Reconstitution system for drug delivery via high vacuum vial

Abstract

The reconstitution device includes a first piercing member, a second piercing member and a receiver. The first piercing member has a first end and a second end. The first end of the first piercing member is configured to engage a drug delivery port. The first piercing member includes a first fluid channel extending from the first end of the first piercing member to the second end of the first piercing member. The receiver includes a cuff and a cap. The cuff is configured to engage a vial. The cap extends from the cuff and holds the second piercing member. The first end of the second piercing member is disposed within the cuff.

Description

Background Art

[0001] Drug therapy usually requires, for example, fluid for correcting electrolyte imbalance, drug solution for delivering drugs and / or intravenous administration of nutrients for providing nutrition to patients who cannot receive oral or enteral nutrition. Intravenous injection ("IV") fluids are usually available in sterile single-chamber or multi-chamber flexible containers, which include a drug administration port and a drug port. The IV drug administration kit is usually inserted into a flexible container (e.g., an IV bag) via a drug administration port to allow fluid to be administered to the patient from the flexible container. Similarly, drugs and / or nutrients can be injected into the flexible container via the drug port.

[0002] Specific active agents (such as drugs 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 IV fluids, sensitive to light, or have other instabilities, so dry form storage is required. Generally, the active agent in dry form can be stored in a glass bottle sealed with a rubber stopper, or stored in other containers (such as plastic containers, ampoules), or in a small bag that can be closed with a standard screw cap. Before administration to the patient, these active agents in dry form are reconstructed. Reconstruction generally includes removing the protective cap, exposing the rubber stopper, wiping the stopper with a disinfectant wipe, adding the diluent to the bottle by inserting the needle of the syringe through the rubber stopper and depositing the contents of the syringe (such as diluent) in the bottle, and shaking the bottle to completely dissolve the active agent or suspend the active agent. Subsequently, by inserting the needle of the syringe through the rubber stopper, aspirating the solution or suspension into the syringe and injecting the contents of the syringe into a flexible container via a drug port, extracting the resulting reconstructed solution or suspension from the bottle. However, some drugs and nutrients begin to degrade once mixed into the flexible container. For example, ascorbic acid (vitamin C) and vitamin B1 may degrade in a total parenteral nutrition mixture, while vitamins A and E may degrade in a parenteral nutrition mixture when exposed to light.

[0003]

[0006] Therefore, there is a need for improved systems and methods for administering drugs, especially rapidly degrading drugs, using reconstitution devices. Summary of the invention

[0004] To improve the administration of drugs, particularly those that degrade rapidly, a new paradigm for drug delivery to a patient is provided herein. To achieve new and alternative modes of drug administration, new and alternative reconstitution devices, systems, and methods are disclosed. More specifically, a reconstitution device is provided to establish a fluid pathway between a source (e.g., an intravenous ("IV") bag) and a location (e.g., a patient). Along the fluid pathway, a drug (e.g., a powdered drug, a lyophilized drug, or a liquid drug) is introduced via a connection to a reconstitution device of a drug container (e.g., a drug vial).

[0005] According to the disclosure herein, and without limiting the scope of the invention in any way, in a first aspect of the disclosure (which may be combined with any other aspects listed herein, unless otherwise stated), a reconstitution device includes a first piercing member and a receiver. The first piercing member has a first end and a second end. The first end of the first piercing member is configured to engage a drug delivery port. The first piercing member includes a first fluid channel extending from the first end of the first piercing member to the second end of the first piercing member. The receiver includes a cuff configured to engage a vial. The receiver includes a cap extending from the cuff and holding a second piercing member, wherein the first end of the second piercing member is arranged in the cuff.

[0006] In a second aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the cap is integrally formed with the cuff.

[0007] In a third aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the cuff is cylindrical and configured to concentrically engage the vial.

[0008] In a fourth aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the cuff engages the vial so that the first end of the second piercing member extends into the vial. In addition, the first piercing member is in fluid communication with the vial via a second fluid passage extending from the first end of the first piercing member to the first end of the second piercing member.

[0009] In a fifth aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the drug administration port is an intravenous ("IV") bag port. The first end of the first piercing member is configured to pierce the IV bag port so that the first piercing member is in fluid communication with the IV bag port.

[0010] In a sixth aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the reconstitution device further comprises an IV line.The second end of the first piercing member is configured to connect to an IV line.

[0011] In a seventh aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the first piercing member is in fluid communication with the IV line via the first fluid channel. In addition, the second piercing member is in fluid communication with the IV line via a third fluid channel extending from the first end of the second piercing member to the second end of the first piercing member.

[0012] In an eighth aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the reconstitution device further comprises a membrane, such as a removable membrane or a pierceable membrane.

[0013] In a ninth aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), each of the first and second piercing members is vertically oriented when placed in the operating position.

[0014] In a tenth aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the first end of the first piercing member is integrally formed with the drug administration port.

[0015] In an eleventh aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the administration port is connected to an IV solution container.

[0016] In a twelfth aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), at least one of the first end of the first piercing member, the second end of the first piercing member, and the first end of the second piercing member comprises or defines a syringe needle or a plastic tip.

[0017] In a thirteenth aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the vial is initially sealed and under vacuum.

[0018] In a fourteenth aspect of the present disclosure (which may be combined with any other aspect listed herein, unless otherwise specified), a reconstitution system includes a drug vial, a fluid container, and a reconstitution device. The reconstitution device includes a first piercing member and a receptacle. The first piercing member has a first end and a second end. The first end of the first piercing member is configured to engage the fluid container. The second end of the first piercing member is configured to engage an IV line. The first piercing member includes a first fluid channel extending from the first end of the first piercing member to the second end of the first piercing member, so that the fluid in the fluid container can be communicated with the IV line. The receptacle includes a cuff configured to engage the drug vial. The receptacle includes a cap extending from the cuff and holding the second piercing member, wherein the first end of the second piercing member is arranged in the cuff.

[0019] In a fifteenth aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the cuff engages the drug vial so that the first end of the second piercing member extends into the drug vial. In addition, the first piercing member is in fluid communication with the drug vial via a second fluid passage extending from the first end of the first piercing member to the first end of the second piercing member.

[0020] In a sixteenth aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the second piercing member is in fluid communication with the IV line via a third fluid channel extending from the first end of the second piercing member to the second end of the first piercing member.

[0021] In a seventeenth aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), a pharmaceutical vial contains one of a medicament or a nutritional supplement.

[0022] In an eighteenth aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the pharmaceutical vial is initially sealed and under vacuum.

[0023] In a nineteenth aspect of the present invention (which may be combined with any other aspect listed herein unless otherwise stated), the reconstitution system further comprises an infusion pump in operative communication with the IV line.

[0024] In a twentieth aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the pharmaceutical vial is formed of an ultraviolet ("UV") light blocking material.

[0025] In a twenty-first aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), a drug reconstitution method includes enabling a first end of a first piercing member to engage with a fluid container. The method includes enabling a first end of a second piercing member to engage with a drug vial so that an IV fluid can flow along a second fluid channel extending from the fluid container to the drug vial. The method includes enabling the IV fluid to mix with a reagent located in the drug vial to form a mixed drug so that the mixed drug can flow along a third fluid channel extending from the drug vial to the IV line. The method includes enabling a second end of the first piercing member to engage with an IV line so that the IV fluid can flow along a first fluid channel extending from the fluid container to the IV line.

[0026] In a twenty-second aspect of the present disclosure (which may be combined with any other aspect listed herein unless otherwise stated), a drug reconstitution method comprises enabling IV fluid and a mixed drug to flow simultaneously from a second end of a first piercing member to an IV line.

[0027] In a twenty-third aspect of the present invention (which may be combined with any other aspect listed herein unless otherwise stated), a reconstitution device comprises a first piercing member and a second piercing member. The first piercing member has a first end and a second end. The first end of the first piercing member is configured to engage with a fluid container. The second end of the first piercing member is configured to engage with an IV line so that the IV fluid can flow along a first fluid channel extending from the fluid container to the IV line. The second piercing member has a first end configured to engage with a drug vial so that the IV fluid can flow along a second fluid channel extending from the fluid container to the drug vial. The IV fluid is mixed with a reagent located in the drug vial to form a mixed drug so that the mixed drug can flow along a third fluid channel extending from the drug vial to the IV line. The IV fluid and the mixed drug can flow from the second end of the first piercing member to the IV line simultaneously.

[0028] According to the present disclosure and aspects set forth herein, therefore, it is an advantage of the present disclosure to provide a reconstitution system that ensures complete infusion of the drug from a drug vial by gravity by implementing an inverted vial.

[0029] Another advantage of the present disclosure is to provide a reconstitution system that reduces drug degradation by reconstituted drug and immediately delivers the drug to an IV dosing kit. The particular system can further be configured to limit environmental degradation by avoiding solution interaction with external factors (e.g., light or air). Immediate delivery can further ensure that the reconstituted drug is delivered during the first portion of treatment, thereby avoiding incomplete delivery that may be associated with premature interruption of treatment.

[0030] Another advantage of the present disclosure is to provide a reconstitution system that ensures that the contents of a vial (eg, a reconstituted drug) are diluted prior to administration to a patient to prevent any medical or efficacy risks based on osmotic pressure.

[0031] Another advantage of the present invention is to provide a ready-to-use reconstitution system configured to directly accept a vial.

[0032] Another advantage of the present disclosure is to provide a reconstitution system that avoids the cumbersome preparation steps associated with typical dry drug reconstitution by directly accepting vials.

[0033] Another advantage of the present disclosure is that the vials are pre-stopped to ensure that medication prescriptions and deliveries are not inadvertently missed by medical professionals.

[0034] Another advantage of the present invention is to provide a reconstitution system that ensures passive reconstitution by connecting the drug vial to the delivery site, so that in one embodiment, no additional actions are required for reconstitution and administration.

[0035] In yet another advantage of the present disclosure, each discrete component of the reconstitution system can be individually handled, sterilized, and manipulated on a component-by-component basis.

[0036] Furthermore, it is an advantage of the present disclosure to provide a reconstitution system that ensures that the risk of microbial contamination is minimized by accepting pre-stoppered vials in a sterile manner.

[0037] Additional features and advantages of the disclosed devices, systems, and methods are described in, and will be apparent from, the following detailed description and accompanying drawings. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the drawings and description. Furthermore, any particular embodiment does not necessarily have all of the advantages listed herein. Furthermore, it should be noted that the language used in the specification is selected for readability and instructional purposes, and not for the purpose of limiting the scope of the subject matter of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Understanding that the drawings depict only typical embodiments of the invention and are not to be considered limiting of the scope of the disclosure, the disclosure will be described and explained with additional specificity and detail through the use of the drawings. The drawings are listed below.

[0039] Figure 1 is an exploded cross-sectional view of one embodiment of a reconstitution device according to an exemplary embodiment of the present disclosure.

[0040] Figure 2 According to an exemplary embodiment of the present disclosure Figure 1 A cross-sectional view of the reconstructed device further illustrating device engagement.

[0041] Figure 3 According to an exemplary embodiment of the present disclosure Figure 1 A front cross-sectional view of the reconstructed device further illustrating device engagement.

[0042] Figure 4 is an elevational cross-sectional view of an alternative embodiment of a reconstitution device of the present disclosure including an integrated fluid container.

[0043] Figure 5 is a schematic diagram of one embodiment of a system employing any of the reconstitution devices described herein.

[0044] Figure 6 is a graph of osmotic pressure concentration profiles as a function of time performed by a reconstitution device of the present disclosure.

[0045] Figure 7 is a graph of reconstitution drug infusion as a function of time performed by a reconstitution device of the present disclosure. DETAILED DESCRIPTION

[0046] Certain embodiments described herein relate generally to the field of intravenous ("IV") administration of active agents. More specifically, some embodiments described herein relate to reconstituting an active agent in a vial and subsequently administering the active agent using an IV administration kit.

[0047] As discussed herein, adding dry medication to an IV bag typically involves several cumbersome steps. For example, a medical professional may need to remove a protective cap from a vial, wipe the stopper of the vial, add a diluent to the vial, and shake the vial. The medication must then be drawn from the vial and injected into, for example, an IV line or IV bag. Additionally, as discussed above, once the medication is reconstituted, it may begin to degrade; therefore, it is important to keep the infusion time to a minimum.

[0048] Typical commercially available vial reconstitution systems (e.g., Baxter Vial-Mate TM In some embodiments, the IV bag of the present invention is a kind of system that is constructed so that the medicine contained in the bottle is directly added to the IV bag through the port. In such a system, the medicine in the bottle is mixed with the whole IV bag before being administered to the patient. For example, the medicine is delivered to the IV bag through the medicine port, mixed in the IV bag, and then administered to the patient through the administration port (for example, by the IV kit connected to the IV bag at the administration port). Under this delivery paradigm, the medicine is not fully delivered until the entire contents of the IV bag have been delivered. The longer the time that the medicine stays in the IV bag under the reconstructed state, the more likely the medicine is to degrade when waiting for delivery. In addition, when the IV bag is a multi-chamber bag, especially when the bag has been activated, the approach of the typical reconstructing device is difficult. In these cases, because the bag has an underfilling characteristic and is usually a large-size bag, it is difficult to deliver the medicine to the multi-chamber bag, ensure that the medicine is reconstructed in the multi-chamber bag, and then the reconstructed medicine is delivered to the patient from the multi-chamber bag.

[0049] In contrast, the reconstitution devices, systems and methods disclosed herein are configured so that the vial containing the drug is directly connected to the delivery site. This connection allows the reconstituted drug to travel directly to the delivery site, such as an IV kit, thereby avoiding the requirement to mix the drug in an IV bag. For example, the reconstituted drug can flow directly into an IV dosing kit for direct delivery to the patient during IV treatment. By reconstructing the drug in a smaller volume container (such as the drug vial itself) and delivering it from the smaller volume container, the delivery time can be reduced. It is believed that this structure will reduce the possibility that the drug will degrade before delivery.

[0050] The reconstitution system disclosed herein can implement several flow paths, including flow paths that are in fluid communication with the drug vial and flow paths that are not in fluid communication with the drug vial. This structural configuration can enhance the efficacy of the drug being reconstituted in the vial and subsequently delivered to the patient. In addition, the vial can initially be sealed and placed under vacuum. When initially reconstituted, the vacuum can further enhance the efficacy of the drug being reconstituted in the vial and subsequently delivered to the patient.

[0051] Referring now to the drawings, and in particular to Figure 1 One embodiment of a reconstitution device of the present disclosure is illustrated by reconstitution device 10. Reconstitution device 10 may be constructed of any suitable plastic or rubber material, such as polyvinyl chloride ("PVC"), non-DEHP PVC, a Creighton polypropylene blend, or other similar materials.

[0052] The reconstitution device 10 includes a first piercing member 12 and a receptacle 14. The receptacle 14 includes a cylindrical cuff 16. In alternative embodiments, the cuff 16 may have other cross-sections (e.g., hexagonal, square, triangular, or other suitable geometric shapes). The cylindrical cuff 16 is configured to engage the vial 18 (e.g., by concentric engagement). The vial 18 may be equipped with a stopper 20, which may be a rubber stopper, a plastic stopper and / or include a foil cap, or any other similar structure for sealing the vial 18. The stopper 20 may protect the contents of the vial 18 from environmental factors (e.g., ambient air). In an embodiment, the vial 18 is formed of an ultraviolet ("UV") light blocking material, which may further protect the contents of the vial 18 from environmental factors (such as light).

[0053] In the illustrated embodiment, the stopper side of the vial 18 can be received within the cylindrical cuff 16 of the device 10, so that the cylindrical cuff 16 is disposed around the outside of the stopper side of the vial 18. The vial 18 typically contains an active agent, such as a pharmaceutical agent or a nutritional supplement. The active agent can be in the form of a dry powder (e.g., a powder obtained by lyophilization). Alternatively, the active agent is in the form of an aqueous solution or suspension or other typical liquid form. As discussed herein, the reconstitution device 10 is particularly suitable for connection to an IV line to deliver the reconstituted solution to a patient.

[0054] The receptacle 14 also includes a cap 22. The cap 22 may be integrally formed with or attached to the cuff 16. The cap 22 extends from the cuff 16 and holds a second piercing member 24. A first tip 26 of the second piercing member 24 is disposed within the cuff 16.

[0055] The first piercing member 12 has a first tip 28 and a second end 30. The first piercing member 12 defines a first fluid passage 32 extending from the first end 28 of the first piercing member 12 to the second end 30 of the first piercing member 12. The first end 28 of the first piercing member 12 can be configured to engage with a dosing port of an IV bag such that the second end 30 of the first piercing member 12 is in fluid communication with the IV bag via the first fluid passage 32. In an embodiment, at least one of the first end 28 of the first piercing member 12, the second end 30 of the first piercing member 12, and the first end 26 of the second piercing member 24 can include or form a syringe needle or a plastic tip.

[0056] In an embodiment, the second end 30 of the first piercing member 12 is configured to be placed in fluid communication with an IV line. In an embodiment, the second end 30 of the first piercing member 12 may include a connector (e.g., a male Luer connector or a female Luer connector) to fluid-tightly engage a delivery site, such as a matching Luer connector of an IV line, which is then connected to a patient. In addition to the Luer connection, other types of connections, such as hose barbs or compression fittings, can be used to connect the second end 30 of the first piercing member 12 to a delivery site (e.g., an IV line tube). The second end 30 of the first piercing member 12 also includes a membrane 38 (e.g., a removable membrane or a pierceable membrane). Although the membrane 38 is described with reference to the first piercing member 12, it should be understood that the membrane 38 is shared by both the first fluid channel 32 and the third fluid channel 36 (described in more detail below). Therefore, the membrane 38 can prevent the flow from each of the first piercing member 12 and the second piercing member 24 from leaving the reconstruction device 10 too early to reach the delivery site.

[0057] For example, the membrane 38 is configured to temporarily block the flow of fluid through the second end 30 of the first piercing member 12. In this way, the membrane 38 defines a common mixing chamber 42, whereby the fluid (e.g., saline or glucose) from the first fluid channel 32 is mixed with the fluid (e.g., reconstituted drug) from the third fluid channel 36 before administration to the delivery location (e.g., IV line). Once the drug is reconstituted / mixed and ready for delivery, the membrane 38 can be removed or removed (e.g., pierced) so that the mixing chamber 42 is connected to the IV line. The membrane 38 can further ensure that there is a vacuum in the various fluid channels connected to the vial 18 during reconstitution to advantageously generate a pressurized fluid flow for reconstitution, as described in more detail below. In addition, the membrane 38 can reduce or eliminate leakage from the reconstitution device 10, such as when the IV solution container is attached to or detached from the first end 28, or when the IV line is attached to or detached from the second end 30.

[0058] In the illustrated embodiment, the first end 28 of the first piercing member 12 is configured to pierce a drug administration port (e.g., an IV bag port) such that the first end 28 of the first piercing member 12 is in fluid communication with the drug administration port. The drug administration port may be connected to an IV solution container or may be integrally formed with the IV solution container.

[0059] The reconstitution device 10 can be configured to engage with the administration port of any suitable IV bag. The first piercing member 12 and the second piercing member 24 can be made of metal (e.g., stainless steel), medical grade plastic, or any other suitable material. In an alternative embodiment, the first end 28 of the first piercing member 12 is integrally formed with the administration port of the IV bag. For example, in an embodiment, the IV bag can be permanently fixed to the reconstitution device 10, so that the reconstitution device 10 and the IV bag are manufactured and constructed together.

[0060] In an embodiment, the reconstitution device 10 loads the contents of the vial 18 vertically downward into the second piercing member 24 of the cylindrical cuff 16, whereby each of the vial 18, the first piercing member 12, and the second piercing member 24 are vertically oriented. For example, when the reconstitution device 10 is placed in an operating position, each of the first piercing member 12 and the second piercing member 24 is vertically oriented. In an embodiment, the cylindrical cuff 16 is vertically oriented so that the vial 18 is held vertically in response to concentric engagement with the vial 18. By ensuring that the vial 18 is vertically engaged with the reconstitution device 10 (e.g., in a stopper-side-down configuration), the reconstitution material is easily urged out of the vial 18 by gravity. In addition, the vertical orientation ensures that the liquid reconstitution material can easily leave the vial 18, while the foam reconstitution material can float above the stopper side of the vial and, therefore, above the second piercing member 24.

[0061] Figure 2 yes Figure 1 1 is a cross-sectional view of the reconstructed device 10 , further illustrating the engagement of the device 10 according to an exemplary embodiment of the present disclosure.

[0062] As illustrated, the vial 18 is engaged in the cuff 16 such that the first end 26 of the second piercing member 24 pierces the stopper 20 of the vial 18. In one embodiment, the user pushes the vial 18 down onto the cap 22 to secure the engagement between the vial 18 and the cuff 16. The inner surface of the cuff 16 may include a plurality of ridges 40 configured to engage, for example, by spring-like deformation, to press fit or snap fit onto the stopper side of the vial 18 such that the stopper side of the vial 18 is held inside the plurality of ridges 40 of the cuff 16, as by Figure 2In one embodiment, the first end 26 of the second piercing member 24 pierces the stopper 20 (e.g., a rubber stopper) of the vial 18 and extends into the vial 18. In a related embodiment, the engagement between the cuff 16 and the vial 18 may also include rotating or twisting the vial 18. For example, the cuff 16 may include internal threads and the vial 18 may include external threads such that the threaded engagement between the vial 18 and the cuff 16 is achieved for a secure engagement between the two components.

[0063] Once engaged, the first piercing member 12 is in fluid communication with the vial 18 via the second fluid passage 34 extending from the first end 28 of the first piercing member 12 to the first end 26 of the second piercing member 24. In this manner, the vial 18 can be placed in fluid communication with an IV bag connected to the first end 28 of the first piercing member 12. In an embodiment, the vial 18 is initially sealed and under a vacuum prior to engagement with the cuff 16.

[0064] It should be understood that the above-described piercing with respect to each of the first end 28 of the first piercing member 12 and the first end 26 of the second piercing member 24 ideally occurs almost simultaneously. For example, once the first end 28 of the first piercing member 12 pierces the administration port (e.g., an IV bag port), the first end 28 of the first piercing member 12 is in fluid communication with the administration port; thus, liquid can begin to flow from the administration port into the first end 26 of the second piercing member 24 via the second fluid channel 34. To ensure that liquid does not inadvertently overflow from the first end 26 of the second piercing member 24 (e.g., via the second fluid channel 34), the first end 26 of the second piercing member 24 should pierce the stopper 20 of the vial 18 almost immediately (e.g., almost simultaneously) after the first end 28 of the first piercing member 12 pierces the administration port. In this way, inadvertent overflow is prevented.

[0065] In an alternative embodiment, the reconstitution device 10 includes a valve. For example, the first end 28 of the first piercing member 12 includes the valve, which can be configured to completely seal each of the first fluid channel 32 and the second fluid channel 34. When the valve is closed, and it seals each of the first fluid channel 32 and the second fluid channel 34, the piercing does not necessarily need to be performed almost simultaneously (as previously described). For example, once the first end 28 of the first piercing member 12 pierces the administration port (e.g., IV bag port), the first end 28 of the first piercing member 12 is in fluid communication with the administration port; however, the valve will prevent liquid from flowing from the administration port via the second fluid channel 34 into the first end 26 of the second piercing member 24. The valve will ensure that liquid does not inadvertently overflow from the first end 26 of the second piercing member 24 (e.g., via the second fluid channel 34). Whenever the first end 26 of the second piercing member 24 pierces the stopper 20 of the vial 18, the valve will also ensure that the vacuum in the vial 18 is maintained. Thus, once the valve is opened and it unseals each of the first and second fluid channels 32, 34, fluid can flow into each of the first and second fluid channels 32, 34. In this way, inadvertent spillage is prevented; likewise, inadvertent loss of vacuum in the vial 18 is prevented. It should be understood that the valve can be located at other locations on the reconstitution device 10 and / or there can be multiple valves (e.g., one valve for each of the first, second, and third fluid channels 32, 34, 36).

[0066] Continuing, in an embodiment, a fluid (e.g., fluid in an IV bag) can flow directly from the first end 28 of the first piercing member 12 to the second end 30 of the first piercing member 12 via the first fluid channel 32. The fluid can flow into the mixing chamber 42 via the first fluid channel 32. Initially, the membrane 38 prevents the fluid from flowing into the IV line. Once the membrane 38 is displaced or removed (e.g., pierced), the mixing chamber 42 is in communication with the IV line, and the fluid can flow via the first fluid channel 32 to the IV line in communication with the second end 30 of the first piercing member 12. The fluid (e.g., fluid in an IV bag) can also flow from the first end 28 of the first piercing member 12 to the vial 18 via the second fluid channel 34 by gravity. The fluid (e.g., reconstitution solution in the vial 18) can flow from the vial 18 to the second end 30 of the first piercing member 12 via the third fluid channel 36. Thus, in an example, a fluid (e.g., saline or dextrose from an IV bag) may pass into the first end 28 of the first piercing member 12 and then into the vial 18 via the second fluid passage 34. The saline or dextrose mixes with the dry (e.g., granulated) drug in the vial 18 to form a reconstituted solution.

[0067] More specifically, and as described in more detail below, the fluid can initially flow into the vial 18 from each of the second and third fluid channels 34, 36 as a stream of pressurized fluid (e.g., a jet). The powdered drug typically remains adhered to the bottom of the vial 18 when the vial 18 is vertically engaged with the reconstitution device 10 in a stopper-side-down configuration, which means that the powdered drug is typically above the first end 26 of the second piercing member 24. The stream of pressurized fluid can flow upward into the vial 18, thereby contacting the powdered drug to remove it from the bottom (e.g., top side) of the vial 18 to reconstitute the powdered drug with the pressurized fluid and subsequently deliver it to the patient from the vial 18 (e.g., via the third fluid channel 36). Because the vial 18 is oriented in a stopper-side-down configuration, the reconstituted drug can easily flow into the first end 26 of the second piercing member 24 (e.g., into the third fluid channel 36) by gravity. For example, the reconstitution solution may flow from the vial 18, through the third fluid channel 36, out the second end 30 of the first piercing member 12, and into a delivery site, such as an IV line.

[0068] It should be understood that the structural characteristics of each of the first fluid channel 32, the second fluid channel 34, and the third fluid channel 36 can be dimensioned according to performance to optimize characteristics such as hydraulic resistance. The first fluid channel 32 can be configured as a parallel and independent bypass path directly leading to the infusion port. It is expected that the design of the fluid channel including the first fluid channel 32, the second fluid channel 34, and the third fluid channel 36 can be configured for a specific hydraulic resistance of the fluid system, thereby optimizing the infusion curve in the vial 18. Depending on the medical needs associated with the intended therapeutic application, the size and / or shape of the various fluid channels can be adjusted (i.e., increase or decrease the diameter and / or increase or decrease the length and / or change the cross-sectional shape of the fluid channel) to control and monitor the duration and / or concentration of the infusion. For example, increasing the diameter of the first fluid channel 32 will result in a slower administration from the vial 18 because a lower proportion of the fluid will be delivered to the vial 18 (e.g., via the second fluid channel 34) when compared to the first fluid channel 32. It should be understood that the systems disclosed herein may implement different fluid channels for different fluids, different reconstituted drugs, etc., to optimize the delivery of any particular substance. In addition, any one or more or all of the fluid channels 32, 34, 36 may be equipped with manually operated flow restrictors to tailor the flow rate to a particular treatment.

[0069] Providing multiple fluid channels and thereby splitting or dividing the flow from the first end 28 of the first piercing member 12 to the second end 30 of the first piercing member 12 can be beneficial, for example, to adjust the dosing of a reconstitution solution (e.g., a vitamin or a medicament). In other words, there may be situations where the dose delivered to the patient may be too concentrated. Providing multiple fluid channels at the first end 28, some of which (e.g., the first fluid channel 32) do not interact directly with the vial 18, results in a more modest dose (e.g., via the first fluid channel 32) that is diluted by the non-reconstitution fluid, thereby lengthening or prolonging the administration of the composition.

[0070] Figure 3 According to an exemplary embodiment of the present disclosure Figure 1 1, further illustrating the device engagement. Again, the cuff 16 can be cylindrical in nature so as to concentrically receive the vial 18. An exemplary method of using the reconstitution device 10 includes engaging the first end 28 of the first piercing member 12 with a fluid container (e.g., an IV bag). In an example, if the IV bag is a multi-chamber bag, the IV bag may require additional activation of the multi-chamber component, such as via a roll-up or peel seal opening. In this way, the fluid can flow from the fluid container along the first fluid channel 32 to the mixing chamber 42.

[0071] The method may also include engaging the first end 26 of the second piercing member 24 with the drug vial 18. In this way, the fluid can flow from the fluid container to the drug vial 18 along the second fluid channel 34. Likewise, the fluid can flow along the first fluid channel 32 to the mixing chamber 42, and then from the mixing chamber 42 to the vial 18 along the third fluid channel 36. During this initial mixing, the fluid can be prevented from leaving the device 10 (e.g., entering an IV line) by the membrane 38. The method may also include mixing the fluid with a reagent (e.g., a dry drug or a nutritional solution) located within the drug vial 18 to form a mixed or reconstituted drug or nutritional solution.

[0072] Finally, the method may include engaging the second end 30 of the first piercing member 12 with the IV line. This may include, for example, removing the membrane 38. In this way, IV fluid may flow from the fluid container to the IV line along the first fluid pathway 32. Likewise, a mixed or reconstituted medication or nutrient solution may flow from the medication vial 18 to the IV line along the third fluid pathway 36.

[0073] In an embodiment, initially, the first end 28 of the first piercing member 12 pierces the fluid container. In this embodiment, the vial 18 is initially sealed and under vacuum (e.g., a low pressure such as 100 millibars, which is less than the ambient air pressure). When the vial 18 is sealed under vacuum and then engaged by the first end 26 of the second piercing member 24, the fluid from the fluid container will initially be rapidly sucked into the vial 18 by the negative pressure imbalance. This initial suction of the fluid can generate a pressurized fluid stream (e.g., a jet stream) from the first end 26 of the second piercing member 24 into the vial 18. In a particular embodiment, the pressurized fluid stream facilitates mixing and reconstitution of the dry drug in the vial 18. The membrane 38 on the second end 30 of the first piercing member 12 further ensures that the reconstitution device 10 is airtight so that the pressurized fluid stream will not be inadvertently dispensed from the second end 30 of the first piercing member 12. The membrane 38 can also facilitate the initial filling of the vial 18.

[0074] In an embodiment, the pressurized fluid flow (e.g., a jet flow) within the vial 18 is generated by each of the second fluid channel 34 (described above) and the third fluid channel 36. For example, the first piercing member 12 initially engages the fluid container. Therefore, when the first end 26 of the second piercing member 24 engages the vial 18, due to the lower pressure in the vial 18, the pressurized fluid flow can be pulled from each of the second fluid channel 34 (e.g., from the fluid container to the vial 18) and the third fluid channel 36 (e.g., from the fluid container to the mixing chamber 42 of the first piercing member 12, and then from the mixing chamber 42 of the first piercing member 12 to the vial 18). In this way, reconstitution can be performed via two pressurized fluid streams 34 and 36, thereby dissolving, filling and mixing the contents of the vial 18 in just a few seconds. The vacuum in the vial 18 can be adjusted to obtain the best spray effect. If the vial 18 is instead kept at atmospheric pressure, the vacuum also helps to reduce or eliminate the problem of removing air.

[0075] In embodiments, an alternative auto-priming process may be performed on the reconstitution device 10. For example, connection of the IV line to the second end 30 of the first piercing member 12 may be performed prior to engagement of the first end 26 of the second piercing member 24 with the medication vial 18. This results in an auto-priming effect in which fluid is recovered from the IV line (which may have originally come from an IV bag) via a vacuum into the vial 18 so as to thereby fill both the vial 18 and a drip chamber associated with the IV line. In certain embodiments, auto-priming may require removal of the membrane 38 prior to engagement of the vial 18. The auto-priming process may advantageously eliminate any squeezing of the IV line drip chamber required to fill it, which is a typical step currently performed by medical professionals prior to IV medication administration.

[0076] In an alternative embodiment, the reconstitution device 10 can be implemented with an IV bag that is initially empty. For example, the reconstitution device 10 with the vial 18 is connected to an empty IV bag (e.g., via a dosing port). The empty IV bag can then be subsequently filled with any desired solution, such as saline or glucose, through a dedicated port. This may be advantageous for applications where it is costly or difficult to provide solutions in advance. In this alternative embodiment, a solution for the IV bag can be prepared and the IV bag can be filled during dosing. When the solution is added to the empty IV bag (which has been connected to the reconstitution device 10), reconstitution will occur as described above.

[0077] Figure 4 Another front cross-sectional view of an alternative embodiment of the reconstruction device 100 of the present disclosure is shown. Figure 4 The reconstitution device 100 shown in the figure integrates a fluid container 110 with a pointed structure, and the fluid container 110 can be a rigid fluid container or a flexible fluid container. In one embodiment, the fluid container 110 is an IV bag. For example, the fluid container 110 can be configured to be pre-filled with saline or glucose solution. The rigid portion of the reconstitution device 100 can be made of any of the materials listed above for the reconstitution device 10. If the fluid container 110 is flexible, it can be made of any suitable material known to those skilled in the art.

[0078] The reconstitution device 100 includes a first piercing member 12 and a receptacle 14. The receptacle 14 includes a cylindrical (or other shaped) cuff 16. The cylindrical cuff 16 is configured to engage a vial 18 (e.g., by concentric engagement). In the illustrated embodiment, the stopper side of the vial 18 can be received in the cylindrical cuff 16 so that the cylindrical cuff 16 is disposed around the outside of the stopper side of the vial 18. Again, the vial 18 can contain an active agent, such as a pharmaceutical agent or a nutritional supplement. The active agent can be a dry powder, such as a powder obtained by lyophilization. It should be understood that in alternative embodiments, the drug or active agent can be a liquid. In other words, the reconstitution device 10, 100 can be suitable for delivering both solids and liquids from the vial 18 to the patient.

[0079] The receiver 14 also includes a cap 22. The cap 22 may be integrally formed with or attached to the cuff 16. The cap 22 extends from the cuff 16 and holds a second piercing member 24. The first end 26 of the second piercing member 24 is disposed within the cuff 16. In an embodiment, at least one of the first end 28 of the first piercing member 12, the second end 30 of the first piercing member 12, and the first end 26 of the second piercing member 24 may include or form a syringe needle or a plastic tip.

[0080] The first end 28 (not shown) of the first piercing member 12 is configured to engage the fluid container 110. In an embodiment, the first end 28 of the first piercing member 12 is integrally formed with the fluid container 110. The second end 30 of the first piercing member 12 is configured to engage an IV line. The first piercing member 12 includes the first fluid channel 32 extending from the first end 28 of the first piercing member 12 to the second end 30 of the first piercing member 12, so that the fluid container 110 is in fluid communication with the IV line. The second end 30 of the first piercing member 12 also includes the membrane (e.g., a removable membrane or a pierceable membrane).

[0081] In an embodiment, the vial 18 engages the cuff 16 so that the first end 26 of the second piercing member 24 extends into the vial 18. Here, the first piercing member 12 is in fluid communication with the vial 18 via a second fluid passage 34 extending from the first end 28 of the first piercing member 12 to the first end 26 of the second piercing member 24. Thus, the vial 18 can be placed in fluid communication with the fluid container 110. In an embodiment, the fluid container 110 holds a fluid, such as saline or glucose, that travels from the fluid container 110 to the vial 18. Again, the vial 18 can be initially sealed and placed under vacuum prior to engagement with the cuff 16. In an embodiment, the vial 18 contains one of a pharmaceutical agent or a nutritional supplement.

[0082] In an embodiment, the second piercing member 24 is in fluid communication with the IV line via a third fluid channel 36 extending from the first end 26 of the second piercing member 24 to the second end 30 of the first piercing member 12. Thus, the fluid from the fluid container 110 can travel into the first end 28 of the first piercing member 12 and then into the vial 18. A membrane 38 (not shown) can be used to help backfill the vial 18 with IV fluid from the container 110. The fluid is mixed with the dry (e.g., granular) drug in the vial 18 to form a reconstitution solution. In addition, for example, the membrane 38 can define a common mixing chamber, whereby the fluid from the first fluid channel 32 (e.g., the fluid from the fluid container 110) is mixed with the fluid from the third fluid channel 36 (e.g., the reconstituted drug) before administration to the delivery location (e.g., IV line). Once the drug is reconstituted / mixed and ready for delivery, the membrane 38 can be removed or removed (e.g., pierced) so that the mixing chamber 42 is in communication with the IV line. Once the membrane 38 is removed or eliminated, the reconstitution solution may then flow from the vial 18, through the third fluid channel 36, out the second end 30 of the first piercing member 12, and into the IV line.

[0083] Figure 5One embodiment of a system 200 employing the reconstitution device 10 or the reconstitution device 100 is shown, which is configured to engage with a drug vial 18 as described above. The system 200 includes an IV bag 202 suspended from a rack 204. The IV bag 202 may include a fluid, such as saline, dextrose, or other similar fluid, for delivery to a patient 206. As illustrated, the IV bag 202 is positioned on the rack 204 to ensure that the IV bag 202 is vertically above the patient 206. This ensures that the fluid in the IV bag 202 flows by gravity to the patient 206.

[0084] System 200 includes reconstitution device 10 (or 100). Reconstitution device 10 is connected to IV bag 202 as previously described (e.g., via first end 28 of first piercing member 12), and is connected to vial 18 as previously described (e.g., via first end 24 of second piercing member 26). For device 100, IV bag 202 is integrally formed with reconstitution device 100. System 200 also includes second end 30 of first piercing member. Delivery tube 208, such as IV tubing, is engaged with second end 30 of first piercing member by any of the teachings listed above. Delivery tube 208 is also connected to patient 206 at IV location 210. For example, delivery tube 208 extends to an intravenous needle inserted into patient 206 at IV location 210.

[0085] The delivery tube 208 is configured to deliver fluid in the IV bag 202 from the reconstitution device 10 to the patient 206 at the IV site 210. Although fluid delivery can be facilitated by gravity, as described above with respect to the IV bag 202 positioned on the support 204, additional or alternative modes of fluid delivery can be implemented. For example, the system 200 can also include an infusion pump 212, which can be, for example, a Sigma 5000 pump provided by the assignee of the present disclosure. TM Large Volume Pump ("LVP"). An infusion pump 212 can control the delivery of fluid along the delivery tube 208 (eg, from the reconstitution device 10 to the patient 206 at the IV site 210). In this case, the bag 202 can be located vertically below the patient 206.

[0086] refer to Figure 1 and Figure 5, the fluid in the IV bag 202 can travel to the first end 28 of the first piercing member 12 via the second fluid channel 34, and then travel into the vial 18. The fluid mixes with the dry drug in the vial 18 to form a reconstitution solution. The reconstitution solution can then flow from the vial 18 to the second end 30 of the first piercing member 12 via the third fluid channel 36. At the same time, the fluid in the IV bag 202 can flow directly from the IV bag 202 to the second end 30 of the first piercing member 12 via the first fluid channel 32. Therefore, both the IV fluid and the reconstitution solution from the IV bag 202 can be delivered from the second end 30 of the first piercing member 12 to the delivery tube 208. The IV fluid from the IV bag 202 and the reconstitution drug solution can then flow together to the IV location 210 and then be administered to the patient 206. In various embodiments, the flow to the IV location 210 is delivered via gravity and / or via an infusion pump 212.

[0087] In certain embodiments, the above-described fluid delivery process may include additional steps. For example, the reconstitution device 10 or 100 may engage the drug vial 18 at the cylindrical cuff 16; however, prior to this engagement, the delivery tube 208 may be clamped (e.g., via a typical medical wire clamp). The medical professional may do this to first ensure that any online air (e.g., air in the delivery tube 208 or in the reconstitution device 10) is removed from the system 200. More specifically, once the reconstitution device 10 or 100 is secured to both the IV bag 202 and the delivery tube 208, any online air flows upward into the IV bag 202. Upward air flow may be facilitated by positioning the IV bag 202 on the support 204 so that it is located vertically above the reconstitution device 10 or 100 and the patient 206. The medical professional may further ensure that no online air remains through additional techniques (e.g., tapping the reconstitution device 10 or 100 and / or the tube 208). Once all in-line air has been purged into the bag 202, the delivery tube 208 is released and the fluid transfer process described can begin.

[0088] The main problem with parenteral nutrition is that the solution administered peripherally to the patient (e.g., via a peripheral vein) must be kept within certain osmotic pressure limits. If the osmotic pressure is too high, the patient may experience pain or, in some cases, other adverse medical problems, such as venous thrombosis. Therefore, the osmotic pressure of the administered solution should be controlled and within a safe range. For example, a range of 850 milliosmoles (mOsm) / liter to 900 milliosmoles / liter is a typical range of osmotic pressure limits.

[0089] Osmolality studies have been performed to quantify and monitor the infusion administration of nutritional compounds that will be administered using the Baxter PeriOlimel TMN4E multi-chamber bag (1000 ml volume) and the reconstitution device 10 disclosed herein for administration. The nutritional compound in lyophilized or sterile powder form may contain the following vitamins:

[0090] Retinyl palmitate (vitamin A) corresponding to retinol 3500IU <![CDATA[Cholecalciferol (vitamin D3)]]> 200IU DL-α-Tocopherol 10.2 mg Corresponds to α-tocopherol (vitamin E) 11.2IU Ascorbic acid (vitamin C) 125 mg <![CDATA[Nicotinamide (Vitamin B3)]]> 46 mg Dexpanthenol 16.15 mg <![CDATA[Corresponding to pantothenic acid (vitamin B5)]]> 17.25 mg Pyridoxine Hydrochloride 5.5 mg <![CDATA[Corresponding to pyridoxine (vitamin B6)]]> 4.53 mg Riboflavin Sodium Phosphate 5.67 mg <![CDATA[Corresponding to riboflavin (vitamin B2)]]> 4.14 mg Carboxylase tetrahydrate 5.8 mg <![CDATA[Corresponding to thiamine (vitamin B1)]]> 3.51 mg Folic acid 414 micrograms D-Biotin 60 micrograms <![CDATA[Cyanocobalamin (vitamin B 12 )]]> 5.5 micrograms Other ingredients Glycine 250 mg Glycolic acid 140 mg Soy lecithin 112.5 mg

[0091] The reconstruction device 10 implemented in this study employed each of the first fluid channel 32, the second fluid channel 34, and the third fluid channel 36 as described above. The diameter of the first fluid channel 32 was approximately 2.0 mm and the length was approximately 51 mm. The diameter of each of the second fluid channel 34 and the third fluid channel 36 was approximately 1.1 mm and the length was approximately 71 mm. It should be understood that other dimensions (e.g., the diameter and length of each of the first fluid channel 32, the second fluid channel 34, and the third fluid channel 36) may be considered. Each of the first fluid channel 32, the second fluid channel 34, and the third fluid channel 36 has a circular cross-section.

[0092] The following scenarios were implemented:

[0093] Take 1 ml of PeriOlimel TM Aliquots of N4E were used as reference

[0094] · Start to discharge the PeriOlimel attached to the reconstruction device 10 TM N4E+ Nutrient Compounds

[0095] Collect 1 ml aliquots every 10 minutes

[0096] Stop dispensing after 16 aliquots

[0097] Open the nutrient compound vials and measure the volumes of the solutions and sample aliquots

[0098] • Measure the osmolarity of all 18 aliquots (16 + reference + vial) using an osmometer and convert it to osmolarity (mIOsm / L).

[0099] Figure 6 is a graph of the osmotic pressure profile as a function of time for the above test using the reconstitution device 10 of the present disclosure. This graph provides an illustration of an example performance of the device 10 and is not intended to limit the foregoing disclosure in any respect. Graph 600 shows two separate tests under the same experimental circumstances: drain N1 and drain N2.

[0100] More specifically, refer to Figure 6, graph 600 shows that at the start of dosing, the osmotic pressure is at a maximum level of 800 mOsm / L, which is still below typical indicators for peripheral use. As the infusion time increases, the osmotic pressure slowly decreases. Providing multiple fluid channels, some of which do not directly interact with the vial 18 (e.g., the first fluid channel 32), enables the reconstitution device 10 to achieve a desired osmotic pressure by providing an intermediate dose that is diluted with no reconstitution fluid (e.g., via the first fluid channel 32), thereby prolonging or extending the administration of the composition. Utilizing Figure 6 The osmotic pressure was measured and the percentage of vitamin infused was determined for each time point and Figure 7 Draw it out in .

[0101] Figure 7 is a graph of infusion as a function of time for the above tests using the reconstitution device 10 of the present disclosure. This graph provides an illustration of example performance of the device 10 and is not intended to limit the foregoing disclosure in any respect. Graph 700 shows two separate tests under the same experimental circumstances: Drain N1 and Drain N2.

[0102] More specifically, refer to Figure 7 , graph 700 shows that the infusion curve of the reconstitution device 10 is very smooth. After 2.5 hours, approximately 60-70% of the vitamins have been infused, while approximately 30-40% remain. This smooth delivery curve confirms that delivery is proceeding moderately, thereby avoiding rapid dosing. When the full IV bag holding approximately 650 ml is completely drained, approximately 98% of the vitamins have been infused. In an embodiment, the drug vial used for infusion is formed of a material that blocks ultraviolet light to limit degradation of any reconstitution material, ensuring that the reconstitution material is protected until infusion (e.g., via an IV tube).

[0103] The above-described reconstitution devices, systems, and methods can be used, for example, during parenteral nutrition therapy. Here, reconstitution can be used to improve the administration of a multivitamin product that would otherwise be added to a total parenteral nutrition ("TPN") bag through a medication port. Examples of known parenteral nutrition products that can be used with the present devices, systems, and methods include Olimel, Olclinomel, Clinomel, Clinimix, Numeta, ClinOleic, SmofKabiven, Kabiven, PeriKabiven, StructoKabiven, Aminomix, Nutriflex, Nutriflex Lipid, Pediaven, and the like. In various examples, the reconstitution device 10 or 100 can be permanently connected to a TPN bag, or can be added to a TPN bag prior to use. Likewise, multi-chamber bags or single-chamber bags can be used with the present devices, systems, and methods.

[0104] As used in this specification (including claims), the term "and / or" is an inclusive or exclusive conjunction. Therefore, the term "and / or" indicates that there are two or more things in a group, or that a selection can be made from a group of alternatives.

[0105] Without further elaboration, it is believed that one skilled in the art can, using the foregoing description, utilize the claimed invention to its fullest extent. The examples and embodiments disclosed herein should be construed as merely illustrative and not limiting the scope of the present disclosure in any way. It will be apparent to one skilled in the art that changes may be made to the details of the above-described embodiments without departing from the basic principles discussed. In other words, various modifications and improvements of the embodiments specifically disclosed in the above description are within the scope of the appended claims. For example, any suitable combination of the features of the various embodiments described is contemplated. Note that elements described in a "means plus function" format should be construed in accordance with 35 USC § 112. 6. Therefore, the scope of the present invention is defined by the appended claims.

Claims

1. A reconstruction device, comprising: a first piercing member having a first end and a second end, wherein the first end of the first piercing member is configured to engage a drug delivery port, wherein the second end of the first piercing member comprises a removable or pierceable membrane, and wherein the first piercing member comprises a first fluid passageway extending from the first end of the first piercing member to the second end of the first piercing member; a second piercing member configured to extend into the vial, the second piercing member defining an additional fluid passage extending from the first end of the second piercing member to the second end of the first piercing member; and A receiver, the receiver comprising: a cuff configured to engage the vial, and a cap extending from the cuff and retaining the second piercing member, wherein the first end of the second piercing member is disposed within the cuff, Wherein the removable or pierceable membrane defines a mixing chamber whereby fluid from the first fluid channel mixes with fluid from the additional fluid channel.

2. The reconstitution device of claim 1, wherein the cap is integrally formed with the cuff.

3. The reconstitution device of claim 1, wherein the cuff is cylindrical and configured to concentrically engage the vial.

4. The reconstitution device of claim 1 , wherein the cuff engages the vial such that the first end of the second piercing member extends into the vial and such that the first piercing member is in fluid communication with the vial via another additional fluid channel extending from the first end of the first piercing member to the first end of the second piercing member.

5. The reconstitution device of claim 1 , wherein the administration port is an IV bag port, and wherein the first end of the first piercing member is configured to pierce the IV bag port to place the first piercing member in fluid communication with the IV bag port.

6. The reconstitution device of claim 1, further comprising an IV line, wherein the second end of the first piercing member is configured to connect to the IV line.

7. The reconstitution device of claim 6, wherein the first piercing member is in fluid communication with the IV line via the first fluid channel, and wherein the second piercing member is in fluid communication with the IV line via the additional fluid channel.

8. The reconstruction device according to claim 1, wherein: When placed in the operating position, each of the first and second piercing members is vertically oriented.

9. The reconstitution device of claim 1, wherein the first end of the first piercing member is integrally formed with the administration port.

10. The reconstitution device of claim 9, wherein the administration port is connected to an IV solution container.

11. The reconstitution device of claim 1 , wherein at least one of the first end of the first piercing member, the second end of the first piercing member, and the first end of the second piercing member comprises or defines a syringe needle or a plastic tip.

12. The reconstitution device of claim 1, wherein the vial is initially sealed and under vacuum.

13. A reconstruction system comprising: Vials of medication; fluid container; and A reconstruction device, the reconstruction device comprising: a first piercing member having a first end and a second end, the first end of the first piercing member being configured to engage the fluid container and the second end of the first piercing member being configured to engage an IV line, wherein the second end of the first piercing member comprises a removable or pierceable membrane, and wherein the first piercing member comprises a first fluid passageway extending from the first end of the first piercing member to the second end of the first piercing member such that fluid in the fluid container can communicate with the IV line; a second piercing member configured to extend into the drug vial, the second piercing member defining an additional fluid passage extending from the first end of the second piercing member to the second end of the first piercing member; and A receiver, the receiver comprising: a cuff configured to engage the drug vial, and a cap extending from the cuff and retaining the second piercing member, wherein the first end of the second piercing member is disposed within the cuff, Wherein the removable or pierceable membrane defines a mixing chamber whereby fluid from the first fluid channel mixes with fluid from the additional fluid channel.

14. The reconstitution system of claim 13, wherein the cuff engages the drug vial such that the first end of the second piercing member extends into the drug vial and such that the first piercing member is in fluid communication with the drug vial via another additional fluid channel extending from the first end of the first piercing member to the first end of the second piercing member.

15. The reconstitution system of claim 14, wherein said second piercing member is in fluid communication with said IV line via said additional fluid channel.

16. The reconstitution system of claim 13, wherein the drug vial contains one of a pharmaceutical agent or a nutritional supplement.

17. The reconstitution system of claim 13, wherein the drug vial is initially sealed and under vacuum.

18. The reconstitution system of claim 13, further comprising an infusion pump in operable communication with the IV line.

19. The reconstitution system of claim 13, wherein said drug vial is formed of an ultraviolet ("UV") light blocking material.

20. A reconstruction device, comprising: a first piercing member having a first end and a second end, wherein the second end of the first piercing member comprises a removable or pierceable membrane, and wherein the first end of the first piercing member is configured to engage with a fluid container, and wherein the second end of the first piercing member is configured to engage with an IV line so that IV fluid can flow along a first fluid pathway extending from the fluid container to the IV line; and a second piercing member having a first end, wherein the first end of the second piercing member is configured to engage a medication vial to enable IV fluid to flow along a second fluid pathway extending from the fluid container to the medication vial, wherein the IV fluid is mixed with a reagent located within the medication vial to form a mixed medication such that the mixed medication is able to flow along a third fluid channel extending from the medication vial to the IV line such that the IV fluid in the first fluid channel and the mixed medication from the third fluid channel are able to simultaneously flow from the second end of the first piercing member to the IV line.

Images