently filled with any desired solution, such as saline or glucose, through a dedicated port. This may be advantageous for applications where providing the solution ahead of time is costly or difficult. In this alternative embodiment, the solution for the IV bag may be prepared and the IV bag may be filled during administration. As solution is added to the empty IV bag (that is already connected to reconstitution device <NUM>), reconstitution may occur as described above.

<FIG> illustrates one embodiment of a system <NUM> employing reconstitution device <NUM>, which is configured to engage with drug vial <NUM> as described above. System <NUM> includes an IV bag <NUM> (e.g., multi-chamber bag <NUM>) hanging from a stand <NUM> (e.g., via loop <NUM>). The IV bag <NUM> may include a fluid, such as saline, glucose, or other similar fluid, for delivery to a patient <NUM>. As illustrated, IV bag <NUM> is positioned on the stand <NUM> to ensure that the IV bag <NUM> is located vertically above the patient <NUM>, which ensures that fluid in the IV bag <NUM> gravity flows to patient <NUM>. Furthermore, the IV bag <NUM> is illustrated as a single-chamber in <FIG>; it should be appreciated, however, that IV bag <NUM> is alternatively a multi-chamber bag (e.g., multi-chamber bag <NUM> illustrated in <FIG>), and that the seals between chambers have already been opened in <FIG>.

System <NUM> as illustrated includes reconstitution device <NUM> and vial <NUM>. Reconstitution device <NUM> is connected to IV bag <NUM> as previously described using first piercing member <NUM>, while vial <NUM> is connected as previously described using second piercing member <NUM>. A delivery tube <NUM>, such as an IV tube, engages with IV bag <NUM>. Delivery tube <NUM> is also connected to patient <NUM> at an IV location <NUM>. For example, delivery tube <NUM> may extend to an intra-venous needle inserted into the patient <NUM> at the IV location <NUM>.

Delivery tube <NUM> is configured to convey the fluid in the IV bag <NUM>, mixed with drug <NUM> from vial <NUM> in IV bag <NUM>, to the patient <NUM> at IV location <NUM>. While fluid conveyance may be facilitated via gravity due to IV bag <NUM> being elevated on the stand <NUM>, additional or alternative modes of fluid conveyance may be implemented. For example, system <NUM> may use an infusion pump <NUM>, which may for example be a Sigma™ Large Volume Pump ("LVP") provided by the assignee of the present disclosure. Infusion pump <NUM> may control fluid conveyance along delivery tube <NUM> (e.g., from the IV bag <NUM> to the patient <NUM> at the IV location <NUM>). In such a case, bag <NUM> may be located even or vertically below patient <NUM>.

With reference to <FIG> and <FIG>, the fluid in the IV bag <NUM> may travel into the first piercing member <NUM> and subsequently travel into the vial <NUM>, via the first fluid pathway <NUM>. The fluid mixes with drug <NUM> in vial <NUM> to form a reconstituted solution. Upon flipping of reconstitution device <NUM> and vial <NUM>, as illustrated by <FIG>, and subsequent removal (or opening) of plug <NUM>, as illustrated by <FIG>, the reconstituted solution may then flow from vial <NUM> to IV bag <NUM> via first fluid pathway <NUM>. Consequently, as illustrated in <FIG>, IV fluid from IV bag <NUM> mixed with reconstituted solution may both be delivered, from the IV bag <NUM>, into delivery tube <NUM>. IV fluid from the IV bag <NUM> and the reconstituted drug solution may then flow to patient <NUM> via IV location <NUM>. Flow to the IV location <NUM> may be conveyed via gravity and/or via infusion pump <NUM>.

The fluid conveyance process described above may include additional steps. For example, the reconstitution device <NUM> may engage drug vial <NUM> at the cylindrical collar <NUM>; however, prior to this engagement, the delivery tube <NUM> may be clamped via a typical medical line clamp. The medical professional may do this to initially ensure that any inline air (e.g., in delivery tube <NUM> or in reconstitution device <NUM>) is removed from the system <NUM>, such as by tapping the reconstitution device <NUM> and/or tube <NUM>.

The above described reconstitution device, system, and method may be used, for example, during a parenteral nutrition therapy. Here, reconstitution may be used to enhance the administration of a multivitamin product that would otherwise be added to a total parenteral nutrition ("TPN") bag through the medication port. Examples of known parenteral nutrition products, which could be used with the present device, system, and method, include Olimel®, Oliclinomel, Clinomel, Clinimix®, Numeta®, ClinOleic®, SmofKabiven®, Kabiven®, PeriKabiven®, StructoKabiven, Aminomix, Nutriflex, Nutriflex Lipid, Pediaven products, and the like. In various examples, the reconstitution device <NUM> may be permanently connected to a TPN or multi-chamber bag <NUM>, or may be added to the TPN or multi-chamber bag <NUM> prior to use.

As used in this specification, including the claims, the term "and/or" is a conjunction that is either inclusive or exclusive. Accordingly, the term "and/or" either signifies the presence of two or more things in a group or signifies that one selection may be made from a group of alternatives.

Claim 1:
A reconstitution device (<NUM>) comprising:
a body (<NUM>);
a first piercing member (<NUM>) located at a first end (<NUM>) of the body;
a retaining end (<NUM>) located at a second end of the body, the retaining end including
a collar (<NUM>) configured to engage a vial (<NUM>) that is sealed and under vacuum, and
a cap (<NUM>) extending from the collar and holding a second piercing member (<NUM>), wherein the second piercing member is disposed within the collar;
a first fluid pathway (<NUM>) formed within and extending from the first piercing member (<NUM>) to the second piercing member (<NUM>);
a second fluid pathway (<NUM>) formed within and extending from the second piercing member (<NUM>) to a portion (<NUM>) of the body (<NUM>) between the first piercing member (<NUM>) and the second piercing member (<NUM>); the second fluid pathway (<NUM>) forming a vent conduit; and
a removable plug (<NUM>) fitted within the second fluid pathway (<NUM>) at the portion (<NUM>) of the body (<NUM>) between the first piercing member (<NUM>) and the second piercing member (<NUM>), wherein the removable plug forms a hermetic seal with the portion of the body between the first piercing member and the second piercing member, and
wherein removal of the plug (<NUM>) from the second fluid pathway (<NUM>) allows atmospheric air to flow into the vial (<NUM>) via the second fluid pathway, the incoming atmospheric air pushing a reconstituted solution from the vial into a fluid container (<NUM>, <NUM>) via the first fluid pathway.